BRCA-Associated Ovarian Carcinoma

Company Adds New Chief Medical Officer, Vice President of Project Management & Strategic Initiatives, and Vice President of Technical Operations REDWOOD CITY, Calif., Oct. 18, 2023 /PRNewswire/ -- Antiva Biosciences, a biopharmaceutical company developing novel, topical therapeutics for the treatment of high-risk infections and pre-cancerous lesions caused by human papilloma virus (HPV), today announced several key new appointments designed to strengthen the company's leadership as it continues to advance its lead development candidate, ABI-2280. The company has added Elaine Chien, M.D., FACOG, as chief medical officer, Susan Wilson, Ph.D., as vice president of project management and strategic initiatives, and Rajashree Joshi-Hangal, Ph.D., as vice president of technical operations. Collectively, these individuals bring Antiva significant industry experience in areas directly related to the company's ongoing work in developing innovative treatments for diseases caused by HPV infection. "With the closing of our Series E financing earlier this year, Antiva entered an important new phase as we work to advance ABI-2280 into key efficacy studies across multiple indications. With this as a backdrop, we are thrilled to bring aboard Elaine, Susan, and Rajashree to fortify our growing team, while expanding the range of leaderships' expertise to align with our ambitious clinical development strategy," said Kristine Ball, chief executive officer of Antiva. "These individuals have each established themselves as highly regarded biopharmaceutical executives with impressive resumes of accomplishments and we look forward to them continuing to make an impact by contributing to Antiva's important work in the areas global and women's health." Antiva is currently working to advance ABI-2280 into key efficacy studies. Planned studies include Phase 2a clinical trials for the treatment of high-grade cervical intraepithelial neoplasia (CIN 2,3) and for the treatment for high-risk HPV infection, specifically in subtypes that can lead to cancer. ABI-2280 has potent antiviral activity across all genotypes of HPV and works by both directly blocking HPV replication and inducing apoptosis in HPV-infected lesions, while sparing normal cells. Antiva has leveraged its development expertise to formulate a vaginal tablet of ABI-2280 that will enable self-administration at diagnosis and facilitate worldwide distribution, increasing impact potential for patients. Dr. Chien is a board-certified, licensed OB/GYN physician with more than 25 years of clinical and biopharmaceutical industry experience, including leading multidisciplinary teams in support of the advancement of early to late-stage clinical programs. In her role as Antiva's CMO, Dr. Chien will be responsible for the creating and overseeing strategy, direction, and execution of the company's clinical development plans. Prior to joining Antiva, she served as vice president, clinical development and medical safety at Mirum Pharmaceuticals, where she was responsible for overall strategic and executional oversight of all development programs for the company's clinical-stage asset, as well as global medical safety and pharmacovigilance for all of Mirum's commercial and clinical assets. Prior to Mirum, Dr. Chien was the clinical development lead for the Myfembree® global Phase 3 endometriosis program at Myovant Sciences, and the medical safety lead at Clovis Oncology for the U.S. and EU approvals of Rubraca® for BRCA-positive ovarian cancer. Dr. Wilson is a seasoned biopharmaceutical industry executive with more than 25 years of experience leading and managing complex global research and development programs. As vice president of project management and strategic initiatives, she will be charged with establishing and leading Antiva's program management function, aligning and mobilizing cross-functional teams to drive execution of the company's development programs. Most recently, Dr. Wilson served as vice president, program, portfolio and alliance management (PPAM) at Revolution Medicines. During this time, she provided PPAM leadership for the company's portfolio of oncology-focused research and development assets from startup through rapid expansion of its clinical-stage portfolio. Dr. Wilson also provided key contributions to KAI Pharmaceuticals leading up to its July 2012 acquisition by Amgen, serving as the company's vice president, project management and project leader for KAI-4169, its lead development asset. Dr. Joshi-Hangal possesses more than 25 years of product development experience in the biopharmaceutical industry combining technical, operational, and regulatory aspects of chemistry, manufacturing, and controls (CMC). In her new role as vice president of technical operations with Antiva, she will be responsible for providing strategic direction, technical leadership, and operational execution of CMC development and manufacturing activities in support of the company's clinical development programs. Previously, Dr. Joshi-Hangal led CMC, regulatory affairs at Myovant Sciences, where she developed, implemented, and advised on global CMC regulatory strategies for new and