On February 10, 2025 Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, reported clinical trial updates for its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac) (Press release, Convergent Therapeutics, FEB 10, 2025, View Source;at-the-american-society-of-clinical-oncology-asco-genitourinary-cancers-symposium-2025-302372722.html [SID1234650140]). Data will be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, which will take place February 13-15, 2025, in San Francisco, California.

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The first presentation, titled "Mature phase 1 follow up of alpha emitter 225Ac-J591 with 177Lu-PSMA-I&T in advanced prostate cancer," reported clinical follow-up of a Phase I dose-escalation trial exploring the addition of CONV01-α to 177Lu-PSMA-I&T, a PSMA-targeted beta emitting small molecule for the treatment of advanced prostate cancer. The study population presented included 18 patients (six at each dose level of CONV01-α) with progressive metastatic castration-resistant prostate cancer (mCRPC). Relatively low doses of CONV01-α were used.

Data showed that the median overall survival was 29.8 months, with 10 patients still alive at the time of submission. Five patients were free from PSA progression at one year including one patient progression-free at 34 months on no active therapy. A decline in prostate-specific antigen (PSA) levels was seen in 94% of patients, 64% of patients achieved a PSA50 and 28% achieved a PSA90 response. Additionally, circulating tumor cell count changes were seen, with 80% of evaluable patients converting from "unfavorable" to "favorable." High grade adverse events were rare.

"The impressive clinical activity is consistent with our pre-clinical data demonstrating that the antibody/ligand combination delivers a synergistic dose to tumor. Importantly, the synergistic tumor dose is achieved in the absence of additive toxicity due to the non-overlapping normal organ biodistribution of the ligand and antibody. This was also confirmed by the benign safety profile in the trial. The dosimetry and safety profile suggest the potential for additional cycles beyond the two cycles used in this trial. That the overall survival in this trial was double that of the Phase III VISION trial of 177Lu PSMA-617 further increases our enthusiasm for future trials of this combination," said Neil Bander, MD, Convergent’s Co-Founder and Chief Scientific Officer and Professor Emeritus of Urology at Weill Cornell Medicine.

The second presentation, titled "CONVERGE-01: Dosimetry, randomized dose optimization, dose escalation, and efficacy of Ac-225 rosopatamab tetraxetan in participants with PSMA-positive castration-resistant prostate cancer," is a "Trials in Progress" presentation of the three-part company sponsored Phase II trial evaluating the safety and efficacy of CONV01-α (225Ac-J591) monotherapy in patients with castration-resistant prostate cancer. Philip Kantoff, MD, Co-Founder and CEO said, "CONVERGE-01 is intended to confirm the high response rate and durability of CONV01-a monotherapy and solidify the path forward to our pivotal trial."

About CONV01-α
CONV01-α, Convergent’s alpha-emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha-emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA), which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen, and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called Ac-225, which releases alpha particles that kill cancer cells through DNA double-strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful, yet precise, payload offers the ideal combination to treat many types of cancers. Convergent Therapeutics is currently enrolling into the CONVERGE-01 Phase II monotherapy trial to confirm the high response rate, durability and safety of CONV01-a pre and post radioligand beta.

On February 10, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (NASDAQ: TCBP) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported the first Cohort B patient in the ACHIEVE Phase 2B UK clinical trial, evaluating TCB008 in Acute Myeloid Leukemia, has completed the full dosing regiment (Press release, TC Biopharm, FEB 10, 2025, View Source [SID1234650141]).

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The ACHIEVE trial is an open-label Phase II study dedicated to evaluating the efficacy and safety of TCB008. This trial is focused on assessing the treatment’s effectiveness and tolerability on patients suffering from acute myeloid leukemia (AML) and myelodysplastic syndromes (MDS/AML) with challenging cases such as refractory or relapsed conditions. Cohort B recruits patients who have achieved remission following previous treatment yet continue to have a detectable or minimal residual disease (MRD).

