On November 2, 2021 – OncoResponse, a clinical-stage biotech company advancing immunotherapies derived from the immune systems of elite cancer responders, reported initiation of a Phase 1/2 study of OR2805 in patients with advanced cancer. OR2805 is a fully human monoclonal antibody identified from an elite cancer responder using OncoResponse’s proprietary B-cell discovery platform (Press release, OncoResponse, NOV 2, 2021, View Source [SID1234609566]).

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The study will evaluate the safety, pharmacokinetics and preliminary anti-cancer activity of OR2805 in patients with advanced solid tumors alone and in combination with anti-PD-1 therapy. The trial will include a dose escalation phase, followed by several expansion cohorts. The role of potential biomarkers will be evaluated throughout the study, and more intensively in a separate biology cohort. ClinicalTrials.gov identifier: NCT05094804

"The initiation of our Phase 1 clinical trial of OR2805 represents a significant milestone for OncoResponse. OR2805 has the potential to reverse the inhibitory effect of tumor associated macrophages, or TAMs, and unlock a potent anti-tumor response," said Bob Lechleider, MD, Chief Medical Officer of OncoResponse. "Preclinical studies have demonstrated the ability of OR2805 to effectively counter the inhibitory activity of M2 macrophages, and we now intend to determine how that will translate to clinical activity. OncoResponse is dedicated to bringing novel and effective therapies that modulate the tumor microenvironment into the clinic to help patients who desperately need additional treatment options."

OR2805 is a fully human antibody discovered using B cells derived from an elite responder to checkpoint inhibitor (CPI) therapy. This antibody binds to CD163 which is highly expressed on tumor associated macrophages (TAMs) that create an immunosuppressive tumor microenvironment and inhibit anti-tumor T-cell responses. High frequency of CD163-expressing TAMs generally predicts an unfavorable prognosis in solid tumors.improve anti-tumor T-cell responses, the immunosuppression of TAMs, as a therapeutic strategy for monotherapy and in combination with CPI.

OncoResponse recently highlighted platform and preclinical data on OR2805 in an oral presentation "Using the Human Immune System to Identify Antibodies that Modulate the Tumor Microenvironment" at the Macrophage-Directed Therapies Summit. The presentation, by Kamal D. Puri, PhD, Chief Scientific Officer, can be accessed from the Publications page of the OncoResponse website.

On November 2, 2021 BioTheryX, Inc., a clinical-stage company focused on targeted protein degradation to create life-saving medicines, reported that the U.S. Food and Drug Administration (FDA) cleared the company to proceed with a Phase 1 clinical trial of BTX-1188 in hematologic and solid malignancies (Press release, BioTheryX, NOV 2, 2021, View Source [SID1234596452]).

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BTX-1188 is a novel oral small molecule cereblon binder that has immunomodulatory properties and promotes the degradation of a neosubstrate G1 to S phase transition 1 (GSPT1), a translation termination factor, as well as IKZF1/3, zinc finger transcription factors important in hematological function. By degrading multiple proteins including GSPT1 and IKZF1/3, BTX-1188’s profile is expected to be differentiated from protein degraders that exclusively target GSPT1. BTX-1188 has demonstrated promising preclinical activity against a variety of leukemias and solid tumors.

"The FDA clearance to begin our Phase 1 study for BTX-1188 is a major milestone for BioTheryX, which represents our first molecular glue to enter clinical development, and the second IND clearance for our pipeline," said Zung Thai, M.D., Ph.D., Chief Medical Officer of BioTheryX. "We plan to study BTX-1188 in patients with hematological and solid malignancies who have limited treatment options and for whom new therapies are desperately needed. We expect to initiate patient enrollment in the Phase I study by year end."

The Phase I clinical trial is designed to assess the safety and tolerability of BTX-1188 and to determine the recommended Phase 2 dose. Following determination of the recommended Phase 2 dose, the company plans to further evaluate the safety and efficacy of BTX-1188 in expansion cohorts in both hematological and solid tumor malignancies.

