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First Patient Enrolled in CHM CDH17 Phase 1/2 Clinical Trial
July 24, 2024
Chimeric Therapeutics (ASX:CHM, “Chimeric” or the “Company”), an Australian leader in cell therapy, is pleased to announce that the first participant has been enrolled in the Phase 1/2 multi-centre clinical trial for CHM CDH17 cell therapy.
The Phase 1/2 trial (NCT06055439) is a two-stage study designed to determine a recommended Phase 2 dose of CHM CDH17 and evaluate its safety and objective response rate in patients with advanced colorectal cancer, gastric cancer, and intestinal neuroendocrine tumours.
“This is great progress for this first-in-human study for bowel cancer patients with significant unmet need; congratulations to the CHM team and our investigational sites on this milestone.” said Dr Rebecca McQualter, Chief Operating Officer of Chimeric Therapeutics.
“It is exciting to see the advancement from the development of the CDH17 CAR T technology in our laboratory to the enrollment of the first patient in this Phase 1/2 study,” said Xianxin Hua, MD, PhD, Professor of Cancer Biology in Penn’s Perelman School of Medicine, an investigator at the Abramson Family Cancer Research Institute and a Harrington Scholar Innovator.
Additional clinical trial sites are anticipated to open in the second half of 2024.
ABOUT CHIMERIC THERAPEUTICS
Chimeric Therapeutics, a clinical stage cell therapy company and an Australian leader in cell therapy, is focused on bringing the promise of cell therapy to life for more patients with cancer. We believe that cellular therapies have the promise to cure cancer, not just delay disease progression.
To bring that promise to life for more patients, Chimeric’s world class team of cell therapy pioneers and experts is focused on the discovery, development, and commercialization of the most innovative and promising cell therapies.
Chimeric currently has a diversified portfolio that includes first in class autologous CAR T cell therapies and best in class allogeneic NK cell therapies. Chimeric assets are being developed across multiple different disease areas in oncology with 3 current clinical programs and plans to open additional clinical programs in 2024.
Click here for the full ASX Release
This article includes content from Chimeric Therapeutics Limited, 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.
09 December
StickIt Technologies Inc. Announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults for 2025
StickIt Technologies Inc.(the" Company "or "StickIt") (CSE: STKT), an Israeli Canadian technology company, announces a ground-breaking new development of a medical straw for delivering vitamins to children and adults and start the research in 2025 once fund raising will be completed.
Stickit Technologies has developed a straw plus cartridge for delivering vitamins and/or medications for children and/or adults who have difficulty swallowing pills or for children who regularly miss medications and/or vitamins. The company, which filed a patent for a straw plus cartridge for transporting cannabinoids and/or medications, decided to develop a model of a medical straw for transporting vitamins and medications for children and adults.
The company intends to raise 1.5 million Canadian dollars for the new medical straw project during Q1 and Q2 2025. StickIt Technologies will establish a new subsidiary named "Stickit Pharma Ltd". and will be owned by the public company and the new investors who will join.
The company intends to seek partnerships with generic pharmaceutical companies globally that are interested in being part of the research and submission for FDA approval.
"This is a significant breakthrough for our company and the investors." says Eli Ben Haroosh, CEO of StickIt Technologies Inc. "We are looking for every opportunity to develop our technology and lead the global market. I believe that if we will raise the necessary fund and also succeed in raising partnerships with generic pharmaceutical companies, making Stickit a pharma leader very soon." concluded Ben Haroosh.
About StickIt Technologies Inc
StickIt is a technology company that invented and manufactures innovative products ("devices") that can contain varying quantities of Catabolites or Vitamins for recreational and medical users. Its operating model is to establish joint ventures/licensees ("partners") in countries around the world that will establish a production facility in which they will add the cannabinoid content to the "sticks" and "straws" produced and supplied by StickIt. The Company's precise dosing options cater to a wide range of effects, including painkilling, energizing, focus, sleep improvement, etc., and can be tailored to meet local preferences and regulations. StickIt Technologies serves customers worldwide.
For more information, please contact:
StickIt Technologies Inc.
