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Radiopharm Theranostics Receives FDA IND Approval for Phase 2b Imaging Trial in Brain Metastases
July 22, 2024
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that it has received clearance for its Investigational New Drug (IND) application with the US Food and Drug Administration (FDA), for F18-Pivalate (RAD 101).
Pivalate, labelled with the radioisotope F18, is a small molecule that selectively targets fatty acid synthetase, which is overexpressed in brain tumours but not in normal cells. Pivalate is a novel proprietary imaging agent under clinical investigation for the detection and characterisation of brain metastases.
The IND approval is a clear recognition by the FDA of clinical data already generated for RAD 101 and is a significant milestone towards starting a Phase 2b multi-center trial for the imaging of brain metastases. Radiopharm anticipates having the first patient dosed during the fourth quarter of 2024. Based on current enrolment expectations, the 30-patient Phase 2b read-out is expected by mid-2025 and will be followed by a Phase 3 registrational study.
Previously reported positive data from the Imperial College of London’s Phase 2a imaging trial of Pivalate in 17 patients with brain metastases showed significant tumour uptake that was consistent with and independent from the tumour of origin¹. This supports the potential use of pivalate to monitor brain metastases.
“Pivalate represents a potential new target for radiopharmaceutical brain imaging agents, and its unique mechanism of action may offer eligible patients and the medical community an alternative to overcome the limitations of current standard of care for imaging brain metastasis.” said Riccardo Canevari, CEO and Managing Director of Radiopharm Theranostics. “We are very pleased by this FDA approval as it allows us to commence late-stage clinical studies and address the high unmet medical need in around 300,000 patients that are diagnosed with brain metastases in the U.S. every year.”
Radiopharm holds an exclusive global license for the pivalate platform technology and has a collaboration in place with Imperial College of London to develop a therapeutic candidate leveraging the same mechanism of action.
¹ S. Islam, M. Inglese, P. Aravind, A. Waldman, M. Williams, E.O. Aboagye. 18F-Fluoropivalate PET/MRI: imaging of treatment naïve patients and patients treated with radiosurgery [Poster #135]. 24th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics, October 26 2022.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
10 July
Top 5 NASDAQ Biotech Stocks of 2024
The NASDAQ Biotechnology Index (INDEXNASDAQ:NBI) has traded at three-year highs in the first half of 2024 in response to looming interest rate cuts, breakthrough innovations and increased deals in the space.
After dropping to a low of 3,637.05 in October 2023, the index climbed to start 2024 at 4,457.02. It did hit a bump in the road early in Q2 when it plunged to 4,056.3 in April, but it quickly recovered and has since tracked even higher, reaching 4,634.21 on June 24. But while the current economic environment means the biotech sector may have a complex road ahead, robust growth could be in store in the future.
According to a recent report from Precedence Research, the global biotech market is expected to grow at a compound annual growth rate of 11.8 percent from now to 2033, reaching a valuation of US$4.25 trillion.
Driving that growth will be favorable government policies, investment in the sector, increased demand for synthetic biology and a rise in chronic disorders such as cancer, heart disease and hypertension.
The top NASDAQ biotech companies have seen sizeable share price increases this past year. For those interested in investing in biotech companies, here are the top gainers outlined below.
Data was gathered on July 8, 2024, using TradingView’s stock screener, and all NASDAQ biotech stocks had market caps between US$50 million and US$500 million at that time.
1. Elevation Oncology (NASDAQ:ELEV)
Year-to-date gain: 416.67 percent; market cap: US$152.17 million; share price: US$2.79
Elevation Oncology’s focus is on developing cancer therapies targeting a range of solid tumors. The company’s oncology pipeline is based on its expertise in antibody-drug conjugates (ADC) and includes lead candidate EO-3021, which is designed to target solid tumors associated with gastric, gastroesophageal junction, pancreatic or esophageal cancers.
In April, Elevation presented preclinical data demonstrating proof-of-concept for its HER3-ADC program targeting solid tumors, including breast cancer, EGFR-mutant non-small cell lung cancer and pancreatic cancer.
