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Enteris BioPharma and Nordic BioScience’s KeyBioScience Enter Strategic Licensing Agreement to Develop Metabolic Peptides Using Enteris’ Proprietary Oral Drug Delivery and Manufacturing Platform

Enteris BioPharma, Inc., an industry leader in innovative oral dosage formulations, and KeyBioScience, a wholly-owned subsidiary of Nordic Bioscience, recently announced a strategic licensing agreement for Enteris’ oral drug delivery and recombinant manufacturing technologies to advance the development of KeyBioScience’s recently acquired family of proprietary metabolic peptides for various indications, including the treatment of Type 2 diabetes, obesity and other inflammatory conditions with high unmet medical and socioeconomic needs.

EMD Serono Establishes Immuno-Oncology Research and Early Development Platform to Advance Innovation in Cancer Therapies

EMD Serono, Inc., a subsidiary of Merck KGaA, Darmstadt, Germany, recently announced its commitment to the field of cancer immunotherapy by creating a fully dedicated immuno-oncology innovation platform integrating research, early development and biomarker strategies. In addition to the company’s existing oncology platform, this new immuno-oncology platform will focus on developing therapies that leverage the immune system’s natural ability to fight tumors, and work in combination with existing and future therapies.

“We are pleased to announce our commitment to immuno-oncology, recognizing that the complexity of cancer requires diverse approaches that will enable alternative therapeutic interventions,” said Bernhard Kirschbaum, Head of Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “In order to spur research and early development in this specialized area, we have created an innovative environment where researchers and clinicians work side-by-side to advance potential new cancer immunotherapies.”

The new immuno-oncology platform includes three innovation clusters, each of which is focused on discovery research and the advancement of molecules into the clinic through proof of confidence:

  • Therapeutic cancer vaccines: targeting tumor antigens to elicit a tumor-specific immune response
  • Cancer stem cells: targeting cancer stem cells to prevent or reduce tumor formation and inhibit metastases
  • Immunotolerance: eliminating or circumventing inhibitory mechanisms in the immune system that prevent cancer cells from being recognized and attacked by the body

To ensure a broad immuno-oncology research and early development platform, EMD Serono has assembled an in-house team of preeminent researchers and clinicians who will focus resources and technologies to build a portfolio of investigational immunotherapies, while collaborating with premier academia, research and industry organizations to complement internal capabilities.

The current immuno-oncology portfolio comprises therapeutic candidates in early clinical development and a robust pipeline of pre-clinical molecules. Leading therapeutic concepts in the clinic are:

  • A monoclonal antibody targeting PD-L1 (programmed cell death ligand) expressed by various tumors, currently in Phase I in solid tumors
  • NHS-IL12, a cancer immunotherapy targeting IL-12 to the necrotic regions of tumors, sponsored by the United States National Cancer Institute (NCI), currently in Phase I in solid tumors
  • NHS-IL2, targeting IL-2 to the necrotic regions of tumors, completed Phase I and currently preparing for Phase II in solid tumors

“Our goal is to develop leading immunotherapies that work in combination with other therapeutic modalities, understanding that attacking multiple cancer targets simultaneously increases the possibility of therapeutic success,” said Helen Sabzevari, Head of Immuno-Oncology, Global Research and Early Development at Merck Serono, a division of Merck KGaA, Darmstadt, Germany. “We are committed to delivering on the promise of immuno-oncology by combining creative thinking with strong research and clinical excellence, and, more importantly, by keeping patient needs at the heart of our efforts.”

Source: EMD Serono

Arno Therapeutics to Collaborate with Veridex on Development of Diagnostic Test

Arno Therapeutics, Inc. (OTCQB:ARNI), a clinical stage biopharmaceutical company focused on the development of oncology therapeutics, recently announced that it has signed an agreement with Veridex, LLC, a Johnson & Johnson company, to develop a diagnostic test to detect the presence of activated progesterone receptors (APRs) as a potential biomarker of anti-progestin activity in circulating tumor cells (CTCs). The diagnostic will help identify patients whom could potentially benefit from treatment with anti-progestins including onapristone, an orally-administered, investigational type 1 progestin receptor antagonist being developed by Arno.

