On April 9, 2018 Verastem, Inc. (NASDAQ:VSTM), a biopharmaceutical company focused on developing and commercializing medicines to improve the survival and quality of life of cancer patients, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing with Priority Review its New Drug Application (NDA) for its lead product candidate duvelisib (Press release, Verastem, APR 9, 2018, View Source [SID1234529549]). Duvelisib is a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, for which Verastem is seeking full approval for the treatment of relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated approval for the treatment of relapsed or refractory follicular lymphoma (FL). The FDA target action date is October 5, 2018.

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"Obtaining Priority Review in the U.S. for duvelisib marks another important milestone for Verastem and speaks to the unmet need in relapsed/refractory CLL/SLL and FL and the urgency to identify effective therapies to treat these patients," said Robert Forrester, President and Chief Executive Officer of Verastem. "As an orally administered therapy, we believe duvelisib will provide an important treatment option for patients with CLL/SLL and FL, and for the physicians who treat them. We look forward to working with the FDA during the review process. We are continuing our commercial preparations for duvelisib to execute the launch promptly in the U.S. if approved. In parallel, we are exploring ex-U.S. partnering opportunities for duvelisib and plan to file a European Marketing Application towards the end of the year."

Priority Review is granted by the FDA to drugs that, if approved, would provide significant improvements in the safety or effectiveness of the treatment, diagnosis, or prevention of a serious condition. Duvelisib has received Fast Track Designation from the FDA for patients with CLL who have received at least one prior therapy and for patients with FL who have received at least two prior therapies. In addition, duvelisib received orphan drug designation in the United States and the European Union for patients with CLL, SLL and FL.

About Duvelisib

Duvelisib is a first-in-class investigational, 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 and the FDA is reviewing a 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). Duvelisib is also being developed by Verastem for the treatment of peripheral T-cell lymphoma (PTCL), which has Fast Track status, 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.

On April 9, 2018 Constellation Pharmaceuticals, Inc., a clinical-stage biopharmaceutical company developing tumor-targeted and immuno-oncology therapies based on its pioneering research and development in cancer epigenetics, reported a $100 million financing (Press release, Constellation Pharmaceuticals, APR 9, 2018, View Source [SID1234525214]). New investors include Cormorant Asset Management, Deerfield Management, Fidelity Management and Research Company, Hillhouse Capital, NS Investment, OrbiMed, Sirona Capital, and Venrock Healthcare Partners. Current investors, including The Column Group, Third Rock Ventures, Venrock, SROne, University of California Investment Office, Topspin Partners, and Casdin Capital, also participated in the financing.

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"We are thrilled to welcome this new group of high-quality investors, and we are grateful for the continued support from our existing investors. Their strategic guidance and financial support will be instrumental to help accomplish our goal of improving outcomes for cancer patients," said Jigar Raythatha, president and chief executive officer of Constellation Pharmaceuticals. "This financing gives us additional flexibility and runway to pursue the clinical development of CPI-1205 and CPI-0610, our lead product candidates, as well as advance other novel molecules from our cancer epigenetics platform into development."

The company plans to utilize the proceeds of this financing to advance multiple clinical trials across its portfolio. Specifically, the ongoing ProSTAR and ORIOn-E trials are designed to demonstrate the potential for CPI-1205 to enhance the effectiveness of current-generation androgen inhibitors in metastatic castration-resistant prostate cancer and cancer immunotherapies in other solid tumors, respectively. The company also plans to progress CPI-0610, a clinical-stage candidate, as a treatment for myelofibrosis either as a monotherapy or in combination with a JAK inhibitor.

Additionally, Constellation Pharmaceuticals plans to advance its second-generation EZH2 program into the clinic and identify more experimental therapies derived from its epigenetics discovery platform.

On April 9, 2018 Allogene Therapeutics, Inc. (Allogene) reported the completion of the previously announced transaction between Pfizer Inc. (NYSE: PFE) and Allogene for Pfizer’s portfolio of assets related to allogeneic chimeric antigen receptor T cell (CAR T) therapy, an investigational immune cell therapy approach to treating cancer (Press release, Cellectis, APR 9, 2018, View Source [SID1234525478]).

