Daré Bioscience Selected to Receive $10 Million Award from ARPA-H’s Sprint for Women’s Health
Daré Bioscience has been selected to receive a $10 million award from ARPA-H's Sprint for Women's Health program for the development of DARE-HPV, a potential first-in-category treatment for HPV-related cervical disease. The funding will be distributed over two years through the launchpad track for later-stage health solutions. DARE-HPV aims to provide an alternative to current surgical treatments, which can increase risks of preterm birth and sexual dysfunction. The treatment could potentially address both late-stage cervical lesions and earlier stage HPV-related cervical infections, potentially transforming clinical HPV management with an at-home strategy.
Daré Bioscience è stata selezionata per ricevere un finanziamento di 10 milioni di dollari dal programma Sprint for Women's Health di ARPA-H, per lo sviluppo di DARE-HPV, un potenziale trattamento innovativo per le malattie cervicali correlate all'HPV. I fondi saranno distribuiti nel corso di due anni attraverso la sezione launchpad per soluzioni sanitarie avanzate. DARE-HPV si propone di fornire un'alternativa ai trattamenti chirurgici attuali, che possono aumentare i rischi di parto pretermine e disfunzione sessuale. Il trattamento potrebbe affrontare sia le lesioni cervicali in fase avanzata che le infezioni cervicali correlate all'HPV in fase iniziale, trasformando potenzialmente la gestione clinica dell'HPV con una strategia per il trattamento a domicilio.
Daré Bioscience ha sido seleccionada para recibir un premio de 10 millones de dólares del programa Sprint for Women's Health de ARPA-H para el desarrollo de DARE-HPV, un tratamiento potencialmente innovador para enfermedades cervicales relacionadas con el HPV. La financiación se distribuirá a lo largo de dos años a través de la vía launchpad para soluciones de salud en etapas avanzadas. DARE-HPV tiene como objetivo proporcionar una alternativa a los tratamientos quirúrgicos actuales, que pueden aumentar los riesgos de parto prematuro y disfunción sexual. El tratamiento podría abordar tanto las lesiones cervicales avanzadas como las infecciones cervicales relacionadas con el HPV en etapas tempranas, transformando potencialmente la gestión clínica del HPV con una estrategia de tratamiento en el hogar.
Daré Bioscience가 ARPA-H의 여성 건강 프로그램 'Sprint for Women's Health'에서 1000만 달러의 지원금을 받기로 선정되었습니다. 이는 HPV 관련 자궁경부 질환 치료를 위한 잠재적인 최초의 카테고리 치료제인 DARE-HPV 개발을 위해 사용됩니다. 자금은 후속 단계의 건강 솔루션을 위한 launchpad 트랙을 통해 2년 동안 분배될 예정입니다. DARE-HPV는 현재의 외과적 치료에 대한 대안을 제공하는 것을 목표로 하며, 이는 조산 및 성기능 장애의 위험을 증가시킬 수 있습니다. 이 치료는 후기 단계의 자궁경부 병변과 초기 단계의 HPV 관련 자궁경부 감염 모두를 다룰 수 있으며, 잠재적으로 자가 치료 전략으로 임상 HPV 관리의 변화를 일으킬 수 있습니다.
Daré Bioscience a été sélectionnée pour recevoir une subvention de 10 millions de dollars dans le cadre du programme Sprint for Women's Health de l'ARPA-H pour le développement de DARE-HPV, un traitement potentiel novateur pour les maladies cervicales liées au HPV. Le financement sera réparti sur deux ans via la voie launchpad pour des solutions de santé avancées. DARE-HPV vise à fournir une alternative aux traitements chirurgicaux actuels, qui peuvent augmenter les risques de naissance prématurée et de dysfonction sexuelle. Ce traitement pourrait potentiellement traiter à la fois les lésions cervicales avancées et les infections cervicales liées au HPV à un stade précoce, transformant potentiellement la gestion clinique du HPV avec une stratégie de traitement à domicile.
Daré Bioscience wurde ausgewählt, um einen Preis von 10 Millionen Dollar vom Programm Sprint for Women's Health der ARPA-H für die Entwicklung von DARE-HPV zu erhalten, einer potenziell ersten Behandlung dieser Art für HPV-bedingte Gebärmutterhalskrankheiten. Die Finanzierung wird über zwei Jahre verteilt über den Launchpad-Track für fortgeschrittene Gesundheitslösungen bereitgestellt. DARE-HPV zielt darauf ab, eine Alternative zu den aktuellen chirurgischen Behandlungen zu bieten, die das Risiko von Frühgeburten und sexuellen Funktionsstörungen erhöhen können. Die Behandlung könnte sowohl späte Gebärmutterhalsläsionen als auch frühere HPV-bedingte Gebärmutterhalsinfektionen ansprechen und könnte somit das klinische Management von HPV mit einer Home-Strategie transformieren.
- Secured $10 million in government funding over two years
- Development of potential first-in-category HPV treatment
- Access to ARPA-H's Launchpad Accelerator program and entrepreneurial support
- None.
Insights
This
- Potential for at-home treatment of both early and late-stage HPV lesions
- Non-surgical approach avoiding cervical removal complications
- Addresses a market of 100,000 annual precancer treatments in the US alone
The milestone-based funding structure and inclusion in the Launchpad Accelerator program provides both capital efficiency and strategic development support, potentially accelerating the path to commercialization.
The
DARE-HPV is a potential first-in-category treatment for human papillomavirus (HPV)-related cervical disease which could change the treatment paradigm for clinical HPV management.
Essentially all cervical cancer cases worldwide are caused by HPV infection.
