Follow the Money: PCORI Approves Awards For Multiple CER Studies, Advancing Women’s Reproductive Immunotherapies, Collaborations, More

By Clinical Research Staff 

December 27, 2023 | The Patient-Centered Outcomes Research Institute (PCORI) approves funding awards to support 20 new patient-centered comparative clinical effectiveness research (CER) studies; Freya Biosciences intends to advance the clinical development of its lead drug candidate; Sanofi enters a multi-year research collaboration with French pharmatech company Aqemia; and more. 

 

$225M: Awards for Various Clinical Effectiveness Research Studies 

The Patient-Centered Outcomes Research Institute (PCORI) has approved funding awards totaling $225 million, which include $207 million to support 20 new patient-centered comparative clinical effectiveness research (CER) studies. By comparing various approaches to care, these studies will help fill evidence gaps related to maternal illness and death, adolescent mental health, delirium in older adults, cardiovascular disease, and a range of other high-burden health conditions. Four awards include support for large patient-centered CER studies in which community organizations and research institutions as coequal partners will tackle clinical and social factors that contribute to inequities in maternal morbidity and mortality. This latest round of PCORI funding awards also includes CER studies researching questions about how to optimally use brief interventions to prevent alcohol use among adolescents; ways to prevent delirium among hospitalized patients, a particular concern for older adults and their families; strategies to achieve better blood pressure control; and ways to enhance use of cancer screening and treatment of depression.

$140M: Collaboration for Improving Drug Development Pipeline 

In a new move that underscores the pharmaceutical industry’s commitment to harnessing the power of artificial intelligence (AI) for drug discovery, Sanofi has entered a $140 million multi-year research collaboration with French pharmatech company Aqemia. The collaboration is poised to help reshape the landscape of drug development and improve the way new therapeutic compounds are identified and optimized. The traditional drug development pipeline is a time-consuming and resource-intensive journey, often taking years to bring a new molecule from the laboratory to the market. By leveraging Aqemia’s advanced AI algorithms, Sanofi aims to streamline this process, identifying promising small molecules more efficiently and expediting the development of innovative therapies. The collaboration between Sanofi and Aqemia also signifies a broader shift in the industry towards embracing AI as an integral part of the drug development process.

$121M: Series B for Advancing Phase 1 Proof-of-Mechanism Trials 

Seismic Therapeutic has closed a $121 million Series B financing. The Series B was led by new investor Bessemer Venture Partners with participation from other new investors, Amgen Ventures, Codon Capital, Alexandria Venture Investments, Gaingels and GC&H, as well as existing investors, Timothy A. Springer, Lightspeed Venture Partners, Polaris Partners, Boxer Capital, GV, Samsara BioCapital, and management and founders. Proceeds from the Series B financing will be used to advance through Phase 1 proof-of-mechanism trials with Seismic’s two lead programs: a pan‑immunoglobulin (Ig) G protease sculpting (Sc) enzyme candidate (S-1117) and a PD-1 agonist:Fc gamma receptor IIb selective Dual-cell Bidirectional (DcB) antibody candidate (S-4321). In addition, the Series B will enable the continued growth of the company’s pipeline in both the IgSc and DcB product areas, beyond the lead programs. The funding will also enable the company to further expand its proprietary machine learning-enabled IMPACT platform with the development and implementation of additional cutting-edge methods to enhance biologics drug discovery in immunology.

$101M: Series E for Weekly Oral Med Platform 

Lyndra Therapeutics has closed a $101 million Series E financing round. The proceeds of the round, led by Sarissa Capital and including Sun Pharmaceutical Industries Limited and Polaris Partners, will support the development of Lyndra’s pipeline, including oral weekly risperidone (LYN-005), which is near completion of a pivotal phase 3 study. Lyndra’s investigational therapies are enabled by the company’s LYNX drug delivery platform, which creates long-acting oral medicines that can be taken once weekly. As part of the financing, Sun Pharma will receive an exclusive license to manufacture and market oral weekly risperidone (antipsychotic), oral weekly dapagliflozin (type 2 diabetes) and oral weekly aripiprazole (antipsychotic) in six countries, including Brazil and India, pending further clinical development of these investigational candidates.