late-stage programs including Myfembree® and Orgovyx®. She has also held positions of increasing managerial responsibilities in both technical and regulatory CMC areas at Astex Pharmaceuticals. During that time, Dr. Joshi-Hangal aided in the approval of hypomethylating agents, Dacogen® followed by Inqovi® by strategizing creative dose escalation formulations and shortening early phase of clinical development. About HPV-Related Diseases and Cervical Cancer Human Papilloma Virus (HPV) is so common that nearly all sexually active men and women are infected with the virus at some point in their lives. Many of these are transient infections the body is capable of clearing, but this typically takes months to years. When the infections persist, they are known to drive the formation of malignancies, including cervical, anal, vulvar, penile, and head and neck cancers. The introduction of prophylactic vaccines for HPV was a major step forward in the fight against HPV-associated cancers by preventing infection by certain high-risk HPV subtypes. However, due to low adoption rates in the US, EU, and Japan, and limited access to the vaccines in developing countries, HPV infections and the disease states driven by such infections remain a major unmet clinical need. Globally, cervical cancer is the fourth most common cancer in women and as such represents a major public health problem. According to the World Health Organization, an estimated 604,000 women were diagnosed with cervical cancer worldwide and approximately 342,000 women died from the disease in 2020. About Antiva Biosciences Antiva Biosciences, Inc. is a clinical-stage biopharmaceutical company developing novel, topical therapeutics for the treatment of diseases caused by HPV infection. The company, based in the San Francisco Bay Area, was founded in 2012 by Dr. Karl Hostetler of The University of California San Diego. The company's lead drug candidate, ABI-2280 is being developed as a topical treatment for high-grade cervical intraepithelial neoplasia (HSIL, CIN 2,3) and for women with high-risk HPV infection. For more information, please visit: . Contact Information: Kristine Ball Antiva Biosciences, Inc. 650-822-1400 [email protected] Tim Brons Vida Strategic Partners (media) 646-319-8981 [email protected] SOURCE Antiva Biosciences, Inc.

Junshi Biosciences plans to engage with regulators “in the near future.” Junshi Biosciences has established its credentials as the next challenger for the increasingly congested Chinese PARP inhibitor market. A phase 3 trial of the candidate hit its primary endpoint, setting Junshi up to compete with products including AstraZeneca and Merck & Co.’s Lynparza for the ovarian cancer space.  AstraZeneca and Merck won the first approval for a PARP inhibitor in China in 2019, but their monopoly on the market was short-lived. The next year, Zai Lab won approval for GSK’s Zejula and Jiangsu Hengrui Pharmaceuticals got the green light to sell AiRuiYi. BeiGene joined the party in May 2021. The drugs have slightly different labels and, according to a 2022 paper, Lynparza and Zejula are the most widely used.  Despite the thicket of competitors, Junshi sees an opportunity for another PARP inhibitor. The Chinese drug developer secured access to a candidate, senaparib, in 2020 by forming a joint venture with Impact Therapeutics.  At the time of the deal, Impact was eight months into a phase 3 clinical trial designed to show senaparib extends progression-free survival when given as a maintenance therapy to BRCA-positive ovarian cancer patients after first-line chemotherapy. The top-line findings, released late Tuesday in the U.S., showed the primary endpoint met the predefined efficacy boundary.  The top-line data release lacks the figures behind the hit on the primary endpoint and details of how the drug candidate performed on other measures of safety and efficacy. Junshi thinks it has the data to file for approval, though, and plans to work with Impact to engage with regulators “in the near future.” In the absence of data from the trial, it is hard to gauge how senaparib is likely to fare in a market with established incumbent products, but the little that is known points to some potential ways for Junshi and Impact to try to differentiate the treatment.  Jianjun Zou, president of global research and development at Junshi, hailed the trial as “the first phase 3 clinical study of a domestically developed PARP inhibitor that has achieved positive results for advanced ovarian cancer maintenance treatment following first-line therapy” in a statement. Zou added that the PARP inhibitor significantly extended progression-free survival regardless of BRCA mutation status. BRCA mutation, according to local pathological diagnosis, was on the inclusion criteria for the clinical trial. AiRuiYi was the first domestically developed PARP inhibitor to hit the Chinese market, but its approval in 2020 was limited to patients with the germline BRCA mutation who had undergone second-line or above chemotherapy. Zejula was the first PARP drug approved in China in first-line and recurrent maintenance treatment settings regardless of biomarker status, but it originated outside of the country.

