On April 12, 2021 PharmAbcine Inc. (KOSDAQ: 208340ks), a clinical-stage biotech company focusing on the development of antibody therapeutics, reported that the company presented an e-poster featuring the non-clinical data of PMC-309 at American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2021 Annual Meeting taking place virtually (Press release, PharmAbcine, APR 12, 2021, View Source [SID1234577940]).

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PMC-309, one of the company’s first immuno-oncology drug candidates, is a monoclonal IgG (Immunoglobulin G) that targets human VISTA (V-domain Ig Suppressor of T cell Activation), an immune checkpoint regulator. VISTA is found overexpressed on MDSC (Myeloid-Derived Suppressor Cells) and M2 macrophages both of which are immunosuppressive cells found abundantly around TME (Tumor Microenvironment).

The presentation highlighted that PMC-309 inhibits VISTA pathway on immunosuppressive cells and increases T cell activities in in vitro settings and shows potent anti-tumor effects in in vivo studies.

The in vitro studies confirmed that PMC-309 inhibits VISTA interaction and promotes T cell activation. PMC-309 blocked the VISTA pathway with its partner molecules such as VSIG3 (V-Set and Immunoglobulin domain containing 3), PSGL1 (P-selectin glycoprotein ligand-1) and other VISTA. In addition, there was a rise in the level of IFN-y, a pro-inflammatory cytokine, which indicates that PMC-309 enhanced T cell activities.

In in vivo studies, the test subjects administered with PMC-309 in both hPBMC (human Peripheral Blood Mononuclear Cell) engrafted mouse model and human VISTA Knock-In mouse model showed notable tumor growth inhibition. PMC-309 also showed a possible synergistic effect when used in combo with an anti-PD1 antibody because the combination of two antibodies demonstrated significantly improved tumor growth inhibition.

"Our non-clinical studies revealed PMC-309’s unique binding mechanism and its anti-tumor effect," said Dr. Jin-San Yoo, CEO of PharmAbcine. "The study results add to our confidence that PMC-309 can be a promising immunotherapeutic strategy in both mono and combo therapies for patients who do not respond to other immuno-oncology drugs."

Dr. Yoo also added, "We plan to initiate the IND (Investigational New Drug)-enabling studies and evaluate the potential toxicity risk this year. We expect PMC-309 to enter a clinical stage in 2022."

The e-poster presentation is currently available on the AACR (Free AACR Whitepaper) website. The details of the presentation are as follows:

Title: PMC309, a highly selective anti-VISTA antibody enhances T cell activation through blocking the interaction of T cells and myeloid derived suppressor cells (MDSC)
Session category/title: Immunology/Immune Checkpoints
Abstract number: 1116
Poster number: 1626
Presentation Type: E-poster with audio presentation

On April 12, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the National Medical Products Administration (NMPA) of China has granted a conditional approval to toripalimab for the treatment of patients with locally advanced or metastatic urothelial carcinoma who failed platinum-containing chemotherapy or progressed within 12 months of neoadjuvant or adjuvant platinum-containing chemotherapy (Press release, Shanghai Junshi Bioscience, APR 12, 2021, View Source [SID1234578061]). This is the third approved indication for toripalimab in China. In December 2018, the NMPA granted a conditional approval to toripalimab for the second-line treatment of unresectable or metastatic melanoma. In February 2021, the NMPA granted a conditional approval to toripalimab for the treatment of patients with recurrent or metastatic nasopharyngeal carcinoma (NPC) after failure of at least two lines of prior systemic therapy.

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"Following the approval of indications in melanoma and nasopharyngeal carcinoma, toripalimab has reached a new milestone in the treatment of urothelial carcinoma, under the joint efforts of patients, investigators, and our R&D personnel," said Dr. Patricia Keegan, Chief Medical Officer of Junshi Biosciences. "Junshi Biosciences has pioneered clinical exploration for unselected UC patients in China and achieved remarkable results, which makes us very excited and confident in the development potential of toripalimab as an anti-tumor drug with a broad therapeutic profile. We also look forward to providing Chinese UC patients with more treatment options that work better and cost less through the company’s collaboration with AstraZeneca."

The supplemental NDA is based on the POLARIS-03 study (NCT03113266) led jointly by Professor Guo Jun of the Peking University Cancer Hospital and Professor Huang Yiran of Renji Hospital affiliated to the Shanghai Jiao Tong University School of Medicine. Among the 136 patients with locally advanced or metastatic urothelial carcinoma after failure of platinum-based chemotherapy including neoadjuvant or adjuvant chemotherapy within 12 months, the evaluation results of the Independent Review Committee (IRC) indicated that the overall objective response rate (ORR) was 27.2%, the disease control rate (DCR) was 46.3% and the median overall survival (mOS) reached 14.6 months. The median duration of response (DOR) had not yet reached a mature stage, with 67.1% of patients with objective responses continuing after a 12-month period.

