PMC-309 / PharmAbcine - LARVOL DELTA

Aprogen announced on the 12th that it is accelerating the global development of biosimilars and new drug pipelines, expanding CMO (consignment production) and CDMO (consignment development production) capabilities, and speeding up the leap forward of global bio companies (Maeil Business Newpaper) - "In particular, as major pipelines such as Herceptin and Humira biosimilars and immuno-cancer drugs 'PMC-309' are materialized, expectations for copyright contracts and licenses are growing in the future....Herceptin biosimilar 'AP-063' has reorganized its development strategy in line with changes in the global regulatory environment....Humira biosimilar 'AP-096' is also in the final stages of preparation for entering the global market."

Commercial • Breast Cancer • Colorectal Cancer • Melanoma • Mesothelioma

PharmAbcine to transfer technology for immuno-oncology drug 'PMC-309' [Google translation] (HIT News) - "Aprogen will be granted exclusive licensing rights and manufacturing rights for research, development, and commercialization of PMC-309. PMC-309 is currently undergoing Phase 1a/b clinical trials in Australia, with completion expected in December 2027. Terms of the agreement were not disclosed."

Licensing / partnership • Trial completion date • Solid Tumor

Aprogen…announced on the 21st that the Australian Safety Review Committee unanimously recognized and approved the safety of PMC-309…at a low to medium dose of 2 mg/kg. [Google translation] (HIT News) - "This safety review focused on the clinical trial results of 2 mg/kg of PMC-309 administered to patients with right-sided mesothelioma, vulval melanoma, and colorectal adenocarcinoma. In this trial, patients experienced only a very mild Grade 1 cytokine-releasing symptom, and no other adverse effects were observed."

P1 data • Colorectal Cancer • Mesothelioma • Vulvovaginal Melanoma

PharmAbcine Announces Safety Approval for the First Dose Cohort in Phase 1a/b Clinical Trial of PMC-309 in Patients with Advanced or Metastatic Solid Tumors (PRNewswire) - "PharmAbcine...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....This open-label Phase 1a/b clinical trial involves a total of 67 patients and comprises two phases: Phase 1a and Phase 1b."

Trial status • Solid Tumor

PharmAbcine Announces First Patient Dosed in Phase 1a/b Clinical Trial of PMC-309 in Combination with KEYTRUDA (pembrolizumab) in Patients with Advanced or Metastatic Solid Tumors (PRNewswire) - "PharmAbcine...announced today the initiation of patient dosing in the Phase 1a/b clinical trial of PMC-309 in patients with advanced or metastatic solid tumors....This open-label clinical trial comprises two phases, Phase 1a and Phase 1b. Phase 1a involves PMC-309 monotherapy and combination therapy with KEYTRUDA (pembrolizumab), determining the maximum tolerated dose (MTD) and the recommended Phase 2 dose (RP2D)....The clinical trial aims to enroll a total of 67 patients across four institutions in Australia."

Trial status • Solid Tumor

KEYNOTE-E80: Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 (clinicaltrials.gov) - P1 | N=67 | Not yet recruiting | Sponsor: PharmAbcine | Phase classification: P1a/1b ➔ P1

Metastases • Monotherapy • Phase classification • Oncology • Solid Tumor • CD4

PMC-309: A highly selective anti-VISTA antibody reverses immunosuppressive TME to immune-supportive (ESMO 2023) - "PMC-309 increased the number of T cell infiltration while a decrease of MDSCs in the TME. PMC-309 in combination with chemotherapy or other IO drugs could address the high medical unmet needs of patients with drug resistance to currently available IO treatment options."

