PharmAbcine expands partnership with Samsung Biologics for PMC-403

PharmAbcine Inc. | September 21, 2020

PharmAbcine Inc. (KOSDAQ: 208340ks) entered into a strategic partnership with Samsung Biologics (KRX: 207940.KS) for the development and manufacturing of PMC-403 pipeline, the next generation therapeutic antibody candidate to treat neovascular disorders. Samsung will provide the full scope of its CDO services from cell line development, process development, cGMP clinical manufacturing to IND filing support. PharmAbcine is a clinical-stage biotech company developing fully human therapeutic antibodies to treat cancer and neovascular disease. Olinvacimab, the company's lead molecule, is in phase II clinical trials for a combination therapy to treat cancer with MSD's Keytruda. PMC-403 is a novel agonistic antibody that binds to the human Tie2 receptor. PharmAbcine is developing PMC-403 as a therapeutic drug for both non ocular and ocular pathological vessel related diseases. The company expects PMC-403 to enter a global ophthalmological clinical trial in 2022. More recently, PharmAbcine signed a material cooperative research collaboration agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), in which NIAID will assess the efficacy of PMC-403 to treat Systemic Capillary Leak Syndrome (SCLS or Clarkson Disease).

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Scott Dylla, Ph.D., Vice President of Research and Development, Chief Scientific Officer, AbbVie Stemcentrx and Tom Hudson, M.D., Vice President of Oncology Discovery and Early Development, AbbVie, discuss 'What is the most exciting field of cancer research right now?'

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Scott Dylla, Ph.D., Vice President of Research and Development, Chief Scientific Officer, AbbVie Stemcentrx and Tom Hudson, M.D., Vice President of Oncology Discovery and Early Development, AbbVie, discuss 'What is the most exciting field of cancer research right now?'

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Lucid Diagnostics, a Subsidiary of PAVmed, Announced Launch of VA EsoGuard® Study

Lucid Diagnostics | March 25, 2022

Lucid Diagnostics Inc., a commercial-stage cancer prevention diagnostics company and a majority-owned subsidiary of PAVmed Inc, announced that investigators at the Louis Stokes Cleveland Department of Veterans Affairs Medical Center had enrolled their first patient in a Department of Defense ("DoD")- Katarina B. Greer, M.D., an associate professor of medicine at Case Western Reserve University School of Medicine in Cleveland, is the lead investigator of the research. Lucid supplies the study with EsoCheck® Esophageal Cell Collection Devices and will conduct EsoGuard testing on the obtained samples. We are proud to be partnering with Dr. Greer and the Cleveland VA on this important investigator-initiated clinical study, The study will add important clinical evidence on the impact of EsoGuard in enhancing early detection of esophageal precancer to prevent esophageal cancer deaths by reserving endoscopy for those with a positive EsoGuard test.” Lishan Aklog, M.D., Lucid’s Chairman and Chief Executive Officer. Despite strong clinical practice guideline recommendations, endoscopy has had limited success as a widespread screening tool for Barrett’s Esophagus (BE), a precursor for esophageal adenocarcinoma, a highly lethal form of esophageal cancer, We hope to demonstrate that a strategy that incorporates initial office-based non-endoscopic testing of at-risk patients with EsoGuard improves endoscopy yield and overall cost-effectiveness.” Dr. Greer. Only around 10% of at-risk GERD patients advised for esophageal precancer (BE) screening undergo traditional, invasive upper gastrointestinal endoscopy (EGD). Over 80% of people who undergo EGD screening have a negative result, subjecting the overwhelming majority of these patients to a complicated, invasive, expensive, and inconvenient surgery requiring anesthesia in a specialist procedure center or hospital. EsoGuard has been demonstrated to be 90% sensitive and specific for identifying esophageal precancer and cancer when done on EsoCheck samples, potentially removing the bulk of these negative EGDs, benefiting patients, providers, and the healthcare system. The trial will include up to 100 Cleveland VA patients who meet the American College of Gastroenterology's criteria for esophageal pre-cancer screening. The research compares two screening strategies: (1) regular EGD screening; and (2) EsoGuard testing followed by EGD exclusively in individuals with a positive EsoGuard result. The trial will determine if utilizing EsoGuard to triage patients to EGD improves overall BE screening rates and decreases the number of EGDs with negative screening results. Additionally, the research will analyze the economic implications for the VA system of these two options.

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CELL AND GENE THERAPY

Sartorius Stedim Biotech Strengthens its Product Portfolio for Cell and Gene Therapies by Acquiring a Majority Stake in CellGenix

Sartorius | July 05, 2021

Sartorius Stedim Biotech, a leading international biopharmaceutical partner, has acquired a majority stake in CellGenix GmbH, a reagent manufacturer. The company, headquartered in Freiburg, Germany, and with a sales subsidiary near the biotechnology center in Boston, Massachusetts, USA, manufactures and distributes cell culture components in GMP grade for the manufacture of cell and gene therapy products. Sartorius Stedim Biotech originally purchased 51% of this company, which was previously privately held, for about 100 million euros in cash. Sartorius Stedim Biotech plans to purchase the remaining CellGenix shares in 2023 and 2026. CellGenix, founded in 1994 at the University Medical Center of Freiburg, employs about 70 employees and aims to produce revenues of more than 20 million euros in 2020, with a very high double-digit EBITDA margin. Sartorius Stedim Biotech intends to significantly expand the Freiburg facility and establish it as a center of excellence within the company to develop and produce high-quality critical raw materials for the cell and gene therapy markets. This press release includes forward-looking statements regarding the Sartorius Stedim Biotech Group's future development. Forward-looking statements include known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those expressed or indicated by such statements. Sartorius Stedim Biotech disclaims all obligation for revising such statements in light of new information or future events. The following is a translation of the original French news release. Sartorius Stedim Biotech accepts no responsibility for the accuracy of this translation. The legally binding version is the original French news release. Sartorius Stedim Biotech's profile Sartorius Stedim Biotech is a leading international biopharmaceutical industry partner. As a complete solutions provider, the business helps its clients produce biotech medications in a safe, timely, and cost-effective manner. Sartorius Stedim Biotech, headquartered in Aubagne, France, is listed on the Eurolist of Euronext Paris. Sartorius Stedim Biotech has a worldwide reach thanks to its production and R&D facilities in Europe, North America, Asia, and an international network of sales companies. The Group's yearly growth rate has been in the double digits on average, and it has constantly been extending its portfolio via acquisitions of related technology. In 2020, the business had about 7,500 employees and a sales revenue of 1,910 million euros.

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Ginkgo Bioworks Announces Partnership with Totient to Identify Neutralizing Antibodies Against COVID-19

Ginkgo Bioworks | September 11, 2020

Today, Ginkgo Bioworks announced a partnership with Totient, an AI-driven drug discovery company emerging from stealth, to rapidly identify neutralizing antibodies against COVID-19. Through this partnership, Totient will leverage Ginkgo's bioengineering platform to express and screen thousands of antibody candidates with the aim of identifying broadly neutralizing therapeutic antibodies against COVID-19 for further development. Totient leverages tertiary lymphoid structures (TLSs) to identify novel tissue-specific antigens and develop matching high-affinity antibody therapeutics. As the broader scientific community mobilizes to address the coronavirus pandemic, Totient has partnered with Ginkgo to adapt and scale its platform, which has been validated in oncology and autoimmunity, to aid in the effort to discover COVID-19 antibodies. Totient's population-scale antibody discovery platform reconstructs anti-SARS-CoV-2 antibodies from bronchoalveolar lavage fluid (BALF) samples.

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