Halifax, Nova Scotia-based Sona Nanotech’s (CSE:SONA,OTCQB:SNANF) patented nanoparticle manufacturing processes have allowed it to develop an innovative cancer therapy that can shrink tumors from the inside out, and in so doing, enables standard immunotherapy drugs to work significantly better and potentially on patients for whom no other treatment has worked. Sona’s gold nanorod manufacturing technology uniquely does not rely on the use of toxins, making them an ideal agent to be intratumorally injected in humans which can be used to generate therapeutic heat in the tumor.
Sona’s therapy will be applied to the late-stage melanoma tumors that cannot safely be resected and for which no other therapy has worked. Once Sona’s gold nanorods are injected into a tumor, Sona’s laser directs non-thermal, near infrared light energy that is tuned to the same wavelength as the gold nanorods. The gold nanorods react by vibrating, turning the light energy into heat, killing the cancer cells selectively and causing apoptosis in their cells, resulting in the release of new antigens into the system. These new antigens prime the innate immune system permitting immune-oncology drugs to be more effective at eliminating the treated tumor and can serve as a tumor specific vaccine for the body, attacking distant tumors that were not treated, acting much like a vaccine does.
Sona’s board includes the key builder of vaccine maker Sanofi-Pasteur, a Khosla Ventures biotech PhD CEO and a long-time president of Medtronic Canada. Its management team includes an experienced capital markets CEO, CSO with a PhD, and a CMO who is a highly experienced surgical oncologist and researcher.
Sona Nanotech is advancing nanotechnology-based healthcare through its proprietary, biocompatible gold nanorod manufacturing technology that has the potential to change the face of cancer therapy.
Modern nanotechnology has some very real — and very promising — applications in medicine. It can help make novel diagnostic instruments and imaging significantly more effective. It can help physicians deliver treatments and medications with greater precision and improved safety. And, when combined with other technologies such as predictive analytics and artificial intelligence, nanotechnology can offer a better prognosis, diagnosis, and treatment for a multitude of complex conditions. Sona Nanotech believes it can also be used to beat cancer.
Most of these use cases are made possible through a material known as a nanoparticle, a near-atomic-scale piece of matter that can be manipulated in a variety of different ways.
Sona Nanotech has, for the past several years, been diligently developing and operationalizing its biocompatible nanoparticle technology for use in targeted cancer therapy.
Biocompatibility is key to the application of nanotechnology in medicine due to concerns of toxicity for anything to be administered in vivo. Because of the promise of nanomedical devices and materials, both medical and regulatory agencies are embracing the technology and have already developed frameworks to assess their impact on the human body.
Sona Nanotech's technology platform leverages its patented and uniquely biocompatible gold nanorods (GNRs). Measuring between 10 and 100 nanometres in length, these rod-shaped nanoparticles are manufactured by chemical synthesis and can be conjugated to a multitude of different molecules. They can also be conjugated to a multitude of different molecules and agents, giving them a range of potential applications, including for targeted drug delivery, diagnostic imagery, immunoassay and biosensing.
Unlike traditional GNRs produced with cetrimonium bromide, Sona's patented GNRs are synthesized without toxin, enhancing their biocompatibility profile and making them ideal for advanced nanomedical applications, in vivo. Biocompatibility is key to the application of nanotechnology in medicine due to concerns of toxicity for anything to be administered in vivo. Because of the promise of nanomedical devices and materials, both medical and regulatory agencies are embracing the technology and have already developed frameworks to assess their impact on the human body.
Sona’s GNR biocompatible GNR manufacturing technology is patented and Sona has submitted a provisional patent application with the United States Patent and Trademark Office, for its proprietary photothermal light device. A prototype of Sona's medical laser was engineered to apply non-thermal, 860-nanometer wavelength high-intensity infrared laser light. The device has been designed for use with Sona's GNRs that efficiently convert its non-thermal light energy, which can pass harmlessly through up to 1.5 cm of healthy cells, into heat.
Current cancer treatments are risky, expensive and potentially harmful. Chemotherapy and radiotherapy, for instance, are completely non-selective in cell destruction. Advanced therapies are frequently beyond the price point of most patients, while manual surgery is risky, particularly for the infirm. Sona's Targeted Hyperthermia Therapy (THT) represents a potential solution to all three of these problems.
THT’s ‘hyperthermia’ approach heats tumors to 41-48°C – enough to kill cancer cells, but not enough to harm healthy cells. THT promotes apoptosis, a type of cell death in which a series of molecular steps in a cell lead to its death.
There are no current cancer treatments shown to consistently work in reversing late-stage melanoma that cannot be safely resected. The preferred treatment of the National Comprehensive Cancer Network guidelines (v. 2.2023) calls for systemic therapy which raises concerns about toxicity given the volume of drugs needed to permeate the entire body, when it is only desired to be in the tumor. Sona’s THT therapy will be a localized, intratumorally administered adjuvant to immunotherapy, thereby mitigating systemic toxicity concerns and leveraging and empowering immuno-oncological drugs.
