Cirqle Biomedical Contraception ApS

COPENHAGEN, Denmark, Aug. 6, 2024 /PRNewswire/ -- BioInnovation Institute (BII), an international non-profit foundation, incubating and accelerating world-class life science research, today announces it has entered into a collaboration with Massachusetts Institute of Technology (MIT) and the University of North Carolina (UNC) to support a research project through its company creation program, Bio Studio. Under the terms of the collaboration agreement, BII will contribute to the funding of the Project by means of a grant with a total annual market value of up to DKK 7,860,000, for a project period of up to three years. Alongside the grant, BII will support the project with business development expertise, intellectual property support, access to investor network, and both wet lab and office infrastructure. The Bio Studio project, named Pivot, will focus on how mucus can combat antibiotic resistance. The project aims to leverage the mucus barrier, an essential component of the innate immune system, to address the unmet medical needs of chronic lung diseases. The project will be led by Principal Investigators, Professor Katharina Ribbeck and Associate Professor Matthew Wolfgang. Katharina Ribbeck, Professor of Biological engineering at MIT, leads The Ribbeck Lab which has become a world-leader in elucidating the role of mucus and the basic mechanisms of the mucus barrier. Matthew Wolfgang, Associate Professor at the Department of Microbiology and Immunology and the Marsico Lung Institute at UNC, leads the team at The Wolfgang Lab and focuses on the pathogenesis of chronic respiratory infection in muco-obstructive airway diseases. Trine Bartholdy, Chief Innovation Officer at BioInnovation Institute said: "We are excited to enter into a collaboration with world-leading research institutes, MIT and UNC. The Pivot project is a fantastic addition to our Bio Studio portfolio as antibiotic resistance remains a key concern for society. The combination of expertise from both Prof. Ribbeck and Associate Prof. Wolfgang is a truly unique asset for this project and we look forward to supporting the team in developing innovative solutions to address antibiotic resistance." Professor Katharina Ribbeck, Principal Investigator at Massachusetts Institute of Technology added: "The critical role of the mucus barrier has been overshadowed by the historical emphasis on antibiotics. However, with antibiotic resistance presenting a growing global threat, leveraging the power of this natural defense system offers a new frontier in therapeutic development. By harnessing the potential of the mucus barrier, a cornerstone of our innate immune system, we can achieve significant benefits for patients and society as a whole. BII's Bio Studio program provides the perfect platform to explore the commercial potential of this innovative science and pave the way for company creation." Professor Matthew Wolfgang, Principal Investigator at University of North Carolina said: "As the prevalence of lung disease and chronic lung infection continue to increase world-wide, there is a dire need for new more effective therapies to treat these highly recalcitrant infections. I am thrilled to be part of this innovative team and look forward to advancing Pivot to the next level with the support of the Bio Studio program." Read more about the Bio Studio program here. About the BioInnovation Institute Foundation: At BioInnovation Institute (BII), we accelerate world-class life science start-up innovation for the benefit of people and society. As a non-profit institute, BII operates the company creation programs, Bio Studio, Venture Lab and Venture House, to support life science start-ups with knowledge, network, infrastructure and funding of up to 3M EUR per projects and 1,8 M EUR per start-up. With our expertise, network, funding, and infrastructure, we empower startups to succeed and believe in the transformative power of life science innovation. Read more on Since its inception in 2018, BII has supported 100 start-ups and projects with EUR 97 million alongside the venture capital, industry and business expertise it provides to help them accelerate to the next level. In total, BII's start-ups have raised over EUR 428 million in external funding from both local and international investors. Recent company successes include, Adcendo, Stipe Therapeutics, Twelve Bio, Octarine Bio, and Cirqle Biomedical. SOURCE BioInnovation Institute

“We need women to step forward, wave their arms and say, ‘You know what? I want to further science,’” Organon’s R&D head Sandy Milligan, M.D., says. When it comes to getting women's health therapies to market, nothing is ever straightforward. From encouraging women to "step forward" for clinical trials to battling for R&D funding, it remains a tough arena—yet Organon is building a pipeline to mount a challenge. “Every woman has a story to tell,” Organon’s R&D head Sandy Milligan, M.D., told Fierce Biotech in an interview. “I just absolutely love the fact that we are lowering that sort of taboo culture of not being able to talk about it. We need more women to tell us about their experience, to come forth and raise their hands.” While interest in women’s health has risen in recent years, Organon is still one of the few companies with a pipeline nearly wholly built around healthcare innovations for women specifically. In 2020, only 1% of biopharma R&D investment was in female-specific conditions excluding oncology, according to a McKinsey report. For female-specific cancers, clinical-phase investments sat at 4%. Even with so little research in women's health, Milligan has found trial recruitment a challenge. Organon wants to change that, starting in-house. The Merck & Co. spin-out encourages its own workers to speak up, offering internal forums where all employees can talk about personal challenges related to women’s health. Milligan said this gives employees a face—potentially even one of a leader or executive—to match with the conditions or diseases the company is trying to treat.   