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FDA Accepts New Drug Application for Duvelisib and Grants Priority Review

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.

Allogene Therapeutics Completes Agreement for Pfizer’s Allogeneic CAR T Immuno-oncology Portfolio

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]).

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.

Morphotek Announces Agreement to License its Proprietary Eribulin-Linker Payload to Bliss Biopharmaceutical Co., Ltd. for Development of a Therapeutic Antibody-Drug Conjugate (ADC)

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.

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.

F-star to Present New Preclinical Data on FS118,
a First-in-Class Immuno-Oncology Bispecific Antibody,
at the AACR 2018 Annual Meeting

On April 9, 2018 F-star, a biopharmaceutical company developing novel bispecific antibodies, reported that new preclinical data from its lead immuno-oncology programme FS118 will be highlighted at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in Chicago, US from 14 – 18 April 2018 (Press release, f-star, APR 9, 2018, View Source [SID1234526828]).

FS118 is a first-in-class bispecific antibody that simultaneously blocks LAG-3 (Lymphocyte -Activation Gene 3) and PD-L1 (Programmed Death-Ligand 1) two key pathways in tumours evading the immune system. The new preclinical data show evidence of FS118’s efficacy both in primary human T cell assays and syngeneic tumour models. Specifically, FS118 is able to suppress LAG-3 expression on T cells in the tumour microenvironment and to promote a potent CD8+ T cells-mediated anti-cancer immune
response.

Neil Brewis, CSO of F-star commented: "Despite major advances on the PD-1/PD-L1 axis, many patients remain unresponsive to or relapse following treatment. FS118 preclinical data suggest that it can improve both efficacy and response rate compared to monotherapies or monotherapy combinations. It is a very exciting time for F-star, as these studies support the potential for FS118 to provide significant clinical benefits to cancer patients."

The new data will be published in a poster entitled "Dual blockade of PD-L1 and LAG-3 with FS118, a unique bispecific antibody, induces CD8+ T cell activation and modulates the tumour microenvironment to promote anti-tumour immune responses".

Details are below:

Session Title: Immune Checkpoints 2
Session Start Time: Monday, 16th April at 1pm
Session End Time: Monday, 16th April at 5pm
Location: Poster Section 32
Poster Board Number: 11
Poster Number: 2719

In June 2017, Merck and F-star entered into a new strategic collaboration that provides Merck with an exclusive option to acquire several immuno-oncology bispecific assets, including FS118, through the acquisition of F-star Delta Ltd

For further information, please contact:
At F-star For media enquiries
Pierre Peotta
Communications Manager
+44 (0)7392 080 279
[email protected]
Instinctif Partners (EU & RoW)
Sue Charles/Ashley Tapp
+44 (0)20 7866 7923
[email protected]
Lazar Partners (USA)
Glenn Silver
+1 (0)212 867 1762
[email protected]

Immunomedics appoints Dr. Robert Iannone head of Research & Development and Chief Medical Officer

On April 9, 2018 Immunomedics, Inc., (NASDAQ:IMMU) ("Immunomedics" or the "Company"), a leader in the field of antibody-drug conjugates (ADCs), reported the appointment of Robert Iannone, M.D., M.S.C.E., as Head of Research & Development and Chief Medical Officer, effective today (Press release, Immunomedics, APR 9, 2018, View Source [SID1234525811]). In his new role, Dr. Iannone will oversee and lead all clinical development, regulatory, pre-clinical, translational research and medical affairs strategies and activities of the Company. Dr. Iannone brings more than thirteen years of experience in clinical drug development, including the approval of several targeted and immuno-oncology medicines at AstraZeneca/MedImmune and Merck & Co.

"Rob is not only a highly accomplished oncology drug developer but also is deeply rooted in science with outstanding development experience and an established track record in a number of disease settings of interest to Immunomedics. We are thrilled that Rob is bringing his strong industry, medical, scientific and strategic leadership to Immunomedics," commented Michael Pehl, President and Chief Executive Officer. "Through his unique expertise, Rob will be instrumental in aggressively advancing development of our programs with the right drug combinations and in the most appropriate patient segments. I look forward to working closely with Rob to unlock the full potential of our ADC platform and further strengthen Immunomedics as a leader in this field."

Dr. Iannone comes to Immunomedics from AstraZeneca/MedImmune where he oversaw the development of Imfinzi and was, most recently, Senior Vice President and Head of Immuno-oncology, Global Medicines Development. He joined AstraZeneca/MedImmune in July 2014 as Global Products Vice President. Prior to AstraZeneca/MedImmune, Dr. Iannone served as Executive Director, Clinical Research, and Section Head of Oncology at Merck Research Laboratories and was a development leader for Keytruda.

"Immunomedics has a unique and highly differentiated ADC pipeline and platform technology. I am very excited to be joining the Company to help develop sacituzumab govitecan and other pipeline assets, to be foundational therapies in a wide variety of hard-to-treat solid cancer indications, in both early- and late-line settings, including the potential for combining with immune checkpoint inhibitors and other targeted cancer therapies," remarked Dr. Iannone.

Dr. Iannone received his M.D. from Yale University School of Medicine with Alpha Omega Alpha honors and a Master of Science in Clinical Epidemiology from the University of Pennsylvania School of Medicine. Dr. Iannone completed his Residency at Johns Hopkins

Hospital, where he also served as Chief Resident for one year and completed his Pediatric Hematology and Oncology Fellowship. Dr Iannone is the author or co-author of numerous articles in peer-reviewed journals and has served on the Biomarkers Consortium of the Cancer Steering Committee of the Foundation for the National Institutes of Health since 2011.