On December 20, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported that Robert Coffin, Ph.D., Chief Executive Officer and Director of Replimune, will present at the 37th Annual J.P.Morgan Healthcare Conference on Wednesday, January 9, 2019 at 8:00 AM PT at the Westin St. Francis Hotel in San Francisco, CA (Press release, Replimune, DEC 20, 2018, View Source [SID1234532180]).

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A simultaneous webcast will be available in the Investors section of Replimune’s website at www.replimune.com. A replay will be available for 30 days following the conference.

On December 20, 2018 Relay Therapeutics, a new breed of company at the intersection of computation and biotechnology, reported the successful completion of a $400 million Series C financing (Press release, Relay Therapeutics, DEC 20, 2018, View Source [SID1234532195]).

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Relay Therapeutics combines unprecedented computational power with leading-edge experimental approaches across the fields of structural biology, biophysics, chemistry and biology. The integration of these disparate disciplines, tools and cultures enables Relay Therapeutics to overcome challenges that prior attempts have failed to solve and to design therapies against validated but previously intractable targets. Relay Therapeutics’ initial discovery programs in cancer have led to the development of highly selective inhibitors of disease-causing proteins in genomically defined patient populations.

The Series C financing was led by the SoftBank Vision Fund and included participation from additional new investors including Foresite Capital, Perceptive Advisors and Tavistock Group. Existing investors GV, Casdin Capital, BVF Partners, EcoR1 Capital, Alexandria Venture Investments, and an affiliate of D.E. Shaw Research also participated in the round.

Proceeds from this financing are anticipated to be used to accelerate the implementation of Relay Therapeutics’ long-term strategy. It will support the expansion of the company’s discovery efforts, advance existing programs into the clinic and bolster its broad platform and diverse team.

"We are at a unique moment in the evolution of drug discovery where we can realize the promise of integrating ever more powerful experimental and computational discovery tools to tackle previously undruggable protein targets. The success of our early programs validates the potential of our platform to create breakthrough therapies that address a broad range of diseases," said Sanjiv Patel, M.D., President and Chief Executive Officer of Relay Therapeutics.

"A financing of this magnitude allows Relay Therapeutics to significantly scale and advance both its platform and its pipeline. We are thrilled by the strong support of our investors for our mission, vision and strategy," said Alexis Borisy, Chairman of Relay Therapeutics and Partner at Third Rock Ventures.

"We are proud to support Relay Therapeutics’ world-class team expand its efforts across a larger number of programs and therapeutic areas to develop tomorrow’s life-saving treatments," said Deep Nishar, Senior Managing Partner at SoftBank Investment Advisers, investment adviser to the SoftBank Vision Fund.

On December 20, 2018 Dova Pharmaceuticals, Inc. (NASDAQ: DOVA), a pharmaceutical company focused on acquiring, developing, and commercializing drug candidates for diseases where there is a high unmet need, reported that David Zaccardelli, Pharm. D., has been appointed President and Chief Executive Officer (Press release, Dova Pharmaceuticals, DEC 20, 2018, View Source [SID1234532211]). Dr. Zaccardelli brings substantial specialty pharmaceutical executive leadership and operational expertise, including most notably, serving in several senior management roles at United Therapeutics Corporation. In addition, Jason Hoitt, a seasoned pharmaceutical sales and marketing executive, joins Dova as Chief Commercial Officer. Alex Sapir, the company’s prior President and Chief Executive Officer, is no longer President and Chief Executive Officer of the company, effective as of December 16, 2018.

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"We are very pleased to have both Dr. David Zaccardelli and Jason Hoitt join Dova, as they are highly experienced leaders with the expertise to accelerate the ongoing launch of DOPTELET, prepare for the potential launch in chronic immune thrombocytopenia (ITP), and oversee the clinical development of the chemotherapy-induced thrombocytopenia indication. We believe we have a strong team in place to lead Dova into its next phase of growth" said Paul B. Manning, Chairman of Dova.