In late June, Elevation announced the expansion of its ongoing Phase 1 clinical trial for EO-3021 to include two combination cohorts evaluating the drug for the treatment of advanced gastric or gastroesophageal junction cancer. This expansion will see the company evaluating EO-3021 in combination with Eli Lily's (NYSE:LLY) ramucirumab, a VEGFR2 inhibitor, in second-line patients, and in combination with GSK's (LSE:GSK) dostarlimab, a PD-1 inhibitor, in the front-line setting.
Elevation Oncology's share price reached the highest point in 2024 on March 1, hitting US$5.01. While it's no longer at that peak, the company's stock is still up considerably from the start of the year.
2. Candel Therapeutics (NASDAQ:CADL)
Year-to-date gain: 287.92 percent; market cap: US$171.69 million; share price: US$5.77
Candel Therapeutics is another NASDAQ biotech company focused on developing oncology treatments. The company’s pipeline includes two clinical stage multimodal biological immunotherapy platforms.
Candel’s lead product candidate CAN-2409 is in a Phase 2 clinical trial in non-small cell lung cancer and borderline resectable pancreatic cancer, as well as Phase 2 and 3 trials for localized, non-metastatic prostate cancer. Positive interim data for the trial on pancreatic cancer, released on April 4, sent the company's share price spiking upwards.
Its second lead product candidate is CAN-3110, which is in an ongoing Phase 1 clinical trial in recurrent high-grade glioma (HGG).
The company has had a number wins with the US Food and Drug Administration (FDA) so far this year. In February, Candel’s CAN-3110 received regulatory approval for a fast track designation for the treatment of recurrent HGG. The agency also granted Candel orphan drug designation for CAN-2409 for the treatment of pancreatic cancer in April and CAN-3110 for HGG in May.
This NASDAQ biotech stock has had an excellent second quarter this year. After spiking on positive interim trial data for CAN-2409 in April, it continued climbing to hit a year-to-date high of US$14.00 on May 15.
3. Benitec Biopharma (NASDAQ:BNTC)
Year-to-date gain: 201.25 percent; market cap: US$90.58 million; share price: US$9.67
California-based Benitec Biopharma is advancing novel genetic medicines via its proprietary “Silence and Replace” DNA-directed RNA interference platform. The company is currently focused on developing therapeutics for chronic and life-threatening conditions including oculopharyngeal muscular dystrophy (OPMD). Its drug candidate BB-301 was granted orphan drug designation by the FDA and the European Medicines Agency.
In April, Benitec reported positive interim clinical trial data for its first OPMD subject treated with BB-301 in its Phase 1b/2a study. Following the report, Benitec's share price began trending upward, and reached its highest point in 2024 on May 20 when it hit US$10.47. The company expects to report additional interim safety and efficacy data in the second half of the year.
4. Eliem Therapeutics (NASDAQ:ELYM)
Year-to-date gain: 151.11 percent; market cap: US$452.81 million; share price: US$6.78
Eliem Therapeutics is undergoing a transformation this year following the acquisition of private biotech firm Tenet Medicines in June. Going forward, Eliem’s focus will be on developing therapeutics for autoimmune-driven inflammatory diseases. Its lead product candidate is now TNT119, an anti-CD19 antibody targeting a range of autoimmune diseases, including systemic lupus erythematosus, immune thrombocytopenia and membranous nephropathy.
Eliem has also completed a US$120 million private placement bringing its total cash and cash equivalents of approximately US$220 million. The company says its planned operations are now sufficiently funded into 2027, and expects to initiate Phase 2 clinical trials of TNT119 this year.
Eliem is another NASDAQ biotech stock that had a great second quarter this year, posting a year-to-date high of US$10.20 on May 7.
5. Cardiol Therapeutics (TSX:CRDL)
Year-to-date gain: 128.77 percent; market cap: US$129.03 million; share price: US$1.87
Biopharma company Cardiol Therapeutics is developing novel treatments for inflammation and fibrosis in cardiovascular conditions, including pericarditis, myocarditis, and heart failure.
The company has two drug candidates in its pipeline: CardiolRX, an orally administered cannabidiol under clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis; and CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
The FDA granted CardiolRx orphan drug designation in February. Cardiol released positive top-line results in mid-June for its Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis. The company believes the results will support moving the drug to Phase 3 clinical trials.
