On November 28, 2017 PharmaCyte Biotech, Inc. (OTCQB: PMCB), a clinical stage biotechnology company focused on developing targeted cellular therapies for cancer and diabetes using its signature live-cell encapsulation technology, Cell-in-a-Box, reported that Eurofins Lancaster Laboratories, a leading Contract Manufacturing Organization that PharmaCyte selected to prepare its Master Cell Bank (MCB), has successfully completed its independent growth evaluation of the cells that PharmaCyte will use in its Cell-in-a-Box-based pancreatic cancer therapy (Press release, PharmaCyte Biotech, NOV 28, 2017, View Source [SID1234522277]). This is a significant step in preparing for PharmaCyte’s pancreatic cancer clinical trial.

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Commenting on the cell testing, PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said, "The satisfactory completion of this important work by Eurofins is good news. Now the door is open for Eurofins to grow the cells that will be necessary to populate our Master Cell Bank. We have authorized Eurofins to begin production of the MCB. Once that is completed, the MCB will be shipped to Austrianova for encapsulation into what will ultimately become our clinical trial product."

This vital step in the overall product development process has been achieved using the optimal cell culture medium, which has only recently become available. The growth evaluation of the cells is a necessary pre-step to produce the MCB, which is required to comply with FDA guidelines. During the process, Eurofins independently confirmed Austrianova’s selection of cell culture medium for optimal cell growth as well as the growth kinetics of the cells themselves. The cells from the MCB will go on to become the "engine" of the Cell-in-a-Box encapsulated cell product for the treatment of pancreatic cancer.

"We are pleased to be working with Eurofins, who has been both professional and interactive, during this process leading up to what will be the creation of PharmaCyte’s Master Cell Bank of the cells that make up the Cell-in-a-Box encapsulated cell product for the treatment of pancreatic cancer. This step certainly clears the way to produce the MCB," stated Prof. Walter H. Günzburg, Chairman of the Board and Chief Development Officer of Austrianova and PharmaCyte’s Chief Scientific Officer.

On November 28, 2017 Purdue Pharma (Canada) reported that AKYNZEO (netupitant/palonosetron hydrochloride) capsules are now available to Canadian cancer patients for the prevention of chemotherapy-induced nausea and vomiting (CINV) (Press release, Purdue Pharma, NOV 28, 2017, View Source [SID1234522278]).

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AKYNZEO (netupitant/palonosetron hydrochloride) capsules received Notice of Compliance (NOC) from Health Canada on September 28, 2017 and is the first approved fixed dose combination oral agent that targets two critical signalling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV[i].

The effects of chemotherapy can vary from patient to patient and CINV is often a common side effect that can occur during a patient’s chemotherapy treatment. If left uncontrolled, CINV may lead to dehydration, electrolyte imbalances, loss of appetite, fatigue and a reduced quality of life[ii].

David Pidduck, President and CEO, Purdue Pharma (Canada), commented: "Cancer, an upsetting and often overwhelming diagnosis for patients and their families, requires safe and effective therapies that not only attempt to save patient lives, but also increase their quality of life. We are proud to bring AKYNZEO to market in Canada. We believe it is an important and novel treatment in cancer supportive care that will offer physicians and their patients a new option to help mitigate the distressing effects of chemotherapy-induced nausea and vomiting."

Purdue Pharma (Canada) has been granted from Helsinn Healthcare S.A. (hereafter "Helsinn"), a Swiss Group focused on building quality cancer care, the exclusive right to register, market, promote, distribute and sell AKYNZEO in Canada. Helsinn will retain clinical development activities, as well as the manufacture and supply of AKYNZEO to Purdue Pharma (Canada).

– END –

About AKYNZEO

AKYNZEO (netupitant/palonosetron hydrochloride), in combination with dexamethasone, is indicated for once per-cycle treatment in adult patients for the prevention of acute delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy as well as for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone. It is the first approved fixed dose oral combination agent that targets two critical signaling pathways associated with CINV by combining netupitant, an NK1 receptor antagonist, and palonosetron, a 5-HT3 receptor antagonist, in a single capsule for the prevention of CINV. The most common adverse events reported with AKYNZEO in clinical trials were headache (3.6%), constipation (3.0%) and fatigue (1.2%)i.

AKYNZEO has been recommended under the antiemetic guidelines of the National Comprehensive Cancer Network (NCCN), an alliance of the world’s leading cancer centers, both in Highly Emetogenic Chemotherapy (HEC) and Moderately Emetogenic Chemotherapy (MEC). It is also recommended in the Clinical Practice Guidelines from the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) as one of the therapeutic options to facilitate the application of antiemetic standard of care for patients receiving HEC regimens by preventing nausea and vomiting in both the acute and delayed phases following chemotherapy treatment.

Purdue Pharma (Canada) will be the sole distributor for AKYNZEO in Canada under terms of the current commercialization contract with Helsinn Group. AKYNZEO is already approved in 47 countries including the US, EU, Switzerland and Australia.

Please consult the Product Monograph posted at www.purdue.ca for complete administration and safety information.

