More and more individuals now have chronically implanted brain-computer interface (BCI) systems in their heads. Devices that can record and stimulate neural signals are increasingly moving from labs to real-world settings to test their potential to treat neurological disorders. At the same time, startups are emerging, investors are pouring money into the space and companies are accelerating their development programs. After decades of clinical research and false starts, are BCI systems finally here? There are an estimated 100 patients worldwide chronically implanted with a BCI system as part of research and trials, and the technology holds the potential to transform the lives of millions of people living with neurological disorders. “A limitation of neurosurgery is that we cannot repair a neural pathway once it is destroyed,” William Muirhead, a consultant neurosurgeon at the National Hospital for Neurology and Neurosurgery, U.K., told BioWorld. “With BCI we can now digitally reconstruct that lost connection, which for patients can mean the return of autonomy after a devastating injury.”

Abbvie pads immunology pipeline in $10.9B Apogee buy

In a deal viewed as a big win for both companies, Abbvie Inc. is buying Apogee Therapeutics Inc. for $10.9 billion. The transaction calls for shareholders of Apogee to receive $135.11 per share in cash, marking a nearly 50% premium over Friday’s closing stock price, and puts pipeline-leading zumilokibart, a late-stage, half-life extended monoclonal antibody targeting IL-13 that has shown competitive phase II data in atopic dermatitis, in the hands of a pharma giant with a well-established immunology franchise. For Abbvie, the acquisition bolsters its pipeline by adding multiple differentiated assets with “mega blockbuster peak sales potential,” said Abbvie Chairman and CEO Rob Michael during a morning investor call.

Definium phase III wins big in MDD with single-dose LSD

Shares of New York-based Definium Therapeutics Inc. (NASDAQ:DFTX) were trading at $35.64, up 45%, or $11.16, on positive top-line results from Emerge, the first randomized, double-blind, placebo-controlled phase III study evaluating a single dose of DT-120 (lysergide, otherwise known as LSD), given as an orally disintegrating tablet 100 µg in adults with major depressive disorder (MDD). The trial met its primary endpoint, turning up a statistically significant and clinically meaningful improvement from baseline compared with placebo, as measured by the change in Montgomery-Asberg Depression Rating Scale (MADRS) total score at week six. The least squares (LS) mean change from baseline in MADRS score at that time point was -13.3 for subjects on active drug compared with -5.2 for those given placebo, an LS mean difference of -8.1 points. Beyond the primary endpoint, the effect proved rapid, with a placebo-adjusted LS mean reduction in MADRS total score at the first week of -14.2. Upside was durable, too, showing a placebo-adjusted LS mean reduction in MADRS of -7.3 at week 12. CEO Rob Barrow called the efficacy in MDD “staggering” and said the drug could “redefine what patients can expect” from treatment for the challenging condition.

K2 nabs two Antengene bispecific TCEs in $2B license, option deal

MPM Bioimpact-spawned K2 Therapeutics Inc. inked a license deal plus option agreement, worth $980.5 million apiece, to gain ex-China rights to two of Antengene Corp. Ltd.’s preclinical anticancer bispecific T-cell engager (TCE) assets. The deal, announced June 21, will grant Singapore-based K2 exclusive rights to develop and commercialize Antengene’s ATG-106, a preclinical CDH6/CD3 bispecific TCE candidate in development for solid tumors, outside of mainland China, Hong Kong, Macau and Taiwan. Through the option deal, K2 secures an option to develop and commercialize an undisclosed preclinical bispecific TCE candidate outside the greater China region.

Bionyra closes $165M series A to develop antibodies for inflammation

Bionyra Pharma has emerged with a $165 million oversubscribed series A and a portfolio of three antibodies with extended half-lives that are designed to offer improvements over existing classes of monoclonal antibodies for treating chronic inflammatory diseases. “We have built Bionyra around assets and targets with clear therapeutic rationale, relevant biology and optimized clinical strategy,” said Frédéric Marrache, CEO. “To this day, if you look at patients suffering from severe forms of immune-mediated inflammatory diseases … on average the response rates remain below 50%. … We need to do better,” he told BioWorld. The two lead programs, BYN-002 and BYN-003, were in-licensed from Truelab Biopharmaceutical, of Ningbo, China, in a deal with a headline value of $985 million that stretches up to marketing approvals. In addition, Truelab has been granted an equity stake in Bionyra following the closing of the series A.

Cynata’s Cymerus flops in osteoarthritis, GVHD

Neither of Cynata Therapeutics Ltd.’s pivotal trials for its Cymerus stem cell platform met the primary endpoints, with no statistically significant differences between active and control groups on primary or key secondary efficacy measures, CEO Kilian Kelly told investors during a June 22 conference call. The off-the-shelf induced pluripotent stem cell-derived mesenchymal stem/stromal cell candidates were being tested in the phase III Sculptor trial in knee osteoarthritis and a phase II trial in high-risk acute graft-vs.-host disease. “The graft-vs.-host disease (GVHD) outcome was particularly unexpected,” Kelly said, noting that earlier phase I data had given the company “grounds for optimism.” The osteoarthritis trial was “in a bit of a different category,” he said, because Cynata did not have prior clinical efficacy data in that indication.

Europe’s health system under threat, prevention and innovation key

Europe must focus on prevention and innovation to ensure its health care systems are sustainable in the long term, said Olivér Várhelyi, European Commissioner for Health & Animal Welfare. With an aging population, rising chronic diseases, a stretched workforce and geopolitical tensions, the universal health coverage that Europeans enjoy is under threat, he told delegates at the HLTH Europe conference in Amsterdam last week.

Holiday notice

BioWorld's offices were closed in observance of Juneteenth in the U.S. No issue was published Friday, June 19.

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