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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]).

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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.

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.

RedHill Biopharma Provides Semi-Annual Business Update

On April 9, 2018 RedHill Biopharma Ltd. (NASDAQ:RDHL) (Tel-Aviv Stock Exchange:RDHL) ("RedHill" or the "Company"), a specialty biopharmaceutical company primarily focused on late clinical-stage development and commercialization of proprietary drugs for gastrointestinal diseases and cancer, reported that business update of its main activities and key highlights expected in 2018, including two Phase III readouts (Press release, RedHill Biopharma, APR 9, 2018, View Source [SID1234525807]).

Key Highlights:

Top-line results from the ongoing Phase III study with RHB-104 for Crohn’s disease (MAP US study) are expected in mid-2018. Enrollment of all 331 subjects in the study has been completed and the last patient to reach the primary endpoint assessment (remission at week 26) is expected by early May 2018.

Top-line results from the ongoing confirmatory Phase III study with TALICIA (RHB-105)1 for H. pylori infection (ERADICATE Hp 2 study) are expected in H2/2018. To date, approximately 60% out of a planned total of 444 subjects have been enrolled in the study. TALICIA was previously granted QIDP fast-track designation by the FDA, including an extended market exclusivity period, if approved.

Amendment to RHB-106 agreement with Salix Pharmaceuticals. RedHill and Salix recently amended their 2014 worldwide license agreement relating to the
RHB-106 encapsulated bowel cleanser, as well as additional related rights. The amendment clarifies the development efforts to be used by Salix, as well as provides for enhanced involvement by RedHill in certain intellectual property matters. In addition, the parties have agreed to increase the lower end of the range of royalty payments to be paid to RedHill on net sales from low single digits to high single digits, such that the potential royalties now range from high single digits up to low double digits. Milestone payments remain unchanged.

Expected continued quarterly revenue growth. Net revenues in the fourth quarter of 2017 were $2 million, an increase of 31% over the third quarter of 2017. RedHill expects continued quarter over quarter net revenue growth. RedHill’s sales force of approximately 40 sales representatives is calling on thousands of gastroenterologists across the U.S.

Continued cost reduction in 2018. Cash to be used in operating activities is expected to continue to gradually decrease on average to approximately $8.5 million per quarter during 2018. RedHill’s cash position was approximately $46 million at the end of 2017, with no debt.
Additional Updates:

First five patients enrolled in the single-arm Phase IIa study with YELIVA (ABC294640) for the treatment of cholangiocarcinoma (bile duct cancer); Enrollment is expected to be completed by the end of 2018. The Phase IIa study was recently initiated at Mayo Clinic major campuses in Arizona and Minnesota, University of Texas MD Anderson Cancer Center and the Huntsman Cancer Institute, University of Utah Health, and is planned to enroll up to 39 patients. YELIVA was granted Orphan Drug designation by the FDA for the treatment of cholangiocarcinoma.

Ongoing discussions with the FDA on planned Phase III development programs for BEKINDA (RHB-102) for acute gastroenteritis and for IBS-D. Following the positive results of the Phase III study with BEKINDA 24 mg for acute gastroenteritis (GUARD study) and guidance provided by the FDA, RedHill is currently in discussions with the FDA on the design of a confirmatory Phase III study to support a potential New Drug Application (NDA). Following positive results of the Phase II study with BEKINDA 12 mg for IBS-D, RedHill plans to meet with the FDA in the second quarter of 2018 to discuss the design for one or two pivotal Phase III studies.

A pivotal Phase III study with RHB-104 for the treatment of nontuberculous mycobacteria (NTM) infections (QIDP fast-track designation, including an extended market exclusivity period, if approved) is expected to be initiated in H2/2018, subject to completion of a supportive non-clinical program and additional input from the FDA. RHB-104 is planned to be assessed as a first-line treatment of NTM disease caused by mycobacterium avium complex (MAC) infection.