On January 8, 2020 Verastem, Inc. (Nasdaq:VSTM) (Verastem Oncology or the Company), a biopharmaceutical company focused on developing and commercializing medicines seeking to improve the survival and quality of life of cancer patients, reported a global licensing agreement with Chugai Pharmaceutical Co., Ltd., (Chugai) whereby Verastem Oncology is obtaining worldwide development and commercialization rights to the RAF/MEK inhibitor CH5126766 (CKI27) from Chugai currently under development for the treatment of KRAS mutant solid tumors (Press release, Verastem, JAN 8, 2020, View Source [SID1234552858]). The Company will host an investor call to discuss the opportunity and a development update today (details below).

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CH5126766 in combination with Verastem Oncology’s focal adhesion kinase (FAK) inhibitor, defactinib, is currently the subject of a clinical study (Phase I followed by expansion cohorts) with the expansion cohorts now ongoing in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC).1 This clinical study of the defactinib/CH5126766 combination is supported by the single-agent Phase 2 studies of defactinib in KRAS mutant NSCLC2 and CH5126766 in KRAS mutant NSCLC and LGSOC.3

"Based on the single-agent defactinib results in KRAS mutant NSCLC, we conducted an internal pre-clinical effort to identify drug classes that were synergistic with defactinib and saw the highest level of synergy in combination with MEK inhibitors and, specifically, with CH5126766," said Dan Paterson, President and Chief Operating Officer of Verastem Oncology. "The exciting early clinical results led to our decision to enter into a partnership with Chugai for CH5126766 and accelerate the combination development program for patients with KRAS mutant cancers, which are highly aggressive and recurrent. We plan to initiate discussions with regulatory authorities about our development plans and to define the registration path early this year."

"We found that MEK blockade activates FAK signaling as a potential escape mechanism," stated Professor Udai Banerji, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research and Honorary Consultant in Medical Oncology, MBBS, MD, DNB, PhD, FRCP at The Royal Marsden NHS Foundation Trust, London, England, and lead investigator of the clinical study. "Based on the synergy between FAK and MEK inhibitors observed in preclinical KRAS mutant models, we have been assessing the combination of defactinib and CH5126766 for treatment of patients with KRAS mutant cancers. The results to date have been encouraging and we look forward to sharing our clinical findings, including the response rate in an upcoming scientific presentation."

"CH5126766 is a unique and particularly promising inhibitor of the RAS/RAF/MEK signaling pathway," noted Neal Rosen, MD, PhD, Memorial Sloan Kettering Cancer Center, NY, NY. "In contrast to other MEK inhibitors in development, CH5126766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows CH5126766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The clinical data with the combination of defactinib and CH5126766 are striking and suggest promise for patients with KRAS mutant solid tumors."

Under the terms of the agreement, Verastem Oncology is responsible for the development and worldwide commercialization of CH5126766. The Company will make an upfront payment of $3M and pay royalties to Chugai. Given the potential of the opportunity, the Company will be evaluating various partnering strategies.

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast on Wednesday, January 8, 2020, at 4:00 PM (ET). The call can be accessed by dialing (877) 341-5660 (U.S. and Canada) or (315) 625-3226 (international), five minutes prior to the start of the call and providing the passcode 3756707 and web PIN 1655.

The live, listen-only webcast of the conference call can be accessed by visiting the investors section of the Company’s website at View Source A replay of the webcast will be archived on the Company’s website for 90 days following the call.

About Defactinib

Defactinib is an oral small molecule inhibitor of FAK and PYK2 that is currently being evaluated as a potential combination therapy for various solid tumors. The Company has received orphan drug designation for defactinib in ovarian cancer and mesothelioma in the US, EU and Australia. Preclinical research by Verastem Oncology scientists and collaborators at world-renowned research institutions has described the effect of FAK inhibition to enhance immune response by decreasing immuno-suppressive cells, increasing cytotoxic T cells, and reducing stromal density, which allows tumor-killing immune cells to enter the tumor.4,5 A Phase 1/2 clinical trial of defactinib in combination with CH5126766 in patients with KRAS mutant advanced solid tumors, including low grade serous ovarian cancer (LGSOC), non-small cell lung cancer (NSCLC) and colorectal cancer (CRC) is underway.1 The defactinib/CH5126766 combination is supported by the single-agent Phase 2 studies of defactinib in KRAS mutant NSCLC2 and CH5126766 in KRAS mutant NSCLC and LGSOC.3 Defactinib is also in clinical testing in combination with pembrolizumab for treatment of patients with pancreatic cancer, NSCLC and mesothelioma.6

