On May 15, 2023 Therapeutic Solutions International (TSOI) spin-off Res Nova Bio announced today a collaboration with Cure Stat Rx, a premiere compounding Pharmacy in the manufacture of initiate doses of FloraStilbene for a planned 12 patient Phase I/II trial aimed at assessing immunomodulatory activity of the drug candidate in advanced breast cancer patients (Press release, Therapeutics Solutions International, MAY 15, 2023, View Source [SID1234631761]).

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The Company previously announced Institutional Review Board clearance to initiate the clinical trial. As part of the collaboration, Ramesh Chigurupati, President of Cure Stat Rx has joined the Advisory Board of Res Nova.

"I am honored to partner with Chigurupati and the team at Cure Stat Rx who have second-to-none expertise in compounding and drug formulation across a range of therapeutic indications," said Famela Ramos, President, and CEO of Res Nova Bio. "Based on our preclinical and pilot clinical data, we are confident that our proposed Phase I/II trial will support the use of FloraStilbene as an immune enhancer in general and specifically a stimulator of natural killer cell activity in advanced cancer patients."

"I have worked with Chigurupati for many years in delivering personalized medicine to patients," said Dr. James Veltmeyer, Chief Medical Officer of Res Nova. "Having seen first-hand the potent therapeutic effects of the Res Nova immunotherapy product ValloVax, I look forward to working with Cure Stat Rx to translate FloraStilbene into the clinical domain."

Cure Stat Rx is an accredited compounding pharmacy specializing in cancer treatments. Cure Stat Rx clinical and compounding staff is knowledgeable and well trained in immuno-oncology.

"Despite significant advances in cancer immunotherapy, many approaches do not induce responses because patients have low immune responses to begin with. By leveraging the significant body of work developed by TSOI in the area of pterostilbene and immuno-oncology, it is exciting to watch how rapidly Famela Ramos and her team are moving towards treating patients with this first in class approach," said Timothy Dixon, President, and CEO of Therapeutic Solutions International and Chairman of Res Nova Bio.

On May 15, 2023 Investigators from Baylor College of Medicine (BCM) in collaboration with Immunai reported to have published results from a clinical study in which Immunai’s technology helped identify BTG1 as a novel molecular target that can be used to enhance the potency of natural killer T (NKT)- and T cell-based cancer immunotherapy (Press release, Immunai, MAY 15, 2023, View Source [SID1234631760]). The study was published today in Nature Medicine.

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As part of this collaboration, Immunai leveraged its advanced multi-omics platform to analyze clinical samples from an ongoing trial conducted at BCM. These studies led to the identification of BTG1 as a novel driver of NKT cell hyporesponsiveness that can be targeted to enhance CAR-NKT cell anti-tumor function. This discovery has the potential to improve the ability of NKT and T cell therapy products to target and eliminate malignant cells.

BCM conducted extensive in vitro and in vivo studies to validate the superior anti-tumor activity of CAR-NKT cells modified to target BTG1, demonstrating the potential of this approach for use as a cutting-edge therapy. Importantly, CAR-NKT cells genetically modified to target BTG1 were able to overcome exhaustion, a major obstacle for developing effective cell therapy products.

This breakthrough is significant as it opens the door to more effective and targeted immunotherapies to treat a range of malignancies and other diseases. By combining Immunai’s expertise in multi-omics platforms with BCM’s research capabilities, the collaboration has paved the way for innovative treatment options that could improve patient outcomes worldwide.

"This project highlights Immunai’s platform capabilities in discovering and improving therapeutics, applicable to diverse types of cell therapies and other immune modulating therapies within oncology and inflammatory diseases," said Noam Solomon, CEO of Immunai. "Immunai has been committed from the beginning to developing its cutting-edge platform to deliver actionable therapeutic insights that have the potential to transform patients’ lives, and our work with BCM is also a great reflection of our commitment to improving clinical outcomes with our partners."

"Effectively harnessing knowledge from precious patient samples poses a paramount challenge in clinical research. The state-of-the-art single-cell RNA sequencing technology developed by Immunai allowed us to accurately measure gene expression changes in thousands of individual CAR-NKT cells before and after infusion into patients. The discoveries made during BCM and Immunai’s productive collaboration have already resulted in two Nature Medicine publications in less than three years and informed the development of more effective cancer immunotherapy," said Dr. Leonid Metelitsa, Director, Center for Advanced Innate Cell Therapy at Texas Children’s Hospital and Baylor College of Medicine.

The study was made possible through a long-standing collaboration between the two organizations structured around joint IP ownership, highlighting the power of combining industry-leading technology with top-tier academic research.

On May 15, 2023 BiOneCure Therapeutics, Inc. reported a strategic collaboration with Nanjing Leads Biolabs to develop a range of innovative anti-drug conjugates (ADCs) for treating solid tumors (Press release, BiOneCure Therapeutics, MAY 15, 2023, View Source [SID1234631759]). BiOneCure is a clinical-stage biopharmaceutical company dedicated to developing next-generation ADCs, while Leads Biolabs is a clinical-stage biotech focused on the research, development, and commercialization of next-generation tumor immunotherapy antibody drugs.

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"We are excited to collaborate with Leads Biolabs to develop ADC drugs," said Dr. Haifeng Bao, CEO of BiOneCure. "Through this collaboration, we aim to accelerate innovation and development in the ADC field and provide better treatment options for patients."

