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Clovis Oncology to Present at the Morgan Stanley Global Healthcare Conference

On September 6, 2018 Clovis Oncology, Inc. (Nasdaq: CLVS) reported that Patrick J. Mahaffy, Chief Executive Officer and President, will present at the 16th Annual Morgan Stanley Global Healthcare Conference on Thursday, September 13, 2018 at 2:55 PM Eastern Time (Press release, Clovis Oncology, SEPT 6, 2018, View Source [SID1234529327]). The conference will be held at the Grand Hyatt New York in New York City.

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A live webcast of the presentation can be accessed through the investor relations section of the Company’s website at www.clovisoncology.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for 30 days.

Verastem Oncology Announces Investigator Sponsored Study on Duvelisib in Combination with Venetoclax

On September 6, 2018 Verastem, Inc. (Nasdaq:VSTM), operating as Verastem Oncology, a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported dosing of the first patient in a multicenter Phase I/II clinical trial at the Dana-Farber/Harvard Cancer Center of duvelisib in combination with venetoclax in patients with relapsed or refractory chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL) (Press release, Verastem, SEPT 6, 2018, View Source [SID1234529326]).

"Duvelisib and venetoclax target different pathways fundamental to CLL biology and have distinct mechanisms of action. We have found that CLL cells from duvelisib-treated patients are primed for apoptosis in response to treatment with agents such as venetoclax. We now have the opportunity to explore whether this combination may be an effective therapy for the treatment of patients with CLL," said Matthew Davids, MD, MMSc, Assistant Professor of Medicine, Harvard Medical School, and Associate Director, Center for Chronic Lymphocytic Leukemia, Dana-Farber Cancer Institute and the study’s principal investigator. "We are excited to conduct this trial, as these new, targeted agents in development have the potential to improve patients’ response through combination therapies."

This trial will investigate venetoclax, an oral, potent, selective inhibitor of BCL-2 – a key mediator of the intrinsic pathway of apoptosis, the process of programmed cell death – given in combination with duvelisib. Preclinical data support this combination, as duvelisib has been shown to upregulate BCL-2 transcript and protein expression levels and enhance the ability of venetoclax to induce apoptosis in ex vivo human CLL cells. The trial will use BH3 profiling – a functional assay that determines the apoptotic threshold of a cell – which Davids and colleagues previously used to show that inhibition of phosphoinositide 3-kinase (PI3K) enhances the apoptotic threshold of CLL cells and sensitivity to BCL-2 inhibition.

The phase I primary objectives are to determine the maximum tolerated dose, as well as the recommended phase II dose of venetoclax for this combination regimen with duvelisib in patients with relapsed or refractory CLL/SLL. The phase II primary objective is to determine the rate of complete response (CR) of the combination, as defined by the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) 2008 criteria.

"As we continue to explore the potential of duvelisib, we are very encouraged by the strong scientific rationale and the preclinical data supporting the combination of duvelisib and venetoclax. We expect this trial will help enhance our understanding of the effects of this combination in the treatment of patients with CLL/SLL," said Diep Le, MD, PhD, Chief Medical Officer of Verastem Oncology. "Our goal at Verastem Oncology is to bring innovative therapeutic options to patients living with cancers that are in need of additional treatment options. Given the significant unmet need that exists among patients living with CLL and SLL, we look forward to the insight generated from this trial that could inform potential future clinical development for duvelisib."

More information about this trial is available at www.clinicaltrials.gov.

