Monthly Archives

February 2022

United States Pharmacopeia CEO Ron Piervincenzi, Ph.D., returns to BioTalk

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Ron Piervincenzi, Ph.D., CEO of United States Pharmacopeia, sits down with host, Rich Bendis, to discuss USP’s growth since his last visit, the nature of their organization, and plans on hosting the 2022 BioHealth Capital Region Forum in person at their beautiful building in Rockville, Maryland.

Listen now via Apple, Google, Spotify, and TuneIn

Ronald T. Piervincenzi, Ph.D., has served as Chief Executive Officer of the United States Pharmacopeia since February 2014. Dr. Piervincenzi provides strategic leadership to USP’s global staff of over 1,300 across sites in the US (Rockville, Frederick, D.C.), India, China, Ghana and Switzerland, and global public health field offices including Nigeria, Indonesia, Ethiopia, and Kenya. His transformative vision has launched key USP initiatives in bringing quality across the healthcare spectrum, upholding USP’s reputation as a quality leader since its founding in 1820. Under his leadership, USP has modernized its operations and launched innovative new science, including in the areas of digital medicine, cutting-edge manufacturing technologies and advanced biologics. More recently, USP has begun building a robust “capability building” services suite of offerings including quality manufacturing consulting, donor-funded work, and education. Dr. Piervincenzi served as Chair of the Council of Experts, USP’s scientific standards-setting body of 24 Expert Committees and over 750 standards-setting experts until June 2015, when he transferred this responsibility to USP’s new Chief Science Officer.

Dr. Piervincenzi brings more than 20 years of industry experience across pharmaceutical sciences, research and business strategy. Before joining USP, Dr. Piervincenzi served as Vice President of Development Sciences with Biogen Idec, Inc., where he designed and launched Biogen’s value-based medicine group focusing on applying tools and technologies of personalized medicine in the treatment and management of multiple sclerosis. Dr. Piervincenzi was a partner and leader in McKinsey & Company’s global pharmaceutical and medical products practice for over 12 years. In this capacity, Dr. Piervincenzi launched McKinsey’s global drug safety, medical and regulatory service line. With McKinsey, Dr. Piervincenzi also led the global research and information analytics team, managing staff in New Jersey, London, Brussels, and India.

Dr. Piervincenzi earned his M.S. and Ph.D. from Duke University in Biomedical Engineering, with research focused on protein engineering. He is the proud co-founder and chairman of the board for MENTOR Newark.

Click here to read the transcript.

Children’s National uses HIFU to perform first ever non-invasive brain tumor surgery

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Children’s National Hospital successfully performed the first-ever high-intensity focused ultrasound (HIFU) surgery on a pediatric patient with neurofibromatosis (NF). This is the youngest patient to undergo HIFU treatment in the world. The advancement of children’s medical devices in the U.S. continues to significantly lag behind adult devices. This is why this milestone marks a significant advance in making pediatric surgery more precise and less invasive.

The hospital is offering this treatment to patients under an ongoing research clinical trial. Children’s National is one of the first pediatric hospitals in the nation to use HIFU for neuro-oncology patients. It’s also the first hospital in the world to use it to treat a pediatric patient with NF. NF is a condition that occurs in approximately 1 in 3,500 births and causes tumors to form in the brain, spinal cord and nerves.

“Using HIFU to treat our pediatric patients is a quantum leap towards non-invasive surgery for kids,” said Robert Keating, M.D., division chief of Neurosurgery and co-director of the HIFU program at Children’s National. “It’s exciting because the future is now here and it’s significantly better for our kids, in terms of non-invasive surgery with lower risk of complications and no exposure to radiation.”

Focused ultrasound (FUS) is a non-invasive therapeutic technology with the potential to transform the treatment of many medical disorders by using ultrasonic thermal energy to specifically target tissue deep in the body. The technology can treat without incisions or the need of radiation.

Click here to read more via Children’s National.

MaxCyte Signs Strategic Platform License with Intima Bioscience to Advance Tumor Infiltrating Lymphocytes Programs

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Intima Bioscience to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform to accelerate the development of its solid tumor cell-therapy candidates NEW YORK and GAITHERSBURG, Md., Jan. 31, 2022 (GLOBE NEWSWIRE) — MaxCyte, Inc., (Nasdaq: MXCT; LSE: MXCT, MXCN), a leading provider of enabling platform technologies for ex-vivo cell engineering, today announces the signing of a strategic platform license (SPL) with Intima Bioscience, Inc., a clinical stage biotechnology company developing genetically engineered cell therapies for solid tumor cancer. Intima joins a group of 15 other leading cell therapy companies who have partnered with MaxCyte.

Under the terms of the agreement, Intima obtains non-exclusive clinical and commercial rights to use MaxCyte’s Flow Electroporation® technology and ExPERT™ platform. In return, MaxCyte is entitled to receive platform licensing fees and program-related milestone payments.

Intima is currently running a Phase 1/2 clinical study (NCT04426669) of its lead checkpoint cell therapy candidate, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

“As we advance our innovative eTIL CISH knock out programs, we are preparing for the future by securing access to MaxCyte’s industry leading cellular engineering technology,” said Alessandro Riva, M.D., Intima CEO.

