On October 26, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported three upcoming poster presentations discussing INTASYL compounds, including posters being delivered by two development partners, AgonOx, Inc. and the Helmholtz Zentrum München, at the 35th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2020), to be held virtually from November 9-14, 2020 (Press release, Phio Pharmaceuticals, OCT 26, 2020, View Source [SID1234569042]).

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Poster details are as follows:

Poster Sponsor:

Phio Pharmaceuticals

Title:

Combination intratumoral treatment with INTASYL self-delivering RNAi
targeting TIGIT and PD-1/PD-L1 improves tumor control compared to
monotherapy in a CT26 model of murine colorectal cancer

Authors:

Benjamin Cuiffo, et al.

Abstract Number:

198

Poster Sponsor:

AgonOx, Inc.

Title:

Increasing activation of human tumor-reactive T cells (CD39+CD103+CD8+) by
gene silencing of PD1 with self-delivering RNAi INTASYLTM

Authors:

Colin J. Thalhofer, et al.

Abstract Number:

172

Poster Sponsor:

Helmholtz Zentrum München

Title:

New checkpoints controlling function of cytotoxic lymphocytes infiltrating human carcinoma

Authors:

Anna Herbstritt, et al.

Abstract Number:

599

An archived version of the Phio presentation will be made available on the "Investors – Events and Presentations" section of the Company’s website (click here).

On October 26, 2020 Arch Oncology, Inc., a clinical-stage immuno-oncology company focused on the discovery and development of anti-CD47 antibody therapies, reported upcoming presentations at conferences and medical meetings (Press release, Arch Oncology, OCT 26, 2020, View Source;utm_medium=rss&utm_campaign=arch-oncology-to-present-at-upcoming-conferences [SID1234569041]):

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Investor Conference:

Event: Stifel 2020 Annual Healthcare Conference
Date: November 17, 2020, 4:40 pm ET

Medical and Scientific Meetings:

Event: Macrophage-directed Therapies Summit 2020
Date: October 27-29, 2020

Event: CD47/SIRPα Summit 2020
Date: November 4-5, 2020

Event: SITC (Free SITC Whitepaper) Annual Meeting 2020
Date: November 11-14, 2020
Abstract Title: AO-176, a highly differentiated clinical stage anti-CD47 antibody, preferentially binds tumor versus normal cell CD47 when complexed to b1 integrin

Event: PEGS Europe Virtual 2020
Date: November 9-13, 2020

On October 26, 2020 Forma Therapeutics Holdings, Inc. (Nasdaq: FMTX), a clinical-stage biopharmaceutical company focused on rare hematologic diseases and cancers, reported positive top-line data from a planned interim analysis of a registrational Phase 2 clinical trial of olutasidenib, Forma’s selective inhibitor for hematological malignancy cancers with mutations in isocitrate dehydrogenase 1 (IDH1m) (Press release, Forma Therapeutics, OCT 26, 2020, View Source [SID1234569039]). Olutasidenib demonstrated a favorable tolerability profile as a monotherapy in patients with IDH1m relapsed/refractory acute myeloid leukemia (R/R AML), and achieved a composite complete remission (CR+CRh, or complete remission plus complete remission with partial hematologic recovery) rate of 33.3% (30% CR and 3% CRh), the primary efficacy endpoint. While a median duration of CR/CRh has not been reached, a sensitivity analysis (with a hematopoietic stem cell transplant or HCST as the end of a response) indicates the median duration of CR/CRh to be 13.8 months.

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Safety results are consistent with previously reported Phase 1 clinical trial results1,2. The most common adverse events (AEs) observed were nausea, constipation, increased white blood cell count, decreased red blood cell count, fever, febrile neutropenia and fatigue.

"We are pleased to announce these compelling top-line data," said Patrick Kelly, MD, chief medical officer of Forma Therapeutics. "The safety profile and the duration of the response we’re seeing supports the potential for olutasidenib to become a leading therapy for R/R IDH1m AML patients. While the multi-cohort Phase 2 trial is ongoing, this specific cohort was designed to serve as a pivotal study; these efficacy data support an early stop in enrollment in favor of moving the program forward."

Additional analyses and other outcome measures will be presented at an upcoming medical meeting.

Study Design

The Phase 1/2 study is a multicenter, open-label, multi-cohort evaluation of the safety, efficacy and pharmacokinetics/pharmacodynamics (PK/PD) of olutasidenib for patients with AML or myelodysplastic syndrome (MDS) with an IDH1 mutation. Phase 1 of the trial, FT2102-HEM-101, was an open-label, dose-escalation and expansion study of olutasidenib alone and in combination with azacitidine (AZA). The pivotal Phase 2 study is an open-label, fixed-dose study of olutasidenib as a monotherapy in IDH1m AML patients. The Phase 2 study includes other cohorts of olutasidenib in combination with AZA in IDH1m AML/MDS populations. The primary efficacy-evaluable population of the pivotal phase 2 study is comprised of 123 R/R AML patients, who received olutasidenib 150 mg BID at least six months prior to the interim analysis cutoff date of June 18, 2020. The primary endpoint is a composite of a complete remission (CR) plus a complete remission with partial hematological recovery (CRh), defined as less than 5% blasts in the bone marrow, no evidence of disease and partial recovery of peripheral blood counts (platelets >50,000/microliter and ANC >500/microliter).

