On November 4, 2019 ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD) reported the appointment of Ponni Subbiah, M.D., M.P.H., as Senior Vice President, Global Head of Medical Affairs and Chief Medical Officer (Press release, ACADIA Pharmaceuticals, NOV 4, 2019, View Source [SID1234550268]). Dr. Subbiah will report to Serge Stankovic, M.D., M.S.P.H., ACADIA’s President and be responsible for corporate medical affairs including medical strategy, scientific communications, and medical science liaison activities.

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"I am very excited to welcome Ponni to our executive team. Her extensive experience as a clinician and pharmaceutical physician as well as her strong leadership track record in global medical and scientific affairs, are extremely valuable at this transformational time for our organization," said Dr. Serge Stankovic.

"ACADIA has transformed treatment of patients with Parkinson’s disease psychosis and has the potential to also play a crucial role in how we continue to improve the lives of patients with other CNS disorders," said Dr. Subbiah. "I am excited to join ACADIA on this journey and use my relevant medical affairs and clinical development experience to advance the company’s strong portfolio of approved and investigational programs for some of today’s biggest challenges in neuro health."

Dr. Subbiah is a neurologist with over 20 years of experience in the pharmaceutical industry and global health sector. She has led the development and execution of medical and clinical research strategies in various therapeutic areas, including neurology, psychiatry, opioid addiction, pain, oncology, diabetes, urology, inflammation, respiratory, and infectious diseases.

Dr. Subbiah was most recently Chief Medical Officer for Indivior Inc., with responsibility for pharmacovigilance and medical affairs globally. She was also the company spokesperson at policy discussions including testifying at the Presidential Commission on Combating Drug Addiction and Opioid Crisis and the hearing by the House Committee on Energy & Commerce on the opioid crisis. During her previous tenure of over 15 years at Pfizer, Inc., she held various leadership roles in global medical affairs and led Pfizer’s Global Access program to improve healthcare access for low-income populations in the developing world through approaches that were commercially viable and sustainable.

Dr. Subbiah received her medical degree from Madras Medical College in Chennai, India and completed a residency in neurology at the Mayo Graduate School of Medicine in Rochester, MN. She completed a research/clinical fellowship in AIDS Neurology at Johns Hopkins University School of Medicine and earned a Master’s degree in Public Health from the Johns Hopkins Bloomberg School of Public Health in Baltimore, MD.

On November 4, 2019 Seattle Genetics, Inc. (Nasdaq:SGEN) reported that management will present at the Credit Suisse 28th Annual Healthcare Conference on Tuesday, November 12, 2019 at 10:20 a.m. Mountain Time (Press release, Seattle Genetics, NOV 4, 2019, View Source [SID1234550267]). The presentation will be webcast live and available for replay from Seattle Genetics’ website at www.seattlegenetics.com in the Investors section.

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On November 4, 2019 Immunomic Therapeutics, Inc., a privately-held clinical stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that Immunomic scientists will present data from its oncology programs at the following scientific and medical conferences (Press release, Immunomic Therapeutics, NOV 4, 2019, View Source [SID1234550266]).

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"The data to be presented at the conferences will show the broad promise of Immunomics’ pipeline and the productivity of our UNITE proprietary technology platform," said Dr. Teri Heiland, Chief Scientific Officer. "We are committed to advancing our research into the clinic for patients in the years ahead."

Upcoming Medical & Scientific Conferences:

