On September 3, 2024 HighField Biopharmaceuticals, a clinical stage company using lipid-based therapeutics to treat cancer, diabetes and other diseases, reported that it has filed an investigational new drug (IND) application with China’s National Medical Products Administration to conduct a clinical trial of HF50, a first-of-its-kind immunoliposome that directs T cells to attack solid tumors and enhances the anticancer activity with an immune modulator (Press release, HighField Biopharmaceuticals, SEP 3, 2024, View Source [SID1234646332]).

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HF50 is a lipid bilayer system with two different antibodies attached; the first bind to T cells and the second bind to tumor cells, engaging the T cells to destroy the cancer. This unique lipid structure is called a T cell Redirecting Antibody Fragment-anchored Liposome, or TRAFsome. It also carries a payload of Resiquimod, a small molecule compound that modulates T cell response, enhancing anti-tumor activity.

"Our TRAFsomes attach to receptors on the surface of T cells, externally coating the immune cells with tumor targeting antibodies, converting the T cells into an army of cancer destroyers," said Yuhong Xu, Ph.D., HighField’s CEO and Scientific Founder. "HF50 also represents the first systemic use of Resiquimod, and data show that stimulating the immune T cells in this manner greatly enhances the anti-tumor activity."

As a T cell engager of cancer, HF50 has multiple advantages over others such as bispecific antibodies and CAR T therapy, Dr. Xu added. "Bispecifics have very limited antibody conjugation schemes," she explained, "limiting their efficacy in solid tumors. As for CAR T, the goal is to produce T cells expressing anti-tumor antibodies on their outer membrane. HF50 achieves this goal without the complex and expensive processing inherent in CAR T therapies."

In addition, Dr. Xu observed, most existing T cell engagers have a higher risk of toxicity than HF50. "Our product has a liposome-based in vivo action process," she said, "which is less distributed in normal tissues, but can concentrate in solid tumors through the enhanced permeability and retention effect."

In preclinical studies, HF50 has shown to be a highly effective anti-cancer agent in both in vitro and in vivo. The data demonstrate that it processes a novel cell bridging function between T cells and tumor cells, with the capability of activating immune cells. HF50 effectively stimulates T cell activation and displays significant efficacy in humanized tumor-bearing mice models. Pharmacokinetic research also confirms HF50 successfully maintains drug levels in the bloodstream, and improves drug accumulation within tumor tissues.

On September 3, 2024 Obsidian Therapeutics, Inc., a clinical-stage biotechnology company pioneering engineered cell and gene therapies, reported that the U.S. Food and Drug Administration (FDA) has granted Regenerative Medicine Advanced Therapy (RMAT) designation to OBX-115 for the treatment of patients with unresectable or metastatic melanoma that is resistant to immune checkpoint inhibitor (ICI) therapy (Press release, Obsidian Therapeutics, SEP 3, 2024, View Source [SID1234646331]). OBX-115 is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with membrane-bound IL15 (mbIL15) that is pharmacologically regulated using FDA-approved small molecule drug acetazolamide. This second FDA designation follows a July 2024 announcement of Fast Track designation for OBX-115.

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"RMAT designation for OBX-115 highlights the unmet need in ICI-resistant melanoma and OBX-115’s potential to provide patient-centric, transformative care in this setting," said Parameswaran Hari, M.D., Chief Development Officer of Obsidian. "In an oral presentation at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, initial Phase 1 data showed that OBX-115 exhibited a favorable safety profile relative to what has been observed historically from IL2-dependent non-engineered TIL cell therapy, encouraging efficacy in patients with heavily pre-treated disease, and compatibility with non-surgical core needle biopsy tumor tissue procurement. We look forward to continued collaborative interaction with the FDA as we advance OBX-115 clinical development in both melanoma and non-small cell lung cancer (NSCLC)."

Established under the 21st Century Cures Act, RMAT designation is a dedicated program that includes the benefits of Fast Track and Breakthrough Therapy designations and is designed to expedite the development and review processes for certain promising drug candidates, including cell therapies. An investigational cell therapy is eligible for RMAT designation if it meets the definition of regenerative medicine therapy, is intended to treat, modify, reverse, or cure a serious or life-threatening disease or condition, and preliminary clinical evidence indicates that the therapy has the potential to address unmet medical needs for that disease. RMAT designation provides early and frequent interactions with the FDA, including intensive guidance on efficient drug development. Candidates receiving RMAT designation may also be eligible for Accelerated Approval and Priority Review.

About OBX-115

Obsidian’s lead investigational cytoTIL15 program, OBX-115, is a novel engineered tumor-derived autologous T cell immunotherapy (tumor-infiltrating lymphocyte [TIL] cell therapy) armored with pharmacologically regulatable membrane-bound IL15 (mbIL15). OBX-115 has the potential to become a meaningful therapeutic option for patients with advanced or metastatic melanoma and other solid tumors by leveraging the expected benefits of mbIL15 and Obsidian’s proprietary, differentiated manufacturing process to enhance persistence, antitumor activity, and clinical safety of TIL cell therapy. Obsidian is investigating OBX-115 in a multicenter trial in patients with advanced melanoma or relapsed / refractory NSCLC (NCT06060613).

