On December 18, 2019 Arcus Biosciences, Inc. (NYSE:RCUS), an oncology-focused biopharmaceutical company discovering and developing highly-differentiated therapies, reported a clinical collaboration with Genentech, a member of the Roche group, for the evaluation of novel combinations with AB928, Arcus’s dual antagonist of adenosine receptors A2aR and A2bR, for colorectal (CRC) and pancreatic (PDAC) cancers (Press release, Arcus Biosciences, DEC 18, 2019, View Source [SID1234552520]). The collaboration will utilize the MORPHEUS Phase 1b/2 platform for rapid and efficient combination development, with upfront randomization versus control groups, in two studies:

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Third-line metastatic CRC: two combination arms, (1) AB928 plus atezolizumab (TECENTRIQ) and regorafenib, and (2) atezolizumab plus regorafenib, will be randomized versus regorafenib monotherapy.
First-line metastatic PDAC: the combination of AB928 plus atezolizumab and gemcitabine/nab-paclitaxel will be randomized versus gemcitabine/nab-paclitaxel.
These new studies further broaden Arcus’s portfolio of ongoing trials with AB928, which include prostate, colorectal, lung and breast cancers – all settings in which adenosine has been shown to play a central role in mediating an immunosuppressive tumor micro-environment, inhibiting the ability of both the body’s immune system and anti-cancer treatments to effectively detect and kill cancer cells.

"We are thrilled to collaborate with Genentech to expeditiously develop the broad potential of AB928 across settings and combinations where blocking the immunosuppressive role of adenosine may be critical," said Bill Grossman, M.D., Ph.D., Chief Medical Officer of Arcus. "This collaboration represents a shared commitment from Arcus and Genentech to maximize the potential of innovative combination treatment approaches, based on a deep knowledge of the underlying cancer biology, to address significant unmet needs."

Under the agreement, each company is supplying its respective anti-cancer agent to support the trial and jointly funding the studies. Additional financial terms were not disclosed.

About AB928

AB928, the first and only dual adenosine A2aR/A2bR receptor antagonist in the clinic, is designed to maximally inhibit the adenosine-driven impairment of tumor-infiltrating lymphocytes (mainly CD8+ T cells and NK cells) and myeloid cells (dendritic cells, macrophages), mediated by A2aR and A2bR, respectively. A2bR is also upregulated by certain cancer cells, such as in prostate cancer and KRAS-mutated cancers. As a result, AB928 may uniquely block adenosine’s immunosuppressive and cancer cell-intrinsic effects. Developed specifically for the oncology setting, AB928 achieves high penetration of tumor tissue, robust potency in the presence of high adenosine concentrations, and minimal shift in potency from non-specific protein binding. AB928 has demonstrated a favorable safety profile with a variety of combination regimens and exhibits pharmacokinetics / pharmacodynamics consistent with once-daily dosing. AB928 is currently being evaluated in several Phase 1b/2 studies across multiple indications.

On December 18, 2019 Exicure, Inc. (Nasdaq: XCUR), a pioneer in gene regulatory and immunotherapeutic drugs utilizing spherical nucleic acid (SNA) constructs, reported that it intends to offer and sell shares of its common stock in an underwritten public offering (Press release, Exicure, DEC 18, 2019, View Source [SID1234552519]). In addition, Exicure intends to grant the underwriters a 30-day option to purchase up to an additional fifteen percent (15%) of the shares of its common stock offered in the public offering. All of the shares are being offered by Exicure. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Exicure intends to use the net proceeds from the offering to advance AST-008 through a Phase 1b/2 clinical trial; to initiate a second arm in its Phase 1b/2 clinical trial in cutaneous squamous cell carcinoma; to develop an SNA-based therapeutic candidate for the treatment of Friedreich’s ataxia, initiate IND-enabling studies and advance it into Phase 1 clinical trials; to develop a second SNA therapeutic candidate for a neurology condition and initiate IND-enabling studies; and for general corporate purposes.

Guggenheim Securities is acting as sole book-running manager for the offering.

The securities described above are being offered by Exicure pursuant to a shelf registration statement on Form S-3 (No. 333-230175) that was declared effective by the Securities and Exchange Commission (SEC) on July 24, 2019. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: Guggenheim Securities, LLC Attention: Equity Syndicate Department, 330 Madison Avenue, New York, NY 10017 or by telephone at (212) 518-5548, or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these 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 that state or jurisdiction. Any offer, if at all, will be made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On December 18, 2019 Epizyme, Inc. (Nasdaq: EPZM), a late-stage biopharmaceutical company developing novel epigenetic therapies, reported that the Oncologic Drugs Advisory Committee (ODAC) of the U.S. Food and Drug Administration (FDA) voted 11 – 0 in favor of the benefit-risk profile of tazemetostat as a treatment for patients with metastatic or locally advanced epithelioid sarcoma (ES) not eligible for curative surgery (Press release, Epizyme, DEC 18, 2019, View Source [SID1234552518]).

