This Startup Is Turning a Horse IUD into More Painless Birth Control for Humans.

3Daughters wants to replace the traditional T-shaped IUD with its own IUD made of three, tiny elliptical units with a magnetic core that is covered in polymer and then coated in copper.

3Daughters

By Hannah Green - Inno Reporter

October 25, 2022, 11:00am EDT

A new startup is aiming to use a new technology—first developed for use in horses—to create a more painless intrauterine device.

IUDs are one of the most effective forms of birth control, but the insertion and removal process can be painful. 3Daughters wants to replace the outdated, T-shaped IUDs with its new magnetic, frameless IUD. This month, the startup closed an early-stage round of just over $1 million to push its work forward. 

Typically to insert an IUD, a doctor starts by using a sounder, a rod with measurement markers on it, to find the top of the uterus. This is where the T-shaped device must be placed. 3Daughters co-founder Mary Beth Cicero said the sounder and the IUD hitting the top of the uterus is often one of the worst pain points in this process.

3Daughters’ IUD is made of three, tiny elliptical units with a magnetic core that is covered in polymer and then coated in copper, said co-founder Shelley Amster. The three units are fed single file through an inserter into the uterus where they form a triangle shape. The IUD floats in the lower quadrant of the uterus. A magnetic retriever is used for removal. This eliminates the need to use a sounder and push on the top of the uterus, Amster said.

This new IUD technology was invented by Carlos Gradil, a veterinarian and professor of veterinary and animal science at UMass Amherst. Gradil first created this IUD for use in horses.

“He had really tested it, proven the safety and efficacy in horses, and has published on it,” Cicero said. “And he didn’t really understand the human market. And that’s where Shelley came in.”

Amster is one of the founding board members of the Mansfield Bio-Incubator and an original organizer of the Massachusetts Life Sciences Innovation (MALSI) Day. Amster said she came in with a diligence team to vet Gradil’s work and determine if it could be translated to human use. She brought in Cicero, a pharma executive with experience in business development marketing, and the pair approached Gradil about commercializing the technology in humans.

“Mary Beth and I basically told UMass and Carlos that if we could get some translation grants to prove…and develop a prototype, we would license the technology and form a corporation,” Amster said.

That was about a year ago. With six grants now under their belt, the co-founders spent the last year developing prototypes of the IUD and the glider for insertion and retrieval and meeting with the FDA to map out the clinical path forward.

The co-founders have also brought on board a team of advisors, including Dr. David Archer, director of clinical research for the Contraceptive Research and Development Program; Dr. Mary Lake Polan, professor and Ob/Gyn Yale University School of Medicine; and Dr. Tara Kumaraswami, director of the Ob/Gyn residency program at UMass Medical School. 

“We have people that are key opinion leaders of key opinion leaders,” Amster said.

Amster said they were able to land these advisers because she and Cicero have been working in the field of women’s health innovation for decades. Amster and Cicero said they considered starting 3Daughters a full circle moment in their careers. Amster started working in a preterm clinic working in infertility. Cicero headed up U.S. marketing at Serono when the company focused on infertility before starting her own consulting practice and working with many women’s health companies.

Cicero said the company plans to use its new capital to finalize the prototype design, transfer it to manufacturing, and begin preclinical work. They also plan to file new IP under the 3Daughters name. The U.S. and European patents for the technology are licensed from UMass Amherst, Cicero said.

Their goal is to file an IND by the end of next year. The startup also expects to raise a $10 million round next year to propel it through its Phase 1 feasibility study in 2024. After that, Cicero said 3Daughters would look for a commercialization partner to help them break into this industry.

Member Company Spotlight: AOA Dx is Aiming to Detect Ovarian Cancers Sooner.


AOA Dx Inc has partnered with a leading researcher at McGill University to develop the first early stage ovarian cancer liquid biopsy diagnostic test. The co-founders have worked together at two previous startups in the women’s health space, both resulting in successful exits upon commercialization. Ovarian cancer is the deadliest gynecological disease because there is no accurate testing method and therefore its symptoms are continuously mistaken for benign conditions, making it incredibly difficult to diagnose the disease in the early stages. The team has previously raised a $7M Seed round and completed a 400+ retrospective patient study showing excellent sensitivity and specificity. Ovarian cancer is just the beginning. AOA has a platform of novel ganglioside tumor markers to disrupt early cancer detection. AOA Dx is currently developing their assay and conducting further clinical studies.

