Weekly Quick Hits (Philly) – Week of July 31, 2023

Charles River Labs to Open Accelerator and Development Lab in Philly while Penn Med and CHOP Receive $26 Million NIH Grant. Continue reading for these life science stories in the Philadelphia Region and more.

By Mark Terry

August 4, 2023

Quick Hits is BioBuzz’s weekly round up of all the life science news you don’t want to miss, in your region of interest. Don’t miss a beat; SUBSCRIBE to our weekly Quick Hits newsletter via LinkedIn (BioHealth Capital Region, Greater Philadelphia, Research Triangle Park) or get it delivered to your inbox every week.

Funding, Awards and Collaborations 

The Innovation Space Will Host NASA’s ClimateTech Startup Studio Event

The Innovation Space (Wilmington, Del.) will host the first NASA Climate Tech Startup Studio showcase on October 4, 2023. It will feature pitches from a cohort of entrepreneurs who are working to use existing NASA tech toward new commercial climate-focused solutions.

Incyte Q2: Total Net Product Revenues of $827 Million, Growing 25% Year Over Year

Wilmington, Del.-based Incyte reported its 2023 second-quarter financial results. The company reported total net product revenues of $827 million, growing 25% year over year led by double-digit Jakafi (ruxolitinib) growth and continued momentum from Opzelura (ruxolitinib) cream in atopic dermatitis and vitiligo in the U.S. 

United BioSources Picks Oracle Cloud Safety Tech for its Safety Programs

Austin, Texas-based United BioSource selected Blue Bell, Pa.-based Oracle Argus Cloud Service for its safety programs. Oracle will provide United BioSource with state-of-the-art safety case processing for its clinical trials as well as post-marketing programs.

Charles River Labs to Open Accelerator and Lab in Seattle and Philadelphia

Charles River Laboratories International (Wilmington, Mass) announced planned openings of Charles River Accelerator and Development Lab (CRADL) locations in Seattle and Philadelphia. The Seattle location is expected to open in September. CRADL Philadelphia is expected to open in October in uCity Square.

AmerisourceBergen Q3: $66.9 Billion in Revenue, an 11.5% Increase Year-Over-Year

AmerisourceBergen (Conshohocken, Pa.) reported its fiscal year 2023 third quarter, citing a revenue increase of 11.5% year-over-year to $66.9 billion. It also updated its outlook for the fiscal year, raising its adjusted diluted EPS guidance from the previous range of $11.70 to $11.90 to a range of $11.85 to $11.95.

Harmony Biosciences Q2: Wakix Net Revenue Increased 25% Year-over-Year

Plymouth Meeting, Pa.- based Harmony Biosciences reported its Q2 2023 finances, noting that its Wakix (pitolisant) net revenue increased 25% year-over-year to $134.2 million for the quarter, with the average number of patients increasing by 350 sequentially to 5,450. Jeffrey M. Dayno, MD, President and CEO of the company noted, “This sustained momentum in our core business, driven by robust underlying demand, reinforces our confidence in Wakix being a $1 billion-plus opportunity in narcolepsy alone.”

Penn Med and CHOP Receive $26 Million NIH Grant for Rare Newborn Genetic Diseases

A team from Penn Medicine and Children’s Hospital of Philadelphia (CHOP) received a $26 million grant from the NIH to develop treatments for three rare, incurable genetic diseases. The research will focus on phenylketonuria (PKU), hereditary tyrosinemia type 1 (HT1), and mucopolysaccharidosis type 1 (MPS1), also called Hurler’s Syndrome.

Thomas Scientific Acquires Quintana Supply

Thomas Scientific, based in Swedesboro, NJ, completed the acquisition of Massachusetts-based Quintana Supply, which specializes in cleanroom, packaging, and industrial products. This expands Thomas Scientific’s national footprint, and distribution and sales capabilities.

OraSure Q2: $85.4 Million in Second Quarter, Growth of 3% Year-Over-Year

Bethlehem, Pa.-based OraSure Technology reported its second-quarter financials, citing 3% growth year-over-year to $85.4 million. InteliSwab test revenue was $47.5 million for the quarter.

Teleflex Announced Quarterly Dividend

Teleflex (Wayne, Pa.) declared a quarterly cash dividend of 34 cents per share of common stock, payable September 15, 2023. Teleflex brands include Arrow, Deknatel, LMA, Pilling, QuikClot, Rusch, UroLift and Weck.