Doug Doerfler, President and CEO of MaxCyte, said: “We are proud to be working with Intima, a cell therapy leader leveraging the unique power of genetically engineered tumor infiltrating lymphocytes (eTIL). This relationship represents an important achievement for MaxCyte as it expands the use of our next-generation technology platform to support engineering in additional novel cell types.”

MaxCyte’s ExPERT™ instrument portfolio is the next generation of leading, clinically-validated, electroporation technology for complex and scalable cell engineering. By delivering high transfection efficiency, seamless scalability and enhanced functionality, the ExPERT™ platform delivers the high-end performance essential to enabling the next wave of biological and cellular therapeutics. Intima Bioscience is MaxCyte’s 16th SPL, which generate pre-commercial milestone revenue and the vast majority of which include post-commercial revenue.

About MaxCyte

MaxCyte is a leading commercial cell-engineering company focused on providing enabling platform technologies to advance innovative cell-based research as well as next-generation cell therapeutic discovery, development and commercialization. Over the past 20 years, we have developed and commercialized our proprietary Flow Electroporation® platform, which facilitates complex engineering of a wide variety of cells. Our ExPERT™ platform, which is based on our Flow Electroporation technology, has been designed to support the rapidly expanding cell therapy market and can be utilized across the continuum of the high-growth cell therapy sector, from discovery and development through commercialization of next-generation, cell-based medicines. The ExPERT family of products includes: four instruments, the ATx™, STx™ GTx™and VLx™; a portfolio of proprietary related processing assemblies or disposables; and software protocols, all supported by a robust worldwide intellectual property portfolio.

About Intima Bioscience

Intima Bioscience is a company advancing checkpoint cell therapy, an approach that combines the use of patients’ own immune cells with immune checkpoint targeting, in solid tumors with curative intent. Intima is currently running a Phase 1/2 clinical study of its checkpoint cell therapy, which targets the immune checkpoint CISH in patients with gastrointestinal and colon cancers.

MaxCyte Contacts:

US IR Adviser Gilmartin Group David Deuchler, CFA

+1 415-937-5400

Nominated Adviser and Joint Corporate Broker Panmure Gordon Emma Earl / Freddy Crossley Corporate Broking Rupert Dearden

+44 (0)20 7886 2500

UK IR Adviser Consilium Strategic Communications Mary-Jane Elliott Chris Welsh

+44 (0)203 709 5700

American Gene Technologies’ HIV Clinical Trial Shows Blood Markers of Efficacy in Two More Patients

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Data from a Total of Five Patients Demonstrates Critical Markers of the Company’s HIV Cure Gene & Cell Therapy American Gene Technologies (AGT), a clinical-stage biotechnology company working to cure HIV, announced that it has reached another important milestone for its HIV cure program. Five participants were treated with AGT103-T and are stably engrafted with genetically modified cells.

Laboratory studies confirmed substantial increases in virus-specific T cells consistent with improved immunity against HIV in all participants. The early data addresses key trial endpoints and is aligned with the objective of restoring natural immunity against HIV.

“These latest laboratory studies of clinical material are extremely encouraging,” said AGT CEO Jeff Galvin. “To see these markers in all five trial participants indicates that prospects are bright for a potential one-and-done therapy to functionally cure HIV. This milestone brings us another step closer to our goal of returning people living with HIV to a normal life without the side effects of ART and having no further consequences of HIV.”

To date, all participants that have been infused with the cell and gene therapy product AGT103-T are engrafted with modified cells and are displaying enhanced antiviral T cell immunity. The treatment withdrawal studies are planned to begin in Q2 and will test the efficacy of this therapy. AGT is moving closer to the goal of allowing people living with HIV to discontinue daily medication without fear of developing AIDS or infecting others.

Phase 1 Trial Background

  • Overview: Designated the RePAIR trial (Restore Potent Antiviral Immune Responses, NCT04561258), AGT’s first-in-human study for AGT103-T is currently underway at trial sites in the Maryland / Washington, D.C. area. Participants in the Phase 1 trial receive a single infusion of their own HIV-specific CD4 T cells after those cells are enriched and genetically modified to resist infection. Without any observed negative or adverse events, the DSMB has allowed the trial to continue without adjustments or delays.
  • Focus: The primary endpoints of RePAIR are safety and efficacy. Testing related to secondary endpoints evaluates responses to treatment, including changes in the immune response to HIV.
  • Participant Criteria: Participants range in age from 18 to 60 and include males and females. Participants have been diagnosed with HIV for at least three years and must have taken HIV antiretroviral medication for more than two years prior to enrollment. Participants cannot be pregnant and must be available to attend 17 study visits over a 10-month period. Anticipated completion of treatments in the Phase 1 study is Q3 2022, although final data and long-term monitoring will continue. The Phase 1 study will include up to 18 participants. (The recruitment status of the Phase 1 RePAIR clinical trial, along with information on the trial sites, can be found on the official website.)
  • Timeframe: Participants treated with AGT103-T are followed for 6 months in this safety study before enrolling in an FDA-mandated, 15-year, long-term follow up (required for all gene therapy trials). The first infusion occurred in May 2021, the second in August 2021, the third in September 2021, the fourth and fifth in November 2021, and the sixth in February 2022. A treatment withdrawal study to determine product efficacy is planned for Q2 of 2022.

