Monthly Archives

January 2022

Hibiscus BioVentures Partners with the Barbara Ann Karmanos Cancer Institute to Advance Translational Cancer Research

By | News | No Comments

– Partnership aims to drive innovation and clinical development of novel therapeutics for cancer treatment –

ROCKVILLE, Md.–(BUSINESS WIRE)–Hibiscus BioVentures, a firm committed to building patient-focused companies around transformative technologies, today announced it has entered into a partnership agreement with the Detroit-based Barbara Ann Karmanos Cancer Institute (Karmanos). This partnership between Hibiscus’ venture studio, Hibiscus BioTechnology, and Karmanos seeks to leverage the combined resources of the two organizations to develop innovative therapeutics for the treatment of cancer. Karmanos is one of only 51 National Cancer Institute (NCI)-designated Comprehensive Cancer Centers in the country.

“We are excited to advance this patient-centric approach by leveraging the highly-respected development resources at Karmanos,” said Chris Jeffers, CEO of Hibiscus BioTechnology. “As translational and clinical research partners, this collaboration is focused on combining programs, capabilities and infrastructure from Hibiscus Biotechnology’s Studio Companies with Karmanos’ vast clinical research and development resources to advance cancer therapies and address unmet patient needs.”

Hibiscus BioTechnology Studio Companies each have financial and executive guidance and operating support to advance a broad range of science and technology development programs and address unmet patient needs. The collaboration with Karmanos will bring emerging Hibiscus BioTechnology Studio Companies valuable clinical resources, including laboratory and research access, scientific and thought leadership, clinical development strategy and access to the robust network of Karmanos hospitals to more rapidly advance cancer care.

“Working with emerging companies to bring innovation into the clinic is critical to help drive new cancer therapies closer to patients,” said Elisabeth Heath, MD, FACP, associate center director of Translational Sciences and leader of the Genitourinary Oncology Multidisciplinary Team at Wayne State University and Barbara Ann Karmanos Cancer Institute. “We believe the combined resources and mission that Karmanos and Hibiscus share will bring new hope and new tools to cancer treatment.”

About The Barbara Ann Karmanos Cancer Institute The Barbara Ann Karmanos Cancer Institute is a leader in transformative cancer care, research and education through courage, commitment, and compassion. The Karmanos Cancer Institute’s vision is a world free of cancer. As part of McLaren Health Care, Karmanos is the largest provider of cancer care and research in the state of Michigan. For more than 75 years, the administrative and research headquarters, along with the premier specialty cancer hospital, have been located in downtown Detroit. 15 network sites throughout the state deliver market-leading cancer care and clinical trials conveniently to the communities where many of its patients live. Karmanos is recognized by the National Cancer Institute as one of the best cancer centers in the nation.

Learn more about Karmanos Cancer Institute at karmanos.org.

About Hibiscus BioTechnology Hibiscus BioTechnology, a venture studio focused on building “Studio Companies” based on innovative technologies, engages in the process of building new companies by obtaining rights to technologies with the promise of underpinning development programs that can improve human health. Technologies, products, and business models are typically selected and designed to reach proof of concept or a meaningful clinical inflection within one to three years, representing significant potential value creation.

About Hibiscus BioVentures Hibiscus BioVentures (Hibiscus) is committed to advancing patient care by supporting the development of commercially viable therapies – building patient-focused companies around transformative technologies. Hibiscus has “two sides of the house,” a Venture Studio focused on building companies from the ground up, and a Venture Capital Firm focused on investing in promising early-stage biotechnology companies. Hibiscus brings years of experience building and investing in biotechnology companies and is led by a team of industry experts who can bring the resources necessary to successfully develop new therapies that address unmet patient needs.

Learn more about Hibiscus Biotechnology and Hibiscus BioVentures at hibiscusbio.com.

Contacts Media: Shani Lewis LaVoieHealthScience Email: slewis@lavoiehealthscience.com Phone: 609-516-5761

Tamara Collins Karmanos Cancer Institute Email: collinst@karmanos.org Phone: 734-476-9330

REGENXBIO Announces Initiation of Second Pivotal Trial

By | News | No Comments

OCKVILLE, Md., Jan. 10, 2022 /PRNewswire/ —

  • ASCENTTM, a Phase III clinical trial conducted in partnership with AbbVie, is expected to enroll patients in the United States and Canada
  • Pivotal trials expected to support BLA submission for RGX-314 in 2024

REGENXBIO Inc. (Nasdaq: RGNX) today announced the initiation of ASCENTTM, the second of two Phase III pivotal trials to evaluate the efficacy and safety of subretinal delivery of RGX-314 in patients with wet age-related macular degeneration (wet AMD). ASCENT, the first trial to be initiated by REGENXBIO under the eye care collaboration with AbbVie, is currently active and screening patients. RGX-314 is being investigated as a potential  one-time gene therapy for the treatment of wet AMD.

