Biotechnology rule: FDA approval to conduct a trial of a therapeutic vaccine for cancer – the capital market

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Clal Biotechno
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It is reported that the holding company (18%) Alicio has received approval from the US Food and Drug Administration (FDA) to conduct a clinical trial of a therapeutic vaccine for cancer targeted against mutant KRAS (mKRAS).

This is an approval of IND (Investigational New Drug application) for a clinical trial of the company’s therapeutic vaccine, ELI-002. The company plans to begin clinical trials in the first quarter of 2021, in patients with pancreatic cancer as well as patients with other solid cancerous tumors expressing mKRAS.

According to the report, in the first part the trial will evaluate several doses, will be open, uncontrolled and will include up to 18 patients with pancreatic cancer or with colon cancer. The second part of the trial will include up to 90 pancreatic cancer patients to be evaluated compared to conventional treatment. Patients will be included in the trial after undergoing tumor removal surgery and chemotherapy followed by tumor DNA remaining in their blood, indicating that they are at high risk for disease recurrence and its rapid spread even if tumor recurrence cannot yet be detected by imaging. The trial will evaluate the safety of the vaccine and provide an indication of its ability to prevent tumor recurrence.

The mKRAS protein promotes the development of cancer and is found in about 25% of all solid cancerous tumors in humans, especially pancreatic cancer (90% of cases) and colon cancer (40% of cases). The company hopes that its vaccine will elicit an immune response as well as short proteins that cover 99% of the mutations in KRAS that encourage cancer development. The company hopes that the vaccine will elicit a strong therapeutic immune response against tumors expressing mKRAS, unlike other approaches against this protein such as mKRAS inhibitors.

In addition, Alicio plans to launch a clinical trial of the corona virus vaccine in the coming months. In an investor talk about two months ago, Clal Biotechnology CEO Ofer Gonen said of the prominent competitors’ corona vaccines that “if we find that there is no vaccine memory, we will have to get vaccines every few months or every year.” It is indeed great: “It is one vaccine and we are done,” Gonen added. Funding for the promotion of this vaccine is expected to come from an external partner, according to Gonen.

Clal Biotechnology recently received a court approval for a dividend of NIS 36 million, which will be made within six months. The application was submitted to the court at the end of December, following the sale of Cadent, a company (13%) owned by Clal Biotechnology, to Novartis. The value that the deal reflects for the cadet is expected to result in Clal Biotechnology recording an profit of NIS 88 million in the 2020 reports, according to estimates.