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 Amgen (NASDAQ:AMGN) reported that new pre-clinical data for several of its novel investigational oncology candidates will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, April 14-18, 2018 (Press release, Amgen, APR 9, 2018, View Source;p=RssLanding&cat=news&id=2341642 [SID1234525232]). Data spans Amgen’s early pipeline, including the first presentation of data for its most advanced chimeric antigen receptor (CAR) T cell therapy programs, targeting DLL3 in small cell lung cancer and FLT3 in acute myeloid leukemia (AML). In addition, pre-clinical data for Amgen’s DLL3 CAR T cell therapy and bispecific T cell engager (BiTE) program will be featured in an oral presentation.

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"As part of our overarching research and development strategy, Amgen is committed to advancing multiple modalities to gain biological insights before selecting the optimal treatment approach," said David M. Reese, M.D., senior vice president of Translational Sciences and Oncology at Amgen. "With a variety of tools in our toolkit, we have the ability to comprehensively evaluate these novel approaches to determine how each may perform in different treatment settings. We look forward to seeing how the pre-clinical data ultimately translate in the clinic."

Research presented at the meeting will also include pre-clinical studies examining pharmacodynamic markers for Mcl-1 inhibition, as well as the combination of Amgen’s Mcl-1 inhibitor (AMG 176) with a selective BCL-2 inhibitor in models of AML. AMG 176 is a highly selective and reversible Mcl-1 inhibitor and is being studied in a Phase 1 clinical trial involving patients with relapsed or refractory AML or multiple myeloma. Studies have shown that hematologic malignancies including AML, multiple myeloma and non-Hodgkin lymphoma are particularly sensitive to Mcl-1 inhibition.

In addition, Amgen will present for the first time pre-clinical data evaluating its half-life extended (HLE) anti-BCMA BiTE for the treatment of multiple myeloma. A phase 1 study evaluating Amgen’s anti-BCMA HLE-BiTE (AMG 701) is ongoing.

With the exception of late-breaking research, abstracts are available and can be reviewed on the AACR (Free AACR Whitepaper) website at View Source Identified below are select abstracts of interest on Amgen research:

Immuno-oncology

Targeting DLL3 with BiTE antibody constructs and cell-based therapies for the treatment of SCLC
Abstract #DDT02, Oral Presentation, Sunday, April 15 from 3:24-3:48 p.m. CT at McCormick Place South (Level 1), Room S103
Generation and evaluation of a FLT3 CAR-T cell therapy for the treatment of acute myeloid leukemia
Abstract #2559/18, Poster Session, Monday, April 16 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 24
Cynomolgus monkey plasma cell gene signature to quantify the in vivo activity of a half-life extended anti-BCMA BiTE for the treatment of multiple myeloma
Abstract #LB-299/21, Poster Presentation, Tuesday, April 17 from 1-5 p.m. CT at McCormick Place, Exhibit Hall A, Poster Section 44
Mcl-1 Inhibition

The utilization of a human MCL-1 knock-in mouse suggests that reductions in B-cells and monocytes may serve as clinically relevant pharmacodynamic markers of MCL-1 inhibition
Abstract #2978, Oral Presentation, Monday, April 16 from 4:35-4:50 p.m. CT at McCormick Place North (Level 4), Room N427
Combined inhibition of MCL-1 and BCL-2 with AMG 176 and venetoclax induces apoptosis and tumor regression in models of acute myeloid leukemia
Abstract #3972/6, Poster Session, Tuesday, April 17 from 8 a.m.-noon CT at McCormick Place, Exhibit Hall A, Poster Section 41
About CAR T Cell Therapy
CAR T cell therapy is an evolving area of personalized medicine in which a patient’s own T cells (a type of white blood cell) are engineered to recognize tumor-specific antigens and incite an immune system attack against the cancer cells. Amgen is exploring the application of CAR T cell therapy across hematologic and solid tumor malignancies. Amgen and Kite Pharma, a subsidiary of Gilead Sciences Inc., are collaborating on engineering and commercializing Car T cell therapies.

About BiTE Technology
Bispecific T cell engager (BiTE) antibody constructs are a type of immunotherapy being investigated for fighting cancer by helping the body’s immune system to detect and target malignant cells. The modified antibodies are designed to bridge T cells to tumor cells, using the patient’s own immune system to eradicate cancer. BiTE antibody constructs help place the T cells within reach of the targeted cell, with the intent of allowing T cells to inject toxins and trigger the cancer cell to die (apoptosis). BiTE antibody constructs are currently being investigated for their potential to treat a wide variety of cancers.

About Amgen’s Commitment to Oncology
Amgen Oncology is committed to helping patients take on some of the toughest cancers, such as those that have been resistant to drugs, those that progress rapidly through the body and those where limited treatment options exist. Amgen’s supportive care treatments help patients combat certain side effects of strong chemotherapy, and our targeted medicines and immunotherapies focus on more than a dozen different malignancies, ranging from blood cancers to solid tumors. With decades of experience providing therapies for cancer patients, Amgen continues to grow its portfolio of innovative and biosimilar oncology medicines.

