On April 1, 2014 BioRap Technologies reported that Fairjourney Biologics signed a Research and Option Agreement with BioRap Technologies at the Rappaport Institute and Hadasit Medical Research Services and Development Ltd. to develop antibodies against Heparanase (Press release, BioRap Technologies, APR 1, 2014, View Source [SID1234516033]). Heparanase was discovered as a target for anti-cancer therapy by Prof. Israel Vlodavsky, a cancer research scientist at the Rappaport Institute and Hadassah Medical Center (Nat. Med. 1999. 5: 793-802).

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Under the terms of the agreement, Fairjourney Biologics will use its expertise in antibody discovery and engineering to develop a superior panel of antibodies, using phage display to tackle multiple epitopes of this target. BioRap Technologies will perform the in-vitro and in-vivo proof of concept at the Rappaport Institute. Fairjourney Biologics has an option to develop the antibody drug candidates on an exclusive basis.

Vlodavsky’s discovery of the extracellular matrix as a reservoir for bioactive molecules provided the basis for the current appreciation of the tumor microenvironment and its significance in cancer progression and treatment. A major achievement of Vlodavsky is the cloning and characterization of heparanase (endo-β-D-glucuronidase), the sole functional enzyme responsible for degradation and remodeling of the extracellular matrix. The normal physiological functions of Heparanase include tissue remodeling and repair.
Abnormal expression of Heparanase is implicated in a variety of pathologic processes, including tumor growth, angiogenesis, metastasis, inflammation and glomerular diseases. Preferential expression of this enzyme has been shown in various human tumors. Heparanase knock-out mice have been reported to lack significant abnormalities. Vlodavsky is the pioneering scientist in this area of research, offering basic insights and new treatment strategies for various cancers and other diseases.
Currently, various chemically modified heparins or heparan sulfate mimics have been generated as Heparanase inhibitors. PI-88 (sulfated malto-oligosaccharide), PG545 (fully sulfated tetrasaccaride), Roneparstat (SST0001), and M402 (both glycol-split species of heparin) are being tested in Phase I/II clinical trials (hepatocellular carcinoma, melanoma, myeloma, lung carcinoma, pancreatic carcinoma).

"The biology of Heparanase makes this enzyme a very attractive novel therapeutic target. We are delighted with the opportunity to generate neutralizing antibodies that are expected to profoundly affect tumor growth, angiogenesis and metastasis," commented Maria Gonzalez-Pajuelo, Fairjourney Biologics’ CSO.
António Parada, Fairjourney Biologics’ CEO emphasized, "After an outstanding track record developing new therapeutic antibodies to partners, it’s time for the company to also have assets. This move will foster value creation and secure broader services from our clients, by demonstrating our capability to deliver more comprehensively on the value chain."
Israel Vlodavsky received his Ph.D. from the Wiezmann Institute (Rehovot, Israel) followed by a postdoctoral training in UCLA and UCSF. He then established the Tumor Biology Research unit of the Hadassah-Hebrew University Medical Center. In 2002, he was recruited to the Technion (Haifa, Israel) where he established the Cancer & Vascular Biology Research Center View Source

On April 1, 2014 FORMA Therapeutics, an innovative R&D organization in pursuit of ground-breaking medicines in oncology and other therapeutic areas, reported a second strategic collaboration and option agreement with Celgene Corporation, a leader in addressing high unmet medical needs (Press release, Forma Therapeutics, APR 1, 2014, View Source [SID:1234509320]).
"It is extremely rewarding to have our team recognized for their creativity and productivity and to receive substantial funding. Most of all, we look forward to expanding our relationship with Celgene, which is based on a deep and open scientific interchange."

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This new collaboration will enable FORMA to extend its unique capabilities across broad areas of chemistry and biology. Upon signing the agreement, FORMA received an upfront cash payment of $225 million, and the parties entered into a collaboration with a term of 3 ½ years. In addition to the 3 ½ year collaboration, Celgene has the option to enter into up to two additional collaborations with terms of two years each for additional payments totaling approximately $375 million. Should each collaboration be successful and Celgene ultimately elect to enter all three collaborations, the combined duration of the three collaborations may extend for at least 7 ½ years. During the third collaboration term, Celgene will have the exclusive option to acquire FORMA, including the U.S. rights to all licensed programs, and worldwide rights to other wholly owned programs within FORMA at that time.
"This new alliance enables FORMA to maintain autonomy in defining our research strategy and conducting discovery through early clinical development of our product portfolio."

