Last update 11:17:03 AM EST

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FDA Grants Orphan Drug Designation to Insys' Investigational Brain Tumor Drug


Today, Insys Therapeutics, Inc. announced that the US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to its investigational glioblastoma multiforme (GBM) drug.

The agency granted this designation to Insys’ pharmaceutical cannabidiol (CBD) for the treatment of GBM, the most common and most aggressive malignant primary brain tumor in humans. The designation provides Insys with some financial incentives to support development and seven years of US marketing exclusivity if the drug is approved. The drug has also received ODD for its potential to treat Lennox-Gastaut Syndrome and Dravet Syndrome, rare forms of epilepsy.

“We are pleased to have received orphan drug designation for this aggressive and often incurable form of brain cancer. We look forward to advancing development of this product and offering a potential efficacious treatment for patients,” said Michael L. Babich, President and Chief Executive Officer.

The company also announced that it has recently entered into an exclusive licensing agreement with California Pacific Medical Center on behalf of its Research Institute (CPMCRI) based in San Francisco to license CPMCRI’s patent rights related to the usage of cannabinoids for the treatment of GBM. Insys is collaborating with Dr. Sean McAllister at CPMCRI with respect to his pre-clinical research focusing on the ability of CBD to sensitize GBM to current standard of care chemotherapy treatment.

“Based on previous research conducted with CBD to treat brain tumors, we believe that there is supportive evidence for the use of CBD as an adjunct treatment in GBM and eagerly anticipate the results from our in-vivo models to further support clinical studies in humans,” said Dr. McAllister.

In addition to GBM, Lennox-Gastaut Syndrome and Dravet Syndrome, Insys is evaluating the potential use of pharmaceutical CBD in several additional indications including adult epilepsy, chemotherapy-induced peripheral neuropathy, and addiction in cocaine, amphetamines and opioids.

Source: Insys Therapeutics, Inc.

Last updated: 8/25/14; 3:40pm EST

Advaxis and Merck Collaborate to Test Prostate Cancer Combo Therapy


Today, Advaxis, Inc. announced that it has entered into a clinical trial collaboration agreement with Merck to test a combination therapy for treatment of prostate cancer patients.

The companies will evaluate the combination of Advaxis’ Lm-LLO cancer immunotherapy, ADXS-PSA, with Merck’s investigational anti PD-1 antibody, pembrolizumab in a Phase 1/2 study of patients with previously treated metastatic, castration-resistant prostate cancer.  The planned clinical trial will evaluate the safety and efficacy of ADXS-PSA as monotherapy and in combination with pembrolizumab.

The Phase 1 part of the trial is designed to establish a recommended dose regimen for ADXS-PSA alone and combined with pembrolizumab. The Phase 2 portion will assess the safety and efficacy of the combination. The study will be sponsored and funded by Advaxis, and Merck will provide pembrolizumab. The study, which is planned to begin in early 2015, will be overseen and conducted by both companies. Results of the study will be used to determine the path for further clinical development of the combination.  

“We are excited to be working with Merck. Equally as exciting is the combination potential of our Lm-LLO immunotherapy with Merck’s anti-PD-1 immune checkpoint inhibitor,” said Advaxis’ President and Chief Executive Officer Daniel J. O’Connor. “We believe the combination of Advaxis Lm-LLO cancer immunotherapies and checkpoint inhibitors holds significant promise for the treatment of prostate and other cancers.”

Both ADXS-PSA and pembrolizumab are investigational members of a new class of cancer drugs known as immunotherapies, which are designed to enhance the body’s own defenses in fighting cancer. Preclinical evidence suggests that Advaxis Lm-LLO immunotherapies in combination with a PD-1 inhibitor may lead to an enhanced anti-tumor immune response.

“Collaborations such as this are an integral part of Merck’s strategy to evaluate the potential of pembrolizumab in multiple combinations for a broad range of cancers,” said Dr. Eric Rubin, vice president Oncology, Merck Research Laboratories. “We look forward to working with Advaxis to evaluate this novel investigational combination immunotherapy for the treatment of advanced prostate cancer.”

In July, Advaxis partnered with AstraZeneca to test its other leading drug, ADXS-HPV in combination with AstraZeneca’s antibody MEDI4736 for treatment of cancers caused by human papillomavirus (HPV).

Source: Advaxis, Inc.

Last updated: 8/25/14; 11:50am EST

Study Finds Hera Therapeutics' Experimental Drug Stops Common HPV Cells

Hera Therapeutics

Hera Therapeutics Inc. has identified a therapy that appears to combat three types of human papillomavirus (HPV), according to research presented at the 29th Annual International Papillomavirus Conference.  

When tested in several cultured human cell models, HTI-1968 blocked replication of HPV-16, HPV-18 and HPV-11 cells. HPV-16 and HPV-18 are two types of HPV that cause 70 percent of all cervical cancer. Findings were presented by Louise T. Chow, PhD and Thomas Broker, PhD, who conducted the work at the University of Alabama, Birmingham. The work was funded by the National Institute of Allergy and Infectious Diseases in the National Institute of Health.

“HTI-1968 is potent and selective, inhibiting the growth of these high-risk HPV types. Dr. Chow’s findings, though early stage, offer hope to millions of women infected by one of these high-risk HPV types, including two that are responsible for 70 percent of cervical cancer cases,” said Karl Hostetler, MD, CEO, Hera Therapeutics.