CTCs are cancer cells that have detached from a solid tumor in the body and are found in the bloodstream. The collaboration will allow Arno to utilize Veridex’s proprietary technology, CELLSEARCH®, which uses an advanced cell separation technique called microfluidic separation integrated with innovative magnetic sorting, to isolate CTCs and further analyze the cells for the presence of APR. The CELLSEARCH® CTC System is the first and only standardized, FDA-cleared, semi-automated system that captures, isolates, and counts CTCs with a high level of sensitivity and specificity.

In pre-clinical studies, the presence of APR has shown to be predictive of onapristone activity. Onapristone is believed to work by binding to progesterone receptor proteins, thereby inhibiting dimerization, phosphorylation and DNA transcription activity. Progesterone receptors (PRs) are found in particular cells including those of the female reproductive tissue and some cancers.i The hormone progesterone binds to the receptors and may cause the cells to grow. Preclinical studies have shown that PRs can play a role as drivers of malignant cell growth in certain cancers.

“We are pleased to work with Veridex as we believe its pioneering technology for isolating circulating tumor cells will serve as an important tool for the continued development and study of onapristone,” said Glenn Mattes, chief executive officer and president, Arno Therapeutics. “By taking blood samples from patients rather than obtaining tissue samples, we hope to create a simplified and less invasive process for identifying patients that are most likely to benefit from treatment with onapristone.”

The diagnostic test will be used in future clinical studies of onapristone, which the company is planning to begin in the second half of 2013.

Source: Arno Therapeutics

Roche and Isis Pharmaceuticals Form Alliance for Huntington’s Disease

Roche (SIX: RO, ROG; OTCQX: RHHBY) and Isis Pharmaceuticals, Inc (NASDAQ: ISIS) recently announced that they have formed an alliance to develop treatments for Huntington’s disease (HD) based on Isis’ antisense oligonucleotide (ASO) technology. This alliance combines Isis’ antisense expertise with Roche’s scientific expertise in developing neurodegenerative therapeutics. In addition, Isis and Roche will be collaborating to combine Isis’ ASOs and Roche’s proprietary “brain shuttle” program with the objective of increasing the brain penetration of ASOs with systemic administration.

Huntington’s disease is an inherited genetic brain disorder that results in the progressive loss of both mental faculties and physical control. Symptoms usually appear between the ages of 30 to 50, and worsen over a 10 to 25 year period. Ultimately, the weakened individual succumbs to pneumonia, heart failure or other complications. Presently, there is no effective treatment or cure for the disease, and current treatments focus on reducing the severity of some disease symptoms.

Initially, research will focus on Isis’ lead drug candidate that blocks production of all forms of the huntingtin (HTT) protein, the protein responsible for HD and thus has the potential to treat all HD patients. Isis is also conducting research into treatments that specifically block production of the disease-causing forms of the HTT protein which has the potential to treat subsets of HD patients. In parallel, Roche will combine its proprietary brain shuttle technology with Isis ASO technology that, if successful, will also allow systemic administration of antisense drugs to treat asymptomatic patients.

Under the terms of the agreement, Roche will make an upfront payment of $30 million to Isis, with total payments related to license fee and pre- and post-licensing milestone payments reaching potentially $362 million, including up to $80 million in potential commercial milestone payments. In addition, Isis will receive tiered royalties on sales of the drugs. Roche has the option to license the drugs from Isis through the completion of the first Phase 1 trial. Prior to option exercise, Isis is responsible for the discovery and development of an antisense drug targeting HTT protein. Roche and Isis will work collaboratively on the discovery of an antisense drug utilizing Roche’s “brain shuttle” program. If Roche exercises its option, it will be responsible for global development, regulatory and commercialization activities for all drugs arising out of the collaboration.

Commenting on the deal, Luca Santarelli, Head of Neuroscience and Small Molecules Research at Roche, said: “Huntington’s is a severely debilitating neurodegenerative disease and a large unmet medical need. Patients experience gradually worsening motor function and psychological disturbances, with a significant shortening of life expectancy after the disease is diagnosed. Treatments are urgently needed, and we believe that the Isis approach in combination with Roche’s brain shuttle represent one of the most advanced programs targeting the cause of HD with the aim of slowing down or halting the progression of this disease.”

