For Chimeric Therapeutics (CHM: $0.029), achieving Phase Ib data from its programs is expected to position the company for licensing deals ahead of registration Phase II studies with CAR-T cell therapies.
Unlike most other pharmaceutical and biological therapies, CAR-T cell therapy products have been approved following single arm, Phaser II studies. Chimeric CEO Jennifer Chow said that potential partners do not want to license products in Phase II, but rather before these studies have commenced so that the design and execution can be controlled by the larger partner.
In 2024 Chimeric expects to have four Phase Ib studies underway.
Glioblastoma Treatment Program
Chimeric's most advanced program is in glioblastoma with its autologous therapy CTLX CAR T. An 11-patient study has been completed in advanced patients in a fourth-line treatment setting.
Four doses were explored with a disease control rate achieved of 55%. This compares to historical disease control rates with chemotherapeutics of 20% (with lomustine) and 37% (with temozolomide).
The median survival was 9.9 months, when around a seven month median survival can be expected historically after the first recurrence of disease. A dose response was not clear, with one of the best performing patients (still alive after 14 months) receiving the second lowest dose, and the other patient who has responded and remains alive receiving the highest dose.
The safety profile of the therapy was good with no dose-limiting toxicity and no evidence of cytokine release syndrome, which has been a hallmark of the early approved CAR T therapies.
In June this year Chimeric started the first part of a Phase Ib study which will enrol between three to six patients. The difference from the Phase Ia study is that patients will be recruited at an earlier stage (second line treatment and third line treatment rather than fourth) and patients will be receive the maximum dose tested in the Phaser Ia study. It will also be a multi-centre study.
From there the company expects to move on to the second part of the Phase Ib study, which will seek to recruit a further 12 - 26 patients next year treated at the same dose.
Gastrointestinal Cancers - IND Received for Phase Ia study in 2024
This week Chimeric received IND clearance from the FDA to start a Phase Ia study with its CDH19 CAR T therapy in patients with colorectal cancer, gastric cancer and neuroendocrine tumours. This is the second of the company funded studies after the glioblastoma study above.
The trial is expected to start next year. It will look at the three different cancers, and may expand into one of those tumour types when positive efficacy signals generated.
CORE NK Program
In November last year Chimeric in-licensed the CORE NK platform from Case Western University following positive Phase Ia data that had been achieved, particularly in blood-based cancers.
One of the key differences with this program is that it uses allogeneic cells from healthy volunteers which means the same therapy can be used for all patients without reprogramming the patient's own immune cells.
A Phase Ib study commenced in January this year with this treatment in combination with the oncology drug vactosertib in patients with colorectal and blood cancers. The study is being conducted by oncologists from Case Western University and is not being funded by Chimeric.
A second Phase Ib study is expected to start by year's end, combining the therapy with standard-of-care treatment (azacitidne and venetoclax) in patients with Acute Myeloid Leukemia. Chimeric will provide only modest funding for this study which will be conducted at the MD Anderson Cancer Center. It will seek to enrol 20 patients and has received FDA IND clearance.
Rights Issue
Chimeric is currently conducting a rights issue to raise up to$10 million at $0.028 per share. The company had $4.5 million in funds at the end of September. The company's net cash outflow from operations in FY2023 was $16.3 million.
Chimeric Therapeutics is capitalised at $26 million, excluding the capital raise underway.
Bioshares recommendation: Speculative Buy Class B
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