Emmaus Life Sciences, Cedars-Sinai Sign Option Deal to Advance L-glutamine in Pancreatic Cancer After Phase 1 Tumor Shrinkage Data
核心洞察
Emmaus Life Sciences (搜索) has signed an exclusive option agreement with Cedars-Sinai to continue evaluating L-glutamine oral powder (搜索) combined with chemotherapy in pancreatic ductal adenocarcinoma (搜索).
The agreement follows GlutaPanc Phase 1 results, recently published in Nature Cancer, showing tumor shrinkage in 94% of 16 patients, including two complete responses.
The option grants Emmaus an exclusive 18- to 24-month window to exercise the option and sign a license agreement, building on a 2021 collaboration.
Emmaus Life Sciences (搜索), Inc. (OTCQB: EMMA) announced on Aug. 31 an exclusive option agreement with Cedars-Sinai to continue investigating the clinical utility of L-glutamine oral powder (搜索) in combination with chemotherapy as a potential treatment for pancreatic ductal adenocarcinoma (搜索) (PDAC). The Torrance, California-based commercial-stage biopharmaceutical company said the agreement follows results from the GlutaPanc trial (NCT04634539), which were recently published in Nature Cancer.
Phase 1 Data Show Tumor Shrinkage in Most Patients
According to the company's announcement, the 16-patient Phase 1 clinical trial was associated with tumor shrinkage in 94% of patients, including two patients in whom all signs of cancer disappeared. Shares of Emmaus Life Sciences (搜索), a penny stock, rose on these results, reaching a 52-week high of 8 cents on Aug. 28 in the over-the-counter market.
The safety and efficacy of L-glutamine for the treatment of PDAC have not been established, and the company stated there is no guarantee that L-glutamine will receive regulatory approval for this investigational use.
An 18- to 24-Month Option Window
A spokesperson for Emmaus Life Sciences (搜索) said the option agreement builds on a 2021 agreement between the two parties and grants the company an exclusive period of 18 to 24 months to exercise the option and sign a license agreement. Researchers from Emmaus and Cedars-Sinai have been investigating the use of the drug in combination with chemotherapy for PDAC since 2020.
The spokesperson added that Cedars-Sinai's Beverly Grove campus will likely be one of the sites for the upcoming large-scale Phase 3 clinical trials, which will include at least several hundred patients. Phase 3 trials are generally regarded as the final clinical trial step before a drug is submitted to the FDA for review.
Repurposing an Approved Sickle Cell Therapy
Endari (L-glutamine oral powder (搜索)) is indicated to reduce the acute complications of sickle cell disease (搜索) in adults and children 5 years and older. The FDA approved the drug in 2017 for the treatment of pediatric sickle cell disease, and it is also approved for this use in several Persian Gulf countries. Endari is approved for marketing in the United States, Kuwait, Qatar, the United Arab Emirates, Bahrain, and Oman, and is available on a named-patient early access program in other countries.
"We are incredibly proud to explore the broader potential of our therapies," said Willis Lee, chairman and chief executive officer of Emmaus Life Sciences (搜索). "While Emmaus has historically been recognized for our breakthrough treatment in sickle cell disease (搜索), we believe that this agreement represents an important step in exploring new options for patients with pancreatic cancer."
Unmet Need in PDAC
PDAC is the most common type of pancreatic cancer and is notoriously difficult to treat, often presenting with late-stage diagnoses and limited therapeutic options, according to the company. The collaboration with Cedars-Sinai researchers leverages the institution's oncological research capabilities alongside Emmaus' expertise in drug development for orphan diseases.
Emmaus noted that its forward-looking statements regarding the potential efficacy of L-glutamine for pancreatic cancer and the expected publication of Phase 1 study results are subject to assumptions, risks, and uncertainties, and that actual results may differ materially.