About Duvelisib

Duvelisib is a first-in-class investigational oral, dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, two enzymes known to help support the growth and survival of malignant B-cells and T-cells. PI3K signaling may lead to the proliferation of malignant B- and T-cells and is thought to play a role in the formation and maintenance of the supportive tumor microenvironment.1,2,3 Duvelisib was evaluated in late- and mid-stage extension trials, including DUO, a randomized, Phase 3 monotherapy study in patients with relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),4 and DYNAMO, a single-arm, Phase 2 monotherapy study in patients with refractory indolent non-Hodgkin lymphoma (iNHL).5 Both DUO and DYNAMO achieved their primary endpoints. Verastem Oncology’s New Drug Application (NDA) requesting the full approval of duvelisib for the treatment of patients with relapsed or refractory CLL/SLL, and accelerated approval for the treatment of patients with relapsed or refractory follicular lymphoma (FL) was accepted for filing by the U.S. Food and Drug Administration (FDA), granted Priority Review and assigned a target action date of October 5, 2018. Duvelisib is also being developed by Verastem Oncology for the treatment of peripheral T-cell lymphoma (PTCL), and is being investigated in combination with other agents through investigator-sponsored studies.6 Information about duvelisib clinical trials can be found on www.clinicaltrials.gov.

BeiGene and SpringWorks Therapeutics Enter into Global Clinical Collaboration to Evaluate Targeted Combination Therapy in Advanced Solid Tumors

On September 6, 2018 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and SpringWorks Therapeutics, a clinical-stage rare disease and oncology company focused on sourcing and developing innovative treatments for underserved patient populations, reported that the companies have entered into a global clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining BeiGene’s investigational RAF dimer inhibitor, lifirafenib (BGB-283) and SpringWorks Therapeutics’ investigational MEK inhibitor, PD-0325901, in patients with advanced solid tumors (Press release, BeiGene, SEPT 6, 2018, View Source;p=irol-newsArticle&ID=2366390 [SID1234529325]). Under the terms of the agreement, BeiGene will be responsible for administering the Phase 1b clinical trial that is expected to commence during the first quarter of 2019 in patients with advanced solid tumors that harbor RAS, RAF mutations and other MAPK pathway aberrations, with all costs of the clinical studies and governance responsibilities to be shared equally among both parties. SpringWorks Therapeutics will also oversee fixed-dose formulation work as part of the collaboration.

"BeiGene is committed to developing innovative medicines for cancer patients with little or no treatment options. We are delighted to work with SpringWorks Therapeutics to explore the potential benefits of this combination in patients with RAS mutations, a patient population with high unmet medical needs," said John V. Oyler, co-founder, chief executive officer and chairman of BeiGene.

"Mutations in RAS genes are found in roughly one-fourth of all human cancers, making this a critically important area for developing new cancer treatments. Despite decades of research, no anti-RAS therapies have been approved to date," said Saqib Islam, chief executive officer of SpringWorks Therapeutics. "The combination of a MEK inhibitor with a RAF dimer inhibitor has strong scientific rationale, and we look forward to partnering with BeiGene to build upon the existing preclinical data, which have demonstrated potential benefits with this combination therapy approach."

About Lifirafenib

Lifirafenib was discovered in BeiGene’s research facilities in Beijing, China, and is an investigational small molecule kinase inhibitor with RAF monomer and dimer inhibition activities. Lifirafenib has shown antitumor activities in preclinical models and in cancer patients with tumors harboring BRAF V600E mutations, non-V600E BRAF mutations, non-small cell lung cancer and endometrial cancer harboring KRAS mutations. To date, lifirafenib has been dosed in more than 150 patients globally.

About PD-0325901

PD-0325901 was originally discovered by Pfizer scientists and is an inhibitor of MEK, a key signaling protein for cellular survival and proliferation. PD-0325901 has been shown in clinical biopsies to block MEK phosphorylation, thereby arresting cellular growth and causing cell death to occur. Preclinical models have demonstrated significant synergy between MEK and RAF inhibition in RAS-mutant solid tumors. By vertically inhibiting the MAPK pathway, the combination approach of PD-0325901 and lifirafenib may potentially overcome feedback loops that have impeded therapeutic development for RAS-mutant solid tumors.

SpringWorks Therapeutics also plans to initiate a Phase 2b study of PD-0325901 as monotherapy for neurofibromatosis type 1 patients with plexiform neurofibromas in 2019. The company is also continually evaluating new licensing and partnership opportunities for its MEK program and is seeking other innovative partnerships designed to complement the existing clinical programs to advance its ambition of developing novel therapies for underserved patient populations.