Eli Ben Haroosh, CEO
E: info@stickit-labs.com
Sophie Galper , CFO
E: sophie@stickit-labs.com
Website: www.stickit-labs.com
Facebook: @Stickit
Twitter "X": @STICKIT74776509
LinkedIn: @Stickit-labs
Neither the Canadian Securities Exchange nor its Regulation Services Provider (as that term is defined in the policies of the Canadian Securities Exchange) accepts responsibility for the adequacy or accuracy of this press release.
Forward-Looking Statements
This news release includes certain statements and information that constitute forward-looking information within the meaning of applicable Canadian securities laws. All statements in this news release, other than statements of historical facts, are forward-looking statements. The Company provides no assurance that forward-looking statements and information will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements or information. Accordingly, readers should not place undue reliance on forward-looking statements or information. The Company does not undertake to update any forward-looking statements, other than as required by law. More detailed information about potential factors that could affect financial results is included in the documents filed from time to time with the Canadian securities regulatory authorities by StickIt Technologies Inc. Readers are cautioned not to place undue reliance on forward-looking statements.
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03 December
Invion Doses First Patient in Phase I/II Non-Melanoma Skin Cancer Trial
Invion Limited (ASX: IVX) (“Invion” or the “Company”) is pleased to announce the dosing of the first patient in its Phase I/II non- melanoma skin cancer (NMSC) trial conducted at Veracity Clinical Research (Veracity) in Brisbane.
Highlights:
- First patient has been dosed in Invion’s open label Phase I/II non-melanoma skin cancer (NMSC) trial using topical INV043.
- The study is being conducted at Veracity Clinical Research’s facilities, based in Queensland Australia.
- Skin cancer is one of the world’s most common cancers and NMSC constitutes >98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322.
- Preclinical studies indicate INV043 may have distinct advantages over current NMSC treatments, such as efficacy without scarring and with minimal pain.
- The NMSC trial follows the release of promising Phase II prostate cancer trial results using INV043, and Invion plans to leverage the NMSC data into a planned Phase II anogenital cancer trial
The trial marks a significant milestone for Invion and is designed to evaluate the safety and efficacy of its lead drug candidate INV043, a novel photosensitiser developed in Australia for use in Photodynamic Therapy (PDT) for the treatment of multiple cancers.
Trial Design and Objectives
This open-label, adaptive trial provides flexibility to go beyond the testing and collection of human safety data of the topical formulation of INV043.
The initial part of the study aims to assess the safety profile of the topically applied INV043 in non-metastatic cutaneous Squamous Cell Carcinoma (cSCC). Subsequent parts aim to address dose optimisation (dose-light interval and light intensity) and the identification of efficacy signals. Part 3 will expand testing to include superficial Basal Cell Carcinoma (sBCC)
The adaptive design allows for modifications to the trial procedures based on interim results, enhancing the efficiency and effectiveness of the study. As such, the trial will enrol a minimum of 18 patients, which can be increased depending on the results.
Veracity will select male and female patients over the age of 18 with non-metastatic cSCC and sBCC, although other NMSCs may be approved on a case-by-case basis. Other screening criteria include size and location of the lesion.
Significance of NMSC
Skin cancer is one of the world’s most common cancers and NMSC makes up over 98% of all skin cancers1 with the global treatment market to hit US$21.1 billion by 20322. The prevalence of the disease highlights the urgent need for effective and affordable treatments with minimal side effects.
Currently, the mainstream treatment for SCC and BCC is surgery, which can lead to permanent scarring. Preclinical studies undertaken at the Hudson Institute of Medical Research showed the potential for INV043 to regress cancers without scarring and with minimal pain.
Next Steps
The NMSC trial follows the release of promising results from a Phase II prostate cancer trial using the same active pharmaceutical ingredient, INV043. Once the trial results have been analysed, in addition to progressing the NMSC program, Invion plans to leverage this data into a planned Phase II anogenital cancer trial using topical INV043, and potentially including the use of immune checkpoint inhibitors (ICIs) on the back of solid in vivo data from the Peter MacCallum Cancer Centre.
This study showed 80% complete pathological control of anal squamous skin cancers versus a 12% response rate on ICI treatments on a standalone basis.
