On May 25, 2021 Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies and cytokines for the treatment of cancer and autoimmune diseases, reported it has entered into a technology license agreement with Bristol-Myers Squibb Company (NYSE:BMY) under which Bristol Myers Squibb will have non-exclusive access to Xencor’s Xtend Fc technology to extend the half-life of a novel antibody combination therapy that is intended to neutralize the SARS-CoV-2 virus ("SARS-CoV-2 mAb Duo") for treatment or prevention of COVID-19. SARS-CoV-2 mAb Duo was discovered by researchers at The Rockefeller University and was subsequently licensed by Bristol Myers Squibb (Press release, Xencor, MAY 25, 2021, View Source [SID1234580573]). Phase 1 clinical evaluation to assess dosing and safety of the antibody combination is being conducted by investigators at Rockefeller University Hospital, while the initial Phase 2 and 3 studies are being planned as part of the NIH ACTIV-2 trial examining treatment of infected outpatients.

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"Xencor’s Xtend Fc domains have been incorporated into more than a dozen clinical-stage programs or commercialized medicines, including two programs under investigation for the treatment of COVID-19 and five for other infectious diseases," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "This reflects the potential of Xencor’s XmAb protein engineering platforms to enhance the therapeutic performance of novel antibody candidates. By extending half-life, we improve upon a candidate’s product profile and potentially reduce costs – both of which are important features, particularly for an anti-viral therapy intended for pandemic use. We are committed to partnering with industry and the academic community to support the development of potential treatments for COVID-19, as well as other areas of urgent unmet medical need."

Under the terms of the agreement, Bristol Myers Squibb will have sole responsibility for supporting and advancing the research, development, regulatory and commercial activities for SARS-CoV-2 mAb Duo. Xencor is eligible to receive royalties from net sales of products including these antibodies.

About Xtend XmAb Fc Technology

Xencor’s Xtend XmAb Fc domains have been shown to increase circulating half-life by increasing binding affinity to the receptor FcRn. FcRn is present inside lysosomes in endothelial cells lining the blood vessels and functions to rescue antibodies from the degradation that makes most proteins short-lived in circulation. Half-life extension can be exploited to potentially improve therapeutic antibody performance in several ways, such as increasing dosing interval or decreasing drug quantities at the same dosing interval compared to a parent antibody. Xtend technology is currently in multiple clinical-stage programs and one approved therapy, Alexion’s Ultomiris (ravulizumab-cwvz).

Ultomiris is a registered trademark of Alexion Pharmaceuticals, Inc.

On May 25, 2021 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that it will webcast management participation as follows (Press release, Regeneron, MAY 25, 2021, View Source [SID1234580589]):

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Bernstein’s 37th Annual Strategic Decisions Conference at 8:00 a.m. ET on Wednesday, June 2, 2021
Goldman Sachs 42nd Annual Global Healthcare Conference at 10:30 a.m. ET on Tuesday, June 8, 2021
BMO Biopharma Day at 8:00 a.m. ET on Tuesday, June 22, 2021
The sessions may be accessed from the "Investors & Media" page of Regeneron’s website at View Source Replays of the webcasts will be archived on the Company’s website for at least 30 days.

On May 25, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that the U.S. Food and Drug Administration (FDA) has accepted the Biologics License Application (BLA) for ublituximab, the Company’s investigational glycoengineered anti-CD20 monoclonal antibody, in combination with UKONIQ (umbralisib), the Company’s once-daily, oral, inhibitor of PI3K-delta and CK1-epsilon, as a treatment for patients with chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) (Press release, TG Therapeutics, MAY 25, 2021, View Source [SID1234580524]). The FDA has set a Prescription Drug User Fee Act (PDUFA) goal date of March 25, 2022. The FDA also notified the Company that it is not currently planning to hold an advisory committee meeting to discuss this application.

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Michael S. Weiss, Executive Chairman and Chief Executive Officer of TG Therapeutics stated, "We are extremely pleased that the ublituximab BLA has been accepted by the FDA. This is an important milestone for us as it brings us one step closer to our goal of providing a novel combination treatment option to patients with both treatment naive and relapsed or refractory CLL and SLL. We look forward to collaborating with the FDA throughout this review process."