The positive news flow contributed to the strong momentum the stock has enjoyed this year, leading to a year-to-date share price high of US$2.91 on June 12.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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10 July
First Patient Dosed with PD-L1 Nanobody in Phase 1 Therapeutic Non-Small Cell Lung Cancer Trial
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce the therapeutic dosing of the first patient in its Phase 1 clinical trial of RAD 204, a proprietary nanobody which targets Programmed death-ligand 1 (PD-L1)-positive expression in Non-Small Cell Lung Cancer (NSCLC), the most common type of lung cancer.
- First patient dosed with RAD 204 (PD-L1 nanobody) in a Phase 1 therapeutic trial at Wollongong Hospital, New South Wales.
- Phase 11 First-In-Human study designed to assess safety and tolerability of 177Lu-RAD204 in PD-L1-positive individuals with metastatic Non-Small Cell Lung Cancer (NSCLC).
- 16 patients previously dosed in Phase 1 diagnostic study demonstrated safety and effective biodistribution, and validate the strong potential for 177Lu-RAD204 for the treatment of advanced NSCLC.
- First patient dosed with RAD 204 marks a significant milestone in Radiopharm’s commitment to developing transformative oncology radiotherapeutics.
The open-label Phase 1 study, entitled “Study of the Safety and Tolerability of 177Lu-RAD 204, a Lutetium-177 Radiolabelled Single Domain Antibody Against Programmed Cell Death-Ligand 1 in Patients with Metastatic Non-small Cell Lung Cancer”, is a First-In-Human dose escalation trial of 177Lu-RAD 2041, and is designed to evaluate the safety and preliminary efficacy of this novel radiotherapeutic in eligible individuals with advanced NSCLC. Previously published2 Phase I data of 16 NSCLC patients imaged with RAD 204 have demonstrated that the diagnostic is safe and associated with acceptable dosimetry.
The study is currently being conducted in Australia at Wollongong Hospital (NSW), Princess Alexandra Hospital (QLD), and Hollywood Private Hospital (WA), with the support of GenesisCare CRO.
“Radiopharm is delighted to announce this important milestone in our evolution to a clinical-stage company,” said Riccardo Canevari, CEO and Managing Director of Radiopharm. “Despite progressive improvements in the first-line setting for metastatic NSCLC, the majority of patients will progress and require further therapeutic options in the second-line setting. Current options following progression offer modest activity, making this setting an area of unmet need. With RAD 204, we hope to provide an alternative strategy that can improve clinical outcomes for NSCLC patients, while preserving quality of life.”
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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04 July
Can AI Help Detect Cancer? Data Analysis Could Open Up Possibilities for Healthcare Industry
Artificial intelligence (AI) has emerged as a valuable tool for solving complex societal issues, and although it's a new industry, its impact is already being felt in key areas of the life science sector.
AI models in healthcare are quickly advancing beyond basic tasks like medical transcription and administrative streamlining; many systems can now effectively analyze extensive genetic data.
By harnessing AI models' ability to identify patterns and make predictions, medical professionals can institute more effective, personalized treatments and develop precision tests to catch diseases earlier.
At this year’s Collision event, held in Toronto from June 18 to 20, Wesley Chan, co-founder and managing partner at venture capital firm FPV Ventures, shared insights on AI's role in healthcare with Fox Business correspondent Susan Li.
Chan said that while the life science market has been somewhat overlooked in the AI boom so far, his company predicts that it will benefit greatly from AI technology over the next five to 10 years.
“We’re in a lot of life science companies,” he said about FPV Ventures. “A lot of them use AI to help accelerate drug discovery, or to validate their thesis or to test out some of their assumptions without having to go in depth.”
Guardant using liquid biopsy tests to look for signs of cancer
Liquid biopsies, a non-invasive blood test, have shown strong promise in cancer detection, especially when it comes to monitoring ongoing treatment and detecting cancer recurrence.
Speaking at Collision, Dr. Craig Eagle, chief medical officer at large-cap biotechnology company Guardant Health (NASDAQ:GH), outlined SHIELD, a blood test his company has developed to screen for colorectal cancer.