Sona recently received positive interim results from its triple negative breast cancer mouse model study with the Giacomantonio Immuno-Oncology Research Group at Dalhousie University, indicating that tumors treated with a single THT treatment shrunk within the first 24 hours, with an average reduction in size of 80 percent compared to matched controls. The results also showed that THT created a synergistic effect when combined with a current leading cancer immunotherapy agent, with the combination working much more effectively than either THT or the drug alone. The combination of the two also activated a systemic immune response that caused distant, untreated tumors to also shrink. This response is indicative of an ‘abscopal effect’ in which a local treatment stimulates a broad response, and it could lead to the development of personalized cancer vaccines.
The preclinical results suggest that Sona’s THT therapy can be a complete game changer in the fight against cancer.
The findings also provide early evidence for increased local and distant immune reactivity following tumor GNP activation and Interleukin-2 (IL-2). Within 12 hours of receiving IL-2 plus a single administration of intratumorally-activated GNRs, there was a significant, 80 percent reduction in tumor volume, though with some regrowth overtime, which will be explored in scheduled longevity studies. There was a transient decrease in tumor volume with activated GNRs alone. The results also showed that THT created a synergistic effect when combined with IL-2, with the combination working much more effectively than either THT or the drug alone. (see green line in Figure 1 below)
Figure 1
Figure 2
An immune response was also demonstrated in lymph nodes using a dual flank model (See
figure 2), with the left flank being the treated flank and the right, the observed flank. IL-2 plus THT showed immune stimulation in the lymph node on the treated side (LLN) with
significant increases in CD8+ T-cells and natural-killer (NK) cells compared with the right flank. This evidence shows the activation of a systemic immune response that caused distant, untreated tumors to also shrink. This response is indicative of an ‘abscopal effect’ in which a local treatment stimulates a broad response, and it could lead to the development of personalized cancer vaccines.
Sona is well-positioned to address the challenges of fully developing its THT therapy. Its GNR materials have already undergone a multi-stage independent assessment by the US National Cancer Institute’s Nanotechnology Characterization Laboratory. The results, thus far, have been excellent, with highly uniform particle size and no microbial contamination or endotoxins detected in Sona’s GNRs, making them potentially ideal for in vivo applications.
A detailed biomarker analysis of the recently reported pre-clinical melanoma study conducted at Dalhousie University indicates that, beyond shrinking tumors on its own, Sona's Targeted Hyperthermia Therapy (THT) also stimulates the innate immune system to target and eliminate untreated (contralateral) tumors when combined with a standard immunotherapeutic drug, IL-2. Based on efficacy, data achieved in two different murine cancer models (triple negative breast cancer and malignant melanoma), the company is now proceeding with safety and biocompatibility testing that will be required by regulating agencies to enter into human studies.
Sona has submitted a provisional patent application with the United States Patent and Trademark Office, for its proprietary photothermal light device. A prototype of Sona's medical laser was engineered to apply non-thermal, 860-nanometer wavelength high-intensity infrared laser light. The device has been designed for use with Sona's patented biocompatible gold nanorods which efficiently convert the non-thermal light energy into heat.
It's not just Sona's proprietary technology that makes it so promising, either. The company's management team and advisory group includes experts from across the scientific and healthcare industries. One of the most notable is scientific advisor, and the principal investigator for Sona’s current THT efficacy study, Dr. Carman Giacomantonio, a surgical oncologist and researcher at Dalhousie University, who recently signed on to be Sona’s chief medical officer.
Finally, its board of directors also includes Mark Lievonen, co-chair of Canada's COVID-19 Vaccine Taskforce and former CEO of vaccine maker Sanofi-Pasteur; Walter Strapps, CSO of Khosla Ventures’ Liberate Bio; and Neil Fraser, who was a longtime president of Medtronic Canada and a current member of Health Canada's Advisory Panel on Health Innovation.
As the chief executive officer of Sona Nanotech, David Regan has led Sona since 2020 through four financings, the acquisition of Siva Therapeutics, the development of its cancer therapy, and is responsible for business and commercial operations oversight. A strategy consultant and corporate director, Regan has over 20 years of public company experience in strategy, IR and corporate development. He holds an MBA from INSEAD and a BBA with Honours from St. Francis Xavier University.
Dr. Carman Giacomantonio is a practicing surgical oncologist, professor of surgery and principal of The Giacomantonio Immuno-Oncology Research Group. Giacomantonio’s research focuses on the impact of surgical procedures, specifically biopsies on the tumor microenvironment and subsequent development of cancer metastases, and ways to mitigate this risk through targeted therapies. His lab is also studying the mechanism of action of interleukin-2 therapy in the treatment of melanoma and other cancers.