Recently, Oriana Papin-Zohgbi, the company’s Co-founder and CEO, met with Mansfield Bio-Incubator’s Advisory Board as part of the routine check-in with the member companies. “I had a great meeting with our Advisory Board at Mansfield Bio-Incubator to brainstorm fundraising strategy and growing our company! Excited to continue working with this team.”

Mansfield Bio-Incubator is excited to have AOA Dx as our member company and is committed to supporting their work to ensure their success. They are currently hiring a Director of Clinical Operations: https://www.aoadx.com/clinical-director-operations.

For more information, visit their website at https://www.aoadx.com/.

Member Company Spotlight: Omnigen is Taking Her First steps into the United States

Omnigen as a member of the Mansfield Bio-Incubator in Boston

In the beginning of February, Omnigen went on a mission to Boston for the SLAS2022 International Conference and Exhibition, organised and financed by DIGI-B-CUBE. During this mission, Omnigen and Mansfield Bio-Incubator crossed paths, and it turned out to be a great match. In this interview, one of the co-founders of Mansfield Bio-Incubator, Alexander Margulis, tells us why that is the case.

Hi Alexander, nice to meet you! Can you tell us more about your educational background?

“Hi! So, my name is Alexander Margulis, and I have a PhD in Biochemistry and Molecular Biology from Stony Brook University in New York. My PhD project focused on the role of cell cohesion on cancer progression using three-dimensional models. After receiving my doctorate, I continued to work with similar models as a postdoctoral researcher at what is now Pfizer. What followed was a position at Genzyme, where I focussed on cell-based assays. It was not until later in my scientific career that I contributed to other life science companies with my knowledge. After my time at Genzyme, I set up laboratories for a biotech start-up called Bioarray Genetics, who were developing a test to stratify breast cancer patients in terms of response to chemotherapy.”

You have quite some impressive experiences under your belt. How did you end up co-founding the Mansfield Bio-incubator?

“Well, it began with some of the feedback I received from one of my supervisors back in the day. She felt that, with the personality I have and the skills I possess, you would be great at building something from scratch. So, at the age of forty, I decided to take this feedback and jump into a new opportunity to build a life science ecosystem in this region. In 2017, Mansfield Bio-Incubator opened the initial lab space, thanks to a generosity of private donors, and then secured money from Massachusetts Life Science Center to facilitate the expansion, right before the pandemic in 2020. Despite some delays due to the pandemic, we are now finally operational as of the end of February. We are filling up, and are, of course, always trying to attract new exciting companies from anywhere in the world. For this reason, I was really glad that the Netherlands mission in Boston brought exciting life science companies into our space, including Omnigen.”

 

“It becomes more paramount to connect companies like Omnigen to the Massachusetts network”

 

You have certainly come a long way since 2017. Can you tell us more about the mission that the incubator holds?

“Basically, our mission is to provide assistance to companies that make ground-breaking diagnostic therapeutics and other life science products. Besides that, we want to grow the entrepreneurial economy of this part of Massachusetts. The way our economy is currently developing is, also partly due to our geography, not sustainable. Obviously, Boston Cambridge is at the centre of the world in terms of biotech. But what people fail to understand is that the prices and real estate are exorbitant, and the commute is a nightmare. So, it becomes more paramount to connect companies like Omnigen to the Massachusetts network, and to provide them with options outside of Boston Cambridge. And that is what we are about.”

Why do you think a company such as Omnigen is suitable to connect to the Massachusetts network your incubator has?

“In my opinion, Omnigen is a great fit, because like our other incubator companies, Omnigen works in a variety of disciplines, from cancer diagnostic therapeutics to DNA-tests for horses. I am very impressed given the fact that Omnigen has a relatively small team with a big portfolio of products. I sincerely hope that we can help Omnigen in any way we can.”

 

“It is about what the company really needs. The opportunities are plentiful.”

 

Talking about offering help, what are the precise services and support you can offer life science companies such as Omnigen?