“One of the things that’s challenging in oncology is that the cause of the disease is a molecular abnormality, often centered around the DNA. That abnormality can either be purely inherited or environmental, but for most people it’s in between," he explained to the audience at the conference.
Standard cancer diagnosis procedures typically involve retrieving a tissue sample, which Dr. Eagle said represents a challenge when the suspected cancer is deep within the body.
“So what we’re developing is blood-based testing. A simple tube of blood, no different to what you can do with a cholesterol or diabetes sugar test," he said on stage at the event, noting that during cell growth and turnover, some cancer cells are shed into the bloodstream. Liquid biopsy is a method of cancer detection that analyzes these shed cells to look for cancer signals in the bloodstream. Blood tests can also help physicians monitor cancer as it progresses and changes, which can help them develop the best treatment plan for each individual patient.
“You can't really treat or manage a cancer or disease unless you understand it. So by understanding the deeper molecular causes of cancer, we're actually able to get those insights even further and enable informed decision making," Dr. Eagle commented. "A simple liquid biopsy test gets the information you need at the molecular level."
How were liquid biopsy tests first developed?
One of the earliest liquid biopsy tests was the prostate-specific antigen test, which was approved by the US Food and Drug Administration (FDA) in 1986. It was initially only used to monitor cancer that had already been diagnosed, but in 1994 physicians began using it alongside digital rectal exams to screen for cancer signals in men over 50.
Later, researchers developed liquid biopsy tests that searched for two types of biomarkers in blood samples: circulating tumor cells (CTCs), which have detached from the primary tumor and entered the bloodstream, and circulating tumor DNA (ctDNA), smaller fragments that enter the blood when cancer cells die and break apart.
Ongoing efforts have been devoted to developing more comprehensive liquid biopsy tests. A 1999 study that detected aberrant p16 methylation in the blood of liver cancer patients provided the concept that biomarkers more specific to certain types of cancer can be detected in the blood. The completion of the Human Genome Project in 2003 helped further develop comprehensive cancer detection methods, including liquid biopsy tests.
The Cancer Genome Atlas was launched in 2006. It maps out the genomic changes in cancer and provides insights into its molecular basis, creating a clearer picture of cancer-specific biomarkers. Technologies like next-generation sequencing and microfluidic technologies were developed concurrently, enhancing the sensitivity of liquid biopsy tests by enabling the detection of rare cancer biomarkers. These new technologies also reduced costs and improved throughput.
Additionally, since the early 2000s the FDA has granted approval to multiple technologies specifically designed to capture and enumerate CTCs. Prior to the FDA's approval of CellSearch tumor detection technology for metastatic breast cancer in 2004, finding CTCs was challenging due to the rarity of these cells in the bloodstream. The development of the CellSearch technology revolutionized CTC detection by offering a non-invasive and highly sensitive approach.
Furthermore, the CellSearch technology helped researchers gain insights into the genomic alterations and signaling pathways that drive tumor growth, which can be used to tailor treatments to target specific molecular vulnerabilities.
Harnessing AI for better cancer detection
Guardant is one of the few companies with FDA-approved liquid biopsy companion diagnostic tests in the US market, and Dr. Eagle presented a compelling case for the widespread adoption of liquid biopsies in oncology.
He stressed that liquid biopsy tests offer a more effective and accessible way to test for cancer when compared to traditional screening methods. They are non-invasive and can easily be administered during other standard blood tests, eliminating the need for additional appointments or specialized equipment.
Dr. Eagle also noted that the convenience and simplicity of regular screenings would likely encourage more patients to participate, as they can be seamlessly integrated into their ongoing healthcare routines.
Aside from that, he pointed out that traditional cancer screenings can pose accessibility challenges for patients due to various barriers, such as geographical constraints, financial limitations or other factors. These obstacles can lead to prolonged waiting periods or limited access to procedures like colonoscopies, stool or tissue sample collection and imaging scans. Additionally, liquid biopsy tests provide results sooner than other methods. Meanwhile, the simplicity of the tests, combined with their ability to detect multiple cancer types, reduces their overall cost.
