NES-ZIONA, ISRAEL / ACCESSWIRE / April 14, 2023 / This month, H.C. Wainwright & Co. reiterated its buy rating for Enlivex Therapeutics Ltd. (NASDAQ:ENLV) with a 12-month price target of $15 per share, based on a valuation estimated at $320 million. Despite forecasting a net loss of $1.75 per share in 2023 largely due to high R&D spend, analysts believe the clinical-stage company's $50.2 million in cash and short-term deposits is enough to fund operations through to the second half of 2024. Meanwhile, Enlivex is expecting topline data from multiple ongoing clinical trials for its novel macrophage reprogramming immunotherapy, Allocetra, including a recent high-profile collaboration with BeiGene Ltd throughout the end of 2023 and early 2024. Here's a look at some of the promising developments behind the buy rating.

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The Recent BeiGene Collaboration Could Set The Stage For Broader Applications Across Checkpoint Inhibitor Market

Earlier this month, Enlivex announced a new collaboration agreement with BeiGene, one of the world's leading developers of cancer therapies. Under the agreement, Enlivex will amend its current, ongoing phase 1/2a clinical trial of Allocetra as a treatment for advanced-stage solid tumors to include a second stage of patients that will be treated with a combination of Allocetra and BeiGene's Tislelizumab.

Tislelizumab is an anti-PD-1 checkpoint inhibitor, a class of immunotherapies that have shown a lot of promise in treating many types of cancers. But they have had limited success in treating solid cancers because they struggle to break through a tumor's immune microenvironment.

To overcome that barrier, BeiGene and other developers have been looking for combination regimens that could improve the results of their checkpoint inhibitors across these difficult-to-treat cancers. So far, that effort has been met with a series of failures. Last April, for example, Bristol Myers Squibb announced two failed clinical trials that were evaluating a combination of Opdivo and BEMPEG, Nektar Therapeutics' immunotherapy drug candidate. In March, Merck also reported two failed clinical trials, one combining Keytruda with chemotherapy and another combining it with a hormone therapy.

So positive results in the Allocetra-Tislelizumab trial would be a major step forward in the checkpoint inhibitor space and put Enlivex's drug candidate in a position to be used in combination with other checkpoint inhibitors in the market.

Hope for those positive results is high because preclinical data has already shown strong potential for the combination of Allocetra with checkpoint inhibitors, including an ovarian cancer study that found an 83% increase in survival duration in mice that received the combination treatment, compared to just 42% in mice who received just the checkpoint inhibitor. Similarly, a mesothelioma study reported up to 100% cancer remission in mice who received the combined therapy, compared to 25% remission in mice treated with a checkpoint inhibitor alone.

Multiple Clinical Trials Already In Progress With Topline Data Slated For Early 2024

The phase 1/2a trial has already begun enrolling patients and expects to complete enrollment for stage one and the low-dose group in stage two by the end of the second quarter this year. In addition to that amended phase 1/2a trial that will add BeiGene's Tislelizumab, Enlivex has two other phase 1 and 2 clinical trials in progress.

The first is a phase 1/2 trial of Allocetra in combination with a chemotherapy drug to treat advanced-stage solid tumors. Recruitment for that trial is on track and the company is expecting topline data by the second quarter of 2024.

The second is a phase 2 trial evaluating Allocetra as a treatment for sepsis patients. The company recently made plans to submit an amended protocol for the trial to regulators that would expand the criteria to enroll patients with more severe sepsis. The proposed changes would also switch from four cohorts to just two cohorts: a treatment cohort and a placebo control cohort. Even with the changes, Enlivex says it's still on track to release topline data by the first quarter of 2024.

Contact:

Shachar Shlosberger
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