All Posts By

Andrew Eckert

Altimmune Announces Successful Pre-IND Meeting with FDA

By | News | No Comments

Meeting on HepTcell Phase 2 program for treatment of chronic hepatitis B (HBV)

GAITHERSBURG, Md., June 10, 2019 (GLOBE NEWSWIRE) — Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, today announced that it successfully completed a pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) regarding its Phase 2 trial design and manufacturing plans for HepTcell. The FDA did not object to the planned study design and patient populations, as well as plans for manufacturing and product testing, and did not recommend any additional studies in preparation for an IND submission and initiation of Phase 2 trials. A recently completed Phase 1 study in chronically infected subjects was performed in the United Kingdom and South Korea. Altimmune intends to conduct a Phase 2 study in the United States and the pre-IND meeting was held to obtain feedback from the FDA on our intended development path.

“We are pleased to have completed the pre-IND meeting with the FDA and will move forward with our plans to file the IND and initiate a Phase 2 trial of HepTcell,” said Vipin K. Garg, Ph.D., President and Chief Executive Officer of Altimmune. “We appreciate the FDA’s guidance as we endeavor to find a cure for chronic hepatitis B.”

HepTcell is an immunotherapeutic product candidate composed of nine synthetic peptides chosen from across the HBV proteome with a proprietary T-cell epitope identification method. In a Phase 1 clinical study conducted under clinical trial agreement in the United Kingdom and South Korea, three monthly injections at two dose levels of HepTcell peptides were given with and without IC31® adjuvant (Valneva) as add-on therapy to entecavir or tenofovir in patients with HBe antigen negative chronic infections. All arms were well tolerated, and both high and low peptide doses given in combination with IC31® resulted in increased cellular immune responses against HBV antigens.

Breaking immune tolerance against HBV antigens is the key to clearance of infection. This occurs naturally in the majority of acute HBV infections through a T-cell immune response. However, in chronically infected patients immune tolerance prevents the clearance of the virus and these patients can progress to cirrhosis and are at risk of developing liver cancer. Currently licensed treatments do not clear infection and require lifelong therapy to control the disease. The goal of all HBV therapeutics currently in development is to achieve functional cure by reactivating the T-cell immune response, either indirectly by further lowering the HBV antigen expression, or directly, as is the goal of HepTcell.

In the planned Phase 2 trial, Altimmune will evaluate immune responses after a 6-month treatment course of HepTcell in an expanded population of HBV infected patients. The Phase 2 trial is anticipated to start in 2020.

Click here to read the entire press release.

Emergent BioSolutions Awarded 10-Year HHS Contract Valued at Approximately $535 Million to Deliver Vaccinia Immune Globulin Intravenous (VIGIV) in Support of Smallpox Preparedness

By | News | No Comments

GAITHERSBURG, Md., June 03, 2019 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE: EBS) today announced a contract award by the Office of the Assistant Secretary for Preparedness and Response (ASPR) in the U.S. Department of Health and Human Services (HHS) valued at approximately $535 million over 10 years for the continued supply of Vaccinia Immune Globulin Intravenous (VIGIV) into the U.S. Strategic National Stockpile (SNS) in support of smallpox preparedness.

“Emergent is pleased to continue its successful track record of being a solutions provider to governments to help address serious public health threats such as smallpox,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “VIGIV is the only product licensed by the U.S. Food and Drug Administration (FDA) for the treatment of complications due to smallpox vaccination. We look forward to delivering on this long-term $535 million contract to supply VIGIV, which, together with our ACAM2000®, (Smallpox (Vaccinia) Vaccine, Live) smallpox vaccine, are integral to the government’s overall preparedness and response strategy to have a sustainable and sufficient supply of medical countermeasures in the SNS to protect the U.S. population against the threat of smallpox.”

The contract consists of a one-year base period of performance valued at $23 million and nine option years that, when exercised, would bring the total contract value to approximately $535 million. The scope of work under the contract includes the collection of plasma, manufacturing, and delivery of finished drug product. During year one, Emergent will use plasma provided by the U.S. government to manufacture VIGIV doses, while all subsequent years will involve Emergent-led plasma collection and production efforts resulting in higher annual revenue potential. VIGIV is the only therapeutic licensed by the FDA for the treatment of complications due to smallpox vaccination and has been stockpiled at a ratio of one dose of VIGIV per 10,000 doses of first or second generation smallpox vaccine (https://www.cdc.gov/mmwr/pdf/rr/rr6402.pdf). This multi-year contract follows the conclusion of a one-year, $26 millionprocurement contract signed with the U.S. government in February 2018.

“Through this 10-year contract with HHS, Emergent is honored to continue its long-term partnership with the U.S. government, whose support of the VIGIV program reflects its commitment to protect the population against serious public health threats,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent. “The VIGIV product has been a critical component of the government’s preparedness strategy, dating back to 2002 when it was first procured for inclusion in the stockpile.”

