Morphogenesis Inc. Acquires TυHURA Biopharma’s First-in-Class Antibody Drug Conjugates (ADCs) Technology Designed to Overcome Acquired Resistance to Cancer Immunotherapy

Proprietary bi-functional ADCs target and inhibit unique Delta receptor on tumor–associated Myeloid Derived Suppressor Cells (MDSCs); increasing tumor’s susceptibility to checkpoint inhibitors and cellular therapies

TAMPA, Fla., March 28, 2023 (GLOBE NEWSWIRE) — Morphogenesis Inc., a Phase 3 clinical stage biopharmaceutical company developing novel personalized cancer vaccines, announced today that it has entered into a definitive asset purchase agreement, in a stock for stock transaction, to acquire TυHURA’s novel ADCs targeting MDSCs to modulate tumor microenvironment immunosuppression. The technologies were developed by researchers at Moffitt Cancer Center, West Virginia Research Corporation and TυHURA. Through this acquisition, Morphogenesis now has exclusive worldwide license rights to TυHURA’s patents and patented technologies related to the ADC platform.

“Tumor-associated MDSCs are a major obstacle to immunotherapy, being responsible for acquired resistance to checkpoint inhibitors, and contribute to T cell and NK cell exhaustion, preventing cellular therapies from being more effective in attacking cancer. TυHURA’s technology represents a new paradigm. Unlike conventional ADCs where an antibody is used as a targeting agent and a cellular toxin is the payload, TuHURA’s ADCs are bi-functional, where a small molecule inhibitor of MDSC function is the targeting agent, and an immune effector like a checkpoint inhibitor is the payload. These bi-functional ADCs block MDSC’s immune suppressing effects, while localizing an immune effector in the tumor microenvironment. Through this technology represents a promising new approach to overcoming resistance to cancer immunotherapy,” commented James A. Bianco, M.D., Chief Executive Officer of Morphogenesis. “We believe through this strategic acquisition, TυHURA’s novel technology will be complementary to our IFx personalized cancer vaccine technology in addressing obstacles to overcoming resistance to immunotherapies.”

“TυHURA and Moffitt researchers are the first to identify a novel Delta receptor on MDSCs that controls many of MDSC immune suppressing functions, representing a major advance in the ability to increase a tumor’s susceptibility to immune attack, with the promise of increasing the effectiveness and safety profile of immunotherapy,” added Alan F. List, M.D., former President and CEO of Moffitt Cancer Center, a noted expert on the central role of MDSCs contribution to tumorigenesis and resistance to immunotherapy, and member of the independent committee of the Morphogenesis Board of Director’s who evaluated and negotiated the TυHURA asset purchase.

“Modulating the tumor microenvironment is an area of intense research and development among large pharmaceutical companies given its importance in preventing the effective use of immunotherapies like checkpoint inhibitors. This acquisition not only provides Morphogenesis a truly novel approach to block MDSC induced immunosuppression, but also significantly de-risks and bolsters our development pipeline. We look forward to further elucidating the unique characteristics of the Delta receptor and advancing a new generation of bi-functional ADCs toward first-in-human clinical trials,” concluded Dr. Bianco.

About TυHURA Biopharma

TυHURA is a Delaware Company founded by James Bianco, M.D. in 2019 in partnership with Moffitt Cancer Center, where researchers, in collaboration with Dr. Bianco, identified a unique Delta receptor highly expressed on tumor-associated MDSCs linked to MDSC’s migration and their potent immune suppressing functions. The Company has several worldwide exclusive licenses from Moffitt Cancer Center to these and related technologies. Moffitt is a shareholder of TυHURA.

The Company also licensed a complementary novel technology from West Virginia University, conjugating small molecule Delta receptor inhibitors to immune effectors, like checkpoint inhibitors. The current generation of ADC’s utilize an antibody as the targeting agent and a cellular toxin as the payload. In contrast, TυHURA’s first in class bi-functional ADCs utilize a highly selective small molecule inhibitor to target the Delta receptor on MDSCs with an immune effector as the payload. These novel ADCs are bi-functional shutting off MDSC immune suppression of the tumor microenvironment, while localizing an immune effector like a checkpoint inhibitor on MDSCs in the microenvironment, increasing their effectiveness, while limiting indiscriminate toxicity to normal tissues from checkpoint released cytotoxic T cells.

About Morphogenesis

Morphogenesis is a Phase 2/3 clinical stage biotechnology company developing IFx-Hu2.0, a novel intratumoral pDNA, and Ifx-Hu3.0, an intravenous or autologous whole cell mRNA, as personalized cancer vaccines. Clinical studies have demonstrated IFx-Hu2.0’s ability to overcome primary resistance to checkpoint inhibitors like pembrolizumab. Following IFx-Hu2.0 therapy among patients progressing on checkpoint inhibitor therapy, rechallenge with checkpoint inhibitors resulted in durable systemic partial or complete anti-tumor responses in patients with advanced Merkel cell carcinoma. Similar rates of anti-tumor responses were observed in advanced refractory melanoma and squamous cell carcinoma. Based on these data and discussions with the FDA, the Company expects to initiate a single Phase 3 registration trial in first line therapy of patients with advanced Merkel cell carcinoma in sequence with pembrolizumab in late 2023.

The Company’s IFx technology uses a proprietary gene technology to allow tumor cells to express an immune activating bacterial protein on the surface of the tumor cell. In doing so it “tricks” the body’s immune system to attack the tumor by making tumor cells look like bacteria. Recognizing the bacterial protein molecular patterns as being foreign, the patient’s immune system is activated “ingesting” the tumor cell, educating the patient’s immune system to all of the patient’s tumor’s neoantigens regardless of their number or uniqueness. In doing so the Company’s technology provides a more potent and multivalent response against the entire complement of neoantigens in a patient’s tumor.

Contact:
JTC Team, LLC
Jenene Thomas
(833) 475-8247
morphogenesis@jtcir.com