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Curis Announces Allowance of U.S. Patent Covering Compounds Targeting HDAC and PI3K Activities in a Single Molecule

On October 28, 2014 Curis reported the receipt of a Notice of Allowance of a US. patent that covers a broad genus of compounds that target histone deacetylase (HDAC) and phosphoinositide 3-kinase (PI3K) activities in a single chemical structure including CUDC-907, Curis’ oral, dual HDAC and PI3K small molecule inhibitor that is currently being studied in Phase 1 clinical trials (Press release Curis, OCT 28, 2014, View Source [SID:1234500885]). This patent, along with prior patents issued to Curis, further strengthens the Company’s intellectual property portfolio of compounds including CUDC-907 that inhibit HDAC and PI3K enzymes in a single small molecule for the treatment of certain human diseases.

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Collectively, these patents generically cover composition-of-matter and methods of use of CUDC-907 as well as a broad range of proprietary chemical entities that target HDAC and PI3K enzymes, and in some instances mammalian target of rapamycin (mTOR), within a single molecule for the treatment of certain human diseases.

"The allowance of the most recent patent application further enhances Curis’ strong intellectual property portfolio and protection around our promising drug candidate, CUDC-907. Additionally, it also emphasizes the novelty and importance of combining two distinct inhibitory moieties that target HDAC and PI3K enzymes in a single molecule," stated Michael Gray, Curis’ Chief Financial and Business Officer. "We are encouraged by the progress being made in CUDC-907’s program and look forward to data from the expansion phase of the trial to understand the role of this molecule in the treatment of patients with diffuse large B cell lymphoma and multiple myeloma."

CUDC-907 is being investigated in a first-in-human Phase 1 study in patients with relapsed/ refractory lymphoma or multiple myeloma. As part of the Phase 1 study, Curis has also opened expansion cohorts to enroll patients with diffuse large B cell lymphoma and multiple myeloma. In addition, Curis also expects to initiate an additional study under a second open IND that will enroll patients with advanced solid tumors, including patients with hormone receptor positive breast cancer, among others.

Bristol-Myers Squibb Enters into Agreement that Provides an Exclusive Option to Acquire F-star Alpha Ltd. and its Novel HER2-Targeted Therapy

On October 28, 2014 Bristol-Myers Squibb Company and F-star Alpha reported that the companies, together with the F-star Alpha Ltd. shareholders, have entered into an agreement that provides Bristol-Myers Squibb the exclusive option to acquire F-star Alpha Ltd, and gain worldwide rights to its lead asset FS102 (Press release Bristol-Myers Squibb, OCT 28, 2014, View Source [SID:1234500884]). FS102 is a novel Phase 1 ready Human Epidermal growth factor Receptor 2 (HER2)-targeted therapy in development for the treatment of breast and gastric cancer among a well-defined population of HER2-positive patients who do not respond or become resistant to current therapies.

“This agreement is consistent with our R&D strategy to develop promising treatments that address areas of high unmet medical need, and provides the opportunity to complement our oncology portfolio with a novel targeted therapy,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer, Bristol-Myers Squibb. “We look forward to working with F-star and leveraging our broad clinical expertise in oncology to uncover the full potential of FS102.”

“We are thrilled that a company with the oncology experience and expertise of Bristol-Myers Squibb will be advancing our first clinical asset with the potential to provide a significant improvement over the current standard of care for a defined group of patients with HER2-positive cancer,” said John Haurum, M.D., D.Phil., chief executive officer at F-star Biotechnology Ltd. “In addition to the important improvement of cancer therapy FS102 may provide to patients, this program also provides validation of the Modular Antibody Technology platform as a powerful engine to discover and rapidly develop novel targeted biologics.”

HER2 is a highly validated target in breast and gastric cancers, and plays a significant role in the growth of tumors and subsequent poor clinical outcome for patients with breast cancer and other solid tumors. Therapies that target HER2 have shown success in improving patient outcomes; however, a high proportion of HER2-positive patients do not respond to currently available treatments, and those who do may eventually develop resistance.

FS102 is a HER2 targeted Fcab that has the potential to eliminate cancer cells through a novel mechanism of action in a biomarker-defined patient population. FS102 works differently than current HER2-targeted therapies, with the potential to overcome resistance that has developed against other HER2-targeted drugs. It binds to a unique site on HER2 and then induces programmed cell death in HER2-positive tumour cells. In preclinical studies, FS102 has demonstrated encouraging efficacy against certain HER2-positive cancers and major regression in tumors, including those that are refractory to treatment with trastuzumab plus pertuzumab.

Under the terms of the agreement, Bristol-Myers Squibb will make payments aggregating to $50 million that consist of an option fee for the right to acquire F-star Alpha Ltd., payment for certain rights and licenses from F-star Alpha Ltd. and a clinical milestone payment upon initiation of the Phase 1 trial. Bristol-Myers Squibb will be responsible for conducting and funding development of FS102 during the option period. Bristol-Myers Squibb can exercise the option to acquire F-star Alpha Ltd. in its sole discretion upon its decision to commence a Phase 2b trial. Total aggregate consideration may reach $475 million, which includes the payments aggregating to $50 million, the option exercise fee, and milestone payments upon the commencement of a Phase 3 clinical trial and regulatory approvals in the U.S. and Europe.

