Galectin Therapeutics stock increases by more than 40% before market: why it happened
- Galectin Therapeutics Inc.’s (NASDAQ: GALT) share price has risen more than 40% before market. That’s why it happened.
Galectin Therapeutics Inc.’s (NASDAQ: GALT) share price has risen more than 40% before market. Investors are reacting positively to Galectin Therapeutics and Earle A. Chiles Research Institute announcing first-rate clinical data from the extension cohort of a phase 1b clinical trial initiated by a researcher on Belapectin, an inhibitor of galectin-3, in combination with KEYTRUDA (pembrolizumab) in patients with metastatic melanoma and head and neck cancer. The study was conducted under the direction of Dr. Brendan D. Curti, MD, a renowned cancer and melanoma specialist.
This extension study included 9 patients with melanoma and 5 patients with squamous cell carcinoma of the head and neck. Compared to the initial phase 1b patients, reported previously, the cohort of this extension study was strongly pretreated with systemic therapy, including chemotherapy, immunotherapy with checkpoint inhibitors and cytokines, directed therapies against melanoma mutations (BRAF inhibitors and MEK inhibitors) as well as surgery and radiotherapy (external and radiolabelled). And patients also had a high burden of metastases, with the lungs, soft tissues and liver being the most commonly affected organs. Four of the nine melanoma patients had a choroidal (eye) tumor as the primary site of their cancer and had also developed liver metastases.
The treatment consisted of Belapectin 4 mg / kg lean body mass administered every 3 weeks by infusion, after the infusion of pembrolizumab. Pembrolizumab was administered according to its label. And patient response was assessed on day 85, according to the Response Assessment Criteria in Solid Tumors (RECIST). The median number of treatment cycles was four (range 3-15) for patients with melanoma and five (range 4-8) for patients with head and neck cancer.
The results of melanoma patients included 1 partial response, 4 stable diseases and 4 progressive diseases, providing a disease control rate of 56% (five out of nine patients). The head and neck cancer patients observed included 2 stable diseases and 3 progressive diseases, providing a disease control rate of 40% (2 out of 5 patients).
The combination of Belapectin and pembrolizumab was well tolerated and appeared to be safe. And the most common adverse event related to pembrolizumab, in 6 patients, was grade 1 (mild) pruritus (itching), a known and labeled side effect of pembrolizumab.
The second most common adverse event related to pembrolizumab was grade 2 fatigue in 3 patients. All other adverse events were mild (grade 1). There were no grade 3 or higher adverse events. Similar to the initial results of the Phase 1 study, the frequency and severity of toxicities associated with pembrolizumab, including immune-mediated adverse events, were lower than expected. No adverse events were considered to be related to belapectin.
“Patients in this extension cohort had a significantly higher tumor burden when enrolled compared to the original study, and I find these results encouraging. The results of the extension cohort support the rationale for performing a phase 2 randomized controlled study to further evaluate the combination of belapectin with KEYTRUDA versus KEYTRUDA alone and to fully establish the benefit and immunological effects of this combination. .
– Dr Brendan Curti, MD, principal investigator of the study
“A very large volume of data has recently accumulated demonstrating the harmful role that galectin-3 plays in the tumor microenvironment to stimulate tumor progression. More recently, we have been able to understand how inhibition of galectin-3 helps modify this microenvironment to possibly enhance the action of cancer immunotherapy efforts while possibly reducing side effects 1, 3. With these new data clinics, I strongly support galectin Therapeutics move to the next stage of development to bring hope to cancer patients who urgently need new treatments. “
– Dr Ben Carson, MD, Professor Emeritus of Oncology at the Johns Hopkins School of Medicine and Senior Advisor, Galectin Therapeutics
“The advantageous tolerance and the safety profile of the combination seem to be confirmed by the extension study. This can help patients avoid the frustrating side effects that cause them to stop taking pembrolizumab (KEYTRUDA) for safety reasons, even if they seem to benefit from the drug. Better tolerance would also lead to better compliance and, ultimately, to a better risk / benefit profile of the combination. The good apparent safety profile is also consistent with what we see in cirrhotic patients who, like patients with advanced cancer, are also very fragile. The dose used in the extension is indeed the highest dose we used in our NAVIGATE study in NASH cirrhosis.
“I look forward to launching a more ambitious oncology program for the combination of belapectin with a PD-1 inhibitor that could provide crucial data for regulators. We are exploring the best options for operationalizing such a program and believe that potential partners will interpret these confirmatory results as convincing. “
– Dr Pol Boudes, MD, Chief Medical Officer at Galectin Therapeutics
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