Shafique Virani, Global Head Neuroscience, Cardiovascular & Metabolism at Roche Partnering, added: “Central to the partnership is Roche’s brain shuttle program, which we see as highly complementary to Isis’ drug development work. This dual track development program ensures whichever candidate compound proves to be most promising — Isis’ lead target or Roche’s brain shuttle version — can be taken forward to pivotal clinical trials.”

“We are pleased to be working with Roche, a global leader in drug development with significant experience in developing and commercializing drugs to treat neurological diseases. We believe that Roche’s expertise in developing CNS drugs, along with their clinical development experience, will greatly enhance our development efforts for this program and allow us to move forward more rapidly. In addition, by utilizing Roche’s brain shuttle technology with our antisense drug discovery capabilities, we have the potential to significantly improve the therapeutic potential for this program,” said B. Lynne Parshall, Chief Operating Officer of Isis. “By partnering our more complex and nuanced research and development programs earlier in development, like our Huntington’s disease CNS program, we add value and resources with partners that bring unique benefits.”

“We are excited to be working with Roche,” said Frank Bennett, Senior Vice President of Research at Isis. “We believe our mature antisense drug discovery platform is a perfect fit for Roche’s neuroscience franchise, and we anticipate a fruitful collaboration to advance our pre-clinical compounds.”

CHDI Foundation, a non-profit foundation exclusively dedicated to the development of therapies that slow the progression of HD, provided financial and scientific support to Isis’ HD drug discovery program through a development collaboration with Isis. CHDI’s support has enabled Isis to make significant progress in discovering a drug to treat HD. Together Isis and CHDI demonstrated that antisense compounds can be used to inhibit the production of HTT protein in both brain and peripheral tissues, and that the inhibition of normal HTT protein was well tolerated. Over time, CHDI will be reimbursed for its support of Isis’ program out of the milestone payments received by Isis. CHDI will receive $1.5 million associated with the signing of the Roche agreement. CHDI will continue to provide advice to Isis and Roche on the development of antisense drugs to treat patients with HD.

Isis also recognizes the tremendous benefit provided to its HD program by its academic collaborators, Drs. Don Cleveland at the Ludwig Institute, University of California San Diego and David Corey at University of Texas Southwestern. These collaborators have been instrumental in Isis’ early preclinical work demonstrating that antisense drugs can inhibit the HTT protein and produce activity in animal models of disease.

Source: Isis Pharmaceuticals

Pfizer-KineMed Collaboration Extends to Target Novel Diabetes Pathways

KineMed Inc. (www.kinemed.com) today announced the renewal of a non-exclusive research collaboration with Pfizer Inc. (NYSE: PFE) for the advancement of novel approaches towards metabolic disease, in particular Type II Diabetes. The collaboration will employ KineMed’s unique dynamic proteomics technology platform to map the impact of potential drug candidates on specific metabolic pathways.

Diabetes is an emerging global healthcare epidemic with an estimated 347 million people affected, according to the WHO. Diabetes is predicted to become the seventh leading cause of death in the world by the year 2030 and total deaths from diabetes are projected to rise by more than 50% in the next 10 years.

In the United States Type II diabetes affects over one quarter of Americans over the age of 65. Diabetes is a major cause of heart disease and stroke, and is now also the leading cause of kidney failure, non-traumatic lower-limb amputations and new cases of blindness among adults.

Despite 50 years of drug research, over 60% of patients remain unresponsive to current therapies, requiring novel approaches to address fundamental metabolic processes in diabetes.

“We are very pleased to announce the renewal of this ongoing partnership in an important area of medicine that affects so many Americans. Powerful discovery and investigative abilities of novel disease pathways are key strengths of our translational platform,” said Dr. Scott Turner, Executive Vice-President, R&D at KineMed. “We look forward to continuing to work with Pfizer to accelerate and rapidly de-risk the advancement of novel compounds in pre-clinical and clinical trials.”

Source: Business Wire