On February 13, 2025 DAAN Biotherapeutics, a leading innovative drug development company specializing in T-cell receptor (TCR)- based therapies, reported that it has signed an exclusive licensing agreement with LigaChem Biosciences for a novel tumor-targeting antibody to advance the development and commercialization of Antibody-Drug Conjugates (ADC) (Press release, DAAN Bio Therapeutics, FEB 13, 2025, View Source [SID1234650225]).

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By leveraging DAAN Biotherapeutics’ next-generation antibody technology, built upon its exceptional target discovery and antibody development capabilities, LigaChem Biosciences is now positioned to take a significant step forward in ADC development for solid tumor patients.

DAAN Biotherapeutics has successfully established a proprietary pipeline for efficiently developing antibodies targeting overexpressed tumor targets in solid cancers through a strategic partnership with OmniAb.

Byoung Chul Cho, MD, the CEO of DAAN Biotherapeutics, stated, "We will continue to develop state-of-the-art antibodies targeting solid tumors and collaborate with global pharmaceutical companies in the ADC field. Beyond ADCs, we also aim to become a global leader in solid tumor-targeting T-cell engagers using our proprietary TACTIC (Tumor Targeting Conditionally Activated T Cell Engager) platform."

On February 12, 2025 MimiVax, Inc., a leader in clinical-stage pharmaceutical research, reported that its now fully enrolled Phase 2b clinical trial of SurVaxM in glioblastoma, [SURVIVE] (NCT05163080), has successfully progressed following the first interim analysis of trial data (Press release, MimiVax, FEB 12, 2025, View Source;utm_medium=rss&utm_campaign=mimivax-survaxm-interim-analysis [SID1234650255]). The analysis, conducted as part of the company’s rigorous clinical development program, has provided valuable insights that support the continued advancement of the trial. The purpose of this study is to determine whether adding SurVaxM to standard-of-care (resection, radiation/chemotherapy) is better than standard treatment alone for patients with newly diagnosed glioblastoma.

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While the company is unable to disclose specific details about the interim analysis due to regulatory requirements set forth by the U.S. Food and Drug Administration (FDA), MimiVax remains confident in the potential of SurVaxM and is committed to advancing the study as planned.

"We are encouraged by the progress of our clinical trial and remain focused on our goal to develop innovative therapies that can address glioblastoma and other cancers. Although we are unable to provide detailed information at this stage, we are excited about the continued advancement of this important program," said Dr. Michael Ciesielski, CEO of MimiVax. "We are working closely with the FDA to ensure compliance with regulatory guidelines as we move forward with the trial."

Based on the results of the recent interim futility analysis, and ongoing review by the study’s Independent Data Safety Monitoring Committee, the SURVIVE trial will continue as designed without modification.

The clinical trial is designed to evaluate the safety, efficacy, and overall benefit of SurVaxM in patients with newly diagnosed glioblastoma who receive standard-of-care treatment combined with SurVaxM at 11 participating major Cancer Centers in the United States. The company will provide updates at appropriate milestones, in accordance with regulatory requirements.

MimiVax thanks all participants, healthcare professionals, clinical support teams and investigators involved in the study for their continued support and commitment to the advancement of SurVaxM.

About SurVaxM:

SurVaxM is a peptide mimic immunogen that targets ‘survivin’, a cell-survival protein present in most glioblastomas and in many other cancers. SurVaxM stimulates a patients’ own immune response to control tumor growth and prevent disease recurrence. Because survivin is present in most cancers, SurVaxM could potentially have applicability in many other forms of cancer.

On February 12, 2025 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer and obesity drugs, reported an update from the Company’s ongoing Phase 1/1b clinical trial evaluating BP1002 for the treatment of refractory/relapsed acute myeloid leukemia (AML), including venetoclax-resistant patients (Press release, Bio-Path Holdings, FEB 12, 2025, View Source [SID1234650242]). The Company announced a meaningful patient response to treatment and the clinical trial has progressed to the fourth, higher dose cohort of 90 mg/m2.

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"We were excited to learn that one patient in the third cohort had a meaningful response to just one treatment cycle, experiencing stable disease and a significant reduction in blast count, which we believe offers promise for venetoclax-resistant AML patients with limited treatment options," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "AML patients that fail or relapse from frontline venetoclax-based therapy have very poor prognosis with a median overall survival of less than three months. The third dosing cohort completed enrollment faster than expected, which we believe reflects the urgent need for additional treatment options. We look forward to quickly advancing this study through the fourth dosing cohort and into the combination therapy segment of this Phase 1/1b study with increased levels of BP1002 for the treatment of these vulnerable patients."

The current standard of care for patients with AML not eligible for intensive chemotherapy is venetoclax, an oral Bcl-2 inhibitor that targets the BH3 domain of the Bcl-2 protein, in combination with a hypomethylating agent or with low-dose cytarabine. However, many patients become resistant to venetoclax treatment. A published study found that AML patients who had relapsed from frontline venetoclax-based treatment were refractory to salvage therapy and had a median survival of less than 3 months. By targeting Bcl-2 at the mRNA level rather than the protein, BP1002 may overcome and prevent some of the mechanisms of resistance that affect venetoclax treatment.

The Phase 1/1b clinical trial is being conducted at several leading cancer centers in the United States, including the Weill Medical College of Cornell University, The University of Texas MD Anderson Cancer Center, Scripps Health, and The University of California at Los Angeles Cancer Center. The approved treatment cycle is two doses per week over four weeks, resulting in eight doses administered over twenty-eight days. The Phase 1b portion of the study is expected to commence after completion of BP1002 monotherapy cohorts and will assess the safety and efficacy of BP1002 in combination with decitabine in refractory/relapsed AML patients.