Click here to read the entire release.

With $110M and Johns Hopkins tech, Thrive aims to make early cancer screening routine

By | News | No Comments

Steven Kafka, the former Foundation Medicine chief operating officer who landed at Third Rock Ventures after a globetrotting “gap year,” has a new gig: CEO of Thrive Earlier Detection, a liquid biopsy company looking to catch cancer earlier through a routine blood test.

The company comes to life with $110 million in series A financing and CancerSEEK, a liquid biopsy test licensed from Johns Hopkins University that measures DNA and proteins in the blood to screen for multiple cancers. Third Rock led the financing, with Section32, Casdin Capital, Biomatics Capital, BlueCross BlueShield Venture Partners, Invus, Exact Sciences, Cowin Venture, Camden Partners, Gamma 3 and others pitching in.

“The context of launching Thrive is about being part of a shift in the oncology community toward earlier detection,” Kafka told FierceBiotech. “Most of the resources in our industry, on the drug discovery and development side or the diagnostics side, tend to focus on late-stage disease, where folks are already pretty sick, and their options are fairly limited.”

Click here to read more via fiercebiotech.

Navitas Life Sciences buys up KAI Research, adding to later-stage trial offerings

By | News | No Comments

Contract research organization KAI Research has been snapped up by fellow CRO Navitas Life Sciences as it looks to boost its study offerings.

Specifically, the buy, financial details of which have not been shared, will see Navitas expand its phase 2 and 3 trial work in North America while adding to its current capabilities in Europe and the Asia-Pacific region.

The integration of KAI into Navitas will also help “support larger and more complex clinical deals with addition of sites and local clinical trial management capabilities in U.S.,” it said in a statement.

Given KAI’s focus, the deal also strengthens Navitas’ therapeutic expertise in mental health, musculoskeletal diseases, neurological disorders, pain, diabetes, infectious diseases and oncology.

Srinivasan H R, managing director of Navitas, said: “We are on track in terms of our acquisitions, KAI Research will further strengthen our capabilities in clinical services and expand our therapeutic expertise. Through this acquisition, we also gain a unique standpoint in serving Federal agencies like FDA, NIH, CDC, Department of Defense etc.

Click here to read more via fiercebiotech.

With FDA Approval Of Zolgensma, Regenxbio Sets Out For First Revenue Stream

By | News | No Comments
Summary:

Regenxbio expects to obtain royalty payments from Novartis for Zolgensma after it was approved by the FDA to treat patients with spinal muscular atrophy.

To date, Regenxbio has taken in about $190 million in payments for Zolgensma, with a lot more expected as the drug starts being sold on the market.

Regenxbio has a robust NAV technology platform and about 100 or more AAV vectors in its arsenal to target a host of different types of diseases.

The most promising treatment stemming from the biotech would be RGX-314 which is being developed to treat patients with wet age-related macular degeneration.

Regenxbio (RGNX) announced that a gene therapy developed based on its technology was approved by the FDA. This gene therapy product is known as Zolgensma, which Novartis (NVS) now owns after acquiring AveXis for $8.7 billion back in 2018. While Novartis does own Zolgensma, it will have to pay royalties to Regenxbio on net sales for it. That means Regenxbio can start earning revenue for one of its very first products. The company is in good shape because it has many other gene therapy programs in its pipeline. The most notable one would be RGX-314, which is being developed to treat patients with wet age-related macular degeneration.

Click here to read more via Seeking Alpha.

Johns Hopkins founded medical research firm LifeSprout gets financing boost

By | News | No Comments

A Baltimore-based regenerative medicine firm called LifeSprout, which makes synthetic products used to restore soft tissue, has secured $6.5 million in financing.

LifeSprout, a private company founded out of Johns Hopkins University, said Wednesday it closed on seed-stage financing to develop the first products using its Regenerative Matrix technology, which uses materials designed to look and feel like natural tissues. The injectable material is designed to prevent scarring.

Hopkins researchers said in a scientific paper this month that the technology could help patients suffering soft tissue losses from tumor removal, trauma or aging.

LifeSprout’s first product is an aesthetic dermal filler called Lumina. The financing will allow the company to develop additional regenerative medicine products targeting rare diseases.

“In a few years we have taken the technology from inception at Johns Hopkins to pre-clinical manufacturing of our first products in aesthetic medicine,” said Dr. Sashank Reddy, co-founder and president of LifeSprout, in an announcement.

Read more via the Baltimore Sun.

Qiagen launches companion test for Novartis breast cancer treatment

By | News, Partner News | No Comments

Dive Brief:

  • Qiagen said it has launched the first FDA-approved companion diagnostic for identifying breast cancer patients who may benefit from treatment with Novartis’ Piqray (alpelisib).
  • Novartis last week announced FDA approval of the kinase inhibitor designed specifically for hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative​ advanced breast cancer patients with a PIK3CA mutation.
  • Qiagen said it has a worldwide co-exclusive license from Johns Hopkins University for PCR-based companion diagnostics based on mutations in the PIK3CA gene.