SITC (Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)) 34th Annual Meeting
Title: Lysosomal-associated membrane protein-1-targeting of a poly-neoepitope DNA vaccine elicits potent immune responses and inhibits tumor growth
Presentation Date: Saturday, November 9th 7:00 am – 8:30 pm Eastern Time
Location: Poster Hall (Prince George AB), Gaylord National Hotel and Convention Center, National Harbor, Maryland
International Conference on Vaccines Research & Development
Title: Rapid activation of antigen-specific CD4 T cells by HER2-UNITE therapeutic vaccine suppresses tumor growth and prolongs survival
Presentation Date: Tuesday, November 19th at 10:55 a.m. – 11:20 a.m. Eastern Time
Location: Session-I Cancer Vaccines | Immunotherapy & Immunodominance, HALL-A, Crowne Plaza Boston, Newton, Boston
2019 Society for Neuro-Oncology Annual Meeting
Title: CMV-Based Plasmid DNA Vaccine for GBM Using the UNITE Platform
Presentation Date: Friday November 22, 2019 at 4:30 p.m. Eastern Time
Location: Concurrent Session 2C: Drug Discovery/Drug Resistance and Experimental Therapeutics (2C), JW Marriott Desert Ridge, Phoenix, Arizona

On November 4, 2019 Genprex, Inc. (NASDAQ: GNPX), a clinical-stage gene therapy company, is reported lung cancer prevention measures in an effort to educate the public, prevent new cases and raise awareness of lung cancer while supporting November’s Lung Cancer Awareness Month (Press release, Genprex, NOV 4, 2019, View Source [SID1234550265]).

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Each patient’s cancer is unique, but there are some preventive efforts that can be made to lower the risk of getting lung cancer. The following are preventive actions that may lower the risk of getting lung cancer:

Do not smoke, or if you smoke, then quit smoking – Tobacco, cigarettes and other smoking products all increase the risk of lung cancer.
Reduce your exposure to secondhand smoke – People who inhale secondhand smoke are exposed to the same cancer-causing agents as smokers, but at a reduced amount.
Reduce your exposure to radon – Have your home tested and treated for high radon levels, which can cause lung cancer.
Know your family’s history with lung cancer – If you have a family history of lung cancer, then you are at an increased risk of getting lung cancer.
According to the World Health Organization, lung cancer is the leading cause of cancer deaths worldwide, causing more deaths than breast, colon, kidney, liver, prostate or skin cancers, and lung cancer is one of the most common types of cancer. Each year, there are more than 2 million new lung cancer cases and 1.7 million deaths from lung cancer worldwide.

The American Cancer Society’s 2019 report states that each year in the United States there are more than 228,000 new cases of lung cancer and more than 142,000 deaths from lung cancer. NSCLC represents 84 percent of all lung cancers and has a 23 percent five-year relative survival rate. However, according to the National Cancer Institute, 57 percent of lung cancer diagnoses are distant, or have metastasized, and the five-year relative survival rate for distant diagnoses is less than 5 percent.

LUNGevity Foundation points out that 10-15 percent of lung cancer cases are in never smokers, and it is possible to get lung cancer even if you have never smoked.

Genprex is working to put an end to this deadly disease. The company is developing potentially life-changing technologies for cancer patients, based upon a unique proprietary technology platform, including Genprex’s initial product candidate, Oncoprex immunogene therapy for non-small cell lung cancer (NSCLC).

On November 4, 2019 AVEO Oncology (NASDAQ: AVEO) reported a regulatory update following a meeting with the U.S. Food and Drug Administration (FDA) to discuss results from the August 2019 overall survival (OS) analysis of the TIVO-3 trial and the Company’s proposal to proceed with a New Drug Application (NDA) for tivozanib (Press release, AVEO, NOV 4, 2019, View Source [SID1234550264]).

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TIVO-3 is the Company’s Phase 3 randomized, controlled, multi-center, open-label study to compare tivozanib, the Company’s vascular endothelial growth factor receptor tyrosine kinase inhibitor (VEGFR-TKI), to sorafenib in 350 subjects with highly refractory metastatic renal cell carcinoma (RCC). The TIVO-3 trial was designed to address the FDA’s concerns regarding the OS trend in the TIVO-1 trial. In the TIVO-1 trial, the Company’s initial RCC pivotal trial, the FDA found that the inconsistent progression free survival (PFS) and OS results and imbalance in post study treatments made the trial results uninterpretable and inconclusive when making a risk-benefit assessment necessary for drug approval.

