Current Stage: Pre-Clinical
Therapeutic Areas:  Inflammatory Bowel Disease (IBD), metabolic disease, oncology

Allonix Therapeutics is developing novel small molecule drugs that target a cell-signaling pathway implicated in inflammation, cholesterol homeostasis, and cellular metabolism.  Allonix’s lead program aims to modulate the biology controlled by this target to treat inflammatory bowel disease (IBD), through a unique mechanism of action. Deep structural biology insights into this target have allowed Allonix to develop not only a candidate IBD therapeutic, but a broad library of molecules with potential to treat diseases such as diabetes, obesity, and a range of cancers.  Ultimately, Allonix aims to fully exploit the biology of this signaling pathway to build a robust pipeline of therapeutics to treat numerous diseases.

To support this mission, Allonix has forged a partnership with the Crohn’s & Colitis Foundation, the leading non-profit organization in the IBD space.  The Crohn’s & Colitis Foundation’s IBD Ventures group has also invested in Allonix.

The biological insights that form the foundation of Allonix’s R&D efforts was born out of the pioneering work conducted by Eric Ortlund and Dr. John Calvert at Emory University and builds decades of pioneering science and millions of dollars in NIH grant funding.

Current Stage: Pre-Clinical
Target pathway: TGF-beta
Initial Therapeutic Area: Fibrosis

DomainOne Therapeutics is focused on developing small molecule inhibitors that modulate the TGF-beta pathway, a key regulator of fibrosis, inflammation and cancer. As an initial therapeutic target, DomainOne is focusing on fibrosis, a serious and significant medical condition without effective treatments. Fibrosis involves the excessive formation of fibrous connective tissue due to abnormal tissue repair, leading to scarring and impaired function in vital organs such as the liver, lungs, heart, and kidneys. By targeting the underlying pathological process that leads to fibrosis, DomainOne seeks to provide new therapeutic options for a range of fibrosis-related diseases.

DomainOne was founded by Orange Grove Bio (“OGB”) based on research and intellectual property developed at the University of Alabama and Southern Research Institute. The company’s small molecules are designed to inhibit TGF-beta activation by interacting with the first domain (Domain One) of the protein thrombospondin 1 (TSP1), a key regulator of TGF-beta production at sites of tissue damage. This novel approach promises to overcome the limitations associated with direct targeting of TGF-beta and to effectively address fibrosis and enhance patient outcomes.

Current Stage: Pre-Clinical
Indication: Cystic Fibrosis

Genexys is developing a novel highly modular non-viral, non-lipid gene therapy platform for the treatment of cystic fibrosis (CF), a genetic disorder caused by mutations in the cystic fibrosis transmembrane conductance regulator (CFTR) gene, affecting the lungs and digestive system. Genexys is leveraging its well-differentiated platform technology to address the need for powerful non-viral or non-lipid gene therapies in the CF space, where the majority of current gene therapy approaches rely on viral methods like adeno-associated virus (AAV) vectors or lipid nanoparticles. Non-lipid-based gene therapy vectors offer unique advantages in terms of immunogenicity, scalability, customization, targeting capabilities, biocompatibility, and versatility.

Genexys’ gene therapy technology originated from Cincinnati Children’s Hospital and was developed in the lab of Dr. Assem Ziady. The company has successfully received a Phase 1 Small Business Innovation Research (SBIR) grant from the National Heart, Lung, and Blood Institute (NHLBI). Genexys has shown promising in vitro and in vivo data and is currently focusing on optimizing the delivery and functionality of the CFTR gene, which is mutated in CF patients.

Current Stage: Pre-Clinical 

Indication: Proteasome modulating therapeutics for Oncology, AutoImmune and Inflammatory Diseases 

IpiNovyx Bio is a biopharmaceutical company dedicated to the development of next-generation proteasome inhibitors that will revolutionize the treatment of disease. At the heart of IpiNovyx’s mission is the development of a platform capable of delivering best-in-class proteasome modulating therapeutics designed to target cells responsible in individual diseases. These innovative small molecule inhibitors are being developed with precision to selectively target the immunoproteasome — a key component of the immune system responsible for degrading intracellular proteins, as well as the constitutive proteasome which plays key roles in maintaining malignant cell viability. IpiNovyx’s approach focuses on developing bespoke proteasome inhibitors with superior efficacy and safety profiles compared to current agents, offering patients a safer and more effective alternative to conventional therapies. 

The foundational science behind IpiNovyx’s technology stems from leading research conducted at Weill Cornell Medicine and the Hospital for Special Surgery (HSS) Research Institute. To date, discovery efforts have led to the identification of highly selective and reversible proteasome inhibitors which are being developed for bespoke applications in various disease settings. 

IpiNovyx Bio has to-date closed a $10 million seed financing round; alongside Orange Grove Bio (“OGB”), prominent investors include Eli Lilly and Company, Viva BioInnovator, Opaleye Management, and Alexandria Venture Investments. With this backing, IpiNovyx Bio is poised to advance its lead drug candidates through preclinical studies and towards clinical trials, with the ultimate goal of delivering innovative treatments for oncology, autoimmune and inflammatory diseases. The company’s lead program is progressing toward the clinic to realize the full potential of proteasome targeting in Oncology, with a mid-2026 target timeline for entry into the clinic. 

Website:  IpiNovyx Bio | Transforming Proteasome Inhibition for Disease

Current Stage: Pre-Clinical
Indication: Ex Vivo Platelet Additive

Preservation Bio, a subsidiary of Orange Grove Bio (“OGB”), is at the forefront of developing a revolutionary ex vivo platelet additive designed to transform the shelf life and quality of donated platelets for transfusions. Built upon discoveries from the University of Cincinnati and Cincinnati Children’s Hospital Medical Center, Preservation Bio was formed to address the global platelet shortage caused by decreasing donations and supply waste due to the short shelf life of donated platelets that must currently be stored at room temperature. The company has secured the rights to this cutting-edge technology directly from renowned academic investigators, Dr. Jose Cancelas and Dr. Yi Zheng, who serve as the scientific co-founders of Preservation Bio and are widely regarded as leading authorities in the field of transfusion medicine.

Dr. Cancelas, a distinguished expert in transfusion medicine, and Dr. Zheng, an expert in RhoA biochemistry, led the pioneering research efforts at the University of Cincinnati and Cincinnati Children’s Hospital Medical Center, laying the groundwork for Preservation Bio’s innovative platelet storage solution. They have played a pivotal role in advancing Preservation Bio’s mission to improve patient outcomes and revolutionize the platelet donation storage process. The company’s ex vivo additive protects platelets from the damage normally caused by cold temperatures,allowing them to be stored in the refrigerator. This represents a commercial opportunity that will benefit both hospitals and cancer clinics and their patients.

Preservation Bio’s product is designed to be added to bags of donated platelets, allowing them to be refrigerated and extending their shelf life from the current 5-7 days up to 14 days or possibly longer. This could significantly reduce the number of platelets that are discarded each year due to expiration (currently 10-15%). Additionally, the additive causes the platelets to enter a “quiet” state, improving their quality after storage. Refrigeration of platelets will minimize the risk of bacterial contamination that currently exists with room temperature stored platelets.

Preservation Bio is preparing to file an IND and initiate a Phase 1 clinical trial. The trial will enroll approximately 24 patients and will be conducted at the Hoxworth Blood Center in Cincinnati. The key endpoints will be platelet survival and recovery. Following successful Phase 1 results, the company plans to conduct a pivotal trial at major cancer centers.