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Adimab Announces Platform Transfer with Lilly

On July 18, 2017 – Adimab, LLC, a global leader in the discovery and optimization of fully human monoclonal and bispecific antibodies, reported that it has entered into an agreement with Eli Lilly and Company to transfer the Adimab Platform to Lilly for the discovery and optimization of antibody-based drugs in all therapeutic areas View Source This technology transfer expands an ongoing collaboration between the two companies that was initiated in 2010, which has yielded several undisclosed therapeutic candidates for Lilly.

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"Given our commitment to discover and develop breakthrough medicines, we are excited to be entering this new agreement with Adimab," said Thomas Bumol, Senior Vice President for Biotechnology and Immunology Research at Lilly. "We believe that adding the Adimab Platform to our existing portfolio of capabilities is an important step for Lilly as we work to quickly and efficiently develop solutions that will make a positive impact on people’s lives."

"Lilly has a strong foundation in protein-based therapeutics and excellent R&D capabilities. We are delighted to see our platform in the hands of such a competent team," said Tillman Gerngross, Chief Executive Officer and Co-Founder of Adimab. "Adimab is a technology company that does not pursue its own internal pipeline. As such, we are very invested in the success of our collaborators. We typically enter into smaller collaborations intended to demonstrate the capabilities of the platform and then broaden the relationship by either doing more funded discovery or transferring the platform for internal use."

Under the terms of the agreement, Adimab will transfer and license its proprietary antibody discovery and optimization platform to Lilly research sites in San Diego and New York. Lilly will receive a unique, custom human antibody library that is exclusive to Lilly, and will obtain a license to the Adimab Platform for use in all therapeutic areas without any target restriction. Lilly has also secured options to receive continued improvements to the Adimab Platform, including access to new antibody libraries. Adimab will receive an undisclosed upfront fee, future payments upon achievement of specified preclinical and clinical milestones, and royalties on any therapeutic products resulting from use of the technology.

Over the past 8 years, Adimab has established partnerships with 50 pharmaceutical and biotechnology companies. In addition to Lilly, the Adimab technology has been transferred and implemented at Merck, Novo Nordisk, Biogen and GSK. Funded discovery partners include leading pharmaceutical companies, such as Novo Nordisk, Biogen, GSK, Roche, Novartis, Lilly, Genentech, Celgene, Gilead, Kyowa Hakko Kirin, Sanofi and others. Adimab has also partnered with many mid-size and early-stage venture-backed companies, including Merrimack, Five Prime, Jounce, Innovent, Alector, Acceleron, Surface Oncology, Potenza, Arsanis and others.

Sunesis Pharmaceuticals Announces First Patient Dosed in Phase 1b/2 Study Evaluating Oral Non-Covalent BTK-inhibitor SNS-062 in Adults with Chronic Lymphocytic Leukemia and other B-Cell Malignancies

On July 18, 2017 Sunesis Pharmaceuticals, Inc. (Nasdaq:SNSS) reported that the first patient has been dosed at the Dana-Farber Institute in the Phase 1b/2 dose-escalation and cohort-expansion study of its reversible, non-covalent Bruton’s Tyrosine Kinase (BTK)-inhibitor, SNS-062, in adults with chronic lymphocytic leukemia (CLL), small lymphocytic leukemia, Waldenstrom’s macroglobulinemia and mantle cell lymphoma that have progressed after prior therapies (Press release, Sunesis, JUL 18, 2017, View Source [SID1234519830]).

"Resistance to ibrutinib, the only FDA approved BTK inhibitor, is a growing area of unmet need in the treatment of relapsed CLL," said Dr. Jennifer Brown, Director of the CLL Center at Dana-Farber Cancer Institute. "SNS-062 is designed to retain its activity in the presence of the C481S mutation, the primary resistance mechanism thus far identified to treatment by covalent-binding BTK inhibitors such as ibrutinib. We look forward to participating in Sunesis’ Phase 1b/2 study to explore the therapeutic potential of SNS-062."

"The start of this Phase 1b/2 study marks a significant milestone for the Company," said Daniel Swisher, Chief Executive Officer of Sunesis. "This study is designed to provide initial proof of concept that SNS-062 can become a new treatment option for patients with relapsed CLL. We look forward to progressing this trial to identify a recommended dose and to characterize the profile of SNS-062 across a range of B-cell malignancies."

The Phase 1b/2 trial is an open-label, sequential-group study that will enroll up to 124 subjects and is being conducted at five leading sites in the United States: Dana-Farber Cancer Institute, MD Anderson Cancer Center, The Ohio State University Comprehensive Cancer Center, U.C. Irvine Medical Center, and Weill Cornell Medicine. The target population comprises adult subjects who have advanced B-cell malignancies that have relapsed/progressed after prior therapy, including a BTK inhibitor. Phase 1b is the dose escalation portion of the study designed to evaluate the safety, pharmacokinetics, pharmacodynamics and antitumor activity of a range of SNS-062 dose levels, to determine the maximum tolerated and/or recommended dose. The Phase 2 portion is the cohort expansion that will further explore the clinical activity and safety of SNS-062 mono-therapy within specific disease cohorts, including relapsed CLL patients with C481S mutations.

About SNS-062

SNS-062 is a selective, oral, reversible, non-covalent inhibitor of Bruton’s tyrosine kinase (BTK). BTK is a validated target for the treatment of B-cell malignancies driven by B-cell receptor signaling. SNS-062 is designed to retain its activity in the presence of a C481S mutation in BTK’s kinase domain, a leading resistance mechanism of ibrutinib for the treatment of chronic lymphocytic leukemia (CLL). In preclinical studies, SNS-062 demonstrated potent activity in both wild-type and C481S mutant BTK. In a Phase 1A randomized, double-blind, placebo-controlled single ascending dose study in healthy volunteers, SNS-062 demonstrated improved pharmacokinetics over ibrutinib, and sustained inhibition of BTK. SNS-062 is now being investigated in a Phase 1B/2 study in patients with relapsed B-cell malignancies, including CLL.