Recruitment into Cohort B was initiated during the fourth quarter of 2024, ahead of the Company’s anticipated schedule. The first Cohort B patient received their dose in October 2024. The initial Cohort B patient has completed the dosing regiment, receiving all four planned doses of TCB008, and is expected to receive an additional fifth dose. Enrolment of a second Cohort B patient has also been initiated.

The safety objectives and endpoints of ACHIEVE evaluate patient responses to TCB008, including; grading of adverse events experienced and the incidence and severity of cytokine release syndrome and neurotoxicity. In a review of preliminary data, there are no drug-related adverse events following cumulative infusions of TCB008, containing up to a billion cells. These data continue to support the positive safety profile of TCB008 and the ACHIEVE UK study safety objectives and endpoints.

"The ACHIEVE study progressed at an incredible rate in 2024," stated Alison Bracchi, EVP of Clinical Operations. "Thanks to the hard work and dedication of both the TC BioPharm team and Clinical sites, we’ve reached a significant study milestone in under six months. We’re seeing a fantastic safety profile from our initial data review and exciting efficacy signals that indicate cellular recovery and a reduction of inflammation in AML patients. The TC BioPharm team and I are inspired by the progress to date and look forward to sharing further updates on Cohort B."

"The progression of ACHIEVE, with dosing underway in the second cohort, is a key milestone in the clinical development of our gamma delta therapy candidate TCB008. We believe it has potential to serve as an efficacious treatment for AML patients, whom still have significant unmet needs," said Bryan Kobel, CEO of TC BioPharm. "The therapy has been well-tolerated with no unexpected events or toxicities observed and promising efficacy results observed in some patients, with additional data being collected and analyzed. Cohort B is an extremely compelling patient population for TCB008 for many reasons, including patients having a more intact immune system to amplify the impact of TCB008 and the lack of true treatment options for these patients who are unfortunately on a path to relapse. We expect to complete enrolment in the second cohort in the first half of 2025, with data readout anticipated later this year."

On February 10, 2025 PHC Corporation reported to have signed a Master Collaboration Agreement with CCRM to work together on the development of primary T-cell(*1) expansion culture processes that will seek to accelerate the manufacturing of cell and gene therapy (CGT) products (Press release, CCRM, FEB 10, 2025, View Source [SID1234650119]). This joint initiative will integrate "LiCellGrowTM(*2), PHC’s cell expansion system under development, with CCRM’s deep knowledge of regenerative medicine and biomanufacturing to establish new culture processes to improve cell culture efficiency and quality for CGTs.

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Primary T-cells are used in process development and manufacturing for CGTs, such as in CAR-T cell therapy.(*3) However, primary T-cells derived directly from patients often exhibit significant variability in growth rates and quality, making it challenging for researchers to ensure stable cell counts and maintain quality throughout the culture process. To address these challenges and improve the quality of cell-based therapeutics, better cell culture processes are needed.

Chikara Takauo, Director of PHC and Head of the Biomedical Division that leads the company’s Life Science business, commented: "We are delighted to begin this joint research and development initiative with CCRM, a leader with 14 years of experience in the commercialization of regenerative medicine and CGT. By combining the technologies and expertise of both of our organizations, we aim to advance the manufacturing processes for cell-based therapeutics and cell culture technologies, contributing to the early practical application of CGT."

PHC has developed proprietary In-Line monitoring technology to track key indicators of cell metabolism in real-time, which can help researchers address issues like cell quality and reproducibility, and establish optimal cell culture methods. This technology enables precise, continuous measurement of glucose uptake and lactate production during cell culture, providing a more precise understanding of changes in cell metabolism over time than is possible to observe using traditional sampling methods. In 2024, PHC launched the live-cell metabolic analyzer "LiCellMoTM(*4)" incorporating this technology in the United States, Canada, Europe and some Asian markets including Japan, China, Singapore and Taiwan.

