Weekly Quick Hits (BioHealth Capital Region) – Week of April 24, 2023

By Sarah Ellinwood, Alex Keown, and Mark Terry
April 28, 2023

Funding, Awards and Collaborations

Quest Diagnostics Acquires Haystack Oncology, Adding Sensitive Liquid Biopsy Technology to Oncology Portfolio

Quest Diagnostics (NYSE: DGX), a leading provider of diagnostic information services, and Haystack Oncology, an early-stage oncology company focused on minimal residual disease (MRD) testing to aid in the early, accurate detection of residual or recurring cancer announced a definitive agreement for Quest to acquire Haystack in an all-cash equity transaction. Following the close of the acquisition, Quest expects to adapt the MRD test developed at Haystack as the basis for new clinical lab services available beginning in 2024. Development efforts will focus initially on MRD tests for colorectal, breast and lung cancers.

Maryland Tech Council Announces 2023 ICON Award Winners

The Maryland Tech Council announced the winners of its 2023 ICON Awards on Thursday. Among the winners were local life science companies Kite Pharma, MaxCyte and Theradaptive, among others.

In the Clinic

I-Mab Doses First Patient in Phase 3 China Study of CD47 Antibody Lemzoparlimab

I-Mab (Nasdaq: IMAB) dosed its first patient in a Phase 3 registrational trial (ClinicalTrials.gov Identifier: NCT05709093) in China for patients with higher-risk myelodysplastic syndrome (MDS) has been treated with lemzoparlimab, a novel CD47 antibody, in combination with azacitidine (AZA). The Phase 3 trial is a randomized, controlled, open-label, multi-center study to evaluate the efficacy and safety of lemzoparlimab in combination with AZA versus AZA monotherapy as first-line therapy in subjects with higher-risk MDS. This is the first approved Phase 3 trial for anti-CD47 therapies in mainland China.

NexImmune to Present Phase 1/2 Clinical Data at ASCO

NexImmune (Nasdaq: NEXI), a biotechnology company developing immunotherapies that direct antigen-specific T cells against both liquid and solid tumors, will be presenting clinical data from its Phase 1/2 dose escalation study of NEXI-001 in a poster session at the American Society of Clinical Oncology (ASCO) 2023 Annual Meeting in June.

Alphyn Biologics to Present Pediatric Data from Atopic Dermatitis Trial at European Society for Pediatric Dermatology Congress

Alphyn Biologics will present for the first time new pediatric data from its Phase 2a clinical trial of a topical candidate for mild-to-moderate atopic dermatitis at the 22nd European Society for Pediatric Dermatology Congress (ESPD), May 4-6. AB-101a, a non-steroid, topical AD treatment, is in development to uniquely treat the immune and bacterial components of AD in patients ages 2 through adulthood. The pediatric population met all of its primary clinical trial endpoints. The randomized, vehicle-controlled, double-blind trial is evaluating the treatment protocol of AB-101a across multiple sites using standard scales for assessing AD. 

Ascentage Pharma to Present Results from Four Clinical Studies Highlighting Extended Therapeutic Potential of Lead Drug Candidates at ASCO

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, will be sharing results from four clinical studies of the company’s key assets, including the first China-approved third-generation BCR-ABL tyrosine kinase inhibitor (TKI) olverembatinib (HQP1351), Bcl-2 selective inhibitor lisaftoclax (APG-2575), MDM2-p53 inhibitor alrizomadlin (APG-115), and FAK/ALK/ROS1 inhibitor (APG-2449), at ASCO in June.

Precigen to Present Latest Clinical Advancements for PRGN-3005 UltraCAR-T® and PRGN-2009 Off-the-Shelf AdenoVerse™ Immunotherapy at ASCO

Precigen (Nasdaq: PGEN) announced that clinical data from the Phase 1 dose escalation study of PRGN-3005 UltraCAR-T in patients with advanced, recurrent platinum resistant ovarian cancer, and the Phase I study of PRGN-2009 AdenoVerse immunotherapy alone or in combination with an anti-PDL1/TGF-Beta trap checkpoint inhibitor in patients with HPV-associated cancers will be presented at ASCO in June.

