Gilead and Carna Biosciences Announce Research and Development Collaboration to Develop Novel Immuno-Oncology Therapies

On June 24, 2019 Gilead Sciences, Inc. (NASDAQ: GILD) and Carna Biosciences Inc. (JASDAQ: 4572) reported that the companies have entered into a research and development collaboration to develop and commercialize small molecule compounds in immuno-oncology and to access Carna’s proprietary lipid kinase drug discovery platform (Press release, Gilead Sciences, JUN 24, 2019, View Source [SID1234537246]).

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Under the terms of the license agreement, Gilead will license from Carna worldwide rights to develop and commercialize inhibitors against an undisclosed immuno-oncology target. In connection with this agreement, Carna will receive an upfront payment of $20 million and is eligible to receive up to an additional $450 million in potential milestone payments upon achievement of certain development and commercial milestones. Carna will also receive royalties on future net sales.

"We are delighted to partner with Gilead on our immuno-oncology pipeline targeting the lipid signaling pathway, as we believe modulators of lipid signaling have the potential to become the next generation of cancer immunotherapies," said Masaaki Sawa, Ph.D., Chief Scientific Officer and Head of Research and Development at Carna Biosciences.

Under the collaboration, Gilead will also have exclusive access to Carna’s proprietary lipid kinase drug discovery platform.

"We are excited to work with Gilead, a biopharmaceutical company known for its science-driven innovation and productivity," said Kohichiro Yoshino, Ph.D., President and Chief Executive Officer at Carna Biosciences. "We are proud that our drug discovery support team can also help the development of potentially innovative cancer immunotherapies at Gilead by utilizing Carna’s proprietary kinase drug discovery technology platform."

"Gilead is committed to building a pipeline in immuno-oncology with a focus on opportunities with the potential to be first-in-class or to be meaningfully differentiated from other therapeutic options," said John McHutchison, AO, MD, Chief Scientific Officer and Head of Research and Development at Gilead Sciences. "Our Carna collaboration also reflects this strategy and we look forward to working with the Carna team to advance novel immunotherapies into clinical testing for the potential benefit of patients."

MorphoSys Appoints Jean-Paul Kress, M.D., as New Chief Executive Officer

On June 24, 2019 MorphoSys AG (FSE: MOR; Prime Standard Segment; MDAX & TecDAX; Nasdaq: MOR) reported that its Supervisory Board has appointed Jean-Paul Kress, M.D., as its new Chief Executive Officer (CEO) (Press release, MorphoSys, JUN 24, 2019, View Source [SID1234537240]). The appointment will take effect on September 1, 2019.

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Dr. Kress brings over 20 years of experience in the pharmaceutical and biotechnology industry, with a strong track record of commercial and operational leadership in various senior management roles in North America and Europe. His focus has been on operations, corporate development and especially the commercialization of innovative products addressing unmet medical needs across diverse disease indications. Prior to joining MorphoSys, Dr. Kress served as Chief Executive Officer at Syntimmune, a clinical-stage biotechnology company developing differentiated drug candidates in a wide range of autoimmune diseases, which was acquired by Alexion in November, 2018. Previously, he acted as Head of North America at Sanofi Genzyme, where he was instrumental in launching dupilumab, the first biologic agent approved in atopic dermatitis.

In his new position, Dr. Kress will succeed Dr. Simon Moroney, who will step down as CEO on September 1, 2019. Dr. Moroney will support Dr. Kress during a transition period.

"I am delighted to welcome Jean-Paul Kress as the new CEO of MorphoSys." said Dr. Marc Cluzel, Chairman of the Supervisory Board of MorphoSys. "He is a seasoned and highly experienced pharma executive with a strong commercial and operational track record. MorphoSys is at an inflection point of its business evolution, bringing its first product to the market and establishing a commercial presence in the U.S. Jean-Paul’s industry expertise will perfectly complement the experienced MorphoSys Management Board to ensure successful execution on the key business priorities while continuing to grow shareholder value."

