Last update 09:24:55 AM EST

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Johnson & Johnson Enters into CAR-T Field through a Partnership with Transposagen


Privately-held Transposagen Biopharmaceuticals and Janssen Biotech have entered into a research collaboration and licensing agreement for development of allogeneic Chimeric Antigen Receptor T-cells (CAR-T).

Johnson & Johnson’s Janssen will enter into the CAR-T development field with pharma giants including Novartis, Celgene and GlaxoSmithKline (GSK). CAR-T therapies have shown promise in early human clinical trials to date for treating blood cancers, and CAR-Ts have the potential for use without the need of matching donor with recipient.

Under the agreement, Janssen will pay up to $292 million per CAR-T therapeutic, which includes an upfront fee and potential development, regulatory and commercial milestone payments. Transposagen will also receive tiered royalties on net sales of any allogeneic CAR-T products that are commercialized by Janssen.

Transposagen will use its proprietary genome editing technologies to create the allogeneic CAR-T therapies. Under the agreement, Janssen has exclusive rights to any allogeneic CAR-T therapy that is jointly developed by the companies. Janssen has also received a non-exclusive research license to use Transposagen’s proprietary gene editing technologies for gene and cell therapy solutions for treating diseases with significant unmet medical need. Transposagen will retain the rights to develop autologous CAR-T therapies and CAR-T therapies using Natural Killer (NK) cells or NK-like cells.

The agreement will last for three years, during which both companies will collaboratively conduct preclinical research on the treatment. Janssen will be responsible for manufacturing and commercialization of allogeneic CAR-T therapies.

“The research collaboration with Janssen will pair Transposagen’s cutting-edge gene editing and gene delivery technology and expertise with Janssen industry-leading technologies in the antibody alternative areas to create what may be the ideal CAR-T therapy,” said Eric Ostertag, President and CEO of Transposagen.

Source: Transposagen Biopharmaceuticals, Inc.

Last updated: 11/26/14; 11:30am EST

Amgen Terminates Studies of its Late-Stage Gastric Cancer Candidate


Amgen Inc. has ended clinical trials of its experimental treatment rilotumumab in patients with advanced stomach cancer after data revealed an increase in the number of deaths among individuals receiving the drug.

The company said that its decision to terminate all of the clinical studies evaluating rilotumumab in advanced gastric cancer, including the Phase III RILOMET-1 and RILOMET-2 studies, is based on a planned safety review by the RILOMET-1 independent data monitoring committee that found an increase in number of deaths in the rilotumumab and chemotherapy treatment arm when compared to the chemotherapy treatment only arm.

“While we are disappointed with these results, we will work with lead investigators to further analyze the data in order to help inform future research and therapies in this area,” said Sean E. Harper, MD, executive vice president of Research and Development at Amgen. “There is a high unmet need for new treatments to address advanced gastric cancer, one of the leading causes of cancer death worldwide.”

Rilotumumab is an investigational fully-human monoclonal antibody, which is designed to inhibit the hepatocyte growth factor/scatter factor (HGH/SF): MET pathway. That inhibition has the potential to reduce cell proliferation, impair survival signals, and prevent the migration and invasion of tumor cells. Amgen has not disclosed any other potential indications for rilotumumab beyond gastric cancer, nor any subpopulation that the drug may prove beneficial for.

Amgen said that it is in communication with investigators in the studies evaluating rilotumumab to coordinate study termination and provide guidance for following-up on the subjects involved in the studies.

Source; Amgen

Last updated: 11/24/14; 2:55pm EST

Bristol-Myers Squibb and Five Prime Enter Immuno-Oncology Deal

BMS-Five Prime

Bristol-Myers Squibb (BMS) will collaborate with Five Prime Therapeutics on a Phase Ia/Ib study evaluating the combination of the companies’ cancer drugs.

The companies said that they have entered into an exclusive clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining BMS’ investigational PD-1 immune checkpoint inhibitor, Opdivo (nivolumab), with Five Prime’s CSF1R, FPA008. The Phase Ia/Ib study will evaluate the combination as a potential treatment option for patients with several different cancer types including non-small cell lung cancer (NSCLC), melanoma, head and neck cancer, pancreatic cancer, colorectal cancer and malignant glioma.

This is the companies’ second cancer alliance. Earlier this year, BMS agreed to use Five Prime’s target protein discovery platform to discover, develop and commercialize new immuno-oncology therapies for two undisclosed immune checkpoint pathways. Five Prime is eligible for up to $350.5 million from the alliance.

Under the agreement announced today, BMS will pay Five Prime $30 million and will be responsible to cover the costs of the study. Five Prime will conduct the clinical trial, which the companies expect to start next year. The agreement provides exclusivity with respect to the development, with a collaborative partner, of combination regimens of anti-PD-1/PDL1 antagonists together with anti-CSF1R antagonist. BMS will have a time-limited right of first refusal subject to certain conditions if Five Prime wishes to seek a partner for FPA008.

“This collaboration supports our strategy to expand the clinical development of Opdivo, including novel combination regimens and across numerous tumor types,” said Michael Giordano, senior vice president, Head of Development, Oncology, Bristol-Myers Squibb. “We are excited to build upon our existing relationship with Five Prime Therapeutics in immuno-oncology, and explore the full potential of Opdivo and FPA008 in multiple tumor types.”

