Merck & Co., Inc.

PROVIDENCE, R.I., July 10, 2024 /PRNewswire/ -- Bolden Therapeutics, Inc., a biotechnology company developing first-in-class therapeutics to promote neurogenesis for the potential treatment of CNS illnesses, today announced their invitation to present at the 4th Annual Oligonucleotides for CNS Summit on July 10th in Boston, MA. Justin Fallon, Ph.D., Scientific Co-Founder and Scientific Advisory Board Chair of Bolden Therapeutics, will present an update on the development of Bolden's first-in-class treatment to promote adult hippocampal neurogenesis. "We are appreciative of the opportunity to present at the Oligonucleotides for CNS Summit and I am excited to share our progress with the broader antisense and CNS drug development communities," said Dr. Fallon. "Adult neurogenesis is a promising target for the treatment of a wide range of neurological conditions and neurodegenerative diseases, and we have made significant achievements towards our goal of developing an antisense candidate to increase neurogenesis." Dr. Fallon will present today, Wednesday, July 10th at 2PM in the Hilton Boston Back Bay in Boston, MA. Interested parties who are unable to make the presentation may submit inquiries or request additional information by emailing [email protected]. About Bolden Therapeutics, Inc. Bolden Therapeutics, Inc., is a biotechnology company developing first-in-class therapeutics to promote neurogenesis for the potential treatment of central nervous system illnesses such as Alzheimer's disease. Bolden's foundational research originated from two Brown University research labs in Providence, RI. Bolden received two 'Golden Tickets' from Biogen, allowing the company to take residence at LabCentral and providing the company with two years of sponsored laboratory space within that innovative ecosystem. Bolden's research facility is currently located at the Tufts Launchpad | biolabs incubator. Bolden is currently raising funds to support ongoing in vivo experiments and preclinical development. More information about Bolden Therapeutics can be found at . About Oligonucleotides for CNS Summit The Oligonucleotides for CNS Summit is the only summit centered on the needs of biotech and pharma specific to CNS oligos. The Summit consists of three days including 20+ world-class speakers from the likes of Roche, Ionis, Genentech, Merck, Stoke Therapeutics, and Janssen. More information about this exciting event can be found at . SOURCE Bolden Therapeutics, Inc.

LAG-3 (Lymphocyte Activation Gene-3) has emerged as a significant target in cancer immunotherapy, representing a new frontier in the ongoing efforts to harness the immune system to combat cancer. First discovered in 1990, LAG-3 is a cell surface molecule that plays a crucial role in regulating T cell function and has been identified as an important immune checkpoint. Following this, the approval to worldwide first LAG-3 inhibitor therapy; Opdualag™ (nivolumab and relatlimab-rmbw), developed by Bristol Myers Squibb, in March 2022, for the treatment of adult and pediatric patients 12 years of age or older with unresectable or metastatic melanoma, further aid to expand the realm as well as competitve landscape. According to Neeraj Chawla, Research Head at Kuick Research, the global market opportunity for LAG 3 drugs will surpass US$ 3 Billion by 2029 and more LAG 3 drugs are expected to enter the market by end of this decade. From clinical perspective, LAG-3 has garnered significant attention as a potential target for cancer immunotherapy. It has been found to synergize with other immune checkpoints, such as PD-1 and CTLA-4, to enhance immune evasion by tumors. This understanding has led to the development of LAG-3 inhibitors, including monoclonal antibodies that block LAG-3 and restore T cell function. Several of these inhibitors are currently undergoing clinical trials, both as monotherapies and in combination with other immune checkpoint inhibitors, showing promising preliminary results in terms of safety and efficacy across various cancer types, including melanoma, non-small cell lung cancer, and renal cell carcinoma. As well as, commercially, the LAG-3 inhibitor market is poised for growth due to augmenting triumph of approved therapy whose sales have increased twice and has crossed half a Billion-dollar sales in 2023; representing opportunism to come in pharma sector. Additionally, the potential for combination therapies that include LAG-3 inhibitors offers significant commercial opportunities, as these combinations may provide superior clinical outcomes compared to monotherapies. For that reason, many clinical trials are ongoing in the domain in order to understand the role of LAG-3 in cancer. For instance, ABL Bio, a Biotech company based in South Korea, has begun a first-in-human (FIH) phase 1 open-label, multicenter, multiple-dose, dose-escalation and dose-expansion study of ABL501 to evaluate the safety, tolerability, MTD and/or RP2D, PK, immunogenicity, preliminary anti-tumor activity, and the PD effect of ABL501 in subjects with any progressive locally advanced (unresectable) or metastatic solid tumors. It is an interventional study (NCT05101109) which has an estimated enrollment of 36 participants, begun in October 2021 and will be completed by December 2024. Accompanied with clinical trials, many preclinical contenders targeting LAG-3 have been developed. Like, Y Biologics has developed a novel, cutting-edge mono- specific LAG-3 therapy, YBL-011 which is currently in the preclinical stage for the treatment of solid tumors. Above this, the global interest in LAG-3 therapies is influencing immunotherapy market, as multinational pharmaceutical companies seek to collaborate with local firms and tap into the advanced research capabilities available in the global segment. This international collaboration not only enhances the technological exchange but also opens up the new investment and growth opportunities. Such as, in June 2024, Immutep, an Australian based company, announced that it has settled into a clinical trial collaboration as well as supply agreement with Merck through a subsidiary with the foremost obejctive to access eftilagimod alfa (efti) in combination with anti-PD-1 therapy, Keytruda (pembrolizumab) along with chemotherapy for the first-line treatment of metastatic non-small cell lung cancer (NSCLC) in a pivotal Phase III trial. In nutshell, targeting LAG-3 in cancer therapy represents a promising avenue for enhancing anti-tumor immune responses and overcoming resistance to current immunotherapies. The ongoing clinical trials in addition to robust commercial interest underscore the potential impact of LAG-3 inhibitors in the evolving landscape of cancer treatment, although continued research and clinical validation are essential to fully realize their therapeutic potential.