(Press release, Compugen, OCT 27, 2014, View Source [SID:1234505008])

Celator(R) Pharmaceuticals Announces Phase 3 Clinical Study of CPX-351 Achieved Target Enrollment in High Risk (Secondary) Acute Myeloid Leukemia

On October 27, 2014 Celator Pharmaceuticals reported that the target enrollment of 300 patients has been achieved in the company’s multicenter, randomized, open-label Phase 3 study of CPX-351 (cytarabine:daunorubicin) Liposome for Injection versus the current standard of care, conventional cytarabine and daunorubicin therapy (7+3) in patients with untreated high-risk (secondary) acute myeloid leukemia (AML) (Press release Celator Pharmaceuticals, OCT 27, 2014, View Source [SID:1234500882]). The study randomized the 300th patient ahead of schedule and will remain open for a short time to enable all patients currently in the process of referral and evaluation to complete enrollment into the study.

"AML continues to be a devastating condition with a particularly poor prognosis in the high-risk population. Unlike other cancers, treatments for AML have not significantly advanced patient outcomes for several decades. Based on results to date and the combination-optimizing mechanism behind CPX-351, I am hopeful that we can soon offer a superior option to standard chemotherapy in older patients with high-risk AML," commented Jeffrey Lancet, M.D., Senior Member and Chief of the Leukemia/Myelodysplasia Program at Moffitt Cancer Center.

Celator is conducting the pivotal Phase 3 study in partnership with The Leukemia & Lymphoma Society (LLS). The study enrolled patients between the ages of 60 and 75 with newly diagnosed, previously untreated AML arising from prior myelodysplasia or chronic myelomonocytic leukemia, prior history of chemotherapy or radiotherapy treatment, or with cytogenetic evidence of abnormalities associated with myelodysplasia. Patients were randomized to receive CPX-351 (100u/m2; Days 1, 3, 5) or conventional 7+3 chemotherapy. The primary efficacy endpoint of the study is overall survival. Secondary endpoints include complete response (CR+CRi) rate, duration of remission, 30- and 60-day mortality, event-free survival, aplasia rate, and rate of stem cell transplant. The study began enrollment in December 2012 and is being conducted at leading institutions in the U.S. and Canada. Results from the final analysis of induction response rate are expected in the second quarter of 2015, and overall survival data, the primary endpoint of the study, are expected in the first quarter of 2016.

"We are excited to achieve our target enrollment ahead of schedule and believe it demonstrates both the great need for a new treatment for AML patients, as well as strong clinical interest in CPX-351," said Scott Jackson, Chief Executive Officer of Celator Pharmaceuticals. "Completion of patient accrual in this pivotal Phase 3 study is an important milestone for Celator. We look forward to reporting the induction response rate results in the second quarter of 2015 and we project the primary endpoint data of overall survival to be available in the first quarter of 2016. In addition, we are especially grateful to the patients, the clinical investigators, and our partner, the LLS, for participating in this study."

CTI Acquires Exclusive Worldwide License to Tosedostat, a Selective Oral Anti-Cancer Therapy

On October 27, 2014 CTI BioPharma reported that it has acquired worldwide rights to tosedostat through concurrent transactions with Vernalis R&D Limited (Vernalis), the originator of tosedostat, and Chroma Therapeutics Ltd. (Chroma), through which CTI previously held a sublicense with respect to tosedostat in North, Central and South America (Press release CTI BioPharma, OCT 27, 2014, View Source;p=RssLanding&cat=news&id=1981514 [SID:1234500881]). Tosedostat is a first-in-class selective inhibitor of aminopeptidases, which are required by tumor cells to provide amino acids necessary for growth and tumor cell survival. Tosedostat is currently being evaluated in multiple Phase 2 clinical trials for the treatment of patients with Acute Myeloid Leukemia (AML) or high-risk Myelodysplastic Syndrome (MDS), which are intended to inform the design for a Phase 3 registration study to support potential regulatory approval.

"Our portfolio strategy is to acquire novel best-in-class agents that, either as monotherapy or in combination with other therapies, can have a profound effect in the treatment of patients with blood-related cancers," said James A. Bianco, M.D., President and CEO of CTI. "We are committed to building our blood-related cancer franchise. We feel there is strong interest in this oral, once-daily drug candidate, which we believe is attributable to the positive clinical results to date, and we are pleased to have exclusive worldwide rights to develop tosedostat for patients in areas where there remains an unmet medical need. Over the next year, CTI and its advisors intend to develop a registration path for tosedostat in the US and Europe. In the event of positive clinical data and productive regulatory discussions, we would intend to start a pivotal program commencing in 2016."

Under the terms of an asset purchase agreement with Chroma, CTI acquired all of Chroma’s right, title and interest in tosedostat and certain related assets in exchange for issuing to Chroma $21.3 million in shares of CTI’s preferred stock convertible into 9 million shares of CTI common stock, 12 percent of which has been placed in escrow pending expiry of Chroma’s indemnification obligations. Chroma and CTI also terminated their prior license agreement relating to tosedostat, thereby eliminating potential future developmental and sales milestone payments by CTI of up $209 million thereunder. Concurrently, CTI entered into a license agreement with Vernalis for the exclusive worldwide right to use certain patents and other intellectual property rights to develop, market and commercialize tosedostat and certain other analogues. Under the Vernalis license agreement, CTI agreed to make tiered royalty payments of no more than a high single-digit percentage, on a country-by-country basis, for the longer of ten years following commercial launch or the expiration of relevant patents.