By, Mitchell Young

NEW HAVEN: When a company reports organic revenue growth of 18.6% year over year, hats typically get tipped to the company, all over Wall Street.
New Haven’s Alexion Pharmaceuticals [ NASDAQ: ALXN] did just that and more, its fourth quarter income was up substantially, from $67 million to $93 million. That’s real money, in anyone’s book, but there remain Alexion doubters still.

Alexion logo colorOnly a couple of months back the company parted ways with its CEO David Hallal and CFO Vikhas Sinha and installed an interim CEO, David Brennan a board member and former CEO of Astra Zeneca.

 

cancer Cell with nucleus 22123754NEW HAVEN:  A Yale-led research team has found that a melanoma cell and a white blood cell can fuse to form a hybrid with the ability to metastasize. The hybrid contains the properties of a white blood cell allowing it to migrate through the body taking the Cancer DNA in the hybrid along with it.

According to senior research scientist and study author John Pawelek collaborated with colleagues at the University of Colorado Anschutz Medical Center and the Denver Crime Laboratory to examine how cancer spreads from solid tumors.

The researchers said the theory of how cancers may spread was first presented more than 100 years ago.

The possibility that the discovery can lead to new approaches to controlling cancer’s ability to spread, could create new drugs. Explaining, Pawelek said, “we need to focus on how fusion between white blood cells and cancer cells actually occurs,” adding. “there are a lot of steps involved in that process and those steps are all vulnerable to targeting.”

The researchers said that future therapies could aim to either prevent fusion of cells derived from bone marrow, for example, or limit the integration of fused genes into hybrids. Research focused on such pathways could produce new techniques for targeting the metastasis process itself, the researchers said.

rosenberg uconnFARMINGTON: CaraGen an emerging immunotherapy company is collaborating with researchers at the University of Connecticut in Farmington to develop a vaccine for treatment of patients with colon cancer.

CaroGen employs what it says is a “transformative virus-like vesicle (VLV) platform technology” developed by Professor John Rose at Yale University School of Medicine  

and exclusively licensed to CaroGen.

The UCONN effort is being led by UConn Health Professor of Medicine, Daniel Rosenberg, PhD, the collaboration has a specific target studied by UConn researchers Kepeng Wang, assistant professor of immunology, and Anthony T. Vella, professor and Boehringer Ingelheim Chair in Immunology.

Internal Investigation, Lawsuits, Management Changes, A Failed Clinical Trial and New Competition, Heighten Speculation About the Future.

AlexionHQWinter2016NEW HAVEN: The Elm City’s new flagship company Alexion Pharmaceuticals [NASDAQ: ALXN] is finding itself under the microscope of lawyers, financial regulators, investment bankers and even bio-scientists as it reacts to significant financial and drug discovery events in the past 30 days.

In late November, the company announced an internal investigation into sales practices of its main revenue producing drug, Soliris. To date Soliris, with 2015 revenues of 2.5 billion has been the company’s sole financial driver.

A Novel Business Approach and New Technology Bring Funds To Two Companies

By Mitchell Young

NEW HAVEN: Biohaven, a privately held Hew Haven-based “pharmaceutical holding company,” has secured $80 million in new funding. Biohaven has created a diverse portfolio of potential drugs and drug platforms through investments and licensing. 

The company has licensing and drug development agreements with Yale University, Massachusetts General Hospital and Rutgers University, among others.

The company says its role is to apply its “expertise in late stage clinical development” to bring drug development forward.

Vlad Coric

Vlad Coric, M.D., CEO of Biohaven is marshalling funds and new drug candidates to company.

 
DavidSpiegel 253x379

Yale researcher and Kleo CEO found a local partner to help push his “novel” technology forward.

The FDA gave the company the Orphan Drug status this summer and the authority to begin a clinical trial for a drug to treat Spinocerebellar Ataxia [SCA], a rare, debilitating neurodegenerative disorder that is estimated to affect approximately 150,000 people in the United States. 