DAEJEON, South Korea, July 8, 2024. PharmAbcine Inc., a clinical-stage biotech company focusing on next-generation antibody therapeutics, announced that PMC-309, VISTA-targeting immuno-oncology program, received safety approval for the first dose cohort (0.2mg/kg) in Phase 1a/b clinical trial for patients with advanced or metastatic solid tumors in Australia. The second dose cohort (0.5mg/kg) is currently ongoing. The first dose cohort (0.2mg/kg) of PMC-309 was initially administered in January 2024 and received safety approval in April 2024. Currently, the second dose cohort (0.5mg/kg) has been administered to two patients, with the third patient scheduled to receive treatment soon. PMC-309 is an IgG1 monoclonal antibody specifically binding to VISTA on immunosuppressive cells, demonstrating excellent binding affinity at various pH conditions within the tumor microenvironment (TME). By inhibiting VISTA, PMC-309 offers a differentiated mechanism of action, contributing to anti-cancer effects through the activation of T cells, monocytes, and the proliferation of M1 macrophages. This open-label Phase 1a/b clinical trial involves a total of 67 patients and comprises two phases: Phase 1a and Phase 1b. Phase 1a includes PMC-309 monotherapy and combination therapy with KEYTRUDA (pembrolizumab) to determine the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D). Phase 1b will evaluate the safety and tolerability of PMC-309 monotherapy and combination therapy with KEYTRUDA at the RP2D. The clinical trial is being conducted at four institutions in Australia. Dr. Jin-San Yoo, Chief Executive Officer of PharmAbcine Australia Pty, the Australian subsidiary of PharmAbcine Inc., stated, "It has been 10 years since the first generation of immuno-oncology drugs entered the market. During this time, these drugs have been administered to numerous cancer patients. While some patients have benefited, many have developed resistance, and others have passed away. The need for next-generation immuno-oncology drugs is critical. The confirmation of the safety of the first dose cohort of PMC-309 is just the beginning of this trial. We look forward to gradually verifying the safety and efficacy of PMC-309 through the planned higher dose cohorts. We are also preparing for the combination trial of PMC-309 with KEYTRUDA in collaboration with MSD without any delays." He added, "We are committed to providing new treatment options to patients suffering from the limitations of first-generation immuno-oncology drugs." For more information on the clinical trial, please visit clinicaltrials.gov, identifier NCT05957081. KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About PharmAbcine Inc. PharmAbcine is a clinical stage public company developing next generation IgG based therapeutics to treat cancer, neovascular eye diseases, and vascular related unmet needs. The Company's main pipeline include clinical assets olinvacimab, PMC-403, and PMC-309. Olinvacimab, the Company's lead asset, is ongoing a Phase 2 trial in combination with MSD's pembrolizumab for mTNBC patients in Australia to reconfirm the encouraging result from Phase 1b olinvacimab plus pembrolizumab trial, delivering 50% ORR, 67% DCR, and clean safety profile. PMC-403 is a novel TIE2-activating antibody that stabilizes dysfunctional leaky disorganized pathological vessels and can be used for vascular-related eye disease, including wet AMD (Age-related Macular Degeneration). PMC-403 is currently undergoing Phase 1 trial for neovascular AMD patients in Korea. PMC-403 is also being explored to expand into wider therapeutic areas related to pathological vessels including vessel-related rare diseases and non-rare diseases. PMC-309, a novel anti-VISTA-antagonizing IgG in pan pH conditions, is an immune checkpoint regulator that targets MDSC (myeloid derived suppressor cells) and M2 macrophages which play pivotal role in maintaining immunosuppressive TME (Tumor Microenvironment). Phase 1a is ongoing at multicenter in Australia and Phase 1b in combination with MSD's pembrolizumab PMC-309 + Pembrolizumab combo is in plan. PMC-005, is an anti-EGFRviii IgG that only binds to EGFRviii expressed on cancer cells and can be applied to various modalities including CAR-T, CAR-NK, CAR-Macrophage, T cell/NK cell engager, and Radio-Immunotherapy. SOURCE PharmAbcine Keytruda (pembrolizumab) FDA Approval History Whatever your topic of interest, subscribe to our newsletters to get the best of Drugs.com in your inbox.