Formerly a professor of bioengineering and laboratory medicine at the University of Washington, Dr. Len Pagliaro is the chief science officer of Sona Nanotech, with over two decades of experience with biotechnology products, services and licensing. During his four years at Biolmage, he worked on a commercialization strategy that took the company from concept to a $26-million P&L in just four years.
Darren Rowles has 17 years' experience with nanoparticle diagnostics with a company that grew nanoparticle sales from $200,000 to $5.5 million with a ~$ 4 million profit. In addition to his role at Sona, he is an advisory board member to Gold Conference and multiple university collaboration projects. Rowles has an MBA from Bath University and a B.Sc. in biomedical science and toxicology from Cardiff Metropolitan University.
A named author on 35 research papers and two patents, Dr. Kulbir Singh is responsible for GNR development. He holds a PhD. in chemistry from Guru Nanak Dev University. Singh is also co-founder of a science-based consumer products company.
A registered CPA, Robert Randall has extensive public company experience as a CFO with organizations including Torrent Capital (CVE:TORR), Antler Gold (CVE:ANTL) and ExeBlock Technology (CSE:XBLK). He holds a bachelor's degree in commerce from St. Mary's University with a chartered accountant designation with Coopers and Lybrand Chartered Accountants dating back to 1987.
Formerly the president of Sanofi Pasteur, Mark Lievonen serves as co-chair of the Government of Canada's COVID-19 Vaccine Task Force. He is also a director of OncoQuest Pharmaceuticals (KRX:078590), Biome Grow (CNSX:BIO) and the Gairdner Foundation. Lievonen holds both an MBA and an FCPA.
Walter Strapps is the CSO of Liberate Bio, a biotechnology company using machine learning, advanced chemistry and molecular biology techniques to identify novel delivery vehicles for oligonucleotides. He has also served as CEO of Carver Biosciences, chief scientific officer at Gemini Therapeutics (NASDAQ:GMTX) and head of discovery at Intellia Therapeutics (NASDAQ:NTLA), in addition to working with RNA Therapeutics. Strapps holds an MA, M. Phil. and PhD.
A member of the Canadian Chamber of Commerce's Life Sciences Strategy Council, Neil Fraser is also the former president of Medtronic Canada. He is part of Health Canada's advisory panel on health innovation, which is chaired by Dr. David Naylor. Fraser is also a director at CloudMD (CVE:DOC).
James Megann has 25 years of experience in venture capital, capital markets and marketing. As managing director of Numus Financial, he has overseen over $1.5 billion in transactions. He also serves on the board of Torrent Capital (CVE:TORR).
Dr. Carman Giacomantonio is a practicing surgical oncologist at the QEII Health Sciences Centre and a professor of surgery at Dalhousie University. Dr. Giacomantonio leads a productive translational research group at Dalhousie University and has successfully initiated two clinical trials in cancer immunotherapy. He is widely published in the field of cancer immunobiology and immunotherapy research, and a recognized innovator in the field of intra-tumoral cancer immunotherapy. Dr. Giacomantonio currently serves on Sona's advisory board and is the principal investigator for Sona's pre-clinical studies using Sona's gold nanorods in its Targeted Hyperthermia Therapy (THT) for triple negative breast cancer, melanoma, and colorectal cancer.
Longeveron Inc. (NASDAQ: LGVN), a clinical stage biotechnology company developing regenerative medicines, today announced that it will participate in the Emerging Growth Virtual Conference taking place June 12-13, 2024.
Details for the Company's presentation:
| Date: | Wednesday, June 12, 2024 | |
| Time: | 1:45 p.m. ET |
The webcast for this conference presentation may be accessed at the " Events and Presentations " section of the Company's website. A replay of the webcast will be available on the Longeveron website for 180 days following the conference.
Questions may be submitted in advance to Questions@EmergingGrowth.com or asked during the event.
About Longeveron Inc.
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is Lomecel-Bâ„¢, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-Bâ„¢ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and Aging-related Frailty. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn , X , and Instagram .
Investor Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
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Veru Inc. (NASDAQ: VERU), a late clinical stage biopharmaceutical company focused on developing innovative medicines for preserving muscle for high quality weight loss, oncology, and viral induced acute respiratory distress syndrome, today announced that the Company will present two presentations at the American Diabetes Association's 84 th Scientific Sessions, taking place June 21-24, 2024, in Orlando, Florida.