Oncology • IFNG • IL2 • TNFA • VSIR

MarkV-01: Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 (clinicaltrials.gov) - P1a/1b | N=67 | Not yet recruiting | Sponsor: PharmAbcine | Initiation date: Aug 2023 ➔ Nov 2023

Metastases • Monotherapy • Trial initiation date • Oncology • Solid Tumor • CD4

PharmAbcine gets Australian nod for p1 clinical trial of Keytruda-combined cancer drug (Korea Biomedical Review) - "PharmAbcine received approval from the Australian Human Research Ethics Committees (HRECs) last Friday to conduct a phase 1a/b clinical trial of PMC-309....The phase 1 study in Australia will evaluate the safety and efficacy of PMC-309 monotherapy and in combination with Keytruda (pembrolizumab). Merck (MSD) will provide Keytruda free of charge for this study. The trial will enroll up to 67 patients at four Australian institutions....In phase 1a, PharmAbcine will identify the maximum tolerated dose (MTD) and recommended phase 2 dose (RP2D) of PMC-309 alone and combined with Keytruda in patients with advanced or metastatic solid tumors. The phase 1b study will evaluate the safety and tolerability..."

Trial status • Oncology • Solid Tumor

MarkV-01: Study to Assess the Safety, Tolerability, and Blood Concentration of PMC-309 (clinicaltrials.gov) - P1a/1b | N=67 | Not yet recruiting | Sponsor: PharmAbcine

Metastases • Monotherapy • New P1 trial • Oncology • Solid Tumor • CD4

PharmAbcine to participate in "BIO International Convention 2023" (PRNewswire) - "PMC-309, a first-in-class anti-VISTA antagonistic antibody, is an immuno-oncology asset....IND submission for Phase 1 study in Australia will be submitted within the second quarter of 2023."

New P1 trial • Oncology

PharmAbcine Announces Collaboration Agreement with MSD to Evaluate Anti-VISTA Antibody PMC-309 in Combination with KEYTRUDA (pembrolizumab) (PRNewswire) - "PharmAbcine Inc....announced today that the Company has entered into a clinical collaboration agreement with MSD (Merck & Co., Inc., Rahway, NJ., USA), to initiate a Phase I combination trial of PMC-309, a novel anti-VISTA (V-domain Ig suppressor of T cell activation) antibody, in combination with KEYTRUDA (pembrolizumab), MSD's anti-PD-1 therapy. Under the terms of the agreement, PharmAbcine will sponsor a Phase I study in Australia to evaluate the safety and clinical efficacy of the combination therapy for the treatment of multiple advanced solid tumors, and MSD will supply KEYTRUDA."

Licensing / partnership • Oncology • Solid Tumor

PMC-309, a highly selective anti-VISTA antibody reverses immunosuppressive TME to immune-supportive TME. (SITC 2022) - "Conclusions PMC-309 increased the number of T cell infiltration while a decrease of MDSCs in the TME. PMC-309 in combination with chemotherapy or other IO drugs could address highly medical unmet needs from patients with drug resistance to currently available IO treatment options."

Oncology • CD14 • IFNG • IL2 • TNFA • VSIR

PharmAbcine Announces Poster Presentations on Its anti-VISTA Antibody Candidate at SITC 2022 (PRNewswire) - "PharmAbcine...announced today that the Company will present preclinical data of PMC-309, one of the Company's first immuno-oncology drug candidates, at SITC (Society for Immunotherapy of Cancer) Annual Meeting taking place November 8-12 in Boston."

Preclinical • Oncology • Solid Tumor

PharmAbcine to Participate in BIO-Europe 2022 (PRNewswire) - "PharmAbcine Inc...announced today that the Company will participate in the upcoming BIO-Europe 2022 which will take place in Leipzig, Germany on October 24 – 26, 2022....PMC-309 is expected to submit a Clinical Trial Application for a Phase I global clinical trial in the second half of 2022."

IND • Oncology

PharmAbcine Inc. (BIO 2022) - "Our lead asset olinvacimab is a tumor angiogenesis inhibitor with a best-in-class potential, and is currently in three clinical studies. Our potentially first-in-class preclinical assets are being prepared for clinical studies in 2022: PMC-309 (anti-VISTA mAb) and PMC-403 (anti-TIE2 mAb)."

Oncology • Ophthalmology

"#VISTA #PMC309 #TME #aacr2022 Hasta la VISTA baby! https://t.co/Jg6kHWMa9E" (@wincancer)

Oncology

PMC-309, a highly selective anti-VISTA antibody reverses immunosuppressive TME to immune-supportive TME (AACR 2022) - "PMC-309 is a fully human anti-VISTA antibody that targets human VISTA specifically. PMC-309 enhanced both T cell activation and monocyte activation when monocytes were cultured with or without T cells by targeting VISTA. PMC-309 increased the number of T cell infiltration while a decrease of MDSCs in the TME."