About Olutasidenib

Olutasidenib is an oral, potent and small molecule investigational agent designed to selectively bind to and inhibit mutated IDH1 enzymes. This targeted treatment has the potential to provide therapeutic benefit by reducing 2-HG levels and restoring normal cellular differentiation. Forma is currently evaluating olutasidenib in a registrational Phase 2 trial for relapsed/refractory AML and in an exploratory Phase 1 trial for glioma and other solid tumors.

IDH1 is a natural enzyme that is part of the normal metabolism of all cells; when mutated, its activity can promote blood malignancies and solid tumors. IDH1 mutations are present in 6-8% of patients with AML and as many as 70 to 80% of patients with grade II/III gliomas and secondary glioblastoma. In gliomas, IDH1 mutations occur early in the tumor pathogenesis and persist throughout progression from a neural stem or progenitor cell. Gliomas are the most common, aggressive and difficult-to-treat primary brain tumors, and high-grade gliomas are associated with poor long-term prognosis. Treatment options for relapsed glioma are limited.

On October 26, 2020 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its third quarter 2020 financial results on Monday, November 2, after the close of the U.S. financial markets (Press release, Syndax, OCT 26, 2020, View Source [SID1234569026]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, November 2, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following:

Conference ID: 7974533
Domestic Dial-in Number: (855) 251-6663
International Dial-in Number: (281) 542-4259
Live webcast: View Source

For those unable to participate in the conference call or webcast, a replay will be available on the Investors section of the Company’s website, www.syndax.com.

On October 26, 2020 Cogent Biosciences, Inc. ("Cogent") (NASDAQ: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported the appointment of Andrew Robbins as President and Chief Executive Officer (CEO) (Press release, Cogent Biosciences, OCT 26, 2020, View Source [SID1234569024]). Mr. Robbins will also serve as a member on the Cogent Board of Directors. Mr. Robbins succeeds Chuck Wilson, PhD, who served as President and CEO of Cogent (formerly Unum Therapeutics Inc.) since founding the company in 2014.

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Mr. Andrew Robbins, CEO and President, Cogent Biosciences

"We are thrilled to welcome Andy to Cogent as we continue to rapidly develop our lead asset, PLX9486, to treat patients living with systemic mastocytosis and GIST," said Peter Harwin, Chair, Board of Directors for Cogent. "Andy’s strong track record and deep expertise in developing and commercializing precision therapies will be invaluable, and his passion for bringing new therapies to patients will be critically important as he leads Cogent into the future."

Mr. Harwin continued, "We extend our deep appreciation and gratitude to Chuck for his excellent leadership over the years and commend his dedication to bringing meaningful solutions to patients in serious need."

Mr. Robbins is an accomplished executive with extensive commercial, development, and strategic leadership experience during a 20-year career in the pharmaceutical industry, with a specific focus on oncology and hematology products. Most recently, he served at Array Biopharma as the Chief Operating Officer where he was responsible for the successful commercialization of two novel precision oncology products before Array’s acquisition by Pfizer in 2019.

"I am excited to join Cogent, a company committed to developing best-in-class precision medicines to improve the lives of patients fighting rare, genetically defined diseases," said Andrew Robbins, President and CEO of Cogent. "I look forward to working together with the leadership team, the Board, and the dedicated Cogent employees to advance PLX9486 through clinical development while identifying the best opportunities to broaden our research and development pipeline in the near future."

Prior to joining Array, Mr. Robbins held management positions at both Hospira, Inc., a global pharmaceutical and medical device company, and Pfizer, Inc. as part of its Oncology business unit. He currently serves on the Board of Directors for Harpoon Therapeutics and Turmeric Acquisition Corporation. Mr. Robbins holds a Master of Business Administration degree from the Kellogg School of Management, Northwestern University and a Bachelor of Arts degree from Swarthmore College.

Inducement Equity Award
Cogent today also announced that, on October 23, 2020, the Board of Directors for Cogent approved an inducement award to Mr. Robbins of an option to purchase 7,442,421 shares of common stock. The option has an exercise price equal to the closing price of Cogent’s common stock on October 23, 2020 (the "Grant Date") and will be exercisable over four years with 25% of the shares becoming exercisable on the first year anniversary of the Grant Date, and the remaining 75% of the shares becoming exercisable in 36 equal monthly installments thereafter. The option has a ten-year term and is subject to the terms and conditions of the Cogent 2020 Inducement Plan (the "2020 Inducement Plan") and the stock option agreement pursuant to which the option was granted.

The 2020 Inducement Plan is used exclusively for the grant of equity awards to individuals who were not previously an employee or non-employee director of Cogent (or following a bona fide period of non-employment), as an inducement material to such individual’s entering into employment with Cogent, pursuant to Rule 5635(c)(4) of the Nasdaq Listing Rules.