Spectrum Pharmaceuticals to Present at Two Upcoming Investor Conferences in November

On November 6, 2020 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported that management will present an overview of the company’s business strategy and development-stage programs at two upcoming virtual investor conferences (Press release, Spectrum Pharmaceuticals, NOV 9, 2020, View Source [SID1234570336]):

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Stifel Virtual Healthcare Conference, Monday, November 16th, 2020 at 2:40 p.m. ET.
Jefferies London Healthcare Conference, Wednesday, November 18th, 2020 at 2:20 p.m. ET.
A live webcast of the presentations will be available from the Investor Relations section of the company’s website at View Source with a replay available shortly after each event.

Calithera Biosciences Presents New Preclinical Data for CB-668 at Society for Immunotherapy of Cancer (SITC) 2020 Annual Meeting

On November 9, 2020 Calithera Biosciences, Inc. (Nasdaq: CALA), a clinical stage biotechnology company focused on discovering and developing novel small molecule drugs for the treatment of cancer and other life-threatening diseases, reported that new preclinical data for the company’s novel IL4I1 inhibitor CB-668 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Virtual Annual Meeting 2020 (Press release, Calithera Biosciences, NOV 9, 2020, View Source [SID1234570335]).

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CB-668 is a potent, selective, small-molecule, oral inhibitor of IL4I1, an amino acid oxidase that inhibits anti-tumor immunity and promotes tumor growth. IL4I1 regulates several aspects of adaptive immunity, including inhibition of cytotoxic T cells through its production of both hydrogen peroxide and activators of the aryl hydrocarbon receptor. CB-668 increases pro-inflammatory gene expression in tumors leading to an anti-tumor effect in mouse tumor models. Calithera has selected CB-668 as a clinical candidate and IND-enabling studies are ongoing.

"We are excited to share these new preclinical data on CB-668, which is the first compound in development designed to target IL4I1," said Susan Molineaux, Ph.D., president and chief executive officer of Calithera. "Given the overexpression of IL4I1 in human tumors, particulary ovarian tumors and B cell lymphomas, CB-668 has the potential to provide a new therapeutic approach for a variety of cancer types."

The preclinical data being presented by Andrew MacKinnon, Ph.D., demonstrate that CB-668 is a potent and selective inhibitor of IL4I1, exhibiting immune-mediated, single agent activity in syngeneic mouse tumor models. CB-668 was well-tolerated at efficacious doses in animal studies. In addition, CB-668 augments checkpoint inhibitors in these models.

Title: Anti-tumor activity of CB-668, a potent, selective and orally bioavailable small-molecule inhibitor of the immuno-suppressive enzyme Interleukin 4 (IL-4)-Induced Gene 1 (IL4I1)
Abstract: #506
Location: SITC (Free SITC Whitepaper) Virtual Poster Hall
Dates/Times:November 11-14, 2020, 9:00 a.m.-5:00 p.m. ET

Additional meeting information can be found at the SITC (Free SITC Whitepaper) website www.sitcancer.org. The CB-668 poster presentation will be available at www.calithera.com on the Publications page beginning November 11th.

Cogent Biosciences Reports Third Quarter 2020 Financial Results and Provides Corporate Updates

On November 9, 2020 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported financial results for the third quarter ended September 30, 2020 and provided several corporate updates (Press release, Cogent Biosciences, NOV 9, 2020, View Source [SID1234570334]).

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"Over the past quarter, Cogent Biosciences has made tremendous progress establishing a clear strategy and focus that positions us as an emerging leader in the field of precision medicines for patients with genetically driven diseases," said Andrew Robbins, President and CEO of Cogent Biosciences. "We are excited by the potential of our lead program, PLX9486, and look forward to presenting final clinical data from its Phase 1/2 study in GIST patients at CTOS 2020. We look forward to initiating new clinical trials of PLX9486 in patients with systemic mastocytosis and GIST in 2021, beginning in 1H 2021 with a trial of PLX9486 in advanced systemic mastocytosis (ASM) patients."

Recent Program and Corporate Highlights

Andrew Robbins appointed President, CEO and Director
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, as COO of Array Biopharma, he led the successful launch of MEKTOVI (binimetinib) and BRAFTOVI (encorafenib) for BRAF-mutant metastatic melanoma patients.

