TRPV6

Suzhou, China, February 21, 2025 — Coherent Biopharma (“Coherent”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1019 for Injection (CBP-1019) for the treatment of recurrent endometrial cancer (EC) after at least one line of platinum-based systemic therapy. Dr. Robert Huang, Founder and CEO of Coherent, commented: “This represents the second FTD granted to Coherent Biopharma, following the designation of CBP-1008, another drug derived from Coherent’s proprietary Bi-XDC technology platform, in October 2024 for the treatment of platinum-resistant ovarian clear cell carcinoma. This further underscores the platform's therapeutic potential and highlights the company’s robust innovation capabilities in drug development and offering new therapeutic options for patients with advanced/metastatic EC worldwide.” About Fast Track Designation Fast Track Designation is granted to facilitate the development and expedite the review of drugs to that treat serious conditions and fulfill unmet medical needs, enabling these treatments to reach patients earlier. Clinical programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met. About CBP-1019 CBP-1019 is a Bi-specific ligand drug conjugate developed using Coherent’s proprietary Bi-XDC technology platform. The drug targets Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6) (an Oncochannel), both broadly, and often highly expressed in many cancers including gynecological and GI cancers. The drug carries DX-8951 derivative, a topoisomerase I inhibitor (TOPOi) as payload. Promising early Phase I/II results of CBP-1019 demonstrate its therapeutic potential in addressing advanced solid malignancies, including recurrent endometrial, colorectal and pancreatic cancers. The CBP-1019-101 study is a global, multicenter, open-label Phase I/II clinical trial (conducted in the U.S. and China) designed to evaluate the safety, tolerability, and preliminary efficacy of CBP-1019 in patients with advanced solid tumors. As of October 31, 2024, 61 patients with advanced solid tumors were enrolled and treated with CBP-1019 at various dose levels, administered intravenously every two weeks (Q2W) in 4-week cycles. CBP-1019 demonstrated a favorable safety and tolerability profile, with no observed cases of interstitial lung disease (ILD), stomatitis, or ocular toxicity—typical adverse events associated with TOPOIi-based antibody-drug conjugates (ADCs). Among the 10 advanced/metastatic EC patients enrolled, all had received at least one prior line of platinum-based systemic chemotherapy and presented with visceral metastases. The study results showed that CBP-1019 exhibited superior efficacy regardless of FRα/TRPV6 expression status. At the 3.0 mg/kg dose level (potential recommended Phase II dose, RP2D), 7 out of 9 evaluable advanced/metastatic EC patients achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%. Median duration of response (DoR) and progression-free survival (PFS) were not yet reached, and all patients remained on treatment as of the data cutoff date. About advanced/metastatic EC Endometrial cancer is a serious gynecological malignancy threatening women’s health, with approximately 15% of patients who are in the advanced stage of the disease. Limited treatment options and poor prognosis result in a 5-year survival rate of only 17%, highlighting a significant unmet medical need. The development of CBP-1019 offers a breakthrough therapeutic option for these patients. The FDA’s Fast Track Designation for CBP-1019 represents a major milestone in addressing unmet medical needs and providing new therapeutic options for patients with advanced/metastatic EC on a global scale. Coherent is committed to advancing the clinical development of CBP-1019 and delivering more effective treatment options for patients. About Coherent Biopharma Coherent Biopharma is a clinical-stage biotechnology company developing bispecific-targeting ligand drug conjugates (Bi-XDC). CBP-1008, the leading asset targeting patients with low to high Folate Receptor alpha has demonstrated impressive efficacy and safety pro over 350 patients treated. CBP-1018, targeting PSMA has also shown a superior pro Phase I/II studies with 120 patients treated, with 8.5 months of median rPFS for all mCRPC patients. Finally, its next-gen drug, CBP-1019 has shown incredible safety and efficacy advantages compared to ADCs with TOPI inhibitors. Superior efficacy was obtained in advanced/metastatic EC patients irrespective of receptor expression level. In addition, cellular targeted PROTACs and Radiopharmaceutical Therapy (RPT) are among the company’s early pipelines.

