On Sept 14, 2020 SpringWorks Therapeutics a clinical-stage biopharmaceutical company focused on developing life-changing medicines for patients with severe rare diseases and cancer, reported that the company has entered into a clinical collaboration and supply agreement with Janssen Biotech, Inc. (Janssen) to evaluate SpringWorks Therapeutics’ investigational gamma secretase inhibitor (GSI), nirogacestat, in combination with Janssen’s bispecific antibody targeting B-cell maturation antigen (BCMA) and CD3, teclistamab, in patients with relapsed or refractory multiple myeloma. (Press release, Janssen Research & Development, SEP 14, 2020, View Source [SID1234574085]).

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Gamma secretase inhibition prevents the cleavage and shedding of BCMA from the surface of myeloma cells. In preclinical models, nirogacestat has been shown to increase the cell surface density of BCMA and reduce levels of soluble BCMA, which may enhance the activity of BCMA-targeted therapies, including CD3 bispecific antibodies.

"We are delighted to enter into this collaboration with Janssen to study nirogacestat in combination with teclistamab," said Saqib Islam, Chief Executive Officer of SpringWorks Therapeutics. "We now have three collaborations with industry-leading BCMA developers to evaluate nirogacestat in combinations across modalities, including with an antibody-drug conjugate, an allogeneic CAR-T cell therapy and now a bispecific antibody. This collaboration is an important step in continuing to advance our goal of developing nirogacestat as a best-in-class BCMA potentiator."

Under the terms of the agreement, Janssen will sponsor and conduct the Phase 1 study to evaluate the safety, tolerability and preliminary efficacy of the combination, and will assume all costs associated with the study, other than expenses related to the manufacturing of nirogacestat. SpringWorks Therapeutics will also form a joint oversight committee with Janssen. Pending discussions with regulators, the study is anticipated to commence by early 2021.

In addition to its ongoing clinical collaborations with BCMA-directed therapies, SpringWorks is also currently conducting a global Phase 3, double-blind, randomized, placebo-controlled clinical trial (the DeFi Trial) to evaluate nirogacestat in adults with progressing desmoid tumors.

On September 14, 2020 Targovax ASA, reported that Øystein Soug, CEO of Targovax, will present the company at H.C. Wainwright 22nd Annual Global Investment Conference on Wednesday 16 September, at 10:30am EDT / 4:30pm CET (Press release, Targovax, SEP 14, 2020, https://www.targovax.com/en/targovax-is-invited-to-present-at-h-c-wainwright-22nd-annual-global-investment-conference/ [SID1234565062]).

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To access a live webcast of the presentation, please see link here. It can also be accessed through "Events" at www.targovax.com. A replay of the webcast will also be available following the event.

The presentation will be available to download at www.targovax.com after the event.

On September 14, 2020 Diffusion Pharmaceuticals Inc. (Nasdaq: DFFN) ("Diffusion" or "the Company"), reported its management will present at the H.C. Wainwright 22nd Annual Global Investment Conference to be held virtually on September 14-16, 2020 (Press release, Diffusion Pharmaceuticals, SEP 14, 2020, View Source;Virtual-Global-Investment-Conference/default.aspx [SID1234565082]). Robert Cobuzzi, Ph.D., chief executive officer, will present a corporate overview of the Company on Tuesday, September 15th, at 3:00 p.m. Eastern time.

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A link to the live webcast of the presentation will be available online through the investor relations section of Diffusion’s website here. Following the event, a replay of the presentation will be archived on the Diffusion website for approximately 90 days.

On September 14, 2020 Verastem, Inc. (Nasdaq:VSTM) (also known as Verastem Oncology), a biopharmaceutical company committed to advancing new medicines for patients battling cancer, reported that management will host an investor conference call to discuss the updated clinical data from the low-grade serous ovarian cancer (LGSOC) cohort of the ongoing investigator-initiated Phase 1/2 FRAME study (Press release, Verastem, SEP 14, 2020, View Source [SID1234565100]). The ongoing study is evaluating VS-6766, Verastem’s RAF/MEK inhibitor, in combination with defactinib, its FAK inhibitor.

