Back to top

Image: Bigstock

Verastem (VSTM) Begins Dosing in Solid Tumors Study in China

Read MoreHide Full Article

Verastem Oncology (VSTM - Free Report) announced that it has dosed the first patient in a phase I/II study evaluating its KRAS G12D inhibitor, GFH375/VS-7375, for treating KRAS G12D mutant solid tumors. Verastem’s collaboration partner GenFleet Therapeutics is conducting the study in China.

Shares of VSTM were up 12.8% on Jul 12 following the announcement of the news.

Verastem entered into a collaboration agreement with GenFleet in 2023, wherein GFH375/VS-7375 was selected as its lead program. GFH375/VS-7375 is an oral, potent and selective KRAS G12D dual inhibitor of ON (GTP) and OFF (GDP) states.

The phase I study is designed to investigate the safety and efficacy of GFH375/VS-7375 in patients with advanced KRAS G12D mutant solid tumors in China. The study will also help in determining the recommended dose of GFH375/VS-7375 for a phase II study.

The phase II study will further evaluate the safety and efficacy of GFH375/VS-7375 in patients with advanced solid tumors, such as pancreatic ductal adenocarcinoma, colorectal cancer and non-small cell lung cancer.

Verastem stock has plunged 58.7% year to date compared with the industry’s decrease of 2.7%.

Zacks Investment Research
Image Source: Zacks Investment Research

We note that after evaluating the initial dose escalation data from the above mentioned phase I study in China, VSTM plans to expedite the development path ahead for GFH375/VS-7375 in the United States.

GenFleet’s investigational new drug application seeking approval to begin clinical studies on GFH375/VS-7375 in China was cleared in June.

Verastem is a clinical-stage company engaged in developing new medicines for the treatment of cancer.

In May 2024, VSTM initiated the rolling submission of a new drug application to the FDA, seeking accelerated approval of the combination of avutometinib and defactinib for treating adult patients with recurrent KRAS mutant low-grade serous ovarian cancer who received at least one prior systemic therapy.

Both avutometinib and defactinib have been in-licensed by Verastem from other pharmaceutical companies. Avutometinib is an RAF/MEK clamp, while defactinib is a best-in-class selective FAK inhibitor.

Also in May 2024, Verastem announced positive interim safety and efficacy data from the dose level 1 cohort of its phase I/II study evaluating avutometinib and defactinib in combination with standard-of-care first-line chemotherapy (gemcitabine and Nab-paclitaxel) in metastatic pancreatic cancer patients.

Verastem is also simultaneously evaluating avutometinib in combination regimens targeting other cancer indications.

Zacks Rank & Stocks to Consider

Verastem currently carries a Zacks Rank #4 (Sell).

Some better-ranked stocks in the healthcare sector are Acrivon Therapeutics, Inc. (ACRV - Free Report) , Adaptive Biotechnologies Corporation (ADPT - Free Report) and RAPT Therapeutics, Inc. (RAPT - Free Report) , each holding a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Acrivon Therapeutics’ 2024 loss per share have narrowed from $3.05 to $2.47. Loss per share estimates for 2025 have narrowed from $3.04 to $2.55. Year to date, ACRV shares have rallied 51.4%.

ACRV’s earnings beat estimates in three of the trailing four quarters and missed the same on the remaining occasion, the average surprise being 3.56%.

In the past 60 days, estimates for Adaptive Biotechnologies’ 2024 loss per share have narrowed from $1.30 to $1.29, while loss per share estimates for 2025 have narrowed from $1.08 to $1.02. Year to date, ADPT shares have declined 18.3%.

ADPT’s earnings beat estimates in two of the trailing four quarters, meeting the same once and missing on the remaining occasion, the average surprise being 0.65%.

In the past 60 days, estimates for RAPT Therapeutics’ 2024 loss per share have narrowed from $2.94 to $2.93. Loss per share estimates for 2025 have narrowed from $2.06 to $2.05. Year to date, RAPT shares have declined 86%.

RAPT’s earnings beat estimates in two of the trailing four quarters while missing the same on the remaining two occasions, the average surprise being 3.19%.

Published in