Curis Reports Dosing of First Patient in Phase 1 Trial of CUDC-907; FUJIFILM Completes Acquisition of Kalon Biotherapeutics Print E-mail
By William Kent   
Thursday, 18 December 2014 20:14
Below is a look at some of the headlines for companies that made news in the healthcare sector on December 18, 2014.

Curis, Inc. (Nasdaq:CRIS), a drug development company seeking to develop next generation targeted small molecule drug candidates for cancer treatment, today announced that the first patient has been treated in a Phase I clinical study of CUDC-907 in patients with relapsed or refractory lymphoma or multiple myeloma. CUDC-907 is an orally-administered first-in-class small molecule drug candidate that has been designed as a dual inhibitor of phosphatidylinositol-3-kinase (PI3K) and histone deacetylase (HDAC). As a result of this clinical advance, Curis is entitled to receive an additional $350,000 in milestone payments under the terms of its agreement with The Leukemia and Lymphoma Society (LLS).

"We're very pleased to announce the initiation of the CUDC-907 Phase I clinical study in patients with advanced hematological cancers," said Dan Passeri, Curis' President and Chief Executive Officer. "The synergistic effects of targeting PI3K and HDAC with CUDC-907 have shown very potent antitumor activity in preclinical models of lymphoma and multiple myeloma. We are hopeful that CUDC-907 will demonstrate an adequate safety profile and also provide clinical activity in this study population. We look forward to seeking to advance this important molecule through this Phase I dose escalation study and further clinical trials."

"LLS is pleased that Curis has met this significant milestone," said Richard Winneker, Ph.D, LLS senior vice president of research. "Initiating this first human clinical trial for this drug candidate is a major advance, and we are hopeful that this therapy could yield promising outcomes for patients with lymphomas and multiple myeloma, who are often in critical need of new treatment options."

This clinical trial is designed as a standard dose escalation study in which CUDC-907 will be orally administered to patients with relapsed or refractory lymphoma or multiple myeloma at up to four study centers in the United States. The primary objectives of the study are to determine the maximum tolerated dose and recommended oral dose of CUDC-907 for Phase II study. The secondary objectives of this study are to assess safety and tolerability, to assess pharmacokinetics, to evaluate biomarker activity and to assess preliminary anti-cancer activity of CUDC-907 in this patient population.

In the absence of dose limiting toxicity, each patient will receive oral CUDC-907 once daily for a minimum of 21 days of continuous daily dosing (1 cycle), and may continue to receive additional cycles of study treatment until disease progression or other treatment discontinuation criteria are met. Additional details about this study can be found on (NCT01742988).



 FUJIFILM Diosynth Biotechnologies U.S.A. Inc. (FDBU), a FUJIFILM Corporation subsidiary, today announced the completion of its acquisition of Kalon Biotherapeutics LLC, marking an important new chapter in the emergence of the Texas biosciences industry as a center for world-class development and manufacturing of life-saving biopharmaceuticals and biotechnology while providing FUJIFILM Diosynth Biotechnologies with expanded capacity for its growing vaccine capabilities.  The completion of the previously announced Purchase Interest Agreement of Kalon Biotherapeutics, LLC, was made with the owners of Kalon: the State of Texas, acting by and through the Office of the Governor, and The Texas A&M University System.  The announcement was made jointly today by Governor Rick Perry; officials of FUJIFILM Corporation, FDBU and Mitsubishi Corporation; Kalon Biotherapeutics LLC; and the Texas A&M System.  Going forward, the company is now known as FUJIFILM Diosynth Biotechnologies Texas, LLC. 

“Healthcare business, above all, the pharmaceutical business, is one of Fujifilm's focal areas,” said Shigehiro Nakajima, President & COO, FUJIFILM Holdings Corporation.  "This acquisition provides an important addition to our business, bringing together diverse capabilities and technical expertise in the area of biopharmaceuticals.”