The presentations are:
Pooled Safety Analysis of Enobosarm from Phase 2 and Phase 3 Placebo-Controlled Clinical Trials
Date: Saturday, June 22, 2024
Start and end time: 12:30 PM-01:30 PM Eastern Daylight Time
Location: West Concourse A4-B2
Potential to Optimize Weight Loss with Enobosarm—Meta-analysis of Body Composition from Three Randomized Clinical Trials Support the Ability of Enobosarm to Preserve Muscle while Reducing Fat
Date: Saturday, June 22, 2024
Start and end time: 12:30 PM-01:30 PM Eastern Daylight Time
Location: West Concourse A4-B2
Additional information on the meeting can be found on the American Diabetes Association website: https://professional.diabetes.org/scientific-sessions
About the Enobosarm Phase 2b clinical trial
The Phase 2b, multicenter, double-blind, placebo-controlled, randomized, dose-finding clinical trial is designed to evaluate the safety and efficacy of enobosarm 3mg, enobosarm 6mg, or placebo as a treatment to preserve muscle and augment fat loss in approximately 150 patients with sarcopenic obesity or overweight elderly (>60 years of age) patients receiving semaglutide (Wegovy®). The primary endpoint is total lean body mass, and the key secondary endpoints are total body fat mass and physical function as measured by stair climb test at 16 weeks. The Phase 2b clinical trial is actively enrolling patients from up to 15 clinical sites in the United States. Topline clinical results from the trial are expected by the end of calendar year 2024.
After completing the efficacy dose-finding portion of the Phase 2b clinical trial, it is expected that participants will then continue in blinded fashion into a Phase 2b extension clinical trial where all patients will stop receiving a GLP-1 RA, but will continue taking placebo, enobosarm 3mg, or enobosarm 6mg for an additional 12 weeks. The Phase 2b extension clinical trial will evaluate whether enobosarm can maintain muscle and prevent the fat and weight gain that occurs after discontinuing a GLP-1 RA. The topline results of the separate blinded Phase 2b extension clinical study are expected in calendar Q2 2025.
About Sarcopenic Obesity
According to the CDC, 41.5% of older adults have obesity in the United States and could benefit from a weight loss medication. Up to 34.4% of these obese patients over the age of 60 have sarcopenic obesity. This large subpopulation of sarcopenic obese patients is especially at risk for taking GLP-1 drugs for weight loss as they already have critically low amount of muscle due to age-related muscle loss. Further loss of muscle mass when taking a GLP-1 RA medication may lead to muscle weakness leading to poor balance, decreased gait speed, mobility disability, loss of independence, falls, bone fractures and increased mortality which is a condition like age-related frailty. Because of the magnitude and speed of muscle loss while on GLP-1 RA therapy for weight loss, GLP-1 RA drugs may accelerate the development of frailty in older obese or overweight elderly patients.
About Enobosarm
Enobosarm (aka ostarine, MK-2866, GTx-024, and VERU-024), a novel oral daily selective androgen receptor modulator (SARM), has been previously studied in 5 clinical studies involving 968 older normal men and postmenopausal women as well as older patients who have muscle wasting because of advanced cancer. Advanced cancer simulates a "starvation state" where there is significant unintentional loss or wasting of both muscle and fat mass which is similar to what is observed with in patients taking GLP-1 RA drugs. We believe the totality of the clinical data from these previous five clinical trials demonstrates that enobosarm treatment leads to dose-dependent increases in muscle mass with improvements in physical function as well as significant dose-dependent reductions in fat mass. The patient data that were generated from these five enobosarm clinical trials in both elderly patients and in patients with a cancer induced starvation-like state provide strong clinical rationale for enobosarm. The expectation is that enobosarm in combination with a GLP-1 RA would potentially augment the fat reduction and total weight loss while preserving muscle mass.
Importantly, enobosarm has a large safety database, which includes 27 clinical trials involving 1581 men and women, some of which included patients dosed for up to 3 years. In this large safety database, enobosarm was generally well tolerated with no increases in gastrointestinal side effects. This is important as there are already significant and frequent gastrointestinal side effects with a GLP-1 RA treatment alone.
About Veru Inc.
Veru is a late clinical stage biopharmaceutical company focused on developing novel medicines for the treatment of metabolic diseases, oncology, and ARDS. The Company's drug development program includes two late-stage novel small molecules, enobosarm and sabizabulin.
Enobosarm, a selective androgen receptor modulator (SARM), is being developed for two indications: (i) Phase 2b clinical study of enobosarm as a treatment to augment fat loss and to prevent muscle loss in sarcopenic obese or overweight elderly patients receiving a GLP-1 RA who are at-risk for developing muscle atrophy and muscle weakness and (ii) subject to the availability of sufficient funding, Phase 3 ENABLAR-2 clinical trial of enobosarm and abemaciclib for the treatment of androgen receptor positive (AR+), estrogen receptor positive (ER+) and human epidermal growth factor receptor 2 negative (HER2-) metastatic breast cancer in the 2nd line setting.
Sabizabulin, a microtubule disruptor, is being developed as a Phase 3 clinical trial for the treatment of hospitalized patients with viral-induced ARDS. The Company does not intend to undertake further development of sabizabulin for the treatment of viral-induced ARDS until we obtain funding from government grants, pharmaceutical company partnerships, or other similar third-party external sources.
The Company also has an FDA-approved commercial product, the FC2 Female Condom® (Internal Condom), for the dual protection against unplanned pregnancy and sexually transmitted infections.
