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Pharmacyclics Enters Into Agreement with Roche to Evaluate IMBRUVICA® and GAZYVA® in Lymphoma and Leukemia

On October 16, 2014 Pharmacyclics reported that it has entered into a master clinical drug supply agreement with Roche to evaluate the safety, tolerability and preliminary efficacy of IMBRUVICA (ibrutinib), an oral Bruton’s tyrosine kinase (BTK) inhibitor, in combination with GAZYVA (obinutuzumab), a new CD20-directed antibody that attacks targeted cells both directly and together with the body’s immune system, in patients with non-Hodgkin Lymphoma (NHL) and Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma (CLL/SLL) (Press release Pharmacyclics, OCT 16, 2014, View Source [SID:1234500840]). The agreement allows for multiple studies to be considered and conducted. Initially, a Phase 3 study will be conducted by Pharmacyclics in CLL/SLL. Plans to evaluate the combination for NHL currently are in development. IMBRUVICA is being jointly developed and commercialized by Pharmacyclics and Janssen Biotech, Inc.

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Both products are approved and marketed for the treatment of CLL. IMBRUVICA is used to treat CLL in patients who have received one prior therapy, and in CLL patients with deletion of the short arm of chromosome 17 (del 17p CLL), including treatment naive and previously treated del 17p CLL patients. GAZYVA is used with the chemotherapy drug, chlorambucil, to treat CLL in patients with previously untreated chronic lymphocytic leukemia. The use of these products in combination is investigational only.

"We are committed to evaluating the potential activity of IMBRUVICA as a single agent and in combination with other agents to determine the benefits that IMBRUVICA may provide through a variety of uses across several hematologic malignancies," said Bob Duggan, Chairman & CEO, Pharmacyclics. "We look forward to a rewarding and productive partnership with Roche to evaluate our product with GAZYVA in order to deliver new treatment options to patients with NHL and CLL."

The study of the investigational combination of IMBRUVICA and GAZYVA through several investigator-sponsored trials also is being considered. Additional details of the agreement were not disclosed.

Aduro Expands Collaboration with Johnson & Johnson Innovation and Janssen for Lung Cancer Immunotherapies

On October 16, 2014 Aduro BioTech reported that it has entered into its second agreement with Janssen Biotech part of the Janssen Pharmaceutical Companies of Johnson & Johnson, granting an exclusive, worldwide license to certain product candidates engineered for the treatment of lung cancer and certain other cancers based on its novel LADD immunotherapy platform (Press release Aduro BioTech, OCT 16, 2014, View Source [SID:1234500839]). Under the agreement, facilitated by the Johnson & Johnson Innovation center in California, Aduro will receive a $30 million up-front payment and is eligible to receive significant development, regulatory and commercialization milestone payments up to a potential total of $817 million. In addition, Aduro is eligible to receive high single-digit to double-digit tiered royalties on worldwide net sales upon successful launch and commercialization.

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Under the agreement, Janssen will have exclusive rights to develop and commercialize LADD product candidates in lung cancer and will assume responsibility for all research, development, manufacturing, regulatory and commercialization activities for the licensed products. Aduro may provide assistance in any of these areas upon request and will receive additional fees for these support activities.

"Since our initial agreement with Janssen in May of this year for new immunotherapies for prostate cancer, they have been terrific partners and we’ve established a strong collaboration focused on advancing our technologies forward in their licensed indications," said Stephen T. Isaacs, chairman, president and chief executive officer of Aduro. "We believe our LADD technology also offers tremendous promise as a potential treatment for lung cancer and we are pleased to expand our relationship with Janssen, a company with significant experience and resources focused in both lung and prostate cancer. Separately, Aduro continues to make progress with our broad array of immunotherapy platforms in a number of other oncology indications, including pancreatic cancer, mesothelioma and glioblastoma among others."

The transaction is subject to clearance by the US antitrust authorities under the Hart-Scott-Rodino Act and will become final as soon as such clearance has occurred.

In May of this year, Aduro announced its first agreement with Janssen Biotech, Inc. granting the company an exclusive, worldwide license to certain product candidates specifically engineered for the treatment of prostate cancer based on its novel LADD immunotherapy platform. Under that agreement, also facilitated by the Johnson & Johnson Innovation center in California, Aduro is eligible to receive up to $365 million in upfront and development and commercialization milestones.

10-Q – Quarterly report [Sections 13 or 15(d)]

Burzynski Research Institute has filed a 10-Q – Quarterly report [Sections 13 or 15(d)] with the U.S. Securities and Exchange Commission .

