Gubra A/S

Novartis ends a radiopharma trial with PeptiDream : The Swiss drug giant terminated a Phase 1 trial of [177Lu]Lu-FF58 in patients with selected advanced solid tumors, a spokesperson confirmed to Endpoints News . The spokesperson cited “careful evaluation of available clinical data” as the reason and noted it “was not based on safety concerns.” All patients have either discontinued treatment or completed safety follow-up, the spokesperson added. The asset is part of Novartis’ collaboration with PeptiDream . A PeptiDream spokesperson didn’t respond to a request for comment. The Novartis spokesperson didn’t comment on the future of the candidate. Radiopharma has become a key focus for Novartis, which markets Pluvicto and Lutathera and has inked multiple deals in the space . — Kyle LaHucik Solve Therapeutics eyes $75 million funding round: The Belmont, CA-based ADC biotech, led by former VelosBio CEO Dave Johnson, has raised $50 million so far in a $75 million equity round, according to an SEC filing on Thursday. Johnson declined to comment. He sold VelosBio to Merck for $2.75 billion in cash in 2020. About a year later, Solve raised a $126 million Series A from Matrix, Decheng Capital, General Atlantic and Surveyor Capital, according to Johnson’s LinkedIn page . The company acquired Cereius, a radiodiagnostics and radiotherapeutics spinout from Duke University, in 2023. — Kyle LaHucik Veru sold off some non-essential assets: The company announced Tuesday that it’s selling its FC2 Female Condom business to a New York investment firm called Riva Ridge Capital Management for $18 million. The deal lets Veru focus on its obesity program called enobosarm, which is expected to read out topline Phase 2b data in January. — Max Gelman Ideaya Biosciences makes an ADC deal with Hengrui Pharma : The South San Francisco biotech will pay $75 million upfront and up to $1.04 billion in total, for ex-China access to Hengrui’s DLL3-targeting ADC called SHR-4849. The candidate, with a Topo-I payload, could be combined with Ideaya’s PARG inhibitor, which is called IDE161 . The drug is in Phase 1 in solid tumors in China, and Ideaya plans to ask for FDA trial clearance in the first half of next year. — Kyle LaHucik Amylyx expands GLP-1 work with a new Gubra collaboration: The neurodegenerative biotech said Monday it is paying a “small upfront fee” plus research payments, with more than $50 million in milestones available to Gubra to identify a novel long-acting GLP-1 drug. Amylyx will have the option to lead future development if a candidate is found. — Max Bayer Good news for Novartis ’ intrathecal Zolgensma: The treatment succeeded in a Phase 3 trial in patients with spinal muscular atrophy (SMA) type 2 between the ages of 2 and 18 who can sit but have never walked independently. Patients given the gene therapy had increased scores on a rating scale of motor ability and disease progression compared with sham control. Further data and regulatory submissions are expected to come in 2025. An approval would extend Zolgensma’s reach; it is currently only approved in SMA patients aged younger than 2. — Elizabeth Cairns Immedica Pharma announces plans to buy Marinus Pharmaceuticals : The Swedish rare disease company agreed to acquire Marinus for an enterprise value of about $151 million . Marinus’ shares $MRNS were up about 42% to 52 cents apiece in early trading on Monday, nearly matching the offer of 55 cents per share. Marinus markets the rare seizure drug Ztalmy. The medicine, also known as ganaxolone, recently failed a late-stage trial, leading the company to again lay off employees . Also on Monday, Orion and Marinus mutually terminated a marketing and distribution pact for ganaxolone in Europe. — Kyle LaHucik Johnson & Johnson is partnering with the Japanese company Kaken on a STAT6 program. J&J will get the rights to KP-723, an oral STAT6 inhibitor still in preclinical testing, and take over development after Kaken completes Phase 1 studies. Kaken gets $30 million upfront and up to $1.2 billion. — Max Gelman Kronos Bio and Roche ended their R&D alliance following Kronos’ significant downsizing, according to SEC documents. The biotech elected to end development on a CDK9 inhibitor called istisociclib last month, resulting in layoffs of about 83% and the departure of CEO Norbert Bischofberger. Kronos and Roche had partnered in 2023 on a different program for $20 million upfront and $554 million in milestones. — Max Gelman AusperBio raised a $73 million Series B round led by HanKang Capital, the proceeds of which will fund mid-stage development of its lead candidate AHB-137. The antisense oligonucleotide, intended as a functional cure for hepatitis B, is in a Phase 2 trial in China that could be reported next year. The company said the new financing will also enable global trials of AHB-137, as well as expansion of its therapeutic pipeline, manufacturing and operational capabilities. — Elizabeth Cairns A few months after announcing a strategic review , London-based Achilles Therapeutics is offloading data and samples from its non-small cell lung cancer study to AstraZeneca for $12 million. The UK pharma will also get access to a platform and network of tumor samples from nearly 300 cancer patients. — Kyle LaHucik AstraZeneca and Daiichi Sankyo have withdrawn their European Medicines Agency application for the ADC datopotamab deruxtecan in lung cancer. While AstraZeneca has positioned the drug as a successor to Enhertu, the company said in May that a lung cancer trial failed to reach its overall survival goal. — Max Gelman China’s CASI Pharmaceuticals said in a securities filing that its experimental drug CID-103 has been put on a clinical hold by the FDA. The drug is an anti-CD38 antibody that’s being studied to prevent the rejection of transplanted kidneys. The company said it plans to respond to the FDA. — Drew Armstrong Assembly Biosciences reported interim Phase 1b data for its hepatitis B antiviral program ABI-4334. In patients who were predominantly hepatitis B e antigen (HBeAg) negative, ABI-4334 induced a 99.9% average decline of hepatitis B virus DNA (a 2.9 log10 reduction). Among those with detectable virus RNA at baseline, there was an average decline of 99.7% (2.5 log10). Assembly said there were “limited changes in viral antigens” due to the nature of the 28-day study. The company is partnered with Gilead on a trio of antivirals, including ABI-4334. — Max Gelman

