On June 10, 2019 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 its Chief Executive Officer, Kenneth L. Waggoner, and his team are now in Bangkok, Thailand (Press release, PharmaCyte Biotech, JUN 10, 2019, View Source [SID1234536964]). They have been attending meetings on site at Austrianova’s GMP manufacturing facility. Production of PharmaCyte’s clinical trial material for the treatment of locally advanced, non-metastatic, inoperable pancreatic cancer (LAPC) is already underway.

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On Tuesday, June 11, Mr. Waggoner and PharmaCyte’s consultant cellular biologist, David A. Judd, will observe and assist the team from Austrianova, if needed, as they continue their work to produce the necessary clinical trial material for PharmaCyte’s planned clinical trial for LAPC.

PharmaCyte’s Chief Executive Officer, Kenneth L. Waggoner, said of the necessity to be on the ground at the GMP production facility, "We are at a very crucial point on our path to a clinical trial. The production of our clinical trial material is vital to our success in the clinic, and it is vital to advancing our clinical development timeline. We need the testing of the finished cancer product to get underway. The data from those tests should enable us to complete our Investigational New Drug application (IND). After the changes Austrianova made to the manufacturing process, about which we have already reported, we are back on track. We’ll be here in Thailand overseeing the production runs that will produce the clinical trial material PharmaCyte needs to continue its journey to the clinic."

Also, a film crew will be on hand to document the company’s manufacturing process for the production of a video that will tell PharmaCyte’s pancreatic cancer therapy story in its entirety.

As a reminder, Mr. Judd has a broad array of experience in development of cell culture media for many primary cells and cell lines and is particularly knowledgeable in the growth of HEK-293 cells. He has developed manufacturing processes, cell assays, biochemical analysis, cell culture processes and downstream recovery strategies for over 35 years, 30 of which have been with a major biotechnology company in the United States.

On June 10, 2019 Alliance HealthCare Services, Inc., a leading national provider of outsourced healthcare services, is reported two executive changes: William (Bill) Larkin as Executive Vice President & Chief Financial Officer, and Douglas (Doug) McCracken as President of Alliance HealthCare Oncology ("Alliance Oncology") (Press release, Alliance HealthCare Services, JUN 10, 2019, View Source [SID1234536981]).

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"We are pleased to welcome Bill to the Alliance family, and to promote Doug—a fifteen-year veteran of Alliance—to his new role," said President & Chief Executive Officer Rhonda Longmore-Grund. "Both assume these roles at an exciting and important time for our organization and within the wider healthcare landscape."

Larkin takes on the chief financial officer role from Longmore-Grund, who was promoted to chief executive officer in November of 2018. Larkin’s experiences span a diverse set of corporate environments ranging from entrepreneurial startups, high growth mid-caps and mature multi-billion enterprises across varied industries including automotive, battery materials R&D and fuel system design and manufacturing. Over the last ten years, Bill has served as chief financial officer of both public and privately held companies at Fuel Systems Solutions, Westport Innovations and SouthWest Dealer Services Inc. In each case, the companies were experiencing significant growth, expansion and change in operating complexities both in the U.S. and internationally. Larkin began his career as a CPA with Deloitte & Touche and is a veteran of the US Army; he has a B.S. in Accounting from the University of Southern California.

"We are very excited to have Bill join the Alliance team with his capital markets and global finance experiences," said Longmore-Grund. "His experiences will be invaluable to the leadership team and organization as we continue building on our growth strategy as the partner of choice to hospitals, health systems and providers who seek to accelerate the performance of their radiology, oncology and interventional service lines."

McCracken became president of Alliance Oncology following the retirement of Greg Spurlock in May. McCracken has had extensive experience across the Alliance portfolio, most recently serving as chief operating officer of Alliance HealthCare Radiology ("Alliance Radiology"). Prior to that role, he was a cross-division senior vice president with responsibilities in the Oncology and Interventional divisions, as well as operational start-up responsibilities with Alliance International. McCracken was also a vice president of finance for the Radiology division for the first seven years of his tenure. Prior to joining the company, McCracken served in a variety of positions in the telecommunications and chemical industries. McCracken received his B.A. in Business from Michigan State University and M.B.A. in Finance and Marketing from Indiana University.

