Genmab Announces that the Patent Infringement Lawsuit Relating to DARZALEX® is Over

On January 31, 2019 Genmab A/S (Nasdaq Copenhagen: GEN) reported that the patent infringement lawsuit launched by MorphoSys relating to DARZALEX is finally over (Press release, Genmab, JAN 31, 2019, View Source [SID1234532986]).

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As previously reported, on January 25, 2019, the U.S. District Court of the District of Delaware ruled that all three patents that MorphoSys had asserted against Genmab and Janssen Biotech, Inc. (Janssen) are invalid. As noted at that time, Genmab and Janssen’s allegations that the patents were unenforceable for inequitable conduct remained to be resolved, and MorphoSys had the right to appeal the invalidity decision to the United States Court of Appeals for the Federal Circuit.

Today, MorphoSys dismissed its infringement claims with prejudice (for good), and Genmab and Janssen have, in turn, dismissed their inequitable conduct claims. As such, there will be no further proceedings in the case. The case is now over.

"Genmab is an antibody innovation powerhouse committed to conducting business in an ethical manner in accordance with our core values, and we are very pleased that this case is finally over and behind us," said Jan van de Winkel, Ph.D., Chief Executive Officer of Genmab.

West to Host Fourth-Quarter and Full-Year 2018 Conference Call

On January 31, 2019 West Pharmaceutical Services, Inc. (NYSE: WST), a global leader in innovative solutions for injectable drug administration, reported that it will release fourth-quarter and full-year 2018 financial results before the market opens on Thursday, February 14, 2019, and will follow with a conference call to discuss the results and business expectations at 9:00 a.m. Eastern Time (Press release, West Pharmaceutical Services, JAN 31, 2019, View Source [SID1234532982]). To participate on the call, please dial 877-930-8295 (U.S.) or 253-336-8738 (International). The conference ID is 2287302.

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A live broadcast of the conference call will be available at the Company’s website, www.westpharma.com, in the "Investors" section. Management will refer to a slide presentation during the call, which will be made available on the day of the call. To view the presentation, select "Presentations" in the "Investors" section of the Company’s website.

An online archive of the broadcast will be available at the West website three hours after the live call and through Thursday, February 21, 2019, by dialing 855-859-2056 (U.S.) or 404-537-3406 (International). The conference ID is 2287302.

SELLAS Life Sciences to Present at the 2019 BIO CEO & Investor Conference

On January 31, 2019 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that Angelos Stergiou, M.D., ScD h.c., President and Chief Executive Officer of SELLAS, will present a corporate overview at the 2019 BIO CEO & Investor Conference on Tuesday, February 12, 2019 at 9:30 a.m. ET in New York, NY (Press release, Sellas Life Sciences, JAN 31, 2019, View Source;Investor-Conference/default.aspx [SID1234532979]).

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A live audio webcast of the presentation will be available under "Events & Presentations" in the Investors section of SELLAS’ website at www.sellaslifesciences.com/investors. A replay of the webcast will be available for up to 30 days on SELLAS’ website following the presentation.

Advancements in the Treatment of Myelodysplastic Syndromes and RAS-Mutated Lung Cancers to be Presented by Key Opinion Leaders on Thursday, February 7, 2019, in New York City

On January 31, 2019 Onconova Therapeutics, Inc. (Nasdaq: ONTX), a Phase 3 stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with a primary focus on Myelodysplastic Syndromes (MDS), reported it will host a KOL breakfast for security analysts and institutional investors on Thursday, February 7, 2019, in New York City (Press release, Onconova, JAN 31, 2019, View Source [SID1234532975]).

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The event will include presentations by Lewis Silverman, MD, Associate Professor of Medicine and Director of the Translational Research Center for the Myelodysplastic Syndrome in the Division of Hematology/Oncology/Tisch Cancer Institute and Rajwanth Veluswamy, MD, MSCR, Assistant Professor of Medicine, Thoracic Oncology, Tisch Cancer Institute, Institute for Translational Epidemiology, Icahn School of Medicine, Mount Sinai Health System. In addition, Steven Fruchtman, MD, President and Chief Executive Officer of Onconova, will present a Company overview and detailed information from the Company’s Phase 2 rigosertib trial and the Company’s clinical strategy and near-term milestones.

Presentations will begin at 8:00 a.m. Eastern Standard Time. A live and archived audio and slide webcast of the event will be available on Onconova’s Corporate Events and Presentations page. Following the presentations, all speakers will be available for questions. This on-site event is open to analysts and institutional investors only. Kindly RSVP in advance if you would like to attend in person, as space is limited. To request a spot, please send an email to [email protected].

"We are excited to host this important educational event on recent advances in the treatment of myelodysplastic syndromes and other RAS-mutated cancers, and honored that two prominent research leaders in their field, Dr. Lewis Silverman, a recognized expert in MDS, and Dr. Rajwanth Veluswamy, a prominent researcher and clinician in lung cancer, have agreed to speak," said Steven M. Fruchtman, MD, President and Chief Executive Officer of Onconova. "In addition to the presentations by Drs. Silverman and Veluswamy, we will be discussing our Phase 2 oral rigosertib data, which were recently presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December. We will also discuss future plans and near-term milestones, including pivotal Phase 3 data with IV rigosertib in high-risk MDS patients."

