Weekly Quick Hits (BioHealth Capital Region) – Week of April 3, 2023

By Sarah Ellinwood, Alex Keown, and Mark Terry
April 7, 2023

Funding, Awards and Collaborations

Horizon Therapeutics Named to the 2023 Fortune 100 Best Companies to Work For List for Third Consecutive Year

To determine the 100 Best Companies to Work For, Great Place To Work analyzed the anonymous survey responses of more than half a million employees from Great Place To Work-Certified™ companies with at least 1,000 workers. Companies also submitted essays describing their efforts to offer generous and innovative support for their teams, which were validated against employee survey responses. This is yet another ribbon on the list, as Horizon has been recognized nearly 70 times since 2015 for its workplace and culture.

Cystic Fibrosis Foundation Commits Up to $15.5M in Additional Funding for Investigational Enzyme Replacement Therapy

The Cystic Fibrosis Foundation agreed to provide up to $15.5 million to Anagram Therapeutics (formerly known as Synspira Therapeutics) to conduct early-stage clinical trials of a novel enzyme replacement therapy. Anagram is planning to start a Phase 1 clinical trial of the enzyme therapy over the summer. If the therapy is successful, most people with the disease would be able to decrease the number of enzyme pills they must take to digest food properly, going from a handful of pills to only one per meal.

Phlow Nabs Over $35M in Series B Round to Improve National Medicine Supply Chain

Richmond-based public benefit corporation and CDMO Phlow closed a $36 million Series B capital raise as part of its mission to protect America’s medicine cabinet. The new capital will be used to expand Phlow’s commercial offerings, including the rapid growth of its CDMO program, called cdmoX, that provides a range of customized services to pharmaceutical and biotech companies resulting in reduced production costs, decreased development time, improved quality, and lower negative environmental impact.

OpGen’s Subsidiary Curetis Signs Expansion of R&D Collaboration with FIND

OpGen signed an amendment to its research and development collaboration agreement with FIND expanding on the collaboration which was originally started in fall of 2022. The work already completed under the collaboration will be expanded by three work packages increasing total project volume to up to €830 thousand in revenue potential. The added deliverables will address the following topics: An Antimicrobial Stewardship Module that can help in making the best treatment choices based on respective hospital’s drug availability; A “Data everywhere” concept investigating hardware and software options for remote connectivity in low- and middle- income countries; and Next Generation Sequencing (“NGS”) strain analysis including isolates from several sub-Saharan African countries to investigate any potential sequence differences.

Curetis Also Meets Milestones in Collaborative Research Project with InfectoGnostics

In addition to the above, OpGen also reported that it has completed two interim milestones as part of its collaboration project with InfectoGnostics. Funded as part of the PREPLEX project, the completed milestones contribute to the project collaboration focused on artificial intelligence (AI) powered assay development for phenotypic carbapenemase resistance in Gram negative bacteria.

Precigen amends exclusive license agreement with Alaunos to bolster portfolio and broaden strategic opportunities

Under this amendment, which eliminates all future royalties to Alaunos, Precigen can utilize the clinically validated UltraCAR-T platform for unencumbered development and commercialization of two proven CAR-T targets, CD19 and B-cell maturation antigen (BCMA). Precigen also regained exclusive rights to its IL-12 gene therapy, including application through the off-the-shelf AdenoVerse™ immunotherapy platform.

In the Clinic

Deka Biosciences Celebrates First-in-Human Dose in Phase 1 Clinical Trial of DK210 (EGFR)

The first patient was dosed at NEXT Oncology in Fairfax, Virginia. The Phase 1, first-in-human, multicenter clinical study seeks to characterize the safety, potential efficacy and evaluate possible biomarkers of response to DK210 (EGFR) in patients with advanced solid cancer who are expressing epidermal growth factor receptors (EGFR). DK210 (EGFR) is the first of several experimental therapeutics developed as part of Deka’s platform of molecules, which combines the cytokines full strength IL-2 and a high affinity IL-10.

CureSearch to fund Phase I clinical trial for pediatric brain cancer 

The trial is led by David Munn, MD and Theodore Johnson, MD, PhD of the Medical College of Georgia at Augusta University. Munn has a track record of forming collaborative teams that move basic-science discoveries into innovative clinical trials. In 2015, his team developed the first-in-class IDO-inhibitor drug (indoximod) and advanced this therapy through early-stage clinical trials. Munn and his team will now examine if the addition of ibrutinib can promote anti-tumor activity in brain cancer patients who are actively progressing, and have already become resistant to chemoimmunotherapy with indoximod alone. 

Precision Biologics Publishes Data Of First-In-Human Phase 1 Clinical Trial With NEO-201

Precision Biologics shared the publication of its first in human Phase I clinical trial with its novel monoclonal antibody, NEO-201, targeting the truncated core-1 O-glycan. This trial was performed in patients with refractory solid tumors and has been published in the Journal of Experimental and Clinical Cancer Research. Based on the safety and activity of NEO-201 a Phase II study is currently enrolling patients with metastatic Non-Small Cell Lung Cancer (NSCLC), Head and Neck Cancers, Endometrial Cancer and Cervical Cancer, who have already been treated with checkpoint inhibitor therapy (including prior Keytruda). The article can be found here.