Oncology • IFNG • IL2 • TNFA • VSIR

PharmAbcine Presents Updated Preclinical Data of Its Anti-VISTA Antibody Candidate at AACR 2022 (PRNewswire) - "The new findings from the poster presentation are as follows: 1) PMC-309 indirectly activates T cells by inhibiting VISTA expressions on immunosuppressive cells. 2) It has shown to inhibit MDSCs and M2 macrophages. 3) It activates monocytes, one of key factors in innate immunity, which also led to the proliferation of pro-inflammatory M1 macrophages. 4) The animal model study showed significantly improved tumor growth inhibition when PMC-309 is used in combo with an anti-PD1 drug...'We received a notice from our CRO partner that the toxicology studies are completed and the final report will be ready in 2Q22. In 2Q22, the Company will also submit a clinical trial application to the HREC (Human Research Ethics Committee) in Australia for a Phase 1 study'."

Clinical data • Non-US regulatory • Preclinical • Oncology • Solid Tumor

"#VISTA #PMC309 #AACR2022 https://t.co/SvqObsB9Wg" (@wincancer)

Oncology

PharmAbcine to Present Updated Data of Its Anti-VISTA Antibody Candidate at AACR 2022 (PRNewswire) - "PharmAbcine...announced today that the Company will present the updated data of PMC-309...'The presentations highlighted that PMC-309 inhibits VISTA pathways on immunosuppressive cells, such as MDSC (Myeloid-Derived Suppressor Cells) and Tregs (regulatory T cells) which resulted in T cell proliferation in in vitro settings and encouraging anti-tumor effects in in vivo studies. This year's presentation will include PMC-309's effect on monocyte activation, which is one of key immune-supportive factors. The Company is preparing an IND submission for a global clinical trial in 2022.'"

IND • Preclinical • Oncology • Solid Tumor

PharmAbcine Announces Patent Grant in Australia for Its Anti-VISTA Antibody (PRNewswire) - "PharmAbcine Inc...announced today that the patent for PMC-309, one of the Company's first immuno-oncology assets, has been granted by IP Australia, the Australian government agency that administers intellectual property rights...The Company also plans to get more patents approved in other countries, including the U.S, Canada, China, Japan, European nations, and etc...In April 2021, PharmAbcine initiated IND-enabling studies of PMC-309....The Company expects to enter a Phase I global trial in 2022."

New P1 trial • Patent • Oncology

PharmAbcine to Participate in ACCESS CHINA Biotech Forum (PRNewswire) - "PharmAbcine Inc...announced today that the Company will virtually participate in ACCESS CHINA Biotech Forum. The event will take place from September 23 – September 30, 2021...During the event, PharmAbcine's pre-recorded presentation video will be made available to Chinese pharmas or biotechs that are looking to enrich their pipeline through in-licensing deals. In the presentation video, the Company will introduce its core technology and update the R&D progress of the main pipelines such as olinvacimab, PMC-403, and PMC-309...PMC-309 is expected to enter a global clinical trial in 2022."

Clinical • New trial • Oncology

PharmAbcine to Participate in H.C. Wainright 23rd Annual Global Investment Conference (PRNewswire) - "During the conference...CEO of PharmAbcine, will update PharmAbcine's R&D progress via a presentation video, highlighting the Company's core technology and pipelines such as olinvacimab, PMC-403, and PMC-309...The Company expects PMC-403 to enter global clinical trials for both ophthalmology and oncology in 2022...PMC-309 is expected to enter a global clinical trial in 2022."

Clinical • New trial • Oncology

PharmAbcine to Participate in Biotechgate Digital Partnering (PRNewswire) - "During the event, PharmAbcine's business development team will hold one-on-one virtual meetings with global pharmas, biotechs, and healthcare companies to discuss potential licensing deals or collaborations for the Company's main pipelines such as olinvacimab, PMC-403, and PMC-309."

Commercial • Oncology