Cancer research has come a long way in the past few decades, pioneering treatments like chemotherapy and radiation treatments that have become essential weapons in the fight against this deadly and difficult to treat disease. Even so, many cancers don’t respond to the current standard of care and the harsh side effects of existing treatments can become debilitating or even life-threatening in their own right.
That reality is what reportedly motivated leading minds in the pharmaceutical and biotech space Shai Novik and Dr. Roger Pomerantz to join Enlivex Therapeutics Ltd. ENLV in its quest to develop a cancer therapy that could offer safer, more effective and more affordable treatment to cancer patients around the world.
Novik Brings Decades Of Experience Working With Biotech And Life Sciences Companies
Now serving as executive chairman at Enlivex, Novik has a decades-long track record in biotech and life sciences. After founding PROLOR Biotech Ltd. in 2005, Novik led the company from a garage-based startup to a New York Stock Exchange listing in 2010 and then he sold the company for $560 million in 2013. The acquiring company, OPKO, asked Novik to stay and manage the company for an additional two years. He did that, and during that time frame executed a strategic partnership with Pfizer for PROLOR’s lead drug candidate, a long-acting growth hormone for children with growth hormone deficiency, who had completed successful Phase II studies at the time. Pfizer paid a $295 million down payment and continued to run Phase III studies, after which Novik’s product was approved for marketing in many countries including Australia, Canada, Japan and Europe.
Before that, he was the chief operating officer and head of strategic planning at THCG Inc., an investment company specializing in technology and life sciences with a broad portfolio featuring a number of innovative life sciences and medical device companies.
Pomerantz Leverages A Background In Developing Pioneering Biotech Startups
One of the newest members of the Enlivex team, Pomerantz brings a depth of knowledge and experience to his new role as vice-chairman.
After having served as the global head of infectious diseases at Johnson & Johnson, and then worldwide head of licensing and acquisitions at Merck & Co. Inc. MRK, Pomerantz joined Flagship Pioneering’s team, one of the world’s leading life sciences investment funds, who created transformational companies such as Moderna Inc. MRNA and Seres Therapeutics Inc. MCRB.
Reprogramming Macrophages To Aid In The Fight Against Cancer?
Together with the rest of the company’s leadership, Pomerantz and Novik say they are leveraging their decades of experience to develop Enlivex into a cutting-edge pharmaceutical company poised to transform the cancer therapy landscape.
The clinical-stage company’s approach taps into the power of macrophages, the first responders and regulators of the immune system.
When working properly, macrophages patrol the entire body, circulating through the bloodstream and residing in tissue. If they detect a possible threat, they immediately engulf it, kill it and send out instructions to the other cells in the immune system. In this role, they’re responsible for telling the immune system when and where to attack — and when to stop to avoid excess damage to surrounding healthy tissue and cells.
In cancer, however, the disease can infiltrate the macrophage and manipulate it to the cancer’s will. In doing so, cancer can trick the macrophage into thinking cancerous cells are normal cells that not only shouldn’t be targeted but should be actively protected from the rest of the immune system.
Those reprogrammed macrophages weaken the body’s ability to fight cancer and can make it difficult for cancer treatments to do their work. Some of the best immunotherapies, for example, can only do so much if there’s an army of macrophages actively suppressing the immune response.
That’s where Enlivex reports its leading drug candidate Allocetra comes in. Formulated from healthy donor cells, Allocetra uses macrophages that have been reprogrammed to send out an “eat me” signal to the patient’s own macrophages.
Once engulfed, the Allocetra macrophage is meant to restore balance to the host macrophage, boosting its ability to recognize cancer as a threat and reactivating its ability to properly regulate the immune system.
The company recently disclosed impressive preclinical data that reaffirms the macrophage reprogramming concept. In one study that the company conducted in collaboration with the Yale Cancer Center, when Allocetra was combined Allocetra with an anti-PD-1 inhibitor similar to Keytruda, for example, mice with ovarian cancer that were treated with anti-PD-1 alone had a reported 10% survival, while the combination treatment saved 50% of the mice.
Similar improvements were seen in a preclinical study pairing Allocetra with an anti-CTLA-4 inhibitor similar to Yervoy, another advanced anti-cancer drug, to treat mesothelioma, a very aggressive cancer. Between 60% and 100% of mice receiving the combination therapy saw complete cancer remission and survival, depending on the dose received, while the untreated group had 0% survival, and anti-CTLA-4 stand-alone provided 25% survival.
Building on that data, Enlivex states it has recently received regulatory approval to initiate a Phase I/II clinical trial in patients with advanced-stage solid tumors, that will receive combination treatment of Allocetra and chemotherapy, and is planning an additional Phase I/II clinical trial later this year in patients with advanced-stage solid tumors that have low survival probabilities, treating with anti-PD-1 and Allocetra combination for advanced-stage solid tumor. Enlivex states it is working fast to bring this potentially groundbreaking cancer treatment to market as soon as possible.
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