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

 
20200226_115646.jpg
 

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!

A Growing Mansfield Life Science Cluster Benefits the Greater MA Ecosystem

By: Alexander Margulis PhD, Chief Operating Officer, Mansfield Bio-incubator

A recent article in Boston Business Journal By Scott Kirsner extolled the virtues of Kendall Square as the best place in the world to start a biotech company. Proximity to the groundbreaking research from Harvard and MIT is ‘a’ key catalyst in creating hundreds of technology and life science startups.  It’s true that it has attracted major international corporations such as Novartis, Takeda, Sanofi, Google, and Boeing, to name a few, to establish a large footprint in the area. This in turn contributed to the prices per square foot in a typical lab space to skyrocket to the $100 mark and to an ever-increasing congestion in the area.

In response, to reduce the real estate cost, miles outside Kendall Square are numerous life science clusters from the North Shore in Beverly to Woburn/Burlington to Natick/Framingham and Worcester and yes Mansfield.

Mansfield sits at the juncture of I-495/I-95 between Boston and Providence with a Commuter Rail stop connecting these two major New England cities.  Mansfield is the home of most of the successful medical device companies, including Smith & Nephew, Medtronic, Integra Life Sciences. A number of contract organizations like, New England Controls, Bridgemedica, and Proven Process, also reside in Mansfield. And now, it is also the home of the Mansfield Bio-Incubator.

The real truth is few and far between of the emerging companies launching in the region can afford to rent more than a docking station in the CIC and it is culture shock for established companies to justify a three- to four-fold increase their annual budget on real estate alone.

It is astonishing for those arrived in Boston even as recently as 30 years ago to believe it is the same place where it was unsafe to walk near any of these leading academic institutions and medical centers.

I know you hear every day how much the Venture Capital firms and the many key stakeholders love to talk about their ‘daily’ serendipity encounters and regular meet ups at Starbucks.

Digs a little deeper and you will learn that most of the workforce in the labs and tech positions are barely able to find affordable rentals on convenient public transportation train or bus lines.

Just help me out – reverse commuting or living closer to home in more affordable neighborhoods along or even outside 128 with better schools and neighborhoods for young families to thrive does not sound more sustainable and healthier?

So when you are finally worn out, after a day of the grueling lab work, commuting 1-2 hours each way and emptying your wallet on real estate and all other expenses that come with living and working inside the Kendall Square or Boston Seaport footprint, remember those of us that weighed work life balance to being too tired to enjoy random serendipity. 

Trade organizations located near Kendall Square have been vocal to push for improvement of the quality of life for the workforce commuting to Cambridge from all the 351 Massachusetts cities and towns and surrounding states.   To accomplish this, multiple initiatives were proposed.  These include modernizing the Red Line, upgrading the Commuter Rail, encouraging the employers to incentivize the use of public transportation and carpooling, implementing the congestion pricing on the roads, and encouraging the telecommuting.

The ideas listed above should improve the commuting experience to Kendall Square. However, given the limited physical space, these initiatives will still not be able to sufficiently address the congestion and the cost per square foot and will take at least a decade to implement.

We at Mansfield Bio-Incubator recognize that to maintain the health of the life science ecosystem across the state, creating mini-hubs like ours is vital. The property we are situated at, an old glass factory, is intended to be converted into the life science manufacturing hub. In this way, we can serve both as a convenient place for the entrepreneurs living in the Southeastern New England region to start the venture and grow the company. Moreover, by attracting other more established companies from Boston/Cambridge or other parts of the world, to establish the manufacturing facilities, we will keep the groundbreaking science inside the region and create more local job opportunities. Many of our entrepreneurs and their employees, as well as those from other suburban locales, can attest that it is science that attracts the talent throughout the state, not the location of the company.

Therefore, we ask the life science community in the state, together with the state officials and other relevant organizations, to continue practicing a more holistic approach in the economic growth and encourage a more even life science-driven economic development across the state and the surrounding region. This will go a long way in deploying the capital efficiently, maintaining strong communities and families, providing a just access to job opportunities, and reducing the traffic-related carbon emissions to combat climate change. 

Mansfield Bio-Incubator is Aiming to Promote 3D Bioprinting

MANSFIELD, MASSACHUSETTS-February 18, 2020- Allevi and Mansfield Bio-Incubator signed an agreement to promote the 3D bioprinting technology in the start-up community.

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.  

Allevi creates tools and solutions to design, engineer and build with life. Our 3D bioprinters and bioinks are used around the world to find solutions to humanity’s most difficult problems – to cure disease, to test novel drugs, and to eliminate the organ transplant waiting list.

Founded in 2014, our mission is to make it easy to design and engineer 3D tissues.  We created our desktop 3D bioprinters to be the most versatile, powerful and easy-to-use bioprinters on the market. Allevi is trusted by leading researchers and industry giants in hundreds of labs globally in the fields of tissue engineering, organ-on-a-chip research, pharmaceutical validation, biomaterial development, and regenerative medicine.