About HIV

According to UNAIDS, approximately 37.7 million people worldwide live with HIV/AIDS. In the United States, government statistics show 1.2 million people have HIV and estimate that 34,800 Americans were newly infected with HIV in 2019. Across the globe, UNAIDS estimates that approximately 1.5 million individuals were newly infected with HIV in 2020. The Washington D.C./Baltimore area is often cited as a ‘hot spot’ for HIV, with Washington, D.C., having the highest rate of infection at nearly 46 cases per 100,000 population and Baltimore City having rates of 17 cases per 100,000. Maryland also ranks sixth among U.S. states and territories in HIV diagnosis rates, with more than 900 new cases in 2019 alone, according to the Maryland Department of Health.

Since the late 1980s, antiretroviral drugs have restored quality of life to persons living with HIV and, in some cases, have even been used to prevent new infections. However, no approved treatment has demonstrated the ability to cure HIV. AGT is committed to addressing this unmet medical need.

About AGT103-T

AGT103-T is a genetically modified cell product made from a person’s own cells. AGT’s unique approach focuses on permanently repairing the key immune system damage caused by HIV. AGT’s goal is to develop a cell and gene therapy capable of repairing the immune system so it will provide natural control over HIV replication.

About American Gene Technologies AGT is a gene and cell therapy company with a proprietary gene-delivery platform for rapid development of cell and gene therapies to cure infectious diseases, cancers, and inherited disorders. AGT’s mission is to transform people’s lives through genetic medicines that rid the body of disease. AGT has been granted four patents for the technology used to make AGT103-T and 11 patents for its unique immuno-oncology approach to stimulate gamma-delta (γδ) T cells to destroy a variety of solid tumors. The company has developed a synthetic gene for treating Phenylketonuria (PKU), a debilitating inherited disease. AGT’s treatment for PKU has been granted Orphan Drug Designation by the Food and Drug Administration (FDA), and it is expected to reach the clinic in 2022.


Media Contact: Kathy Fowler American Gene Technologies Phone: (410) 963-2345 Email:


Geoffrey Lynn, co-founder Avedia, SVP, Synthetic Immunotherapies, Vaccitech, joins BioTalk

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Geoffrey Lynn, SVP, Synthetic Immunotherapies, Vaccitech, visits Rich Bendis to discuss his career from NIH, to CEO of Avidea, to their merger with Vaccitech.

Listen now via Apple, Google, Spotify, and TuneIn

Dr. Geoffrey Lynn is leveraging his background in synthetic chemistry and cellular immunology to lead Avidea’s efforts to develop precision immunotherapies for treating cancer and autoimmune diseases. Dr. Lynn has expertise in designing, GMP manufacturing and assessing safety, efficacy & MOA of polymer-drug conjugate / nanoparticle technologies for immunotherapeutic applications. Previously, Dr. Lynn was a visiting scientist in the laboratory of Professor Christopher Jewell at the Fischell Department of Engineering at UMD and trained as a post-doctoral fellow with Dr. Robert Seder at the Vaccine Research Center of the National Institutes of Health (NIH). Dr. Lynn attended medical school at Johns Hopkins University; obtained a Ph.D. in Biomedical Engineering from the University of Oxford as an NIH-Oxford and National Science Foundation Graduate Research Fellow; and received his B.S. in chemistry from Elon University, where he was a Goldwater Scholar.

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How Johns Hopkins Inventors’ Vision for Early Cancer Detection Got a $2.1B Boost

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Johns Hopkins researchers Nickolas PapadopoulosKen Kinzler and Bert Vogelstein have spent their careers working on ways not just to treat cancer but to detect it before it becomes a threat. The goal: a blood test for the earlier detection of cancer incorporated into routine medical care. Their dream is closer to reality thanks in part to a $2.15 billion acquisition of their company, Thrive Earlier Detection Corp., one year ago by Exact Sciences Corp., a global leader in cancer-detection testing.

The heart of the researchers’ work is the liquid biopsy, a test done on a blood sample to look for signals derived from cancer cells circulating in the blood. In 2011, they invented SafeSeqS, a next-generation gene sequencing technology that simultaneously and individually analyzed millions of DNA molecules to identify mutations in the bloodstream more accurately than other methods.

Two years later, SafeSeqS was incorporated into a pilot study of their liquid biopsy test, which used cervical fluid obtained during routine Pap tests to detect endometrial and ovarian cancer. The “PapGene” test accurately detected all 24 endometrial cancers and nine of 22 ovarian cancers in the study. In 2018, the researchers reported that PapSEEK, the screening test, was nearly 99% specific for cancer and detected 81% of endometrial cancers and 33% of ovarian cancers in a study of 2,000 samples from nearly 1,700 women.

Click here to more via JHU.

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