The Executive Chair and Chief Executive Officer of Invion, Thian Chew, said:
“Having the first patient dosed in our NMSC trial is a significant milestone for Invion in demonstrating the potential for the Photosoft technology to address limitations and undesirable side effects of current standard of care for NMSCs, including scarring and pain.”
“On the back of the recently announced prostate cancer results, this trial can also provide clinical evidence that INV043 can be safely used in more than one formulation to treat multiple cancers. This can then open up the potential for our next-generation PDT to become an important alternative modality for treating cancers.”
The NMSC trial will be conducted under International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) good clinical practice (GCP) and ISO 14155 standards.
Click here for the full ASX Release
This article includes content from Invion Limited, 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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19 November
Resonance Contracted by Major Global Pharma Company for Clinical Drug Trial Worth $13.775 Million over 24 Months
Resonance Health Ltd (ASX: RHT) (Resonance or the Company) advises that it has been contracted by Sun Pharmaceutical Industries Limited, an international, publicly listed pharmaceutical company with global operations (Customer) to be the local Australian sponsor, and to provide clinical research organisation (CRO) services, trial site services, and imaging analysis services (collectively, Services), for their clinical trial in Australia of a new drug compound (Clinical Trial).
New Clinical Trial
The newly executed clinical trial agreement (Agreement) is worth an estimated AUD $13.775 million in revenue to the Resonance group over the next ~24 months, with the first payment of AUD $2.066 million due within 30 days of Agreement execution. Resonance, through its wholly owned subsidiary, CRO Services Pty Ltd (CRO Services), will serve as CRO and Local (Australian) Sponsor for the Customer and will engage and make payment to the institutions, trial sites, and the vendors needed to conduct the Clinical Trial.
Whilst the Company will receive the first payment within 30 days of Agreement execution, provision of the Services under the Agreement (and the remaining payments) are subject to (among other things) receipt of regulatory approvals to commence the Clinical Trial including human research ethics committee approval (Regulatory Approvals).
Resonance will provide its imaging analysis services at various timepoints throughout the Clinical Trial along with clinical trial site services through its recently acquired TrialsWest business. It is notable that trial sites are among the largest vendors for clinical trials of this nature, so a benefit of the TrialsWest acquisition is that a significant portion of the revenues payable to trial sites will now stay within the Resonance group.
The Company expects patient recruitment for the Clinical Trial could commence in early 2025, subject to receipt of Regulatory Approvals, with both TrialsWest sites expected to play a key role in the recruitment of subjects and the conduct of the Clinical Trial.
This contract win highlights Resonance’s strategy of providing its technology and services to the burgeoning and highly technical global pharma and clinical trials markets.
The material commercial terms of the Agreement are set out at Annex A.
Resonance Health CEO, Mr Andrew Harrison commented:
“The Agreement is a direct result of the incredible work the team have done in executing the existing clinical trial with the customer and more broadly the Company’s focus on winning more work in the global clinical trials ecosystem. This illustrates our ability to win repeat work from customers, and our capacity to scale the size of contract wins.”
This announcement has been authorised for release in accordance with the delegated authority of the Board of Directors of Resonance Health Ltd.
Click here for the full ASX Release
This article includes content from Resonance Health Ltd, 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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18 November
ISLA-101 Phase 2a/b PROTECT Clinical Trial Progress Update
Australian antiviral drug development company, Island Pharmaceuticals Ltd (ASX: ILA; Island or the Company) is pleased to announce progress on its ISLA-101 Phase 2a/b clinical trial in dengue fever.
- All key data samples have been collected following dosing of all subjects in the Phase 2a (prophylactic) trial as part of Island’s ISLA-101 Phase 2a/b PROTECT clinical trial in dengue fever
- Data currently being consolidated for review by the Safety Review Committee (SRC) in the coming weeks
- On track to release SRC recommendation on advancing the trial to Phase 2b by end of this calendar year
In Island’s Phase 2a trial, subjects receive ISLA-101 before being infected with a weakened dengue virus developed by the US Army. The trial aims to assess whether ISLA-101 can prevent or reduce viremia and symptoms compared to a placebo, based on previous control data showing elevated viremia and symptoms in untreated subjects.