Building on this technology, the company is also developing "LiCellGrow," a cell expansion system designed to exchange media automatically based on the metabolic state of the cells and to maintain the culture environment in an optimal state. PHC aims to further expand its product lineup to seamlessly support research, process development, and commercial manufacturing of cell-based therapeutics.

"We are excited to collaborate with PHC to unlock new possibilities in cell culture," explained Michael May, President and CEO of CCRM. "Technology development partnerships, like this one, are key to advancing the industry and making CGT more cost effective, and therefore more accessible to patients around the world."

The joint research with CCRM will allow PHC to analyze culture conditions using "LiCellGrow" to establish optimal culture processes for primary T-cells. The collaboration will seek to accelerate LiCellGrow’s development, contributing to improved cell quality, enhanced manufacturing efficiency, and cost reduction in the production of cell-based therapeutics.

On February 10, 2025 Hoth Therapeutics, Inc. (NASDAQ: HOTH), a biopharmaceutical company dedicated to developing innovative therapies for unmet medical needs, reported its collaboration with OnTargetx R&D Inc. to advance research for its cancer-fighting therapeutic, HT-KIT (Press release, Hoth Therapeutics, FEB 10, 2025, View Source [SID1234650143]). This immunohistochemistry study, conducted in partnership with Charles River Laboratories Montreal ULC, represents a key step in the preclinical development of HT-KIT.

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The study focuses on:

Development and optimization of staining methods for (c-Kit) markers, a critical target in HT-KIT therapeutic mechanism.

Processing and qualitative evaluation of tissue samples by a board-certified pathologist to determine the presence of markers.

Comprehensive reporting and insights to support the continued development of HT-KIT.

"This partnership is instrumental in our efforts to advance HT-KIT, a promising therapeutic aimed at targeting c-Kit in cancer treatments," said Robb Knie, CEO at Hoth Therapeutics. "We are committed to driving innovative solutions that can transform patient care."

The study aligns with Hoth Therapeutics’ mission to accelerate groundbreaking therapies and address unmet medical needs in oncology.

About HT-KIT

HT-KIT is Hoth’s preclinical therapeutic candidate targeting c-Kit, a receptor tyrosine kinase involved in various cancers. This candidate represents a potential advancement in precision oncology therapies.

On February 9, 2025 TheraPPI Bioscience ("TheraPPI"), a preclinical biotechnology company focused on developing small molecules that modify protein interactions, reported the first closing of its Pre-Seed financing (Press release, TheraPPI, FEB 9, 2025, View Source [SID1234657194]). All investors have substantial experience in the biotech sector.

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TheraPPI will use the proceeds today’s announced to advance the development of its lead program targeting ERK/MyD88, a novel protein interaction in the Ras-MAPK pathway to tackle cancer drug resistance and to offer more effective and safer therapies to patients with advanced cancers.

TheraPPI also announced the inception of TheraPPI Bioscience SA (Geneva, Switzerland) and the nomination of a Board of Directors of this new company. Patricia Delaite, MD, a clinical oncologist and executive in biotech companies, joins the company’s Board as Chairwoman. John Tchelingerian, PhD, a serial entrepreneur and private investor in the biotech sector, and Barthélemy Helg, LL. M. & MBA, an executive in the biotech and food tech sectors, join the company’s Board as independent Directors. Luc Otten, MD, PhD, founder CEO, and Toufic Renno, PhD, founder CSO of TheraPPI, are also Board Directors.

"TheraPPI is developing a first-in-class drug for bringing efficacious therapy to patients with cancer who can’t any longer benefit from modern targeted therapies or immunotherapies. TheraPPI lead program tackles a real unmet medical need by fighting cancer drug resistance, a major cause of death. I am deeply honoured to support TheraPPI on this exciting journey" said Patricia Delaite. "Thanks to the support of our new investors, our Board of Directors, and this open Pre-Seed financing round, we are moving forward by expediting TheraPPI’s lead program and preparing additional developments. The combination of long experience in both academia and industry from the team with strong corporate governance provides a solid foundation for future TheraPPI successes," added Luc Otten.