Oviva Therapeutics, Inc.

[12-September-2023] NEW YORK, Sept. 12, 2023 /PRNewswire/ -- Oviva Therapeutics, a premier biotech company dedicated to addressing the vast unmet need in women's health by developing first-in-class therapeutics to preserve ovarian function and consequently extend female healthspan, today announced the appointment of Rachel Rimsky Rubin as its new Chief Operating Officer (COO), effective as of September 5, 2023. Rubin joins Oviva with nearly a decade of experience developing the business operations and strategy of early stage biotech organizations, working from her foundation in investment management. She brings with her a proven track record of designing and implementing operational structures and strategy in dynamic biotechnology and healthcare technology companies that support and accelerate execution of the business vision. Prior to joining Oviva, Rubin served as Vice President of Investments and Programs at Roivant Social Ventures. Before that, she led business operations and talent acquisition for Roivant Health, a subsidiary of Roivant Sciences that incubates new healthcare technology and biotechnology businesses. Earlier in her career, Rubin worked as Vice President of the Alternative Investments and Manager Selection business at Goldman Sachs, and she held hedge fund investment roles at financial institutions GAM and Deutsche Bank. Rachel holds a B.S. from Cornell University. "We are thrilled to welcome Rachel Rimsky Rubin to the Oviva team as our first Chief Operating Officer," said Daisy Robinton, Co-Founder and CEO of Oviva Therapeutics. "Her exceptional leadership and expertise will undoubtedly propel us forward as we navigate this critical juncture of growth and innovation. We believe her addition to our leadership team will significantly accelerate our mission to transform women's health." In her role, Rubin will build infrastructure and implement company strategy to usher Oviva through its next phase of growth. She will lead global operations and work collaboratively with Oviva's cross-functional team to formulate and implement company objectives. Rubin will play a key role in ensuring Oviva's preclinical and programmatic goals are translated into operational procedures and will work alongside Oviva's CEO to continue building the Oviva team in parallel to the business' growth. "I am thrilled to join the Oviva team at this exciting time for the business. We are building and scaling Oviva's business as we pursue development of medicines that will support women throughout each stage of their lives," said Rubin. "I am passionate about increasing women's success with IVF - and, importantly - giving women agency over their health. Our work at Oviva directly targets these areas and I could not be more excited to work on this mission." The appointment of Ms. Rubin signifies an exciting chapter in Oviva's journey, aligning seamlessly with Oviva's commitment to initiate a new era of women's health that is informed by foundational biomedical research and innovative therapeutics development to extend ovarian function and female healthspan, paired with advocacy to broaden the reach of the findings and of the therapeutics developed. To learn more please visit . About Oviva Therapeutics Oviva Therapeutics, Inc., a Cambrian Bio PipeCo, is a biotechnology company dedicated to addressing the vast unmet need in women's health by driving biomedical research and clinical development of first-in-class therapeutics aimed at preserving ovarian function and extending female healthspan. We are engaging with scientists, clinicians, policy makers and the general public to elevate the conversation around women's health and galvanize advocacy in this field. In bringing together stakeholders across disciplines, we are inviting diverse perspectives and skill sets to drive innovation and progress in this space. For more information, please visit or follow us on LinkedIn. About Cambrian Bio Cambrian Bio is a clinical-stage drug development company focused on creating therapeutics targeting key biological pathways that decline or malfunction with age. The medicines developed at Cambrian have the potential to treat and prevent some of today's most debilitating diseases. Each program at Cambrian is run by its R&D team in collaboration with a team of experts dedicated to a Pipeline Company (PipeCo). This model allows Cambrian to develop new drugs efficiently with highly qualified individuals, partner flexibly across the healthcare ecosystem, and return rewards to the scientists whose vision and drive build new medicines. To date, Cambrian Bio has more than a dozen novel therapeutics in its pipeline. For more information, please visit or follow them on Twitter @CambrianBio and LinkedIn.