Forward-Looking Statements
This press release contains "forward-looking statements" as that term is defined in the Private Securities Litigation Reform Act of 1995, including, without limitation, express or implied statements related to whether and when the phase 2b trial of enobosarm discussed above will produce topline data or patients will progress into the extension study, the planned design, number of sites, timing, endpoints, patient population and patient size of such trial and whether such trial will successfully meet any of its endpoints, whether enobosarm will enhance weight loss or preserve muscle in, or meet any unmet need for, obesity patients and whether it will enhance weight loss, whether the Company's scientific advisors will make valuable contributions to the Company's enobosarm program and whether the Company will be successful in its transformation into a late stage biopharmaceutical company focused on obesity and oncology. The words "anticipate," "believe," "could," "expect," "intend," "may," "opportunity," "plan," "predict," "potential," "estimate," "should," "will," "would" and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Any forward-looking statements in this press release are based upon current plans and strategies of the Company and reflect the Company's current assessment of the risks and uncertainties related to its business and are made as of the date of this press release. The Company assumes no obligation to update any forward- looking statements contained in this press release because of new information or future events, developments or circumstances. Such forward-looking statements are subject to known and unknown risks, uncertainties and assumptions, and if any such risks or uncertainties materialize or if any of the assumptions prove incorrect, our actual results could differ materially from those expressed or implied by such statements. Factors that may cause actual results to differ materially from those contemplated by such forward-looking statements include, but are not limited to: the development of the Company's product portfolio and the results of clinical studies possibly being unsuccessful or insufficient to meet applicable regulatory standards or warrant continued development; the ability to enroll sufficient numbers of subjects in clinical studies and the ability to enroll subjects in accordance with planned schedules; the ability to fund planned clinical development as well as other operations of the Company; the timing of any submission to the FDA or any other regulatory authority and any determinations made by the FDA or any other regulatory authority; the Company's existing product, FC2, and any future products, if approved, possibly not being commercially successful; the ability of the Company to obtain sufficient financing on acceptable terms when needed to fund development and operations; demand for, market acceptance of, and competition against any of the Company's products or product candidates; new or existing competitors with greater resources and capabilities and new competitive product approvals and/or introductions; changes in regulatory practices or policies or government-driven healthcare reform efforts, including pricing pressures and insurance coverage and reimbursement changes; risks relating to the Company's development of its own dedicated direct to patient telehealth platform, including the Company's lack of experience in developing such a platform, potential regulatory complexity, development costs, and market awareness and acceptance of any telehealth platform we develop; risks relating to our ability to increase sales of FC2 after significant declines in recent periods due to telehealth industry consolidation and the bankruptcy of a large telehealth customer; the Company's ability to protect and enforce its intellectual property; the potential that delays in orders or shipments under government tenders or the Company's U.S. prescription business could cause significant quarter-to-quarter variations in the Company's operating results and adversely affect its net revenues and gross profit; the Company's reliance on its international partners and on the level of spending by country governments, global donors and other public health organizations in the global public sector; the concentration of accounts receivable with our largest customers and the collection of those receivables; the Company's production capacity, efficiency and supply constraints and interruptions, including potential disruption of production at the Company's and third party manufacturing facilities and/or of the Company's ability to timely supply product due to labor unrest or strikes, labor shortages, raw material shortages, physical damage to the Company's and third party facilities, product testing, transportation delays or regulatory actions; costs and other effects of litigation, including product liability claims and securities litigation; the Company's ability to identify, successfully negotiate and complete suitable acquisitions or other strategic initiatives; the Company's ability to successfully integrate acquired businesses, technologies or products; and other risks detailed from time to time in the Company's press releases, shareholder communications and Securities and Exchange Commission filings, including the Company's Form 10-K for the year ended September 30, 2023, as amended by the Form 10-K/A, and subsequent quarterly reports on Form 10-Q. These documents are available on the "SEC Filings" section of our website at www.verupharma.com/investors .
* Wegovy ® is a registered trademark of Novo Nordisk A/S
Investor and Media Contact:
Samuel Fisch
Executive Director, Investor Relations and Corporate Communications
Email: veruinvestor@verupharma.com
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CEL-SCI Corporation (NYSE American: CVM) today announced Dr. Giovanni Selvaggi, an oncology key opinion leader instrumental in successfully bringing several drugs to market has joined CEL-SCI as a Clinical Advisor. Dr. Selvaggi joins CEL-SCI as the Company recently received its go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer.
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Multikine is the first investigational pre-surgical cancer drug in newly diagnosed head and neck cancer. Multikine is a copy of the pro-inflammatory cytokine immune response human bodies produce every day and is designed to empower a person's intact immune system cells to attack their own cancer. Patients are treated with Multikine right after diagnosis, before any other standard of care treatment (surgery and radiation therapy) since that is when the immune system is strongest. There is robust safety and efficacy data from 750 patients who have been treated with Multikine.
