Intravacc Receives US NIH/NIAID Contract to Develop Enterovirus D68 Vaccine

Intravacc | September 08, 2020

Intravacc, a global leader in translational research and development of viral and bacterial vaccines, today announced that it has been awarded a contract with base and options that may total US$9.4 million from the US National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), for the development of a prophylactic vaccine against enterovirus D68 (EV D68). EV D68 is a respiratory virus that can cause childhood paralysis, Acute Flaccid Myelitis (AFM). Intravacc will develop an inactivated EV D68 vaccine, based on Intravacc's proprietary Vero cell technology, from early product selection through to Phase I clinical testing.

Spotlight

Artemisinin-based combination therapy (ACT) is the best available treatment to treat malaria Thanks to a successful partnership with Medicines for Malaria Venture (MMV), a dispersible version is now available for children.

Spotlight

Artemisinin-based combination therapy (ACT) is the best available treatment to treat malaria Thanks to a successful partnership with Medicines for Malaria Venture (MMV), a dispersible version is now available for children.

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BUSINESS INSIGHTS

WuXi STA Opens New Large-scale Oligonucleotide and Peptide Manufacturing Facility

WuXi STA | July 07, 2022

WuXi STA, a subsidiary of WuXi AppTec, announced the opening of a new large-scale oligonucleotide and peptide manufacturing facility at its Changzhou campus. The new facility underscores WuXi STA's ongoing commitment to enhance its capacity and capability to meet the fast-growing customer needs for oligonucleotide and peptide therapeutics development and manufacturing worldwide, making more innovative therapies accessible to the patients. With the opening of the new 30,570 sq.ft. oligonucleotide plant, WuXi STA extends its leadership in oligonucleotide development and manufacturing worldwide, with four large-scale oligonucleotide production lines and more than 20 small- to mid-scale production lines that increase the overall manufacturing capacity of a single synthesis run from 1.9 mol to 6.0 mol. The new 22,260 sq.ft. peptide plant features three new production lines with reactors that can accommodate up to 1,000 L, increasing WuXi STA's overall Solid Phase Peptide Synthesis total reactor volume to 6,490 L. The new facility is an essential part of WuXi STA's comprehensive end-to-end Contract Research, Development, and Manufacturing Organization platform for new modalities. The platform supports oligonucleotides and peptides, including novel monomers and linkers, and complex conjugates, from early discovery to development and commercial production at any scale. With this enhanced manufacturing capacity and over 850 dedicated scientists, WuXi STA's new modality CRDMO platform can better enable global partners as their projects progress to late and commercial stages. In addition, WuXi STA offers injectable formulation development and manufacturing services, including Lipid NanoParticle technology as well as comprehensive analytical and Chemical, Manufacturing, and Controls dossier preparation services, which further accelerate the development of new oligonucleotide and peptide therapeutics for the market. "We are pleased to support our global partners in their efforts to develop new modality therapies for patients in need. WuXi STA is committed to enabling partners by enhancing our new modality CRDMO platform's capacity and capability to expedite the development and commercialization of more innovative therapies to benefit patients worldwide." Dr. Minzhang Chen, Co-CEO of WuXi AppTec and CEO of WuXi STA WuXi STA has a global network of multiple R&D and manufacturing sites across Asia, North America and Europe, including a new pharmaceutical manufacturing campus in Middletown, Delaware that is scheduled to open in 2024. About WuXi STA WuXi STA, a subsidiary of WuXi AppTec, is a leading pharmaceutical development and manufacturing capability and technology platform company serving the life sciences industry with operations across Asia, North America and Europe. As a premier Contract Research, Development, and Manufacturing Organization, WuXi STA offers our worldwide partners efficient, flexible, and high-quality solutions for integrated CMC solutions from preclinical to commercial uses.

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QHP Capital Acquires Lexitas Pharma Services

