Celldex Therapeutics, Inc. (CLDX - Free Report) presented data from the phase II study on CDX-3379 at the annual meeting of the American Society of Clinical Oncology (“ASCO”). The phase II study is evaluating the CDX-3379 in combination with Lilly’s (LLY - Free Report) Erbitux (cetuximab) in advanced human papillomavirus (“HPV”) negative HNSCC patients who have received treatment with an anti-PD1 checkpoint inhibitor.
The company is evaluating CDX-3379 as monotherapy or in combination Erbitux in multiple studies for treating head and neck squamous cell carcinoma (“HNSCC”) as a part of clinical development program.
Data from the ongoing phase II study along with earlier studies showed that antitumor activity, following treatment with CDX-3379, may be associated with somatic mutations in certain genes. An exploratory biomarker analysis done by the company supported further development of CDX-3379in biomarker-selected HNSCC patients. Celldex is planning to amend the existing study or initiate a new clinical study to focus on the development of CDX-3379 in biomarker selected patient population.
The CDX-3379 and Erbitux combo regimen is in early stage of phase II development. However, data suggests that the combination regimen has the potential to achieve encouraging results in the biomarker selected patient population.
However, shares of Celldex fell 10.2% as investors are probably anticipating a delay in study completion due to any amendment or new study initiation. Moreover, biomarker selection may lead to decrease in a targeted patient population. The company’s shares are up 8% so far this year compared with the industry’s decline of 0.8%.
Data from stage I of the phase II study showed that one patient among 15 enrolled patients achieved a durable confirmed complete response, which is more than 11 months. The patient is still receiving treatment and the response is ongoing. So far, seven patients have experienced stable disease and clinical benefit rate is 29%.
Biomarker analysis done using next-generation sequencing on tumor samples from patients across three studies in the CDX-3379 clinical program showed four patients with clinical responses, including two durable complete responses and greater than 92% tumor shrinkage in one patient. These four patients had FAT1 and NOTCH1, NOTCH2, or NOTCH3 mutations.
Zacks Rank & Stocks to Consider
Celldex currently carries a Zacks Rank #4 (Sell).
A couple of better-ranked stocks from the biotech sector include Anika Therapeutics Inc. (ANIK - Free Report) and Acorda Therapeutics, Inc. (ACOR - Free Report) , both sporting a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.
Anika’s earnings estimates have been revised 4.9% upward for 2019 and 9.9% for 2020 over the past 60 days. The stock has gained 13.3% so far this year.
Acorda’s loss estimates have narrowed 6.5% for 2019 and 6.9% for 2020 over the past 60 days.
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