Based on the following efficacy data, the FDA has agreed to CEL-SCI's 212-person Registration Study to confirm the findings for regulatory approval:
Dr. Selvaggi is a US-based drug developer, cancer researcher, and strategic advisor to big pharma and early-to-late stage biotech companies. He is currently Chief Medical Officer at Xcovery Holdings, where he manages an ongoing New Drug Application with the FDA for ensartinib, an ALK-TKI for non-small cell lung cancer (NSCLC). He is also a Clinical Consultant to Tubulis GmBH for a first-in-class ADC program in solid tumors, and Clinical Strategy Senior Advisor to Alira Health. He formerly served as Medical Director, Cancer Immunotherapy, in the MAGE-A3 lung cancer vaccine program at GSK. Later, Dr. Selvaggi played an instrumental role in the successful development and approval of ceritinib (Zykadia) in ALK-translocated NSCLC at Novartis. At Oncolytics he was VP of Clinical Development. Most recently, Dr. Selvaggi was part of the immunotherapy team at Bristol-Myers Squibb, serving as a program lead in thoracic malignancies, with a focus on SCLC and mesothelioma, leading to the approval of nivolumab (Opdivo) in third line small cell lung cancer. Dr. Selvaggi received his medical degree at the University of Torino School of Medicine, in Torino, Italy, and served as staff physician of thoracic oncology at the University Hospital in Torino, participating in several clinical trials in lung cancer and mesothelioma over a span of 20 years.
Dr. Selvaggi commented, "Multikine is a first in class immunotherapy that has demonstrated to meaningfully and safely prolong survival in a selected orphan population of newly diagnosed head and neck cancer. The importance of tackling cancer at the earliest stages to guarantee the most relevant impact in patients' lives is undeniable, especially in head and neck cancer which has no approved therapeutic options before surgery. I am fully committed to supporting CEL-SCI leadership to bring this asset to patients through an expedited registrational path that has been agreed with regulatory authorities and that has a potential for cure."
"Dr. Selvaggi has a passion for bringing cancer drugs to market to save lives and lead clinical research toward a cure for cancer. We are excited to have him join CEL-SCI as a Clinical Advisor at this pivotal point for Multikine which is set to commence a confirmatory FDA Registration Study," stated CEL-SCI CEO, Geert Kersten. "The data on Multikine is excellent, and as we proceed with and wrap up this final study, Dr. Selvaggi's experience and successful track record in navigating late-stage development, clinical trials, and the regulatory approval process will be hugely valuable for us."
Dr. Selvaggi joins several other top-tier physician consultants and head and neck cancer key opinion leaders who are advisors to CEL-SCI.
About Cel-Sci Corporation
CEL-SCI believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor.
Multikine (Leukocyte Interleukin, Injection), a true first-line cancer therapy, has been dosed in over 750 patients and received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck. Multikine significantly extended life in its target patient population demonstrating a 73% survival rate with Multikine vs. only 45% without at 5 years after treatment. Based on this very strong data, the FDA agreed to CEL-SCI's target patient selection criteria and gave the go-ahead to conduct a small, focused, confirmatory Registration Study which will enroll 212 patients. CEL-SCI will enroll newly diagnosed advanced primary head and neck cancer patients with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy), representing over 100,000 patients annually.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
View source version on businesswire.com: https://www.businesswire.com/news/home/20240606671425/en/
Gavin de Windt
Cel-Sci Corporation
(703) 506-9460
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VTX3232 demonstrated improvements in body weight, systemic inflammatory biomarkers and cardiometabolic parameters in diet-induced obesity (DIO) mice
Additive effects were observed for VTX3232 in combination with the GLP-1 receptor agonist semaglutide across key endpoints compared to semaglutide or VTX3232 alone
Ventyx Biosciences, Inc. (Nasdaq: VTYX) ("Ventyx"), a clinical-stage biopharmaceutical company focused on advancing novel oral therapies that address a broad range of inflammatory diseases with significant unmet medical need, today announced positive preclinical data for its CNS-penetrant NLRP3 inhibitor VTX3232 in murine diet-induced obesity models.
"We are excited by these data showing that in the diet-induced obesity mouse model, VTX3232 monotherapy demonstrated a reduction in body weight, body fat content, food consumption, liver triglycerides and liver fat deposits as well as improvements in insulin resistance, cardiometabolic parameters and biomarkers of systemic inflammation," said John Nuss, PhD, Chief Scientific Officer. "In addition, combining VTX3232 with the GLP-1 receptor agonist semaglutide demonstrated additive effects across these outcomes. These preclinical data increase our confidence in the role of NLRP3 in obesity and we look forward to initiating a Phase 2a trial of VTX3232 in participants with obesity and other cardiovascular risk factors during the second half of this year."