Liquid biopsies also have the potential to help researchers recognize signals of other diseases. Dr. Eagle explained that DNA damage is used as a metric to assess an individual's risk of developing a disease.
Rather than focusing only on the DNA sequence itself, epigenetics — the study of how genes are expressed and regulated — can help researchers understand the role of gene expression in cancer development and progression, as well as provide additional information about a person’s health.
“So that programming now becomes a massive database that we get to see in liquid biopsy,” said Dr. Eagle.
This is where AI becomes the most crucial. He emphasized that AI analytics will accelerate over the next five to 10 years, and that this technology will be essential for the successful analysis of enormous data sequences. He believes that there will be a rapid evolution in the field of oncology from its current state.
“We've got trials going on in smokers looking for lung cancer from a blood test, and we're seeing if we can break the back of that challenge. We're also looking at multiple cancers beyond that, whether it be lung cancer in nonsmokers, whether it be liver cancer, kidney cancer, breast cancer, etc. They're all going to be from a blood test.”
Investor takeaway
The integration of AI with innovative technologies like liquid biopsies holds immense potential to revolutionize disease detection, treatment and monitoring. These developments could pave the way for a future where personalized, preventative medicine becomes the norm.
Don’t forget to follow us @INN_Technology for real-time news updates!
Securities Disclosure: I, Meagen Seatter, hold no direct investment interest in any company mentioned in this article.
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03 July
Top 3 Canadian Biotech Stocks of 2024
Biotech is a dynamic industry that is driving scientific advancements and innovation in healthcare.
According to Grandview Research, the global biotech market was worth US$1.55 trillion in 2023, and the firm expects it to grow at a CAGR of 13.96 percent between 2024 and 2030 to reach a value of US$3.08 trillion.
In Canada, the biotech industry is home to companies pursuing cutting-edge therapies and medical technologies, and the Investing News Network has identified the top three biotech stocks based on their year-on-year gains.
Data on Canadian biotech stocks was collected on July 2, 2024, using TradingView's stock screener and companies listed had market capitalizations of over C$50 million at that time. Companies on the TSX, TSXV and CSE were considered, but no TSXV-listed stocks made the list this time. Read on to learn what's been driving these biotech firms.
1. ME Therapeutics Holdings (CSE:METX)
Year-on-year gain: 7,900 percent; market cap: C$93.45 million; share price: C$4.00
ME Therapeutics Holdings is a biotechnology company focused on developing cancer-fighting drug candidates that can increase the efficacy of current immuno-oncology drugs by targeting suppressive myeloid cells, which have been found to hinder the effectiveness of existing immuno-oncology treatments. Immuno-oncology is a relatively new area of cancer drug research, and has shown promising results when used to treat cancer with low survival rates.
In December 2023, ME Therapeutics announced that its most advanced preclinical asset, h1B11-12, an antibody targeting G-CSF, had been found to bind to and neutralize G-CSF in lab tests and animal studies. Studies conducted with Dr. Kenneth Harder’s laboratory at the University of British Columbia revealed that G-CSF is involved in many different processes influencing how breast and colon cancers grow and spread.
In a January update, ME Therapeutics shared that preliminary results for clinical trials of h1B11-12 on non-human primates were tolerated well up to a dose of 10 milligrams per kilogram. The next step is to study how the drug behaves inside the body, which will help the company plan future research and decide how to continue developing h1B11-12.
ME Therapeutics saw a major share price boost on February 27, when it announced a non-brokered private placement to raise gross proceeds of up to C$1.55 million. It said it was unaware of any other change that would account for the rise.
2. Medicenna (TSX:MDNA)
Year-on-year gain: 172.86 percent; market cap: C$153.89 million; share price: C$1.91
Medicenna is a clinical-stage immuno-oncology company specializing in the development of innovative therapies for patients with challenging unmet needs. Its focus is on creating novel, highly selective versions of cytokines, such as IL-2, IL-4, and IL-13, which it refers to as "Superkines" and "empowered superkines."
Cytokines are small proteins that play a crucial role in regulating immune responses and helping cells communicate. Interleukins, which Medicenna says are at the core of its therapies, are groups of cytokines. The company's interleukins are engineered to fuse with specific molecules to optimize their function.
