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, Xoma, JUN 10, 2019, View Source [SID1234539296]). 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, 2019Sesen 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 Oncologie, an innovative biopharmaceutical company using proprietary biomarkers to drive clinical development of next-generation oncology therapeutics, reported that it has closed an $80M Series B financing (Press release, Oncologie, JUN 10, 2019, View Source [SID1234536984]). Existing investors, led by Nan Fung Life Sciences and Pivotal BioVentures China, are joined by a syndicate of new investors including Panacea Venture Healthcare and Korea Investment Partners.

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The funding will be used to advance Oncologie’s three clinical stage programs, as well as its proprietary biomarker platform and in-licensing activities. Oncologie will initiate key clinical trials in the coming months, including a global proof of concept gastric cancer study with its lead compound, bavituximab, in combination with pembrolizumab (Keytruda). Bavituximab is an investigational immune-modulatory monoclonal antibody that targets phosphatidylserine (PS), a phospholipid that inhibits the ability of immune cells to recognize and fight tumors. Oncologie’s other programs include a TLR9 activator, lefitolimod, and a unique VEGF-targeting antibody, varisacumab. Oncologie’s biomarker platform is designed to better inform patient selection across the portfolio by matching patients lacking a genetic "driver" mutation with the right medicine and allowing for selection of patients for treatment based on the microenvironmental defects of their tumor. The Company will also continue to leverage its platform to identify best-in-class assets for licensing and development.

"Expectations for precision medicine are increasing worldwide. By matching the right drug to the right patient, Oncologie’s innovative biomarker platform is designed to build value by narrowing patient populations, accelerating development timelines and reducing failure," said Laura E. Benjamin, PhD, Founder, President, and CEO. "This funding allows us to accelerate the development of our pipeline and platform, and grow our portfolio through partnering or acquisition."

"Over the past year, Oncologie has assembled an outstanding team of experienced professionals and a robust pipeline around a truly innovative biomarker platform," said Peter Bisgaard, Managing Director for NanFung Life Sciences and Managing Partner of Pivotal BioVenture Partners. "I am particularly excited by Oncologie’s biomarker strategy and approach, which leverages cutting-edge science to optimize patient selection in the challenging arena of the tumor microenvironment. This team has ambitious and strategic growth plan for building a leading oncology therapeutics company around this platform and around a pipeline of next-generation immunotherapies. "

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 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 F-star, a clinical-stage biopharmaceutical company delivering tetravalent bispecific antibodies for a paradigm-shift in cancer therapy, reported the appointment of Louis Kayitalire, MD, as Chief Medical Officer (CMO), which will be effective on 17 June 2019 (Press release, f-star, JUN 10, 2019, View Source [SID1234536980]).

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F-star believes this newly created management position will be crucial to F-star’s transition to a wholly-owned portfolio strategy as it expands its clinical operation capabilities and accelerates progression of its proprietary pipeline.

Dr Kayitalire will oversee the clinical development of F-star’s lead product candidate, FS118, a LAG-3/PD-L1-targeting tetravalent bispecific antibody currently in a Phase 1 clinical trial, recruiting the expansion cohorts of the two highest dose levels. He will also lead the clinical strategy and operations for F-star’s pipeline of potential first- and best-in-class immuno-oncology bispecific antibody therapeutics, including FS120 and FS222, two proprietary product candidates currently in cGMP production and on track for investigational new drug application submissions this year.

Louis Kayitalire said: "This is an exciting time for me to join F-star as the company pivots to a wholly-owned portfolio strategy and accelerates the clinical development of its pipeline. As we saw at the recent ASCO (Free ASCO Whitepaper) meeting, bispecific antibodies are leading a paradigm shift in cancer care and the potential to improve the outcome for cancer patients has never been greater. I believe F-star is ideally positioned to become the next leader in this field."

Dr Kayitalire will bring over 20 years’ experience in oncology and immuno-oncology, having previously held positions at major pharmaceutical companies including Bristol-Myers Squibb, Celgene and Eli Lilly. Dr Kayitalire has strong commercial acumen to complement his extensive clinical expertise with a proven track record of developing and delivering clinical research programmes and ensuring alignment with overall medical and commercial strategies. Dr Kayitalire completed his medical training at Butare University, Rwanda and later held a position as Assistant Professor in Oncology at the Paris XI University of France. He is an active member of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) and the American Association for Cancer Research (AACR) (Free AACR Whitepaper).

Eliot Forster, CEO of F-star, said: "We are delighted to welcome Louis to the F-star team. His oncology expertise and extensive experience advancing clinical research programmes will be invaluable at this stage in F-star’s evolution as we accelerate development of our lead product candidate, FS118, and work to rapidly progress more assets into the clinic."