Two separate 28-day studies were conducted with VTX3232 in DIO mice. In DIO Study 1, VTX3232 and semaglutide were evaluated as monotherapies compared to standard diet and DIO vehicle (high fat diet) controls. DIO Study 2 included an additional treatment group evaluating VTX3232 in combination with semaglutide. Key findings are summarized below.
DIO Study 1 (VTX3232 monotherapy):
DIO Study 2 (VTX3232 in combination with semaglutide):
The Company intends to submit the comprehensive results of these studies for future publication or presentation in a scientific forum. Slides summarizing the results from the two DIO mouse studies can be found in the Investors section of the Company's website at www.ventyxbio.com .
About Ventyx Biosciences
Ventyx is a clinical-stage biopharmaceutical company focused on developing innovative oral medicines for patients living with autoimmune and inflammatory disorders. We believe our ability to efficiently discover and develop differentiated drug candidates will allow us to address important unmet medical need with novel oral therapies that can shift inflammation and immunology markets from injectable to oral drugs. Our current pipeline includes internally discovered clinical programs targeting NLRP3, S1P1R and TYK2, positioning us to become a leader in the development of oral immunology therapies for peripheral and neuroinflammatory diseases. Ventyx is headquartered in San Diego, California. For more information about Ventyx, please visit www.ventyxbio.com .
Forward-Looking Statements
Ventyx cautions you that statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on Ventyx's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding: the anticipated timing for the initiation of a Phase 2a trial of VTX3232 in participants with obesity and other cardiovascular risk factors in H2 2024; and the intention to submit for publication in a scientific journal the results of the studies described above. The inclusion of forward-looking statements should not be regarded as a representation by Ventyx that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risks and uncertainties inherent in Ventyx's business, including, without limitation: potential delays in the commencement, enrollment and completion of clinical trials; Ventyx's dependence on third parties in connection with product manufacturing, research and preclinical and clinical testing; disruptions in the supply chain, including raw materials needed for manufacturing and animals used in research, delays in site activations and enrollment of clinical trials; the results of preclinical studies and clinical trials not necessarily being predictive of future results; regulatory developments in the United States and foreign countries; unexpected adverse side effects or inadequate efficacy of Ventyx's product candidates that may limit their development, regulatory approval and/or commercialization, or may result in recalls or product liability claims; Ventyx's ability to obtain and maintain intellectual property protection for its product candidates; the use of capital resources by Ventyx sooner than expected; disruption to Ventyx's operations from the ongoing military conflicts in Ukraine and the Middle East, including clinical trial delays; and other risks described in Ventyx's prior press releases and Ventyx's filings with the Securities and Exchange Commission (SEC), including in Part II, Item 1A (Risk Factors) of Ventyx's Quarterly Report on Form 10-Q for the quarter ended March 31, 2024, filed on May 9, 2024, and any subsequent filings with the SEC. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Ventyx undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, which is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.
Investor Relations Contact
Patti Bank
Managing Director
ICR Westwicke
(415) 513-1284
IR@ventyxbio.com
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Longeveron Inc. (NASDAQ: LGVN), a clinical stage regenerative medicine biotechnology company developing cellular therapies for life-threatening and chronic aging-related conditions, today announced the launch of its contract development and manufacturing business at the Company's 15,000 square feet state-of-the-art Good Manufacturing Practice (GMP) facility. This facility contains 3,000 square feet of cleanroom space, including eight ISO 7 cleanrooms and ancillary areas, as well as 1,150 square feet of process development, quality control and warehousing space. The Company also announced the initiation of work under its first manufacturing services contract with Secretome Therapeutics a biotechnology company developing first-in-class therapeutics from neonatal mesenchymal stem cells (nMSC).
"We are delighted to partner with Secretome Therapeutics to advance their portfolio of therapeutics in this, our first contract manufacturing agreement in a new, revenue generating business line," said Wa'el Hashad , Chief Executive Officer of Longeveron. "With cellular therapy manufacturing expertise and capabilities in high demand, and Longeveron's strength in both, we see a significant opportunity to employ currently unused capacity in our state-of-the-art GMP facility. We have assembled a team of experts and proprietary technologies that enable us to take a systematic approach to rapidly develop improved cell therapies. Longeveron's manufacturing expertise, capabilities and facility provide other pharmaceutical organizations the ability to advance their development programs without building their own manufacturing facility. We believe this contract manufacturing opportunity can expand our team's experience and has the potential to generate approximately $4-5 million in annual revenues once it is up and running fully."
"Our platform of neonatal stem cell-based therapeutics has the potential to revolutionize treatment for a wide range of chronic, inflammatory diseases," said Vinny Jindal , President and Chief Executive Officer of Secretome Therapeutics. "As we move our lead product, STM-01, into clinical studies for HFpEF and dilated cardiomyopathy this year, we look forward to tapping into Longeveron's extensive cellular therapy knowledge and manufacturing expertise, which has supported the launch of multiple clinical studies."