Click here to read more via Med Tech Drive.

Viela Bio Enters Strategic Collaboration with Hansoh Pharma to Develop and Commercialize Inebilizumab for Autoimmune Diseases and Hematologic Cancers in China

By | News | No Comments

Partnership accelerates access to inebilizumab in China and supports the mission of both companies to bring transformative therapies to more patients around the world

Viela Bio is eligible to receive an upfront collaboration fee and milestone payments of more than $220 million plus royalties on product sales

GAITHERSBURG, Md. & SHANGHAI–(BUSINESS WIRE)–Viela Bio, Inc. (“Viela”) and Hansoh Pharmaceutical Group Company Limited (“Hansoh Pharma”) today announced a collaboration focused on development and commercialization of inebilizumab – Viela’s humanized anti-CD19 monoclonal antibody – in China for neuromyelitis optica spectrum disorder (NMOSD), as well as other potential inflammation/autoimmune and hematologic malignancy indications.

“Our collaboration with Hansoh Pharma strengthens our ability to commercialize inebilizumab throughout the world,” commented Bing Yao, Ph.D., Viela’s Executive Chairman and Chief Executive Officer. “Their significant commercial, regulatory and clinical development infrastructure gives us a strong strategic partner in China and also may provide support for our global product expansion and lifecycle plans.”

Under terms of the collaboration, Viela will receive an up-front collaboration fee and additional payments contingent on certain development, regulatory, and commercial milestones, totaling potentially more than $220 million, plus tiered royalties on net sales. Hansoh Pharma will be responsible for leading development and commercialization of inebilizumab in China.

“We are thrilled to partner with Viela. They have shown that targeting CD19 to achieve sustained B cell depletion is a compelling monotherapy strategy that brings profound benefits to patients with NMOSD, for whom there is no approved therapy,” said Aifeng Lyu, Ph.D., President of Hansoh Pharma. “Viela is a leader in researching and developing breakthrough treatments for inflammation and autoimmune diseases. Together, we will endeavor to advance inebilizumab as quickly as possible for patients in China, as well as seek to broaden the potential of inebilizumab via combination therapies.”

Viela recently presented positive results from a pivotal study of inebilizumab in patients with neuromyelitis optica spectrum disorder (NMOSD) – a rare autoimmune disease characterized by unpredictable attacks that often lead to severe, irreparable disability including blindness and paralysis. Inebilizumab is not yet approved for sale in either the United States or China. Viela expects to file for a Biologics License Application with the U.S. Food and Drug Administration (FDA) in mid-2019.

Click here to read the entire release.

The Catalyst: Creating Innovation in Health Care – United Therapeutics’ Martine Rothblatt at Healthy Returns

By | News | No Comments

There are few, if any, more innovative, more daring, and more iconic health care executives. We’ll hear about the process that drives groundbreaking invention, and her dream of permanently alleviating the shortage of transplantable organs.Martine Rothblatt, founder and CEO of United Therapeutics presents her organization’s latest innovation, followed by a conversation with “Fast Money” Host and “Power Lunch” co-anchor, Melissa Lee.

Click here to watch the video interview via yahoo.com and CNBC

Regenxbio building Maryland AAV plant to support gene therapies

By | News | No Comments

Regenxbio will construct a GMP facility in Maryland to produce adeno-associated viral vectors for its gene therapy programs using its NAV technology-based platform.

The good manufacturing practice (GMP) plant will be integrated into Regenxbio’s 132,000 square-foot headquarters in Rockville, Maryland, currently under construction. Financial details have not been disclosed but the manufacturing plant is expected to be operational in 2021.

“The creation of this additional manufacturing capacity using our platform suspension cell culture process will allow us to more efficiently advance our development programs from research stage to the clinic and ultimately to patients, while ensuring manufacturing capacity availability,” chief technology officer Curran Simpson said in a statement.

The plant will support the firm’s multiple gene-therapy programs through the production of Regenxbio’s NAV Technology-based vectors at scales up to 2,000 liters.

“Regenxbio’s novel and unique approach to gene therapy focuses on enabling cells in the body to produce therapeutic proteins or antibodies and targeting and correcting genetic defects,” Kenneth Mills, CEO of Regenxbio, said earlier this month during a financial conference call.

“Our NAV Technology serves as a backbone gene therapy research and is widely utilized gene therapy platform across diverse disease applications.”

The technology consists of over 100 adeno-associated viral (AAV) vectors including AAV7, AAV8, AAV9 and AAVrh10, which deliver engineered genes to cells. It has so far been used to treat over 200 patients in clinical trials for Regenexbio and its licensee partners.

Click here to read more via BioProcess International

Join our Mailing List