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3 days ago
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A startup banks $66M to pursue ‘inclusive precision medicine'
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Actio Biosciences, a San Diego-based biotechnology startup, announced Wednesday it raised a $66 million Series B financing to support drug research it's initially aiming at rare genetic diseases, but sees having broader potential, too. Actio's most advanced program is in early-stage testing for the degenerative nerve disorder Charcot-Marie-Tooth disease, but may also be useful in treating overactive bladder, the company said. A second program focused on a genetic form of epilepsy is expected to enter the clinic by the end of the year. The startup's Series B round was co-led by new investor Regeneron Ventures and existing backer Deerfield Management. Canaan, Droia Ventures and Euclidean Capital also participated. Actio emerged from stealth in late 2023 with $55 million in Series A funding and, since then, has brought two small molecule drugs either into or near clinical testing. One of the medicines it's developing, ABS-1230, is for epilepsies caused by mutations in a gene called KCNT1. These KCNT1-related epilepsies can strike early and come with severe health complications, such as an impact on brain function or even death. They're also the target of programs Praxis Precision Medicines, Servier and Atalanta Therapeutics, among others, are pursuing through different drugmaking methods. David Goldstein, Actio's CEO and formerly co-founder of Praxis, claimed that small molecules still hold the most promise for targeting epilepsies related to KCNT1, mutations which cause the overactivation of a kind of ion channel expressed in the brain. Some researchers turned to biologics, believing that they may have a better chance dealing with the disease's myriad mutations, he said. However, Actio believes its drug ABS-1230, which blocks this malfunctioning ion channel, should inhibit all repeatedly observed, disease-causing mutations, making it useful to many patients with the condition. "This kind of inclusive precision medicine is a key priority for the company," Goldstein said. Actio's other drug, ABS-0871, blocks a different ion channel protein called TRPV4 and is currently in a Phase 1 trial with healthy volunteers. By the end of the year, though, Actio intends to start a Phase 1b study in people with the Type 2C form of Charcot-Marie-Tooth, which is characterized by severe muscle weakness and respiratory complications. ABS-0871 is hoping it will show promise in overactive bladder, too, as part of the company's strategy to use insights from its rare disease research in more common disorders. Actio began raising its Series B round at the beginning of the year, and was able to complete it despite an accelerating, sector-wide pullback that's making it harder for companies to close funding rounds. Goldstein attributed its success to picking programs that have 'very high biological plausibility.' 'I'm sure that the climate will return back to funding those ideas that might be huge payoffs later, but it's just a little bit hard to predict,' Goldstein said. 'You really need to have programs that have a pretty predictable path.' Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
Yahoo
13-06-2025
- Business
- Yahoo
BioNTech buys mRNA, courtroom rival CureVac in all-stock deal
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. COVID vaccine maker BioNTech is buying rival CureVac, announcing Thursday an all-stock deal weeks before the two companies were due to face off in a German court over potentially billions of dollars worth of royalties related to intellectual property on messenger RNA drugs. Per deal terms, each CureVac share will be exchanged for about $5.46 worth of BioNTech's U.S.-listed shares, valuing the company at $1.25 billion. Upon the deal's close, CureVac shareholders will own between 4% and 6% of BioNTech. In the early days of the COVID-19 pandemic, BioNTech and CureVac were among the companies racing to develop the first coronavirus vaccines. BioNTech, however, partnered with Pfizer and won approval of the first COVID-19 shot, while CureVac's program never made it to market. The two companies have since been embroiled in patent litigation. CureVac was a leading candidate to develop the first COVID-19 vaccine, launching rumors, later denied, that the U.S. government might even buy the company or its research. But while BioNTech and fellow mRNA drugmaker Moderna succeeded in making vaccines that saved millions of lives and earned billions of dollars in revenue, CureVac fell short. Its initial project