On February 3, 2025 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported an unprecedented clinical response including resolution of a lung metastasis (breast cancer tumor that spread to the lung) with stable disease elsewhere (Press release, BriaCell Therapeutics, FEB 3, 2025, View Source [SID1234650078]). This patient is the first metastatic breast cancer (MBC) patient treated with Bria-OTS.

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Bria-OTS is a personalized off-the-shelf immunotherapy, currently under investigation in a Phase 1/2a dose escalation study (ClinicalTrials.gov identifier: NCT06471673 ) in metastatic recurrent breast cancer. Bria-OTS represents a personalized, next generation, advancement of BriaCell’s lead candidate Bria-IMT which is currently in a pivotal Phase 3 study for metastatic breast cancer.

This 78-year-old woman with metastatic breast cancer (hormone receptor positive, HER2 negative) had failed several prior lines of therapy and received the lowest dose level in the Phase 1/2a Bria-OTS study. At enrollment on Nov 21, 2024, she had extensive metastases including multiple bone, lymph node and lung metastases. Following 4 injections with Bria-OTS every 2 weeks, the lung metastasis completely resolved, and she had stable disease elsewhere.

"Despite recent advancements in cancer treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs), metastatic breast cancer remains an unmet medical need as many patients do not respond to these treatments," stated Dr. Neal Chawla, Associate Director of Clinical Research at the Sarcoma Oncology Center, and Principal Investigator for the Bria-OTS study. "We are very impressed by the clinical response observed showing rapid and robust clinical activity in addition to excellent tolerability in the first patient treated with Bria-OTS and look forward to reproducing these results in other cancer patients in the study."

"This data supports our hypothesis of personalized immunotherapy with Bria-OTS, potentially leading to new and effective treatment of metastatic breast cancer," stated Dr. William V. Williams, BriaCell’s President and CEO. "We hope to transform the way we treat cancer patients with our novel personalized off-the-shelf immunotherapy approach."

"Resolution of metastatic lung disease in this breast cancer patient highlights the clinical effectiveness of Bria-OTS, and its therapeutic potential in MBC," commented Dr. Giuseppe Del Priore, BriaCell’s Chief Medical Officer. "This result represents a major step towards advancing our innovative technology platform and our goal of offering safe and effective treatment to MBC patients and our plans to extend into prostate cancer, melanoma, and lung cancer."

The Phase 1/2a clinical trial is initially evaluating the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with an immune checkpoint inhibitor in metastatic breast cancer. Key inclusion criteria include recurrent metastatic breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design includes a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with an immune check point inhibitor.

On February 3, 2025 AdvanCell, a clinical-stage radiopharmaceutical company developing innovative cancer therapeutics, reported the successful completion of an oversubscribed US$112 million Series C financing (Press release, Advancell, FEB 3, 2025, View Source [SID1234650011]). This milestone funding round was co-led by SV Health Investors, Sanofi Ventures, Abingworth, and SymBiosis. Additional support came from existing investor Morningside, alongside new investors Tenmile, Brandon Capital, and others.

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Since its founding in June 2019, AdvanCell has grown from a belief in the potential of Targeted Alpha Therapy into a global organisation with 60 passionate team members, a 40,000-square-foot manufacturing facility, world-class pre-clinical infrastructure, a potentially best-in-class drug for prostate cancer that is in trials, and a deep and developing pipeline of assets.

This investment will fuel AdvanCell’s ongoing efforts to expand its manufacturing capacity, accelerate the clinical development of its pipeline of radionuclide therapies, and advance its mission of delivering life-changing treatments to cancer patients worldwide.

AdvanCell is currently enrolling patients for the highest dose cohort of its multi-center TheraPb Ph I/II dose escalation clinical trial of ADVC001 for metastatic prostate cancer, a potentially best-in-class Targeted Alpha Therapy. The trial aims to demonstrate the safety and efficacy of Pb-212-based radionuclide treatment.

As part of the financing, Jamil M. Beg from SV Health Investors, Christopher Gagliardi from Sanofi Ventures, and Bali Muralidhar from Abingworth have joined the AdvanCell Board of Directors. They bring extensive industry expertise to support the company’s growth and join existing directors Bill Ferris AC, Anthony Aiudi, Kevin Cameron, and Andrew Adamovich.

