VC investor Paul Manning donates $100M to UVA for new R&D institute

 PBM Capital’s Paul Manning has donated $100 million to the University of Virginia, and it’s going to be used to advance drug development.

At a ceremony on campus Friday, leaders from across the university and UVA Health announced the launch of the Paul and Diane Manning Institute of Biotechnology. State officials, including Virginia Gov. Glenn Youngkin and Virginia House of Delegates Speaker Todd Gilbert, were also present.

While also emphasizing modalities such as cellular therapy, gene therapy and nanotechnology, the institute’s main goal will be to help find new treatments and cures for “even the most challenging and devastating diseases,” according to an announcement from the university. The institute will also allow UVA to expand its clinical trial offerings.

The crown jewel of the new institute will be a new high-tech facility located in Fontaine Research Park, on the west side of the university’s campus. While additional details such as the name are to be announced at a later date, the announcement says that the facility will bring research, manufacturing and patient care space under one roof.

UVA’s provost and chief academic officer Ian Baucom said in a statement that this is the type of facility “most universities can only dream of,” adding that it will help the university in terms of recruiting talent.

The institute, while leveraging $100 million from the Mannings, will be supported by an initial investment of $300 million. The remaining $200 million comes from two other entities: $150 million from UVA, and the final $50 million from the state of Virginia.

Manning got his wealth from the sale of PBM Products, a company that makes private-label infant formula. Following the sale of the company to Perrigo for $800 million, Manning started up PBM Capital in 2010.

Since then, PBM Capital has had its hands involved in several biotechs over the years, including SalioGen, Taysha Gene Therapies, and Candel Therapeutics — the company headed by former GSK vet Paul Peter Tak, once GSK’s chief immunology officer. One of the biggest successes was AveXis, the gene therapy outfit acquired by Novartis in 2018 for $8.7 billion.

https://endpts.com/vc-investor-paul-manning-donates-100m-to-uva-for-new-rd-institute/

FDA proposes shift to annual COVID vaccine shots

 The U.S. health regulator on Monday proposed one dose of the latest updated COVID-19 shot annually for healthy adults, similar to the influenza immunization campaign, as it aims to simplify the country's COVID-vaccine strategy.

The U.S. Food and Drug Administration also asked its panel of external advisers to consider the usage of two COVID vaccine shots a year for some young children, older adults and persons with compromised immunity.The regulator proposed the need for routine selection of variants for updating the vaccine, similar to the way strains for flu vaccines are changed annually, in briefing documents ahead of a meeting of its panel on Thursday.

The FDA hopes annual immunization schedules may contribute to less complicated vaccine deployment and fewer vaccine administration errors, leading to improved vaccine coverage rates.The agency's proposal was on expected lines, following its announcement of its intention for the update last month.

The Biden administration has also been planning for a campaign of vaccine boosters every fall season.

Currently, most people in the United States need to first get two doses of the original COVID vaccine spaced at least three to four weeks apart, depending on the vaccine, followed by a booster dose a few months later.

Pfizer's primary vaccine doses for children and people involve three shots, with the third a bivalent shot given about two months later.

If the panel votes in favor of the proposal, Pfizer Inc and Moderna Inc's bivalent vaccines, which target both the Omicron and the original variants, would be used for all COVID vaccine doses, and not just as boosters.

https://www.yahoo.com/news/u-fda-proposes-simplify-covid-130729948.html

Iovance acquires world rights to Proleukin

Acquisition of Worldwide Rights to Proleukin® Provides Immediate and Ongoing Revenue and Secures IL-2 Supply for Clinical and Future Commercial TIL Therapy

Positive FDA Feedback on Phase 3 Confirmatory Study in Frontline Advanced (Metastatic or Unresectable) Melanoma

Positive Clinical Data in Anti-PD-1 Naïve Metastatic Non-Small Cell Lung Cancer (NSCLC)

Biologics License Application (BLA) Submission in Post-Anti-PD-1 Advanced Melanoma on Track to Complete in Q1 2023

Strengthened Cash Position to Fund Operating Plan Well into 2024

https://finance.yahoo.com/news/iovance-biotherapeutics-provides-corporate-clinical-130000862.html

Regenxbio starts Phase 1/2 study for Duchenne gene therapy

 Company has initiated Phase I/II AFFINITY DUCHENNE™ trial of RGX-202 

-  Company also enrolling newly active observational screening study, AFFINITY BEYOND, evaluating AAV8 antibody prevalence in boys with Duchenne 
-  Commercial-scale cGMP material from the REGENXBIO Manufacturing Innovation Center to be used in the clinical trial 
-  RGX-202 is a potential one-time AAV Therapeutic for the treatment of Duchenne and includes an optimized transgene for a novel microdystrophin and REGENXBIO's proprietary NAV® AAV8 vector

https://finance.yahoo.com/news/regenxbio-announces-phase-ii-trial-120500662.html

Cadrenal Fast Tracked for Thromboembolism in End-Stage Renal Disease, Atrial Fibrillation

  Cadrenal Therapeutics (Nasdaq: CVKD), a biopharmaceutical company focused on developing tecarfarin, a clinical-stage novel cardiorenal therapy with orphan drug designation, announced today that the U.S. Food and Drug Administration (FDA) has granted a Fast Track designation to tecarfarin for the prevention of systemic thromboembolism, more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease (ESRD) and atrial fibrillation (AFib).

https://finance.yahoo.com/news/cadrenal-therapeutics-nasdaq-cvkd-granted-133000290.html

TScan: FDA Clearance of 3 INDAs for Treatment of Solid Tumors

 Primary IND for solid tumor program, T-Plex, supports simultaneous use of multiple TCRs to create customized, multiplexed TCR-T cell therapies based on target and HLA expression

INDs for TSC-204-A0201 and TSC-204-C0702 introduce the first two TCRs into TScan’s ImmunoBank, targeting MAGE-A1 on HLA types A*02:01 and C*07:02, respectively

https://finance.yahoo.com/news/tscan-therapeutics-announces-fda-clearance-120000100.html

Intelligent Bio Solutions Reaches Key Milestone in Biosensor Platform

 Intelligent Bio Solutions Inc. (“Intelligent Bio Solutions” or the “Company”) (Nasdaq: INBS), a life sciences company developing and delivering intelligent, non-invasive, real-time testing solutions, today announced it has successfully completed the review of results from Milestone 7, a phase of its biosensor platform development at the University of Newcastle, Australia, that included testing time-to-result (TTR), sensitivity, and reproducibility. The results showed a record 4x improvement in TTR, enabling the biosensor to return test results in under one minute.

The Company’s biosensor platform is the world’s first platform designed to specifically support multiple non-invasive, real-time, saliva-based diagnostic tests based on Organic Thin Film Transistor (OTFT) technology. It features a small, printable organic strip designed to put the power of accurate, timely diagnosis in the hands of patients and their primary health practitioners.

https://finance.yahoo.com/news/intelligent-bio-solutions-reaches-key-123000371.html