Longeveron is primarily focused on advancing development of its lead investigational therapeutic candidate, Lomecel-B Â TM , a proprietary, scalable, allogeneic cellular therapy, across multiple indications, including hypoplastic left heart syndrome (HLHS) (Phase 2 on-going), Alzheimer's disease (Phase 2 completed), and Aging-related Frailty (Phase 2 completed).
About Longeveron Inc .
Longeveron is a clinical stage biotechnology company developing regenerative medicines to address unmet medical needs. The Company's lead investigational product is Lomecel-Bâ„¢, an allogeneic medicinal signaling cell (MSC) therapy product isolated from the bone marrow of young, healthy adult donors. Lomecel-Bâ„¢ has multiple potential mechanisms of action encompassing pro-vascular, pro-regenerative, anti-inflammatory, and tissue repair and healing effects with broad potential applications across a spectrum of disease areas. Longeveron is currently pursuing three pipeline indications: hypoplastic left heart syndrome (HLHS), Alzheimer's disease, and Aging-related Frailty. For more information, visit www.longeveron.com or follow Longeveron on LinkedIn , X , and Instagram .
Forward-Looking Statements
Certain statements in this press release that are not historical facts are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, which reflect management's current expectations, assumptions, and estimates of future operations, performance and economic conditions, and involve risks and uncertainties that could cause actual results to differ materially from those anticipated by the statements made herein. Forward-looking statements are generally identifiable by the use of forward-looking terminology such as "believe," "expects," "may," "looks to," "will," "should," "plan," "intend," "on condition," "target," "see," "potential," "estimates," "preliminary," or "anticipates" or the negative thereof or comparable terminology, or by discussion of strategy or goals or other future events, circumstances, or effects and include, but are not limited to, the potential demand for Longeveron's contract manufacturing services and its ability to enter into additional service agreements. Factors that could cause actual results to differ materially from those expressed or implied in any forward-looking statements in this release include, but are not limited to, adverse global conditions, including macroeconomic uncertainty; inability to raise additional capital necessary to continue as a going concern; our history of losses and inability to achieve profitability going forward; the absence of FDA-approved allogenic, cell-based therapies for HLHS or other cardiac-related indications; ethical and other concerns surrounding the use of stem cell therapy or human tissue; our exposure to product liability claims arising from the use of our product candidates or future products in individuals, for which we may not be able to obtain adequate product liability insurance; the adequacy of our trade secret and patent position to protect our product candidates and their uses: others could compete against us more directly, which could harm our business and have a material adverse effect on our business, financial condition, and results of operations; if certain license agreements are terminated, our ability to continue clinical trials and commercially market products could be adversely affected; the inability to protect the confidentiality of our proprietary information, trade secrets, and know-how; third-party claims of intellectual property infringement may prevent or delay our product development efforts; the inability to successfully develop and commercialize our product candidates and obtain the necessary regulatory approvals; we cannot market and sell our product candidates in the U.S. or in other countries if we fail to obtain the necessary regulatory approvals; final marketing approval of our product candidates by the FDA or other regulatory authorities for commercial use may be delayed, limited, or denied, any of which could adversely affect our ability to generate operating revenues; we may not be able to secure and maintain research institutions to conduct our clinical trials; ongoing healthcare legislative and regulatory reform measures may have a material adverse effect on our business and results of operations; if we receive regulatory approval of Lomecel-Bâ„¢ or any of our other product candidates, we will be subject to ongoing regulatory requirements and continued regulatory review, which may result in significant additional expense; being subject to penalties if we fail to comply with regulatory requirements or experience unanticipated problems with our therapeutic candidates; reliance on third parties to conduct certain aspects of our preclinical studies and clinical trials; interim, "topline" and preliminary data from our clinical trials that we announce or publish from time to time may change as more data become available and are subject to audit and verification procedures that could result in material changes in the final data; provisions in our certificate of incorporation and bylaws and Delaware law might discourage, delay or prevent a change in control of our company or changes in our management and, therefore, depress the market price of our Class A common stock; we have never commercialized a product candidate before and may lack the necessary expertise, personnel and resources to successfully commercialize any products on our own or together with suitable collaborators; and in order to successfully implement our plans and strategies, we will need to grow our organization, and we may experience difficulties in managing this growth. Further information relating to factors that may impact the Company's results and forward-looking statements are disclosed in the Company's filings with the Securities and Exchange Commission, including Longeveron's Annual Report on Form 10-K for the year ended December 31, 2023, filed with the Securities and Exchange Commission on February 27, 2024, as amended by the Annual Report on Form 10-K/A filed March 11, 2024, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. The forward-looking statements contained in this press release are made as of the date of this press release, and the Company disclaims any intention or obligation, other than imposed by law, to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.
Investor Contact:
Derek Cole
Investor Relations Advisory Solutions
derek.cole@iradvisory.com
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