wasn't effective enough at preventing sickness, prompting it to scrap development. A year later, CureVac sued BioNTech, claiming it infringed four patents. CureVac has since changed course, selling off most rights to influenza and COVID-19 vaccines to partner GSK and focusing on cancer instead. But its legal spat with BioNTech has lingered. The European Patent Office had upheld two CureVac patents, and a trial in a Dusseldorf regional court was set on July 1 to determine if BioNTech had infringed on them. A separate trial in the U.S. was scheduled to begin Sept. 8 in Virginia. Some Wall Street analysts, as a result, speculated that BioNTech's primary purpose is buying CureVac is to sidestep the risk of a loss in court. A single-digit percentage royalty awarded to CureVac could've cost BioNTech as much as $3 billion, Evercore ISI analyst Umer Raffat wrote in a note to clients. 'It seems to us that [BioNTech] assessed the cost of a cash settlement as substantially greater than the cost of buying [CureVac] outright,' Raffat wrote. The deal could also help BioNTech further its oncology ambitions. Like CureVac, BioNTech has made cancer research a top priority. It's invested in a variety of programs, from cell therapies to mRNA vaccines and a coveted type of bispecific antibody. Some are in advanced testing. CureVac's cancer vaccines are in earlier phases of development. A brain cancer shot has delivered early clinical data, while a lung cancer immunotherapy was cleared in April for human testing. The deal should help CureVac because of 'the early stage of the oncology pipeline and the need for a development partner to effectively compete in personalized cancer vaccines – which [BioNTech] is well positioned to execute,' wrote Leerink Partners analyst Mani Foroohar. Raffat, of Evercore ISI, however, wrote that the deal ascribes 'very little value' to CureVac's pipeline. Recommended Reading Recursion to acquire two Canadian drug discovery startups Sign in to access your portfolio
Yahoo
13-06-2025
- Health
- Yahoo
Moderna wins FDA OK to widen use of RSV vaccine
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. The Food and Drug Administration has approved wider use of Moderna's respiratory syncytial virus vaccine in a boost for a company that's been negatively impacted by the recent leadership changes atop U.S. public health agencies. The shot, dubbed mResvia, was cleared on Thursday for adults aged 18 to 59 who are at high risk for increased risk of RSV-related disease. Prior to the label expansion, Moderna's shot was only available to adults 60 or older. "RSV poses a serious health risk to adults with certain chronic conditions, and today's approval marks an important step forward in our ability to protect additional populations from severe illness from RSV," Moderna CEO Stéphane Bancel said in a statement. The expansion is a much-needed win for Moderna, which has been among those hardest hit by the changes in vaccine policy enacted by new FDA leaders Martin Makary and Vinay Prasad, as well as Health and Human Services Secretary Robert F. Kennedy Jr. Makary and Prasad, for instance, have outlined stricter approval standards for COVID-19 vaccines and called for developers to perform more placebo-controlled trials. Kennedy Jr., who has long been critical of the kind of messenger RNA vaccines Moderna is known for, has said the Centers for Disease Control and Prevention would remove COVID shots from the recommended immunization schedules for pregnant women and healthy children. He also, this week, overhauled the CDC panel that determines who should get which vaccines and shapes private insurance coverage for inoculations. Some of the new members of the eight-person panel include vaccine skeptics and doctors with different focus areas. The changes at the CDC could have important implications for Moderna. In April, the CDC panel recommended broadening use of RSV shots to enable adults 50 to 59 years of age who are at a higher risk of severe RSV-related disease to get vaccinated. But the agency still doesn't have an acting director, and Kennedy Jr. has yet to endorse that recommendation. Without a formal clearance, insurers are not required to cover the cost of the shot. The newly constituted panel's first meeting is scheduled for June 25-27, and will be closely watched by investors. In a research note Friday, William Blair analyst Myles Minter noted that the gathering will be 'important for sentiment in the vaccine sector, which continues to decline.' Minter believes Moderna, which has seen its share price plummet more than 80% over the last year, will need to significantly cut costs to meet its objective of breaking even financially by 2028.