Genmab to Present at Morgan Stanley 16th Annual Global Healthcare Conference

On September 6, 2018 Genmab A/S (Nasdaq Copenhagen: GEN) reported that its CEO, Jan van de Winkel, Ph.D., will give a company update at the Morgan Stanley 16th Annual Global Healthcare Conference in New York, New York at 2:15 PM EDT / 8:15 PM CEST on September 12, 2018 (Press release, Genmab, SEPT 6, 2018, View Source [SID1234529323]). A webcast of the update, which will include brief opening remarks followed by a question-and-answer session, will be available on Genmab’s website at View Source

ATARA BIOTHERAPEUTICS AND MOFFITT CANCER CENTER ANNOUNCE STRATEGIC COLLABORATION TO DEVELOP NEXT-GENERATION CAR T IMMUNOTHERAPIES

On September 6, 2018 Atara Biotherapeutics, Inc. (Nasdaq: ATRA), a leading off-the-shelf, allogeneic T-cell immunotherapy company developing novel treatments for patients with cancer, autoimmune and viral diseases, reported that it has entered into a strategic collaboration with Moffitt Cancer Center to develop multi‑targeted chimeric antigen receptor T-cell (CAR T) immunotherapies for patients with AML and B‑cell malignancies (Press release, Atara Biotherapeutics, SEPT 6, 2018, View Source [SID1234529322]). As part of the collaboration, Atara will gain access to novel CAR T targeting and co‑stimulation domains designed to improve T cell proliferation and enhance persistence. This agreement, along with Atara’s prior CAR T collaboration with Memorial Sloan Kettering Cancer Center (MSK), furthers the Company’s strategy to develop next generation engineered CAR T immunotherapies across multiple therapeutic areas and leverage the Company’s off-the-shelf, allogeneic T-cell immunotherapy platform.

"Atara is a leader in the development of off-the-shelf, allogeneic T-cell immunotherapies based on their novel EBV-specific T-cell technology platform," said Marco Davila, M.D., Ph.D., medical oncologist in the Department of Blood and Marrow Transplantation and Medical Director of the GMP Cell Production Facility, Moffitt Cancer Center. "I look forward to rapidly advancing our CAR T engineering and multi-antigen targeting technologies with Atara to address the high unmet need in patients with advanced AML and B-cell malignancies."

Under the agreement, Atara will collaborate with Dr. Davila to develop multi-targeted CAR T immunotherapies designed to address cancers with diverse cell types that often become resistant to treatment such as AML and B-cell malignancies. In addition, the collaboration includes the use of novel CAR T intracellular co-stimulatory domains based on CD28 and 4-1BB that may improve CAR T proliferation when responding to an appropriate antigen and enhance CAR T persistence by reducing T cell exhaustion.

Dietmar Berger, M.D., Ph.D., Global Head of Research and Development of Atara Biotherapeutics said, "Our focus is to rapidly advance development of next generation off-the-shelf, allogeneic CAR T immunotherapies across multiple therapeutic areas by combining our EBV-specific T-cell platform, development, manufacturing and regulatory expertise with cutting edge T-cell engineering discoveries by our external collaborators. Our new strategic collaboration with Moffitt Cancer Center builds our novel CAR T preclinical pipeline and has the potential to benefit patients with myeloid and B cell malignancies."

James J. Mulé, Ph.D., Associate Center Director, Translational Research, and Director of Cell-Based Immunotherapies, Moffitt Cancer Center added, "Atara is a strong technology and development partner. The Company’s clinically advanced EBV-specific T-cell technology platform is complementary to Moffitt’s CAR T engineering and multi-antigen targeting technologies. I look forward to following the progress of Dr. Davila and Atara to develop the next generation of CAR T immunotherapies."

Under the terms of the agreement, Atara will contribute resources and relevant experience to the research activities at Moffitt. Further terms of the agreement were not disclosed.