BiOneCure has developed several proprietary ADC payload-linker platforms, and its first product, BIO-106, an anti-Trop-2 ADC, is currently in a Phase I clinical study. Meanwhile, Leads Biolabs has established a rich portfolio of more than 20 novel mono- or bispecific antibody drug projects to fulfill unmet medical needs. The two companies’ technologies are highly complementary, making this a promising win-win collaboration that will significantly promote the R&D and product development capabilities of both parties.

"We believe that BiOneCure has leading ADC technology platforms, and their ADC molecule is in the clinical stage," said Dr. Xiaoqiang Kang, founder and chairman of Leads Biolabs. "Leads Biolabs is a clinical-stage antibody new drug company, with multiple antibody technology platforms. We are convinced that this collaboration will greatly expand the innovative R&D capabilities of both parties."

On May 15, 2023 Hummingbird Bioscience, a data-driven precision biotherapeutics company discovering and developing transformative biologic medicines for hard-to-treat diseases, reported that it has entered into a clinical trial collaboration and supply agreement with Merck to evaluate HMBD-001 in combination with cetuximab in squamous non-small cell lung carcinoma (sqNSCLC) (Press release, Hummingbird Bioscience, MAY 15, 2023, View Source [SID1234631758]).

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Under this collaboration, Hummingbird Bioscience will evaluate the safety, tolerability, and anti-tumor activity of its potentially best-in-class HER3-targeting antibody, HMBD-001, in combination with standard of care chemotherapy with or without Merck’s cetuximab, anti-EGFR mAb, in patients with sqNSCLC in a Phase 1b clinical trial, to be initiated in the second half of 2023. Merck will supply cetuximab for the Hummingbird Bioscience-sponsored study and both parties will retain all commercial rights to their respective compounds.

"We are excited to collaborate with Merck to study a promising, new treatment regimen for sqNSCLC patients with significant unmet need. This is the first squamous disease setting of several for which HER3 plays a critical role in etiology and where HER targeted therapies could potentially deliver clinical benefit," said Jerome Boyd-Kirkup, Ph.D., Chief Scientific Officer, Hummingbird Bioscience. "In addition to standard of care chemotherapy, the inhibition of HER3 or the concurrent inhibition of HER3 and EGFR has significant potential to improve outcomes in sqNSCLC patients refractory to front-line immunotherapies."

Hummingbird Bioscience recently presented strong scientific rationale and preclinical data for HMBD-001 used as monotherapy and in combination with cetuximab in various squamous cell carcinomas at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2023 Meeting in April.

On May 15, 2023 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) for IMPT-314, a potential first-in-class CD19/CD20 CAR T therapy for the treatment of patients with B-cell mediated malignancies (Press release, ImmPACT-Bio, MAY 15, 2023, View Source [SID1234631757]). These include relapsed or refractory (R/R) aggressive B-cell lymphoma, diffuse large B-cell lymphoma (DLBCL) not otherwise specified (NOS), high grade B cell lymphoma (HGBCL), primary mediastinal B-cell lymphoma (PMBCL), and DLBCL arising from follicular lymphoma (FL), after two or more lines of systemic therapy.

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"Fast track designation from the FDA underscores the serious unmet medical need in patients with aggressive B cell lymphomas and reinforces the differentiated therapeutic promise of IMPT-314," said Sumant Ramachandra, M.D., Ph.D., president and chief executive officer of ImmPACT Bio. "Relapsed or refractory B cell lymphomas are aggressive malignancies that despite the availability of multiple treatment options, are limited by high rates of relapse, low survival rates or serious toxicity. IMPT-314 was specifically designed to target two prevalent B cell antigens, CD19 and CD20 to prolong durability and help overcome treatment resistance arising from antigen escape. In a UCLA-led investigator study, the bispecific CAR construct underlying IMPT-314 has also demonstrated unmatched safety that includes no neurotoxicity and only Grade 1 cytokine release syndrome. We believe IMPT-314 has potential to extend duration of response with a safe, well-tolerated profile that may enhance accessibility. We look forward to dosing the first patient with IMPT-314 in our Phase 1/2 trial in aggressive B-cell malignancies in the second quarter of this year."

IMPT-314 is based on research work by Yvonne Chen, Ph.D., associate professor, University of California, Los Angeles (UCLA). In 2019, Sarah Larson, M.D., also at UCLA, initiated an ongoing investigator-led Phase 1 study of IMPT-314 in patients with R/R non-Hodgkin lymphoma. ImmPACT Bio in-licensed the logic-gate-based CAR T-cell platforms from UCLA.

Key safety and efficacy highlights from the Phase 1 UCLA investigator-led study (n = 11):

91% objective response rate, with 73% achieving a durable complete response
18.2 months median progression-free survival with a median follow-up of 20.5 months
No neurotoxicity or immune effector cell-associated neurotoxicity syndrome
No cytokine release syndrome above Grade 1
Fast track designation is designed to help drugs reach patients faster by facilitating the development and expediting the review of drugs with the potential to fill an unmet medical need and treat serious or life-threatening conditions. Programs receiving FTD benefit from early and frequent interactions with the FDA during the clinical development process and, if relevant criteria are met, the FDA may consider reviewing portions of a marketing application before the sponsor submits the complete application.

ImmPACT Bio will evaluate IMPT-314 in a Phase 1/2 clinical trial for aggressive B-cell lymphoma, including DLBCL. Dosing of the first patient is expected in Q2 2023 with initial Phase 1 safety and efficacy data expected in the second half of 2023.