"I strongly believe it is a transformational time to join Dova to ensure the full potential of DOPTELET, the first orally administered option for the treatment of thrombocytopenia in patients with chronic liver disease (CLD)," said Dr. David Zaccardelli, newly appointed President and Chief Executive Officer. "In addition, the recently submitted supplemental New Drug Application for patients with ITP provides an opportunity for substantial growth, with the potential for a significant impact on the treatment for patients with ITP. Dova will continue its focus on developing new treatments for patients with unmet medical need."

Dr. Zaccardelli continued, "I am also excited Jason Hoitt is joining Dova to lead the commercial team. He has extensive pharmaceutical experience in both sales and marketing and deep

relationships with hepatologists and gastroenterologists from his roles in the successful launches of Viread HBV while at Gilead Sciences and Incivek, largely regarded as one of the most successful launches in the U.S., while at Vertex."

Separately, the company is providing preliminary estimates of expected net product sales of $2.4 to $2.7 million for DOPTELET for the fourth quarter of 2018. The company also expects any change in year-end inventory held by specialty pharmacies to be flat or potentially decrease compared to the inventory levels on September 30, 2018. The company intends to provide additional detail, including specific metrics, on its fourth quarter and full year 2018 earnings call.

Previously, Dr. Zaccardelli served as the Acting Chief Executive Officer of Cempra Pharmaceuticals, Inc. from December 2016 until the company’s merger with Melinta Therapeutics, Inc. From 2004 until 2016, Dr. Zaccardelli served in several senior management roles at United Therapeutics Corporation, including chief operating officer, chief manufacturing officer and executive vice president, pharmaceutical development and operations. Prior to joining United Therapeutics, Dr. Zaccardelli founded and led a startup company focused on contract pharmaceutical development services, from 1997 through 2003. From 1988 to 1996, Dr. Zaccardelli worked at Burroughs Wellcome & Co. and Glaxo Wellcome, Inc. in a variety of clinical research positions. He also served as director of clinical and scientific affairs for Bausch & Lomb Pharmaceuticals from 1996 to 1997. Dr. Zaccardelli currently serves on the board of directors of Melinta Therapeutics, Inc. (NASDAQ: MLNT), Evecxia Therapeutics and CoreRx, Inc. Dr. Zaccardelli received a Pharm.D. from the University of Michigan.

Prior to Dova, Mr. Hoitt served as Vice President and Head of U.S. sales at Insmed Inc. since 2017. Previously, Mr. Hoitt held roles at Sarepta Therapeutics from 2013 to 2017, including Head of U.S. Sales and Senior Director of Medical Affairs. Prior to Sarepta Therapeutics, Mr. Hoitt, served in various sales and marketing leadership positions at Vertex and Gilead Sciences. Mr. Hoitt has been instrumental in the launches of Arikayce (Insmed), exondys51 (Sarepta Therapeutics), Incivek (Vertex) and Viread HBV (Gilead Sciences).

Indication and Important Safety Information

INDICATION

DOPTELET (avatrombopag) is indicated for the treatment of thrombocytopenia in adult patients with chronic liver disease who are scheduled to undergo a procedure.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

DOPTELET is a thrombopoietin (TPO) receptor agonist and TPO receptor agonists have been associated with thrombotic and thromboembolic complications in patients with chronic liver disease. Portal vein thrombosis has been reported in patients with chronic liver disease treated with TPO receptor agonists. In the ADAPT-1 and ADAPT-2 clinical trials, there was 1 treatment-

emergent event of portal vein thrombosis in a patient (n=1/430) with chronic liver disease and thrombocytopenia treated with DOPTELET.

Consider the potential increased thrombotic risk when administering DOPTELET to patients with known risk factors for thromboembolism, including genetic prothrombotic conditions (Factor V Leiden, Prothrombin 20210A, Antithrombin deficiency or Protein C or S deficiency).

DOPTELET should not be administered to patients with chronic liver disease in an attempt to normalize platelet counts.

CONTRAINDICATIONS:

None

ADVERSE REACTIONS:

Most common adverse reactions (> 3%) were: pyrexia, abdominal pain, nausea, headache, fatigue, and edema peripheral.

On December 20, 2018 Gilead Sciences, Inc. (NASDAQ: GILD) and Agenus Inc. (NASDAQ: AGEN) reported the companies have entered into an immuno-oncology (I-O) partnership focused on the development and commercialization of up to five novel immuno-oncology therapies (Press release, Gilead Sciences, DEC 20, 2018, View Source [SID1234532196]).