A Biologics License Application (BLA) is expected to be submitted to the United States Food and Drug Administration (FDA) in 2024 based on two pivotal trials, ASCENT and the ongoing ATMOSPHERE trial.

“The initiation of ASCENT is an important milestone for the pivotal program for subretinal delivery of RGX-314 in patients with wet AMD, and it is the first trial to be started under our partnership with AbbVie,” said Steve Pakola, M.D., Chief Medical Officer of REGENXBIO. “ASCENT is designed similarly to our ongoing ATMOSPHERE trial, and key design elements for both pivotal studies are based on the positive long-term data from our dose-escalation Phase I/IIa trial of RGX-314. We look forward to advancing both trials to support our goal of a BLA filing in 2024.”

“The initiation of this Phase III study, a first under our collaboration with REGENXBIO, is an important advancement in our continued pursuit of innovative treatments for patients living with difficult-to-treat retinal diseases, visual impairment, and devastating vision loss,” said Michael Robinson, MD, vice president, clinical development, ophthalmology, AbbVie. “We look forward to identifying the full potential of RGX-314 as part of our commitment to advancing vision care.”

ASCENT is a multi-center, randomized, active-controlled trial evaluating the efficacy and safety of subretinal delivery of RGX-314 across two dose arms, 6.4×1010 genomic copies per eye (GC/eye) and 1.3×1011 GC/eye, versus intravitreal injections of aflibercept, per label instructions. The primary endpoint of the trial is non-inferiority to aflibercept based on the change from baseline in Best Corrected Visual Acuity (BCVA) at one year. The trial will enroll approximately 465 patients across the two dose arms and the aflibercept control arm.

About RGX-314

REGENXBIO is investigating RGX-314 in collaboration with AbbVie as a potential one-time treatment for wet AMD, diabetic retinopathy, and other chronic retinal conditions. RGX-314 includes the NAV AAV8 vector containing a gene encoding for a monoclonal antibody fragment designed to inhibit vascular endothelial growth factor (VEGF). RGX-314 is believed to inhibit the VEGF pathway by which new, leaky blood vessels grow and contribute to the accumulation of fluid in the retina1.

Two separate routes of administration of RGX-314 to the eye are being evaluated, including a standardized subretinal delivery procedure as well as delivery to the suprachoroidal space. REGENXBIO has licensed certain exclusive rights to the SCS Microinjector® from Clearside Biomedical, Inc. to deliver gene therapy treatments to the suprachoroidal space of the eye.

About Wet AMD

Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina2. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone3. Current anti-VEGF therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients4. These therapies, however, require life-long repeated intraocular injections to maintain efficacy5,6 and patients often experience a decline in vision with reduced frequency of treatment over time7.

About ASCENT™

ASCENT is a multi-center, randomized, active-controlled trial to evaluate the efficacy and safety of a single administration of RGX-314 versus standard of care in patients with wet AMD. The trial is designed to enroll 465 patients at a 1:1:1 ratio across two RGX-314 dose arms (6.4×1010 genomic copies per eye (GC/eye) and 1.3×1011 GC/eye delivered subretinally) and an active control arm of bi-monthly intravitreal injections of aflibercept (0.5 mg/eye), per label instructions. The primary endpoint of the trial is non-inferiority to aflibercept based on change from baseline in Best Corrected Visual Acuity (BCVA) at one year. Secondary endpoints of the trial include safety and tolerability, change in central retinal thickness (CRT) and need for supplemental anti-VEGF injections in the treatment arms. Patient selection criteria will include patients with wet AMD who are responsive to anti-VEGF treatment and will be independent of preexisting neutralizing antibody status. Patients will not receive prophylactic immune suppressive corticosteroid therapy before or after administration of RGX-314. The trial will be conducted at approximately 70 clinical sites across the United States and Canada. REGENXBIO and partner AbbVie are collaborating and sharing costs on this trial.

About REGENXBIO Inc.