In the past seven years, approximately $530 million has been invested in startups addressing menopause care. But that's actually just a drop in the bucket of VC funding. Menopause is having its moment. High-profile investments and startups with celebrity names attached have brought long-overdue attention to this once-taboo area of women's health. Actress Naomi Watts launched a beauty and wellness brand focused on menopause health, called Stripes, in partnership with biotech company Amyris. Actress Judy Greer became a founding partner at menopause-focused startup Wile with a focus on products for women in their 40s and 50s. Generally, women lack education and resources about symptoms related to perimenopause and menopause, Greer said during Fortune's recent Brainstorm Health Conference. "There's so little education out there about perimenopause. Menopause is one day of your life, 365 days after you've had your last period. So we're talking about one day versus potentially 12 years leading up to this one day. We're not educating our health practitioners. They're not learning about this. When you're a woman, and you either are done having kids or you decide you don't want to have kids, it's like, 'Good luck. Don't get osteoporosis'," Greer said during a panel discussion about menopause education. The global menopause market hit $15.4 billion in 2021 and is projected to reach $24.4 billion by 2030, according to data from Grand View Research. The World Health Organization estimates that more than 50 million women in the U.S. are over the age of 51, the average age that menopause hits. Approximately 1.3 million women become menopausal each year. Hormonal changes during menopause often cause women to experience hot flashes, incontinence, sleep loss, mood changes and brain fog, and physical changes such as weight gain or loss, a slowing metabolism, and joint pain. For women, managing menopause and perimenopause symptoms can be challenging both personally and professionally. A national survey in the U.S. revealed that 4 out of every 10 women said menopause symptoms interfered with their work performance or productivity at least on a weekly basis. What's more, 17% of women said they have actually quit a job or considered quitting due to menopause symptoms.  The annual global economic impact of menopause, between productivity loss and healthcare costs, is estimated at $150 billion, Bloomberg reported. There is clearly a huge business opportunity and also a need to fill gaps in care and overcome medical barriers for the millions of women experiencing menopause.  Studies show that medical residents and practitioners have significant knowledge gaps that inhibit their ability to address menopausal symptoms. A survey published in the Journal of the North American Menopause Society published back in 2013 indicated that only 20% of OB/GYN residency programs provide any kind of menopause training, mostly elective courses. According to findings from a survey conducted by the American Association of Retired Persons, only 1 in 5 women in the U.S. received a referral to a menopause specialist. Of the 60% of women who seek medical attention, an appalling 75% of them are left untreated.  "There's this massive white space out there. It goes far beyond the anti-aging rhetoric of like wrinkles and weight gain that really is ripe for innovation," said Gwendolyn Floyd, CEO of Wile, speaking on the same Fortune Brainstorm Health panel as Greer. "There are big challenges but it's such a huge opportunity and it's vital that we address it." Startups disrupting menopause care A recent market analysis from venture capital firm SJF Ventures outlines the startups disrupting menopause care and the opportunities for investors. The menopause market includes therapeutic solutions that lengthen ovarian health, medical devices that cool a body experiencing hot flashes, virtual clinical care that connects patients with physicians who specialize in menopause care and direct-to-consumer subscription services for hormone replacement therapy, according to report author Devon Sanford, an associate at SJF Ventures. The analysis identified 50 companies categorized into five sectors: biopharma, consumer goods, digital technology, medical devices and virtual and hybrid care.  In the biopharma market, Oviva Therapeutics has developed novel therapeutics to address ovarian health and longevity, and Gameto is focused on solving diseases of the female reproductive system. There is a growing list of companies offering health supplements, personal care and sexual wellness products for aging women such as Bonafide Health, which provides hormone- and prescription-free health products for menopause symptoms, Sanford noted in the report. In the digital health space, Midday is one startup that developed a personalized menopause app to help people manage their menopause symptoms and midlife health. There's a big focus on innovation with medical devices and wearables to help alleviate menopause symptoms. Embr Labs is a pioneer in this sector and developed the Embr Wave, a wearable that's a personalized cooling device for hot flashes. Founded in 2014, Embr Labs' technology was invented by the company's founders while at MIT and the company has raised $50 million from investors to date. A growing list of startups offer virtual and hybrid care for menopause symptoms including Elektra Health, Stella and Gennev. Evernow, a telehealth company focused on providing services for perimenopause and menopause, banked $28.5 million in series A funding with backing from notable angel investors Gwyneth Paltrow, Drew Barrymore, Cameron Diaz and Color co-founder Othman Laraki. Northwell Holdings and Aegis Ventures teamed up to launch a new virtual menopause care startup called Upliv. The startup partners with employers to provide telehealth and whole-person care to workers who are dealing with perimenopause or menopause symptoms.  Women's health startups also are expanding their offerings into menopause care. Carrot Fertility rolled out benefits for menopause and low testosterone services to its platform last year and also added hormone replacement therapy (HRT) coverage. Women's health "unicorn" Maven Clinic broadened its services to include a dedicated program for menopause and ongoing care.  Primary care provider Parsley Health also provides menopause support as part of its women's health program. Hello Heart, a startup that helps people manage their heart health at home using their smartphone, rolled out a new feature that provides menopausal women with the tools and information they need to take control of their heart health.  