PLX9486 + sunitinib GIST Phase 1/2 trial selected for CTOS 2020 oral presentation
Title: The Potent and Selective Kit Inhibitor PLX9486 Dosed in Combination with Sunitinib Demonstrates Promising Progression Free Survival (PFS) in Patients with Advanced Gastrointestinal Stromal Tumor (GIST): Final Results of a Phase 1/2 Study
Date: Friday, November 20, 2020 from 11:30 a.m. – 12:30 p.m. ET
Presenter: Jonathan Trent, M.D., Ph.D., University of Miami Health System, Sylvester Comprehensive Cancer Center

Cogent Biosciences positioned as an emerging leader in the field of precision medicine for patients with genetically driven diseases
Completed Kiq LLC acquisition: On July 6, 2020, Cogent Biosciences (previously Unum Therapeutics) announced the sign and close of the Kiq LLC ("Kiq") acquisition including global rights to PLX9486, a selective and potent KIT inhibitor.
Completed $104.4M Series A preferred stock private placement: Concurrent with the acquisition of Kiq, Cogent Biosciences completed the sale of Series A non-voting convertible Preferred Stock ("Series A Preferred Stock") in exchange for gross proceeds of $104.4 million.
Announced new company as Cogent Biosciences: The new name reflects our mission to design rational precision therapies that treat the underlying cause of disease in order to improve patients’ lives.
Out licensed BOXR programs to SOTIO: On August 31, Cogent Biosciences announced the sale of its cell based BOXR programs to SOTIO, a clinical stage immuno-oncology company owned by PPF Group. Under the terms of the agreement, SOTIO made an upfront payment of $8.1 million, and certain Cogent Biosciences stockholders of record (as of July 6, 2020) were granted a non-tradeable contingent value right (CVR). Holders of the CVR will be entitled to receive certain stock and/or cash payments from net proceeds received by Cogent Biosciences.
Reverse Stock Split Enabling Preferred Share Conversion

At a special shareholder meeting held on November 6, 2020, Cogent Biosciences’ stockholders approved a reverse stock split. With this authority, Cogent Biosciences’ board of directors approved the reverse stock split at a ratio of 1-for-4, effective November 6, 2020. This ensured that sufficient common shares were authorized and issuable to allow for full conversion of the Series A Preferred Stock. Cogent Biosciences’ common stock will begin trading on a split-adjusted basis upon market open on November 9, 2020. Immediately following the Reverse Stock Split and assuming full conversion of the Series A preferred stock, Cogent Biosciences would have approximately 52.2 million shares of Common Stock outstanding.

The reverse stock split impacts all holders of Cogent Biosciences stock proportionally and will not impact any stockholder’s percentage ownership of common stock.

Third Quarter 2020 Financial Results

Collaboration Revenue: Collaboration revenue recognized during the third quarter ended September 30, 2020 of $0.3 million compared to $1.0 million in the same period of 2019.
R&D Expenses: Research and development expenses of $5.0 million for the third quarter ended September 30, 2020 compared to $10.3 million for the same period of 2019. This decrease is primarily related to the reduction in clinical activity of legacy cell-therapy clinical trials.
G&A Expenses: General and administrative expenses for the third quarter ended September 30, 2020 were $5.6 million, compared to $2.7 million for the same period of 2019. The increase is primarily related to higher professional fees and stock compensation.
Acquired In-Process R&D Expense: Acquired in-process R&D expense of $46.9 million during the current quarter was a result of the accounting treatment related to the asset acquisition of Kiq LLC, including PLX9486, on July 6, 2020.
Other Income (expense): Other income (expense) for the third quarter ended September 30, 2020 was $7.2 million, compared to $0.1 million for the same period of 2019. The increase is primarily related to the gain on the sale of the BOXR platform to SOTIO.
Net Loss: Net loss attributable to common stockholders was $50.0 million, or $5.07 per share, for the third quarter ended September 30, 2020 compared with a net loss attributable to common stockholders of $11.9 million, or $1.56 per share, for the same period of 2019.
Cash and Cash Equivalents: As of September 30, 2020, Cogent Biosciences had cash and cash equivalents of $129.4 million.

