On June 6, 2017 Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, reported that targeted patient enrollment in the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease has been completed (Press release, Puma Biotechnology, JUL 6, 2017, View Source [SID1234519760]).

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The Phase III NALA trial is a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial has enrolled approximately 600 patients who are randomized (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial is being conducted at sites in North America, Europe and Asia-Pacific. The co-primary endpoints of the trial are progression free survival (PFS) and overall survival (OS). The company reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) has also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial.

The primary analyses of PFS and OS are event driven. The Company anticipates that primary analysis of PFS will be available during the first half of 2018.

Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are very pleased to achieve this important milestone for the Phase III NALA trial of neratinib in HER2-positive metastatic breast cancer. We look forward to reporting initial data from the study, which we anticipate will occur during the first half of 2018. We also look forward to the continued development of neratinib in combination with Kadcyla in HER2-positive metastatic breast cancer (FB-10 trial), in patients with HER2-positive breast cancer that has metastasized to the brain (TBCRC-022 trial) and in patients with HER2 non-amplified tumors that have a HER2 mutation (SUMMIT)."

Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company, announced that targeted patient enrollment in the Phase III NALA trial of the Company’s lead drug candidate PB272 (neratinib) in patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed treatments (third-line disease) in the setting of metastatic disease has been completed. The Phase III NALA trial is a randomized trial of PB272 plus Xeloda versus Tykerb plus Xeloda in patients with third-line HER2-positive metastatic breast cancer. The trial has enrolled approximately 600 patients who are randomized (1:1) to receive either PB272 plus Xeloda or Tykerb plus Xeloda. The trial is being conducted at sites in North America, Europe and Asia-Pacific. The co-primary endpoints of the trial are progression free survival (PFS) and overall survival (OS). The company reached agreement with the U.S. Food and Drug Administration (FDA) under a Special Protocol Assessment (SPA) for the design of the Phase III clinical trial and the European Medicines Agency (EMA) has also provided follow-on scientific advice (SA) consistent with that of the FDA regarding the Company’s Phase III trial design and endpoints used in the trial. The primary analyses of PFS and OS are event driven. The Company anticipates that primary analysis of PFS will be available during the first half of 2018. Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology, said, "We are very pleased to achieve this important milestone for the Phase III NALA trial of neratinib in HER2-positive metastatic breast cancer. We look forward to reporting initial data from the study, which we anticipate will occur during the first half of 2018. We also look forward to the continued development of neratinib in combination with Kadcyla in HER2-positive metastatic breast cancer (FB-10 trial), in patients with HER2-positive breast cancer that has metastasized to the brain (TBCRC-022 trial) and in patients with HER2 non-amplified tumors that have a HER2 mutation (SUMMIT)."

On July 6, 2017 Oxford BioMedica plc (LSE:OXB) ("Oxford BioMedica" or "the Group"), a leading gene and cell therapy group, reported that it has signed an agreement with Novartis for the commercial and clinical supply of lentiviral vectors used to generate CTL019 (tisagenlecleucel) and other undisclosed Chimeric Antigen Receptor T cell (CART) products (Press release, Oxford BioMedica, JUL 6, 2017, View Source [SID1234519759]). The agreement builds on the collaboration announced between the Group and Novartis in October 2014 and anticipates the commercial launch of CTL019 later this year.

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Under the terms of the agreement which includes minimum offtake requirements, Oxford BioMedica could potentially receive in excess of $100 million from Novartis over the next three years. This amount includes a $10 million upfront payment, various performance incentives and bioprocessing and development services. The supply agreement is for three years, extendable to five years subject to the agreement of both parties.

In addition to this, and as previously announced in October 2014, Oxford BioMedica will also receive undisclosed royalties on potential future sales of Novartis’s CAR-T products. On 30 March 2017, Novartis announced that the US Food and Drug Administration (FDA) had accepted its Biologics License Application (BLA) filing and granted priority review for CTL019.

Commenting on the announcement, John Dawson, Chief Executive Officer of Oxford BioMedica, said: "Today’s news demonstrates the value of our LentiVector platform and the quality of work we have delivered to Novartis over the last few years. The new deal with Novartis will strengthen the Group’s balance sheet immediately and will support the Group’s continued growth over the next three years. Oxford BioMedica is recognised as a world leader in the field of lentiviral vectors and we are delighted to be supporting Novartis and patients with commercial supply of the lentiviral vector used to generate CTL019."

On July 5, 2017 GlycoMimetics, Inc. (NASDAQ:GLYC) reported new and updated data from the Phase 2 portion of its ongoing Phase 1/2 clinical trial that showed high remission and low mortality rates of its drug candidate GMI-1271, an E-selectin antagonist being developed as a treatment for patients with acute myeloid leukemia (AML) (Press release, GlycoMimetics, JUL 5, 2017, View Source [SID1234519767]). Clinical investigators are presenting the data today from 79 patients in the trial via posters and discussion at the 2017 annual meeting of the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) in Chicago. In this trial, patients treated with GMI-1271 together with standard chemotherapy continue to achieve higher than expected remission rates based on historical controls, as well as lower than expected induction-related mortality rates. Treatment also continues to be well tolerated in this patient population.

