Hemogenyx – CAR-T

Hemogenyx Pharmaceuticals has constructed Chimeric Antigen Receptor programmed T cells (HEMO-CAR-T) for the potential treatment of Acute Myeloid Leukemia (AML). CAR-T therapy is a treatment in which a patient’s own T cells, a type of immune cell, are modified to recognise and kill the patient’s cancer cells.

Current State

As of 3rd March 2021 Hemogenyx have initiated the process of engaging manufacturing organisations for the production of DNA plasmids, viral vectors and HEMO-CAR-T cells to support clinical trials with Randall Tlachac providing oversight.

An expert in the field taking CAR-T to trials…

With more than 70 INDs our extensive experience focuses on compressing product development timelines, successfully bringing products to Phase I/II and beyond in the most cost effective manner while assuring conformance with regulations and requirements, Quality Systems can accelerate your program.

Mr. Tlachac has extensive experience with development of a wide array of products, including peptides, cell therapies, ……

With the recent funding round Hemogenyx are fully funded to bring HEMO-CAR-T to clinical trials and a Sponsored Research Agreement with the University of Pennsylvania its likely that Clinical Trials will be in a position to commence either in 2021 or early 2022. The team is being led by Dr Saar Gill, Assistant Professor of Medicine, a haematologist-oncologist physician scientist and Scientific Co-Director of the Cell Therapy and Transplantation program at Penn. Penn have extensive experience in this field as the developers of a previous CAR-T treatment, Kymriah, developed and brought through clinical trials by Dr June of Penn and costs $475k per treatment.

The Master Translational Research Services Agreement signed looks to be significant and a previous example has elevated Cabaletta Bio to valuation of $300M in a short space of time.

SAFE-HEMO-CAR-T is the next level above already future treatment CAR-T:

HEMO-CAR-T was further engineered during the year by the Company’s scientists in order to increase the safety and versatility of these cells. This led to the introduction of a safety switch mechanism that modulates the activity of HEMO-CAR-T cells and turns them into a “controllable drug” dubbed SAFE-HEMO-CAR-T. This enhancement should dramatically improve the safety and potential versatility of HEMO-CAR-T cells for the treatment of AML and/or conditioning of bone marrow transplants, as well as a number of additional potential indications. SAFE-HEMO-CAR-T therefore represents a tuneable treatment designed to offer control over immune response, alleviating the risk of cytokine release syndrome, a hard-to-predict issue that has arisen during clinical trials of several other CAR-T therapies, slowing their development.

Potential Market

The market is massive and growing with endorsements for CAR-T coming from the scientific community, there have been studies but these probably vastly underestimate the true value of the emerging market

A paper by Deloitte shows a breakdown of recent pharma deals and includes some CAR-T licencing agreements, the range is vast and dependant on stage in clinical trials, however the range goes from 10’s of millions to multi billion dollar deals. No licencing deal comes even close to the current mCap of Hemogenyx (Currently < £20mil).

Summary

SAFE-/HEMO-CAR-T is the next generation of treatments for cancer sufferers, it has been proven to work in the lab and Hemogenyx have managed to bring onboard one of the worlds leading teams to help bring them through clinical trials. They have contracted an expert in the field to oversee the manufacture of the required products and they are fully funded to begin clinical trials. Except for the fact they have not yet treated a patient (that we know) this has all the characteristics of a clinical pharmaceutical company. CAR-T might fail, it may be abandoned, but likewise it may be a resounding success, the potential upside here is massive. There are sites that can help to value small pharma based on pre and early clinical stages.