AVEO Pharmaceuticals stock rockets on positive results on leukemia drug

AVEO Pharmaceuticals Inc (NASDAQ:AVEO) stock nearly doubled Tuesday after the biotech and its partner Biodesix Inc shared positive results for cancer drug ficlatuzumab, which was formerly known as AV-299, from a Phase 1b trial of ficlatuzumab in combination with cytarabine in patients with relapsed and refractory Acute Myeloid Leukemia (AML), a type of cancer that starts in the blood-forming cells in the bone marrow.

The positive results were presented in a poster session at the annual meeting of the American Association for Cancer Research.

Investors sent shares of AVEO Pharmaceuticals up nearly 65% to $1.83 in afternoon trade.

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Significant elevation of serum human hepatocyte growth factor (HGF) levels are associated with very poor survival rates in AML and other cancers. The company said pre-clinical models have shown that myeloid blasts produce HGF and that blocking the HGF/c-Met pathway sensitizes blasts to cell death.

The Phase 1b trial was funded by Gateway for Cancer Research and is being conducted at the UCSF Medical Center.

“Patients with AML who are refractory to induction therapy or relapse within one year have poor outcomes,” said Dr Charalambos Andreadis, who is directing the study at the UCSF Medical Center. “Elevated serum HGF level is an adverse prognostic factor, and these results demonstrate that the anti-HGF antibody ficlatuzumab combined with cytarabine holds potential to affect outcomes in patients with relapsed or refractory AML.”

Of 12 patients who received ficlatuzumab and cytarabine at the maximally tolerated dose, one of whom was non-evaluable, six achieved a complete response.

Of 18 patients enrolled in the study, 17 were evaluable and nine achieved a complete response. There was one death from sepsis and multi-organ failure that was determined to be disease related, and one patient withdrew from the study due to grade 4 gastrointestinal bleeding determined to be likely due to ficlatuzumab.

“We look forward to potentially evaluating ficlatuzumab in larger outcome studies in AML,” said Professor Andreadis, who is the director of the clinical research support office, at the UCSF Helen Diller Family Comprehensive Cancer Center.

AVEO and Biodesix Inc have a worldwide pact to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in investigator-sponsored trials in squamous cell carcinoma of the head and neck, metastatic pancreatic ductal cancer, and acute myeloid leukemia.

“In addition to an attractive tolerability profile observed to date, we also see the potential to identify biomarkers of response using RNA sequencing. In light of these data, we believe that further evaluation in this patient population is warranted,” said AVEO Pharmaceuticals CEO Michael Bailey.

Cambridge, Massachusetts-based AVEO is a biotech dedicated to advancing a broad portfolio of targeted medicines for oncology and other areas of unmet medical need.

The company’s strategy is to retain North American rights to its oncology portfolio while securing partners in development and commercialization outside of North America.

Contact Uttara Choudhury at [email protected]

Follow her on Twitter: @UttaraProactive 

Story by ProactiveInvestors