AC Immune to Present at the SVB Leerink 11th Annual Global Healthcare Conference

On February 2, 2022 AC Immune SA (NASDAQ: ACIU), a clinical-stage biopharmaceutical company pioneering precision medicine for neurodegenerative diseases, reported that Company management will participate in a fireside chat and one-on-one investor meetings during the SVB Leerink 11th Annual Global Healthcare Conference, taking place virtually February 14-18, 2022 (Press release, AC Immune, FEB 2, 2022, View Source [SID1234607637]).

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During the fireside chat, Prof. Andrea Pfeifer, CEO, AC Immune SA, will discuss the Company’s corporate strategy and upcoming milestones including seven clinical readouts planned this year for both therapeutic and diagnostic candidates in development in neurodegenerative diseases, while highlighting its precision medicine approach.

The fireside chat will take place on February 16, 2022, at 8:00 am ET / 2:00 pm CET. A webcast of the fireside chat will be available on the Events Page of AC Immune’s website. Following the fireside chat, a replay will be archived in the same location.

Fate Therapeutics to Present at Upcoming February Investor Conferences

On February 2, 2022 Fate Therapeutics, Inc. (the "Company" or "Fate Therapeutics") (NASDAQ: FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for patients with cancer, reported that the Company will present at the following upcoming investor conferences (Press release, Fate Therapeutics, FEB 2, 2022, View Source [SID1234607636]):

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4th Annual Guggenheim Oncology Day available on demand on Wednesday, February 9, 2022 at 11:00 AM ET
SVB Leerink 2022 Global Healthcare Conference on demand on Wednesday, February 16, 2022 at 3:00 PM ET
A live webcast, if recorded, of each presentation can be accessed under "Events & Presentations" in the Investors section of the Company’s website at www.fatetherapeutics.com. The archived webcast will be available on the Company’s website shortly after the event.

Onconova Therapeutics to Present at the Guggenheim Oncology Conference

On February 2, 2022 Onconova Therapeutics, Inc. (NASDAQ: ONTX), a clinical-stage biopharmaceutical company focused on discovering and developing novel products for patients with cancer, reported that the Company will be participating in the Guggenheim Oncology Conference taking place virtually February 9, 2022, through February 11, 2022 (Press release, Onconova, FEB 2, 2022, View Source [SID1234607635]).

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Steven Fruchtman, M.D., President & CEO of Onconova, will participate in a fireside chat on February 10, 2022, at 8:30 a.m. ET. A webcast of the fireside chat will be available here. Following the presentation, a replay will be archived on the "Corporate Events and Presentations" section of the Onconova website.

The Company will also be participating in 1×1 meetings February 9, 2022, through February 10, 2022. Meetings can be requested exclusively via Guggenheim.

Evoke Pharma and EVERSANA Extend Commercialization Partnership to Further Support GIMOTI

On February 2, 2022 Evoke Pharma, Inc. (NASDAQ: EVOK), a specialty pharmaceutical company primarily focused on treatments for gastrointestinal (GI) diseases, and EVERSANA Life Science Service LLC, an independent provider of global commercial services to the life science industry, reported the extension of their agreement to continue collaborating on the commercialization and distribution of Gimoti (metoclopramide) nasal spray in the United States through the end of 2026 (Press release, EVERSANA, FEB 2, 2022, View Source [SID1234607632]).

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According to the original agreement signed in January 2020, Evoke retains ownership of the Gimoti NDA and legal, regulatory, and manufacturing responsibilities for Gimoti. EVERSANA utilizes its internal sales organization and other commercial functions for market access, marketing, distribution, and other patient support services. Evoke records sales for Gimoti and retains more than 80% of the net product profits once the parties’ costs are reimbursed. This amendment increases the percentage of net product profit retained by Evoke and accelerates the reimbursement of commercialization costs to Eversana after the product breaks even on a monthly basis. The initial term provided in the original agreement was five years following FDA approval, June 19, 2025, but this amendment will extend the term of the agreement through December 31, 2026.

"Our market research for Gimoti continues to reinforce significant unmet medical need for patients with diabetic gastroparesis and shows strong receptiveness to the potential benefits in favor of delivering treatment outside of the gastrointestinal tract," shared Jim Lang, CEO of EVERSANA, "Together we created a fully integrated commercialization model for this therapy and today we are expanding our investment in this partnership as we continue to believe in the product, the market and the patient need. Through the extension of our multi-year partnership, we are poised to further increase the access of Gimoti to patients and physicians as part of our broader commercial strategy."