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"We are incredibly pleased by ODAC’s unanimous support of the benefit-risk of tazemetostat in ES, and we appreciate the tremendous support received from sarcoma physicians and their medical teams, advocates, caregivers and most notably, patients with ES," said Dr. Shefali Agarwal, chief medical officer of Epizyme. "We believe the strength of the totality of data, including the observed durable responses and stabilization of disease, safety and tolerability, are distinguishing characteristics of tazemetostat for patients living with this disease. We are thrilled by the panel’s support and look forward to working closely with the Agency as they continue their review of our NDA. I am confident that we have submitted a comprehensive clinical data package for ES to support tazemetostat’s approval."

ES is a rare and aggressive soft tissue sarcoma characterized by a loss of the INI1 protein. Patients are most commonly diagnosed as young adults, between 20 and 40 years of age, typically with no patients living past five years from diagnosis. ES becomes more aggressive after recurrence or once it has metastasized, with a typical survival of less than one year for patients with metastatic disease.

"Today’s ODAC outcome is a significant step toward addressing the critical needs of ES patients," said Robert Bazemore, president and chief executive officer of Epizyme. "This is a remarkable achievement marking the culmination of years of hard work by the entire Epizyme team. If approved, we will have the opportunity to change how patients with this devastating cancer are treated. Our commercial-readiness is complete, and we look forward to finalizing our dialog with the FDA."

The ODAC is an independent panel of experts that evaluates data concerning the efficacy and safety of marketed and investigational cancer treatments and makes recommendations to the FDA. The New Drug Application (NDA) for tazemetostat, an investigational, oral, first-in-class EZH2 inhibitor, is currently under Priority Review by the FDA with a PDUFA target action date of January 23, 2020. Epizyme’s NDA submission is based primarily on data from the 62 patient epithelioid sarcoma cohort of its ongoing Phase 2 study of tazemetostat, which were reported at the 2019 ASCO (Free ASCO Whitepaper) Annual Meeting.

On December 18, 2019 Biogen Inc. (Nasdaq: BIIB) reported it will report fourth quarter and year-end 2019 financial results Thursday, January 30, 2020, before the financial markets open (Press release, Biogen, DEC 18, 2019, View Source [SID1234552512]).

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Following the release of the financials, the Company will host a live webcast with Biogen management at 8:00 a.m. ET. To access the live webcast, please go to the investors section of Biogen’s website at View Source Following the live webcast, an archived version of the call will be available on the website.

On December 18, 2019 Exelixis, Inc. ("Exelixis") reported that it has entered into a joint clinical research agreement (the "Clinical Collaboration Agreement") with F. Hoffmann-La Roche Ltd. ("Roche") for the purpose of evaluating the combination of cabozantinib (CABOMETYX) with atezolizumab (TECENTRIQ) in patients with locally advanced or metastatic solid tumors, including in three planned phase 3 pivotal trials in advanced non-small cell lung cancer, castration-resistant prostate cancer and renal cell carcinoma (Filing, 8-K, Exelixis, DEC 18, 2019, View Source [SID1234552502]). If a party to the Clinical Collaboration Agreement proposes any additional combined therapy trials beyond the initial three planned phase 3 pivotal trials, the Clinical Collaboration Agreement provides that such proposing party must notify the other party and that if agreed to, any such additional combined therapy trial will become part of the collaboration, or if not agreed to, the proposing party may conduct such additional combined therapy trial independently, subject to specified restrictions set forth in the Clinical Collaboration Agreement.

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Pursuant to the terms of the Clinical Collaboration Agreement, each party granted to the other a non-exclusive, worldwide (excluding, in the case of Exelixis, territory already the subject of a license by Exelixis to Takeda Pharmaceutical Company Ltd.), non-transferable, royalty-free license, with a right to sublicense (subject to limitations), to use the other party’s intellectual property and compounds solely as necessary for the party to perform its obligations under the Clinical Collaboration Agreement. The parties’ efforts will be governed through a joint steering committee established to guide and oversee the collaboration and the conduct of the combined therapy trials. Each party will be responsible for supplying drug product for all combined therapy trials, and the cost of such drug product supply will be borne by such party. The clinical trial expenses for each combined therapy trial agreed to be conducted jointly under the Clinical Collaboration Agreement, including the initial three planned phase 3 pivotal trials, will be shared equally between the parties, and the clinical trial expenses for each additional combined therapy trial not agreed to be conducted jointly under the Clinical Collaboration Agreement will be borne by the proposing party, except that the cost of drug product supply for all combined therapy trials will be borne by the party that owns the applicable drug product.

Unless earlier terminated, the Clinical Collaboration Agreement provides that it will remain in effect until the completion of all combined therapy trials under the collaboration, the delivery of all related trial data to both parties, and the completion of any then agreed-upon additional analyses. The Clinical Collaboration Agreement may be terminated for cause by either party based on any uncured material breach by the other party, bankruptcy of the other party or for safety reasons. Upon termination by either party, the licenses granted to each party will terminate upon completion of any ongoing activities under the Clinical Collaboration Agreement.
The description of the Clinical Collaboration Agreement in this Current Report on Form 8-K does not purport to be complete and is qualified in its entirety by reference to the Clinical Collaboration Agreement, a copy of which will be included as an exhibit to Exelixis’ Annual Report on Form 10-K for the fiscal year ending January 3, 2020, to be filed with the Securities and Exchange Commission.