The transatlantic biotech ADC Therapeutics is getting a speedy review for its anti-body drug conjugate loncastuximab tesirine (Lonca), developed for relapsed or refractory diffuse large B-cell lymphoma.
ADC $ADCT said Friday morning that the FDA put their drug on the fast lane, providing a priority review for the drug with a May 21 PDUFA date. The biotech won over regulators with Phase II data that reflected an overall response rate of 48.3% (70/145 patients) and a complete response rate of 24.1%.
“The FDA’s acceptance of our BLA and granting of priority review for Lonca is a tremendous accomplishment that brings ADC Therapeutics one step closer to being able to offer patients with relapsed or refractory DLBCL a greatly needed new treatment option in 2021,” said ADC chief Chris Martin. — John Carroll
Qiagen gets to work on a new diagnostic for BioNTech
Qiagen has signed up to work with mRNA pioneer BioNTech on a new diagnostic that can be used to flag patients with squamous cell carcinoma of the head and neck caused by infections with human papillomavirus.
Their assay will be designed to detect the presence of HPV genotypes associated with the biotech’s cancer treatment BNT113. And then Qiagen plans to expand that to become a universal HPV companion diagnostic.
According to Qiagen, head and neck squamous cell carcinoma is the sixth most common cancer, triggering more than 650,000 cases and leading to 330,000 deaths. Those numbers are expected to double by 2035. — John Carroll
Antengene goes public in Hong Kong
Antengene, the Hong Kong-based oncology company long backed by Celgene, has gone public in an oversubscribed offering worth roughly $340 million.
The company launched in 2017 with $21 million and a licensing deal with Celgene. They’ve since added other assets from Karyopharm and AstraZeneca and raised an additional $217 million in private financing, including a $97 million Series C earlier this year.
The biotech now has dozens of programs, but their furthest along asset is the Karyopharm drug Selinexor. Approved in the US, Antengene is now testing it in Phase II for two blood cancers and non-small cell lung cancer. — Jason Mast
Obsidian teams with MD Anderson
MD Anderson has been ratcheting up its biotech partnerships in recent months, particularly around immuno-oncology. Now they’re teaming up with Obsidian Therapeutics.
The Michael Gilman-founded startup has been quiet since their $50 million launch back in 2017, but the company just added a new CSO as they work on their new spin to cell therapy.
The idea is to be able to control cell therapies such as CAR-T with oral drugs that will increase or decrease the number of active T cells in a patient. The two entities will team up on a tumor-infiltrating lymphocyte therapy (TIL) that can be controlled with IL-15, with the goal of treating solid tumors.
“TIL therapy has emerged as a promising option for treating patients with solid tumors, though its widespread use today is limited by safety and efficacy challenges,” Rodabe Amaria, associate professor of Melanoma Medical Oncology at MD Anderson, said in a statement. “We are pleased to work with Obsidian to advance their novel cytoTIL program, which has the potential to drive more durable treatment responses and expand TIL therapy to a broader group of our patients.” — Jason Mast