I-Mab to Present Data on CD73 Antibody Uliledlimab at ASCO

I-Mab (Nasdaq: IMAB) will be presenting a poster featuring the latest clinical data of uliledlimab, the company’s proprietary and highly differentiated CD73 antibody, in combination with PD-1 therapy in non-small-cell lung cancer (NSCLC), will be presented at ASCO in June.

New Products

Capra Biosciences to Build a Green Biochemical Production Facility in Manassas, Virginia

Capra Biosciences is scaling up their novel bioreactor technology to produce sustainable chemicals in Northern Virginia. This project was funded through a special BioMADE Project Call focused on advancing bioreactor design and development, thanks to support from Schmidt Futures. The expansion will jump start Virginia’s bioeconomy and place the state on the map for biochemical production. The Manassas-based company uses a biofilm-forming microbe and its proprietary bioreactors to transform low-cost feedstocks, such as agricultural byproducts or food waste, into a variety of chemicals, including their first product, retinol.

New Patents

60 Degrees Pharmaceuticals Awarded U.S. Patent Covering Tafenoquine for Treatment of COVID-19 and Other Lung Infections

60 Degrees Pharmaceuticals (60P) announced that the United States Patent and Trademark Office (USPTO) has issued a patent covering the use of tafenoquine as a treatment for COVID-19. Tafenoquine is the active molecule in the Company’s FDA-approved regimen for malaria prevention, ARAKODA®. 60P now owns the exclusive rights for the use of tafenoquine for treatment of viral lung infections including COVID-19 in the U.S. through 2040. 60P plans to conduct a double-blind, randomized, placebo-controlled Phase IIB trial to study the efficacy of the ARAKODA regimen of tafenoquine in COVID-19 patients with mild-moderate symptoms and low risk of disease progression. The primary endpoint of the Phase IIB study will be time to sustained clinical recovery from COVID-19 symptoms. The study will enroll patients in 30 out-patient clinics across the U.S. The company is also planning a larger study that will commence in 2024.

Research Roundup

Seraxis Shares Successful Results Using Synthetic Replacement Endocrine Clusters for Type 1 Diabetes

Seraxis, a pre-clinical stage company using islet replacement therapy for insulin-dependent diabetes, presented results from an efficacy study of Synthetic Replacement Endocrine (SRE) pancreatic clusters. These data were presented by William Rust, PhD, Chief Executive Officer at Seraxis, as an oral podium presentation at the 4th International Pancreas and Islet Transplant Association (IPITA) / Harvard Stem Cell Institute (HSCI) / Juvenile Diabetes Research Fund (JDRF) Summit earlier this week. The presentation included an introduction to Seraxis’ proprietary GMP process for manufacturing SRE clusters for nonclinical and clinical use. 

Results from an ongoing type 1 diabetes efficacy study with SRE clusters (SR1423) implanted into the kidney capsule or gonadal fat pad in a diabetic mouse model showed that implantation resulted in sustained euglycemia. Control mice which did not receive an implant remained hyperglycemic. SRE clusters resemble human islets in morphology and distribution of the different hormones expressing cells.

UMD Scientists Say New Avian Influenza Requires Urgent Coordinated Response

A team of researchers from the University of Maryland have been tracking a highly pathogenic avian influenza that has been spreading in the U.S. This avian flu has been more virulent than previous strains and the researchers are assessing the differences from other such strains. The team found that the “deadly impact on wild birds and a shift from seasonal to year-round infections signal dangerous changes in avian influenza in the U.S.” Additionally, the researchers concluded there is an urgent need for “unprecedented coordination” to manage the spread of disease. The team also suggested that H5N1 will likely become endemic, potentially posing risks to food security and the economy. The findings were published in the journal Conservation Biology.