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On April 3, 2018, Allogene and Pfizer announced that the companies had entered into a definitive asset contribution agreement for Pfizer’s allogeneic CAR T portfolio. As a result of the completed agreement, Allogene has received from Pfizer the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR T therapy that is being developed for treatment of CD19-­‐ expressing hematological malignancies. In partnership with Servier, UCART19 is initially being developed in acute lymphoblastic leukemia (ALL) and is currently in Phase I. UCART19 utilizes TALEN gene editing technology pioneered and owned by Cellectis.

With the agreement completed, Allogene is well-­‐positioned to rapidly advance the portfolio of CAR T assets contributed by Pfizer into potential innovative new therapies, and ultimately to reach patients in need more quickly. "The completion of our agreement with Pfizer represents a bold undertaking by leaders in the field to expedite the development of the next wave of cancer immunotherapies," said David Chang, M.D., Ph.D., President and Chief Executive Officer of Allogene.

Pfizer will continue to participate financially in the CAR T portfolio’s development through a 25 percent ownership stake in Allogene. Prior to the agreement completion, Gilead Sciences joined Allogene’s premier Series A investment consortium that already included TPG, Vida Ventures, BellCo Capital, the University of California Office of the Chief Investment Officer, and Pfizer, among others.

Centerview Partners acted as financial advisor to Pfizer, with Ropes & Gray LLP acting as its legal advisor. Cooley LLP served as legal counsel to Allogene, Vida Venture and TPG. Gibson Dunn & Crutcher LLP also served as legal counsel to TPG.

On April 9, 2018 Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing neoantigen cancer vaccines, reported upcoming presentations at the 2018 Annual Meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (AACR 2018), taking place April 14-18, 2018 in Chicago, IL (Press release, Genocea Biosciences, APR 9, 2018, View Source [SID1234525216]).

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Poster 15: "Neoantigen identification using the ATLAS T cell profiling platform highlights the need to empirically define neoantigens"
Vaccines Session 1, Immunology Track
Sunday, April 15, 2018 from 1 pm to 5 pm CDT
Link to abstract

Poster 5718: "Ex vivo ATLAS-identification of neoantigens for personalized cancer immunotherapy in mouse melanoma"
Neoantigens in Cancer Session, Immunology Track
Wednesday, April 18, 2018 from 8 am to 12 pm CDT

On April 6, 2018 NewLink Genetics Corporation (NASDAQ:NLNK) reported a review of its clinical programs (Press release, NewLink Genetics, APR 6, 2018, View Source [SID1234525805]).

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This morning’s announcement by Incyte and Merck on the ECHO-301 trial for patients with advanced melanoma is a disappointing result for the IDO field. Indoximod, NewLink Genetics’ IDO pathway inhibitor, has a differentiated mechanism of action (MOA) which may demonstrate clinical benefit for patients where direct enzymatic inhibitors have not. In light of Incyte’s announcement, however, NewLink is undertaking a review of its clinical programs and will provide an update when it is completed.

NewLink Genetics has generated data for indoximod across several indications, and in combination with different modalities, suggesting the potential for indoximod to improve the outcomes for patients with cancer. The Company will present additional data at AACR (Free AACR Whitepaper) next week, including a poster presentation further supporting indoximod’s differentiated MOA and a plenary session presenting encouraging early clinical data of indoximod plus radiation for pediatric patients with diffuse intrinsic pontine glioma (DIPG), a rare and lethal form of brain cancer.

About Indoximod

Indoximod is an investigational, orally available small molecule targeting the IDO pathway. The IDO pathway is a key immuno-oncology target involved in regulating the tumor microenvironment and immune escape. Indoximod is being evaluated in combination with treatment regimens including anti-PD-1/PD-L1 agents, cancer vaccines, radiation, and chemotherapy across multiple indications such as melanoma, pancreatic cancer and other malignancies.