On November 28, 2017 CytomX Therapeutics, Inc. (Nasdaq:CTMX) reported that Bristol-Myers Squibb has received acceptance of the Investigational New Drug application (IND) from the U.S. Food and Drug Administration (FDA) for a CTLA-4-directed Probody therapeutic (Press release, CytomX Therapeutics, NOV 28, 2017, View Source;p=RssLanding&cat=news&id=2318842 [SID1234522282]). CTLA-4, the clinically validated target of the Bristol-Myers Squibb checkpoint inhibitor Yervoy (ipilimumab), is the first target to advance into the clinic under the companies’ strategic collaboration formed in May 2014. The IND acceptance results in a $10 million milestone payment to CytomX.

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"Immune checkpoint inhibitors are making a profound impact in the treatment of people with cancer," said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. "By localizing antibody binding and therapeutic activity to the tumor microenvironment, our goal with Probody therapeutics is to deliver the same or potentially greater potency as first-generation checkpoint inhibitors, while reducing unwanted side effects. We are excited to see the CTLA-4 Probody advancing into the clinic and look forward to additional progress in our foundational alliance with Bristol-Myers Squibb."

About the Collaboration
In March 2017, Bristol-Myers Squibb and CytomX Therapeutics expanded their 2014 worldwide collaboration to discover, develop and commercialize novel therapies using CytomX‘s proprietary Probody platform taking total upfront payments to CytomX to $275 million. The collaboration provides Bristol-Myers Squibb with the opportunity to select up to ten oncology targets and two non-oncology targets. To date, Bristol-Myers Squibb has selected five oncology targets under the collaboration, including CTLA-4. CytomX is eligible to receive additional preclinical payments and development, regulatory and sales milestone payments totaling up to $4.7 billion across all 12 collaboration targets, as well as tiered royalties from mid-single digit to low-double digits on net sales of each product commercialized by Bristol-Myers Squibb.

On November 28, 2017 Aptevo Therapeutics Inc. (Nasdaq:APVO), a biotechnology company focused on developing novel oncology and hematology therapeutics, reported recent developments related to the Company’s novel ADAPTIR bispecific antibody platform, including the planned commencement of a Phase 2 clinical evaluation of its monospecific antibody candidate, otlertuzumab, in a new indication – peripheral T-cell lymphoma (PTCL), scheduled to begin in the fourth quarter of 2017.

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In addition, Aptevo announced that the Company expects to file 2 Investigational New Drug (IND) applications in 2018 for 2 bispecific antibody candidates, APVO436, being developed for the treatment of acute myeloid leukemia (AML), and APVO210, being developed for the treatment of autoimmune and inflammatory diseases.

"We continue to make solid progress advancing our ADAPTIR portfolio with the expansion of our otlertuzumab clinical development program to include a new indication in PTCL, as well as planned IND filings for two new ADAPTIR candidates in 2018," said Scott Stromatt, Chief Medical Officer. "Recently, intriguing evidence has been reported on the overexpression of CD37 on T-cell malignancies, suggesting a potential role for otlertuzumab in an attractive, orphan drug-eligible indication with high unmet medical need. Based on these developments, Aptevo has decided to expand its existing Phase 2 clinical protocol to evaluate otlertuzumab in PTCL and discontinue enrollment in the ongoing cohorts evaluating otlertuzumab in CLL with the intention of continuing to explore partnership opportunities for Phase 3 development of otlertuzumab in CLL. With clinical proof-of-concept data demonstrating the efficacy and tolerability of otlertuzumab in previous combination studies, we believe that evidence of a clinical effect in PTCL could open up a promising new market opportunity for otlertuzumab in the treatment of T-cell malignancies where there is a significant need for safe and effective new treatments."

"Aptevo is quickly establishing an impressive portfolio of novel immunotherapeutics with a number of candidates advancing, or poised to advance, into the clinic over the next 12 to18 months," continued Dr. Stromatt. "We believe that bispecifics represent the next frontier in antibody therapeutics and are encouraged by Aptevo’s rapid progress in this field. Importantly, the enhancements we have made to our next generation ADAPTIR platform are differentiated from other bispecific platforms, allowing us to assemble bispecific molecules that possess desired antibody-like features, including: efficient manufacturing properties, extended half-life, improved potency, increased stability and the potential for reduced toxicity. We look forward to data read-outs next year from our current clinical candidates, APVO414 and otlertuzumab, and to further expanding our portfolio of clinical candidates."

About the Phase 2 Otlertuzumab Study
The Phase 2 study is an open-label, proof-of-concept evaluation of the safety and efficacy of otlertuzumab in combination with bendamustine in patients with relapsed or refractory peripheral T-cell lymphomas (PTCL). Up to 24 patients will be enrolled in the study. The primary endpoint is response rate, evaluable by the 2017 International Working Group consensus response evaluation criteria in lymphoma (RECIL 2017).