The amylin field is heating up ahead of Novo Nordisk’s much-anticipated CagriSema readout later this year. On Wednesday, Gubra said people taking high doses of its amylin analog, called GUBamy, had a mean loss of 3% of their body weight in a six-week single ascending dose trial. The placebo group, meanwhile, experienced a mean gain of about 1% body weight, the Danish biotech said. Men who were “healthy lean and overweight” were included in the trial. Nausea and reduced appetite were frequent, and vomiting was “occasional” in the trial, Gubra said. Gastrointestinal side effects have been commonly reported with anti-obesity medicines. The news comes the same day obesity biotech Metsera raised $215 million and said it had started testing its own amylin analog in an early-stage clinical study. “I’m excited about these data. It’s confirming what we hoped for that GUBamy is well-tolerated and we were able to dose to quite high levels, and we saw some dose dependency in adverse events,” which is “exactly what you would expect from an amylin,” Gubra CEO Henrik Blou said in an interview with Endpoints News . Gubra’s shares were up about 2%. The company said it plans to share interim results from a multiple ascending dose study in the first half of next year. The biotech believes GUBamy, or GUB014295, can be dosed weekly given its 11 day half-life. Blou declined to disclose Gubra’s expectations for weight loss in the MAD Phase 1b trial. Zealand Pharma’s amylin analog petrelintide led to a mean 8.6% weight loss in a MAD study in June , and the company quickly raised $1 billion off that data. Asked if Gubra also plans to raise money or do a follow-on offering on the back of these data, Blou said Gubra has “no current plans” since the company is “currently well-financed.” Gubra can take GUBamy into Phase 2a, the CEO said, but the company is also exploring partnerships. It counts Boehringer Ingelheim as a partner on other obesity programs. There are likely multiple parties circling the company as amylin has come to the fore as a next-generation approach in the obesity drug landscape. Amylin and other approaches follow the first-generation GLP-1 medicines, which have opened up what is expected to be the biggest pharmaceutical market in history. Novo’s CagriSema, which combines an amylin analog with Wegovy, is slated to have a Phase 3 readout before 2025. Zealand, meanwhile, boasted at the ObesityWeek conference that it believes amylin could potentially replace GLP-1s for some patients. Eli Lilly, AstraZeneca, Structure Therapeutics and others are also in the race. GUBamy is one of multiple shots on goal for Gubra’s obesity pipeline. Its partner Boehringer started testing a triple agonist, of unknown mechanisms, in a Phase 1 this summer. However, Boehringer ended work on a different Gubra obesity drug last month. The duo is also working on other discovery-stage programs, and Gubra is working on its own with other targets, like UCN2 and GLP-1. Blou said Gubra is “still gathering information” on the culled Boehringer drug, a neuropeptide Y receptor type 2 (NPY2) agonist known as BI 1820237. Once it gets the “full picture,” they’ll have a better idea of the drug’s future, he added.

Two weeks after Boehringer Ingelheim pulled the plug on a partnered obesity programme, Gubra is reporting "positive" Phase I data for its long-acting amylin analogue GUBamy (GUB014295), indicating that the Danish biotech's independent assets may offer promising alternatives.In the single ascending dose study, subjects receiving the highest doses (3.5-6.0 mg) achieved approximately 3% weight reduction over six weeks, while the placebo group gained about 1%. The study was conducted in healthy lean and overweight male subjects with a mean body mass index (BMI) of about 26.7 who were randomised into six cohorts treated with either GUBamy or placebo."We are very pleased to see that our data confirms the potential of GUBamy as an anti-obesity treatment," said CEO Henrik Blou. "GUBamy was well tolerated, and the very long half-life supports a weekly dosing regimen."Gubra said the treatment's pharmacokinetic profile revealed a half-life of 270 hours, or 11 days, supporting weekly subcutaneous administration. Adverse events aligned with expectations for the drug class, primarily presenting as gastrointestinal effects including frequent nausea and reduced appetite, with occasional vomiting.Investors are paying close attention to trial outcomes of amylin-based drugs, which could soon represent a new category in weight-loss therapies. Before the end of the year, Novo Nordisk plans to release data from a large study of CagriSema, a combination of the dual amylin and calcitonin receptor agonist cagrilintide, plus GLP-1 agonist semaglutide, the active ingredient in its popular obesity drug Wegovy. The drugmaker recently reiterated its expectation that the new injection will deliver 25% weight loss.Meanwhile, Zealand Pharma has its own amylin compound, petrelintide, and is actively seeking partners to advance the treatment to the next development phases.