On September 3, 2024 Avenzo Therapeutics, Inc. ("Avenzo"), a clinical-stage biotechnology company developing the next generation of oncology therapeutics, reported it has entered into a clinical study collaboration and supply agreement with Gilead Sciences, Inc. ("Gilead") to evaluate the safety and efficacy of AVZO-021, its investigational, potentially best-in-class CDK2 inhibitor, in combination with Gilead’s Trodelvy (sacituzumab govitecan-hziy), a Trop-2 directed antibody-drug conjugate (ADC), as a potential treatment for patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) breast cancer (Press release, Avenzo Therapeutics, SEP 3, 2024, View Source;Metastatic-Breast-Cancer [SID1234646330]).

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"We are excited to advance our oncology pipeline by entering this clinical collaboration with Gilead to evaluate the combination potential of AVZO-021," said Athena Countouriotis, M.D., Co-founder, President and CEO of Avenzo Therapeutics. "We continue to believe AVZO-021 is a potential best-in-class CDK2 selective inhibitor that may provide a new treatment option to patients. We look forward to initiating combination cohorts with Trodelvy, as well as CDK4/6 inhibitors, in the Phase 1b portion of the ongoing clinical study in the fourth quarter of 2024."

Under the clinical study collaboration and supply agreement, Gilead will provide Trodelvy to Avenzo, who will conduct and sponsor the combination study. Avenzo and Gilead will retain all development and commercial rights to their respective compounds, including as monotherapy or as combination therapies.

Trodelvy and Gilead are trademarks of Gilead Sciences, Inc., or its related companies.

On September 3, 2024 Foundation Medicine, Inc. reported that it has received approval from the U.S. Food and Drug Administration (FDA) for FoundationOneCDx and FoundationOneLiquid CDx to be used as companion diagnostics for AstraZeneca’s and Merck’s (known as MSD outside of the United States and Canada) Lynparza (olaparib) in combination with abiraterone and prednisone or prednisolone for the treatment of adult patients with deleterious or suspected deleterious BRCA-mutated (BRCAm) metastatic castration-resistant prostate cancer (mCRPC) (Press release, Foundation Medicine, SEP 3, 2024, View Source [SID1234646328]). This decision from the FDA follows the approval of FoundationOne CDx for Lynparza to identify mCRPC patients with homologous recombination repair (HRR) gene alterations and the approval of FoundationOne Liquid CDx for Lynparza to identify patients with BRCA1, BRCA2 and/or ATM alterations in mCRPC.

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Prostate cancer is one of the most common cancers in men.1 BRCA1- or BRCA2-mutated mCRPC is a particularly aggressive form of the disease,2 occurring in approximately 11% of diagnoses.3 Despite progress in developing new treatment options for this condition, BRCA1- or BRCA2-mutated mCRPC remains difficult to treat and patients often face a poor prognosis.4

"This approval reinforces the importance of testing for genomic mutations at metastatic diagnosis to help guide treatment decisions," said Mia Levy, M.D., Ph.D., chief medical officer at Foundation Medicine. "Our high-quality tissue and liquid biopsy companion diagnostic tests will allow more patients to access genomic testing, regardless of specimen type, and will simplify complex decisions by generating the best information to enable better decision-making. There is a critical unmet need for first-line treatment options for patients with BRCA-mutated metastatic castration-resistant prostate cancer and this combination therapy is an important advancement."

Foundation Medicine is the only company with an FDA-approved portfolio of tissue and blood-based comprehensive genomic profiling tests. Using a tissue sample, the FDA-approved FoundationOne CDx test analyzes more than 300 cancer-related genes for genomic alterations in a patient’s tumor. From a simple blood sample, FoundationOneLiquid CDx analyzes more than 300 cancer-related genes to provide genomic insights.

With today’s approval, Foundation Medicine is the only company that has seven FDA-approved companion diagnostic indications for prostate cancer.5 Foundation Medicine is the global leader in companion diagnostic approvals. The company has 60% of all U.S. companion diagnostic approvals for next-generation sequencing (NGS) testing.6

"This is an important milestone for men with aggressive prostate cancer," said Courtney Bugler, President and CEO of ZERO Prostate Cancer. "Biomarker testing is an important tool for patients and families to help facilitate personalized treatment decision making, and we applaud Foundation Medicine for these additional companion diagnostic indications."

Lynparza is jointly developed and commercialized by AstraZeneca and Merck.

On September 3, 2024 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that Alan H. Auerbach, Chairman, Chief Executive Officer, President and Founder, reported that it will provide an overview of the Company at 3:00 p.m. EDT on Monday, September 9 at the H.C. Wainwright 26th Annual Global Investment Conference (Press release, Puma Biotechnology, SEP 3, 2024, View Source [SID1234646327]). The conference will be held September 9 – 11, 2024 at the Lotte New York Palace Hotel in New York City.

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A live webcast of the presentation will be available on the Company’s website at View Source The presentation will be archived on the website and available for 30 days.