"Doug’s success over the years in leading and serving across divisions, functions and areas of the country is a testament to his acumen, collaborative leadership style and solutions-oriented approach. His leadership within our organization is well-known and respected and we look forward to his leadership of our Oncology division’s expansion," Longmore-Grund said.

"We are entering our next phase of strategic growth at Alliance, based on providing exceptional care to our patients and essential solutions to our partners. Together with our shareholder Tahoe Investment Group and our Executive Leadership Team, we warmly welcome Bill to our company and congratulate Doug on his promotion. We look forward to their important contributions to our mission and our success," Longmore-Grund added.

On June 10, 2019 Sesen Bio (Nasdaq: SESN), a late-stage clinical company developing targeted fusion protein therapeutics for patients with cancer, reported that it has completed a successful Type B Pre-Biologics License Application (BLA) meeting regarding the approval path for Vicinium for the treatment of patients with high-risk, Bacillus Calmette-Guérin (BCG) unresponsive, non-muscle invasive bladder cancer (NMIBC) (Press release, Eleven Biotherapeutics, JUN 10, 2019, View Source [SID1234536965]). The Company has reached alignment with the U.S. Food and Drug Administration (FDA) on an Accelerated Approval Pathway for Vicinium along with Rolling Review, and the Company expects to initiate submission of the BLA in the fourth quarter of 2019. The FDA also indicated that the nonclinical data, the clinical pharmacology data, and the safety database are sufficient to support a BLA submission, and that no additional clinical trials are necessary for a BLA submission.

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Rolling Review of the BLA enables individual modules to be submitted and reviewed on an ongoing basis, rather than waiting for all sections to be completed before submission. The final module submission for the BLA will be CMC, and Sesen Bio plans to meet with the FDA in the second half of 2019 to discuss the content and timing of that module.

"We have now had two successful meetings with the FDA over the last three weeks, which build on our long-term relationship with the Agency and make our regulatory path forward for Vicinium even more clear," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Gaining alignment with the FDA on an Accelerated Approval Pathway, in addition to a rolling review of the BLA, significantly increases our confidence in our regulatory pathway and our ability to bring a product to market that has the potential to save and improve the lives of patients."

On May 21, 2019 Sesen Bio announced a positive outcome from its previous meeting with the FDA, a Type C CMC meeting, where Sesen Bio reached agreement with the FDA on the Analytical Comparability Plan, and confirmed, subject to final comparability data to be provided in the BLA submission, that no additional clinical trials were deemed necessary for comparability.

Sesen Bio plans to schedule two additional meetings with the FDA in the second half of 2019, a Type C meeting to discuss the details of a post-marketing confirmatory trial in support of the Accelerated Approval Pathway for Vicinium, and a Type B CMC meeting to discuss the submission strategy of the CMC module.

Conference Call Information
To participate in the conference call, please dial (844) 831-3025 (domestic) or (315) 625-6887 (international) and refer to conference ID 2958515. The webcast can be accessed in the Investor Relations section of the company’s website at www.sesenbio.com. The replay of the webcast will be available in the investor section of the company’s website at www.sesenbio.com for 60 days following the call.

About Vicinium
Vicinium, a locally-administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of high-risk non-muscle invasive bladder cancer (NMIBC). Vicinium is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicinium is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached until it is internalized by the cancer cell, which is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently conducting the Phase 3 VISTA trial, designed to support the registration of Vicinium for the treatment of high-risk NMIBC in patients who have previously received a minimum of two courses of Bacillus Calmette-Guérin (BCG) and whose disease is now BCG-unresponsive. Additionally, Sesen Bio believes that Vicinium’s cancer cell-killing properties promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. The activity of Vicinium in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On June 10, 2019 Immunicom, Inc., a medical technology company awarded FDA Breakthrough Device Designation for Immunopheresis, its non-pharmaceutical solution for treating stage IV metastatic cancer, reported began treating its first of 170 triple-negative breast cancer (TNBC) patients on Friday, May 31 at the Jagiellonian University Medical College – Hospital in Cracow, Poland (Press release, Immunicom, JUN 10, 2019, View Source [SID1234536983]).