Moleculin Signs Agreement with MD Anderson Cancer Center for Leukemia Drug, Annamycin

On July 18, 2017 Moleculin Biotech, Inc., (NASDAQ: MBRX) ("Moleculin" or the "Company"), a preclinical pharmaceutical company focused on the development of anti-cancer drug candidates, some of which are based on license agreements with The University of Texas System on behalf of the M.D. Anderson Cancer Center, reported it has signed a new technology license agreement with MD Anderson Cancer Center based on new patent applications it intends to file relating to its drug Annamycin for the treatment of relapsed or refractory acute myeloid leukemia (AML) (Press release, Moleculin, JUL 18, 2017, View Source [SID1234519817]).

"In anticipation of beginning our planned clinical trials for Annamycin," commented Walter Klemp, CEO of Moleculin, "one of our priorities has been to ensure the best possible protection for our intellectual property. Some key patent applications had yet to be filed and signing a new license agreement with MD Anderson clears the way for those patents."

Mr. Klemp continued: "we have benefitted greatly from our collaboration with MD Anderson, and this license helps ensure that collaboration continues."

Kura Oncology Announces Issuance of U.S. Patent for Lead Product Candidate Tipifarnib in Head and Neck Cancer

On July 18, 2017 Kura Oncology, Inc. (NASDAQ:KURA), a clinical stage biopharmaceutical company focused on the development of precision medicines for oncology, reported that the United States Patent and Trademark Office has issued a patent protecting the company’s lead product candidate, tipifarnib, which is currently being studied in multiple Phase 2 clinical trials (Press release, Kura Oncology, JUL 18, 2017, View Source [SID1234519816]). The patent includes multiple claims directed to the use of tipifarnib in patients with HRAS mutant squamous cell carcinoma of the head and neck (SCCHN) and has an expiration date of August 2036, excluding any possible patent term extension.

"Our goal is to identify genetically-defined patient populations in which tipifarnib will demonstrate enhanced therapeutic activity and to pursue patent protection in those indications," said Troy Wilson, Ph.D., President and CEO of Kura Oncology. "The granting of this new patent is a major milestone for Kura, and it illustrates the potential of our broader strategy to generate intellectual property related to tipifarnib and its use in treating human diseases."

U.S. Patent No. 9,707,221, entitled "Methods of Treating Cancer Patients with Farnesyltransferase Inhibitors" is directed to the use of tipifarnib for treating patients with relapsed and/or refractory HRAS SCCHN.

About HRAS Mutant SCCHN

Head and neck cancer is one of the leading causes of cancer-related deaths worldwide, with squamous cell carcinomas accounting for most head and neck cancers. The relapsed and/or refractory SCCHN patient population has an overall survival of approximately 6-8 months and few therapeutic options. New therapies for SCCHN, including immunotherapy, typically show a response rate in the range of 10-20%. HRAS is a proto-oncogene that has been implicated in the development and progression of SCCHN. HRAS mutant SCCHN has an estimated annual incidence of approximately 2,800 to 3,400 patients in the U.S. and represents a significant unmet medical need.

About Tipifarnib

Kura Oncology’s lead program, tipifarnib, is an inhibitor of farnesylation, a key cell signaling process implicated in cancer initiation and development. In extensive clinical trials, tipifarnib has shown a well-established safety profile and compelling and durable anti-cancer activity in certain patient subsets. Preclinical and clinical data suggest that, in the appropriate context, tipifarnib has the potential to provide significant benefit to cancer patients with limited treatment options. Leveraging advances in next-generation sequencing as well as emerging information about cancer genetics and tumor biology, Kura Oncology is seeking to identify patients most likely to benefit from tipifarnib.

Kitov Announces Results of Study Demonstrating NT-219 Enhanced Efficacy of Keytruda® in Immune-Oncology Preclinical Model

On July 18, 2017 Kitov Pharmaceuticals Holdings Ltd. (NASDAQ: KTOV) (TASE: KTOV), an innovative biopharmaceutical company, reported results of a pre-clinical study demonstrating that NT-219, the lead drug candidate of its subsidiary TyrNovo Ltd., in combination with Keytruda, converted non-responding tumors to responders and blocked tumor progression in an immune-oncology preclinical model (Press release, Kitov Pharmaceuticals , JUL 18, 2017, View Source [SID1234519813]).

The study, conducted in collaboration with researchers at Bar Ilan University and Rabin Medical Center, assessed NT-219’s ability to overcome cancer drug resistance in a patient-derived xenograft (PDX) model of immune-deficient mice, in which a tumor originated from an esophagus cancer biopsy was implanted. The mice were supplemented with immune cells from the same patient (double autologous). While no response was observed with Keytruda alone or with NT-219 alone, and the tumors aggressively progressed, mice treated concomitantly with a combination of Keytruda and NT-219 demonstrated complete blockage of tumor progression.

"We are excited with these initial results obtained with NT-219 in combination with pembrolizumab (Keytruda)," stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer. "Previous results obtained with NT-219 demonstrated its efficacy in overcoming drug resistance in a variety of cancers and in combination with various pharmacologic cancer therapies. We are focused on advancing this highly promising therapeutic candidate to clinical trials as quickly as possible in order to provide enhanced treatment options to cancer patients."