Medicenna's mission is to leverage its expertise in cytokine biology to design life-changing therapies that can potentially transform people's lives. Its therapies treat solid tumors, which have a low response rate to conventional cancer treatments, and autoimmune and neuroinflammatory diseases.
In April, the company shared the news that its lead candidate, MDNA11 has demonstrated therapeutic activity and an acceptable safety profile during clinical trials of monotherapy dose escalation in treating patients with advanced solid tumors. Late in the month, the company also closed on a C$20 million investment from RA Capital Management. The positive news flow provided enough momentum to push shares of Medicenna to a year-to-date high of C$2.85 on May 31.
More recently, Medicenna received regulatory approval for the European Medicines Agency to expand its phase 1/2 clinical trial of MDNA11 as a monotherapy and in combination with Keytruda to Europe.
3. Cardiol Therapeutics (TSX:CRDL)
Year-on-year gain: 116 percent; market cap: C$188.37 million; share price: C$2.70
Cardiol Therapeutics is a biopharma company developing innovative treatments for inflammation and fibrosis in cardiovascular conditions. Its research is concentrated on pericarditis, which is inflammation of the membrane surrounding the heart; myocarditis, or inflammation of the heart muscle; and heart failure.
Cardiol currently has two drug candidates in its pipeline. CardiolRX, the company's lead candidate, is an orally administered cannabidiol that is being clinically studied for use in rare heart diseases, including recurrent pericarditis and acute myocarditis. Cardiol is also developing CRD-38, a drug formulation of cannabidiol that is administered subcutaneously for treating heart failure.
The company's share price began a significant rise in mid-February, when the US Food and Drug Administration granted it orphan drug designation for CardiolRx. Less than a week later, Cardiol completed patient enrollment in a Phase 2 open-label pilot study investigating the safety, tolerability and efficacy of CardiolRx in patients with recurrent pericarditis.
The company went on to release positive top-line results in mid-June, which Cardiol President and CEO David Elsley said demonstrated "that oral administration of our small molecule CardiolRx™ led to marked reductions in pericarditis pain and inflammation." The company believes the results will help move the drug to Phase 3 clinical trials.
Don’t forget to follow us @INN_LifeScience for real-time news updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
Editorial Disclosure: Cardiol Therapeutics is a client of the Investing News Network. This article is not paid-for content.
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01 July
Investor Webinar – 3pm AEST Tuesday 2 July
Radiopharm Theranostics (ASX:RAD, “Radiopharm” or the “Company”), a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for areas of high unmet medical need, is pleased to announce that CEO and Managing Director Riccardo Canevari and Executive Chairman Paul Hopper will conduct an investor webinar to provide an update following announcement of the Company’s $70 million capital raising.
When: 3pm AEST, Tuesday 2 July 2024
Register at: https://us02web.zoom.us/webinar/register/WN_wcKESuixTf2e5TRIwVAW_Q
Upon registering attendees will receive an email containing information about joining the webinar. A recording will be available at the above link soon after the conclusion of the live session, with the replay to also be made available via Radiopharm’s website and social media channels.
Questions can be sent in advance of the webinar to matt@nwrcommunications.com.au.
About Radiopharm Theranostics
Radiopharm Theranostics is a clinical stage radiotherapeutics company developing a world-class platform of innovative radiopharmaceutical products for diagnostic and therapeutic applications in areas of high unmet medical need. Radiopharm has been listed on ASX (RAD) since November 2021. The company has a pipeline of distinct and highly differentiated platform technologies spanning peptides, small molecules and monoclonal antibodies for use in cancer, in pre-clinical and clinical stages of development from some of the world’s leading universities and institutes. The pipeline has been built based on the potential to be first-to-market or best-in-class. Learn more at Radiopharmtheranostics.com.
Click here for the full ASX Release
This article includes content from Radiopharm Theranostics, licensed for the purpose of publishing on Investing News Australia. This article does not constitute financial product advice. It is your responsibility to perform proper due diligence before acting upon any information provided here. Please refer to our full disclaimer here.
