Morphogenesis, Inc. Announces Corporate Rebranding to TuHURA Biosciences, Inc. and Provides a Business Overview

Company focused on advancing novel personalized cancer vaccines to overcome tumor resistance to immunotherapies like checkpoint inhibitors; and first-in-class bi-functional antibody drug conjugates (ADCs) targeting Myeloid Derived Suppressor Cells (MDSCs) to modulate their immunosuppressive effects on the tumor microenvironment

Company on track to initiate pivotal Phase 3 study of lead program, IFx-2.0, in Merkel Cell Carcinoma (MCC) in 2024 under the FDA's accelerated approval pathway

TAMPA, FL / ACCESSWIRE / December 14, 2023 / Morphogenesis, Inc. ("Morphogenesis"), a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy, today announced its corporate rebranding and provided a business overview. Effective immediately, the company will operate under the name TuHURA Biosciences, Inc. ("TuHURA").

"We are very pleased to announce our corporate rebranding which now clearly aligns with our development focus and emphasizes our commitment to overcoming the major obstacles that limit the effectiveness of cancer immunotherapies," commented James Bianco, M.D., President and Chief Executive Officer of TuHURA. "Our technology platforms have the potential to significantly increase the number of cancer patients that can respond to immunotherapies, such as checkpoint inhibitors. Looking ahead, we are driving our lead clinical program, IFx-2.0 personalized cancer vaccine, forward and are on track initiate our single Phase 3 registration study in 2024."

TuHURA's Strategy

TuHURA's strategy is to leverage its technologies and novel product candidates as adjunctive therapy to overcome primary and acquired resistance to checkpoint inhibitors, molecularly modified immune therapies and cellular therapies. The key elements of this strategy include:

• Shortening the time and cost to product registration;
• Establishing a leadership position in developing first-in-class bi-functional ADCs;
• Expanding the application of its IFx-2.0 personalized cancer vaccine;
• Leveraging the IFx technology platform to develop next generation candidates to expand into blood related cancers; and
• Establishing development and commercial license collaborations.

TuHURA's Focus

The company is focused on advancing its two innovative platform technologies:

IMMUNE FX™ (IFx™): Personalized Cancer Vaccines Harnessing the Power of the Innate Immune Response

TuHURA's IFx technology utilizes a proprietary plasmid DNA ("pDNA") or messenger RNA ("mRNA") which, when introduced into a tumor cell, results in the expression of a highly immunogenic bacterial protein (emm55) from a rare variant of Streptococcus pyogenes on the surface of the tumor cell.

The company's lead program, IFx-2.0, is designed to harness the power of the patient's innate immune response, which has evolved over time to be conserved to detect foreign pathogens like bacterial proteins. By making the surface of a tumor look like a bacterium, IFx-2.0 is designed to use the tumor itself as the source of foreign neoantigens to prime and initiate an innate immune response against the tumor restoring the cancer immunity cycle leading to adaptive immune response.

Program Highlights:

• IFx-2.0 makes patient's entire tumor appear foreign activating the innate immune response allowing checkpoint inhibitors to work where they previously failed or where they normally would not work.
• Produced high rates of durable systemic objective responses across multiple cutaneous malignancies including in advanced or metastatic Merkel Cell Carcinoma (MCC), cutaneous Squamous Cell Carcinoma and Melanoma that exhibited primary resistance to checkpoint inhibitor therapy in Phase 1 and Phase 1b clinical trials.
• Demonstrated excellent safety profile when used as adjunctive therapy with a checkpoint inhibitor.
• Preparing to commence single Phase 3 registration directed pivotal trial to be conducted under Accelerated Approval pathway for first line treatment of advanced or metastatic MCC when used as adjunctive therapy with pembrolizumab.

Bi-Functional Antibody Drug Conjugates (ADCs): Targeting Myeloid Derived Suppressor Cells (MDSCs) to Modulate Their Immunosuppressive Effects on the Tumor Microenvironment

Leveraging its proprietary Delta receptor technology TuHURA is developing first-in-class bi-functional ADCs that target MDSCs: cells which are responsible for creating an immunologic sanctuary through their immunosuppressing effects on the tumor microenvironment (TME). The TME is the tissue surrounding a tumor; MDSCs are a heterogeneous group of immature myeloid cells that are characterized by the ability to suppress both innate and adaptive immune responses. MDSCs are generally believed to be responsible for T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies. Utilizing its ADCs to inhibit the immune suppressing effects of MDSCs, while localizing an immune checkpoint inhibitor or T cell activator in the TME, TuHURA believes it may be able to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies, allowing them to continue working.

Program Highlights:

• First to identify the presence of a novel Delta receptor present in high quantities on the surface of tumor associated MDSCs.
• Delta receptor represents a "master switch" controlling multiple MDSC pathways responsible for creating immune sanctuary where tumor lives.
• Developing Delta specific and selective small molecule inhibitors as core for company's bi-functional ADCs.
• Unlike conventional ADCs, TuHURA's bi-functional ADCs target and inhibit Delta receptor on MDSCs removing their immune suppressing effects while localizing an immune effector like a checkpoint inhibitor where the tumor lives.

Additionally, the company is advancing IFx-3.0, a personalized cancer vaccine to be delivered intravenously, which leverages the clinical validation of the IFx-2.0 clinical program. IFx-3.0 utilizes the company's proprietary emm55 mRNA to target CD22, which is overexpressed on cancerous B-cells. TuHURA expects to begin IND enabling studies in the second half of 2024.

Program Highlights:

• Developed proprietary CD22 targeting antibody fragment (scFv) coupled to mRNA loaded lipid nanoparticle.
• CD22 overexpressed on malignant B cells allowing IFx-3.0 mRNA payload to be selectively targeted to and expressed in cancerous B cells.
• Expands cancer vaccine technology to blood related cancers.

For more information about the company's innovative platform technologies and development programs, please visit tuhurabio.com.

About TuHURA Biosciences, Inc.

TuHURA Biosciences is a Phase 3 registration-stage immuno-oncology company developing novel technologies to overcome resistance to cancer immunotherapy. The company's lead personalized cancer vaccine candidate, IFx-2.0, is designed to overcome primary resistance to checkpoint inhibitors. TuHURA is preparing to initiate a single randomized placebo-controlled Phase 3 registration trial of IFx-2.0 administered as an adjunctive therapy to Keytruda® (pembrolizumab) in first line treatment for advanced Merkel Cell Carcinoma.

In addition to its cancer vaccine product candidates, TuHURA is leveraging its Delta receptor technology to develop first-in-class bi-functional antibody drug conjugates (ADCs), targeting Myeloid Derived Suppressor Cells (MDSCs) to inhibit their immune suppressing effects on the tumor microenvironment to prevent T cell exhaustion and acquired resistance to checkpoint inhibitors and cellular therapies.

For more information, please visit tuhurabio.com.

Investor/Media Contact:
Jenene Thomas
JTC Team, LLC
tuhura@jtcir.com

SOURCE: Morphogenesis Inc.