Surface Oncology Announces First Patient Dosed in Phase 1 Clinical Trial of SRF231

On March 20, 2018 Surface Oncology, an immuno-oncology company developing next-generation antibody therapies that target the tumor microenvironment, reported that the first patient was treated in its Phase I trial of SRF231, the company’s lead product candidate (Press release, , 20 20, 2018, View Source [SID1234524906]). SRF231 is a fully human antibody that inhibits the activity of CD47, a protein overexpressed on many types of cancer cells which prevents them from being engulfed and eliminated by macrophages.

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"The initiation of this clinical trial is a milestone for Surface and demonstrates the outstanding progress we’ve made in advancing our innovative oncology pipeline," said Rob Ross, M.D., chief medical officer of Surface Oncology. "SRF231 is the first of what we expect will be multiple novel agents that we bring into clinical development to help patients suffering from cancer."

Initially, this multi-center, open-label Phase I trial will evaluate the safety and tolerability of SRF231 in multiple ascending doses in patients with advanced solid tumors and hematologic malignancies with the objective of establishing a recommended dose for further study. Following the dose escalation component of the trial, Surface intends to evaluate the safety and efficacy of SRF231 in cohorts of patients with specific types of cancer.

"Targeting the tumor microenvironment has tremendous therapeutic potential," said Amita Patnaik, M.D., F.R.C.P.C., Associate Director of Clinical Research at South Texas Accelerated Research Therapeutics and an investigator on the trial. "Our team is eager to evaluate the role of macrophage activation through SRF231 to expand the opportunities for patients with cancer to benefit from immunotherapy."

ABOUT SRF231

SRF231 is a fully human monoclonal antibody therapeutic targeting CD47, a protein overexpressed on many cancer cells which prevents them from being engulfed and eliminated by macrophage mediated phagocytosis. SRF231 preclinical results presented at the 2016 Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) and the American Society of Hematology (ASH) (Free ASH Whitepaper) meetings demonstrated that SRF231 has potent anti-tumor activity preclinically in several different tumor models and in combination with existing cancer modalities. Importantly, preclinical studies also showed that SRF231 does not induce hemagglutination, an important potential safety advantage.

20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)]

AC Immune has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Filing, 20-F, AC Immune, 2018, MAR 20, 2018, View Source [SID1234526042]).

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Tetraphase Pharmaceuticals to Present at 17th Annual Needham Healthcare Conference

On March 20, 2018 Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH) a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, reported that company management will give a corporate presentation at the 17th Annual Needham Healthcare Conference on Tuesday, March 27 at 11:00 a.m. Eastern Time at the Westin New York Grand Central Hotel in New York City (Press release, Tetraphase, MAR 20, 2018, View Source [SID1234524915]).

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Live audio webcasts of the presentation will be available on the company’s website at View Source Archived presentations will be available for 30 days.

Cotinga Pharmaceuticals Provides Update on COTI-2 Clinical Programs

On March 20, 2018 Cotinga Pharmaceuticals Inc. (TSX Venture:COT) (OTCQB:COTQF) ("Cotinga" or the "Company"), a clinical-stage pharmaceutical company advancing a pipeline of targeted therapies for the treatment of cancer, reported that the Company submitted an updated clinical package to regulatory authorities to expand its ongoing Phase 1 trial of COTI-2 (Press release, Cotinga, MAR 20, 2018, View Source [SID1234533158]). The protocol amendment will expand the clinical trial to evaluate COTI-2 as a combination therapy in a wide spectrum of cancers.

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"Based on the strength of encouraging interim data from our ongoing Phase 1 trial, as well as preclinical studies demonstrating that COTI-2 was efficacious and synergistic when administered alongside standard of care chemotherapeutics, we are excited to push forward the development of COTI-2 as part of a combination therapy regimen," said Alison Silva, President and Chief Executive Officer. "After close consultation with our academic collaborators and investigators, we submitted a substantially updated regulatory package to the FDA seeking approval to evaluate COTI-2 as a combination therapy in our ongoing trial. In addition to evaluating our lead asset as a combination therapy for gynecological malignancies and head and neck squamous cell carcinoma (HNSCC), the protocol amendment will also broaden the trial to include other solid tumors. We look forward to implementing this amendment and dosing the first patient with a combination therapy regimen in the months ahead."

Phase 1 Trial of COTI-2

The ongoing Phase 1 trial of COTI-2 is currently evaluating COTI-2 as a monotherapy for the potential treatment of gynecological malignancies and HNSCC. In 2017, the Company announced top-line data from the gynecological malignancies arm of the trial demonstrating COTI-2 was generally safe and well-tolerated. COTI-2 also exhibited an encouraging pharmacokinetic/pharmacodynamic profile and signals of efficacy.

The protocol amendment submitted by the Company in March 2018 aims to expand the ongoing Phase 1 trial to evaluate COTI-2 in combination with various standard of care chemotherapy regimens in a wide spectrum of cancers. The current gynecological malignancies arm will be expanded to evaluate COTI-2 in combination with bevacizumab and paclitaxel/doxorubicin. The current dose-escalation HNSCC arm will be expanded to evaluate COTI-2 in combination with cisplatin in HNSCC and other solid tumors. Primary outcome measures will evaluate safety and tolerability and determine the maximum tolerated dose and recommended Phase 2 dose for COTI-2 as a combination therapy. Secondary and exploratory outcome measures will evaluate pharmacodynamics and various signals of efficacy. Pending regulatory approval and subject to sufficient financing, the Company expects to implement this protocol amendment for the ongoing Phase 1 trial of COTI-2 in May 2018.

ArQule to Present at the 17th Annual Needham Healthcare Conference on March 27, 2018

On March 20, 2018 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Dr. Brian Schwartz, Chief Medical Officer and Head of Research and Development, will present at the 17th Annual Needham Healthcare Conference on March 27th, 2018, at 3:30 p.m. ET at the Westin Grand Central Hotel in New York, New York (Press release, ArQule, MAR 20, 2018, View Source [SID1234524900]).

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You can access the live webcast of the presentation via the "Investors & Media" section of our website, www.arqule.com, under "Events & Presentations." A replay of the webcast will be available shortly after the conclusion of the presentation.