New Products

Cell Metabolism Publication Validates that the AMP® Type 2 Diabetes Knowledge Portal Can Be a Helpful Tool for Biomedical Researchers

The Foundation for the National Institutes of Health (FNIH) shared that the Type 2 Diabetes Knowledge Portal (T2DKP) was featured in a new Cell Metabolism article. The T2DKP is a publicly available source of genetic datasets dedicated to type 2 diabetes and its related traits. The tool provides provides software infrastructure to support, combine, and harmonize more than 300 anonymized datasets from research studies around the world. An innovative feature of the portal allows the retrieval of genetic data that complies with European Union data protection requirements. The Cell Metabolism article, with more than 50 authors that include FNIH’s David Wholley, Tania Kamphaus, and Lynette Nguyen, discusses the accessibility of the T2DKP data.

New Patents

BrainBox Solutions Secures Patent for its Concussion Test

BrainBox Solutions, the maker of an artificial intelligence-enabled concussion test, has earned a broad patent from the U.S. Patent and Trademark Office for a set of eight biomarkers that correlate to specific findings on MRI tests. The biomarkers covered by the patent include indicators of specific brain dysfunction, “enabling objective assessments of longer-term injury risk and the need for further monitoring and diagnostic testing,” according to CEO Donna Edmonds.

Research Roundup

Johns Hopkins Researchers Identify Response Biomarkers to Immunotherapy for Kidney Cancer

According to this new research, the number of immune cells in and around kidney tumors, the amount of dead cancer tissue, and mutations to a tumor suppressor gene called PBRM1 form a biomarker signature that can predict — before treatment begins — how well patients with kidney cancer will respond to immunotherapy. The conclusions were based on the evaluation of 136 kidney tumor biopsies taken for previous studies. A report about the work was published in Cell Reports Medicine.

Novel Immunotherapy Agent Safe, Shows Promise Against High-Risk Prostate Cancers

A monoclonal antibody, enoblituzumab, was shown to be safe in men with aggressive prostate cancer and may induce clinical activity against cancer throughout the body, according to a Phase 2 study led by investigators at the Johns Hopkins Kimmel Cancer Center and its Bloomberg~Kimmel Institute for Cancer Immunotherapy. If confirmed in additional studies, enoblituzumab could become the first promising antibody-based immunotherapy agent against prostate cancer. In a clinical trial, 32 men with high-risk or very high-risk prostate cancers who were scheduled for prostate cancer surgery were treated with six weekly infusions of enoblituzumab prior to surgery, and were followed for an average of 30 months thereafter. 66% of patients had an undetectable prostate-specific antigen (PSA) level 12 months following surgery, suggesting that there was no sign of residual disease. The data were published in Nature Medicine.

People on the Move

TEDCO’s Welcomes Ruchika Nijhara, Ph.D., as Executive Director of the Maryland Stem Cell Research Fund (MSCRF)

As executive director, Nijhara will oversee all MSCRF activities and seven programs accelerating stem cell research, commercialization and cures. The Maryland Stem Cell Research Commission, which oversees the fund, was established as an independent unit within TEDCO, leading the way in identifying and supporting the most promising stem cell technologies in Maryland.

Emmes Hires Becky Marson as Chief People and Performance Officer

Before joining Emmes, Marson was vice president of human resources at Ingersoll Rand, leading a global HR team to support the company’s 6,600 employees across various countries. Her role included both HR functional leadership, strategic business partnership and mergers and acquisition support. As chief people and performance officer, Marson’s focuses will include employee and leadership development, global recruiting, and employee volunteer activities. She also will broaden the company’s diversity, equity, inclusion and accessibility initiatives and expand the Emmes Foundation to offer STEM-related scholarships.

Cystic Fibrosis Foundation Announces Yvonne Massenburg as Chief People Officer

Massenburg will be responsible for the Foundation’s overall human resources strategy, serving as a strategic advisor and business partner to senior leadership as the organization works to advance its mission and strengthen its partnership with the cystic fibrosis community. Massenburg comes to the Foundation from the Association of American Medical Colleges, a nonprofit organization serving the academic medicine community. Having been its Chief Human Resources Officer since 2015, she has led the overall HR function for the organization’s nearly 800 employees. Most recently, she established and implemented innovative strategies on diversity, equity, and inclusion, and on the future of work.

Qnovia Announces Former Director of FDA’s Center for Tobacco Products, Mitch Zeller, as Policy and Regulatory Strategy Advisor

Zeller joined the company as an advisor to focus on policy and regulatory strategy. Zeller has 40 years of experience working on FDA issues. In his advisory role, he will advise Qnovia on the optimal policy and regulatory strategy that will advance a framework for the development and advancement of new smoking cessation therapies to support the company’s strategy as it advances through the drug approval process in the U.S. and in other global markets.

The National Menopause Foundation Appoints Five New Women’s Health Experts to Its Medical Advisory Committee

New members include Ellen Albertson, PhD, Jennifer Garrison, PhD, Heather L. Johnson, MD, Jennifer Lanoff, JD, and Pamela M. Peeke, MD.