$52M: Series A for Small Molecule Therapeutics 

Apple Tree Partners (ATP) announced $52 million in Series A funding for its portfolio company Deep Apple Therapeutics, created and incubated by ATP to rapidly discover novel small molecule therapeutics for high-value targets through virtual screening of AI-generated virtual libraries. With a powerful discovery engine that combines ensemble cryo-EM, deep learning, and molecular docking screens of ultra-large libraries, Deep Apple can go from target identification to lead optimization in less than 12 months—a fraction of the industry standard time—and can pursue biological target signaling inaccessible to conventional discovery approaches. Deep Apple's discovery engine is broadly applicable across disease areas and is particularly well-suited to expedited hit-finding against integral membrane proteins. The company currently is advancing multiple programs focused on GPCR modulators, a proven target class with applications in metabolic disorders, inflammation, immunology, and endocrine diseases.

$38M: Series A for Women’s Reproductive Immunotherapies 

Freya Biosciences announced a $38 million Series A financing—one of the largest raises to advance women’s reproductive immunotherapies. Led by Sofinnova Partners and OMX Ventures, the funding round also includes The Export and Investment Fund of Denmark, Angelini Ventures, Mike Jafar Family Office, CE-Ventures, Corundum Systems Biology, and Indaco Venture Partners. Freya will advance the clinical development of its lead drug candidate, an investigational vaginal microbial immunotherapeutic, for the treatment of infertility in women with dysbiotic vaginal microbiota who are undergoing assisted reproductive technology (ART). The funding will also advance Freya’s multi-omics data science platform, which includes deep microbiome sequencing and vast multiplexed immune biomarker profiling in human clinical samples.

$23M: Funding for Multi-Omic Platform 

Zafrens announced the close of $23 million in financing led by Prime Movers Lab with participation from BlueYard Capital, KOFA Healthcare, Global Brains, FoundersX Ventures, Alix Ventures, Possible Ventures, Iaso Ventures, Hawktail, and other investors. The financing will be used to optimize breakthrough applications of the company’s Z-Screen platform and advance an internal pipeline. The Z-Screen is a step-change in throughput and resolution of experiments, expanding the conventional 96-well format to 50,000-200,000 wells with imaging and single-cell multi-omic capabilities integrated in every well. Complex cellular co-culture interactions can now be resolved at the molecular and functional levels simultaneously. Large CRISPR, CAR-T, mRNA libraries, or endogenous molecular heterogeneity can be mapped to their individual manifestations as cell behavior, cell-cell interactions, and secretions.

$19M: Series A for Automated Cell Production System 

Mytos has closed $19 million in Series A financing led by Buckley Ventures, with participation from IQ Capital and Wing VC. The funding will accelerate the manufacturing and distribution of Mytos' automated cell production system to more biotech and pharma companies to meet growing demand. The company’s platform is already in use by a number of life sciences companies globally. Mytos also has plans to expand its sales and development team.

$6.5M: Funding for Biological Map Platform 

Pepper Bio announced an oversubscribed $6.5 million seed round led by NFX with participation from Silverton Partners, Merck Digital Sciences Studio, Mana Ventures, Tensility Ventures, VSC Ventures, and more. This funding will accelerate Pepper Bio’s transomics platform capabilities, fueling the pipeline for more accurate and accessible drug discovery. Pepper Bio’s platform maps data across all the -omics layers and translates it into the fastest route for discovering new drugs, finding new uses for existing therapeutics, and rescuing drugs that may otherwise fail. Just like how Google Maps combines layers of data on traffic, weather, and road closures to help drivers find the fastest and safest route, Pepper’s COMPASS platform translates layers of biological maps—genomics (genes), transcriptomics (RNA), proteomics (proteins), and phosphoproteomics (function of proteins)—to offer researchers a complete picture of how diseases impact biology.

$5.3M: Private Placement for AI-Immunology Vaccines

Evaxion Biotech A/S, a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, has announced a private placement financing to raise gross proceeds of approximately $5.3 million. The Private Placement includes participation from existing and new shareholders, with the largest new shareholder being MSD Global Health Innovation Fund (MSD GHI), a corporate venture capital arm of Merck & Co., Inc., Rahway, NJ, USA, accounting for some 25% of the total offering amount. Further, the Private Placement includes significant participation by all members of the Company’s management and the Company’s board of directors. The Private Placement is expected to close on or about December 21, 2023, subject to the satisfaction of customary closing conditions. The company intends to use the proceeds from the Private Placement for working capital and general corporate purposes.

 

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