Market ripe for more investment, innovation In the past seven years, going back to 2015, approximately $530 million has been invested in startups addressing menopause care, according to SJF Ventures' report, citing PitchBook and Crunchbase data. That figure excludes large health tech companies like Everlywell and Maven Clinic, which offer menopause care as part of a suite of services. "While $530 million may seem substantial at first glance, it is a drop in the bucket of VC funding. As a point of comparison, fem-tech startups received $1.9 billion in 2021. This means all menopause care investments account for just 3% of fem-tech funding from one year. In the same year, digital healthcare companies received $30.7 billion," Sanford wrote in the report. In 2022, $10.2 million was deployed in this sector in 17 deals. So far in 2023, funding already has doubled with $25 million invested in menopause startups. Sanford notes that 80% of healthcare dollars are controlled by women, so the people experiencing the problem are the same people deciding how to spend on healthcare costs. "People experience menopause at a greater rate than pregnancy or motherhood, yet patients consistently cite a lack of effective medical support and solutions to menopausal side effects," she wrote. Companies solving for these challenges can reach a large audience with high spending power, Sanford wrote. One challenge for investors and startup founders is that menopause care represents unchartered territory for exit opportunities. Most startups have not surpassed early-stage funding rounds. Of the 50 companies SJF Ventures identified in the analysis, only three have been acquired and no companies in the space have gone public so far. Another hurdle is getting employers and insurers to cover the services. Most menopause care startups are direct-to-consumer companies. "We anticipate that securing payers or employers will be challenging in the near term but will likely gain traction quickly over the next decade. Payers may be less apt to cover menopause care compared to innovations in chronic care (e.g. diabetes, COPD, kidney care) as menopause symptoms are often less acute and cost payers less in hospital stays or ER admissions," Sanford wrote in the analysis. A Gennev survey of 2,500 women in 2021 found that 99% of respondents are not provided with any menopause care benefits at work. But trends in the payer and employer space may be starting to shift. Some players in the market have started pilot partnerships with payers or have secured insurance coverage. Gennev's services are covered by Aetna in all 50 states. Midi, a virtual care clinic for women over 40, works with major insurance plans in 12 states including Aetna, UnitedHealthcare and some Blues plans. A Mercer health and benefits strategy report released earlier this year found that 15% of employers intend to offer menopause care benefits in 2024, up from 4% in 2023. "At SJF, our hope is to see more menopause companies targeting insurance and employer coverage, as such coverage would ensure middle- to low-income Americans can access services that they otherwise could not afford," Sanford wrote. Sanford also noted that it will be interesting to watch menopause care companies compete against one-stop shops such as Maven or Carrot Fertility. "It remains to be seen whether employers will be more interested in specialty services with high-quality care or bundled packages that reduce point-solution fatigue," she wrote.

据不完全统计，仅在美国就有约 3000-8000 万只流浪猫，这些流浪猫生活在城市角落并可能最终在动物收容所面临安乐死。人工手术切除雌猫卵巢和子宫（绝育手术）是控制雌猫不必要繁殖广泛使用的策略，也被认 据不完全统计，仅在美国就有约 3000-8000 万只流浪猫，这些流浪猫生活在城市角落并可能最终在动物收容所面临安乐死。人工手术切除雌猫卵巢和子宫（绝育手术）是控制雌猫不必要繁殖广泛使用的策略，也被认为是人道地减少流浪猫数量的主要手段。目前，还没有能够使包括猫在内的动物能够永久绝育的避孕药物。 近日，由辛辛那提动植物园濒危野生动物保护与研究中心（CREW）、麻省总医院（MGH）和 Horae 基因治疗中心的科学家组成的联合团队开发出一种非手术绝育替代方法，单次抗缪勒管激素（AMH）基因治疗可以使雌猫实现长期避孕，基于长达两年的动物试验验证了这种基因疗法的有效性和安全性。 （来源：Nature Communications） 目前，这项研究发现已经以“Durable contraception in the female domestic cat using viral-vectored delivery of a feline anti-Müllerian hormone transgene”为题发表在 Nature Communications 上。 “传统的‘诱捕、绝育、放生’模式很难大规模实现，因为绝育手术需要对动物进行全身麻醉、设备齐全的手术设施，以及比目前更多的兽医资源。