CPhI Online

- Biopharma News

Piramal to provide sterile fill/finish services for Theratechnologies' lead compound

25 Jan 2021

The CDMO will provide drug product formulation and manufacturing for TH1902, a peptide-drug conjugate designed to tackle hard-to-treat cancers

Piramal Pharma Solutions, the contract development and manufacturing organization (CDMO) arm of Piramal Pharma Limited, has announced that it is providing Theratechnologies with good manufacturing practice (GMP) manufacturing of sterile fill/finish drug product to support their developmental product as it enters into a first-in-humans clinical study.

The clinical material, which is being produced at the CDMO's manufacturing site in Lexington, Kentucky, will be used in a Phase I trial for TH1902 — Theratechnologies' lead peptide-drug conjugate (docetaxel conjugate).

TH1902 has been specifically developed for the treatment of several cancer types expressing the sortilin receptor, including ovarian and triple-negative breast cancer. Recent study findings (December 2020) have also indicated pre-clinical in vivo efficacy and tolerability in colorectal, pancreatic, melanoma and endometrial cancers.

The Phase I trial design includes a dose escalation study to evaluate the safety, pharmacokinetics, maximum tolerated dose and preliminary anti-tumour activity of TH1902 administered once every 3 weeks in patients with advanced solid tumours refractory to available anti-cancer therapies.

Peter DeYoung, Chief Executive Officer, Piramal Pharma Solutions, commented: "Our Lexington team went the extra mile to provide solutions to ensure timely formulation development and production of the material. It's yet another example of how we are focused on working with our customers to reduce the burden of disease on patients."

Read More

Related Content