Suzhou, China, February 21, 2025 — Coherent Biopharma (“Coherent”) announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to CBP-1019 for Injection (CBP-1019) for the treatment of recurrent endometrial cancer (EC) after at least one line of platinum-based systemic therapy. Dr. Robert Huang, Founder and CEO of Coherent, commented: “This represents the second FTD granted to Coherent Biopharma, following the designation of CBP-1008, another drug derived from Coherent’s proprietary Bi-XDC technology platform, in October 2024 for the treatment of platinum-resistant ovarian clear cell carcinoma. This further underscores the platform's therapeutic potential and highlights the company’s robust innovation capabilities in drug development and offering new therapeutic options for patients with advanced/metastatic EC worldwide.” About Fast Track Designation Fast Track Designation is granted to facilitate the development and expedite the review of drugs to that treat serious conditions and fulfill unmet medical needs, enabling these treatments to reach patients earlier. Clinical programs with Fast Track designation can benefit from early and frequent communication with the FDA throughout the regulatory review process. These clinical programs may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met. About CBP-1019 CBP-1019 is a Bi-specific ligand drug conjugate developed using Coherent’s proprietary Bi-XDC technology platform. The drug targets Folate Receptor (FRα) and Transient Receptor Potential Vanilloid Subfamily Member 6 receptor (TRPV6) (an Oncochannel), both broadly, and often highly expressed in many cancers including gynecological and GI cancers. The drug carries DX-8951 derivative, a topoisomerase I inhibitor (TOPOi) as payload. Promising early Phase I/II results of CBP-1019 demonstrate its therapeutic potential in addressing advanced solid malignancies, including recurrent endometrial, colorectal and pancreatic cancers. The CBP-1019-101 study is a global, multicenter, open-label Phase I/II clinical trial (conducted in the U.S. and China) designed to evaluate the safety, tolerability, and preliminary efficacy of CBP-1019 in patients with advanced solid tumors. As of October 31, 2024, 61 patients with advanced solid tumors were enrolled and treated with CBP-1019 at various dose levels, administered intravenously every two weeks (Q2W) in 4-week cycles. CBP-1019 demonstrated a favorable safety and tolerability profile, with no observed cases of interstitial lung disease (ILD), stomatitis, or ocular toxicity—typical adverse events associated with TOPOIi-based antibody-drug conjugates (ADCs). Among the 10 advanced/metastatic EC patients enrolled, all had received at least one prior line of platinum-based systemic chemotherapy and presented with visceral metastases. The study results showed that CBP-1019 exhibited superior efficacy regardless of FRα/TRPV6 expression status. At the 3.0 mg/kg dose level (potential recommended Phase II dose, RP2D), 7 out of 9 evaluable advanced/metastatic EC patients achieved an objective response rate (ORR) of 42.9% and a disease control rate (DCR) of 100%. Median duration of response (DoR) and progression-free survival (PFS) were not yet reached, and all patients remained on treatment as of the data cutoff date. About advanced/metastatic EC Endometrial cancer is a serious gynecological malignancy threatening women’s health, with approximately 15% of patients who are in the advanced stage of the disease. Limited treatment options and poor prognosis result in a 5-year survival rate of only 17%, highlighting a significant unmet medical need. The development of CBP-1019 offers a breakthrough therapeutic option for these patients. The FDA’s Fast Track Designation for CBP-1019 represents a major milestone in addressing unmet medical needs and providing new therapeutic options for patients with advanced/metastatic EC on a global scale. Coherent is committed to advancing the clinical development of CBP-1019 and delivering more effective treatment options for patients. About Coherent Biopharma Coherent Biopharma is a clinical-stage biotechnology company developing bispecific-targeting ligand drug conjugates (Bi-XDC). CBP-1008, the leading asset targeting patients with low to high Folate Receptor alpha has demonstrated impressive efficacy and safety pro over 350 patients treated. CBP-1018, targeting PSMA has also shown a superior pro Phase I/II studies with 120 patients treated, with 8.5 months of median rPFS for all mCRPC patients. Finally, its next-gen drug, CBP-1019 has shown incredible safety and efficacy advantages compared to ADCs with TOPI inhibitors. Superior efficacy was obtained in advanced/metastatic EC patients irrespective of receptor expression level. In addition, cellular targeted PROTACs and Radiopharmaceutical Therapy (RPT) are among the company’s early pipelines.

MONCTON, NB, Dec. 13, 2022 /CNW/ - Soricimed Biopharma Inc., ("Soricimed" or "the Company"), a clinical stage company focused on the development and commercialization of first-in-class targeted cancer therapeutics, has appointed Dr. Siqing Fu, a North American leader in cancer research, to its Scientific Advisory Board. "We are honoured to have Dr. Fu join our Scientific Advisory Board at this pivotal time for our company," said Robert Bruce, Chief Executive Officer of Soricimed. "He brings extensive experience to the research table including investigational cancer therapies – specifically in novel design for phase I and II clinical trials. Dr. Fu's expertise will help enhance the trajectory of our work as we look to continue to validate the efficacy of our targeting platform in treating solid tumour cancers." "I am pleased to be joining Soricimed as a scientific advisor," said Dr. Fu. "Their platform, and the emergence of TRPV6 as a target in the treatment of cancer, have significant potential in multiple oncology applications. The results to date for Soricimed's targeting platform are promising and show that it could be a game-changing frontline therapy for this difficult disease." Dr. Fu has over 20 years of experience in cancer research and is currently a professor in the Department of Investigational Cancer Therapeutics, Division of Cancer Medicine at the University of Texas MD Anderson Cancer Center. His research interests include novel design for Phase I/II clinical trials and chemosensitization via biological targeting agents like epigenetic therapy as complementary medicine for cancer treatment. He received his MD from Tongji Medical University (Shanghai, China) and a Clinical Fellowship, Section of Hematology and Medical Oncology, from the University of Rochester in New York, United States. About Soricimed Biopharma Inc. Soricimed is a privately held clinical stage company focused primarily on the development of targeted, first-in-class cancer treatments. Soricimed was established following the discovery of a unique and proprietary family of paralytic and anti-cancer peptides. The Company is committed to translating this discovery into novel therapies that deliver powerful treatment options for those living with devastating conditions. Soricimed's clinical stage oncology drug candidate, SOR-C13, a targeted anti-cancer peptide, has been granted orphan drug status for the treatment of pancreatic and ovarian cancers by the U.S. Food and Drug Administration. In addition, a portfolio of targeted Peptide-drug Conjugates (PDCs) and Peptide Receptor Radionuclide Therapies (PRRTs) are in various stages of pre-clinical development. For more information, visit . For more information about Soricimed and/or this announcement, please contact: Media Relations: Nick Williams NATIONAL Public Relations nwilliams@national.ca 647-354-2478 Investor Relations: Stephen Kilmer President, Kilmer Lucas Inc. stephen@kilmerlucas.com 646-274-3580 SOURCE Soricimed Biopharma