REGENXBIO is a leading clinical-stage biotechnology company seeking to improve lives through the curative potential of gene therapy. REGENXBIO’s NAV® Technology Platform, a proprietary adeno-associated virus (AAV) gene delivery platform, consists of exclusive rights to more than 100 novel AAV vectors, including AAV7, AAV8, AAV9 and AAVrh10. REGENXBIO and its third-party NAV Technology Platform Licensees are applying the NAV Technology Platform in the development of a broad pipeline of candidates in multiple therapeutic areas.

Forward-Looking Statements

This press release includes “forward-looking statements,” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These statements express a belief, expectation or intention and are generally accompanied by words that convey projected future events or outcomes such as “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “assume,” “design,” “intend,” “expect,” “could,” “plan,” “potential,” “predict,” “seek,” “should,” “would” or by variations of such words or by similar expressions. The forward-looking statements include statements relating to, among other things, REGENXBIO’s future operations and clinical trials. REGENXBIO has based these forward-looking statements on its current expectations and assumptions and analyses made by REGENXBIO in light of its experience and its perception of historical trends, current conditions and expected future developments, as well as other factors REGENXBIO believes are appropriate under the circumstances. However, whether actual results and developments will conform with REGENXBIO’s expectations and predictions is subject to a number of risks and uncertainties, including the timing of enrollment, commencement and completion and the success of clinical trials conducted by REGENXBIO, its licensees and its partners, the timing of commencement and completion and the success of preclinical studies conducted by REGENXBIO and its development partners, the timely development and launch of new products, the ability to obtain and maintain regulatory approval of product candidates, the ability to obtain and maintain intellectual property protection for product candidates and technology, trends and challenges in the business and markets in which REGENXBIO operates, the size and growth of potential markets for product candidates and the ability to serve those markets, the rate and degree of acceptance of product candidates, the impact of the COVID-19 pandemic or similar public health crises on REGENXBIO’s business, and other factors, many of which are beyond the control of REGENXBIO. Refer to the “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of REGENXBIO’s Annual Report on Form 10-K for the year ended December 31, 2020 and comparable “risk factors” sections of REGENXBIO’s Quarterly Reports on Form 10-Q and other filings, which have been filed with the U.S. Securities and Exchange Commission (SEC) and are available on the SEC’s website at www.sec.gov. All of the forward-looking statements made in this press release are expressly qualified by the cautionary statements contained or referred to herein. The actual results or developments anticipated may not be realized or, even if substantially realized, they may not have the expected consequences to or effects on REGENXBIO or its businesses or operations. Such statements are not guarantees of future performance and actual results or developments may differ materially from those projected in the forward-looking statements. Readers are cautioned not to rely too heavily on the forward-looking statements contained in this press release. These forward-looking statements speak only as of the date of this press release. Except as required by law, REGENXBIO does not undertake any obligation, and specifically declines any obligation, to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

About AbbVie AbbVie’s mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people’s lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

Contacts: Tricia Truehart Investor Relations and Corporate Communications 347-926-7709 ttruehart@regenxbio.com

Investors: Brendan Burns, 212-600-1902 brendan@argotpartners.com

Media: David Rosen, 212-600-1902 david.rosen@argotpartners.com

References

  1. Penn JS, Madan A, Caldwell RB, et al. Vascular endothelial growth factor in eye disease. Prog Retin Eye Res. 2008;27(4):331-71.
  2. Carmeliet P. Angiogenesis in life, disease and medicine. Nature. 2005;438:932-6.
  3. Decision Resources Group, 2019
  4. Alexandru MR, Alexandra NM. Wet age related macular degeneration management and follow-up. Rom J Ophthalmol. 2016;60:9–13.
  5. AAO PPP. Preferred Practice Patterns: Age related macular degeneration. American Academy of Ophthalmology. 2019.
  6. Dugel PU, Koh A, Ogura Y, et al. HAWK and HARRIER: phase 3, multicenter, randomized, double-masked trials of brolucizumab for neovascular age-related macular degeneration. Ophthalmology. 2020;127(1):72-84.
  7. Holz FG et al. Br J Ophthalmol. 2015;99:220.

 

SOURCE REGENXBIO Inc.

 

A regional economic development strategy and why commercial real estate should care

By | Uncategorized | No Comments
The U.S. Economic Development Administration announced last month the winners of $500,000 planning grants to 60 jurisdictions across the country for the $1 billion Build Back Better Regional Challenge. Winners of Phase 2 Build Back Better will be eligible for federal grants of up to $100M to create new science and technology parks and districts, accelerators, and other technology infrastructure across the country.