Gail J. Roboz, M.D., is the National Principal Investigator for the Phase 1/1b trial. Dr. Roboz is a Professor of Medicine and Director of the Clinical and Translational Leukemia Program at the Weill Medical College of Cornell University and the New York-Presbyterian Hospital in New York City. Gary Schiller, M.D., The University of California at Los Angeles Cancer Center, Maro Ohanian, D.O., Department of Leukemia, University of Texas MD Anderson Cancer Center, and David Hermel, M.D., Scripps Health, are each serving as principal investigators.

On February 12, 2025 Terrain Biosciences reported the company launches from stealth as the world’s first RNA design-build company, using advanced AI and its proprietary manufacturing platform to accelerate development of the next generation of programmable medicines (Press release, Terrain Biosciences, FEB 12, 2025, View Source [SID1234650230]). RNA-based modalities, including mRNA, cell & gene therapies, and emerging personalized cancer vaccines are promising and rapidly advancing, with hundreds of drug candidates in development for indications ranging from oncology to infectious disease to neurodegenerative illnesses. Despite incredible progress, innovators in the space continue to face challenges in designing, selecting, manufacturing, and delivering optimal customized RNA sequences for therapeutic benefit.

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Founded by Professors Omar Abudayyeh and Jonathan Gootenberg of Harvard Medical School and Professor Patrick Hsu of the Arc Institute and University of California, Berkeley, the company is led by industry veterans including CSO Aaron Larsen (formerly at Beam & Moderna), COO Ted Tisch (formerly at Mammoth Biosciences and Synthego), and founding CEO Chetan Tadvalkar (veteran GM/COO of pharma services companies, including former head of business operations at Ginkgo Bioworks). Terrain has raised $9M in seed funding to bring cutting-edge research in RNA design and manufacturing to innovators building RNA-based therapies and vaccines, and support development of personalized cancer vaccines. Over a dozen biotechs already trust Terrain Bio to help them identify and produce sequences with better expression, greater durability, and optimal manufacturability, accelerating their path to the clinic.

"AI is poised to dramatically accelerate how we design and develop drugs, but the reality is that in silico models can only get us so far in RNA — bringing a drug from the lab to the clinic requires bringing advanced science into the real world. Our partners need excellent machine learning tools combined with a real manufacturing platform and data to enable and accelerate their path to the clinic," said Terrain co-founder Omar Abudayyeh.

"Our partners are brilliant scientists on an incredibly challenging journey to develop new medicines and ultimately help patients," said Chetan Tadvalkar, CEO of Terrain. "Our team has been part of similar journeys before, and today our purpose is to help scientists navigate the complexity of designing the right RNA sequence and guide them towards their goal while ensuring they hit key preclinical milestones."

RNA optimization is critical for therapeutic efficacy and safety — sequence and purity reaches beyond the mechanism of action to have broad impacts across expression, stability, durability, immunogenicity, and manufacturability. "The search space for designing RNA is nearly infinite," said co-founder Jonathan Gootenberg. "Navigating that space computationally and experimentally will unlock enormous potential in medicine, but remains incredibly challenging given the lack of top-quality data for training better models."

"Bridging design and manufacturing in a tight feedback loop means higher quality preclinical data, which means stronger generative models for design, which means better drug candidates," said co-founder Patrick Hsu. "Terrain is all about making the tools for this kind of rapid iteration possible for delivering better RNA."

On February 12, 2025 HAYA Therapeutics, SA, a biotechnology company pioneering precision RNA-guided regulatory genome targeting therapeutics for rare, common, chronic and age-associated diseases, reported that it has been awarded the prestigious Innosuisse Certificate for Sustainable Growth from Innosuisse, the Swiss Innovation Agency, who also provided funding to support HAYA’s research into using its technology to address cancer (Press release, Haya Therapeutics, FEB 12, 2025, View Source [SID1234650229]).

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In addition to Innosuisse’s award for HAYA’s potential for growth and success, it is providing 1.5M CHF (approximately $1.64M USD) in non-dilutive funding for HAYA through Innosuisse’s Start-up Innovation Projects, recognizing HAYA’s cutting-edge approach and broad applicability of their long non-coding RNA (lncRNA) platform in developing disease-modifying therapeutics beyond the heart and into oncology.

The funds will be used over the next two years for translational studies to further develop an innovative therapy targeting cancer-associated fibroblast-specific lncRNA for aggressive solid tumors.

"Solid tumors, which make up approximately 90% of all cancers, require innovative therapeutic strategies due to their complexity and resistance to traditional treatments," said Samir Ounzain, Ph.D., Co-founder and CEO of HAYA Therapeutics. "Fibrosis plays a critical role in shaping the tumor microenvironment, creating a rigid and immunosuppressive barrier that fuels cancer progression and limits treatment efficacy. At HAYA, we are pioneering a novel RNA-guided approach to precisely reprogram cancer-associated fibroblasts, disrupting the fibrotic niche and unlocking new possibilities for more effective and durable cancer therapies."

"By leveraging the exquisite cell specificity of lncRNAs coupled with antisense oligonucleotide’s broad distribution to extra hepatic tissues including tumors, HAYA is able to drug disease modifying targets within the tumor microenvironment. This novel paradigm holds tremendous potential as a next generation treatment strategy for immunotherapy resistant solid tumors such as for pancreatic cancer and triple negative breast cancer," said Sudhir Agrawal, DPhil, FSRC, a member of HAYA’s scientific advisory board and Founder of Arnay Sciences. "HAYA’s strategy could be transformational and offer disease-modifying therapy options to patients in need."

HAYA’s unique RNA-guided regulatory genome technology enables the discovery and development of innovative RNA-based therapeutics for a wide range of diseases. HAYA’s lead candidate, HTX-001, is being developed for the treatment of heart failure, with other preclinical therapeutics in development for other indications.