“This acquisition further reinforces Fujifilm’s global leadership and commitment to the biopharmaceutical industry," said Steve Bagshaw, CEO, FUJIFILM Diosynth Biotechnologies. "Our scientific and manufacturing leadership will be strengthened by adding Kalon’s viral and cell culture vaccine expertise and capabilities to our existing competencies in microbial, mammalian and insect cell process development, analytics, and commercial production.”

“When we first created Kalon in 2011, we set out to change the world through the rapid production of life-saving vaccines and therapeutics. The vision and investment by the state of Texas and the Texas A&M System have been critical to Kalon’s success to date,” said Kalon Founding President Andrew Strong.  “Now, with the combined strength and capability of FUJIFILM Diosynth Biotechnologies, the world’s leading global biotechnology service company, and Kalon, I have no doubt that we are able to emphatically answer the world-wide call for the discovery, testing and manufacturing of vaccines and therapeutics that can prevent diseases or cure the critically ill.”

Founded in 2011 by the A&M System, Kalon is a biopharmaceutical contract manufacturing organization (CMO) with advanced technologies and facilities. It is a key subcontractor to one of the three Centers for Innovation in Advanced Development and Manufacturing (CIADM) awarded by the U.S. Department of Health and Human Services, Biomedical Advanced Research and Development Authority (BARDA) to develop and manufacture medical countermeasures to protect public health in emergencies, including incidents of bioterrorism or an outbreak of pandemic influenza. The State of Texas provided funding for the development and support of this center though the Texas Emerging Technology Fund.

FUJIFILM Diosynth Biotechnologies, a world leader in cGMP biologics manufacturing, is taking an ownership position in Kalon Biotherapeutics, allowing an expansion of Fujifilm’s capabilities to include viruses and viral/vaccine-based products and services. This investment will also provide leveraged biotechnology workforce recruitment to Texas and drive the state’s expansion in biotechnology and biopharmaceuticals.

Texas has a dynamic biotechnology marketplace that yields an estimated annual economic impact of $75 billion. In 2013, one out of every fifteen U.S. biotechnology establishments was located in Texas. The establishment and growth of the biotech industry in Texas is largely due to the vision and leadership of the A&M System, with the support of Governor Rick Perry. Under Texas A&M System’s leadership, the Bryan-College Station region has become a premier biotech location and international leader in all three areas of discovery, combining plant, animal and human scientific breakthroughs. Biotech companies from across the globe are utilizing the infrastructure pipeline at the A&M System and the surrounding corridor for speed-to-market services.

“Today’s signing represents an important next step and an exciting new chapter for the State of Texas, which is fast becoming a global leader in biotechnology and pharmaceutical manufacturing,” Gov. Perry said. “The Texas A&M Center for Innovation in Advanced Development and Manufacturing is at the forefront of an exciting new method to produce life-saving treatments and vaccines, and I’m proud of the role the state has played in helping shape Texas into America’s ‘Third Coast’ in biotechnology.”

Per the Interest Purchase Agreement, FDBU acquired 49 percent of the total membership interests in Kalon, and will be entitled to appoint a majority of Kalon’s board members. Hereafter, FDBU may increase its interest share up to 100 percent, based on achievement of certain milestones. FUJIFILM Diosynth Biotechnologies will support current Kalon operations at the National Center for Therapeutics Manufacturing and a pandemic vaccine manufacturing facility currently under construction. The Kalon innovative facility design utilizes state-of-the-art mobile clean rooms that can be operated independently or in various paired arrangements to meet customer project needs. The acquisition will expand FUJIFILM Diosynth Biotechnologies’ leadership in applying most advanced single-use technology to include high-containment biomanufacturing capabilities. Further, it safeguards continued close business collaboration between the A&M System and the State of Texas to ensure maximum support for customer programs coming to the Kalon facilities.