The scope and potential duration of this collaboration allows the parties to comprehensively evaluate emerging target families for which FORMA’s platform has exceptional strength. Under the terms of the agreement, Celgene has an option to license the rights to select current and future FORMA programs in exchange for undisclosed additional development and regulatory milestone payments. Celgene will assume responsibility for all global development activities and costs after completion of Phase 1 clinical trials. FORMA retains U.S. rights to all such licensed assets, including responsibility for manufacturing and commercialization. For products not licensed to Celgene, FORMA will maintain worldwide rights.

"Progress in our existing collaboration, coupled with emerging evidence of the power of FORMA’s platform to generate unique chemical matter across important emerging target families, leads us to expand the collaboration and enable a unique collaborative relationship — one that complements the significant strengths of our internal discovery and development organization," said Thomas Daniel, M.D., President, Global Research and Early Development, Celgene Corporation.

"Independent from the previously signed partnership with Celgene whereby they secured ex-U.S. rights to a defined set of protein homeostasis targets, this second agreement expands across FORMA’s preclinical and future clinical development efforts, encompassing numerous protein target families and covering a broad range of therapeutic areas," said Steven Tregay, Ph.D., President and CEO, FORMA Therapeutics. "Importantly, this new alliance enables FORMA to maintain autonomy in defining our research strategy and conducting discovery through early clinical development of our product portfolio. It aligns our company with Celgene’s global leadership in hematology and immune-mediated inflammatory diseases and a shared strategic directive to transform healthcare."

Kenneth W. Bair, Ph.D., Chief Scientific Officer and Head of Research and Development, FORMA Therapeutics, added, "It is extremely rewarding to have our team recognized for their creativity and productivity and to receive substantial funding. Most of all, we look forward to expanding our relationship with Celgene, which is based on a deep and open scientific interchange."

"This second collaboration with FORMA is based upon a very strategic relationship and complete alignment between FORMA’s and Celgene’s R&D efforts. This expansive collaboration will allow FORMA’s powerful drug discovery engine to probe multiple emerging areas of biology in the pursuit of step-ahead therapies for future patients," stated George Golumbeski, Ph.D., Senior Vice President for Business Development, Celgene Corporation. "Both organizations take pride in developing creative alliances that fully enable the science to succeed, and this initiative is truly reflective of that concept."

"The expansion of FORMA’s relationship with Celgene demonstrates a mutual belief in the potential of FORMA’s drug discovery programs to provide meaningful clinical outcomes for patients across a broad variety of diseases," noted Rob Sarisky, Ph.D., Chief Business Officer, FORMA Therapeutics. "This substantial collaboration affords us an opportunity to rapidly accelerate FORMA’s innovations to clinical proof of relevance within our capital-efficient business structure."

On April 2, 2014 Bayer HealthCare reported that the company has begun to enroll patients in a new Phase III trial with radium-223 dichloride (radium-223, Xofigo) (Press release Bayer, APR 1, 2014, View Source;L=1&tx_news_pi1%5Bnews%5D=1672 [SID:1234500360]). The study evaluates radium-223 in combination with abiraterone acetate and prednisone/prednisolone for the treatment of asymptomatic or mildly symptomatic chemotherapy-naïve patients with bone predominant metastatic castration-resistant prostate cancer (CRPC). The trial is designed to determine the effects of this combination treatment on symptomatic skeletal event-free survival (SSE-FS).

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Can-Fite BioPharma has filed a 20-F – Annual and transition report of foreign private issuers [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission (Press release Can-Fite BioPharma, MAR 31, 2014, View Source [SID1234500352]).

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A Phase II dose response/dose-confirmation study in patients with advanced cancer is planned (Filing 10-K, TNI BioTech, MAR 31, 2014, View Source [SID:1234501363])

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