This Confidential agreement aims to create the conditions for a partnership cooperation between the between the two parties 

STRATEGIC PARTNERSHIP AGREEMENT BETWEEN CUBE LABS AND MANSFIELD BIO-INCUBATOR

Has been signed on 11TH of February, the Memorandum of Understanding between Cube Labs and Mansfield Bio-Incubator, an American non-profit company that acts as an incubator for biotechnology, pharmaceutical, biological and organic companies.

Mansfield Bio-Incubator has strategic objectives to facilitate and assist the creation, growth, and success of the next generation of biotechnology, pharmaceutical, biological science, and medical device companies by keeping laboratory and office spaces at affordable prices and by developing technologies, services and vanguard, training, tutoring and a network of professional consultants available for small biotechnology companies and health-related start-ups.

Cube Labs, has as strategic objectives the development of biotechnology and science and technologies applied to the health of academic origin in Italy and with partners in other strategic markets.

This Memorandum of Understanding aims to create the conditions for a partnership and institutional cooperation between the parties, which bilaterally supports and will cooperate for the promotion of technological innovations in the American and European markets.

Mansfield Bio-Incubator Welcomes Oncovolution

MANSFIELD, MASSACHUSETTS-January 22, 2020- Mansfield Bio-Incubator is pleased to announce a new member company, Oncovolution LLC, joining our growing life science ecosystem south of Boston. Oncovolution, an early-stage biotechnology company, is developing a new generation of high precision delivery oncology products. These products promise to be highly efficacious and less toxic than current cancer modalities. Oncovolution’s work in Mansfield Bio-Incubator will focus on optimizing several lead candidates to undergo preclinical studies, using our state-of the-art shared BSL-2 laboratory space. We are also grateful to Oncovolution for making several key pieces of laboratory equipment available to present and future member companies. These include PCR machine, HPLC instrument, plate reader, table-top centrifuge and a variety of other small laboratory equipment.

“We are happy to know that this life science incubator space exists south of Boston” said Dr. Mario Di Paola, Founder of Oncovolution”. “When I stepped into Mansfield Bio-Incubator for the first time, I liked the space immediately and the staff was so welcoming and accommodating; all of this at a very competitive price. I live in Scituate, so getting to Mansfield Bio-Incubator was a breeze. It took me only about 50 minutes, travelling mostly against traffic flow, as opposed to nearly 2 hours it would take me to get to a previous job north of Boston, during peak travel time. Even getting to Cambridge, it would take me at least 1 hour 30 minutes by car, and possibly longer by public transportation. While people are psychologically drawn to Cambridge because of the high density of biotech and biopharma companies, talent is dispersed throughout the state and certainly within the South Shore and surrounding areas. Many of the scientists I know would love not to have to commute into Cambridge; therefore, I am very confident that I can attract the right talent while being here.”

About Mansfield Bio-Incubator:

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.

The Mansfield Bio-Incubator is located at 241 Francis Ave. in Mansfield Massachusetts. Please contact Alex Margulis, the COO, for more information at alex.margulis@bioinc.org and 888-490-4443 x4.

Alira Health Expands Acceleration Office Hours Program To Mansfield Bio-Incubator

The expanded Acceleration Office Hours program brings a suite of advisory services to support healthcare and life sciences innovators by expanding the top-ranked Massachusetts Life Science ecosystem to the southern suburbs of Boston.

FRAMINGHAM, MASSACHUSETTS – September 4, 2019 – Alira Health (www.alirahealth.com), a leading international healthcare and life sciences advisory firm, announced the expansion of its Acceleration Office Hours program to include the portfolio companies of Mansfield Bio-Incubator (www.bioinc.org/).

As part of this program, Alira Health provides free monthly open office hours to Mansfield Bio-Incubator tenants at their Mansfield, Massachusetts location. Alira Health’s team of strategists, consultants, bankers, and scientists will be available during this time to provide analysis, recommendations, and strategy across the product and business lifecycle, including regulatory, clinical, reimbursement, market access, business development, banking, and strategy.

“We are excited to bring our Acceleration Office Hours program to Mansfield Bio-Incubator,” says Gabriele Brambilla, Chief Executive Officer, Alira Health. “We share a passion for helping healthcare and life sciences companies grow and succeed, and we are proud to lend our expertise to help their resident companies accelerate their innovations.”

“The comprehensive suite of services Alira Health offers makes them an ideal partner for Mansfield Bio-Incubator to help us build the burgeoning life science ecosystem south of Boston and extend life sciences beyond Boston and Cambridge,” says Alexander Margulis, PhD, Chief Operating Officer, Mansfield Bio-Incubator. “We are delighted to have Alira Health on our team.”

Alira Health announced their first Acceleration Office Hours partnership in July 2019 with Natick’s ABI-LAB and will continue to expand the program to include other healthcare and life sciences incubators throughout Massachusetts.

About Mansfield Bio-Incubator:

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.

The Mansfield Bio-Incubator is located at 241 Francis Ave. in Mansfield Massachusetts. Please contact Alex Margulis, the COO, for more information at alex.margulis@bioinc.org and 888-490-4443 x4.

Original source: https://www.alirahealth.com/news/alira-health-expands-acceleration-office-hours-program-to-mansfield-bio-incubator/