Vlad Coric, M.D., CEO of Biohaven, explained why the FDA moved forward with the designation and trial plan, “our clinical development program in Spinocerebellar Ataxia is particularly important because there are no currently approved drugs for this neurological disorder.”

The Orphan Drug designation is granted for drugs that can treat, prevent or diagnose diseases for fewer than 200,000 people in the U.S. Drugs granted that status, if eventually approved, receive an extended marketing exclusivity.

The financing was led by the venture capital firms Venrock, RA Capital Management, Vivo Capital, Aisling Capital, Rock Springs Capital, John W. Childs, Knoll Capital Management, Osage University Partners, Aperture Venture Partners, Connecticut Innovations, Greg Bailey and Litmore Capital, and two undisclosed “blue chip” pharmaceutical companies. Biohaven’s announcement said the offering was “oversubscribed.”

An investment by Biohaven in September in another New Haven biotech is likely one reason that investors were attracted. Biohaven provided an undisclosed amount of Series A financing to Kleo Pharmaceuticals.

Kleo’s CEO and Co-founder, David Spiegel, is Professor of Chemistry and Pharmacology at Yale University where he heads the Spiegel Research Group and has received wide acclaim and awards for his lab’s research.  While Spiegel co-founded Kleo, he was only appointed CEO in September in connection with the financing.

Biohaven’s investment in Kleo will help the company develop its “novel” Antibody Recruiting Molecules (ARMs) and Synthetic Antibody Recruiting Molecules (SyAMs). Both drug platforms are considered by the company to be able to create entirely new drug types.

The company plans to develop ARMs and SyAMs to treat cancer and infectious diseases.  

Spiegel explained the role he hopes his technology will take, saying, “Biologics have been the gold standard for immunotherapies. With ARMs and SyAMs, we have the opportunity to raise that bar. Our molecules are hundreds of times lighter than their biological counterparts and thus may infiltrate tissue more efficiently than large proteins.”

Of the investment by Biohaven he said, “Combining our expertise in ARMs and SyAMs with Biohaven’s investment and development expertise represents an ideal collaboration.”



schelsinger koltan

Koltan Co-founder
Dr. Joseph Schlessinger recently revealed a “breakthrough in underatanding the genetics of uterine and ovarian cancers.”

HAMPTON, N.J.,  NEW HAVEN,- Celldex Therapeutics, Inc. (NASDAQ:CLDX) has entered into a definitive agreement to acquire Kolltan Pharmaceuticals, Inc., a privately owned clinical-stage company focused on the discovery and development focused primarily on drugs to treat Cancer.

Kolltan has previously reported clinical and preclinical data that its drug candidates “can help overcome tumor resistance mechanisms associated with current tyrosine kinase inhibitors and seen in patients who have failed other cancer therapies.”

Kolltan co-founder  Dr. Joseph Schlessinger, is the William H. Prusoff Professor of Pharmacology; Chair, Pharmacology; Co-Director, Cancer Biology Institute at Yale University School of Medicine.. Early this fall Schlesinger’s lab revealed a major breakthrough for ovarian and uterine cancers, defining the genetic landscape of rare, highly aggressive tumors called carcinosarcomas (CSs), pointing the way to possible new treatments.



Stamford based Cara Therapeutics, Inc. (Nasdaq:CARA), began enrolling patients for a Phase 2b trial.  The trial is an oral tablet formulation of its “peripherally selective kappa opioid agonist, CR845,” for the treatment of pain associated with osteoarthritis (OA). The Company expects to report top-line data from this trial during the first half of 2017.

“The initiation of this osteoarthritis trial is an important step in establishing the potential clinical utility of CR845 in the treatment of chronic inflammatory pain,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “The biggest challenge in analgesic development today centers on providing effective medications that lack the abuse burden of traditional pain drugs, and it appears from our previous preclinical and human abuse liability data that CR845 could represent a novel, non-addicting approach to the treatment of chronic pain.”