“This acquisition proves the tremendous value of public-private partnerships, and the importance of creating an environment in which they can succeed,” said John Sharp, chancellor of the Texas A&M University System. “The State of Texas and the A&M System are delivering on a joint promise to help businesses develop and to create jobs. I applaud the Texas A&M System Board of Regents for their unwavering support in building Kalon and positioning it for this transaction.”

Also Thursday:

Agenus Inc. (Nasdaq:AGEN)
, an immuno-oncology company developing a broad portfolio of checkpoint modulators (CPMs) and heat shock protein peptide-based vaccines as well as adjuvants, announced that its partner GlaxoSmithKline (NYSE:GSK) reported that the ZOE-50 Phase 3 study met its primary endpoint.

Akers Biosciences, Inc. (Nasdaq:AKER) (AIM:AKR.L)
, a leading designer and manufacturer of rapid diagnostic screening and testing products, has entered into its first European distribution agreements since the installment of its international vice president in August 2014.

Aldeyra Therapeutics, Inc. (Nasdaq:ALDX)
, a biotechnology company focused on the development of products to treat diseases related to free aldehydes, today announced that an Investigational New Drug application (IND) to conduct Phase 2 clinical testing of NS2 for the treatment of noninfectious anterior uveitis, was submitted to the United States Food and Drug Administration (FDA) on December 16, 2014.

Amedica Corporation (Nasdaq:AMDA)
, a biomaterial company that has developed silicon nitride ceramics as a material platform to manufacture and commercialize orthopaedic implants, today announced that it expects to report full-year 2014 revenue in the range of $22 million and $24 million.

Anavex Life Sciences Corp. (OTCQX:AVXL)
, a clinical-stage biopharmaceutical company developing novel drug candidates to treat Alzheimer's disease, other diseases of the central nervous system (CNS) and various types of cancer, will present at Biotech Showcase 2015 on Monday January 12, 2015 at 2:00pm PST.

BioCryst Pharmaceuticals, Inc., (Nasdaq:BCRX)
today announced that it has dosed the first patient in OPuS-2 (Oral ProphylaxiS-2), a blinded, randomized, placebo-controlled clinical trial of orally-administered BCX4161 in patients with hereditary angioedema (HAE).

Bio-Reference Laboratories, Inc. (Nasdaq:BRLI)
announces record fourth quarter and full fiscal year results for revenues, net income and patient volumes. Except for per share data or where otherwise noted, numbers are in thousands.

Cara Therapeutics, Inc. (Nasdaq:CARA),
a biotechnology company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI).

CB Pharma Acquisition Corp. (Nasdaq:CNLMU)
, a Cayman Islands exempted company formed as a blank check company for the purpose of entering into a merger, share exchange, asset acquisition, share purchase, recapitalization, reorganization, or similar business combination with one or more businesses or entities, announces the closing of its December 12, 2014 initial public offering of 4,000,000 units at $10.00 per unit.

Chimerix, Inc. (Nasdaq:CMRX)
a biopharmaceutical company developing novel, oral antivirals in areas of high unmet medical need, and ContraVir Pharmaceuticals, Inc. (OTCBB:CTRV), a biopharmaceutical company focused on the development and commercialization of targeted antiviral therapies, announced today that the companies have entered into a strategic collaboration for the further clinical development and commercialization of CMX157.

Celldex Therapeutics, Inc. (Nasdaq:CLDX)
today announced the appointment of Richard A. van den Broek to the Company's Board of Directors.

Coronado Biosciences, Inc. (Nasdaq:CNDO)
reports the closing on December 17, 2014 of the initial public offering of CB Pharma Acquisition Corp. (Nasdaq:CNLMU).

Curis, Inc. (Nasdaq:CRIS)
, an oncology-focused biotechnology company developing novel drug candidates for the treatment of human cancers, today announced that the first patient has initiated treatment with CUDC-907 in a Phase 1 clinical trial in patients with advanced or relapsed solid tumors, including hormone receptor positive (HR+)/ HER2-negative breast cancer or midline carcinoma with certain NUT gene rearrangements.