POLARIS-03 is the first pivotal clinical study on the treatment of advanced urothelial carcinoma with an unselected population after failure of first-line standard treatment in China. Data showed that toripalimab demonstrated explicit anti-tumor activity and continuous efficacy among all patients and within each subgroup. ORR of all patients was 27.2%. ORR of PD-L1 positive patients reached 42.2%. ORR of PD-L1 negative patients reached 18.8%. Therefore, advanced urothelial carcinoma patients benefit from toripalimab regardless of PD-L1 expression. In addition, the safety and tolerability of toripalimab were consistent with previous research results.

On April 12, 2021 Heat Biologics, Inc. (Nasdaq: HTBX), a clinical-stage biopharmaceutical company focused on developing first-in-class therapies to modulate the immune system, including multiple oncology product candidates and a novel COVID-19 vaccine,reported that promising new preclinical data of PTX-35 is presented at the AACR (Free AACR Whitepaper) Annual Meeting 2021 (Press release, Heat Biologics, APR 12, 2021, View Source [SID1234577891]).

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PTX5 is the company’s first antibody-based product, currently in a Phase 1 clinical trial for the treatment of patients with solid tumors. PTX-35 is a novel, potential first-in-class antibody modulating TNFRSF25 (death receptor 3), a receptor that is preferentially expressed by antigen-experienced T-cells. In a B16F10 melanoma mouse model, PTX-35 in the presence of tumor antigen supplied by Heat’s HS-110 immunotherapy, resulted in decreased regulatory T-cell suppression and enhanced T effector responses. These changes were associated with delayed tumor progression.

Jeff Wolf, Chief Executive Officer of Heat, commented, "PTX-35 is designed to harness the body’s natural antigen-specific immune activation. We believe our latest data suggest that PTX-35 can help overcome certain mechanisms of cancer immune evasion. We continue to advance our first-in-human Phase 1 study of PTX-35 in patients with solid tumors and look forward to sharing interim data later this year."

Details of the poster presentation are as follows:

Title: PTX-35, a Potential First-in-class Agonist, Reduced the Suppressive Activity of Regulatory T cells and Enhanced CD4+ T cell Effector Responses in the Presence of Tumor Antigens in a Murine Melanoma Model

Abstract Number: 604

Session: Modifiers of the Tumor Microenvironment

Presenter: Eric Dixon, Director of Discovery Sciences, Heat Biologics

About the AACR (Free AACR Whitepaper) Annual Meeting

The 2021 AACR (Free AACR Whitepaper) Annual Meeting program covers the latest discoveries across the spectrum of cancer research—from population science and prevention to cancer biology, translational, and clinical studies, as well as survivorship and advocacy—and highlights the work of the best minds in research and medicine from institutions all over the world.

On April 12, 2021 Theratechnologies Inc. (Theratechnologies) (TSX: TH) (NASDAQ: THTX), a biopharmaceutical company focused on the development and commercialization of innovative therapies, reported that Paul Levesque, President and Chief Executive Officer, will present at the Bloom Burton & Co. Healthcare Investor Conference on Wednesday, April 21, 2021 at 10:30 a.m. ET (Press release, Theratechnologies, APR 12, 2021, View Source [SID1234577908]).

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The live webcast will be available at View Source The live and archived webcast link will also be available in the ‘News’ section of the Company’s website.

On April 12, 2021 Seneca Therapeutics, Inc. ("STI"), a clinical-stage biopharmaceutical company dedicated to the development of targeted oncolytic immunotherapeutics based on Seneca Valley Virus (SVV-001), reported the poster presentation of Seneca Therapeutics’ abstract titled "Oncolytic Seneca Valley Virus (SVV) overcomes resistance to checkpoint inhibitor therapies in neuroendocrine and melanoma murine models expressing the receptor for SVV" (Press release, Seneca Therapeutics, APR 12, 2021, View Source [SID1234577925]). Key points from the presentation:

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SVV-001 demonstrates the ability to turn cold tumors hot;
Intratumoral administration of SVV-001 in combination with a checkpoint inhibitor demonstrates up to six fold increase in anti-tumor response over SVV-001 alone or check point inhibitor therapy alone;
SVV-001 specifically targets, infects and kills TEM8 positive cancer cells. No cell killing was observed in normal cells;
RNA seq data confirm up regulation of genes known to stimulate an immune response;
A randomized Phase III clinical study comparing SVV-001 administered IT in combination with Opdivo and Yervoy compared to Opdivo and Yervoy alone in TEM8 positive neuroendocrine tumors and neuroendocrine carcinomas is planned to begin later in 2021. STI is also developing SVV-001 for intravenous use in TEM8 positive tumors as well as developing SVV-001 to deliver armed viruses to TEM8 positive tumor cells.