SAN DIEGO, Oct. 23, 2024 (GLOBE NEWSWIRE) -- Daré Bioscience, Inc. (NASDAQ: DARE), a leader in innovation for the health and wellbeing of women, today announced that it has been selected by the Advanced Research Projects Agency for Health (ARPA-H) as an awardee of the Sprint for Women’s Health to address critical unmet challenges in women’s health, champion transformative innovations, and tackle health conditions that uniquely or disproportionately affect women. Daré will receive
DARE-HPV is an innovative investigational treatment for HPV-related cervical disease. Essentially all cervical cancers worldwide are caused by HPV infection, and despite the advancements in HPV screening and vaccination, an estimated 100,000 women are still treated for cervical precancer and an estimated 4,000 women still die from cervical cancer in the U.S. every year. Today, cervical precancers are monitored until they reach a late stage, since the most common treatment is a surgery which removes part of the cervix; however, the surgery is associated with an increased risk of preterm birth and sexual dysfunction and therefore is not recommended for patients with fertility concerns.
“DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention that could treat both late-stage cervical lesions as well as earlier stage HPV-related cervical infections, which could change the paradigm around how HPV-related cervical diseases are clinically managed today,” said Sabrina Martucci Johnson, President and CEO of Daré Bioscience. “We are thrilled that ARPA-H shares our vision for this product candidate's potential to transform the management of HPV-related cervical diseases with this at-home strategy to control the virus that causes cervical cancer.”
ARPA-H sought solutions within six topics of interest in women’s health, and received an unprecedented response of submissions. ARPA-H launched the Sprint for Women’s Health in February, with First Lady Jill Biden announcing the funding as the first major deliverable from the White House Initiative on Women’s Health Research.
The ARPA-H Sprint for Women’s Health is conducted in collaboration with the Investor Catalyst Hub of ARPANET-H, the agency’s nationwide health innovation network that connects people, innovators, and institutions to accelerate better health outcomes for everyone. Daré will work with an ARPA-H Program Manager and the Investor Catalyst Hub over two years to develop DARE-HPV, receiving milestone-based payments aligned to research activities and performance objectives.
The ARPA-H launchpad program accelerates transformative health solutions’ path to impact by providing funding and market transition support. As a launchpad performer, Daré will also work with an Entrepreneur-in-Residence and participate in Launchpad Accelerator, which includes customized curriculum, virtual events, and in-person workshops to support performer market transition.
About HPV-Related Cervical Diseases and DARE-HPV
Human papillomavirus (HPV) is the most common sexually transmitted infection in the United States. Essentially all cervical cancers worldwide are caused by infection with one of 14 carcinogenic, or “high-risk” HPV types (hrHPV). While some HPV infections are transient, persistent hrHPV infection can progress to cervical cancer through the persistence and progression of cervical lesions.
DARE-HPV is an investigational, proprietary fixed-dose formulation of lopinavir and ritonavir in a soft gel vaginal insert with the potential to be a first-in-category treatment for HPV-related cervical diseases. There currently are no U.S. Food and Drug Administration (FDA)-approved, non-surgical pharmaceutical interventions to treat high-grade cervical lesions (also called high-grade squamous intraepithelial lesions (HSIL) or high-grade cervical intraepithelial neoplasia (CIN 2/3)) and no FDA-approved treatments for HPV infection. DARE-HPV has the potential to be the first FDA-approved pharmaceutical intervention for the treatment of CIN and other HPV-related cervical pathologies.
In the U.S., about
About Daré Bioscience
Daré Bioscience is a biopharmaceutical company committed to advancing innovative products for women’s health. The company’s mission is to identify, develop and bring to market a diverse portfolio of differentiated therapies that prioritize women's health and well-being, expand treatment options, and improve outcomes, primarily in the areas of contraception, vaginal health, reproductive health, menopause, sexual health and fertility.
The first FDA-approved product to emerge from Daré’s portfolio of women’s health product candidates is XACIATO™ (clindamycin phosphate) vaginal gel
Daré Bioscience leadership has been named on the Medicine Maker’s Power List and Endpoints News’ Women in Biopharma 2022. In 2023, Daré's CEO was honored as one of Fierce Pharma’s Most Influential People in Biopharma for Daré’s contributions to innovation and advocacy in the women’s health space. Daré Bioscience placed #1 in the Small Company category of the San Diego Business Journal’s 2023 Best Places to Work Awards.
Daré may announce material information about its finances, product and product candidates, clinical trials and other matters using the Investors section of its website (http://ir.darebioscience.com), SEC filings, press releases, public conference calls and webcasts. Daré will use these channels to distribute material information about the company and may also use social media to communicate important information about the company, its finances, product and product candidates, clinical trials and other matters. The information Daré posts on its investor relations website or through social media channels may be deemed to be material information. Daré encourages investors, the media, and others interested in the company to review the information Daré posts in the Investors section of its website and to follow these X (formerly Twitter) accounts: @SabrinaDareCEO and @DareBioscience. Any updates to the list of social media channels the company may use to communicate information will be posted in the Investors section of Daré’s website.
Forward-Looking Statements
Daré cautions you that all statements, other than statements of historical facts, contained in this press release, are forward-looking statements. Forward-looking statements, in some cases, can be identified by terms such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would,” “contemplate,” “project,” “target,” “objective,” or the negative version of these words and similar expressions. In this press release, forward-looking statements include, but are not limited to, statements relating to Daré’s expectation that it will receive
Contacts:
Daré Bioscience Investor Relations
innovations@darebioscience.com
Source: Daré Bioscience, Inc.
FAQ
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