“Firstly, we will ask any company who becomes a member at our incubator to fill out a questionnaire, and then connect them to the advisory board. The advisory board will give the companies tailored advice based on the questionnaire and will involve the right people from the network to get the companies what they need. This can vary from funding opportunities to networking events, from accelerator programs to mentors, and from seminars to intern recruitment. In other words, it is about what the company really needs. The opportunities are plentiful.”

Plentiful indeed! So how do you think the incubator can add value specifically to European life sciences companies entering the United States market?

“We have a range of memberships, starting with the virtual basic business membership that Omnigen has. This membership includes basic analysis, connections to mentors for appropriate guidance and providing any connections necessary to expand into the United States market. When enough money is raised, Omnigen can rent a bench in our shared space. When that is the case, regional officials can add more capacity to let Omnigen grow right in this region of Massachusetts. In this way, we have a virtuous cycle. By providing an additional, affordable option to get your life science venture started, we keep Massachusetts as the number one biotech economy in the world, while European companies such as Omnigen can add more value to this economy and to the well-being of our country by providing products such as their Pancreatic Insightful Treatment Analysis platform.”

To end on a different note, would you recommend anyone to visit Boston?

“Absolutely, I cannot imagine living anywhere else at this point. There is no amount of money that can lure me to live in another place. We have a variety of spectacular nature within two hours of the city, including beaches and mountains. Boston has lots of great cultural events, and the city has a very passionate sports fan base. And I am not even talking about American football, but regular football. Also, I would argue that, for people from Europe, Boston would be the least of a culture shock. It is one of the most compact American cities, although probably not as compact as the Netherlands.”

Do you want to know more about the Mansfield Bio-Incubator? Visit their website here.

Original Source: https://business.omnigen.nl/en/portfolio/omnigen-is-taking-her-first-steps-into-the-united-states-2/

Company Spotlights: Turtle Health and Beyond Biotech are the First Two Companies in the New Laboratory Space at Mansfield Bio-Incubator

On March 1, 2022, Mansfield Bio-Incubator’s new 15,000 sqft space welcomed the first two new member companies.

Turtle Health is a women-led, Boston-based start up building a clinical platform to care for women and couples in the home. The company is working on a suite of devices, diagnostics, and technology that allow doctors to confidently care for patients via telemedicine, including remote pelvic ultrasound.

The woman-led founding team is bring a depth of healthcare experience – including previous leadership roles at Sanofi, Pfizer, Evolent, McKinsey, and Blue Cross Blue Shield – as well as a passion for patient care.

Turtle Health’s team has run three successful pivotal trials that generated a number of publications, most recently a paper in Obstetrics & Gynecology (‘the Green Journal’) comparing the performance of its ultrasound device to existing in-clinic imaging. Turtle Health is hiring a Warehouse & Laboratory Operations Manager. For more information, please click here.

Beyond Biotech provides rAAV-related services and products to biological and medical researchers in the universities and biopharmaceutical companies. Our service includes rAAV vector construction/quality control, shRNA and artificial miRNA design/construction/assay, rAAV packaging, and cell-based assay for gene therapy researches.

Traditional methods of rAAV particle manufacture are time and labor-consuming process with challenge of techniques and expensive equipment. Recent rise of investments in rAAV drug development and commercialization urges plenty of researches and pre-clinical trials to use rAAV as gene delivery vehicle, which requires large quantity and high purity rAAV particles. Beyond Biotech are dedicated to employ novel and standardized protocols to produce rAAV with helper-free system in HEK293 cells, which can decrease turn-around time and the cost of rAAV manufacture.

Since the high technical procedures of rAAV design/production/quality control requires extensive cost and time for rAAV platform development, we are dedicated to develop ready-to-use rAAV packaging kits with step-by-step protocols to produce high-purity rAAV particles, which would benefit junior faculties and scientists in scientific community who work in the gene therapy field with limited funding and technical resources.

Currently, Beyond Biotech are in the early phase of R&D, in order to scale-up our manufacture, we are actively looking for funding, collaboration and investment. Please find the detailed information in our website, www.biotechbeyond.com

Company Spotlight: Akttyva Therapeutics, Inc. (Akttyva) Opening Its Laboratories at Mansfield Bio-Incubator.

