The Gaithersburg biotech, which also detailed changes to a U.K. sales agreement for its Covid vaccine, saw its share price drop in after-hours trading.
Vaccine exclusively delivered with the PharmaJet Stratis® Needle-free Injection System
December 13, 2022 11:00 AM Eastern Standard Time
GOLDEN, Colo.–(BUSINESS WIRE)–PharmaJet®, a company that engineers precision delivery systems that overcome the challenges of vaccine and pharmaceutical companies, today announced that their partner Immunomic Therapeutics received FDA fast track designation (FTD) for the clinical study of their plasmid DNA vaccine ITI-3000 in patients with Merkel cell carcinoma (MCC), a rare but aggressive form of skin cancer. Enrollment is in progress for the phase 1 study that exclusively uses the PharmaJet Stratis Needle-free Injection System (NFIS).
ROCKVILLE, Md., Dec. 14, 2022 /PRNewswire/ — Emmes, a global, full-service Clinical Research Organization (CRO) dedicated to supporting the advancement of public health and biopharmaceutical innovation, today announced that Ching Tian has joined the company as chief innovation officer.
Emmes Chief Executive Officer Dr. Christine Dingivan said, “Ching brings a wealth of data and digital experience, which will be immediately useful as we accelerate our transition to decentralized trials. Her role is to work across the company to integrate technology and processes that strengthen the way we’ll address clinical trials of the future.”
The Richmond area partnership that’s been working to revolutionize U.S. drug making has reached another milestone with the opening of a new lab space in the city.
Two groups – Phlow Corp. and U.S. Pharmacopeia – announced the opening of new laboratories that are co-located at the Advanced Pharmaceutical Development Center at the Virginia Biotechnology Park in Richmond.
Two new labs are aiming to research and develop new manufacturing technologies in the pharmaceutical industry. Those technologies are expected to benefit other pharma and biotechnology companies.
Research and development at the labs is focused on using new advanced manufacturing techniques to make “small molecule” active pharmaceutical ingredients (APIs), and key starting materials (KSMs). It is hoped that those processes can be used to make essential drugs more efficiently and in a more cost effective manner.
Click here to read more via Richmond.com
– Single infusion of UltraCAR-T cells with or without lymphodepletion demonstrated robust expansion and persistence in blood and bone marrow –
– PRGN-3006 infusion with lymphodepletion resulted in a decrease in bone marrow blasts in 60% of heavily pre-treated patients –
– Single infusion of autologous PRGN-3006 cells resulted in 27% objective response rate (ORR) in heavily pre-treated relapsed or refractory (r/r) acute myeloid leukemia (AML) patients infused following lymphodepletion –
– PRGN-3006 was well-tolerated with no dose-limiting toxicities (DLTs) reported to date –
GERMANTOWN, Md., Dec. 12, 2022 /PRNewswire/ — Precigen, Inc., a biopharmaceutical company specializing in the development of innovative gene and cell therapies to improve the lives of patients, today presented positive Phase 1 dose escalation data from the ongoing Phase 1/1b clinical study of PRGN-3006 UltraCAR-T® in patients with r/r AML and higher risk myelodysplastic syndromes (MDS) (clinical trial identifier: NCT03927261) at the 64th American Society of Hematology (ASH) Annual Meeting and Exposition (Abstract# 4633). The presentation was delivered by David A. Sallman, MD, Assistant Member in the Department of Malignant Hematology at the H. Lee Moffitt Cancer Center & Research Institute (Moffitt) and a lead investigator for the PRGN-3006 clinical trial.
In honor of the late John Holaday, Ph.D., renowned scientist, CEO, philanthropist, mentor, and community leader, this award recognizes a regional biohealth leader who embodies Holaday’s personal credo — “do well by doing good”, and exemplifies a similar unwavering devotion to excellence. With this award we want you to nominate a servant leader who is carrying on John’s legacy and lives each day with a passionate pursuit of excellence and innovation in their own work to make a difference in the lives of others. As CEO and Founder EntreMed, and MaxCyte, Holaday had an important role in building the foundation for the biohealth industry that exists here today, and we want to honor that legacy through this award.
This award honors a media campaign that most aligns with our mission; ‘to create exceptional experiences that better connect people and employers and foster a stronger regional ecosystem.’ At its core, it recognizes the media campaigns or platforms that have successfully engaged, informed, and connected people and reflect favorably on the BHCR. Eligible nominations may include social media, podcasts, video series, blog series, event or webinar series, and other advertising, marketing, and public relations campaigns. Nominees should be selected based on the strategic approach, quality, and results achieved.
This award recognizes the companies who have pursued their mission with dedication and perseverance and built momentum towards commercialization with a substantial breakthrough this past year. Nominees should be selected of companies who have achieved important milestones such as advancing to a clinical-stage company, achieving successful pivotal trials, or getting FDA approval to commercialize their technology to bring it to the patients who need it.
A long list of companies had breakthroughs this year and achieved great milestones for their technology, so it was a challenging task to narrow down finalists. These finalists were chosen from that list because their technology addresses an essential advancement in the field of medicine for their patient population or the medical field as a whole. Congratulations to all of the finalists who are on their way to changing the world by saving and improving lives.
New BHI Executives-In-Residence, Jennifer Butler and Luis Gutierrez, join VP Economic Development Sarah Miller on BioTalk with Rich Bendis to discuss the recent launch of this program and cultivating the local life sciences ecosystem by working with start-up and growth-stage companies in diagnostics, medical devices, digital health, bioinformatics, AI/machine learning and therapeutics within Montgomery County, Maryland.
Listen now via Apple https://apple.co/3uJ1NhD, Google https://bit.ly/3W8RZcv, Spotify https://spoti.fi/3Hv93FA, Amazon Podcasts https://amzn.to/3hgMeL4, or TuneIn https://bit.ly/3WbCRem.
New BHI Executives-In-Residence, Jennifer Butler and Luis Gutierrez, join VP Economic Development Sarah Miller on BioTalk with Rich Bendis to discuss the recent launch of this program and cultivating the local life sciences ecosystem by working with start-up and growth-stage companies in diagnostics, medical devices, digital health, bioinformatics, AI/machine learning and therapeutics within Montgomery County, Maryland.
Listen now via Apple https://apple.co/3uJ1NhD, Google https://bit.ly/3W8RZcv, Spotify https://spoti.fi/3Hv93FA, Amazon Podcasts https://amzn.to/3hgMeL4, or TuneIn https://bit.ly/3WbCRem.