On June 10, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported U.S. Food and Drug Administration (FDA) approval of Polivy (polatuzumab vedotin-piiq), which is an antibody-drug conjugate (ADC) targeting CD79b that utilizes Seattle Genetics’ technology. Polivy was developed and will be commercialized by Genentech, a member of the Roche Group (Press release, Seattle Genetics, JUN 10, 2019, View Source [SID1234536977]). It was approved in combination with bendamustine plus Rituxan (rituximab) (BR) for the treatment of adults with relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL), who have received at least two prior therapies. Polivy previously received FDA Breakthrough Therapy Designation, and was approved more than two months ahead of the Prescription Drug User Fee Act (PDUFA) action date of August 19, 2019.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The approval of Polivy under our collaboration with Genentech is an important milestone for Seattle Genetics as it extends the reach of our technology to more patients with significant unmet medical needs," said Clay Siegall, Ph.D., President and Chief Executive Officer of Seattle Genetics. "This approval, along with our own internal ADCs in development and those of other collaborators, such as GlaxoSmithKline, highlights that ADCs continue to grow as an important therapeutic approach to treating both hematologic malignancies and solid tumors."

Polivy was granted PRIME (PRIority MEdicines) designation by the European Medicines Agency (EMA) for the treatment of patients with R/R DLBCL. PRIME is a designation implemented by the EMA to support data generation and development plans for promising medicines, providing a pathway for accelerated evaluation by the agency. Polivy is also being investigated by Genentech in several ongoing clinical trials for the treatment of non-Hodgkin lymphoma (NHL), including frontline DLBCL.

Seattle Genetics’ ADC technology combines the specificity of monoclonal antibodies, innovative linker systems and potent cell-killing agents to treat cancer. The technology has been licensed to several companies, including Genentech and GlaxoSmithKline. Under the terms of these agreements, each company has rights to use the technology with antibodies against selected targets. The licensee is responsible for research, product development, manufacturing and commercialization. Seattle Genetics is entitled to receive fees, progress-dependent milestone payments and royalties on worldwide net sales of any resulting ADC products.

On June 10, 2019 FibroGen, Inc. (NASDAQ: FGEN), a leading biopharmaceutical company discovering and developing a pipeline of first-in-class therapeutics, reported that Chief Executive Officer Thomas B. Neff will participate in a Fireside Chat at the Goldman Sachs 40th Annual Global Healthcare Conference in Rancho Palos Verdes, California, on Wednesday, June 12, at 10:00 a.m. Pacific Time (Press release, FibroGen, JUN 10, 2019, View Source;p=irol-newsArticle&ID=2401014 [SID1234536975]). A live audio webcast of the presentation will be available under the Investors section of the FibroGen website at www.fibrogen.com. The replay of the webcast will be available for at least 14 days following the webcast.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

On June 10, 2019 Onconova Therapeutics, Inc. (NASDAQ:ONTX), a Phase 3-stage biopharmaceutical company focused on discovering and developing novel products to treat cancer, with an initial focus on myelodysplastic syndromes (MDS), reported two presentations at the 24th Congress of the European Hematology Association (EHA) (Free EHA Whitepaper) being held June 13-16, 2019 in Amsterdam, Netherlands (Press release, Onconova, JUN 10, 2019, View Source [SID1234536974]). Dr. Steven Fruchtman, President & CEO, Dr. Ric Woodman, CMO, and Dr. Ronnee Adesanya, VP Medical Affairs, will be attending the conference.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

DETAILS OF THE PRESENTATIONS:

Title: PHASE II STUDY OF ORAL RIGOSERTIB COMBINED WITH AZACITIDINE IN PATIENTS WITH HIGHER-RISK MYELODYSPLASTIC SYNDROMES (MDS)

Format: ORAL PRESENTATION: Abstract S839
Location – Elicium 1

Date/Time: Saturday, June 15 / 12:00 – 12:15

Presenter: Shyamala C. Navada, MD
Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY

Title: RIGOSERTIB MODULATES HEMATOPOIESIS GENE SIGNALING PATHWAYS ALONE OR IN SEQUENCES
COMBINATION WITH AZACITIDINE ON MDS CELLS IN VITRO

Format: POSTER PRESENTATION: Abstract PS1332
Location – Poster area

Date/Time: Saturday, June 15 / 17:30 – 19:00

Presenter: Lewis R. Silverman, MD
Tisch Cancer Institute, Division of Hematology/Oncology, Icahn School of Medicine at Mount Sinai, New York, NY
A copy of the poster and oral presentation slides will be available immediately following the event by visiting the Scientific Presentations section of Onconova’s website: View Source