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25 June
Oncology Stocks: 8 Biggest NASDAQ Companies in 2024
The wide-ranging oncology market covers every area of cancer care, from diagnosis to treatment.
Coming in only after cardiovascular disease, cancer is the second leading cause of death worldwide; unsurprisingly, oncology is one of the biggest sectors in the life science space. With that in mind, biotechnology and pharmaceutical companies alike are working to develop best-in-class therapeutics for the treatment of various cancers, including lung, breast and prostate cancer.
At this point, their work is far from finished — Fortune Business Insights projects that the global oncology market will increase at a compound annual growth rate of 11.3 percent to reach US$518.25 billion in 2032.
As the global oncology market grows, investors who want exposure to companies working to treat cancer should consider taking a look at biotech and pharma companies with a focus on oncology drugs and testing.
This list of the biggest oncology stocks on the NASDAQ was generated using TradingViews's stock screener. The companies are listed in order of market cap, and all figures below were current as of June 19, 2024.
1. AstraZeneca (NASDAQ:AZN)
Market cap: US$244.56 billion; current share price: US$78.42
First on this list of the top NASDAQ oncology companies by market cap is multinational pharma and biotech firm AstraZeneca, which also specializes in several other therapeutic areas, including cardiovascular, respiratory, central nervous system and pain control. The company is aiming to strengthen its position in the oncology market by more than doubling its cancer drug offerings by 2030.
AstraZeneca has several partnerships with other pharma companies, including Merck (NYSE:MRK). The pair brought PARP-inhibitor LYNPARZA to market as a monotherapy and in combination to address multiple cancer types, including in certain breast, prostate, pancreatic and ovarian tumors. The drug’s revenues for these indications are expected to reach US$4 billion by 2027, representing more than 68 percent of the projected global PARP inhibitors market for that year.
2. Amgen (NASDAQ:AMGN)
Market cap: US$164.14 billion; current share price: US$305.99
One of the world's leading independent biotechnology companies, Amgen uses advanced human genetics to develop and manufacture therapeutics targeting oncological diseases, including a range of solid tumors and hematologic malignancies.
Amgen is advancing a robust pipeline with several mid- to late-stage candidates, including drug candidates targeting leukemia, colorectal cancer and solid tumors. Amgen's oncology portfolio includes first-in-class Bispecific T-cell Engager (BiTE) therapy Blincyto, which in June received US Food and Drug Administration (FDA) approval for the treatment of adult and pediatric patients with Philadelphia chromosome-negative B-cell precursor acute lymphoblastic leukemia in the consolidation phase.
This is the second BiTE therapy from Amgen to gain FDA approval. The company's Imdelltra (tarlatamab) got the nod in May for treating adult patients with extensive-stage small cell lung cancer with disease progression on or after platinum-based chemotherapy.
3. Sanofi (NASDAQ:SNY)
Market cap: US$119.61 billion; current share price: US$47.22
Based in France, Sanofi is developing new technologies based on molecular oncology, immuno-oncology and genomic medicine platforms targeting some of the most difficult-to-treat cancers. The company's oncology strategy encompasses four disease areas: blood cancers, including multiple myeloma; skin cancers; lung cancers; and breast cancer and other hormone-positive cancers.
Sanofi's oncology pipeline includes 13 drug candidates in clinical development, with a focus on solid tumors, leukemia, and myeloma. In June, the company shared positive data from its Phase 3 IMROZ regimen study of Sarclisa (isatuximab) in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) followed by Sarclisa-Rd. The results demonstrated a significant reduction in the risk of disease progression or death by 40 percent when compared to VRd followed by Rd alone.
4. Regeneron Pharmaceuticals (NASDAQ:REGN)
Market cap: US$114.48 billion; current share price: US$1,039.11
Biotech leader Regeneron Pharmaceuticals develops and commercializes medicines targeting cancer, pain and a wide variety of diseases, including inflammatory, cardiovascular, metabolic, hematologic and rare diseases.
The company’s drug candidate portfolio includes 18 clinical-stage programs targeting various cancers, including solid tumors, prostate cancer, cervical cancer and metastatic melanoma. Its 12 FDA approved drugs include Libtayo (cemiplimab-rwlc) for cutaneous squamous cell carcinoma, basal cell carcinoma and non-small cell lung cancer.