Akttyva was founded by scientists Usamah Kayyali, Ph.D. and Bruno Villoutriex, Ph.D. and led by an experienced biotech executive and entrepreneur Katya Tsaioun, Ph.D., an Intellectual Property attorney, and Chief Legal Officer of ArrantaBio Lana Gladstein, J.D., and a serial life sciences entrepreneur Mark Tepper, Ph.D.  Inspired by the pandemic, the team is developing a treatment for Acute Respiratory Distress Syndrome (ARDS), a deadly condition with no treatment, which was first described as a “wet lung” during the First World War. Even before the pandemic, ARDS was the leading cause of death in the ICUs worldwide. ARDS is the reason for the death toll of COVID-19, flu, pneumonia, and other respiratory viruses. The current standard of care is mechanical ventilation and immune suppression with corticosteroids, which are consequences of ARDS, not a cause, and still carry 40% mortality. Akttyva is developing a small molecule that repairs vascular leak, which is the root cause of ARDS as well as over 60 other medical conditions. Akttyva currently has a lead molecule in advanced preclinical studies. To discover the lead compound Akttyva’s team led by Bruno started working during the lockdown. Dr. Villoutreix was in Paris and the rest of the team in Boston area. Bruno has remotely deployed advanced AI-assisted in silico screening tools, which he developed over the last 2 decades, to discover the first set of hit molecules. But this was just the beginning of the story. Akttyva got started with a single purpose to find a cure for the pandemic, but its early investors and founders realized that the drug discovery technology and the pathway can be used to address a broader set of medical conditions and targets, building a pipeline of novel therapies for unmet medical needs.

Since its founding in 2020 Akttyva has won a few prestigious competitions and has been selected to be MassChallenge finalist, won an IBM AI Award with resulting partnership with IBM and recently was awarded an NSF grant to advance its AI-based virtual drug-discovery engine.

A key event in advancing Akttyva’s programs was recruitment of Mario DiPaola, Ph.D. to join as Head of Research. Mario is an early investor in Akttyva, and he has established the key laboratory assays to confirm in silico predictions of the hit molecules. Mario is a seasoned biotech leader and entrepreneur, with a track record of getting drugs to clinic and successful exit of his company Blue Streams Labs in 2016. Mario has introduced Akttyva to Mansfield Bio-Incubator, and when the funding from NSF and angel investors came in, Akttyva has joined as a member.

Akttyva is growing and there are currently a couple of opportunities is to join working on the NSF grant and establishing new assays team collaboration and evidence-based research (recent publication reference). Akttyva’s goals are to deliver treatments to patients with unprecedented speed, while maintaining excellence in science, transparency of its research methods, fairness, equity and focus on unmet medical needs. Our team members joining us at all levels will be given an opportunity to make meaningful contributions to research, resulting not only in products that save lives, but reported in publications and new patents arising from our research. Our philosophy is that advancement should be based on drive and performance first, degrees second. Thinking outside the box, desire to learn and work as a team are what we seek in our employees. All employees joining this time will participate in stock options and stock grants, based on contributions.

 

Company Spotlight: Therabene.

Therabene is developing a series of small molecules, called PROTACs, that target certain specific proteins for degradation. Compared to the existing technologies, this approach is expected to reduce the off-target effects that are common to small molecule drugs. Therabene’s lead compound is a first-in-class degrader targeting CDK9, a kinase that phosphorylates RNA Polymerase II, which is required for a high-level transcription of MYC, a key driver of tumorigenesis. MYC addiction is known to be critical to several types of malignant disease, including triple-negative breast cancer (TNBC), representing 15% of the breast tumors, with no treatment currently available. Based on In-vitro data, Therabene’s lead product has demonstrated strong decrease in cell viability; while in-vivo, the drug has shown good efficacy by causing a 50% reduction in tumor burden in a TNBC mouse xenograft model, with excellent tolerability and no loss in body weight. The results suggest an excellent therapeutic window and, likely, a stronger anti-tumor efficacy with more optimal dosing. “Mansfield Bio-Incubator has been extremely supportive of our efforts by providing a personalized attention and great, affordable facilities. Their support has allowed me to find excellent partners and incubate two more companies onsite”, said Dr. Mario DiPaola, Therabene’s co-founder and CEO and a successful serial entrepreneur. “I live in the South Shore, and I am extremely happy to avoid those grueling commutes into Cambridge. Talent lives across the state, including Southeastern Massachusetts; therefore, I am confident to be able to recruit top-notch scientists of all levels to advance my projects.”