Key findings from the Phase 2 trial data presented at ASH (Free ASH Whitepaper) include:

Overall response rate (ORR) of 90% reported in this multi-institutional Phase 2 study in hypomethylating agent (HMA) naïve patients, including Complete Remission (CR) rate of 34%
Median duration of response for the HMA naïve patients was 12.2 months
Acceptable safety profile when oral rigosertib is combined with the FDA-approved dose of azacitidine
KOL Event Presentation Highlights

Participating Key Opinion Leaders

Lewis R. Silverman, MD, is an Associate Professor of Medicine and Director of the Myelodysplastic Syndrome and Myeloproliferative Disease Program, Mount Sinai School of Medicine, in New York City. He served as Principal Investigator of the randomized Phase 3 trial of azacitidine vs. Supportive Care, which served as the basis for approval of azacitidine by the FDA for MDS in the United States. Dr. Silverman is a pioneer in developing treatments for patients with Higher-risk MDS and has served as a Principal Investigator on Onconova’s rigosertib clinical trial program for treatment of Higher-risk MDS patients.

Rajwanth R. Veluswamy, MD, MSCR, is an Assistant Professor of Medicine, Hematology and Medical Oncology, and a board-certified medical oncologist who specializes in the treatment of lung cancer and other thoracic malignancies. He completed both a clinical fellowship in Hematology and Medical Oncology and a General Medicine research fellowship at the Icahn School of Medicine at Mount Sinai. Prior to this, he completed residency in Internal Medicine at Methodist Dallas Medical Center, and a research internship at MD Anderson Cancer Center in Houston.

New developments in the treatment of MDS and the rigosertib clinical trial program
New approaches for the treatment of RAS-mutated lung cancers
Phase 2 efficacy and safety results of oral rigosertib in combination with azacitidine (Vidaza) in high-risk MDS patients, as reported at the 2018 annual meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper)
Onconova’s rigosertib clinical program – the broadest in myelodysplastic syndromes

Repare Therapeutics Announces a Strategic Partnership Agreement With ONO Pharmaceutical Co., Ltd. for Repare’s Polθ Inhibitor Program in Japan and Selected Territories in Asia

On January 31, 2019 Repare Therapeutics, Inc., a privately held precision oncology company pioneering synthetic lethality to develop novel therapeutics that target specific vulnerabilities of tumors in clearly defined patient populations, reported that it has entered into an exclusive strategic research, development and commercialization partnership with ONO Pharmaceutical Co., Ltd., for Repare’s small molecule Polθ inhibitor program in Japan, South Korea, Taiwan, Hong Kong, Macau and ASEAN countries, excluding mainland China. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and EU.

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"We’re excited to have ONO as a discovery and development partner," said Lloyd M. Segal, President and CEO of Repare. "This relationship will support our drive to and through the clinic in this important new area of precision oncology therapeutic development."

"ONO identified Repare Therapeutics as the partner of choice for bringing in a potential first-in-class and best-in-class Polθ inhibitor to our portfolio," said Gyo Sagara, President, Representative Director and CEO of ONO. "We are excited to work with Repare for the benefit of cancer patients."

Under the terms of the agreement, ONO will provide an up-front payment and research service payments potentially totaling US $15M, plus additional cost-sharing through IND. Beyond IND, significant clinical, regulatory and commercial milestones are also included in the agreement, with a potential total of US $160M. ONO will also pay to Repare high single-digit to low double-digit tiered royalties based on net sales of the products. Repare retains all rights to develop and commercialize the products outside the ONO territory, including the US, Canada and the EU.

Polθ inhibitor opportunity

DNA Polymerase θ (Polθ) is a unique, multifunctional DNA polymerase essential to repairing DNA breaks, especially in homologous recombination deficient (HRD) cells. HRD, including deficiency in the BRCA1 and BRCA2 genes, is a clinically important feature across a variety of important tumor types, including breast, ovarian, prostate and pancreatic cancers. Polθ gene expression is low in normal cells but elevated across a broad range of tumor types, including those with HRD. Currently, HRD tumors may be treated with Poly(ADP-ribose) Polymerase (PARP) inhibitors, which represent a rapidly growing, multi-billion dollar global market. A significant fraction of patients does not initially respond to PARP inhibitor treatment, and the vast majority of treated patients eventually develop PARP inhibitor resistance. A Polθ inhibitor has potential as both a mono-therapy across multiple tumor types and in combination with PARP inhibitors, where its distinct mechanism of action may help address both forms of PARP resistance. Additional clinical populations may also be attractive for combination treatment with a Polθ inhibitor, including possible combinations with chemotherapy, radiotherapy and Immuno-Oncology agents.