Global Data has warned that the blood cancer development landscape is “oversaturated” and that the cell therapy market can’t support the “congested” pipeline of blood cancer therapies.
There are now more than 8oo therapies being developed in just five blood cancer indications - acute lymphocytic leukemia (ALL), B-cell non-Hodgkin lymphoma (B-NHL), acute myeloid leukemia (AML), multiple myeloma and chronic lymphocytic leukemia.
ALL is the most contested indication, despite its market being smaller than B-NHL. There are already two approved cell therapies for ALL and another 300+ in development.
Antigen selection is also highly duplicated. As pointed out in yesterday’s PTX presentation, two thirds of the blood cancer cell therapy programs are aimed at the same four antigen targets. These are CD19, the target of almost 300 blood cancer drug programs, BCMA (~100), CD22 (~60) and CD20 (~30).
Unsurprisingly, GlobaData is predicting that most of the ALL programs currently in development will never make it through to market. In a congested pipeline, “me-too” and “late-to-market” drug programs are at particular risk of being pulled by developers due to strategic decisions. Given the high costs of drug development, this represents huge amounts of capital down the drain.
For the few drugs that do make it through to market, Global Data warns that there will continue to be manufacturing and pricing hurdles.
One example given of demand outstripping production capacity was the multiple myeloma CAR-T therapy, Abecma. Drugmaker, BMS, said that production of Abecma was being hampered both by the need to reserve manufacturing slots and a global shortage of viral vectors.
What’s all this got to do with Prescient Therapeutics?
Well, Prescient’s lead CAR-T program is in the highly competitive space of blood cancer but it has pulled out all stops to differentiate its in-house program.
Firstly, it has chosen the indication of AML, not the most chased indication of ALL.
Secondly, Prescient hasn’t chosen to target one of the four most common antigens being studied in two thirds of current blood cancer programs. And from the less-targeted surface antigens implicated in AML, it has chosen multiple targets - CD33 and CLL-1, which are both important and well validated targets in AML. In a further move that is probably unique in the field, it is also hunting a third (undisclosed) intracellular protein target (courtesy of collaboration with the largest cancer centre in the US, M D Anderson) which presents on leukemic blasts and leukaemic stem cells, and whose expression correlates strongly with poor outcomes.
Another differentiating aspect of PTX’s AML CAR-T treatment is its ability to be controlled. With the benefit of the company’s next-gen OmniCar modular platform, duration and potency of T-cell activity can be titrated to safe & efficacious levels, including management of neutropenia, which is a consequence of AML treatment. Also, the multiple antigens can be targeted simultaneously or switched at will.
Finally, with the benefit of PTX’s CellPryme platform which creates more persistent T-cells, the chances of the AML therapy eliciting a more durable response in the patient have been increased.
Returning to Global Data, it sought the opinion of Key Opinion Leaders on which cell therapies in the crowded blood cancer landscape are likely to succeed. A common belief was “that the next iterations of the technology will become the most successful ones by solving several current challenges of cell therapies.”
At this still early stage, PTX’s AML CAR-T program, due to enter the clinic late next year, seems to have all the hallmarks of a winner. To date, no preclinical data have been released for the AML program. But in his AGM address, Steve Yatomi-Clarke said that the data is “big” and coming “soon”.
As for all the undifferentiated blood cancer cell therapy programs currently in development, Prescient's various platforms, some of which can be neatly slotted into existing programs, are available for licensing.
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