Therabene is currently raising Seed Funds, up to $2M, to advance the development of the lead PROTAC candidate for TNBC, and other indications including ovarian and pancreatic cancers, and to expand the CDK9 degrader pipeline, by using AI-based molecular docking to discover novel degraders for oncology and autoimmune targets. For more information and to learn more about the investment opportunity, please contact mdipaola@therabene.com.

More affordable laboratory space to be available less than 40 miles south of Cambridge, MA in Q1, 2022

MANSFIELD, MA, November 4, 2021 – Mansfield Bio-Incubator announced it is adding 15,000 square feet of laboratory space to its existing facility at 241 Francis Ave in Mansfield, MA with a scheduled opening in February of 2022. The new space includes shared laboratory space, private laboratory suites and an enclosed laboratory that meets BSL-2 (biosafety level 2) as specified by the US Centers for Disease Control and Prevention (CDC). The new laboratory space will accommodate a range of enterprises, from a dedicated one-person lab to a medium sized laboratory fit for a team of 12 people. Complete with modern, up-to-date offices and a conference room, the lab area including the latest laboratory equipment, the facility provides a comfortable, productive, and interactive environment.

The facility expansion supports an entrepreneurial life science community less than 40 miles south of the Boston-Cambridge life science cluster and includes the top-tier universities in the region such as Brown University and University of Rhode Island, well-known institutions such as Wheaton College, Bridgewater State University, and local community colleges Massasoit and Bristol Community College.

The Mansfield Bio-Incubator helps entrepreneurs succeed by attracting interest from the investor community, establishing mentorship programs, providing access to legal and financial assistance, supporting networking events such as lunch-and-learn sessions and by creating opportunities for internships and employment. By catalyzing the life science activity in the region, Mansfield Bio-Incubator aims to attract more research, development and manufacturing in the region offering an attractive alternative to the congested Boston-Cambridge area.

“The life sciences continue to unlock economic and workforce opportunities on a statewide basis,” said Massachusetts Life Sciences Center President and CEO Kenn Turner. Mansfield Bio-Incubator received $2 million in capital funding through the Massachusetts Life Science Center’s Open Capital program. “Regionalizing the benefits of the life sciences remains an essential pillar of our mission. We are proud of the progress being made with our partners at Mansfield Bio-Incubator,” Turner added. The expansion was also supported by a grant from a private family charitable foundation.

"The town of Mansfield offers easy access to both Boston and Providence,” said Kevin Dumas, Mansfield Town Manager. “Recently, we invested millions to support a strong infrastructure in terms of utilities, transportation, and housing, and to alleviate both housing shortages and congestion,” he added.

The expanded laboratory space was designed by Cannon Design https://www.cannondesign.com/ and is being built by Timberline Construction https://www.timberlineconstruction.com/.

About Mansfield Bio-Incubator

Mansfield Bio-Incubator is a non-profit organization whose mission is to facilitate and assist the creation, growth, and success of the next generation of biotech companies by maintaining affordable laboratory space. The facility is an open-concept equipped laboratory and office with benches in a shared lab as well as the private laboratory suites of different sizes.

Applications are now accepted to lease the new and existing spaces. For more information, contact Alex Margulis at (888) 490-4443, extension 4, email alex.margulis@bioinc.org or visit us at https://www.bioinc.org/upcoming-expansion"

New Company Spotlight: Geistek Pharma

MANSFIELD, MASSACHUSETTS, May 18, 2020- Mansfield Bio-Incubator is pleased to announce our new member company, Geistek Pharma. Geistek is an innovative Pharmaceutical Company that classifies as a Contract Research Organization focused on pre-clinical and clinical research projects. Our work consists of giving administrative and technical support to Clinical and pre-clinical Trials in the field of Advanced Therapies. Something that makes us different is that we use the Artificial Intelligence technology and Machine Learning for processing data and giving an appropriate forecast to the future results of the experiments the research groups will perform.

