New data point to how Keytruda changed lung cancer treatment; A Houston biotech earns early backers in quest to turn 'cold' tumors 'hot'
25 May 2021
Antibody
Keytruda became standard-of-care in non-small cell lung cancer in part thanks to clinical trials that ultimately showed it could boost survival to over two years — or nearly twice as long as chemotherapy. But how long do patients actually live in the real world?
A new analysis of 230,000 Medicare patients, published Friday in JAMA, found that the answer was far less: 11.9 months. That’s less, they found, than patients who received either chemotherapy or chemotherapy in combination with Keytruda, who collectively lived for about 12.9 months.
Still, neither the study authors nor outside experts say this changes the picture for Keytruda’s benefit, or the question of whether it’s better than chemotherapy. Rather, it points to the subtle ways Keytruda’s powerful effects may be changing cancer treatment, said lead author Kenneth Kehl, a thoracic oncologist at Dana-Farber Cancer InstituteCancer Institute.
For example, he said, it’s possible that because Keytruda is more effective and comes with fewer side effects than chemotherapy, doctors are prescribing it to patients who are older and sicker and, previously, might not have been treated at all. Peter Bach, director of the Center for Health Policy and Outcomes, said doctors have long known medicare patients perform worse than patients in clinical trials, who are generally healthier. This analysis, though, wasn’t deep enough to get at the exact difference between checkpoint inhibitors and chemotherapy in the real world.
“It seems apparent there are not very large effects (beneficial or harmful) across the regimens, which is what most people would anticipate, but this study doesn’t shed further light on the question,” he said in an email, “although it does seem like an important question to ask.” — Jason Mast
A Houston biotech earns early backers in quest to turn ‘cold’ tumors ‘hot’
Houston’s Asylia Therapeutics closed a $14.5 million Series A it will use to advance its lead compound into a clinic, a novel antibody the company is developing to “heat up” tumors to drive an immune system response, the biotech said Tuesday.
The drug, dubbed ASY-77A, works by targeting the extracellular form of heat shock protein (HSP70), a molecule central to antigen delivery to the immune system, Asylia said. That protein carries tumor-derived antigens to dendritic cells in the body, which then present tumor antigens to other immune cells. HSP70 is also implicated in regulating the activity of macrophages and cytotoxic T-cells, Alysia said, driving a multi-prong approach to fighting tumors.
The company has multiple assets under development for cancer and autoimmune diseases, Alysia said.
The round was led by Sporos Bioventures. In addition to the financing, Karthik Radhakrishnan, a Houston-based biotech executive and the former CFO of Opexa Therapeutics, has been appointed CEO. — Kyle Blankenship
Repurposing biotech launches ophthalmic spinout
A New Jersey biotech that repurposes existing drugs is launching a new spinout.
Nevakar announced Tuesday the formation of Vyluma, which will operate as a subsidiary of the company at inception. The purpose of the newco is to focus specifically on therapies for ophthalmic diseases, with an emphasis on refractive errors such as childhood myopia, presbyopia, night vision disturbance, and hyperopia, Nevakar said.
There are currently no FDA-approved treatments for such diseases, and Vyluma will launch with a main pipeline program aimed at slowing the progression of myopia in children called NVK002. It’s currently in Phase III development.
Navneet Puri, CEO of Vyluma, said in a statement that spinning out the ophthalmology business “became clear” after Nevakar signed partnerships with companies in Europe and China, as well as strong preclinical data for other ophthalmic candidates. — Max Gelman
After Covid-19 treatment failure, Abivax finds success in ulcerative colitis trial
Just 2 months after Paris-based Abivax pulled the plug on its clinical trial of ABX464 in high-risk Covid-19 patients, the company has announced that the drug showed positive results in a stud for patients with moderate to severe ulcerative colitis.
There were 254 patients treated once a day with ABX464 in the Phase IIb trial. Only 9% of patients dropped out of the study, a number the company said is “remarkable in view of the Covid-19 situation.” Phase III trials will start by the end of 2021, Abivax said in the release.
CEO Hartmut Ehrlich called the Phase IIb results a game-changer for UC treatment, and said that the lowest dose of 25 mg was effective across the entire study population.
The study confirmed short-term efficacy in patients who don’t typically respond to treatment, as well as patients who have previously been exposed to biological or JAK inhibitor treatments.
“Clearly, this promising drug-candidate needs to be taken into phase 3 as quickly as possible, as the medical need for patients suffering from moderate to severe ulcerative colitis is very high and new safe and effective treatments with innovative modes of action are urgently needed,” Séverine Vermeire, the principal investigator of the study said in the release.
Researchers had tested the anti-inflammatory to see if it could prevent Covid-19, but a planned interim analysis of data from 306 patients showed no difference between the drug and a placebo, despite being well-tolerated and safe, Abivax noted, and so the trial was scrapped in March. The company had already recruited 500 of its 1,000 intended recruits. The results were shocking to some researchers. — Josh Sullivan
Organizations
Indications
Targets
Hot reports
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.