In the Clinic

Molecular Targeting Technologies to Initiate Nasopharyngeal Cancer Trial in Singapore

West Chester, Pa.-based Molecular Targeting Technologies and its wholly owned subsidiary, Molecular Theranostic Center of Singapore, received approval to launch a Phase Ib/II trial in Singapore. The companies will evaluate the safety and efficacy of a 3-dose regimen of ¹⁷⁷Lu-DOTA-EB-TATE (EBTATE) in patients with nasopharyngeal cancer.

Avalo Q2: AVTX-002 Missed Primary Endpoint in Phase II PEAK Asthma Trial 

Avalo Therapeutics, based in Wayne, Pa. and Rockville, Md., announced business updates and financial results for the second quarter. At the top of the report was news that AVTX-002 (quisovalimab) missed the primary endpoint in the Phase II PEAK trial in non-eosinophilic asthma, but significantly reduced serum LIGHT levels for study duration, which indicated strong target engagement. The company reported $6.3 million in cash as of June 30, 2023.

Arbutus Q2: To Launch Phase I Cancer Trial in New Zealand

Warminster, Pa.-based Arbutus Biopharma reported its second-quarter 2023 financial results with a corporate update. The company received approval in New Zealand to launch a Phase I trial of AB-101, an oral PD-L1 inhibitor. It also dosed the first patient in an additional arm of Phase IIa trial combining imdusiran, VTP-300, NA therapy and nivolumab in hepatitis B. As of June 30, the company reported $163.5 million in cash.

LianBio Dosed 1^st Patient in Lung Cancer Trial

LianBio (Shanghai, China and Princeton, NJ) dosed the first patient in its Phase I trial of BBP-398. The drug is an investigational SHP inhibitor. It was dosed in combination with AstraZeneca’s osimertinib, an EGFR inhibitor, for patients with non-small cell lung cancer (NSCLC) with EGFR mutations.

Taiho Oncology Launches Zipalertinib Trial in Non-Small Cell Lung Cancer

Taiho Oncology, Taiho Pharmaceutical Co. and Cullinan Oncology (Princeton, NJ and Cambridge, Mass.) launched the Phase III REZILIENT3 trial of zipalertinib in EGFR non-small cell lung cancer tumors. The drug with chemotherapy is being evaluated as a potential first-line therapy for adults with previously untreated locally advanced or metastatic NSCLC with EGFR exon 20 insertion mutation.

Research Roundup

Drexel Research: National Autism Indicators Report Calls for Health Care Policy Improvements

Drexel University’s A.J. Drexel Autism Institute issued the latest National Autism Indicators Report, evaluating changes in access and disruptions to healthcare services for autistic children and adults during the beginning of the COVID-19 pandemic. The report also created a list of recommendations, including having providers ensure equitable and high-quality access on virtual platforms.

On the Hill – Regulatory and Advocacy

European Commission Approves Marinus’ Ztalmy for Epilepsy

Radnor, Pa-based Marinus Pharmaceuticals announced that the European Commission (EC) approved Ztalmy (ganaxolone) oral suspension for adjunctive treatment of epileptic seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two to 17 years of age. It can be continued into the older population.

Coeptis Files FDA 513(g) Submission for CD38 In Vitro Companion Diagnostic

Coeptis Therapeutics (Wexford, Pa.) submitted a 513(g) request to the FDA for an in vitro companion diagnostic test to be used with anti-CD38 monoclonal antibody therapies. The request introduces the tech to the agency and requests guidance in determining the appropriate classification and regulatory pathway.

Teleflex Received FDA Clearance for Expanded Indication for QuikClot Control+ Hemostatic Device

Teleflex (Wayne, Pa.) received clearance from the FDA for its QuickClot Control+ Hemostatic Device to include mild and moderate bleeding in cardiac surgical procedures and bone surface bleeding after a sternotomy. This allows clinicians to use the QuickClot Control+ Device to control all bleeding in cardiac surgical procedures.

FDA Approves Taiho’s Lonsurf with Bevacizumab for Colorectal Cancer

Princeton, NJ’s Taiho Oncology and Taiho Pharmaceutical Co. announced the FDA approved Lonsurf (trifluridine/tipiracil) as a single agent or in combination with bevacizumab to treat adults with metastatic colorectal cancer (mCRC) previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF biological therapy, and if RAS wild-type, an anti-EGFR therapy. The approval was built in part on data from the Phase III SUNLIGHT trial.

Penn Research: Method to Increase Drug Potency

Researchers at Penn State identified and demonstrated a safe, efficient and practical method to create cyclopropanes on a variety of molecules. These structures can increase the potency and fine-tune drug properties.

People on the Move

Catalent Appoints Lisa Evoli Senior VP and Chief HR Officer

Somerset, NJ-based Catalent appointed Lisa Evoli Senior Vice President and Chief Human Resources Officer. Her previous position was with Integra Lifesciences.