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(Press release, Arch Biopartners, OCT 15, 2014, file:///C:/Users/LYDIAS~1.PPT/AppData/Local/Temp/_pdfdocs_00008603_20141015131316_02267912-00000001-00008603-s@torontonathan_cole973130-pdf.pdf [SID:1234505979])

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Novartis announces CTL019 data published in NEJM demonstrating efficacy in certain patients with acute lymphoblastic leukemia (ALL)

On October 15, 2014 Novartis and the University of Pennsylvania’s Perelman School of Medicine (Penn) reported preliminary results from two pilot clinical trials published in The New England Journal of Medicine (NEJM) evaluating the efficacy and safety of CTL019 in patients with relapsed/refractory acute lymphoblastic leukemia (r/r ALL) (Press release Novartis, OCT 15, 2014, View Source [SID:1234500834]). The studies, conducted by Penn, demonstrated that 27 of 30 pediatric and adult patients, or 90%, experienced complete remissions with the investigational chimeric antigen receptor (CAR) therapy CTL019.

“These interim results, which supported the recent FDA Breakthrough Therapy designation, reinforce the potential CTL019 has as a life-saving therapy for patients with relapsed/refractory ALL,” said Usman Azam, Global Head, Cell & Gene Therapies Unit, Novartis Pharmaceuticals. “These studies are another promising development in CTL019’s history. With each new CTL019 milestone, we are one step closer to potentially offering these seriously ill patients an additional treatment option.”

These data build on earlier research findings and are part of two pilot clinical studies that demonstrated sustained remissions of up to two years in pediatric and adult patients with r/r ALL. Median follow-up was just over six months, with event-free survival of 67% and overall survival of 78%. Probability of six-month CTL019 persistence was 68% and CTL019-modified T cells were detectable in the blood by flow cytometry for up to 11 months. Sustained remissions were seen in 15 patients and were associated with CAR T cell persistence and B cell aplasia. Updated results have been submitted for presentation at a medical congress taking place later in 2014.

“We are excited by these results, which indicated how effective CTL019 may be in fighting ALL, a leading cause of childhood cancer deaths,” said lead investigator Stephan Grupp, MD, PhD, the Yetta Deitch Novotny Professor of Pediatrics in the Perelman School of Medicine at the University of Pennsylvania and director of Translational Research in the Center for Childhood Cancer Research at the Children’s Hospital of Philadelphia (CHOP), where 25 pediatric patients were treated in the study cohort[1]. “This represents the largest experience to date of CD19-CAR T cells and demonstrates the ability of this approach to achieve sustained complete responses in a patient population with few other treatment options. We are especially hopeful for those patients who remain in remission for 1-2 years without further therapy.”

In July 2014, the FDA designated CTL019 as a Breakthrough Therapy under the Penn IND, which is intended to expedite the development and review of drugs that treat serious or life-threatening conditions if the therapy has demonstrated substantial improvement over an available therapy on at least one clinically significant endpoint[3].

Novartis holds the worldwide rights to CARs developed through the collaboration with Penn for all cancer indications, including the lead program, CTL019.

About These Studies
Twenty-five patients enrolled in the pediatric pilot trial at CHOP and 5 patients enrolled in the adult pilot trial at Penn from April 2012 to February 2014. The patients were infused with autologous T cells transduced with a CD19-directed CAR (CTL019) lentiviral vector at doses of 0.7-20.6×106 CTL019 cells/kg. The study found that 27 of 30 pediatric and adult patients with r/r ALL (90%) experienced complete remissions, including two blinatumomab-refractory patients and 15 with prior stem cell transplant.

Of the 27 patients who achieved a complete remission, five went off-study for alternate therapy, three of whom proceeded to allogeneic SCT in remission. Fifteen patients remain in remission with a median follow-up of seven months. Sustained remissions were achieved up to two years with six-month event-free survival 67% (95% CI, 51% to 88%) and overall survival 78% (95% CI, 65% to 95%). The probability of six-month CTL019 persistence was 68% (95% CI, 50 to 92%) and relapse-free B cell aplasia was 73% (95% CI, 57 to 97%). CTL019-modified T cells were detectable in the blood by flow cytometry for up to 11 months, and CTL019 sequences remained detectable by quantitative PCR (Q-PCR) in patients with sustained remissions for up to two years.

All patients experienced cytokine release syndrome (CRS). Of the 30 patients, 74% (n=22) experienced mild to moderate CRS. Severe CRS, seen in 27% of patients (n=8), was associated with higher disease burden and effectively treated with the IL-6 receptor antibody tocilizumab. Several patients experienced neurologic toxicities, which fully resolved without further intervention or apparent long-term implications.