The BLA submission was based on the results of the UNITY-CLL trial, a global Phase 3 trial evaluating the combination of ublituximab plus UKONIQ (U2) compared to obinutuzumab plus chlorambucil in patients with treatment naive and relapsed or refractory CLL. The U.S. FDA previously granted Fast Track designation to the combination of ublituximab and UKONIQ for the treatment of adult patients with CLL and orphan drug designation for ublituximab in combination with UKONIQ for the treatment of CLL.

ABOUT UNITY-CLL PHASE 3 TRIAL
UNITY-CLL is a global Phase 3 randomized controlled clinical trial comparing the combination of ublituximab plus UKONIQ (umbralisib), or U2, to an active control arm of obinutuzumab plus chlorambucil in patients with both treatment-naïve and relapsed or refractory chronic lymphocytic leukemia (CLL). The trial randomized patients into four treatment arms: ublituximab single agent, UKONIQ single agent, ublituximab plus UKONIQ, and an active control arm of obinutuzumab plus chlorambucil. A prespecified interim analysis was conducted to assess the contribution of ublituximab and UKONIQ in the U2 combination arm and allowed for the termination of the single agent arms. Accordingly, the UNITY-CLL Phase 3 trial continued enrollment in a 1:1 ratio into the two combination arms: the investigational arm of U2 and the control arm of obinutuzumab plus chlorambucil. Approximately 420 subjects enrolled to the two combination arms and approximately 60% of patients were treatment-naïve and 40% were relapsed or refractory. The primary endpoint for this study was superior progression-free survival (PFS) for the U2 combination compared to the control arm. The trial met its primary endpoint and results were presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2020. The UNITY-CLL Phase 3 trial is being conducted under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

ABOUT CHRONIC LYMPHOCYTIC LEUKEMIA
Chronic lymphocytic leukemia (CLL) is the most common type of adult leukemia. It is estimated there will be more than 20,000 new cases of CLL diagnosed in the United States in 2020 and approximately 45,000 new cases globally in 2020.1,2 Although signs and symptoms of CLL may disappear for a period of time after initial treatment, the disease is considered incurable and many people will require additional treatment due to the return of malignant cells.

ABOUT FAST TRACK
Fast Track is a program designed to expedite the development and review of drugs that treat serious conditions and that demonstrate the potential to address an unmet medical need. Filling an unmet medical need is defined as providing a therapy where none exists or providing a therapy that may be potentially better than available therapy.

A drug that receives Fast Track designation is eligible for more frequent interactions with the FDA, priority review if relevant criteria are met, and rolling submission of the Biologics License Application or New Drug Application.

ABOUT ORPHAN DRUG DESIGNATION
Orphan drug designation is granted by the FDA to drugs and biologics which are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases/disorders that affect fewer than 200,000 people in the U.S. Orphan drug designation provides certain incentives which may include tax credits towards the cost of clinical trials and prescription drug user fee waivers. If a product that has orphan drug designation subsequently receives the first FDA approval for the disease for which it has such designation, the product is entitled to orphan product exclusivity.

On May 25, 2021 Heron Therapeutics, Inc. (Nasdaq: HRTX), a commercial-stage biotechnology company focused on improving the lives of patients by developing best-in-class treatments to address some of the most important unmet patient needs, reported that Barry Quart, Pharm.D., Chairman and Chief Executive Officer of Heron Therapeutics, will participate in a fireside chat at the 2021 Jefferies Virtual Healthcare Conference on Tuesday, June 1, 2021 at 11:00 am PT/2:00 pm ET (Press release, Heron Therapeutics, MAY 25, 2021, View Source [SID1234580542]).

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A live webcast of the presentation will be available on the Company’s website at www.herontx.com in the Investor Resources section. A replay of the presentation will be archived on the site for 60 days.

On May 25, 2021 Sierra Oncology, Inc. (SRRA), a late-stage biopharmaceutical company on a quest to deliver targeted therapies that treat rare forms of cancer, reported that the company will participate in the 2021 Jefferies Healthcare Conference being held virtually from June 1-4, 2021 (Press release, Sierra Oncology, MAY 25, 2021, View Source [SID1234580558]). Stephen Dilly, MBBS, PhD, President and Chief Executive Officer of Sierra will present an overview of the company on Thursday, June 3 from 1:30 – 1:55 pm ET.

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The presentation will be webcast at the time noted above, and a replay will be made available following the presentation, on the Investors section of Sierra’s corporate website in the Events & Webcast tab.