On April 9, 2018 OncoMed Pharmaceuticals, Inc. (NASDAQ:OMED), a clinical-stage biopharmaceutical company focused on discovering and developing novel anti-cancer therapeutics, reported that five posters will be presented at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting to be held April 14-18, 2018, in Chicago (Press release, OncoMed, APR 9, 2018, View Source [SID1234525233]). Among the presentations will be preclinical data for OncoMed’s novel anti-TIGIT (OMP-313M32) immuno-oncology program, which is currently in a Phase 1a single-agent clinical study. Preclinical data for OncoMed’s differentiated clinical-stage GITRL-Fc (OMP-336B11) program will also be featured. In addition, preclinical immuno-oncology data for OncoMed’s Wnt antagonist vantictumab (anti-FZD, OMP-18R5) in combination with immune checkpoint inhibitors will be presented.

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Details on the poster presentations are provided below:

Poster 20; Abstract 70: Effect of aging on the antitumor activity of GITRL-Fc
Session: Tumor Biology, Dormancy and Aging: The Influential Microenvironment
Date and Time: Sunday Apr 15, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 3

Poster 28; Abstract 1733: Wnt antagonists synergize with immune checkpoint inhibitors to enhance anti-tumor responses
Session: Immunology, Immune Responses to Therapies 2
Date and Time: Monday Apr 16, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 18; Abstract 2726: In vitro functional activity of OMP-336B11, a GITRL-Fc fusion protein, on primary human immune cells
Session: Immunology, Immune Checkpoints 2
Date and Time: Monday Apr 16, 2018 1:00 PM – 5:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 32

Poster 16; Abstract 3826: GITRL-Fc biomarker and mechanism study: GITRL-Fc reduces Treg frequency in tumors and requires effector function for inhibition of tumor growth
Session: Immunology, Therapeutic Antibodies, Including Engineered Antibodies 3
Date and Time: Tuesday Apr 17, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 34

Poster 22; Abstract 5627: Anti-TIGIT biomarker study: Inhibition of TIGIT induces loss of Tregs from tumors and requires effector function for tumor growth inhibition
Session: Clinical Research, Therapeutic Antibodies, Including Engineered Antibodies 4
Date and Time: Wednesday Apr 18, 2018 8:00 AM – 12:00 PM
Location: McCormick Place South, Exhibit Hall A, Poster Section 28

Following the presentations, the posters will be available on the Pipeline section of OncoMed’s website, www.oncomed.com.

Additional information on the meeting can be found on the AACR (Free AACR Whitepaper) website www.aacr.org

On April 9, 2018 Morphotek, Inc., a subsidiary of Eisai Inc., reported that it licensed its eribulin-linker payload to Bliss Biopharmaceutical Co., Ltd. (BlissBio) of China (Press release, Morphotek, APR 9, 2018, View Source [SID1234527215]). The licensing agreement grants BlissBio the exclusive right to use the eribulin-linker payload to develop a therapeutic ADC against an undisclosed oncology target for the China market. The licensing agreement includes an upfront payment, milestones and sales royalty payments, which are undisclosed. BlissBio has an exclusivity option to expand the territory beyond China to the global market and to develop therapeutic ADCs to two additional undisclosed oncology targets.

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Morphotek’s ADC Services offer third parties the opportunity to license the proprietary eribulin-linker payload to develop investigational ADCs using either Morphotek’s REsidue-SPEcific Conjugation Technology (RESPECT) or an alternative approach to conjugation. The eribulin-linker payload consists of a cytotoxic agent, eribulin, modified by a chemical linker to facilitate optimal conjugation. Eribulin’s anti-tumor activity is mediated by the inhibition of microtubule elongation and mitotic spindle formation, resulting in apoptosis. Eribulin mesylate, marketed as Halaven, is approved in the U.S. for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for metastatic disease, including an anthracycline and a taxane in either the adjuvant or metastatic setting.

Our end-to-end ADC Services provide multiple entry points for clients, starting from development of an antigen site-specific bioconjugate-ready monoclonal antibody and ADC through in vivo safety and efficacy validation. Additional options include manufacture of GMP clinical trial material, GLP toxicology studies and development of immunohistochemistry (IHC) companion diagnostics for patient screening. For more information on Morphotek’s ADC Services business and RESPECT platform, please contact [email protected].

*The ADCs described herein are investigational, as efficacy and safety have not been established. There is no guarantee that the ADCs will be available commercially.

On September 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, Allogene, SEP 9, 2018, View Source [SID1234529314]).

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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 1.UCART19 utilizesTALEN 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’s 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. Coole. LLP served as legal counsel to Allogene, Vida Ventures and TPG. Gibson Dunn & Crutcher LLP also served as legal counsel to TPG.