On June 10, 2019 Deciphera Pharmaceuticals, Inc. (NASDAQ:DCPH) reported the addition of a new candidate to its pipeline, DCC-3116, a potential first-in-class small molecule designed to inhibit cancer autophagy, a key tumor survival mechanism. DCC-3116, discovered using the Company’s novel switch control inhibitor platform, is designed to inhibit autophagy by inhibiting the ULK kinase (Press release, Deciphera Pharmaceuticals, JUN 10, 2019, View Source [SID1234536973]). Autophagy is a cellular pathway that has been shown to be upregulated in mutant RAS cancers and that also mediates resistance to inhibitors of the RAS signaling pathway. Subject to favorable investigational new drug (IND)-enabling studies and filing and activation of an IND, Deciphera intends to develop DCC-3116 for the potential treatment of mutant RAS cancers in combination with inhibitors of downstream effector targets including RAF, MEK, or ERK inhibitors as well as with direct inhibitors of mutant RAS.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Based on pre-clinical studies, DCC-3116 selectively inhibits ULK kinase, believed to be the initiating factor that activates autophagy. Autophagy is a cell survival pathway in which cells respond to stress by recycling their own components and/or clearing damaged organelles and proteins from the cell. Mutant RAS cancers, including KRAS, NRAS, and HRAS cancers, are reported to have high basal levels of autophagy, which they use to maintain nutrient supply, regulate cancer cell metabolism, and mitochondria surveillance.1 In multiple in vitro and in vivo models of mutant RAS cancers, autophagy inhibition combined with inhibition of MAPK signaling using MEK inhibitors or ERK inhibitors has demonstrated synergistic anti-tumor effects.2,3 When used in pre-clinical in vitro and in vivo studies in combination with inhibitors of the MAPK pathway, DCC-3116 synergized with these inhibitors to inhibit mutant RAS cancer growth. Cellular studies in mutant RAS cancers have demonstrated that MAPK pathway inhibitors further activate autophagy as a compensatory survival mechanism. Such activation of autophagy is seen with RAF, MEK, and ERK inhibitors as well as with direct inhibitors of mutant KRAS G12C. As an inhibitor of ULK, DCC-3116 is designed to address mutant RAS cancers by inhibiting the basal and compensatory autophagy that mutant RAS cancer cells use for their survival.

"We are very excited to announce our new development candidate, DCC-3116, a potential first-in-class agent aimed at treating mutant RAS cancers through the inhibition of autophagy," said Steve Hoerter, President and Chief Executive Officer of Deciphera. "Recent efforts in the fight against cancer have focused on direct approaches targeting mutant RAS, which comprise approximately 30% of all cancers and that we believe represents one of largest unmet medical needs in oncology. We believe that as a highly selective inhibitor of ULK kinase, DCC-3116 may offer a new and complementary approach to targeting mutant RAS cancer through suppression of autophagy."

"Our new clinical candidate, DCC-3116, is a potent and selective inhibitor of ULK kinase generated using our proprietary switch control inhibitor platform. Inhibition of ULK has potential application in a very wide range of cancers and is an exciting addition to our pipeline," said Daniel Flynn, Executive Vice President, Chief Scientific Officer and Founder of Deciphera.

Deciphera is currently conducting IND-enabling studies for DCC-3116 and, pending favorable results, expects to file an IND in mid-2020.

DCC-3116 Event and Webcast Information

Deciphera will host a live event and webcast to discuss the new program on Tuesday, June 18, 2019 at 8 a.m. ET. The event will feature members of the Deciphera management team and Channing Der, Ph.D., Sarah Graham Kenan Distinguished Professor, Department of Pharmacology, UNC School of Medicine, who is a leading expert in mutant RAS cancers and autophagy.

A live audio webcast of the event and accompanying slides may be accessed through the Investors section of Deciphera’s website at www.deciphera.com. A replay of the webcast will be available for 30 days following the event.

On June 10, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, reported that it has entered into a definitive agreement to acquire Tilos Therapeutics, a privately held biopharmaceutical company developing therapeutics targeting the latent TGFβ complex for the treatment of cancer, fibrosis and autoimmune diseases (Press release, Merck & Co, JUN 10, 2019, View Source [SID1234536972]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"At Merck we continue to enhance our robust pipeline through active execution of our business development strategy," said Dr. Dean Li, senior vice president, discovery and translational medicine, Merck Research Laboratories. "Tilos has developed a compelling portfolio of candidates that employ a novel approach to modulating the potent signaling molecule TGFβ by binding to latency-associated peptide, with potential applications across a range of disease indications."

Under the terms of the agreement, Merck, through a subsidiary, will acquire all outstanding shares of Tilos for total potential consideration of up to $773 million, including an upfront payment as well as contingent milestone payments.

"We are proud that the Tilos team has advanced the discoveries of our scientific founders by developing a portfolio of anti-LAP antibodies designed to realize the full potential of TGFβ-modulating therapeutics," said Dr. Barbara Fox, CEO, Tilos. "This agreement with Merck, an industry leader in biopharmaceutical research and development, provides meaningful validation for our therapeutic approach and best positions our pipeline for broad clinical and commercial success."

Tilos was founded by Boehringer Ingelheim Venture Fund and Partners Innovation Fund, based on discoveries by the laboratory of Dr. Howard Weiner at Brigham and Women’s Hospital and Harvard Medical School. Additional investment was provided by ShangPharma Innovation Fund.

About TGFβ and LAP

TGFβ is a potent cytokine believed to play an important role in the development of cancer and fibrotic diseases. TGFβ is secreted as a complex with the protein, latency-associated peptide (LAP). LAP forms a cage around TGFβ, holding the cytokine in an inactive state until it is deployed. Evidence has shown that anti-LAP antibodies block the release of TGFβ from the TGFβ-LAP complex with the potential to provide a novel therapeutic mechanism to reduce TGFβ activity.