"Gimoti remains the most novel product to treat patients that suffer from symptoms associated with diabetic gastroparesis. Although the pandemic has slowed new product launches across the industry, we continue to see market research that is highly supportive of the opportunity for Gimoti. More importantly, patients have described remarkable benefits after initiating Gimoti therapy. We continue to see expanding enrollments and filled prescriptions for the brand and believe in the long-term opportunity for Gimoti. We are excited to continue leveraging the expertise of EVERSANA’s team for our sales and distribution efforts, given their large-scale commercialization capabilities for products generated by life science companies," commented Dave Gonyer, CEO of Evoke Pharma.

Brickell Biotech Acquires Exclusive Global Rights to Portfolio of Novel STING Inhibitors Targeting Autoimmune and Inflammatory Diseases from Carna Biosciences

On February 2, 2022 Brickell Biotech, Inc. ("Brickell" or the "Company") (Nasdaq: BBI), a clinical-stage pharmaceutical company striving to transform patient lives by developing innovative and differentiated prescription therapeutics for the treatment of autoimmune, inflammatory and other debilitating diseases, and Carna Biosciences, Inc. ("Carna") (JASDAQ: 4572), a clinical-stage biopharmaceutical company focusing on the discovery and development of innovative therapies to treat serious unmet medical needs, reported that they have entered into a licensing agreement, whereby Brickell will have the exclusive, worldwide rights to develop and commercialize Carna’s portfolio of novel, potent, and orally available Stimulator of Interferon Genes (STING) antagonists (Press release, Vical, FEB 2, 2022, View Source [SID1234607631]). STING is a well-known mediator of innate immune responses. Excessive signaling through STING is linked to a number of high unmet need diseases, ranging from autoimmune disorders, such as systemic lupus erythematosus and rheumatoid arthritis, to interferonopathies, which are a set of rare genetic conditions characterized by interferon overproduction.

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"Inhibiting the STING pathway is a compelling and differentiated approach. In many chronic inflammatory conditions, persistent inflammation results in substantial tissue damage and release of DNA fragments into the extracellular space. The cGAS-STING pathway is the crucial sensor for these extracellular DNA fragments, which triggers release of interferons and other pro-inflammatory cytokines that further exacerbates the inflammation," states Dr. Monica Luchi, Chief Medical Officer of Brickell. "STING antagonists, especially those like the lead candidate, BBI-10, that inhibit the palmitoylation site and deactivate downstream kinase signaling have continued to attract the interest of many researchers, as well as pharmaceutical companies, because of their potential to target a broad spectrum of inflammatory diseases. We are particularly excited about the potential future opportunity of STING inhibitors in a precision medicine context, considering the cGAS-STING pathway has shown to be overactive in defined clinical subgroups of autoimmune and autoinflammatory conditions, as well as severe genetic disorders."

"Our acquisition of Carna’s next-generation STING inhibitors represents a tremendous opportunity to expand our presence in immunology and inflammation and bring forward new treatment options for patients in need," commented Robert Brown, Chief Executive Officer of Brickell. "We believe that this portfolio of preclinical STING inhibitors is complementary to our current development-stage pipeline of NCEs, which includes BBI-02, a potential first-in-class DYRK1A inhibitor program that is expected to enter a Phase 1 clinical study in the coming months. These assets position us with two promising and novel immunology targets and we look forward to advancing them further throughout this year."
"These STING antagonists have been identified from our first non-kinase target project, which we expect to become another cornerstone of the company’s drug discovery research. Our compounds have demonstrated strong STING inhibitory potency in various settings, and we are thrilled that they will be further investigated by Brickell," said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences.
"We are pleased to enter into this agreement with Brickell, as we are always looking for opportunities to accelerate the development of our drug candidates," said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences. "We admire Brickell’s expertise in developing innovative therapies, and we look forward to Brickell leading the development of our STING antagonists to potentially deliver valuable new treatment options to patients with autoimmune and inflammatory diseases."

Under the terms of the license agreement, Brickell will make a one-time cash payment to Carna of $2.0 million. In addition, Brickell will pay Carna success-based development, regulatory, and sales milestone payments of up to $258.0 million. Carna is also eligible to receive tiered royalty payments ranging from mid-single digits up to 10% of net sales. Brickell will be responsible for all future development activities and expenses related to the STING inhibitor platform.