Jamil M. Beg, Partner at SV Health Investors, commented:

"We are delighted to support AdvanCell’s growth and play a role in its remarkable journey through leading this oversubscribed Series C. We have looked long and deep at the field of radionuclide therapies and are confident that AdvanCell stands out with a first-in-class Pb-212-PSMA program and a best-in-class manufacturing platform. The company’s exceptional team, technologies, robust infrastructure, collaborations with some of the world’s largest pharma companies and ability to consistently execute, position it to truly change outcomes for patients. We are excited to help AdvanCell realize its potential in transforming cancer care globally."

AdvanCell was founded on the belief that Targeted Alpha Therapies could change the course of cancer treatment and that the scalable supply of isotopes would enable the development of multiple practice-changing drugs. Radionuclide therapies for prostate cancer and gastroenteropancreatic neuroendocrine tumours have transformed patient care. Pb-212 Targeted Alpha Therapy has the potential to further advance this progress by leveraging the radiobiological and physical attributes of Pb-212 to make life-changing treatments for patients.

"This successful Series C round demonstrates strong confidence in our vision and capabilities," said Andrew Adamovich, CEO of AdvanCell. "We are grateful for the continued support from our existing investors, particularly the long-term support from Morningside and are excited to welcome new partners who share our commitment to transforming cancer care. With this funding, AdvanCell is well-positioned to scale our manufacturing operations and progress our cutting-edge therapies towards commercialization."

The Series C funding represents a significant step in AdvanCell’s journey to become a global leader in radionuclide-based cancer therapeutics.

On February 3, 2025 Nuvation Bio Inc. (NYSE: NUVB), a global biopharmaceutical company tackling some of the greatest unmet needs in oncology, reported it has initiated an Expanded Access Program (EAP) for taletrectinib in the U.S. for the treatment of patients with locally advanced or metastatic ROS1-positive (ROS1+) non-small cell lung cancer (NSCLC) when no comparable or satisfactory alternative therapy options are available (Press release, Nuvation Bio, FEB 3, 2025, View Source [SID1234650010]).

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"We are committed to working with the ROS1-positive NSCLC community, and the healthcare providers who serve them, to ensure this EAP provides eligible patients in the U.S. with efficient access to taletrectinib outside of our clinical trials."

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"This EAP reflects our unwavering dedication to patients with ROS1-positive NSCLC," said David Hung, M.D., Founder, President, and Chief Executive Officer of Nuvation Bio. "We are committed to working with the ROS1-positive NSCLC community, and the healthcare providers who serve them, to ensure this EAP provides eligible patients in the U.S. with efficient access to taletrectinib outside of our clinical trials."

The EAP, as authorized by the U.S. Food and Drug Administration (FDA), allows patients with serious or immediately life-threatening ROS1+ NSCLC to access taletrectinib outside of the ongoing pivotal Phase 2 TRUST-II study.

"ROS1-positive NSCLC is a rare form of lung cancer with a unique patient journey to navigate," said Janet Freeman-Daily, Co-Founder and President of The ROS1ders. "At The ROS1ders, we are constantly working toward our goal of improving survival and quality of life for the ROS1-positive cancer community by encouraging the research, development, and commercialization of effective treatments. Despite recent progress, there are times when approved therapies have not provided sufficient benefit or when patients are not eligible for a clinical trial. EAPs represent an opportunity for patients and their families to access investigational drugs that would not have otherwise been available to them."

In December 2024, the U.S. FDA accepted Nuvation Bio’s New Drug Application (NDA) for taletrectinib for the treatment of advanced ROS1+ NSCLC (line agnostic). The U.S. FDA granted the application Priority Review and assigned a Prescription Drug User Fee Act (PDUFA) goal date of June 23, 2025. The NDA is based on the pooled results from the pivotal Phase 2 TRUST-I and TRUST-II studies of taletrectinib, which were presented at the European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress in September 2024.

About Expanded Access to Taletrectinib

EAPs are intended to serve as a potential pathway for a patient with a serious or immediately life-threatening disease or condition to gain access to an investigational medical treatment outside of clinical trials and before it is approved by the U.S. FDA. The EAP for taletrectinib may be available for patients with locally advanced or metastatic ROS1+ NSCLC who, in the opinion of the treating clinician, are not appropriate candidates for approved ROS1 targeted therapies and ongoing taletrectinib clinical studies. For additional information on Nuvation Bio’s clinical trials and EAP, please visit View Source or contact [email protected].