Opdivo and FPA008 are part of a new class of oncology drugs, known as immunotherapies, designed to use the body’s own immune system to fight cancer.  Opdivo is approved for treatment of patients with unresectable melanoma in Japan, and is being developed in multiple tumor types in more than 50 clinical trials. Five Prime’s FPA008 is in development as a potential treatment for rheumatoid arthritis (RA) and solid tumors. The company has initiated dosing for a Phase I clinical trial in RA. Preclinical data suggest that combining antibodies targeting PD-1 and CSF1R may lead to enhanced anti-tumor immune response compared to either approach alone in treating cancer.

“We are pleased to establish a second collaboration with Bristol-Myers Squibb in the area of immuno-oncology,” said Lewis T. “Rusty” Williams, MD, PhD, president and chief executive officer of Five Prime. “Their vision aligns with our commitment to advancing promising immune-modulating targets, alone or in combination, to create next-generation immunotherapies for cancer patients. We look forward to initiating this study and expanding the development of FPA008 as a potential immunotherapy for these six types of cancer.”

Source: Bristol-Myers Squibb

Last updated: 11/24/14; 1:45pm EST

FDA Breakthrough Therapy Awarded to Juno's CAR-T Therapy

Juno Therapeutics

Today, Juno Therapeutics announced that the US Food and Drug Administration (FDA) has granted its JCAR015 chimeric antigen receptor product candidate Breakthrough Therapy Designation.

The announcement comes just days after announcing that it has filed for an IPO. The company secured $310 million in private financing in less than a year. The company quickly emerged as a leader in immuno-oncology, developing cell-based cancer immunotherapies based on chimeric antigen receptor and high-affinity T cell receptor technologies to genetically engineer T cells to recognize and kill cancer.

Juno’s JCAR015 received Breakthrough therapy designation for the treatment of relapsed or refractory B-cell acute lymphoblastic leukemia and was filed by Juno’s collaboration partner, Memorial Sloan Kettering Cancer Center, where Phase I clinical trials are currently underway. The designation was created to help accelerate the development and review of new drugs intended to treat serious or life-threatening conditions. The designation provides Juno with several potential benefits, including intensive guidance from the FDA and eligibility for priority review.

“The FDA’s action is important news for patients who may benefit from the accelerated development of JCAR015 and is an important moment for the field of cancer immunotherapy, which has the potential to meet the need for more effective treatments in a range of cancers,” said Hans Bishop, CEO of Juno Therapeutics.

Juno has three CAR-T therapies currently in clinical trials. The products are based on chimeric antigen receptor technology that employs the body’s immune system to attack cancer cells. In addition to JCAR015, the company is testing JCAR017 at Seattle Children’s Hospital for relapsed/refractory CD19-positive pediatric leukemia and JCAR014 is being tested for refractory chronic lymphocytic leukemia, non-Hodgkin’s lymphoma and acute lymphoblastic leukemia at the Fred Hutchinson Cancer Research Center in Seattle, WA. The company said that it will be presenting data on these programs at the 54th Annual Meeting of the American Society of Hematology meeting next week.

Source: Juno Therapeutics, Inc.

Last updated: 11/24/14; 9:45am EST

FDA Grants Fast Track Designation to Merrimack's Pancreatic Cancer Drug


The US Food and Drug Administration (FDA) has granted Fast Track designation to Merrimack Pharmaceuticals’ pancreatic cancer drug.

The company said that the agency has granted its MM-398 (nanoliposomal irinotecan injection), also known as “naI-IRI,” Fast Track status for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The drug has already received orphan drug designation from the FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer.

MM-398 is a nanoliposomal encapsulation of the chemotherapeutic irinotecan. The drug has shown to extend circulation in comparison to free irinotecan in the clinical setting. SN-38 is the activated form of irinotecan, which functions by inhibiting topoisomerase I, an essential enzyme involved in DNA transcription and replication, and promoting cell death.

The agency provided MM-398 with fast track designation based on results from the Phase III NAPOLI-1 study. In the late-stage study, treatment with MM-398 plus 5-fluorouracil (5-FU) and leucovorin extended overall survival (OS) by 37 percent and progression-free survival (PFS) by 44 percent, when compared with 5-FU and leucovorin alone for patients with metastatic pancreatic cancer patients following progression on a gemcitabine-based regimen.

Pancreatic cancer is the fourth leading cause of cancer-related deaths in the US and is projected to become the second leading cause of cancer-related deaths in the US by 2020. It is a rare and deadly disease that is difficult to diagnose and has limited treatment options available.

“It is crucial to develop new therapies for patients with pancreatic cancer, particularly for those patients who have previously received gemcitabine-based therapy where there is currently no consensus on the standard of care,” said Eliel Bayever, MD, Vice President at Merrimack and medical director for MM-398. “We will continue to work diligently on our NDA submission in an effort to bring MM-398 to patients who are facing this aggressive disease as quickly as possible.”

The company said that it expects to start the NDA submission in 2014 and aims to complete it in the first quarter or early in the second quarter of 2015.

Source: Merrimack Pharmaceuticals, Inc.

Last updated: 11/21/14; 10:30am EST