Lexitas and QHP Capital | July 08, 2022

QHP Capital the management company for NovaQuest Private Equity announced its acquisition of Lexitas Pharma Services a full-service ophthalmology contract research organization supporting biopharmaceutical and medical device clinical trials. Since 2011, Lexitas has provided clinical trial and medical strategy solutions to biopharmaceutical and medical device companies developing ophthalmic products. The Company provides end-to-end support and development expertise in the anterior and posterior segments of ophthalmology. Lexitas has conducted clinical trials for dry eye disease, glaucoma, cataract, uveitis, pediatric myopia, diabetic macular edema, age-related macular degeneration, and retinitis pigmentosa, among others. The Company’s therapeutic area expertise, relationships with ophthalmic KOLs, and network of high-performing research sites has led to strong outcomes for its international customer base. “For the past decade, Lexitas has had the incredible opportunity and privilege to partner with talented companies with amazing science as they develop their ophthalmic drugs and devices. Partnering with the QHP team brings deep expertise and domain knowledge that is going to allow Lexitas to improve and increase the scope, quality, and efficiency of our capabilities. We couldn’t be more thrilled to be working with QHP and are excited at the prospect of getting safe and efficacious ophthalmic drugs to patients efficiently and quickly,” George Magrath, M.D., CEO of Lexitas “Lexitas is an excellent fit with QHP’s philosophy and strategy of providing strategic capital to growing clinical trial services providers in niche, specialized therapeutic areas,” said Vern Davenport and Jeff Edwards, Partners at QHP. “We look forward to supporting the Lexitas team as they continue to build out their capabilities and provide best-in-class ophthalmic drug development services.” Additionally, Lexitas appointed Jeanne Hecht as Executive Chairwoman of the Board. Jeanne is a seasoned ophthalmology CRO industry executive having previously served as CEO of Ora, an ophthalmic CRO, where she expanded Ora’s international presence, introduced new lines of business, and furthered its goals along numerous strategic paths. About Lexitas Lexitas is a full-service ophthalmic biopharmaceutical solutions company focused on providing end-to-end eyecare support and exceptional service to biopharma and medical device clients globally. About QHP Capital QHP Capital, L.P. is the management company for NovaQuest Private Equity NQPE is a private equity firm that invests in lower middle market healthcare companies primarily in North America. The Firm invests in services and technology companies where a strategic partner and operating resources can accelerate growth, targeting companies in healthcare and pharmaceutical services industries. NQPE invests in the form of buyouts, growth equity, and recapitalizations.

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AMPLICORE, INC. ANNOUNCES US FDA CLEARANCE OF FIRST INVESTIGATIONAL NEW DRUG APPLICATION (IND) AND ADDITION OF EXPERIENCED FINANCIAL LEADER TO BOARD

Amplicore, Inc. | July 15, 2022

Amplicore Inc., a Mason, OH-based, early-stage biopharmaceutical company specializing in the development of minimally invasive therapeutic solutions for musculoskeletal disorders, today announced that the Food and Drug Administration has cleared their first application for AM3101, a novel treatment to promote healing of acute meniscal tears. The move enables the initiation of a Department of Defense-sponsored phase 1/2b clinical study in concert with the University of Cincinnati. The FDA clearance marks the company's transition into a clinical stage company. In addition to AM3101, the company's pipeline also includes AM1101, which is being developed for osteoarthritis, and AM2101, with an indication to treat degenerative disc disease. "We are very proud to announce the clearance for AM3101. Despite their commonality, service men and women have limited treatment options for acute meniscal tears. While suturing is often the most frequent approach, the failure rate for surgery is quite high due to the limited reparative capacity of much of the tissue. Our research has found that our Active Pharmaceutical Ingredient (API) provides pain relief and promotes regeneration of the meniscus, as well as several other structurally related joint tissues. In this way, the transition of Amplicore into a clinical stage company represents a critical development for all patients suffering from musculoskeletal conditions." Chief Executive Officer/Founder Dr. James Lin Amplicore also announced the addition of Steve Schrader to its advisory board. A high-impact financial leader with three decades of experience in corporate finance, Schrader has held Chief Financial Officer positions in a variety of industries, including an international auto glass company, a private healthcare company, a Fortune 500 public utility, and a NASDAQ-listed startup. Throughout his career, Steve has increased revenue and raised over $1.3 Billion in capital for companies. He has also taken two firms from start-up to manufacturing. Schrader will advise on financial planning and fundraising efforts. "Amplicore is a leader in developing injectable therapeutics for musculoskeletal disorders. I am excited to join the board during this pivotal time as they work to close their Series A investment round, and I look forward to being a part of their future success." ABOUT AMPLICORE, INC. Amplicore, Inc. is an early-stage biotech start-up company based on technology developed in the laboratory of CEO/Founder Dr. Chia-Ying Lin at the University of Cincinnati. Headquartered in Mason, OH, the company is dedicated to developing novel injectable therapeutics to serve unmet medical needs for degenerative musculoskeletal disorders. Unlike current therapies that focus solely on palliative treatment, Amplicore is also taking a regenerative approach to treating these disorders. The company's lead products, AM3101, AM1101, and AM2101, address significant deficiencies in the current standard of care for the treatment of acute meniscal tear, osteoarthritis, and degenerative disc disease, respectively. Amplicore's overall mission is to translate scientific innovation into effective but minimally invasive products that can be easily delivered to patients.

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