On June 10, 2019 Oncternal Therapeutics, Inc., (Nasdaq: ONCT) a clinical-stage biotechnology company developing potential first-in-class product candidates for cancers with critical unmet medical need, reported that the reverse merger with GTx, Inc., closed on June 7, 2019 (Press release, GTx, JUN 10, 2019, View Source [SID1234536962]). The combined company will operate under the name Oncternal Therapeutics, Inc., and its shares will commence trading on the Nasdaq stock exchange on June 10, 2019, under the ticker symbol "ONCT."

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"We believe that the closing of the merger signifies a transformative event that will provide Oncternal with the opportunity to achieve its next level of corporate growth as we continue to advance our promising oncology drug candidates through development," said James Breitmeyer, M.D., Ph.D., Oncternal’s President and CEO. "We recently presented updated interim data from an ongoing clinical study of our investigational monoclonal antibody, cirmtuzumab, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and we look forward to achieving a number of exciting milestones in our development programs in the future."

Pursuant to the merger, all of Oncternal’s outstanding shares of common stock and securities convertible into or exercisable for Oncternal’s common stock were converted into GTx common stock and securities convertible into or exercisable for GTx common stock. Immediately following the completion of the merger, the former stockholders of Oncternal held approximately 77.5% of the outstanding shares of common stock of the combined company. In addition to retaining an ownership interest representing approximately 22.5% of the outstanding shares of common stock of the combined company, the GTx stockholders of record as of immediately prior to the effective time of the merger received contingent value rights (CVR) entitling the holders to receive, in the aggregate, 75% of any net proceeds derived from the grant, sale or transfer of rights to GTx’s selective androgen receptor degrader (SARD) and selective androgen receptor modulator (SARM) technology during the term of the CVR and, if applicable, to receive royalties on the sale of any SARD products by the combined company during the term of the CVR.

Oncternal’s development pipeline consists of the following programs:

Oncternal’s lead program, cirmtuzumab, is an investigational, potential first-in-class anti-receptor tyrosine kinase-like orphan receptor 1 (ROR1) monoclonal antibody. Cirmtuzumab is currently in a Phase 1/ 2 clinical trial in combination with ibrutinib for the treatment of chronic lymphocytic leukemia (CLL) and mantle cell lymphoma (MCL). Last week, the company presented interim data from the study at the ASCO (Free ASCO Whitepaper) 2019 Annual Meeting. In addition, an investigator-initiated Phase 1 clinical trial of cirmtuzumab in combination with paclitaxel for women

with metastatic breast cancer is being conducted at the University of California San Diego (UC San Diego) School of Medicine. The California Institute for Regenerative Medicine (CIRM) has provided funding to support the cirmtuzumab development program.

TK216, an investigational, potential first-in-class small molecule designed to inhibit the biological activity of E26 transformation-specific (ETS) oncoproteins, is being evaluated alone and in combination with vincristine in a Phase 1 clinical trial in patients with relapsed or refractory Ewing sarcoma, a rare pediatric cancer. Oncternal is also planning a Phase 1 clinical trial in patients with relapsed acute myeloid leukemia (AML).

A ROR-1 targeted chimeric antigen receptor T-cell (CAR-T) program is in preclinical development in collaboration with UC San Diego for hematologic cancers and solid tumors.

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."

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.