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"We are excited to share this promising new data for GMI-1271, which continue to support the potential for this new drug candidate to treat AML, a disease that has often eluded medical interventions thus far," said Rachel King, Chief Executive Officer of GlycoMimetics. "We are increasingly optimistic that GMI-1271 may help address unmet needs in this and other cancers."

Among the 54 relapsed/refractory AML patients participating in the trial for whom data is available:

The overall response rate (complete remission/complete remission with incomplete marrow recovery, or CR/CRi) was 41 percent, which is higher than historical controls, and the 60-day induction related mortality rate was 7 percent, which is lower than historical controls.
Oral mucositis, or inflammation with mouth ulcers that is a sign of adverse effects of chemotherapy, was seen at low rates and severity with only one Grade 3/4 event observed.
The median overall survival time for Phase 1 trial patients was 7.6 months.
Remissions were durable enough to allow 9 patients to receive stem cell transplants.
For patients in the Phase 1 portion of the trial who responded with a remission, more than half survived for at least a year after treatment.
Among the 25 newly diagnosed elderly patients (age 60 and older) participating in the trial for whom data is available:

The overall response (CR/CRi) rate was 68 percent, with 73 percent in patients with de novo AML and 64 percent in patients with secondary AML.
The 60-day mortality rate was 8 percent.
There were no cases of grade 3 or 4 mucositis.
For the 9 evaluable patients achieving CR/CRi, disease-free survival was 100% at 6 months after treatment.
"These results are very encouraging, indicating that the E-selectin antagonist may enhance our ability to improve the complete remission rate and potentially to improve the tolerability of intensive chemotherapy for patients with acute myeloid leukemia," said Daniel J. DeAngelo, MD, PhD, the trial’s Lead Investigator, who serves as Dana-Farber Cancer Institute Director of Clinical and Translational Research, Adult Leukemia, and Institute Physician, and Associate Professor of Medicine at Harvard Medical School. "We look forward to continuing our clinical testing of GMI-1271 and further examining its potential for improving outcomes for patients with AML."

The ASCO (Free ASCO Whitepaper) Annual Meeting is taking place from June 2-5, 2017 at McCormick Place in Chicago. More detail and the meeting abstracts are available at ASCO (Free ASCO Whitepaper)’s website.

Data from the Phase 1/2 trial were submitted to the U.S. Food and Drug Administration (FDA). In May 2017, the FDA granted GMI-1271 Breakthrough Therapy designation for treatment of adult patients with relapsed/refractory AML. In addition, GMI-1271 has been granted Orphan Drug designation and Fast Track status by the FDA and Orphan Drug designation by the European Commission.

On July 5, 2017 BeiGene, Ltd. (NASDAQ:BGNE), a clinical-stage biopharmaceutical company developing molecularly targeted and immuno-oncology drugs for the treatment of cancer, reported that the first patient was dosed in a pivotal clinical trial in China of BGB-A317, an investigational anti-PD-1 antibody, in patients with urothelial cancer (UC), more commonly known as bladder cancer (Press release, BeiGene, JUL 5, 2017, View Source [SID1234519762]). The trial will evaluate BGB-A317 in Chinese patients with previously treated, PD-L1-positive, locally advanced or metastatic UC. BGB-A317 is also being evaluated in a pivotal trial in China in patients with relapsed or refractory classical Hodgkin lymphoma.

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"It is estimated that the annual incidence of bladder cancer in China is between 55,000 and 80,0001,2. Chemotherapy-refractory bladder cancer patients in China have very limited treatment options and poor outcomes. This patient population is just one example of the unmet need for innovative cancer therapies, including PD-1 inhibitors. For this reason, we are committed to developing BGB-A317 broadly and look forward to initiating additional registrational trials of this agent in China," commented John V. Oyler, Founder, Chief Executive Officer, and Chairman.

"This trial will examine BGB-A317’s efficacy and safety in patients with PD-L1-expressing bladder cancer, who we believe may be more likely to benefit from a PD-1 inhibitor. We plan to expand the development program for BGB-A317 in China and other geographies, both as monotherapy and in combination," commented Amy Peterson, M.D., Chief Medical Officer, Immuno-Oncology.

The Phase II single-arm, multi-center trial is designed to investigate the efficacy and safety of BGB-A317 in patients with previously treated, PD-L1-positive, locally advanced or metastatic UC. The trial’s primary endpoint is the overall response rate (ORR) according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST V1.1), as assessed by independent review. Secondary endpoints include ORR as assessed by investigators, duration of response, disease control rate, progression-free survival, overall survival, safety, and tolerability. Professor Dingwei Ye of the Fudan University Shanghai Cancer Center is the lead principal investigator of the trial.

About BGB-A317

BGB-A317 is an investigational humanized monoclonal antibody that belongs to a class of immuno-oncology agents known as immune checkpoint inhibitors. It is designed to bind to PD-1, a cell surface receptor that plays an important role in downregulating the immune system by preventing the activation of T-cells. BGB-A317 has high affinity and specificity for PD-1, and we believe it is differentiated from the currently approved PD-1 antibodies, as the ability to bind to Fc gamma receptors has been specifically engineered out. BGB-A317 is being developed as a monotherapy and in combination with other therapies for the treatment of various cancers.