Yahoo
11-06-2025
- Business
- Yahoo
Scorpion, fresh off Lilly deal, spins out startup Antares
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. Fresh off a multibillion-dollar deal with Eli Lilly, cancer drug startup Scorpion Therapeutics is trying for an encore, debuting a successor company on Tuesday that's carrying forward much of its previous work. Called Antares Therapeutics, the startup is launching with $177 million in financing from nearly a dozen investors, among them previous backers Omega Funds and Atlas Venture. Antares will use that cash to advance a group of small molecule drugs Scorpion had been working on, as well as programs the company had been advancing through a 2022 partnership with AstraZeneca. Its work will specifically focus on cancer and other unspecified 'serious diseases,' according to a statement. The company didn't divulge more details about its pipeline, only noting on its website that its first program should begin human testing in 2026 and multiple others are in preclinical development. In a statement, CEO Adam Friedman, who previously ran Scorpion, said the company's research is "fueled by discoveries in drugging previously inaccessible targets.' Antares could also get future milestone payments and royalties from a pair of cancer drugs involved in a Scorpion alliance with Pierre Fabre Laboratories. Another startup, Moma Therapeutics, has rights to a PARP inhibitor Scorpion was advancing, too. Scorpion was co-founded in 2020 by Gary Glick, who helped the company raise nearly $300 million in venture funding before departing in 2021. Prior to Scorpion, Glick led Lycera, which formed a 2015 deal with Celgene, and IFM Therapeutics, which has spun off multiple companies that were acquired by larger drugmakers. Glick went on to lead inflammatory drug developer Odyssey Therapeutics, which has been trying to go public. In the meantime, Scorpion was helmed by Friedman, who helped the company raise additional funding, form multiple partnerships and generate six cancer drug candidates, three of which are in clinical testing, according to its statement. Scorpion sold one, dubbed STX-678, to Eli Lilly in January for as much as $2.5 billion. As part of that deal, it formed a new company holding its other assets and inheriting its employees. That company, now known as Antares, is supported by Scorpion's old shareholders and also led by Friedman. 'Antares will build on what Scorpion started: combining cutting edge computational and experimental chemistry and biology with laser-focused clinical development,' said Keith Flaherty, a board member and director of clinical research at Massachusetts General Hospital Cancer Center, in a statement. Error while retrieving data Sign in to access your portfolio Error while retrieving data Error while retrieving data Error while retrieving data Error while retrieving data
Yahoo
11-06-2025
- Business
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SpliceBio lands $135M for a new kind of eye gene therapy
This story was originally published on BioPharma Dive. To receive daily news and insights, subscribe to our free daily BioPharma Dive newsletter. SpliceBio, a Spanish biotechnology company working on next-generation gene therapies, said Wednesday it raised $135 million in a Series B round to advance its lead program in Stargardt disease into further clinical testing. The startup is built around a technology that's meant to overcome a key limitation of current gene therapies. Scores of gene therapy developers use adeno-associated viruses, or AAVs, to deliver genetic cargo into the body. But because of their small size, AAVs can't carry larger corrective genes, leaving many diseases out of reach or forcing companies to come up with creative solutions. One example is in Duchenne muscular dystrophy. Because of the large size of the gene coding for the muscle-protecting protein dystrophin Duchenne patients lack, several companies, like Sarepta Therapeutics, have developed gene therapies that make a shortened form. The approach comes with drawbacks, however, as a truncated version of the protein might not work as well as the original. SpliceBio has a different workaround. The company is using two separate AAVs to send pieces of a large gene into cells. Once inside, specially engineered splicing molecules help reassemble their cargo into full-length proteins. Stargardt disease, for example, is caused by mutations to the ABCA4 gene, which is too large to stuff into an AAV. SpliceBio says its method can help the body produce a functional version of the protein that gene produces. Its lead program, SB-007, is in a Phase 1/2 trial. SpliceBio isn't the only biotech pursuing this type of approach to treat Stargardt, an inherited eye condition that causes progressive vision loss. Another European company, AAVantgarde, has a similar type of program in early-stage testing. SpliceBio's technology is based on research conducted at Princeton University, where co-founder and CEO Miquel Vila-Perelló was studying protein design and engineering. Launched in 2014 under the name ProteoDesign, the biotech is also working on additional programs in ophthalmology, neurology and other undisclosed therapeutic areas. Its Series B round was co-led by EQT Life Sciences and Sanofi Ventures, and involved seven other backers including Roche Venture Fund, New Enterprise Associates and Novartis Venture Fund. "The support from such high-quality investors underscores the strength of our programs and our unique protein splicing platform and its potential to unlock gene therapies for diseases that remain untreatable today,' Vila-Perelló said in a statement. The company raised €50 million in a Series A round in 2022. Gene and cell therapy startups backed by the roughly two dozen investment firms BioPharma Dive tracks have secured a little over $1.1 billion in venture dollars so far in 2025. Half of those fundings have come in the form of 'megarounds' exceeding $100 million apiece, continuing an ongoing trend. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