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The investor conference call is scheduled for Wednesday, September 16, 2020 at 8:00 a.m. ET. The conference call coincides with the oral presentation of this data at the 2nd Annual RAS-Targeted Drug Development Summit.

The call will feature members of the Company’s management team and Rachel Grisham, MD, Memorial Sloan Kettering Cancer Center, a medical oncologist and an expert in LGSOC.

Verastem Oncology plans to commence a Phase 2 registration-directed trial investigating the VS-6766/defactinib combination in patients with recurrent LGSOC, as well as patients with KRAS-mutant NSCLC, by the end of 2020.

Details for the RAS-Targeted Drug Development Summit oral presentation are as follows:

Title: Clinical Combinations: Dual RAF-MEK Inhibitor & FAK for Treatment of KRAS Mutant Cancers With a Focus Low Grade Ovarian Cancer
Lead author: Udai Banerji, Professor of Molecular Cancer Pharmacology at The Institute of Cancer Research, London, and Honorary Consultant in Medical Oncology, MBBS, MD, DNB, PhD, FRCP at The Royal Marsden NHS Foundation Trust, London.
Date and Time: Wednesday, September 16, 2020; 3:35 p.m. ET (12:35 p.m. PT)

Conference Call and Webcast Information

The Verastem Oncology management team will host a conference call and webcast on Wednesday, September 16, 2020, at 8:00 AM ET to discuss the updated Phase 1/2 FRAME study data. 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 5278200.

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

About VS-6766

VS-6766 (formerly known as CH5126766, CKI27 and RO5126766) is a unique inhibitor of the RAF/MEK signaling pathway. In contrast to other MEK inhibitors in development, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors.

About Defactinib

Defactinib (VS-6063) 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.1,2

About the VS-6766/Defactinib Combination

RAS mutant tumors are present in 30% of all human cancers and have historically presented a difficult treatment challenge and are often associated with significantly worse prognosis. Challenges associated with identifying new treatment options for these types of cancers include resistance to single agents, identifying tolerable combination regimens with MEK inhibitors and new RAS inhibitors in development addressing only a minority of all RAS mutated cancers.

The combination of VS-6766 and defactinib has been found to be clinically active in KRAS mutant tumors (KRASmt). In an ongoing investigator-initiated Phase 1/2 FRAME study, the combination of VS-6766 and defactinib is being evaluated in patients with LGSOC, KRASmt NSCLC and colorectal cancer (CRC). Based on an observation of higher response rates seen in patients with KRAS-G12V mutations in the study, Verastem will also be further exploring the role of VS-6766 and defactinib in KRAS-G12V NSCLC. The FRAME study was expanded in August 2020 to include new cohorts in pancreatic cancer, KRASmt endometrial cancer and KRAS-G12V NSCLC.

On September 14, 2020 PANTHERx Rare Pharmacy reported that it has been selected by Blueprint Medicines as a limited distribution partner for new drug GAVRETO (pralsetinib), which was granted ­accelerated approval for the treatment of adult patients with metastatic RET fusion-positive non-small cell lung cancer (NSCLC) as detected by an FDA approved test (Press release, PANTHERx Rare Pharmacy, SEP 14, 2020, View Source [SID1234565118]). Developed by Blueprint Medicines, GAVRETO is a once-daily oral precision therapy designed to selectively and potently target oncogenic RET alterations.

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RET activating fusions and mutations are key disease drivers in many cancer types, including NSCLC. RET fusions are implicated in approximately 1 to 2 percent of patients with NSCLC.

"PANTHERx is honored to be chosen by Blueprint Medicines to deliver this breakthrough oncology therapy to people living with RET fusion-positive metastatic NSCLC," said Dr. Gordon Vanscoy, Chairman and CEO of PANTHERx. "As a partner, we are proud to do our part in advancing rare oncology by providing award-winning white-glove services to this previously underserved patient population as part of our innovative RxARECARE model."

For more information about the symptoms, diagnosis, and treatment of RET fusion-positive NSCLC, please click here.