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Alligator Bioscience presents at the SITC 35th Annual Meeting

On November 9, 2020 Alligator Bioscience (Nasdaq Stockholm: ATORX) reported that it will present data from three immuno-oncology projects at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 35th Virtual Annual Meeting, November 9-14, 2020 (Press release, Alligator Bioscience, NOV 9, 2020, View Source [SID1234570338]).

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The presentations will include the Phase I study of ATOR-1015, the Phase I-ready ALG.APV-527 developed in partnership with Aptevo Therapeutics, as well as the novel bispecific concept Neo-X-Prime.

"The fact that three of our immuno-oncology projects have been selected for presentation at this year’s SITC (Free SITC Whitepaper) is a clear confirmation of Alligator’s strong presence in the field. The presentations span from advanced clinical patient data to thrilling early data from our next generation drug concept Neo-X-Prime", said Per Norlén, CEO at Alligator Bioscience.

Abstracts are available on the SITC (Free SITC Whitepaper) website and the accompanying posters will be available in the Virtual Poster Hall open from 8:00 am ET on Monday, Nov. 9, until the Virtual Poster Hall closes on Dec. 31, 2020. The posters are also posted on the Alligator Bioscience website.

Title: Safety and pharmacodynamic activity of ATOR-1015, a CTLA-4 x OX40 bispecific antibody, in a Phase I dose escalation study of patients with advanced solid malignancies

Poster summary: ATOR-1015 is currently evaluated in clinical Phase I at a flat dose of 750 mg, which is the highest dose to be evaluated in the ongoing study. One dose limiting toxicity (infusion related reaction) has been observed at 750 mg. No severe immune-related adverse events have been reported. Best clinical response is stable disease.

Details of the presentation: Live question and answer sessions will occur for the ATOR-1015 poster (Number 369) on Wednesday, Nov. 11, from 5:15 to 5:45 p.m. ET and Friday, Nov. 13, from 4:20 to 4:50 p.m. ET.

Title: ALG.APV-527: Potent tumor-directed T cell activation and in vivo tumor inhibition induced by a 4-1BB x 5T4 ADAPTIR bispecific antibody

Poster summary: The presentation covers preclinical data demonstrating that ALG.APV-527 has a favorable safety profile with no indications of systemic immune activation or liver toxicity. In experimental disease models, ALG.APV-527 increased anti-tumor responses and promoted tumor-specific memory. Clinical development is planned for ALG.APV-527 and CTA documents are prepared for filing of a Phase I clinical trial in the EU.

Details of the presentation: Live question and answer sessions will occur for the ALG.APV-527 poster (Number 851) on Wednesday, Nov. 11, from 5:15–5:45 p.m. ET and Friday, Nov. 13, from 4:40–5:10 p.m. ET.

Title: A bispecific antibody targeting CD40 and EpCAM induces superior anti-tumor effects compared to the combination of monospecific antibodies

Poster summary: The presentation will cover the Neo-X-Prime bispecific prototype antibody targeting CD40 and EpCAM. Neo-X-Prime induces superior anti-tumor effects compared to a combination of monotargeting compounds. Furthermore, Neo-X-Prime induces a broad immunological memory against tumor antigens.

Details of the presentation: Live question and answer sessions will occur for the Neo-X-Prime poster (Number 858) on Thursday, Nov. 12, from 4:50–5:20 p.m. ET and Saturday, Nov. 14, from 1–1:30 p.m. ET.

For further information, please contact:
Cecilia Hofvander, Director Investor Relations & Communications
Phone +46 46 540 82 06
E-mail: [email protected]

The information was submitted for publication, through the agency of the contact person set out above, at 2:00 p.m. CET on November 9, 2020.

Sunesis Pharmaceuticals to Host Conference Call on November 16th to Discuss Third Quarter 2020 Financial Results and Recent Highlights

On November 9, 2020 Sunesis Pharmaceuticals, Inc. (Nasdaq: SNSS) reported that it will host a conference call on Monday, November 16th, 2020 at 4:30pm Eastern Time to discuss corporate updates and financial results for the third quarter ended September 30, 2020 (Press release, Sunesis, NOV 9, 2020, https://ir.sunesis.com/news-releases/news-release-details/sunesis-pharmaceuticals-host-conference-call-november-16th [SID1234570337]).

The call can be accessed by dialing (844) 296-7720 (U.S. and Canada) or (574) 990-1148 (international) and entering passcode 1776248.

To access the live audio webcast, or the subsequent archived recording, visit the "Investors and Media – Calendar of Events" section of the Sunesis website at www.sunesis.com. The webcast will be recorded and available for replay on the company’s website for two weeks.

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]):

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]).

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]).

"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.