In an effort to expand its cell therapy research, Regeneron acquired biotech 2Seventy Bio’s (NASDAQ:TSVT) cancer drug pipeline earlier this year.
“Our expertise in antibody technologies and emerging genetics capabilities, combined with 2seventy’s cell therapy platforms, presents a significant opportunity to address cancer and other serious diseases in new and impactful ways,” said George Yancopoulos, Regeneron’s chief scientific officer, in a statement.
5. Gilead Sciences (NASDAQ:GILD)
Market cap: US$78.68 billion; current share price: US$63.15
Global biopharmaceutical company Gilead Sciences is in the business of developing breakthrough medicines to prevent and treat serious conditions such as HIV, viral hepatitis and cancer. Last year, the company built up its early oncology pipeline with the acquisition of biotech firm XinThera and its portfolio of small molecule inhibitors targeting PARP1.
One of Gilead's biggest successes is Yescarta, a CAR-T cell therapy for blood cancer and the first such therapy for certain types of non-Hodgkin's lymphoma. Earlier this year, Reuters reported that improvements in its manufacturing process will allow the company "to quadruple production of its cell therapy cancer treatments by 2026."
6. Moderna (NASDAQ:MRNA)
Market cap: US$51.05 billion; current share price: US$133.27
Moderna is a leader in applied mRNA science with a diverse clinical portfolio of vaccines and therapeutics. Its mRNA platform harnesses the body's immune system to identify and kill cancer cells, including individualized mRNA-based personalized cancer vaccines.
In June, Moderna and Merck released positive three-year data from a clinical study evaluating the use of an experimental vaccine in combination with Merck's FDA-approved Keytruda in the treatment of melanoma, the most deadly form of skin cancer. The data showed improved survival rates and long-lasting efficacy.
7. BioNTech (NASDAQ:BNTX)
Market cap: US$20.51 billion; current share price: US$86.27
Biopharma BioNTech is advancing immunotherapies for serious diseases, including various forms of cancer. The company’s oncology portfolio includes mRNA-based therapies, CAR-T cell therapies and targeted cancer antibodies.
BioNTech has a collaboration deal with China-based biotech company Duality Biologics to develop, manufacture and license multiple antibody-drug conjugate candidates targeting solid tumors. Early this year, the FDA granted fast track designation for one of them, the candidate BNT325/DB-1305 for the treatment of platinum-resistant ovarian epithelial cancer, fallopian tube cancer or primary peritoneal cancer in patients who have previously received one to three systemic treatment regimens.
However, in mid-June the FDA placed a partial hold on the Phase 1 trial for the candidate after BioNTech disclosed the deaths of three patients due to “treatment-related adverse effects.” The partial hold prevents the enrollment of any new US patients in the study.
“The fact that patients already enrolled in the Phase I BNT326/YL202 study will continue to receive the drug suggested that the FDA’s concerns were manageable,” commented John Newman, PhD, a senior biotechnology analyst with Canaccord Genuity.
8. Illumina (NASDAQ:ILMN)
Market cap: US$17.22 billion; current share price: US$108.10
Illumina develops, manufactures and markets life science tools and integrated systems that enable the implementation of genomic solutions for the healthcare sector with a focus on oncology testing, genetic disease testing, reproductive health and research. The company is expanding its next-generation sequencing oncology portfolio to help clinical cancer researchers estimate tumor mutational burden, identify neoantigens and study innovative therapies to boost the immune response.
In January, Illumina announced an expansion of its collaboration with Janssen Research & Development for the development of the latter's novel molecular residual disease assay. The assay is based on using whole-genome sequencing for multi-cancer research for the detection of circulating tumor DNA. The purpose is to better understand how oncological diseases can persist reoccur following treatment, and it will look at samples "from patients previously diagnosed with cancer across multiple solid tumor indications," according to the release.
This is an updated version of an article first published by the Investing News Network in 2018.
Don’t forget to follow us @INN_LifeScience for real-time updates!
Securities Disclosure: I, Melissa Pistilli, hold no direct investment interest in any company mentioned in this article.
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