Currently, surgery is the only option available to women who have persistent infection with these types of HPV and show signs of abnormal cells. Hera Therapeutics is developing a topical, non-surgical approach to treat HPV, which could alter the standard of care while preserving structural integrity of the cervix.

Merck’s Gardasil and GlaxoSmithKline’s Cervarix are two cervical cancer vaccines that have been approved by the US Food and Drug Administration (FDA). However, these vaccines have not demonstrated efficacy in people already infected with the HPV virus. According to the Centers for Disease Control, approximately 96 million people worldwide, men and women, are infected with HPV-16 or HPV-18, and almost 4,000 women in the US die from invasive cervical cancer each year.

Source: Hera Therapeutics

Last updated: 8/22/14; 3:25pm EST

MorphoSys Partners with Emergent BioSolutions on Development of Prostate Cancer Candidate

Emergent - MorphoSys

MorphoSys AG and Emergent BioSolutions Inc. recently announced that the companies are partnering to jointly develop an early-stage prostate cancer treatment.

The deal, worth up to $183 million, surrounds Emergent’s ES414, an anti-PSMA/anti-CD3 bi-specific antibody targeting prostate cancer developed using Emergent’s proprietary ADAPTIR platform. Under the agreement, the companies will jointly develop the compound, with MorphoSys bearing 64 percent and Emergent 36 percent of the total costs. MorphoSys will gain exclusive worldwide rights to the drug outside the US and Canada, where Emergent will hold rights to.

MorphoSys will pay an upfront payment of $20 million and milestone payments of up to $163 million, linked to specific events including successful development of ES414 in multiple indications and securing approval in certain territories.  

ES414 will be renamed MOR209/ES414. Preclinical in vitro and in vivo studies have shown that ES415 redirects T-cell cytotoxicity towards prostate cancer cells expressing Prostate Specific Membrane Antigen (PSMA), an antigen commonly found on such cells.

“Emergent looks forward to collaborating with MorphoSys to potentially address important unmet needs amongst patients suffering from prostate cancer. Our companies bring complementary capabilities, compatible cultures and values, and a shared commitment to the highest quality development and commercialization of ES414. We expect to begin clinical development within the next six months. Progress with ES414 will help validate our ADAPTIR platform, which we believe has broad potential to generate additional novel treatments for cancer and other important diseases. We are encouraged by our partnership with MorphoSys and the continued interest of multiple parties in our ADAPTIR platform,” said Barry Labinger, Executive Vice President and President Biosciences Division at Emergent BioSolutions.

The companies plan on starting a Phase I clinical trial to evaluate ES414 in patients with metastatic castration-resistant prostate cancer (mCRPC) within the next six months. The initial phase of the trial will be conducted in the US and Australia, with Emergent as the sponsor.

“We are pleased to be working with Emergent BioSolutions. We believe ES414 has the potential to be important therapy for prostate cancer, where there is a pressing need for better treatments. The preclinical data suggest that the molecule has a number of potential advantages over other drug candidates in this indication. Our goal is to combine our capabilities with those of Emergent to enable the fastest possible development and commercialization of ES414,” said Arndt Schottelius, Chief Development Officer of MorphoSys.

Source: Emergent BioSolutions Inc.

Last updated: 8/20/14; 2:05pm EST



Bristol-Myers Squibb Collaborates with Celgene for Cancer Combination Regimen


Today, Bristol-Myers Squibb Company (BMS) and Celgene Corporation announced that the companies are partnering to evaluate a combination of the companies’ cancer drugs against a host of tumor targets.

The companies established a clinical trial collaboration to evaluate the safety, tolerability and preliminary efficacy of a combination regimen of BMS’ investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), and Celgene’s nab technology-based chemotherapy Abraxane (paclitaxel protein-bound particles for injectable suspension) (albumin-bound), in an early-stage study.  The companies will evaluate the combination in a Phase I study for multiple tumor types, including HER-2 negative metastatic breast cancer, pancreatic cancer and non-small cell lung cancer (NSCLC).

Nivolumab is part of a new class of cancer treatments, known as immunotherapies, which are designed to harness the body’s immune system in fighting cancer. Abraxane works by interfering with the ability of cancer cells to divide. The companies’ hope that combining nivolumab’s effect on the immune system with Abraxane’s ability to stop cancer cell division will result in an enhanced anti-tumor response compared to either drug alone.

“Bristol-Myers Squibb continues to forge partnerships focused on exploring the effects of combination regimens that utilize promising therapies from our immuno-oncology portfolio,” said Michael Giordano, senior vice president, Oncology Development, BMS. “Through this collaboration, Bristol-Myers Squibb and Celgene will work together to advance the science and understanding of how the body’s immune system and chemotherapy might work together to fight cancer.”

According to the companies, the study is expected to begin in the fourth quarter of this year and will be conducted by Celgene. Patients with HER-2 negative breast cancer will be treated with Abraxane and Opdivo, patients with NSCLC will be treated with the combination of Abraxane, carboplatin and Opdivo, and patients with pancreatic adenocarcinoma will be treated with Abraxane, gemcitabine and Opdivo.

“Our collaboration with Bristol-Myers Squibb further underscores our commitment to understanding and modulating the immune system to advance the treatment paradigm in cancer,” said Markus Renschler, MD, Senior Vice President, Global Head of Hematology & Oncology Medical Affairs, Celgene. “We believe that Abraxane is appropriate as a combination partner for novel immuno-oncology therapies due to its proven anti-tumor activity and that it can be administered without steroids premedication.”

Source: Bristol-Myers Squibb Company

Last updated: 8/20/14; 11:35am EST