The Company previously announced that the TIVO-3 trial met its primary endpoint of demonstrating a significant improvement in PFS. The study also demonstrated a significant improvement in the secondary endpoint of overall response rate. The August 2019 analysis of the secondary endpoint of OS was the second prespecified interim OS analysis of the TIVO-3 trial, and showed an updated OS hazard ratio (HR) of 0.99 at two years from the last patient enrolled in the study.

In the FDA’s preliminary feedback, based on its assessment of the totality of evidence presented to date, the FDA recommended that the Company not submit an NDA at this time. The FDA stated that it remained concerned about the results of TIVO-3 in the context of the overall development of tivozanib. The FDA noted that the Company’s current interim OS results do not abrogate the FDA’s concerns over detriment and that those results may worsen with final analysis at 263 events, and that the median OS for tivozanib is worse than that of sorafenib.

In view of the changing first-line treatment landscape as well as the FDA’s continued concerns, the Company informed the FDA that it intends to narrow its proposed indication to relapsed/refractory RCC. At the meeting, the FDA acknowledged AVEO’s responses and reiterated its concerns about the survival information and the totality of data. The FDA noted that the choice to submit the data is the Company’s, and that a discussion with the Oncologic Drug Advisory Committee will likely be required. The FDA said that if AVEO wishes to proceed with a revised OS analysis in June 2020, AVEO should submit an updated statistical analysis plan (SAP) with a planned OS update based on the projected number of events at that time.

AVEO intends to submit to the FDA an update to the SAP for the final OS analysis consistent with these discussions, followed by an NDA submission in the first quarter of 2020. AVEO expects to report the final OS analysis in June 2020 based on a May 1, 2020 cutoff, at which point the Company estimates that the study will have reached approximately 263 OS events, as discussed with the FDA. The FDA and the Company agreed that if the final analysis yields an OS HR above 1.00, the Company will withdraw its NDA application.

"During the meeting with the FDA, we believe that we established an appropriate path forward toward filing an NDA for tivozanib in the near term and a final analysis plan for OS," said Michael Bailey, president and chief executive officer of AVEO. "The continued separation of the PFS curves and the positive trend in OS HR observed from the first to the second interim analysis, together with tenfold more patients remaining progression free and on tivozanib vs. sorafenib therapy, make us believe that the final OS results will not worsen."

About TIVO-3

The TIVO-3 trial was designed to enroll patients with RCC who have failed at least two prior regimens, including VEGFR-TKI therapy. Eligible patients may also have received checkpoint inhibitor therapy in earlier lines of treatment. Patients were randomized 1:1 to receive either tivozanib or sorafenib, with no crossover between arms. The primary endpoint of the study is progression free survival (PFS). Secondary endpoints include overall survival (OS), overall response rate (ORR), and safety and tolerability. TIVO-3, together with the previously completed TIVO-1 trial of tivozanib in the first line treatment of RCC, is designed to support a regulatory submission of tivozanib in the U.S. as a treatment for RCC in multiple lines of therapy. TIVO-3 patients were exclusively enrolled in North America, Western Europe, and Central Europe.

About Tivozanib

Tivozanib (FOTIVDA) is an oral vascular endothelial growth factor (VEGF) tyrosine kinase inhibitor (TKI) discovered by Kyowa Kirin and approved for the treatment of adult patients with advanced renal cell carcinoma (RCC) in the European Union plus Norway, New Zealand and Iceland. It is a potent, selective and long half-life inhibitor of all three VEGF receptors and is designed to optimize VEGF blockade while minimizing off-target toxicities, potentially resulting in improved efficacy and minimal dose modifications.1,2 Tivozanib has been shown to significantly reduce regulatory T-cell production in preclinical models3 and has demonstrated synergy in combination with nivolumab (anti PD-1) in a Phase 2 study in RCC4. Tivozanib has been investigated in several tumor types, including renal cell, hepatocellular, colorectal, ovarian and breast cancers.