About Otlertuzumab
Otlertuzumab is a monospecific antibody targeting CD37 that was built on Aptevo’s ADAPTIR modular protein therapeutic platform. CD37 is a member of the tetraspanin superfamily of molecules and is expressed on the surface of normal and transformed B cells, and also recently discovered to be present on the surface of T-cell lymphomas.

On November 28, 2017 Astellas Pharma Inc. (TSE: 4503, President and CEO: Yoshihiko Hatanaka, "Astellas") reported new data in acute myeloid leukemia (AML) research, including preliminary results from a Phase 1 study of the investigational agent gilteritinib in combination with induction and consolidation chemotherapy in patients with newly diagnosed AML, it will present at the 2017 American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (Press release, Astellas Pharma US, NOV 28, 2017, View Source [SID1234522270]).

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The wide selection of abstracts showcases the company’s full-scale development program across the FLT3 mutation-positive (FLT3mut+) AML care continuum—from newly-diagnosed to relapsed or refractory patients.

"This research further shows FLT3 mutations are one of the most commonly occurring mutations in AML, and we are pleased to be continuing our commitment to addressing the needs of AML patients," said Steven Benner, M.D., senior vice president and global therapeutic area head, Oncology Development, Astellas. "Further, we’re pleased to showcase additional data that examines the cost of care as well as healthcare utilization in the current treatment of FLT3mut+ AML."

The following abstract will be presented during an oral presentation session:

Title: Preliminary Results from a Phase 1 Study of Gilteritinib in Combination with Induction and Consolidation Chemotherapy in Subjects With Newly Diagnosed Acute Myeloid Leukemia (AML) (Abstract 722)

Presenter: Keith W. Pratz, M.D., John Hopkins Sidney Kimmel Comprehensive Cancer Center, Baltimore

Session Date/Time: Monday, December 11, 3:00 p.m. EST
Location: Building B, Level 5, Murphy BR 1-2
In addition to the oral presentation, Astellas will present the following five abstracts during poster sessions:

Title: Treatment Patterns and Healthcare Resource Utilization in Patients with FLT3-mut and FLT3-wt Acute Myeloid Leukemia: A Multi-country Medical Chart Study (Abstract 2186)

Lead Author: James D. Griffin, M.D.

Session Date/Time: Saturday, December 9, 5:30-7:30 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Comparative Assessment of FLT3 Variant Allele Frequency by Capillary Electrophoresis and Next-Generation Sequencing in FLT3mut+ Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) who Received Gilteritinib Therapy (Abstract 1411)

Lead Author: Catherine C. Smith, M.D.

Session Date/Time: Saturday, December 9, 5:30-7:30 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Real-World Occurrence of Symptoms and Toxicities and Associated Cost Implications in Acute Myeloid Leukemia (AML) Treatment Episodes: A Retrospective Database Analysis in the U.S. (Abstract 2118)

Lead Author: Bhavik Pandya, Pharm.D.

Session Date/Time: Saturday, December 9, 5:30-7:30 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Evaluation of the Impact of Minimal Residual Disease, FLT3 Allelic Ratio, and FLT3 Mutation Status on Overall Survival in FLT3 Mutation-Positive Patients with Relapsed/Refractory (R/R) Acute Myeloid Leukemia (AML) in the CHRYSALIS Phase 1/2 Study (Abstract 2705)

Lead Author: Mark J. Levis, M.D., Ph.D.

Session Date/Time: Sunday, December 10, 6:00-8:00 p.m. EST
Location: Building A, Level 1, Hall A2
Title: Economic Burden of Treatment Episodes in Acute Myeloid Leukemia (AML) Patients in the U.S.: A Retrospective Analysis of a Commercial Payer Database (Abstract 4694)

Lead Author: Bruno C. Medeiros, M.D.

Session Date/Time: Monday, December 11, 6:00-8:00 p.m. EST
Location: Building A, Level 1, Hall A2
About Gilteritinib
Gilteritinib is an investigational compound that has demonstrated inhibitory activity against FLT3 internal tandem duplication (ITD) as well as FLT3 tyrosine kinase domain (TKD), two common types of FLT3 mutations that are seen in approximately one-third of all patients with AML. Further, gilteritinib has also demonstrated inhibition of the AXL receptor in AML cell lines, which has been reported to be associated with therapeutic resistance. Astellas is currently investigating gilteritinib in various AML patient populations through several Phase 3 trials. Visit AstellasAMLTrials.com to learn more about ongoing gilteritinib clinical trials.

Gilteritinib was discovered through a research collaboration with Kotobuki Pharmaceutical Co., Ltd., and Astellas has exclusive global rights to develop, manufacture and potentially commercialize gilteritinib. Gilteritinib has been granted Orphan Drug designation and Fast Track designation by the U.S. FDA, and SAKIGAKE designation by the Japan Ministry of Health, Labor and Welfare.

The safety and efficacy of the agent discussed herein are under investigation and have not been established. There is no guarantee that the agent will receive regulatory approval and become commercially available for the uses being investigated. Information about pharmaceutical products (including products currently in development), which is included in this press release are not intended to constitute an advertisement or medical advice.