On May 6, 2015 Juno Therapeutics and Fate Therapeutics reported that they have executed a strategic research collaboration and license agreement to identify and utilize small molecules to modulate Juno’s genetically-engineered T cell product candidates to improve their therapeutic potential for cancer patients (Filing, 8-K, Fate Therapeutics, MAY 6, 2015, View Source [SID:1234503625]). The collaboration brings together Juno’s industry-leading expertise in the development of chimeric antigen receptor (CAR) and T cell receptor (TCR) based cellular immunotherapies and Fate’s innovative platform for programming the biological properties and in vivo therapeutic potential of hematopoietic cells.

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"A deep understanding of T cell biology is the basis of Juno’s approach to creating best-in-class cellular immunotherapies," said Hans Bishop, Chief Executive Officer of Juno Therapeutics. "Partnering with Fate Therapeutics, and accessing its strong science and leading platform for modulating the properties of immunological cells, enables interrogation of new avenues of T cell manipulation and provides an opportunity to enhance the therapeutic profile of our genetically-engineered T cell product candidates."

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Through the four-year research and development collaboration, Fate will be responsible for screening and identifying small molecules that modulate the biological properties of engineered T cells. Juno will be responsible for the development and commercialization of engineered T cell immunotherapies incorporating Fate’s small molecule modulators. Juno has the option to extend the exclusive research term for two years through an additional payment and continued funding of collaboration activities.

"We are excited to establish this strategic alliance with Juno, a company that shares our deep commitment to developing transformative cellular therapeutics for patients afflicted with life-threatening disorders," said Christian Weyer, M.D., M.A.S., President and Chief Executive Officer of Fate Therapeutics. "This partnership exemplifies the extension of our small molecule programming platform to additional hematopoietic cell types, such as T cells, as we continue to build and advance our innovative pipeline of programmed hematopoietic cellular therapeutic candidates."

Financial terms of the agreement include an upfront payment to Fate of $5 million and the purchase by Juno of one million shares of Fate common stock at $8.00 per share. Juno will fund all mutual collaboration activities for an exclusive four-year research term. For each product developed by Juno that incorporates modulators identified through the collaboration, Fate is eligible to receive approximately $50 million in target selection fees and clinical, regulatory and commercial milestones, as well as low single-digit royalties on sales. Fate retains exclusive rights to its intellectual property for all purposes outside of programmed CAR and TCR immunotherapies.

About Chimeric Antigen Receptor (CAR) Technology

Juno’s chimeric antigen receptor (CAR) technology genetically engineers T cells to recognize and kill cancer cells. Juno’s CAR T cell technology inserts a gene for a particular CAR into the T cell, enabling it to recognize cancer cells based on the expression of a specific protein located on the cell surface. When the engineered T cell engages the target protein on the cancer cell, it initiates a cell-killing response against the cancer cell.

On May 6, 2015 ARIAD Pharmaceuticals reported that ARIAD has granted Gen Ilac exclusive rights to distribute Iclusig (ponatinib) in Turkey for patients with Philadelphia-positive leukemias(Press release, Ariad, MAY 6, 2015, View Source [SID:1234503619]).

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Gen Ilac was granted the exclusive right to sell Iclusig as an investigational product in Turkey on a named-patient basis and will provide associated medical affairs and regulatory support. ARIAD retains the option to file for marketing authorization at a later date and, if approved, to hold the Marketing Authorization for Iclusig in Turkey. Gen Ilac has the exclusive right then to market and commercialize the product upon approval.

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"This agreement with Gen Ilac furthers our mission to provide Iclusig to patients in geographies beyond our core commercial footprint," said Marty J. Duvall, executive vice president and chief commercial officer of ARIAD. "We are excited by Gen Ilac’s experience and proven capabilities in this area, which makes them an ideal partner to introduce Iclusig to patients and physicians in Turkey."

"We are excited by our partnership with ARIAD and the hope it provides to refractory CML patients in Turkey," said Abidin Gulmus, chief executive officer of GEN ILAC. "This partnership aligns well with our company mission and our expertise in providing treatments in the field of hematology."

About Iclusig (ponatinib)

Iclusig is a kinase inhibitor. The primary target for Iclusig is BCR-ABL, an abnormal tyrosine kinase that is expressed in chronic myeloid leukemia (CML) and Philadelphia-chromosome positive acute lymphoblastic leukemia (Ph+ ALL). Iclusig was designed using ARIAD’s computational and structure-based drug design platform specifically to inhibit the activity of BCR-ABL. Iclusig targets not only native BCR-ABL but also its isoforms that carry mutations that confer resistance to treatment, including the T315I mutation, which has been associated with resistance to other approved TKIs.

On May 6, 2015 Gilead Sciences and EpiTherapeutics ApS, a privately-held Danish company, announced the signing of a definitive agreement pursuant to which Gilead has acquired EpiTherapeutics for $65 million, subject to certain purchase price adjustments, to be financed through available cash on hand (Press release, Gilead Sciences, MAY 6, 2015, View Source [SID:1234503618]).

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EpiTherapeutics has generated a library of first-in-class, selective small molecule inhibitors of epigenetic regulation of gene transcription, in particular histone demethylases. The company’s lead pre-clinical compounds are being studied for the treatment of certain cancers.

"Epigenetics is a promising area of research and the EpiTherapeutics team is a recognized scientific leader in this field," said Norbert Bischofberger, PhD, Gilead’s Executive Vice President, Research and Development and Chief Scientific Officer. "This therapeutic class represents a strategic fit with our existing research portfolio, including the potential for novel combination approaches. We look forward to working with colleagues from EpiTherapeutics to advance these programs toward clinical development in diseases with significant unmet medical need."

"EpiTherapeutics has done groundbreaking work in a new therapeutic class of small molecule inhibitors with broad implications across various disease states," said Martin Bonde, PhD, EpiTherapeutics’ Chief Executive Officer. "We are confident that with Gilead’s acquisition of the company, our discoveries will have the best chance to be developed into therapies that will benefit patients."

Investors in EpiTherapeutics are NOVO Seeds, SEED Capital, Lundbeckfond Emerge, MS Ventures and Astellas Venture. Back Bay Life Science Advisors of Boston advised EpiTherapeutics on the transaction.

About EpiTherapeutics

EpiTherapeutics is developing novel innovative cancer drugs based on epigenetics, a therapeutic area researched by renowned scientist Professor Kristian Helin and his group at Biotech Research & Innovation Centre (BRIC) at University of Copenhagen. EpiTherapeutics’ development programs are focused on enzymes involved in the regulation of transcription in cancer. For more information, please visit: www.epitherapeutics.com.