Fate Therapeutics, Inc. (Nasdaq:FATE)
, a biopharmaceutical company engaged in the discovery and development of adult stem cell modulators to treat orphan diseases, today reported initial data from the first 12 subjects administered PROHEMA® in the Company's ongoing Phase 2 PUMA study and announced that the study's independent Data Monitoring Committee (iDMC) supported continuation of the clinical trial following a second planned interim safety review.

HealthEquity, Inc. (Nasdaq:HQY)
Chairman Jon Kessler, and CFO Darcy Mott will present at the 33rd Annual J.P. Morgan Healthcare Conference at 2:30 PM PT on January 14th, 2015 at the Westin St. Francis Hotel in San Francisco, California.

Hyperion Therapeutics, Inc. (Nasdaq:HPTX)
today announced that it has been selected for addition to the NASDAQ Biotechnology Index® (Nasdaq:NBI).

announces the acquisition of Midtown Partners & Co, LLC a New York based licensed broker dealer, as part of its strategy to diversify and expand into the legal cannabis industry.

Intersect ENT, Inc. (Nasdaq:XENT)
, a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced that management is scheduled to present an overview of the company's business, including certain preliminary 2014 results and 2015 outlook, at the J.P. Morgan 33rd Annual Conference at the Westin St. Francis Hotel in San Francisco, Calif., on Tuesday, January 13, 2015 at 10:00 a.m. PT/1 p.m. ET.

Meridian Health, a leading not-for-profit health organization in New Jersey, will join Cerner Corp. (Nasdaq:CERN) to help manage patient population health data from multiple non-Cerner acute and ambulatory Electronic Health Records (EHRs).

Nuvilex, Inc. (OTCQB:NVLX)
, a clinical-stage biotechnology company providing cell and gene therapy solutions for the treatment of diseases, today announced that its partner, Austrianova, successfully completed the first live cell encapsulation at Austrianova's new facility in the Thai Science Park in Bangkok, Thailand.

Nymox Pharmaceutical Corporation (Nasdaq:NYMX)
announced today the closing of U.S. $1.07 million in financing, consisting of a 3 year term convertible debenture at 6% with conversion at $0.53.

Pacific Biosciences of California, Inc., (Nasdaq:PACB)
provider of the PacBio® RS II Sequencing System, today announced that it has appointed industry veteran Kathy Ordoñez to its Board of Directors.

Praxsyn Corporation (OTCQB:PXYN)
, the parent company of Mesa Pharmacy, today announced that it has begun to process PPO prescriptions.

Revance Therapeutics, Inc. (Nasdaq:RVNC)
, a specialty biopharmaceutical company developing botulinum toxin products for the use in aesthetic and therapeutic indications, announced today that it has been selected for addition to the NASDAQ Biotechnology Index (Nasdaq:NBI), which will become effective upon market open on Monday, December 22, 2014.

ReWalk Robotics Ltd. (Nasdaq:RWLK)
announced today the appointment of Kevin W. Hershberger, former controller and Chief Accounting Officer at NxStage Medical Inc., as Chief Financial Officer of the Company effective January 1, 2015.

Sharps Compliance Corp. (Nasdaq:SMED)
announced today that Diana Diaz, Chief Financial Officer, will be presenting at the Sidoti & Co. Emerging Growth Institutional Investor Forum to be held at the Grand Hyatt Hotel in New York.

StemCells, Inc. (Nasdaq:STEM)
, a world leader in the research and development of cell-based therapeutics for the treatment of disorders of the central nervous system, announced today that it has transplanted the first subject in its Phase II Pathway® Study assessing the efficacy of its proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI).

Trillium Therapeutics Inc. (TSX:TR) (OTCQX:SCTPF)
, an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that its common shares have been approved for listing on the NASDAQ Capital Market under the symbol "TRIL".

today announced it has agreed to terms with Poland-based investment fund ORTIE to acquire its pharmaceutical logistics company Poltraf Sp. z o.o.

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