“We aspire to be the first full service CRO in the world specialized in Advanced Therapies such as genetic, cellular and protein therapies. These therapies are one of the fields of medicine with the greatest prospects for future development, due to its potential ability to cure diseases that do not find effective treatments in conventional therapies and its ability to focus on patients' characteristics with personalized medicine.” said Diego Fajardo Puig, the CEO. Geistek has been nominated to be one of the 20 Most Innovative Companies of 2020 by Business Worldwide magazine. 

Geistek’s headquarters are located in Madrid, Spain. Geistek’s virtual membership at Mansfield Bio-Incubator enables the company to formulate the strategy to expand into the US market. For more information, please visit the website at https://geistek.com/.

Mansfield Bio-Incubator is a non-profit biotech, pharma, life science, and medical device business incubator facility. Our mission is to facilitate and assist the creation, growth, and success of the next generation of biotech, pharma, life science, and medical device companies.  We were created to nurture entrepreneurial and economic development in the community. We aim to do this by maintaining affordable lab and office space and making cutting-edge technology, services, training, mentoring, and a network of professional advisors available to small biotechnology companies and healthcare-related start-ups.

Alira Health Shared Insights On How To Build A Compelling Investor Deck For Entrepreneurs

 
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MANSFIELD, MASSACHUSETTS, March 2, 2020- For vast majority of life science entrepreneurs, raising money is by far the biggest challenge they are facing. Assembling a compelling slide deck is a crucial part of the process. To assist the entrepreneurs in this important endeavor, Mansfield Bio-Incubator hosted a workshop on February 26 on what the investors are looking for in the slide deck. The workshop was led by a distinguished panel from Alira Health, an advisory firm that supports client’s business with an integrated suite of Product Development, Regulatory, Clinical, Strategy Consulting, and Transaction Advisory services.

According to David Uffer, Senior Partner and VP of MedTech, with the medical innovation flooding the market, the investors are looking for more than EBITDA. It is critical that the products provide the value to the market in the form of leapfrogging of the existing technologies as “me-too” or “me-too plus” products have very hard time exiting. Therefore, as Aude Quesanaga, Manager, a Market Access Specialist, emphasized, it is critical that the entrepreneurs work on the market access strategy early on. They need to understand who the actual patients will be. Many entrepreneurs tend to rely on market research reports to accomplish this. However, while these reports are great sources for the retrospective information, such as epidemiology and the existing treatments, very little could be gleaned from them with respect to the utility of the proposed device or a drug. This is especially true for medical devices. Therefore, the entrepreneurs need to conduct the extensive research, either on their own or by hiring a consultant, by engaging with the key stakeholders and opinion leaders such as patients, physicians, insurance companies, etc. Defining the patient population will in turn allow to optimize the clinical trial, thus leading to a more efficient capital deployment. In this way, the investors are more confident in the management team.

Another way to optimize your clinical trials, as pointed out by Chris Rao, Director, Clinical Development and Mary McNamara-Cullinane, VP of Regulatory Affairs, is to map out the regulatory pathway early on. According to Mary, the first step is to schedule a no-cost meeting with FDA prior to submission. Engaging with FDA early, will enable the entrepreneur to determine if a new 510K submission is necessary as well as negotiate the number of subjects to enroll. Chris Rao pointed out that elements of the competitors’ clinical trial design are publicly available on clinicaltrials.gov. This information can in turn serve as a guide to roughly budget the costs of the trial.

The due diligence described above is essential to be able to map your milestones and inflection points. While the making the timelines as short as possible is important, they need to be realistic. Both Aude and David strongly suggested to start from the endpoints (e.g. exit, different stages of development such as 510K, clinical trial start, etc.) to work backwards, which is contrary to how most of us have been taught.

Taken together, doing homework described above will go a long way for the investors to believe in your team. We at Mansfield Bio-Incubator are thrilled to have Alira Health conduct such an informative session and are privileged to have them as our partner. Alira Health provides free monthly open office hours to Mansfield Bio-Incubator member companies. To become a member, we invite you to contact us here.

In addition to putting together a compelling investor deck, other aspects, such as IP protection reimbursement and business strategy, ability to scale, access to the global market, and building a team are just as critical. Mansfield Bio-Incubator aims to host the educational events on these topics and other critical areas for life science entrepreneurs to succeed in commercializing their inventions. For more information, check our calendar of events here. We look forward to seeing you soon!