Bayer and Arvinas to Collaborate on Human PROTAC® Therapies and Launch a Separate Joint Venture to Develop Agricultural PROTAC® Applications

On June 04, 2019 Bayer and Arvinas, Inc. (Nasdaq: ARVN), a biopharmaceutical company creating a new class of therapies to degrade disease-causing proteins, reported an agreement to leverage Arvinas’ novel PROTAC protein degrader technology to develop new human therapeutics for patients with cardiovascular, oncological, and gynecological diseases (Press release, Arvinas, JUN 4, 2019, View Source [SID1234645312]). In addition, Bayer and Arvinas will jointly launch a new company to leverage Arvinas’ PROTAC technology for agricultural applications. The overall series of arrangements includes over $110 million in upfront cash and committed funding for the human disease collaboration, the agricultural joint venture, and a direct equity investment by Bayer in Arvinas.

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The multi-faceted deal will extend the application of targeted protein degradation to new therapeutic areas and outside human biology. It leverages Arvinas’ expertise in targeted protein degradation, a field the company has led since its founding in 2013, and Bayer’s decades of experience in developing both human therapies and innovative, sustainable agricultural technologies.

"As the first company founded around targeted protein degradation, we’ve been excited about the potential to improve the lives of patients since our inception," said John Houston, Ph.D., President and Chief Executive Officer of Arvinas. "However, we’ve known that the potential of this technology could be broader than drug development. Through these transactions, not only do we plan to expand our reach into new therapeutic areas, but we and Bayer expect to be the first to apply this approach to agriculture, working to safely and efficiently feed the world’s growing population. It’s a natural next step in our commitment to improving human health."

"With our unique position as a leading company in both Crop Science and Pharmaceuticals, we see a great opportunity to partner with the pioneer of the PROTAC technology, to advance this technology as quickly as possible to deliver future solutions for sustainable agriculture and innovative medicines for patients," said Kemal Malik, Bayer Board member for Innovation.

Pharmaceutical Collaboration and Equity Investment
Bayer and Arvinas will collaborate to seek to develop a series of novel product candidates for diseases with serious unmet need. Arvinas will receive an upfront payment and committed R&D funding, as well as a direct equity investment in Arvinas. Combined, these committed funds exceed $60 million. Bayer will own the rights to novel lead structures generated in the collaboration. As programs progress through research, development, and commercialization, Arvinas is also eligible to receive development milestones of over $685 million and commercial royalties ranging from the mid-single digits to the low double-digits.

Agricultural Joint Venture
In launching a joint venture (JV), Bayer and Arvinas are investing in one of the greatest challenges facing the world: feeding the growing global population. PROTAC targeted protein degraders have the potential to address resistance mechanisms in plants to existing agricultural solutions, with solutions to control weeds, insects, and disease by leveraging the selectivity and other features of PROTAC protein degraders. The JV will be committed to leveraging Arvinas’ PROTAC protein degrader technology to create innovative, safe, and sustainable agricultural products. The JV will be supported by intellectual property and over $55 million in committed funding from Bayer, and by technology and intellectual property from Arvinas. Bayer and Arvinas will equally share governance and equity ownership of the JV.

Arvinas Financial Guidance
The closing of this multi-faceted deal with Bayer, including the pharmaceutical collaboration, direct equity investment, and agricultural JV, will lead to updated financial guidance for Arvinas. With the closing of the transaction, which is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions, current cash and investments are expected to be sufficient for planned operations into the second half of 2021.

Publication in Journal for ImmunoTherapy of Cancer Demonstrates ONC201 Immunostimulatory Activity

On June 4, 2019 Oncoceutics, Inc. reported a publication in the Journal for ImmunoTherapy of Cancer demonstrating ONC201 immunostimulatory activity in advanced cancer patients when given the recommended phase II dose (RP2D) of 625 mg orally every one week (Press release, Oncoceutics, JUN 4, 2019, View Source [SID1234558353]). The publication, which describes a Phase I trial conducted by Mark Stein, MD, at the Rutgers Cancer Institute of New Jersey (CINJ) to evaluate weekly oral administration of the company’s lead compound ONC201, also confirmed previous studies, which demonstrated that the drug was well-tolerated. Weekly dosing stimulated intratumoral infiltration and activation of natural killer (NK) cells. The immune stimulatory effects that were observed under weekly dosing were significantly improved over a schedule that used ONC201 every 3 weeks.

