SAN DIEGO, April 15, 2019 /PRNewswire/ -- Tocagen Inc. (Nasdaq: TOCA), a clinical-stage, cancer-selective gene therapy company, today announced the appointment of Fairooz Kabbinavar, M.D., FACP, as senior vice president, clinical development. Dr. Kabbinavar will oversee the advancement of Tocagen's cancer-selective gene therapy platform and lead product candidate, Toca 511 & Toca FC. With this addition, acting chief medical officer Lori A. Kunkel, M.D., will return to the company's board of directors. In another organizational update, the company announced that Harry E. Gruber, M.D., co-founder of Tocagen, will be transitioning out of day-to-day operations by year end and will continue to serve as an adviser to the company and as a member of the board of directors.
"Dr. Kabbinavar brings to Tocagen world-class expertise in oncology drug development and further adds to our leadership team's deep biopharmaceutical R&D and commercialization experience," said Marty Duvall, chief executive officer of Tocagen. "Dr. Kabbinavar's successful track record encompasses decades as a lead investigator of clinical trials for novel therapies that have culminated in the advancement or approval of several leading cancer drugs. He joins our team at an important time as we look towards the results this year from the Phase 3 Toca 5 trial of Toca 511 & Toca FC in patients with recurrent high grade glioma, the initiation of a Phase 2/3 clinical trial with NCI's NRG Oncology in newly diagnosed glioblastoma patients, and preparations for potential commercial launch."
Dr. Kabbinavar has over 25 years of experience in clinical oncology. Most recently, as a principal medical director at Genentech, he led the development of cancer immunotherapy TECENTRIQ® (atezolizumab), in the small cell lung cancer registration study and supplemental biologics license application, as well as serving as the clinical lead for the head and neck cancer program. He previously held academic appointments at the University of California, Los Angeles (UCLA) including professor of medicine and urologic oncology, Henry Alvin and Carrie L. Meinhardt endowed chair in kidney cancer research, director of the medical oncology program in genitourinary and lung cancers, and co-director of the brain tumor program.
During his academic career, Dr. Kabbinavar was the lead investigator for the clinical trials of Avastin® (bevacizumab) in colorectal cancer that led to U.S. FDA approval. Dr. Kabbinavar is board-certified by the American Board of Internal Medicine in Medical Oncology. He has published over 100 peer-reviewed research papers in journals including The New England Journal of Medicine and the Journal of Clinical Oncology. Dr. Kabbinavar holds B.Sc., MBBS and M.D. degrees from Nagpur University. He completed his postdoctoral research fellowship at UCLA'sDivision of Hematology/Oncology, as well as a clinical hematology/oncology fellowship, internship and residency at Beth Israel Deaconess Medical Center.
"Tocagen is pioneering a novel cancer-selective gene therapy platform that could transform how brain cancer is treated," said Dr. Kabbinavar. "The results to date for Toca 511 & Toca FC in high grade glioma are very impressive and highly differentiating, and I am hopeful that the results will provide an effective novel treatment option for patients with recurrent brain cancer. I am eager to advance the current and future opportunities for this regimen, in addition to advancing new product candidates from our gene therapy platform."
"We are grateful to Lori for stepping in to the acting CMO role and now returning to the board," continued Mr. Duvall. "In addition, we appreciate Harry's visionary contributions to Tocagen since our founding, which have been instrumental in our growth and success to date. He has been a trusted advisor to me, and we all look forward to Harry's continued contributions as an advisor to the company and on our board of directors."
Tocagen is a clinical-stage, cancer-selective gene therapy company developing first-in-class, broadly applicable product candidates designed to activate a patient's immune system against their own cancer. Tocagen's lead investigational product candidate, Toca 511 & Toca FC, is under evaluation in a pivotal Phase 3 trial (Toca 5) for recurrent high grade glioma (HGG), a disease with significant unmet medical need. The U.S. Food and Drug Administration awarded Tocagen an orphan drug grant for the Toca 5 trial and has granted Toca 511 & Toca FC Breakthrough Therapy Designation for the treatment of recurrent HGG. The European Medicines Agency has granted Toca 511 PRIME (PRIority MEdicines) designation for the treatment of glioma.
In connection with the hiring of Dr. Kabbinavar, the Compensation Committee of the Board of Directors of Tocagen has approved the grant to Dr. Kabbinavar of an inducement stock option award to purchase 100,000 shares of Tocagen common stock. The stock option will be granted on April 15, 2019 in accordance with Tocagen's general practice. The stock option will have an exercise price per share equal to the closing price of Tocagen's common stock on April 15, 2019, and it will be a non-qualified stock option and will have a 10-year term. The stock option will vest over four years, with 25% of the shares subject to the option vesting on the one-year anniversary of the commencement of Dr. Kabbinavar's employment with Tocagen, and the remainder of the shares vesting in equal monthly installments over the following three years, subject to Dr. Kabbinavar's continued service with Tocagen through the applicable vesting dates. The stock option will be subject to the terms and conditions of Tocagen's 2017 Equity Incentive Plan, as amended, and the award agreement pursuant to which the stock option is granted.
Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding our business plans and objectives and expectations regarding the enrollment, timing and success of our clinical trials as well as future regulatory approval of Toca 511 & Toca FC. Risks that contribute to the uncertain nature of the forward-looking statements include: the timing and results of our ongoing and planned clinical trials; our ability to execute on our strategy, including our ability to complete the clinical development and other activities required for regulatory approval of Toca 511 & Toca FC in the U.S. and other jurisdictions; and regulatory developments in the United States and foreign countries. These and other risks and uncertainties are described more fully under the caption "Risk Factors" and elsewhere in Tocagen's filings and reports with the United States Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Tocagen undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.
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SOURCE Tocagen Inc.