Small cell lung cancer is an aggressive pulmonary carcinoma. Credit: Nephron / commons.wikimedia.org.

The US Food and Drug Administration (FDA) has granted clearance for Phanes Therapeutics’ Investigational New Drug (IND) application to begin Phase I clinical trials of antibody PT217 to treat small cell lung cancer (SCLC) and other neuroendocrine cancer patients.

The Phase I trial will assess the tolerability, safety, pharmacokinetics and initial efficacy of PT217 in patients with advanced or refractory cancers. 

How well do you really know your competitors?

Access the most comprehensive Company Profiles on the market, powered by GlobalData. Save hours of research. Gain competitive edge.

Company Profile – free sample

Thank you!

Your download email will arrive shortly

Not ready to buy yet? Download a free sample

We are confident about the unique quality of our Company Profiles. However, we want you to make the most beneficial decision for your business, so we offer a free sample that you can download by submitting the below form

By GlobalData
Visit our Privacy Policy for more information about our services, how we may use, process and share your personal data, including information of your rights in respect of your personal data and how you can unsubscribe from future marketing communications. Our services are intended for corporate subscribers and you warrant that the email address submitted is your corporate email address.

Subjects with unresectable SCLC, neuroendocrine prostate cancer (NEPC), large cell neuroendocrine cancer (LCNEC) and gastroenteropancreatic neuroendocrine tumours (GEP-NET) will be eligible for screening in the trial. 

These patients must have progressed following standard therapy of a minimum of one line of platinum-based chemotherapy irrespective of immune checkpoint inhibitor status for SCLC or standard treatment that is not effective, tolerable or was deemed not appropriate.

PT217 is an anti-Delta-like ligand 3 (DLL3)/anti-Cluster of differentiation 47 (CD47) bispecific antibody. 

It previously received orphan drug designation from the FDA to treat SCLC.

Apart from PT217, the clinical programme pipeline of the company comprises a differentiated anti-CD73 monoclonal antibody, PT199, and an anti-Claudin 18.2/anti-CD47 bispecific antibody, PT886.

Phanes Therapeutics founder and CEO Dr Ming Wang said: “This is the third programme in our pipeline that has received IND clearance by the FDA this year, which is an important milestone for Phanes and a record for a biotech company of our size. 

“With a strong pipeline targeting both the adaptive and innate immunity and the bispecific antibody technology platforms we have built, Phanes is well positioned to make important impacts in delivering innovative cancer therapies.”

An aggressive pulmonary cancer, SCLC is distinguished by higher early death rates and substantial morbidities throughout the course of the ailment.