Like most women, Organon wears many hats with its three core areas: women’s health, biosimilars and legacy products. In the last 20 months, the company has looked at over 400 potential pipeline candidates, snapping up eight. Most are preclinical, with the majority of the pipeline consisting of early-stage assets, including ObsEva’s ebopiprant for pre-term labor inflammation and uterine contractions, as well as Cirqle’s non-hormonal on-demand contraceptive. While contraception isn’t technically a female-specific condition, society has pushed the brunt of it upon the female body. Organon wants to balance out the burden by exploring contraceptive options for both females and males. With so many early-stage candidates, Organon has a lopsided pipeline and few nearer-term assets to push forward. Milligan said this somewhat mirrors broader trends, noting that there aren’t a lot of new women’s health treatments expected to come to market anytime soon in general. Over the years, many Big Pharmas have deemphasized their investment in women’s health, according to Milligan, which has contributed to the dearth of late-stage assets. Organon is instead looking to medtech devices to fill the pipeline gap. “If you're really focused just on women's health, you almost can't stay in just a pharmaceutical therapeutic option,” according to Milligan.  Everything that happens to women is basically treated like it’s a hormonal imbalance." — Sandy Milligan, M.D., Organon At the beginning of this year, Organon invested in Claria Medical’s device that aims to make hysterectomies a minimally invasive, laparoscopic procedure that would be safer and faster than the current standard. Back in 2021 before Organon’s launch, corporate parent Merck paid out $240 million to acquire Alydia Health and set up the spin-out's portfolio. The acquired assets include a system called Jada designed to stem blood loss during postpartum hemorrhage. On the biopharma side, Organon is particularly interested in understanding the root of disease instead of just controlling symptoms with hormones—the most common band-aid given for many women-specific conditions. “Everything that happens to women is basically treated like it’s a hormonal imbalance,” Milligan said, citing heavy menstrual periods or pain as a prime example. “The Holy Grail, frankly, would be investing in therapeutics that are not just specific to the target, but specific to that woman's expression of the target,” Milligan explained. “We're years away from that, but we need to start investing now or we'll never get there.” As head of R&D, her main focuses are conditions with a high unmet medical need, such as severe peri- or post-menopausal symptoms—which affects 10 million women, according to Milligan—and can include hot flashes, mood changes, anxiety and changes in sexual function. Endometriosis is another. The tissue growth disorder causes the uterine lining to grow outside of the uterus, such as on the ovaries, fallopian tubes or intestines. It can cause chronic pain and infertility and impacts about 1 in 10 females of reproductive age. There are few effective treatments available, with the main options being hormone therapy or surgery. One of Organon’s more advanced pipeline meds for the disorder is OG-6219, a midphase asset obtained from Forendo Pharma in a 2021 acquisition. The drug lowers estrogen production in endometriotic lesions and is currently being evaluated in a clinical study dubbed Elena. The global phase 2a/b trial is still recruiting women who have been surgically diagnosed with endometriosis and have moderate or severe pain. The estimated enrollment goal is 380 participants and completion is expected for the end of 2024.    While Milligan is optimistic the trial will hit its enrollment goals, she said recruitment has been challenging. For instance, fewer women have returned to the clinic since the pandemic began. The company is attracting participants via word-of-mouth and public campaigns. “We need women to step forward, wave their arms and say, ‘You know what? I want to further science,’” Milligan said. Another place Organon needed people to step forward was on staffing. Milligan was worried about attracting talent after the split from Merck. Milligan herself is no stranger to Big Pharma, having clocked in time at Amgen, Genentech and Merck (all after getting her M.D. and J.D.), She was worried that a smaller company focused on women’s health might deter people from joining. However, she’s been pleasantly surprised at how many people have been attracted to the company for its mission, with a current staff roster boasting 10,000 names.  While Milligan is excited about all Organon is working on, the reality of a women’s health-focused company can still be daunting. Engagement in the space has been rising recently, but Milligan said interest—and investment—is still extremely fragmented.   “We're just part of the ecosystem,” she said. “And one company can't do it by itself.” The R&D leader wants to see “the silos go down,” noting that more seamless interactions between pharmas, organizations and health agencies could help move innovation along faster. Organon is working to break those barriers down with more messaging, communication and outreach. Right now, the company is still “trying to find that unifying theme” for outreach, one that can pull people together and drive women’s healthcare forward. But as Organon has found in listening to women, the unifying theme might be right in front of us. 