"On behalf of the entire Supervisory Board, I want to express our sincere gratitude to Simon Moroney for fulfilling the role as CEO over the past 27 years. His tireless efforts for MorphoSys have contributed substantially to making it the biopharmaceutical success story that it is today." Marc Cluzel continued.

"I am excited and privileged to be the next CEO of MorphoSys, and I appreciate the confidence that the Supervisory Board has placed in me," commented Jean-Paul Kress. "This is a dynamic and outstanding time for MorphoSys, and I look forward to working with my new colleagues to deliver innovative medicines to patients all over the globe and contribute to MorphoSys becoming a fully integrated biopharmaceutical company."

Dr. Moroney said, "I am immensely proud of everything we have achieved over the past 27 years since MorphoSys was founded. MorphoSys is stronger than it has ever been and now is an excellent time to make the transition to a new CEO. With Jean-Paul’s medical, commercial and leadership expertise I have every confidence that MorphoSys will make great strides in the execution of its strategy."

About Jean-Paul Kress
Dr. Jean-Paul Kress has a proven track record of senior leadership positions in the biopharma and biotechnology industry. Prior to joining MorphoSys, Dr. Kress served as Chief Executive Officer at Syntimmune, a clinical-stage biotechnology company developing differentiated drug candidates in a wide range of autoimmune diseases. Before, he acted as Executive Vice President and Head of Global Therapeutic Operations at Biogen and Senior Vice President, Head of North America at Sanofi Genzyme, where he was instrumental in launching several therapeutic products, including dupilumab, the first biologic agent approved in atopic dermatitis. He gained further experience in positions at Sanofi Pasteur MSD, Gilead, Eli Lilly and Abbvie. Dr. Kress received an M.D. degree from Faculté Necker-Enfants Malades in Paris, and graduate and post-graduate degrees in pharmacology and immunology from École Normale Supérieure in Paris.

Immunome Appoints Purnanand Sarma, PhD, as President and Chief Executive Officer

On June 24, 2019 Immunome, a biotechnology company focused on discovering first-in-class therapeutics by leveraging the most highly educated components of the human immune system from cancer patients, reported today that industry veteran Purnanand Sarma, PhD, has joined Immunome as President and Chief Executive Officer (Press release, Immunome, JUN 24, 2019, View Source [SID1234537238]). Sarma brings more than 25 years of industry experience with a proven track record in drug development, fund raising, and growing companies across multiple R&D platforms ranging from venture-backed biotechnology start-ups to large-cap pharmaceutical companies. Immunome’s former Chief Executive Officer, Michael Morin, PhD, assumes the role of Chief Scientific Officer, allowing him to focus his time and expertise on maximizing the value of the company’s proprietary breakthrough R&D engine.

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"Immunome is poised to emerge as a dominant player in developing next-generation therapies for cancer, offering tremendous potential for new treatments and hope to patients and their families," said Sarma. "Immunome’s unique ability to harness the information from the most educated human B cells, coupled with its breakthrough target interrogation techniques, delivers a truly powerful discovery engine, and I am very excited to join the team and create what could be a revolution in oncology drug discovery. I am grateful to the exceptional leadership of Mike Morin, producing incredible scientific advances that have rapidly accelerated our discovery engine, which now delivers multiple novel and exciting targets on a monthly basis."

"Sarma is a seasoned biotech executive with an impressive track record in scaling up promising companies," said Morin. "We are thrilled to have him lead our team as we begin to unveil our differentiated approach to immunology, share the recent success and advancements of our innovative discovery platform, build out a development pipeline and articulate our vision for a fully integrated company."

Prior to joining Immunome, Sarma was the President & CEO of Taris Biomedical, which he built during the last nine years into a leader in therapeutic urology focused on diseases such as bladder cancer and overactive bladder. In addition to raising more than $100 million in equity capital, Sarma also sold one of Taris’ products to Allergan in a transaction worth up to $587 million. Prior to TARIS, he served in several leadership roles at Cephalon Corporation, which was acquired by Teva Pharmaceutical Industries; Nektar Therapeutics; and SmithKline Beecham, now Glaxo SmithKline. Sarma earned his PhD in Pharmaceutics from the University of Minnesota and B. Pharm from Andhra University, Visakhapatnam, India. Sarma also serves as an independent Board Member at Ohm Oncology and Vaxess Technologies Inc.