Funding for the technology infrastructure must go to a nonprofit, such as a university, but the nonprofit will need the commercial real estate industry to design, build and manage this technology infrastructure.

The District of Columbia/Maryland/Virginia (DMV) region submitted some very good bids, including ones in quantum technology, biotechnology, advanced manufacturing, and other topics but only Howard County for cyber security, Richmond, Virginia in bio manufacturing, and rural Southwest Virginia in transportation logistics won planning grants.

Given the region’s enormous amount of research and development, universities, federal labs, HBCUs, and other assets, it might have been expected that the three-jurisdiction region would have had more winning Phase 1 proposals. The District of Columbia did not win a grant at all.

One thing hampering the region’s efforts to win EDA funding is a lack of a regional CEDS — Comprehensive Economic Development Strategy. A CEDS is a necessary component of any EDA grant submission. Many counties in the DMV do not have a formally approved CEDS. Previously, CEDS were not that important, as the EDA had relatively little funding and much of it was restricted to economically distressed areas for water and sewer projects.

However, all of that has changed as the EDA has declared the entire U.S. as a distressed region, and Congress has given EDA an enormous amount of funds for a variety of purposes, including billions for new regional technology infrastructure grants.

The U.S. Innovation and Competition Act currently under consideration by Congress authorizes the EDA to receive approximately an additional $10 billion in future years for projects, including regional technology hubs. So, while the region might have punched under its weight with this round, our region and the real estate industry need to be prepared for the next.

Luckily, D.C., Maryland and Virginia were each given $1 million in planning funds by the EDA to do individual economic development strategies. Some of these funds could be used for the regional overlay purpose. The region should learn from the states of Massachusetts, Rhode Island, and Maine that collectively won an EDA planning grant for regional biotechnology manufacturing.

Adding a DMV regional CEDS overlay strategy in areas such as quantum, biotechnology, AI/machine learning, advanced manufacturing, aero and space tech, minority and small business development, HBCU outreach, community college involvement, bio manufacturing, workforce development, federal lab partnerships and other topics would help the region and real estate industry.

The Greater D.C. Partnership and Connected DMV have been doing great work, and adding a regional CEDS overlay zone is a practical way to increase odds of winning EDA funding in the future and creating greater regional cohesion, like our peers across the country.

 

 

Brian Darmody

CEO

Association of University Research Parks (AURP)

AURP DC Area Office

7761 Diamondback Drive

College Park, MD 20742

301-928-0527

briandarmody@aurp.net

www.aurp.net

Horizon Therapeutics plc Announces Significant Expansion of East Coast Research and Development and Technical Operations Capability

By | News | No Comments

DUBLIN–(BUSINESS WIRE)–Jan. 6, 2022– Horizon Therapeutics plc (Nasdaq: HZNP) announced today that it has signed a long-term, full-building lease with Alexandria Real Estate Equities, Inc. to be the first tenant at the Alexandria Center® at Traville Gateway campus in Rockville, Maryland. When completed, the state-of-the-art facility will serve as the company’s primary East Coast research and development and technical operations hub. Construction at the 192,000-square-foot site is underway and Horizon expects to start work on interior improvements in 2023. Additional terms of the agreement were not disclosed.

“Maryland has one of the fastest growing biotechnology communities in the country with a world-class talent pool of scientists and researchers,” said Tim Walbert, chairman, president and chief executive officer, Horizon. “With this new facility we are more than quadrupling our current Maryland footprint and creating a hub that will support job growth, drive our company’s continued efforts to develop new medicines for patients with rare, autoimmune and severe inflammatory diseases and meet the needs of our expanding pipeline. We look forward to expanding our presence in Maryland and appreciate the support from local, state and federal officials who recognize the economic and community value of the life science industry.”

“It is exciting news that Horizon Therapeutics has chosen Maryland for a significant expansion, which will enable the company to continue its important work in treating people impacted by rare, autoimmune and severe inflammatory diseases,” said Governor Larry Hogan. “It is a testament to our outstanding business climate and wealth of resources that we have seen so many life sciences companies expand and add thousands of new jobs in our state in recent years.”