On November 2, 2021 Shoreline Biosciences, Inc. (Shoreline), a biotechnology company developing intelligently designed allogeneic off-the-shelf, standardized, and targeted induced pluripotent stem cells (iPSC) derived natural killer (NK) and macrophage cellular immunotherapies, reported the completion of a $140M financing, led by Ally Bridge Group, with participation from new investors Eventide Asset Management, BeiGene, Irving Investors, Kingdon, NS Investment, Piper Heartland Healthcare Capital, and Superstring (Press release, Shoreline Biosciences, NOV 2, 2021, View Source [SID1234596067]). Existing investors Boxer Capital, BVF Partners, L.P., Commodore Capital, Cormorant Asset Management, Janus Henderson Investors, Kite, a Gilead Company, Stork Capital, Wedbush Healthcare Partners and an undisclosed leading global investment firm, also participated. In connection with the financing, Frank Yu, Founder, CEO and CIO of Ally Bridge Group, joined the Shoreline Board of Directors.

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"We are proud of Shoreline’s tremendous progress over the past year, including next generation, more persistent and more effective iPSC-derived NK cells, enhancing our core technologies, advancing our preclinical programs, establishing transformative and validating partnerships with Kite and BeiGene, creating smart manufacturing methods, and attracting exceptional talent to support our next phase of development and growth," said Kleanthis G. Xanthopoulos, Ph.D., Shoreline’s co-founder, Chairman and Chief Executive Officer. "With this financing and our corporate partnerships, Shoreline has now more than $300 million to continue building our pipeline of safe, effective and affordable cellular immunotherapies for both solid tumors and hematologic malignancies."

"Having invested in – and followed closely for several years — the iPSC-derived NK cells-based therapeutics field which has made highly encouraging progress in the clinic, we are convinced of the true differentiation demonstrated by the Shoreline technology platform. Ally Bridge Group, a leading investor in best-in-class cell therapy companies from oncology to autoimmune diseases, expects Shoreline to be a new category leader," said Frank Yu, Founder, CEO and CIO of Ally Bridge Group.

The proceeds from the financing will allow Shoreline to continue the advancement of its proprietary iPSC platform focused on developing next generation natural killer (NK) cell and macrophage-cell therapies, create potent and persistent NK cell-specific Chimeric Antigen Receptors (CARs) as well as switchable CAR-NK cell engagers and macrophage-specific CARs to treat blood cancers, solid tumors, and other health conditions. With the close of this financing, Shoreline is well-capitalized with greater than $300 million, including committed partnership R&D funding, to execute on its goals and advance its pipeline.

On November 2, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported that company management will participate in the following upcoming investor conferences (Press release, Xencor, NOV 2, 2021, View Source [SID1234595189]):

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Credit Suisse 30th Annual Healthcare Conference
Presentation: Tuesday, November 9, 2:40 p.m. ET / 11:40 a.m. PT

Jefferies London Healthcare Conference
Presentation on-demand availability: Thursday, November 18, 8:00 a.m. GMT / 12:00 a.m. PT
Webcasts of the presentations will be available under "Events & Presentations" in the Investors section of the Company’s website located at www.xencor.com. Replays will be archived on the website for at least 30 days.

On November 2, 2021 Beijing BeiGene reported a global collaboration to develop and commercialize four natural killer-based cell therapies discovered by San Diego’s Shoreline Biosciences (Press release, Shoreline Biosciences, NOV 2, 2021, View Source [SID1234594654]). BeiGene made a $45 million upfront payment and will be responsible for (unspecified) milestones, plus additional R&D funding and royalties. Shoreline is developing off-the-shelf, standardized and targeted natural killer and macrophage cellular immunotherapies, which it derives from induced pluripotent stem cells (iPSC), primarily for cancer. Today, Shoreline closed a $140 million B round led by Ally Bridge Group.

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