Asieris Announces Completion of Enrollment for its US APL-1202 Phase Ib Clinical Trial

On June 24, 2019 Asieris, a China-based biotech company specializing in the development and commercialization of new drugs for the treatment of genitourinary tumors and related diseases, reported the completion of enrollment for its APL-1202 Phase Ib trial in the US (Press release, Asieris Pharmaceuticals, JUN 24, 2019, View Source [SID1234537237]). This new drug is being developed for the treatment of non-muscle invasive bladder cancer (NMIBC). APL-1202 is the first oral and reversible methionine aminopeptidase II type (MetAP2) inhibitor under clinical development in the world. It has novel mechanisms of action of inhibiting both tumor cell growth and angiogenesis. APL-1202 is currently in registration clinical trial in China.

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The primary objective of this Phase Ib clinical trial in the US is to evaluate the safety, tolerability, and PK characteristics of APL-1202 when dosed in combination with intravesical BCG. Enrolled subjects are NMIBC patients who have received at least one induction course of intravesical BCG. This trial is expected to complete all patient follow-up in September. Asieris is currently planning to launch a Phase II global clinical trial to evaluate the efficacy and safety of a combination of APL-1202 with BCG in NMIBC patients.

"We are very excited to have participated in the Phase I trial combining APL-1202 with BCG in patients with non-muscle invasive bladder cancer previously treated and who are resistant to BCG. This trial has the potential to significantly improve the care of patients with non-muscle invasive bladder cancer. This is a very exciting therapeutic option for our patients given its oral route of delivery," commented John P. Sfakianos, MD, Assistant Professor of Icahn School of Medicine at Mount Sinai and a leading investigator of this trial. "I am enthusiastic about the future studies involving this treatment".

"The completion of enrollment for our APL-1202 Phase Ib clinical trial in the US represents a remarkable milestone for APL-1202’s global clinical development. In a Phase II trial in China, APL-1202 as a single agent demonstrated encouraging clinical efficacy and safety. Its combination with intravesical chemotherapy is in a pivotal clinical trial in China. Intravesical BCG is the first-line therapy for NMIBC globally, and through the clinical trials of APL-1202 in combination with intravesical BCG, we hope to provide a better treatment for NMIBC patients in the world," Kevin Pan, co-founder, chairman and CEO of Asieris said.

Bladder Cancer is one of the most common malignant tumors. According to Globalcan, the incidence of bladder cancer in 2018 was 549,343, while mortality was 199,922. The majority of patients are male, and most of them reside in developed countries. Currently, the common treatment of NMIBC is Trans-Urethral Resection of Bladder Tumor (TURBT). Because of high tumor recurrence rate after TURBT, intravesical chemo- or immune-therapies are required after the procedure. At present, the choice of second-line treatment for relapsed patients is very limited. For high-risk NMIBC patients who have failed intravesical therapies, radical cystectomy is the standard treatment. No oral drugs have been approved for NMIBC to date.

Mirati Therapeutics Announces Proposed Public Offering of Common Stock

On June 24, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Mirati, JUN 24, 2019, View Source [SID1234537236]). All of the shares are being offered by Mirati. In addition, Mirati expects to grant the underwriters of the offering a 30-day option to purchase additional shares of its common stock at the public offering price, less the underwriting discounts and commissions. 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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Cowen, Credit Suisse and Barclays are acting as joint book-running managers in the offering.

The securities described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. 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 View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY,11717, Attn: Prospectus Department, or by telephone: (631) 592-5973, or by emailing [email protected]; from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, Eleven Madison Avenue, 3rd floor, New York, NY 10010, or by telephone: (800) 221-1037, or by emailing [email protected]; or from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected].

This press release shall 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 other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.