On January 8, 2020 VBL Therapeutics (Nasdaq: VBLT) reported the publication of clinical data from the Phase 2 and Phase 3 studies of VB-111 (ofranergene obadenovec) in recurrent glioblastoma (rGBM) in two manuscripts published in the peer-reviewed journal Neuro-Oncology, the official journal of the Society for Neuro-Oncology (Press release, VBL Therapeutics, JAN 8, 2020, View Source [SID1234552857]).

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In the Phase 2 study, patients with rGBM who were primed with VB-111 monotherapy that was continued after progression with the addition of bevacizumab (Avastin) showed significant survival (414 vs 223 days; HR 0.48; p=0.043) and progression free survival (PFS) advantage (90 vs 60 days; HR 0.36; p=0.032) compared to a cohort of patients that had limited exposure to VB-111 (see manuscript by Brenner et al). Radiographic responders to VB-111 exhibited specific imaging characteristics related to its mechanism of action. Survival advantage was also seen in comparison to historic controls, with the percentage of patients living more than one year doubling from 24% to 57%.

The GLOBE Phase 3 study, top-line data from which were announced in 2018, compared upfront concomitant administration of VB-111, without priming, and bevacizumab to bevacizumab monotherapy. In this modified regimen, the treatment did not improve overall survival (OS) and PFS outcomes in rGBM. The new manuscript by Cloughesy et al. attributes the contradictory outcomes between the Phase 2 and Phase 3 trials as being related to the lack of VB-111 monotherapy priming in the GLOBE study, providing clinical, mechanistic and radiographic support for this hypothesis. Notably, GLOBE data show improved outcomes associated with a post VB-111 fever reaction, similar to outcomes from previous VB-111 studies, providing further support that fever is a potential biomarker for better survival with VB-111, secondary to the drug’s immunologic mechanism of action.

"The emerging picture from the Phase 2 and Phase 3 trials points to study regimen as a key factor for ofranergene obadenovec efficacy in rGBM," said Patrick Wen, M.D., Director, Center for Neuro-Oncology at Dana-Farber Cancer Institute, Boston, MA, and a key investigator in both clinical trials. "These results warrant further assessment of ofranergene obadenovec, which we intend to advance in a new randomized, controlled, clinical trial in patients with rGBM undergoing a second surgery."

Details on the new investigator-sponsored Phase 2 trial of VB-111 in rGBM were recently presented at the 2019 Society for Neuro-Oncology Annual Meeting (see link). An investigational new drug application for the new study has already gone into effect with the FDA and study launch is expected in early 2020. VB-111 is also being investigated in a Phase 3 pivotal study in ovarian cancer with interim data expected in the first quarter of 2020.

For a link to the newly published VB-111 papers in Neuro-Oncology refer to: Phase 2 manuscript and Phase 3 manuscript.

On January 8, 2020 Supernus Pharmaceuticals, Inc. (Nasdaq: SUPN), a pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system (CNS) diseases, reported that the Company’s management will present a Company overview and update, as well as host investor meetings, at the 38th Annual J.P. Morgan Healthcare Conference (Press release, Supernus, JAN 8, 2020, View Source [SID1234552856]).

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Date: Wednesday, January 15, 2020
Time: 10:30 a.m. PT (1:30 p.m. ET)
Place: Westin St. Francis Hotel, San Francisco, Calif.
Investors interested in arranging a meeting with the Company’s management during this conference should contact the conference coordinator.

A live webcast of the presentation can be accessed by visiting ‘Events & Presentations’ in the Investor Relations section on the Company’s website at www.supernus.com. An archived replay of this webcast will be available for 60 days on the Company’s website after the conference.