About Taletrectinib

Taletrectinib is an oral, potent, central nervous system-active, selective, next-generation ROS1 inhibitor specifically designed for the treatment of patients with advanced ROS1+ NSCLC. Taletrectinib is being evaluated for the treatment of patients with advanced ROS1+ NSCLC in two Phase 2 single-arm pivotal studies: TRUST-I (NCT04395677) in China, and TRUST-II (NCT04919811), a global study.

Based on pooled results of the TRUST-I and TRUST-II clinical studies, the U.S. FDA has accepted for Priority Review Nuvation Bio’s NDA for taletrectinib for the treatment of patients with advanced ROS1+ NSCLC (line agnostic, full approval) and assigned a PDUFA goal date of June 23, 2025. The U.S. FDA previously granted taletrectinib Breakthrough Therapy Designation for the treatment of patients with locally advanced or metastatic ROS1+ NSCLC who either have or have not previously been treated with ROS1 TKIs, and Orphan Drug Designation for the treatment of patients with ROS1+ NSCLC and other NSCLC indications. In January 2025, China’s National Medical Products Administration (NMPA) approved taletrectinib for the treatment of adult patients with locally advanced or metastatic ROS1+ NSCLC.

About ROS1+ NSCLC

Each year, more than one million people globally are diagnosed with NSCLC, the most common form of lung cancer. It is estimated that approximately 2% of patients with NSCLC have ROS1+ disease. Up to 35% of patients newly diagnosed with metastatic ROS1+ NSCLC have tumors that spread to their brain, increasing up to 55% for those whose cancer has progressed following initial treatment. Despite recent progress for patients with ROS1+ NSCLC, there remains a need for more effective and tolerable treatment options.

On February 3, 2025 TriSalus Life Sciences Inc. (Nasdaq: TLSI), a biomedical technology company seeking to transform outcomes for patients with solid tumors by integrating its innovative delivery technology with standard-of-care therapies and its investigational immunotherapy, reported that it has requested a drawdown of $10 million under its previously announced $50 million credit agreement with OrbiMed, a healthcare investment firm (Press release, TriSalus Life Sciences, FEB 3, 2025, View Source [SID1234650009]).

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Pursuant to the to the Agreement, OrbiMed agreed to provide a term loan facility in an aggregate principal amount of $50 million. The $10 million drawdown became available to TriSalus upon achievement of product revenue-based milestone of $30 million for the trailing 12-months ending on January 31, 2025. With the closing of the $10 million tranche, the company has drawn a total of $35 million under the credit agreement with OrbiMed.

On February 3, 2025 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Janssen-Cilag International NV, a Johnson & Johnson company, received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency recommending an extension of marketing authorisation for a subcutaneous (SC) formulation of RYBREVANT (amivantamab) in combination with LAZCLUZE (lazertinib) for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with epidermal growth factor receptor (EGFR) exon 19 deletions or exon 21 L858R substitution mutations, and as a monotherapy for the treatment of adult patients with advanced NSCLC with activating EGFR exon 20 insertion mutations after failure of platinum-based therapy (Press release, Halozyme, FEB 3, 2025, View Source [SID1234650008]).

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"We are pleased that the subcutaneous formulation of amivantamab, which was developed with our ENHANZE drug delivery technology, was recommended for approval in Europe," said Dr. Helen Torley, president and chief executive officer of Halozyme. "The data that support the recommendation could represent a very compelling proposition for patients with the approximate five-minute administration time and five-fold reduction in infusion related reactions."

The CHMP positive opinion is supported by positive results from the Phase 3 PALOMA-3 study (NCT05388669). For more information on the study and its findings, please view Johnson & Johnson’s press release issued today.

Subcutaneous amivantamab is co-formulated with recombinant human hyaluronidase PH20 (rHuPH20), Halozyme’s ENHANZE drug delivery technology.

1 Leighl NB et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor–Mutated Non–Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. ASCO (Free ASCO Whitepaper) Journal of Clinical Oncology. 2024;42(3):3593-3605.

2 Leighl NB, et al. Subcutaneous Versus Intravenous Amivantamab, Both in Combination With Lazertinib, in Refractory Epidermal Growth Factor Receptor-Mutated Non-Small Cell Lung Cancer: Primary Results From the Phase III PALOMA-3 Study. J Clin Oncol. 2024 Oct 20;42(30):3593-3605.

3 ClinicalTrials.gov. A Study of Lazertinib With Subcutaneous Amivantamab Compared With Intravenous Amivantamab in Participants With Epidermal Growth Factor Receptor (EGFR)-Mutated Advanced or Metastatic Non-small Cell Lung Cancer (PALOMA-3). View Source Accessed January 2025.