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Immunicom’s Immunopheresis therapy is a revolutionary new non-drug, blood-filtering immunotherapy treatment, with the potential to effectively treat a wide variety of cancer types more effectively and with fewer side effects, including those that have failed response to other treatment approaches. Immunopheresis works by removing cancer-produced proteins that inhibit the body’s natural immune defenses from recognizing and attacking tumors, potentially enabling a patient’s own body to effectively battle the disease. To learn more about how Immunicom’s technology works, see Immunopheresis Treatment Overview.

This randomized, multi-center, TNBC clinical study compares Immunopheresis alone and its use in combination with low-dose paclitaxel and carboplatin weekly chemotherapy, versus a control arm of low-dose chemotherapy. Clinical trial results, which include endpoints of progression free survival (PFS) and objective response rate (ORR), will be used by Immunicom to pursue global regulatory approvals and European CE marking.

The trial is being conducted under the direction of Principal Investigator, Piotr Wysocki, MD, PhD, who serves as Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow and President of the Polish Society of Clinical Oncology. Professor Wysocki is a renowned leader in immunotherapy and breast & genitourinary cancer research having authored more than 100 published textbook chapters and scientific articles.

"I am extremely pleased to serve as the Principal Investigator for this groundbreaking clinical study" said Professor Wysocki. "While I continue to see exciting advancements in the field of immuno-oncology, most involve expensive new drug therapies which are financially out of reach for many health systems and patient populations. Every week, patients from all over the Europe who have failed all available treatments are coming to my department looking for last chance therapies such as combinations of metronomic chemotherapy and molecularly targeted approaches, we have been developing for many years. In this context, we hope, Immunopheresis may become the ultimate and universal therapy of choice we have been all waiting for. I am really optimistic that the results of this trial will demonstrate Immunopheresis alone or in combination with existing, low-cost, low-toxic standard of care chemotherapy can be an effective, affordable treatment option for TNBC patients."

According to Amir Jafri, Founder and CEO of Immunicom, "Successfully completing the first patient treatment in this pivotal TNBC study is an incredible company milestone. And, with this trial being the first of multiple international clinical studies planned to begin enrollment in 2019, this achievement demonstrates the strong momentum our organization and outstanding team of partners and advisors have created."

On June 10, 2019 Sosei Group Corporation ("the Company"); (TSE: 4565) and its strategic alliance partner Pfizer reported that a new clinical candidate from their multi-target drug discovery collaboration was nominated to advance into clinical development (Press release, Sosei Heptares, JUN 10, 2019, View Source [SID1234552773]). Sosei Heptares will receive a $3 million milestone payment from Pfizer for this achievement. The first clinical candidate under this collaboration was nominated by Pfizer in May 2019.

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Dr. Malcolm Weir, Executive VP and Chief R&D Officer of Sosei Heptares, said: "We are very pleased to reach this development milestone for another candidate in our partnership with Pfizer so soon after nominating the first clinical candidate last month. The teams at Sosei Heptares and Pfizer have worked well together to generate and advance a novel molecule against a difficult GPCR target, highlighting again the power and potential of this approach and the combined capabilities being deployed."

The multi-target drug discovery collaboration between Sosei Heptares and Pfizer was signed in November 2015 to research and develop potential new medicines directed at up to ten GPCR targets across multiple therapeutic areas. Many of these targets have clinical or biological validation as key points for therapeutic intervention potentially targeting a range of diseases but have proven difficult to address with conventional discovery approaches because of inherent technical challenges.

In an effort to address these challenges, Sosei Heptares and Pfizer scientists worked closely together to leverage their respective complementary expertise in enabling GPCR-focused structure-based drug design (SBDD) and development initially directed to the GPCR targets selected by Pfizer. Pfizer will be responsible for developing and commercialising any potential therapeutic agents (small molecules or biologics) for each target and will have exclusive global rights to any potential resulting agents.

Sosei Heptares has delivered multiple stabilized receptors (StaR proteins), X-ray structures and biophysical data on certain programs, triggering milestone payments from Pfizer, including the US$3 million announced today, as well as $3 million in May 2019, both resulting from the nomination of new clinical candidates. Further possible milestones payments are contemplated under the agreement, with potential for royalties also payable provided the criteria under the agreement are satisfied.

Pfizer also made a US$33 million equity investment in Sosei Heptares in 2015. In the future, Pfizer and Sosei Heptares anticipate publication of select research findings from their collaboration.