Following the announcement (ASX: 3 October 2024) that all subjects in the Phase 2a cohort of the trial had been dosed, Island confirms it has now collected the required samples to analyse how the viremia (viral load) levels in the blood of trial subjects have changed through the study. Other samples are being analysed for pharmacokinetic data as well as other blood analyses.
This data is currently being consolidated for review by the Safety Review Committee (SRC), who will meet in the coming weeks. The SRC will evaluate the safety of ISLA-101 in dengue infected individuals and consider if there is evidence of anti-dengue activity. They will then make a recommendation regarding advancing the trial to the Phase 2b cohort before the end of the calendar year.
Island’s CEO and Managing Director, Dr David Foster commented, “We are very pleased to be able to report that 46 days into the trial, we’ve collected the key data required for evaluation by the Safety Review Committee. From here, while we will continue to check in with patients up to 90 days post dosing, we look forward to providing all the data to the SRC for evaluation in the coming weeks. Importantly, this means we remain on track to report data before the end of the year from our Phase 2a component, and next steps for the Phase 2b cohort before the end of the year.”
Phase 2b will include 10 subjects randomised 8:2 (active: placebo) and will examine if ISLA-101 has activity as a treatment against dengue infection. This is the first time a potential countermeasure to combat the dengue virus, which afflicts more than 400 million individuals a year and for which there is no therapeutic option, is being investigated as both a preventative and therapeutic measure.
To subscribe to Island’s monthly newsletter, IslandWatch, and other forms of email communications, please visit this page of our website.
Click here for the full ASX Release
This article includes content from Island Pharmaceuticals, 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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30 October
Interim Data from Accent Pancreatic Cancer Trial Supports Continuation of Trial
Amplia Therapeutics Limited (ASX: ATX), (“Amplia” or the “Company”), is pleased to report the interim data analysis from the Company’s Phase 2a clinical trial investigating narmafotinib in the treatment of advanced pancreatic cancer (the ACCENT trial). The trial is investigating the combination of the Company’s best-in-class FAK inhibitor narmafotinib with the standard-of-care chemotherapy regimen of gemcitabine and Abraxane®. Data cut-off for the interim analysis is 27 September 2024.
HIGHLIGHTS
- Data analysis up to 27 September 2024 from the ongoing ACCENT trial of narmafotinib in combination with chemotherapy has been undertaken
- Fifteen patients of the 26 enrolled in the study remain on trial with six (6) confirmed PRs having been recorded along with four (4) unconfirmed PRs and five (5) SDs
- The median duration on trial is longer than for comparative trials of chemotherapy alone
- The ACCENT trial has resumed recruitment for the final cohort of 24 patients and as of 24 October 2024, 3 patients have been recruited
As previously reported by the Company, narmafotinib continues to be generally well tolerated by patients with no dose reductions. In addition, six (6) patients recorded confirmed partial responses (PRs), meaning in these patients there is at least a 30% decrease in the overall size of tumour lesions, with no new tumour lesions, sustained for two or more months.
Further details regarding the responses observed by trial participants are summarised below and presented in the attached slides:
- 6 patients have recorded unconfirmed PRs, 4 of which are awaiting confirmation whilst 2 have subsequently recorded progressive disease (PD)
- 8 patients recorded sustained stable disease (SD), with 5 of these patients remaining on study
- 3 patients recorded PD as best response, while 3 other participants were considered ineligible or withdrew from the trial
- Of the 24 evaluable patients, 19 have recorded a decrease in tumour size as best response at any scan
- Median duration on trial at data cut-off is 136 days, which compares favourably with historical data for chemotherapy alone of 117 days
- Preliminary analysis indicates patients have a faster response to therapy in terms of tumour reduction, compared to historical data for chemotherapy alone
A total of 50 patients are planned for the Phase 2a ACCENT trial. With the six (6) confirmed PRs obtained, recruitment of the remaining 24 patients has begun. Recruitment of the second cohort of patients is expected to be completed by end of Q1 2025 and three patients have already been enrolled as of 24 October 2024.
Amplia CEO and MD Dr Chris Burns commented: “We continue to be excited by the data coming from the clinical study of narmafotinib in this challenging disease. We thank the patients and their loved ones for their involvement in the study. Further trial updates will be provided to the market in due course."
Click here for the full ASX Release
This article includes content from Amplia Therapeutics, 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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