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Under the terms of the agreement, Agenus will receive $150 million upon closing, which includes a $120 million upfront cash payment and a $30 million equity investment. The agreement also includes approximately $1.7 billion in potential future fees and milestones. Gilead will receive worldwide exclusive rights to AGEN1423, which has an estimated IND filing by year-end 2018. Gilead will also receive the exclusive option to license two additional programs: AGEN1223 and AGEN2373. Agenus has filed the IND for AGEN1223 and has an estimated IND filing for AGEN2373 in first half of 2019. Agenus will be responsible for developing the option programs up to the option decision points, at which time Gilead may acquire exclusive rights to the programs on option exercise. For one of the option programs, Agenus will have the right to opt-in to shared development and commercialization in the U.S. Gilead will also receive right of first negotiation for two additional, undisclosed preclinical programs.

"Recent advances in immuno-oncology have produced unprecedented benefit to patients; however, many people with cancer still require more effective treatment options," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development, Gilead Sciences. "Our collaboration with Agenus gives us access to novel and differentiated immune modulating antibodies that will complement our growing oncology portfolio and cell therapy business. We look forward to partnering with the Agenus team."

"Gilead is an ideal partner for Agenus for the rapid advancement of our pipeline," said Garo Armen, PhD, Chairman and CEO, Agenus. "By year end, our discovery platforms will have resulted in six INDs in 2018 and 13 INDs by the 1H2019. Gilead’s established global presence and commitment to disruptive therapies, combined with our track-record in building a broad pipeline in I-O, has the potential to yield breakthrough I-O treatments for patients with cancer."

This transaction is subject to clearance under the Hart-Scott Rodino Antitrust Improvements Act and other customary closing conditions.

Agenus Conference Call Information:

Date: Thursday, December 20, 2018
Time: 8:30 a.m. ET
Domestic Dial-in Number: 1-844-492-3727
International Dial-in Number: 1-412-317-5118
Conference ID: Agenus call

The presentation will be webcast live and may be accessed by visiting the "Events & Presentations" page within the Investors section of the Agenus website at agenusbio.com or by using the link below. A replay of the webcast will be available on the Agenus website following the conference.

Webcast link: View Source

AGEN1423, AGEN1223 and AGEN2373 are investigational agents that have not been approved for any uses. Efficacy and safety have not been established.

On December 20, 2018 Servier reported the the Food and Drug Administration approved calaspargase pegol-mknl (ASPARLAS, Servier Pharmaceuticals LLC), an asparagine specific enzyme, as a component of a multi-agent chemotherapeutic regimen for acute lymphoblastic leukemia (ALL) in pediatric and young adult patients age 1 month to 21 years (Press release, Servier, DEC 20, 2018, View Source [SID1234645703]). This new product provides for a longer interval between doses compared to other available pegaspargase products.

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Approval was based on a demonstration of the achievement and maintenance of nadir serum asparaginase activity above the level of 0.1 U/mL when using calaspargase pegol-mknl, 2500 U/m2 intravenously, every 3 weeks. The pharmacokinetics of calaspargase pegol-mknl were studied when administered in combination with multiagent chemotherapy in 124 patients with B-cell lineage ALL.

The most common (incidence ≥ 10%) grade ≥ 3 adverse reactions were elevated transaminase, increased bilirubin, pancreatitis, and abnormal clotting studies. In a randomized trial, the safety profile of calaspargase pegol-mknl administered every 3 weeks was similar to that of pegaspargase administered every 2 weeks.

The recommended calaspargase pegol-mknl dose is 2,500 units/m2 intravenously administered at a minimum dosing interval of every 21 days.

View full prescribing information for ASPARLAS.

Calaspargase pegol-mknl received FDA orphan product designation.

Healthcare professionals should report all serious adverse events suspected to be associated with the use of any medicine and device to FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.

Follow the Oncology Center of Excellence on Twitter @FDAOncologyExternal Link Disclaimer.

Check out recent approvals at the OCE’s podcast, Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.).