Over the past few years, the promise of blocking CD47 — a “don’t eat me” signal co-opted by cancer cells — has sent drugmakers big and small into a frenzy. But one biotech is now bowing out.
Zai Lab is deprioritizing ZL-1201, its CD47 inhibitor, scrapping plans for a Phase II trial. It will now “pursue out-licensing opportunities,” the company said in its Q2 update. The decision was based on a review of the competitive landscape, it added.
In an interview with Endpoints News, Josh Smiley — who recently joined as COO after an ethics scandal forced his resignation from the CFO post at Eli Lilly — said given that Gilead is likely to move forward with magrolimab, its frontrunning candidate from its Forty Seven buyout, Zai Lab doesn’t see a “best in class” opportunity.
“With CD47, our view is it’s a good molecule,” he said. “So I mean, I think we feel good about what we saw in Phase I, got to a dose selection, but I think when we look competitively we don’t see a differentiation right now.”
But others could well have a different view, he added, and assessments can change over time.
The move comes as the fever pitch appears to have died down, with clinical holds on magrolimab throwing cold water on the field. Just weeks ago, AbbVie terminated an exploratory study of a CD47 drug it got from a $3 billion alliance with I-Mab, citing “strategic reasons.” It had tested lemzoparlimab as both monotherapy or in combo with other drugs as a multiple myeloma treatment.
Like other later efforts, Zai Lab was familiar with the challenges of this space, especially on the safety side, going into the ZL-1201 program. As researchers wrote in an AACR abstract last year:
Blockade of the CD47/SIRPα interaction using antibodies against CD47 or SIRPα-Fc fusion proteins promotes phagocytosis and tumor cell destruction, which represents a promising strategy for tumor immunotherapy. However, CD47 is ubiquitously expressed on all cells including erythrocytes and platelets, which form a large antibody sink and lead to potential hematological toxicities. In fact, anemia and thrombocytopenia have been observed in non-human primates and tumor patients that are subjected to anti-CD47 treatment in preclinical and clinical studies.
ZL-1201 was thus “engineered to reduce Fc-mediated antibody effector function,” and they reported that it did bind to CD47 while having a better safety profile than the benchmark antibody.
The company has a Phase I trial testing the drug in solid tumors, and it’s already decided on a recommended Phase II dose.
Smiley noted that it’s all about “discipline” as Zai Lab continues to market in-licensed drugs in China and pushes ahead with internal assets.
“We’ve got a pretty rich portfolio,” he said. “So I think as we look at our internal assets, we’re going to use the same hurdle for them that we use for every deal that we do.”
Avance Clinical is the Australian CRO for international biotechs providing world-class clinical research services with FDA-accepted data across all phases. With Avance Clinical, biotech companies can leverage Australia’s supportive clinical trials environment which includes no IND requirement plus a 43.5% Government incentive rebate on clinical spend. The CRO has been delivering clinical drug development services for international biotechs for FDA and EMA regulatory approval for the past 24 years. The company has been recognized for the past two consecutive years with the prestigious Frost & Sullivan CRO Best Practices Award and a finalist in Informa Pharma’s Best CRO award for 2022.
Pfizer was first to the finish line for the next-gen pneumococcal vaccine in adults, but Merck beat its rival with a jab for children in June.
Now, two months after Merck’s 15-valent Vaxneuvance won the FDA stamp of approval for kids, Pfizer is out with some late-stage data on its 20-valent shot for infants.
Known as Prevnar 20 for adults, Pfizer’s 20vPnC will head to the FDA by the end of this year for an approval request in infants, the Big Pharma said Friday morning. Discussions with the FDA will occur first and more late-stage pediatric trials are expected to read out soon, informing the regulatory pathway in other countries and regions.
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Two children with spinal muscular atrophy have died after receiving Novartis’ Zolgensma, a gene therapy designed as a one-time treatment for the rare fatal disease.
The deaths, which resulted from acute liver failure, occurred in Russia and Kazakhstan, Novartis confirmed in a statement to Endpoints News. Having notified health authorities across all the markets where Zolgensma is available, it will update the drug label “to specify that fatal acute liver failure has been reported,” a spokesperson wrote.
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The US House of Representatives today voted along party lines (all Dems voted for it), 220-207 to pass new, wide-ranging legislation that will allow Medicare drug price negotiations for the first time ever, and cap seniors’ drug expenses to $2,000 per year and seniors’ insulin costs at $35 per month.
Setting up a major victory for President Joe Biden, representatives returned from their summer recess to pass the Inflation Reduction Act, even as many noted the bill would only modestly reduce inflation.
Amgen is the latest pharma company to appear on the radar of Senate Finance Committee Chair Ron Wyden (D-OR), who is investigating the way pharma companies are using subsidiaries in low- or zero-tax countries to lower their tax bills.
Like its peers Merck, AbbVie and Bristol Myers Squibb, Wyden notes how Amgen uses its Puerto Rico operations to consistently pay tax rates that are substantially lower than the U.S. corporate tax rate of 21%, with an effective tax rate of 10.7% in 2020 and 12.1% in 2021.
AstraZeneca and Daiichi Sankyo’s antibody-drug conjugate Enhertu scored its second approval in less than a week, this time for a subset of lung cancer patients.
Enhertu received accelerated approval on Thursday to treat adults with unresectable or metastatic non-small cell lung cancer (NSCLC) whose tumors have activating HER2 (ERBB2) mutations, and who have already received a prior systemic therapy.
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After controversially spinning out its talc liabilities and filing for bankruptcy in an attempt to settle 38,000 lawsuits, Johnson & Johnson is now changing up the formula for its baby powder products.
J&J is beginning the transition to an all cornstarch-based baby powder portfolio, the pharma giant announced on Thursday — just months after a federal judge ruled in favor of its “Texas two-step” bankruptcy to settle allegations that its talc products contained asbestos and caused cancer. An appeals court has since agreed to revisit that case.
CSL is gathering its brands under the family name umbrella, renaming its vaccine and newly acquired nephrology specialty businesses with the parent initials.
CSL Seqirus and CSL Vifor join CSL Plasma and CSL Behring as the four now uniformly branded business units of the global biopharma. The Seqirus vaccine division was formed in 2015 with the combination of bioCSL and its purchase of Novartis’ flu vaccine business. CSL picked up Vifor Pharma late last year in an $11.7 billion deal for the nephrology, iron deficiency and cardio-renal drug developer.
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In 2019, Aptinyx’s stock cratered after it reported that its lead candidate failed a diabetic nerve pain trial. After some ‘further analysis,’ the biotech re-upped with that same non-opioid pain drug in two more mid-stage studies — another diabetic nerve pain trial and later a fibromyalgia trial.
In April, Aptinyx reported that its second diabetic nerve pain trial also fell through. However, the Illinois-based penny stock biotech had one more shot for its NMDA-modulating drug, dubbed NYX-2925, in fibromyalgia.
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Bioscience & Technology Business Center The University of Kansas Lawrence, Kansas
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