Weekly Quick Hits (Greater Philly) – Week of March 6, 2023

By Mark Terry, Alex Keown, and Sarah Ellinwood
March 10, 2023

Funding and Collaborations

Adaptimmune and TCR2 Therapeutics to Merge

Adaptimmune, based in Philadelphia, merged with TCR2 Therapeutics (Cambridge, Mass.) in an all-stock deal to create a cell therapy company focused on solid tumors. The lead franchises for the merged company leverage engineered T-cell therapies targeting MAGE-A4 and mesothelin.

Penn Ranks #1 in Licensing Income

In a survey of the Association of University Technology Managers (AUTM), University of Pennsylvania ranked number one in licensing income receipts across all 153 institutions participating. It was more than twice the number two spot held by the entire University of California system.

Sun Pharma Wraps Acquisition of Concert Pharmaceuticals

Mumbai, India-based Sun Pharma completed the acquisition of Princeton, NJ-based Concert Pharmaceuticals. Concert is developing deuruxolitinib, a novel, deuterated, oral JAK1/2 inhibitor for moderate to severe alopecia areata.

Carisma Closes Merger with Sesen Bio

Philadelphia-based Carisma Therapeutics closed the previously announced merger with Sesen Bio. The combined company will trade under the ticker symbol CARM on the Nasdaq Global Market and operate under the name Carisma Therapeutics. The merged companies have $140 million in cash to provide runway through 2024.

Nucleus Biologics and Stoic Bio Ink Supply Deal with the Center for Breakthrough Medicines

San Diego-based Nucleus Biologics and Stoic Bio inked a supply agreement with King of Prussia, Pa.-based Center for Breakthrough Medicines (CBM). The deal makes Nucleus Biologics the preferred supplier of cell culture media and other critical biological solutions for CBM. CBM also announced a strategic partnership with Cell One Partners to accelerate the development and commercialization of cell and gene therapies.

NRx Pharma Closes on $2.9 Million Registered Direct Offering

Radnor, Pa.-based NRx Pharmaceuticals closed an offering of 3,766,666 shares of common stock and 3,7666,666 warrants to purchase common stock at a combined purchase price of $0.75 per share. The gross proceeds are projected to be about $2.9 million, which the company expects to use to initiate its safety database under an FDA expanded access protocol.

In the Clinic

AstraZeneca and Daiichi Sankyo’s Enhertu Hits Mark in HER2 Solid Tumors

AstraZeneca (with offices in Wilmington, Del.) and Daiichi Sankyo, reported high-level results from an analysis of their ongoing DESTINY-PanTumor-2 Phase II trial of Enhertu in HER2-expressing advanced solid tumors. The drug hit the objective response rate (ORR) and demonstrated durable response.

Janssen’s Stelara Long-Term Data Support Safety Profile in Inflammatory Bowel Disease

Spring House, Pa.-based Janssen Pharmaceutical Companies of Johnson & Johnson announced final pooled long-term safety data for Stelara (ustekinumab) through five years in adults with moderately to severely active Crohn’s disease and four years in adults with moderately to severely active ulcerative colitis. They also had final four-year clinical and endoscopic results from the UNIFI long-term extension study of Stelara for adults with moderately to severely active ulcerative colitis. The data reinforced the known efficacy and safety profile of the drug.

Mineralys Presented Positive Phase II Lorundrostat Data in Hypertension

Radnor, Pa.-headquartered Mineralys Therapeutics announced positive data from the Target-HTN Phase II trial of lorundrostat. The drug demonstrated clinically meaningful blood pressure reduction with once-daily dosing.

AstraZeneca Reports Strong Overall Survival in Phase III Lung Cancer Study

AstraZeneca, headquartered in the UK with facilities in Wilmington, Del., reported positive high-level results from the ADAURA Phase III trial of Tagrisso (osimertinib) in patients with early-stage EGFRm non-small cell lung cancer (NSCLC) after complete tumor resection with curative intent. The drug demonstrated a statistically significant and clinically meaningful improvement in overall survival, a key secondary endpoint. Earlier results showed improvement in disease-free survival.

Palvella’s Qtorin Hits Mark in Phase II Study of Microcystic LM

Wayne, Pa.-based Palvella Therapeutics reported positive topline results from its Phase II trial of QTORIN rapamycin in Microcystic Lymphatic Malformations (Microcystic LM). The disease is a rare, chronically debilitating genetic disorder caused by dysregulation of the PI3K/mTOR pathway. All 12 patients in the trial had improvements on the PGI-C and CGI-C scales, all rated as either “Much Improved” or “Very Much Improved” by clinicians after 12 weeks of treatment.

Galera Presents Supplemental Analysis of Phase III ROMAN Trial 

Galera Therapeutics, headquartered in Malvern, Pa., presented supplemental analysis from its Phase III ROMAN trial. The data demonstrated the overall impact of avasopasem manganese in decreasing the burden of severe oral mucositis, a side effect of radiotherapy.

Research Roundup

Penn Research: Genomic Study of Indigenous Africans

An international research team led by University of Pennsylvania published research that analyzed the genomes of 180 indigenous Africans from a dozen diverse populations. The research provided insights into human migration histories and adaptation to local environments.

Virion Presented Preclinical Data from its Checkpoint Modifier Immunotherapy

Philadelphia-based Virion Therapeutics presented preclinical data from a genetically encoded checkpoint modifier-based immunotherapy that enhances CD8+T-cell activation. A single intramuscular injection of the therapy enhanced immune responses 10- to 15-fold to oncogenic antigens.

CHOP Research: Children’s Fatal Opioid Poisonings Doubled Over 13 Years

Researchers from Children’s Hospital of Philadelphia (CHOP) found that more than half of all fatal poisonings in children ages 5 and younger were caused by opioids, more than double the proportion caused by opioids in 2005. The study also found that over-the-counter drugs still cause fatal poisonings in this age group despite increased regulations.

Penn Research: On a State Level, High COVID-19 Mortality Also Linked to Overall Mortality

Researchers out of the University of Pennsylvania, Boston University and the Robert Wood Johnson Foundation published a study in PLOS One that found that U.S. states with high death rates from COVID-19 in the first year of the pandemic also saw significant increases in other causes of death. Those included cardiovascular disease, dementia, diabetes, and influenza. They found that non-COVID causes of death were responsible for about 20% of excess mortality during that period.

Regulatory and Advocacy

Soligenix Requests FDA Type A Meeting Over HyBryte Refusal to File

Soligenix, located in Princeton, NJ, submitted a Type A Meeting Request to the FDA to discuss a refusal to file (RTF) letter it received regarding its New Drug Application (NDA) for HyBryte (synthetic hypericin). HyBrite was developed to treat early-stage cutaneous T-cell lymphoma (CTCL).