“Maryland has quickly become a leader in cutting-edge medical research and development, thanks to companies like Horizon Therapeutics,” said Congressman David Trone. “Not only will this new center bring solutions to those suffering from rare, severe inflammatory, and rheumatic diseases, but it will also bring 21st-century jobs to folks right here in Montgomery County. I’m excited to welcome Horizon to our district, and I look forward to hearing of its future successes.”

“I am thrilled that Horizon Therapeutics has decided to call Montgomery County home for their East Coast research and development hub,” said Montgomery County Executive, Marc Elrich. “The mission and work of Horizon make them a natural fit for Montgomery County, and we stand ready to make them feel welcome in Rockville. Horizon’s move to the county is another point to show that Montgomery County is the home for life sciences in the region, and we are excited to continue our work to bring more companies of Horizon’s caliber to the region.”

Horizon is being represented in the transaction by CBRE.

About Horizon

Horizon is focused on the discovery, development and commercialization of medicines that address critical needs for people impacted by rare, autoimmune and severe inflammatory diseases. Our pipeline is purposeful: We apply scientific expertise and courage to bring clinically meaningful therapies to patients. We believe science and compassion must work together to transform lives. For more information on how we go to incredible lengths to impact lives, visit www.horizontherapeutics.com and follow us on TwitterLinkedInInstagram and Facebook.

Forward Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the expected timing and benefits of the lease and Horizon’s plans and expectations related to its operations in Maryland. These forward-looking statements are based on Horizon’s current expectations and inherently involve significant risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks and uncertainties associated with relocating certain of its existing East Coast operations to the new facility, retaining and hiring qualified personnel at the facility, risk associated with research and development of novel therapeutics and risks associated with the COVID-19 pandemic. For a further description of these and other risks facing Horizon, please see the risk factors described in Horizon’s filings with the United States Securities and Exchange Commission, including those factors discussed under the caption “Risk Factors” in those filings. Forward-looking statements speak only as of the date of this press release and Horizon undertakes no obligation to update or revise these statements, except as may be required by law.

U.S. Media Contact:
Geoff Curtis
Executive Vice President, Corporate Affairs and Chief Communications Officer
media@horizontherapeutics.com

Investor Contacts:
Tina Ventura
Senior Vice President, Investor Relations
Investor-relations@horizontherapeutics.com

Ruth Venning
Executive Director, Investor Relations
Investor-relations@horizontherapeutics.com

Ireland Media Contact:
Gordon MRM
Ray Gordon
ray@gordonmrm.ie

Source: Horizon Therapeutics plc

BioBuzz: Charlottesville’s Molecular Biologicals is Changing the Game in Wound Care

By | News | No Comments

Imagine you’re working outside and accidentally cut your foot on a protruding stick you didn’t see. No big deal. You go inside and wash the wound, perhaps applying an antibiotic cream, and dress it in a bandage. Days and weeks, even months go by, however, and the wound just doesn’t want to seem to fully heal. Even the simplest of tasks such as walking becomes extremely painful, and just one wrong move reopens the wound.

For millions around the world, this is their daily reality. From diabetic ulcers to bedsores, from burns to cancer complications to infections, chronic wounds are complex and vastly underappreciated as a therapeutic space.

Molecular Biologicals, located in the blossoming biotech hub of Charlottesville, VA, is working to change the game in chronic wound care through its unique and proprietary keratin manufacturing platform.

Click here to read more via BioBuzz.

Zalgen Labs’ move to Frederick is another sign of the BioHealth Capital Region’s strengths

By | News | No Comments

Maryland biotech company Zalgen Labs has moved to Frederick, illustrating the magnetism of the biotech hub for leaders like its own Dr. Luis Branco who want to capitalize on the new sense of collaboration the pandemic has brought about in life sciences companies in the region.

The move to Frederick puts Zalgen closer to the epicenter of what’s known as BioHealth Capital Region (BHCR) that encompasses Maryland, Virginia and DC. Frederick alone is home to over 80 biotech companies, according to the county’s Office of Economic Development.

After eight years at the Germantown Innovation Center in Montgomery County — also in the BHCR along the the vaunted I-270 corridor — Zalgen told Technical.ly he’s thankful for the opportunities there but excited to grow in Frederick, which is home to more biotech companies in their specific niche.

“This is one of the premier places in the world for hemorrhagic fever virus research,” said Branco, Zalgen’s cofounder and managing director, about Frederick. “That’s basically what we do. I think we’ll complement that aspect of the local biotech space.”

Click here to read more via technical.ly

Join our Mailing List