Bicycle Therapeutics Presents Posters at the SITC 35th Anniversary Annual Meeting

On November 9, 2020 Bicycle Therapeutics plc (Nasdaq: BCYC), a biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology, reported that preclinical data for BT7480, a tumor-targeted immune cell agonist (TICA), and an EphA2/CD137 TICA will be presented during an e-poster session at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Anniversary Annual Meeting on November 9-14, 2020 (Press release, Bicycle Therapeutics, NOV 9, 2020, View Source [SID1234570333]).

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"We continue to produce compelling data characterizing the preclinical profiles of our novel, fully synthetic immuno-oncology, or IO, candidates," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "The data presented at SITC (Free SITC Whitepaper) provide further evidence of the potential advantages of our TICAs over conventional, biologic-based IO therapies. Our molecules are able to fully engage the local tumor microenvironment with intermittent systemic exposure. Furthermore, because our TICAs are fully synthetic, we can customize each molecule’s pharmacokinetic profile and easily swap tumor-targeting and/or immune cell agonizing Bicycles for a generalizable approach. We believe our TICAs represent a major innovation in precision targeted immune modulation, and we look forward to initiating a clinical trial for our lead IO program, BT7480, in 2021."

In preclinical models, BT7480 exhibited potent, target-dependent anti-tumor activity, and facilitated the development of immunogenic memory. New data presented at SITC (Free SITC Whitepaper) demonstrate that treatment with BT7480 leads to significant modulation of the tumor microenvironment, including immune checkpoints. This finding supports potential dosing of BT7480 in combination with checkpoint inhibitors. At dose levels tested, BT7480 has been shown to be well-tolerated in non-human primates. IND-enabling activities for BT7480 are ongoing.

Based on new data presented at SITC (Free SITC Whitepaper), one of Bicycle’s EphA2/CD137 TICAs demonstrated potent EphA2-dependent activity in both CD137 reporter and primary immune cell assays. As with BT7480, intermittent dosing was associated with robust anti-tumor activity in an MC38 syngeneic mouse model that expresses human CD137. There, complete responder animals became resistant to rechallenge with MC38 tumor cells, implying an immunogenic memory response. Bicycle also showed a potential ability to induce significant modulation of the tumor immune microenvironment, including immune checkpoints. Bicycle announced earlier this year that it has selected an EphA2/CD137 TICA candidate, BT7455.

Together, data to be presented at SITC (Free SITC Whitepaper) demonstrate the potential generalizability of the TICA platform, with a Nectin-4/CD137 TICA and an EphA2/CD137 TICA exhibiting similar anti-tumor activity and immune modulation. Details on Bicycle’s poster presentations at SITC (Free SITC Whitepaper) are as follows:

Poster Title: BT7480, a fully synthetic tumor-targeted immune cell agonist (TICA) induces tumor localized CD137 agonism and modulation of tumor immune microenvironment
Abstract #: 706
Live Q&A: Thursday, November 12, 4:50 p.m. – 5:20 p. m. ET and Saturday, November 14, 1:00 p.m. –1:30 p.m. ET

Poster Title: EphA2/CD137 Bicycle tumor-targeted immune cell agonists (TICAs) induce tumor regressions, immunogenic memory, and reprogramming of the tumor immune microenvironment
Abstract #: 700
Live Q&A: Thursday, November 12, 4:50 p.m. – 5:20 p. m. ET and Saturday, November 14, 1:00 p.m. –1:30 p.m. ET

ORIC Pharmaceuticals to Participate in Upcoming Investor Conferences

On November 9, 2020 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that Jacob Chacko, M.D., chief executive officer, will participate in the following investor conferences in November (Press release, ORIC Pharmaceuticals, NOV 9, 2020, View Source [SID1234570332]):

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Jefferies Virtual London Healthcare Conference – Participating in a virtual fireside chat on November 18, 2020 at 5:00 p.m. GMT/9:00 a.m. PT; and

SVB Leerink Oncology 1×1 Day – Hosting virtual investor meetings on November 19, 2020
A live webcast of the fireside chat will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the events.