July 28, 2022 11:30 UTC Collaboration continues to expand portfolio in women’s health to help address unmet needs JERSEY CITY, N.J.--(BUSINESS WIRE)-- Organon (NYSE: OGN), a global women’s healthcare company, and Cirqle Biomedical today announced they have entered into a research collaboration and exclusive license agreement for a novel investigational non-hormonal, on-demand contraceptive candidate. This press release features multimedia. View the full release here: “As a leader in contraception, we believe it is critically important to bring forward new options for women, especially in the space of non-hormonal contraceptives, a category preferred by many with limited available options,” said Sandra Milligan, M.D., Organon’s head of Research and Development. “Organon is committed to driving innovation across women’s health and collaborating with companies like Cirqle Biomedical to support early science and bring forward new solutions that address the unmet needs of women.” Encouraging preclinical research suggests that Cirqle has discovered a method that has the potential to create a temporary barrier to sperm transport by topically reinforcing the existing cervical mucus barrier. “This collaboration is an important opportunity to advance our preclinical research exploring this asset’s first-in-class potential,” said Frederik Petursson Madsen, Cirqle Biomedical, CEO. “We are excited to join Organon to leverage Organon’s deep expertise in women’s and reproductive health to drive potential change for women who use contraception everywhere.” Under the terms of the agreement, Cirqle will be responsible for conducting preclinical studies according to the mutually agreed research plan. Organon will obtain exclusive worldwide rights to develop and commercialize the asset. Cirqle is entitled to receive a $10 million upfront payment, potential milestone payments of up to $360 million and royalties based on net sales. As stated on Organon’s first quarter conference call, to align with views expressed by the US Securities and Exchange Commission, beginning in 2022 Organon will no longer exclude expenses for upfront and milestone payments related to collaborations and licensing agreements, or charges related to pre-approval assets obtained in transactions accounted for as asset acquisitions, from its non-GAAP results. Organon’s financial guidance does not assume an estimate for these expenses associated with business development not yet executed, and accordingly, the $10 million upfront payment was not included in the full year 2022 guidance Organon provided on May 5, 2022. Organon does not plan to update its guidance inter-quarter based solely on these items. About Cirqle Biomedical Cirqle Biomedical is a pre-clinical stage life science company with the goal of developing a first-in-class non-hormonal contraceptive that can help address the demand from millions of women for an effective contraceptive with minimal side-effects. Cirqle Biomedical’s approach to contraception is based on engineering mucus to leverage the natural barrier properties of cervical mucus. Cirqle Biomedical was launched in 2019 in Copenhagen, Denmark, with backing from BioInnovation Institute (BII) and Rhia Ventures, a San Francisco-based impact investor dedicated to women’s reproductive health. Cirqle Biomedical’s core ethos is to expand freedom and quality of life for women everywhere. We aim to solve the most prominent unmet medical needs in women’s health by developing groundbreaking user-centric innovations. About Organon Organon is a global healthcare company formed to focus on improving the health of women throughout their lives. Organon has a portfolio of more than 60 medicines and products across a range of therapeutic areas. Led by the women’s health portfolio coupled with an expanding biosimilars business and stable franchise of established medicines, Organon’s products produce strong cash flows that will support investments in innovation and future growth opportunities in women’s health. In addition, Organon is pursuing opportunities to collaborate with biopharmaceutical innovators looking to commercialize their products by leveraging its scale and presence in fast growing international markets. Organon has a global footprint with significant scale and geographic reach, world-class commercial capabilities, and approximately 9,300 employees with headquarters located in Jersey City, New Jersey. For more information, visit and connect with us on LinkedIn and Instagram. Forward-Looking Statements This press release includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995, including, but not limited to, statements about Organon’s research collaboration and exclusive license agreement with Cirqle Biomedical, the potential for Cirqle Biomedical’s program to produce a best-in-class non-hormonal, on-demand contraceptive, including the effectiveness of and market opportunity for Cirqle Biomedical’s investigational asset, and Organon’s goal of addressing the unmet needs of women. Forward-looking statements may be identified by words such as “expects,” “intends,” “anticipates,” “plans,” “believes,” “seeks,” “estimates,” “will” or words of similar meaning. These statements are based upon the current beliefs and expectations of Organon’s management and are subject to significant risks and uncertainties. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. Risks and uncertainties include, but are not limited to, general industry conditions and competition; general economic factors, including interest rate and currency exchange rate fluctuations; the impact of the ongoing COVID-19 pandemic and emergence of variant strains; the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally; global trends toward health care cost containment; technological advances; new products and patents attained by competitors; challenges inherent in new product development, including obtaining regulatory approval; Organon’s ability to accurately predict its future financial results and performance; manufacturing difficulties or delays; financial instability of international economies and sovereign risk; difficulties developing and sustaining relationships with commercial counterparties; dependence on the effectiveness of Organon’s patents and other protections for innovative products; and the exposure to litigation, including patent litigation, and/or regulatory actions. Organon undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Organon’s filings with the Securities and Exchange Commission ("SEC"), including Organon’s Annual Report on Form 10-K for the year ended December 31, 2021 and subsequent SEC filings, available at the SEC’s Internet site ( ).