Weekly Quick Hits (BioHealth Capital Region) – Week of January 23, 2023

By Alex Keown, Sarah Ellinwood, and Mark Terry

Welcome to BioBuzz‘s first of many weekly roundups! We don’t have to tell you that there’s a lot of hustle and bustle happening in the BioHealth Capital Region. Starting this week, we’ll be providing you with a roundup of some of the latest happenings in your backyard.

Let’s get to it!

Funding

Precigen Announces Pricing of $75.0 Million Public Offering of Common Stock

Germantown-based Precigen, Inc. (Nasdaq: PGEN) announced the pricing of an underwritten public offering of 42,857,143 shares of its common stock at a public offering price of $1.75 per share. Precigen has also granted the underwriters a 30-day option to purchase up to an additional 6,428,571 shares of its common stock. Gross proceeds from the offering, before deducting underwriting discounts and commissions and estimated offering expenses, are expected to be approximately $75.0 million, excluding any exercise of the underwriters’ option. The offering is expected to close on January 27, 2023, subject to customary closing conditions.

Fzata Looking to Raise Series A For New Oral Biologics Platform Modality

Fzata, Inc., located in Halethorpe, MD, is raising series A funding for its first-in-class Bioengineered Probiotic Yeast Medicines (BioPYM™) platform. Fzata’s vision is to replace needle administration of biologics with a capsule for suffers of gastrointestinal disorders. Elizabeth Smith, Fzata’s Chief Business Officer, will be available for in person partnering at a series of upcoming events.

In the Clinic

REGENXBIO Recruiting Patients for Phase I/II Trial of RGX-202 Gene Therapy Candidate in Duchenne Muscular Dystrophy

RGX-202 is designed to deliver a transgene for a novel microdystrophin protein that includes the functional elements of the C-Terminal (CT) domain found in naturally occurring dystrophin. RGX-202 uses REGENXBIO’s proprietary NAV® AAV8 vector. The AFFINITY DUCHENNE trial is a multicenter, open-label dose evaluation and dose expansion clinical trial to evaluate the safety, tolerability and clinical efficacy of a one-time intravenous (IV) dose of RGX-202 in patients with Duchenne.

Precigen Announces Positive Phase I Dose Escalation and Expansion Cohort Data for PRGN-2012 AdenoVerse™ Immunotherapy

It’s definitely been a busy week for Precigen – in addition to their stock announcement, the company also announced positive Phase I dose escalation and expansion cohort data for the investigational, potential first-in-class PRGN-2012 off-the-shelf (OTS) AdenoVerse™ immunotherapy in patients with recurrent respiratory papillomatosis (RRP). The company will hosted a virtual R&D Day to showcase the data.

ExeGi Pharma Receives IND Green Light for Live Biotherapeutic EXE-346

Rockville-based ExeGi Pharma is a leader in the development of live biotherapeutic drugs and probiotics. EXE-346 is a unique biologic drug that contains strains of live probiotic bacteria in extremely high potency.This clearance allows the company to initiate a clinical trial for patients with an ileal pouch-anal anastomosis (IPAA or “J-Pouch”) who experience excessive stool frequency. ExeGi anticipates initiating the study at multiple centers throughout the U.S. this summer.

New Products

Kerecis Comes Out With New Fish Skin Products to Treat Burns

The GraftGuide Mano product is made of intact fish skin and is specifically designed to fit the shape of a hand. This makes it easy to cover the complex 3D structure of the hand and eliminates the need for tailoring the graft, reducing the number of grafts needed and minimizing surgical time. Additionally, patients can begin physical therapy immediately after the product is applied, which is crucial for preventing loss of range of motion and accelerating recovery.

Research Roundup

Hopkins: Researchers Identify Set of “Persistent Mutations” That Could Better Predict Immunotherapy Response

A study led by researchers at Johns Hopkins Medicine found that “hard-to-lose” mutations in tumors may predict a patient’s response to immunotherapy. The study, published in Nature Medicine, analyzed data from more than 9,000 tumors across 31 tumor types and found that these mutations, which are resistant to standard treatments and difficult to eliminate, may also make tumors more susceptible to attack by the immune system. The study suggests that identifying these mutations could help potentially improve treatment outcomes.

Hopkins: Tumor Microenvironment Could Hold Key to Make Immunotherapy More Effective in Pancreatic Cancer

A new study has revealed a cause of tumor cell resistance to immunotherapy in pancreatic cancer, revealing potential new treatment strategies. The study, published in Cancer Cell,  used data generated by an ongoing platform trial initiated in 2015 to study immunotherapy treatments before and after surgery in patients with pancreatic cancer. The team used banked biospecimens and studied the tissue, cellular, and molecular structure of the tumor microenvironment by using multiomic strategies. The study found two major “defects” in the pancreatic cancer’s tumor microenvironments: one is that T cells are exhausted and still not sufficiently active, and the second is that myeloid cells that infiltrate the tumor’s microenvironment prevent T cells from activating against pancreatic cancer cells, even after treatment with GVAX and anti-PD-1 immunotherapy.

On the Hill – Regulatory and Advocacy

Bladder Cancer Advocacy Network Announces New Call Center to Address Patients’ Psychosocial and Financial Needs

The Bladder Cancer Advocacy Network (BCAN), located in Bethesda, MD, announced the launch of a new, free call center resource for bladder cancer patients and loved ones.  By calling 833-ASK-4-BCA (833-275-4222), callers will be connected with professional oncology social workers with specific expertise on issues affecting bladder cancer patients and their families. 

People on the Move

BioHealth Innovation Announces Two New Entrepreneurs-in-Residence at the National Institutes of Health

BioHealth Innovation Inc. (BHI) announces the addition of Luis Gutiérrez and John K. Hsu, Ph.D., J.D., to the growing Entrepreneurs-in-Residence (EIR) team. Luis will work with the NIH Office of Extramural Research (OER), while John will work with The National Heart, Lung, and Blood Institute (NHLBI).

Dr. Cox-Batson Joins Unity Health Care as CMO, Company Adds Four New Board Members

Dr. Cox-Batson joins Unity Health Care from Chicago’s Near North Health, a Federally Qualified Health Center, where she also served as Chief Medical Officer. 

Advarra Announces Appointments of Scott Hoffman as Chief Commercial Officer and Scott Uebele as Chief Operating Officer

Hoffman will be responsible for managing the commercial organization and driving a unified, client-centric commercial strategy, while Uebele is responsible for strategy and operations for Review Services, including institutional review board (IRB), institutional biosafety committee (IBC), data monitoring, and endpoint adjudication, Global Services and Product Delivery, Consulting Services as well as Advarra’s customer success teams.

Did we miss something? Be sure to reach out to us at [email protected] so we can include your news.