On January 8, 2020 SELLAS Life Sciences Group, Inc. (Nasdaq: SLS) ("SELLAS" or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel cancer immunotherapies for a broad range of cancer indications, reported that it has started patient screening for its pivotal Phase 3 REGAL clinical trial of its lead clinical candidate, galinpepimut-S (GPS), in patients with acute myeloid leukemia (AML) who have achieved complete remission after second-line anti-leukemic therapy (CR2) (Press release, Sellas Life Sciences, JAN 8, 2020, View Source [SID1234552855]). The study is expected to enroll approximately 116 patients across approximately 50 clinical sites in the U.S. and Europe. GPS was previously granted Fast Track designation and orphan drug designation in AML by the U.S. Food and Drug Administration (FDA) and orphan drug designation by the European Medicines Agency (EMA).

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"The commencement of our Phase 3 clinical trial marks an important milestone for SELLAS, and reflects our continued commitment to developing GPS as a potential first-in-class WT1-targeting cancer vaccine for patients with AML. We are indeed excited that patient screening is underway for our REGAL study," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer of SELLAS. "In previous Phase 2 studies in patients with AML, GPS has demonstrated a clinically meaningful and statistically significant prolonging of survival by delaying or preventing recurrence in patients in complete remission, who often are at very high risk of relapse. Of particular note, our Phase 2 AML CR2 study, which is the indication for our Phase 3 study, showed a 10.9 months survival benefit with a p-value of 0.0175. We remain focused on expeditiously enrolling our Phase 3 study. The results from the REGAL study, if positive, will be used as the basis for a Biologics License Application (BLA) submission to the FDA."

The REGAL study is a 1:1 randomized, open-label study comparing GPS monotherapy in the maintenance setting to investigators’ choice best available treatment in AML patients who have achieved hematologic complete remission, with or without thrombocytopenia (CR2/CR2p), after second-line antileukemic therapy and who are deemed ineligible for or unable to undergo allogeneic stem-cell transplantation. The primary endpoint is the overall survival (OS) from the time of study entry. Secondary endpoints include leukemia-free survival, antigen-specific T-cell immune response dynamics, measurable residual disease by multigene array, and assessments of AML clonal evolution and inflammasome molecular signatures in the tumor microenvironment in bone marrow biopsy samples. The Company anticipates interim analysis for safety and futility in the fourth quarter of 2021.

In a previous Phase 2a study in AML patients in the CR2 setting, GPS demonstrated a clinically meaningful and statistically significant median OS of 16.3 months in AML CR2 patients vs. 5.4 months in contemporaneously assessed unvaccinated patients (p = 0.0175). Treatment-related adverse events were primarily comprised of Grade 1 or 2 local injection site reactions and one Grade 3 (transient leukopenia) adverse event. A second previous Phase 2 study of GPS in AML patients who achieved first complete remission (CR1) also met its primary endpoint with an OS rate at 3 years from first vaccination of 47%.

On January 8, 2020 Quest Diagnostics Incorporated (NYSE: DGX), the world’s leading provider of diagnostic information services, reported that it will report fourth quarter and full year 2019 results on Thursday, January 30, 2020, before the market opens (Press release, Quest Diagnostics, JAN 8, 2020, View Source [SID1234552854]). It will hold its quarterly conference call to discuss the results beginning at 8:30 a.m. Eastern Time on that day.

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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

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The conference call can be accessed by dialing 888-455-0391 within the U.S. and Canada, or 773-756-0467 internationally, using the passcode: "Investor." The earnings release and live webcast will be posted on www.QuestDiagnostics.com/investor. The company suggests participants dial in approximately 10 minutes before the call.

A replay of the call may be accessed online at www.QuestDiagnostics.com/investor or by phone at 866-357-4210 for domestic callers or 203-369-0125 for international callers; no passcode is required. Telephone replays will be available from approximately 10:30 a.m. Eastern Time on January 30, 2020 until midnight Eastern Time on February 13, 2020.

Anyone listening to the call is encouraged to read the company’s periodic reports on file with the Securities and Exchange Commission, including the discussion of risk factors and historical results of operations and financial condition in those reports.