这项研究代表了一个重要的里程碑，即可以通过人道方式减少流浪猫的数量。”该论文共同通讯作者、CREW 动物研究主任 Bill Swanson 博士表示。 CREW 成立于 1991 年，是全球同类机构中首个致力于动物和植物保护研究的机构，专注于“用科学拯救物种”。CREW 凭借拯救濒危犀牛、小型猫科动物、北极熊以及特殊植物四个标志性项目的成就而闻名于世，此外，CREW 还对其他一些物种开展了大量涉及多种学科和机构合作的研究工作，以期扩大人类对物种生物学的理解和更好地保护野生动物。 作为 CREW 的动物研究主任，Bill Swanson 自 1997 年以来便开始担任该职位，他负责领导多学科研究项目以保护濒危动物物种，以及开发用于拯救濒危小型猫科动物的繁殖技术，被认为是全球开发动物繁殖技术的领先专家之一。 一次治疗可使雌猫避孕两年以上且无副作用 这项研究的起源可以追溯至十多年前，而当时的目的也并非是用于猫的避孕。 彼时，该论文共同通讯作者、麻省总医院研究员 David Pépin 博士正在研究抗缪勒氏管激素（AMH）对卵巢的影响，并试图开发一种治疗卵巢癌症的新型基因疗法。 “我们发现，如果体内 AMH 水平很高会抑制卵巢功能，随后，这成为了我近十多年来一直在研究的课题，AMH 是如何抑制卵巢的？能把它开发成为避孕药物吗？”David Pépin 回忆道。“虽然能够长期绝育的基因疗法可能对于人类没有太大的吸引力，但它似乎是控制某些动物繁衍的好方法。”他指出。 通常而言，让雌猫避孕的传统手段是在它们约五个月大时通过绝育手术切除子宫和卵巢。对于宠物猫而言，绝育手术的成本并不算太高，然而这种手术难以应对数以千万计的流浪猫。因此，动物福利组织呼吁能够开发出易于操作的非手术长期避孕药物。 于是，David Pépin 向 Michelson Found Animals 基金会申请资金用于动物避孕药物的研究开发。 该基金会是一家投资于非手术动物避孕药物研究的非营利组织，Bill Swanson 担任该组织的董事会成员。“这对我们来说似乎是一种很好的‘纽带’，因为他需要一个熟悉猫科动物繁殖的人，凭借他在基因治疗和 AMH 领域的专业知识，我们携手开展研究。”他说道。 ▲图｜对猫进行基因治疗研究的时间表和安全性（来源：Nature Communications） 在这项研究中，他们利用编码猫 AMH 的基因序列设计了一种腺相关病毒载体（AAV9），然后将其注射到三组（低剂量组、高剂量组和空白对照组）成年雌猫的大腿肌肉中，肌肉细胞表达 AMH，然后通过体内循环最终进入卵巢。 之所以选择肌肉细胞，“首先，AAV9 可以很容易地渗透到肌肉细胞中，更为重要的是，肌肉细胞所持续分泌的时间较长。肌肉细胞不会增殖、分裂或死亡，而且会随着时间的推移得到修复，因此激素会不断分泌到血液中。”他解释说。 随着时间的推移，他们对猫的血液进行测试，发现实际情况与他们设想的一样：参与这项研究的低剂量组和高剂量组的雌猫在为期两年的试验中 AMH 血清浓度水平都保持在目标阈值之上。 ▲图｜对猫进行基因治疗后 AMH 平均血清浓度（来源：Nature Communications） 值得注意的是，这与人类使用的口服避孕药物有所不同，AMH 能够直接作用于卵巢中发育中的卵泡，而不是改变雌激素或孕激素水平。“目前的口服避孕药物会破坏卵巢和垂体之间的信号反馈，以此来阻止排卵信号的传递，而在我们的研究中，激素直接作用于卵泡，但最终的结果是一样的，即卵泡不能正常成熟，所以猫不会排卵。”David Pépin 指出。 “为了验证避孕效果，我们开展了两项为期 4 个月的育种试验，以测试 AMH 基因疗法的疗效。试验结果证明，这种治疗方法是非常有效性的，所有对照（未治疗的）雌猫都生育了猫仔，但接受基因治疗的雌猫都没有受孕。”该论文第一作者、CREW 研究员 Lindsey Vansandt 博士说道。 通过对雌猫体内的激素分析，他们发现，接受基因治疗的猫都没有黄体期，这进一步证实了 AMH 确实能够抑制排卵。 最后，研究人员对接受基因治疗的雌猫进行了跟踪监测，包括定期体检、腹部超声检查和血液检查等，以评估该基因疗法的安全性，他们发现，所有接受治疗的雌猫都没有出现不良反应，这表明在测试的剂量下，这种基因疗法是安全的并且耐受性良好。 现阶段，David Pépin 和 Bill Swanson 正在联合开展成药研究，并希望能够在更多的猫科动物身上启动临床试验来测试这种基因疗法。“与此同时，围绕这项研究我们也在持续跟进中，以确保这种基因疗法的长期安全性和有效性。”Bill Swanson 指出。 对于这种基因疗法安全性和有效性，David Pépin 表示信心十足，在他看来，“与雄激素、雌激素或孕激素不同，AMH 受体的表达仅限于生殖器官，因此这种激素不太可能产生脱靶效应，即使它们体内 AMH 浓度相对较高，我们在研究过程中也没有观察到任何不良影响。虽然将这种基因疗法推进到规模应用之前还有很多工作要做，但我们相信这种疗法最终有望取代传统绝育手术。” 曾创立公司开发卵巢健康疗法 产业落地方面，David Pépin 预计，“如果这种基因疗法真正能够进入临床应用，它的成本应该不会像人类基因疗法那么昂贵。很大程度上是由于需要治疗的‘患者’数以亿计，世界上大约有 6 亿只猫，其中约有 80% 是流浪猫，这些流浪猫基本都是我们的目标‘患者’群体，相较之下，治疗人类罕见病的基因疗法的患者群体太少。显然，这大幅降低了药物开发和制造投资的门槛。”他说道。 “随着时间的推移，病毒载体制造的挑战将会逐步解决，届时基因治疗药物的规模化生产将会变得更加高效，成本会进一步降低。”他指出，“即使是从目前的数据来看，我们也认为这具有成本效益。事实上，这也是我们正在努力实现的目标，即与手术相当，甚至更便宜的疗法。” 值得注意的是，“猫并不是唯一可以获得这种基因治疗的宠物，针对狗的避孕基因疗法的研究也在开展中。”Bill Swanson 指出，“尽管现在下结论还为时过早，但我们认为 AMH 基因治疗的整体思路可能适用于许多不同的哺乳动物物种。”他补充说。 “基于猫避孕基因治疗方面的研究工作有助于验证我们的一些想法，猫的发情周期与人类更为相似，因此我们可以从猫身上收获更多关于人类应用的经验。”David Pépin 说道。 正如 David Pépin 之前所说的，基因疗法或许不会成为人类理想的避孕药物，但这并不意味着 AMH 激素不能以其他方式发挥作用，比如保护正在接受化疗的妇女和女孩的卵巢储备。 围绕 AMH 治疗潜力的研究发现促使 David Pépin 联合其他研究人员 Patricia Donahoe 和 Daisy Robinton 一起创立了 Oviva Therapeutics 公司。 （来源：公司官网） Oviva Therapeutics 成立于 2021 年，总部位于美国纽约。去年 5 月，该公司宣布与麻省总医院就三项专利达成许可协议，并获得由寒武纪生物制药公司支持的 1150 万美元的种子轮资金走出隐匿模式。 先前研究发现，随着年龄的增长，女性卵巢中有限的卵子数量不断减少，相较于其他组织器官，卵巢往往也会更快地失去功能，导致女性生育能力下降和更年期来临。而 Oviva Therapeutics 则专注于使用工程化的激素药物维持卵巢功能，目标是通过限制卵泡生长从而减缓其储备消耗，延长卵巢功能，最终延长女性的健康寿命。 早在 1970 年代，Patricia Donahoe 就曾发表了 AMH 相关论文，经过半个多世纪的研究，她个人将更多精力放在激素对于卵巢癌的作用研究中。在此期间，她与 David Pépin 共同揭示了 AMH 基因在卵巢中的功能。 ▲图丨David Pépin 博士和 Patricia Donahoe 博士（来源：healthylongevitychallenge.org） 2017 年，David Pépin 和 Patricia Donahoe 通过 AAV9-MIS 基因疗法，成功地在小鼠体内实现了可逆的卵巢 “静止”。以此为基础，他们开发了经过生物工程改造的 AMH 激素。临床前数据表明，经过改造的 AMH 可以在化疗期间保护未成熟卵泡，除此之外，该疗法还具有提高成熟卵子数量的潜力。 目前，Oviva Therapeutics 已经从麻省总医院获得了该化合物的专利许可，并将推进至小鼠和非人类灵长类动物的临床前试验阶段。该公司计划利用种子轮资金将该项目推进至 IND 阶段，除此之外，该公司还有一些其他未公开并处于早期开发阶段的项目。