Schrödinger teams up with MD Anderson on WEE1 inhibitor program; Amid JAK safety concerns, AbbVie touts new data for Rinvoq
Physics-based discovery outfit Schrödinger and the University of Texas MD Anderson Cancer Center announced today a two-year research collaboration — focused on accelerating and optimizing development of Schrödinger’s investigational WEE1 inhibitor.
The team, made up of Schrödinger employees and researchers with MD Anderson’s Translational Research to Advance Therapeutics and Innovation in Oncology (TRACTION) platform, will seek to prioritize clinical studies of a WEE1 inhibitor as a single agent in certain cancer indications and in combinations for defined clinical subpopulations, according to a company statement.
“Through our collaboration with Schrödinger, we aim to identify clinically relevant patient populations that may benefit from WEE1 inhibition and to advance innovative targeted therapies that can improve their lives,” said TRACTION executive director Timothy Heffernan.
MD Anderson and Schrödinger will jointly pursue translational studies, and Schrödinger will provide research support funding.
And as part of the arrangement, MD Anderson can receive undisclosed payments based on future development and commercialization milestones for the molecule. Schrödinger will have sole responsibility for the development, manufacture and commercialization of all compounds and products, and exclusive rights to all new intellectual property from the collaboration. — Paul Schloesser
Amid JAK safety concerns, AbbVie touts new data for Rinvoq
AbbVie took a hit last month when its JAK inhibitor Rinvoq was looped into new class-wide FDA warnings, which include risks of serious heart-related events, cancer, blood clots and death. Now it’s looking to make a comeback, touting topline results in two subsets of a chronic inflammatory disease that affects the spine.
The first study, part of the Phase III SELECT-AXIS 2 trial, looked at ankylosing spondylitis (AS), a condition in which patients have structural damage of their sacroiliac joints visible on x-rays. The study enrolled 420 patients who had an inadequate response to biologic DMARD therapy.
At week 14, 45% of patients on Rinvoq achieved an Assessment in SpondyloArthritis International Society (ASAS) 40 response, compared to just 18% of those who took a placebo (p<0.0001). Patients treated with the drug saw statistically significant reductions in signs and symptoms, including back pain and inflammation, as well as improvements in physical function and disease activity, AbbVie said.
In the second study, 45% of patients with non-radiographic axial spondyloarthritis (nr-axSpA) achieved ASAS 40, compared to just 23% of patients on placebo (p<0.0001), according to AbbVie. Nr-axSpA is defined by the absence of definitive x-ray evidence of structural damage to the sacroiliac (SI) joint.
“People living with active non-radiographic axial spondyloarthritis suffer from chronic inflammatory back pain and limited physical function that can be very debilitating,” Michael Severino, vice chairman and president of AbbVie, said in a statement.
No new safety risks were identified in the studies, AbbVie said. And no adjudicated major adverse cardiovascular events, venous thromboembolic events or deaths were reported in either group through week 14. — Nicole DeFeudis
ALX acquires ScalmiBio in pipeline expansion
Oncology biotech ALX announced today that it bought biotech ScalmiBio in an expansion of their immuno-oncology pipeline.
ScalmiBio developed a technology called SHIELD — which is supposed to minimize interaction between antibody therapeutics and normal tissue, working instead to increase target binding ability within a tumor environment, according to ALX.
ALX has plans to develop new anti-cancer drug candidates based on ScalmiBio’s platform — with the intention to address certain cancer patient needs as both stand-alone drugs or in tandem with ALX’s CD47 blocker evorpacept, according to a company statement.
“ALX Oncology was founded to address limitations of CD47 blockade through protein engineering,” said ALX president, founder and CEO Jaume Pons. “ScalmiBio’s universal SHIELD technology allows us to expand our pipeline and bring more treatment options to patients.
ALX Oncology paid ScalmiBio shareholders close to $4.5 million in cash on Monday after close, and will pay an additional $2 million cash in one year, alongside milestone payments and royalties. — Paul Schloesser
Relief files lawsuit in NY against NeuroRx + CEO over breach of contract
Swiss biotech Relief Therapeutics filed a lawsuit against NeuroRx and CEO Jonathan Javitt, the company announced today.
The lawsuit, filed in the Supreme Court of the State of New York in Manhattan, alleges that NeuroRx and Javitt committed multiple breaches of the collaboration agreement between Relief and NeuroRx, related to developing and commercializing the once shot-down Covid treatment aviptadil.
These included, according to the suit, failing to provide Relief with all the required data from a recently-completed Phase IIb/III clinical trial evaluating the drug for acute respiratory failure due to Covid-19; along with failing to allow a financial audit on where NeuroRx spent the money that Relief gave them, among other breaches.
“We are disappointed that NeuroRx has continued to refuse to ameliorate their breaches of the Collaboration Agreement,” stated Relief CFO and treasurer Jack Weinstein in a statement. “While we continue to hope to settle these matters with NeuroRx, we are compelled to bring this action to preserve our rights under the Collaboration Agreement and to allow us to continue to develop aviptadil in a timely manner.” — Paul Schloesser
Amgen’s Lumakras combinations post disappointing responses
A few months after crossing the finish line with the first FDA-approved KRAS inhibitor, Amgen is now looking to see if it can bump up Lumakras’ efficacy with new drug combos. However, two recent studies didn’t turn up the results the company had been hoping for.
In one of the studies, Amgen combined Lumakras with Mekinist, a mitogen-activated protein kinase inhibitor (MEKi), in patients with non-small cell lung cancer (NSCLC), colorectal cancer (CRC) and other solid tumors.
Just two of 18 patients with CRC achieved a partial response, one of whom had already been treated with Lumakras as a monotherapy, according to Amgen. In NSCLC, five of 18 patients achieved a partial response, two of whom had previously received Lumakras.
The most common side effects were diarrhea, rash, dermatitis acneiform, nausea and vomiting, with no new safety concerns identified, Amgen said.
In the other study, Amgen paired Lumakras with Gilotrif, a pan-ErbB tyrosine kinase inhibitor. That one enrolled 33 heavily-pretreated patients with KRAS G12C-mutated NSCLC, including five who had been treated with Lumakras as a monotherapy. Patients were randomized to receive one of two dose regimens: 20 mg of afatinib/960 mg of Lumakras; or 30 mg of afatinib/960 mg of Lumakras.
The cohorts posted objective response rates of 20% and 35% respectively, according to Amgen. In a separate study, Lumakras alone reported a 37.1% overall response rate among 126 patients with advanced NSCLC. — Nicole DeFeudis