Iovance's TIL therapy makes early headway in lung cancer; Antios and Arbutus join hands on HBV combo treatment
Iovance has posted a first look at its tumor infiltrating lymphocytes as a treatment for non-small cell lung cancer, paving the way for a pivotal study.
Among 28 patients enrolled in Cohort 3B of the IOV-COM-202 basket study — 24 of whom were evaluable — investigators recorded an overall response rate of 21.4% at the interim, with 1 complete response and 5 partial responses. All patients in the group had progressed on prior immune checkpoint inhibitor therapy, and some had received tyrosine kinase inhibitors. The six responders also underwent chemotherapy.
The median duration of response was not yet reached after 8.2 months of followup.
CMO Friedrich Graf Finckenstein called the data “very promising.”
“There remains a very significant unmet need to increase response rates and prolong survival in the second line non-small cell lung cancer treatment setting,” he added.
Mizuho analyst Mara Goldstein evidently agreed, writing in a note that the trial included a late-stage population.
“More encouragingly, the initial durability seems consistent with that reported with TILs in melanoma, suggesting that durable responses may be a common theme with TIL therapy,” Boris Peaker of Cowen echoed.
The biotech, which is leading with the cervical cancer indication, said it has dosed the first patient in IOV-LUN-202, a potentially registrational study dedicated for second-line patients who have progressed on one prior checkpoint and chemo. — Amber Tong
Antios and Arbutus join hands on HBV combo treatment
A few days after announcing its hepatitis B candidate worked as billed as a monotherapy, Antios Therapeutics is unveiling a partnership to pair the drug with Arbutus’ RNAi therapy AB-729 and Gilead’s Viread.
The combination will be assessed in a cohort of the ongoing Phase IIa ANTT201 trial. Antios will foot the bill for that portion of the trial, which is expected to kick off in the second half of this year. Arbutus will take responsibility for the manufacturing and supply of AB-729.
“ATI-2173 has, to date, demonstrated a well-tolerated safety profile and sustained on- and off-treatment antiviral responses as a monotherapy in patients with chronic HBV,” Antios CEO Greg Mayes said in a statement.
The candidate is an investigational prodrug of clevudine, which has historically demonstrated potent and sustained reductions in HBV viral load. However, high plasma levels of clevudine have been associated with reversible myopathy, according to CMO Douglas Mayers. ATI-2173 was designed to have a similar mechanism of action in the liver, with minimal plasma exposure.
“We believe that its unique mechanism of action and early evidence of clinical activity may position ATI-2173 as the backbone of a once-daily curative regimen in combination with other agents for chronic HBV,” Mayes said. — Nicole DeFeudis
Norwegian radiopharma player lands $29M
Riding on the growing momentum for radiopharma, a Norwegian biotech has raised NOK 250 million ($29.19 million) to fund mid-stage clinical studies in ovarian and colorectal cancer.
The next step, Oncoinvent was eager to share, will be an IPO in the coming year.
Thanks to enthusiastic support from Hadean Ventures, Geveran, RADFORSK Investeringsstiftelse, Sundt, Must Invest, Canica, MP Pensjon and Watrium, Oncoinvent actually upped the round, CEO Jan Alfheim said, allowing them to start preclinical development of two candidates earlier than planned.
Like others in the space — from pharma giant Novartis to upstarts like RayzeBio and Aktis — Oncoinvent is all about delivering alpha-emitting particles precisely to where the tumors are. What sets it apart, according to the company, is the way it formulates the radioisotopes in a suspension of inorganic microspheres. That means they can go after cancer metastases on intracavitary surfaces and liquid volumes without going too deep into organs and tissues.
The lead candidate, Radspherin, is currently in Phase I trials. — Amber Tong
Looking to turn antibody into ADC, Innovent taps Dutch partner
Having long branded itself as a leading antibody developer in China, Innovent is branching out.
The Suzhou-based company is teaming up with Synaffix, a Dutch specialist of antibody-drug conjugates, to leverage one of its own antibodies and make a best-in-class ADC candidate. Without specifying which one, Innovent said it will have access to Synaffix’s suite of technologies.
The deal follows an initial research period in which the two companies worked together on proof-of-concept. Synaffix will continue to help with the experiments as well as manufacturing of any ADC-related parts. — Amber Tong
Gilead races to the finish line with a new HIV candidate for drug-resistant patients
HIV patients who have developed resistance to multiple drugs could soon have another option. Gilead has submitted a new drug application for its long-acting HIV-1 capsid inhibitor lenacapavir, the company said on Monday.
The filing is based on data from the Phase II/III CAPELLA trial which showed that 88% of patients in the treatment arm achieved a meaningful viral load reduction (at least 0.5 log10) compared to just 17% in the placebo arm over a 14-day period (p<0.0001). The drug was generally well-tolerated, with no serious adverse events related to the study and no discontinuations in the 14-day period, according to Gilead.
“We acknowledge the salvage HIV market is <10% of the total market and perhaps not too material to GILD’s top-line,” Jefferies’ Michael Yee said back in November, when Gilead read out the first pivotal results. “But this is an important step towards broadening of the long-acting opportunity into the bigger on-treatment and PrEP markets.”
At the time, Yee said Gilead’s candidate was looking better than fostemsavir — a GSK drug commonly given to HIV patients with drug resistance. In a pivotal trial, just 68% of patients on fostemsavir achieved the required viral load reduction. — Nicole DeFeudis
Eikonoklastes Therapeutics closes Series A fundraising
An Ohio-based biopharma has completed its Series A round of fundraising, but hasn’t yet disclosed that number, the company announced Tuesday.
Eikonoklastes Therapeutics round was led by CincyTech with participation from Elk Capital Ventures, Jobs Ohio and Rev1. The funds will be used to prepare IND studies for L-ICON3, a tissue factor immunotherapy for the treatment of triple-negative breast cancer, which accounts for 15% of all breast cancers, the company said in a press release. The drug targets tissue factor, but not healthy cells.
The company closed its oversubscribed seed financing in July 2020. The Ohio State University Corporate Engagement Office is also involved with the project. — Josh Sullivan