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These results confirm findings reported in 2018 in the Journal of Clinical Investigation in a study led by Wafik El-Deiry, MD, PhD, FACP that described intratumoral NK cell accumulation and activation in preclinical models. Dr. El-Deiry is the Director of the Joint Program in Cancer Biology at Brown University and the Lifespan Cancer Institute, Associate Dean for Oncologic Sciences at the Warren Alpert Medical School, Brown University, and the Scientific Founder of Oncoceutics.

In addition, the new study showed that weekly oral administration of ONC201 did not result in dose-limiting toxicities, discontinuations, or dose modifications. No Grade 3/4 side effects occurred that were attributed to study drug. The pharmacokinetic profile of weekly ONC201 exceeded preclinical therapeutic thresholds and resulted in intratumoral integrated stress response activation and apoptosis. This was consistent with previously published studies, which also demonstrated that ONC201 was well-tolerated by cancer patients.

"Immune activation further explains the durable tumor regressions reported with ONC201," said Varun Vijay Prabhu, PhD, Associate Vice President of R&D at Oncoceutics, "The safety profile of ONC201 has allowed dose intensification with weekly administration."

"NK cell activation and other immune stimulatory effects contribute to the overall anti-tumor effect of ONC201 and provide a rationale for combination with immune-checkpoint therapies," said Dr. El-Deiry. "Based on these findings, we have worked towards initiating a Phase Ib/II trial to evaluate ONC201 in combination with nivolumab."

NexImmune Management Presents at the Jefferies Healthcare Conference

On June 4, 2019 NexImmune, an emerging leader in the field of antigen-directed immunotherapy, reported that Scott Carmer, NexImmune’s Chief Executive Officer, participated and presented a corporate update at (Press release, NexImmune, JUN 4, 2019, View Source [SID1234554878]):

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Jefferies Healthcare Conference
Thursday, June 6th, 4:00PM ET
New York, NY
The presentation will be Available for 90 days

XBiotech Announces Closing of Public Offering of Common Shares

On June 4, 2019 XBiotech Inc. (NASDAQ: XBIT) reported the closing of its previously reported underwritten public offering of 4,848,485 of its common shares at a public offering price of $8.25 per share (Press release, XBiotech, JUN 4, 2019, View Source [SID1234536906]). In addition, XBiotech has granted the underwriter a 30-day option to purchase up to an additional 351,515 common shares at the public offering price, less underwriting discounts and commissions.

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Piper Jaffray acted as the sole underwriter in the offering.

XBiotech received gross proceeds of approximately $40 million. The proceeds of the offering, after deducting underwriting discounts and commissions and estimated offering expenses payable by XBiotech, will be used primarily to advance bermekimab Phase 2 clinical trials in Hidradenitis Suppurativa and Atopic Dermatitis, and for general corporate and working capital purposes.

The common shares are being issued and sold pursuant to an effective shelf registration statement on Form S-3 previously filed with and declared effective by the Securities and Exchange Commission. A final prospectus supplement and accompanying base prospectus relating to the offering each contain important information relating to the XBiotech common shares. The final prospectus supplement and accompanying base prospectus has been filed with the SEC and is available on the SEC’s website at View Source, and may also be obtained, when available, by contacting Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, or by email at [email protected], or by phone at (800) 747-3924.

This press release shall not constitute an offer to sell nor the solicitation of an offer to buy, nor shall there be any sale of securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Amarantus to Present at 9th Annual LD Micro Invitational Conference

On June 4, 2019 Amarantus Bioscience Holdings, Inc. (OTC Pink: AMBS) (the "Company," or AMBS), a US-based JLABS-alumnus biotechnology holding company developing first-in-class orphan neurologic, regenerative medicine and ophthalmic therapies and diagnostics through its subsidiaries, reported that President & CEO Gerald Commissiong will make a corporate presentation at the 9th Annual LD Micro Invitational Conference. The presentation will be at 8:20am Pacific time on Wednesday, June 5th, 2019 in Track 5 at the Luxe Sunset Bel Air Hotel in Los Angeles (Press release, Amarantus Biosciences, JUN 4, 2019, View Source [SID1234536905]).

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