Sarah Silbiger/Getty Images The FDA has signed off on ImmunoGen’s Elahere (mirvetuximab soravtansine-gynx) for platinum-resistant ovarian cancer, making it the first antibody-drug conjugate approved for this indication. Elahere was approved under the Agency’s accelerated pathway and applies to adult patients with folate receptor alpha-positive ovarian, fallopian tube or primary peritoneal cancers who have received one to three previous lines of systemic therapy. MIRASOL, a confirmatory trial to convert Elahere’s accelerated to full approval, is now fully enrolled, ImmunoGen reported. Initial readouts are expected early next year. During a conference call Tuesday morning, ImmunoGen president and CEO Mark Enyedy said the company will also continue to investigate Elahere in platinum-sensitive disease. Elahere comes with a boxed warning, calling the attention of physicians and patients to possible ocular toxicities such as dry eye, uveitis and visual impairments. The most common adverse reactions associated with Elahere included laboratory abnormalities, fatigue, diarrhea and abdominal pain, and the ocular side effects listed in the label. Data from the pivotal SORAYA trial formed the basis for Elahere’s accelerated approval. With over 100 patients enrolled, SORAYA was a single-arm study assessing the objective response rate and duration of response after Elahere treatment. Overall, 31.7% of patients responded to Elahere treatment, including five complete responders, lasting for a median duration of 6.9 months. All participants in SORAYA had previously been treated with Genentech’s Avastin (bevacizumab). During the call, Enyedy said the FDA’s label allows Elahere treatment regardless of prior Avastin treatment, which effectively “doubles the eligible patient population relative to the SORAYA eligibility criteria.” Alongside Elahere’s regulatory go-ahead, the FDA has also approved the Roche's VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, a companion diagnostic test to identify patients eligible to receive Elahere. A Much-Needed Win for Ovarian Cancer In a statement, Anna Berkenblit, M.D., senior vice president and chief medical officer of ImmunoGen, said Monday’s approval was a “tremendous advance in the ovarian cancer treatment paradigm,” for which no treatment has been approved since 2014. Elahere’s approval also comes amid increasing restrictions on PARP inhibitors, a popular treatment class for ovarian cancer. Last week, at the request of the FDA, GSK limited the use of Zejula (niraparib) only to patients with deleterious or suspected deleterious germline BRCA mutations. GSK had already withdrawn Zejula as a fourth-line treatment for advanced ovarian, fallopian tube or primary peritoneal cancers. Aside from GSK, AstraZeneca has also suffered setbacks in ovarian cancer, with its PARP inhibitor Lynparza losing its indication in advanced ovarian cancer patients with BRCA mutations. In June, Clovis Oncology pulled Rubraca (rucaparib) from the U.S. market, no longer offering the drug as a treatment option for patients with BRCA-mutated ovarian cancer who had been treated with at least two previous lines of chemo. The Colorado-based company warned of potential bankruptcy earlier this month.