Johns Hopkins Researchers ID Novel Treatment Pathway For Deadly Pancreatic Cancers

In laboratory studies with human pancreatic cancer cell lines and genetically engineered mouse models of pancreatic cancer, JHU investigators discovered that the High Mobility Group A1 (HMGA1) protein functions as a “molecular switch” that flips on genes required by tumor cells to grow in an uncontrolled fashion and form invasive tumors. One of these genes activated by HMGA1 leads to the production of fibroblast growth factor 19 (FGF19), which is secreted by tumor cells. FGF19 not only provides signals that coax tumor cells to grow rapidly and invade surrounding tissues, but both HMGA1 and FGF19 cooperate to “build” a dense, fibrous, scar-like wall around the tumor cells, which is known as the stroma. Pancreatic tumors are among a few tumors that form a dense stroma, and the stroma is thought to create a barrier preventing therapy from reaching the tumor cells.

New Study from Johns Hopkins May Advance Use of Spinal Cord Stimulation for Chemotherapy-Related Pain and Cancer Treatment

Researchers at Johns Hopkins University School of Medicine say they have evidence from a new study in rats that spinal cord stimulation (SCS) may be useful in reducing chronic pain in people undergoing active treatment with a common anti-cancer drug. The study found that the use of SCS measurably reduced pain response in rats that were implanted with human lung cancer tissue — without compromising effectiveness of treatment with paclitaxel, a drug used to treat a variety of cancers. The study, published in Neuromodulation: Technology at the Neural Interface, advances strategies to prevent and treat neuropathy that results from paclitaxel and other chemotherapy drugs, according to the researchers.

Regulatory and Advocacy

Ascentage Pharma Passes GMP Compliance Audit by EU QP with Zero Deficiency

Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in developing novel therapies for cancers, chronic hepatitis B (CHB), and age-related diseases, recently received a zero-deficiency report from the GMP compliance audit of Ascentage Pharma’s Global Manufacturing Center by a Qualified Person (QP) of the European Union (EU). This successful audit indicates that the company’s Global Manufacturing Center and quality management system implemented at the site are now compliant with the standards of the EU GMP, marking the achievement of a major milestone that will pave the way for the company’s continued global expansion.

RNAimmune Receives FDA Clearance of Investigational New Drug Application for Phase 1 Trial of RV-1730 COVID-19 Booster Vaccine 

RNAimmune, a biopharmaceutical company specializing in discovery and development of mRNA-based therapeutics and vaccines, has received FDA IND clearance for its Phase I clinical trial for RV-1730, a SARS-CoV-2 vaccine booster candidate. The proposed clinical study will involve in an evaluation of RV-1730 for its safety and prophylaxis efficacy against SARS-CoV-2 infection with people previously immunized with other mRNA-based COVID-19 vaccines. During the proposed Phase I clinical study, RNAimmune will investigate the safety and efficacy of RV-1730 when administered as a single booster dose to healthy adults aged 18-55, previously vaccinated with either the Pfizer-BioNTech or Moderna COVID-19 mRNA vaccine. 

People on the Move

Cartesian Therapeutics Appoints Three World-Renowned Scientists and Engineers as Charter Members of Company’s Scientific Advisory Board

Cartesian Therapeutics, a fully integrated biopharmaceutical company pioneering RNA cell therapy for autoimmune diseases and cancer, announced the appointment of three world-renowned scientists and engineers as charter members of the company’s Scientific Advisory Board (SAB): Prof. Jennifer Elisseeff (Johns Hopkins University), Prof. Andrés García (Georgia Institute of Technology), and Prof. David Mooney (Harvard University).

UMBC Welcomes Tanyka M. Barber as Vice President for Institutional Equity and Chief Diversity Officer

Barber holds a bachelor’s degree from Morgan State University, a master of health sciences degree from the Johns Hopkins University Bloomberg School of Public Health, and a law degree from the University of Baltimore. She joins UMBC from TNG, one of the nation’s largest education-focused law and consulting practices, where she served as partner. TNG serves K-12 schools, colleges and universities, and other organizations, and Barber had the opportunity to work with a wide range of educational institutions nationwide.

Prior to her work with TNG, Barber served as director of diversity and EEO/Title IX coordinator at Morgan State University. There she drafted Morgan State’s first comprehensive policy and procedures to address gender- and sex-based harassment and violence. She also developed and implemented a comprehensive Title IX grievance process and prevention policy, and prioritized initiatives seeking to prevent discrimination and harassment and to increase reporting.