GDF15 may sound familiar. It’s a protein for which Amgen, Merck and Eli Lilly have created analogues in an effort to create new weight-loss drugs. But the drugs that largely failed, and Amgen, the last of the 3, quietly ended their GDF15 program in January. .
But GDF15 is not dead. The science behind weight-loss drugs can be traced back to some cancer patients having high levels of GDF15 and losing a lot of weight, so cancer researchers have created antibodies that inhibit the protein rather than mimic it.
The German biotech Catalym, called “Catalym Antibodies,” is running a medium-term program for a GDF15 antibody, visugromab, in fake tumors. It has now raised 50 million euros (about $49 million) in a Series C to “be more competitive with Phase II,” CEO Phil L’Huillier told Endpoints News.
New investors Brandon Capital and Jeito Capital lead the round, followed by existing investors Forbion, Novartis’ venture capital arm, Vesalius Biocapital III, Bayern Kapital, BioGeneration Ventures and Coparion. In addition, Jonathan Tobin from Brandon and Andreas Wallnöfer from Jeito are registered on the Board of Directors of CatalYm. According to Wallnöfer, CatalYm marks Jeito’s first investment in Germany.
At ESMO last year, Catalym read full data from an 18-person phase I study of visuromab in combination with Opdivo in highly pretreated patients who had progressed to the previous PD-1 cure, patients who had exhausted all their options. In this study, 3 patients had a partial reaction, one of whom had a lasting reaction for more than a year. Three other patients also had solid disease with treatment, and one of the patients also had cancer that did not progress with treatment for more than a year.
Wallnöfer highlighted the possibility of visuromab as a combination cure for patients with fake tumors, noting that the drug had a lasting effect as a last line of treatment in addition to its “benign” protection profile: no dose-limiting toxicity or grade four or five. Adverse occurrences were observed in the phase I study.
In March, Catalym conducted a phase II study of visuromab. Taking the two highest doses from the first study (10 and 20 mg/kg), the new program plans to enroll approximately 160 patients. It’s also expanding to the U. S. after the Phase I reading, L’Huillier said, noting that Catalym met with an MD Anderson physician, who expressed interest in opening an examination site for visugromab.
This phase II examination and biomarker examination are expected to get initial readings in the early part of next year, L’Huillier said.
The C Series comes at a time when the public market is frozen. “In terms of financing, it started quite complicated because of the global scenario and the end of the IPO window,” L’Huillier said. “It has influenced the way we think about funding. We said, “Let’s stay and go on another personal excursion other than a crossover or an initial public offering round. “”In November, only one biotechnology, Acrivon Therapeutics, made the leap from the personal to the public, while others.
Pfizer also has a GDF15 cancer antibody, known as ponsegromab, for which it recently initiated a phase II trial. But Pfizer’s drug has another goal: to stop the loss of weight and muscle mass in cancer patients.
Since squandering a questionable orphan drug exclusivity court case last year, the FDA’s Office of Orphan Product Development has remained completely silent on the orphan exclusivity of any approved product since last November, leaving many sponsors on what to expect.
This silence means that for more than 70 indications designated as orphans for more than 60 products, UNRWA has made a public ruling on seven-year-old orphan exclusivity in the Orange Book, and no new orphan exclusivity lists appear in UNRWA’s search database, as recently noted through George O’Brien, spouse in the Washington office of Mayer Brown. DIRECT CURRENT.
An unknown clinical-stage biotechnology, subsidized by a Korean lighting company and targeting a cancer vaccine from a Thomas Jefferson University lab, is heading to the Nasdaq via the blank check route.
Liminatus Pharma will extract approximately $316 million of proceeds from the SPAC blend to fund its ongoing phase IIa cancer vaccine study, bring CAR-T treatment to the clinic and prepare a CD47 immune checkpoint inhibitor for human trials, the company said this week. .
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Talking about treatment didn’t cause Lily to suffer from attention deficit hyperactivity disorder or ADHD. But a video game did.
As the 10-year-old soars above icy waters and points to flying creatures on the snowy planet Frigidus, she develops her attention skills, thanks to Akili Interactive Labs’ video game EndeavorRx. She is now less worried and scattered, allowing her to continue taking a low dose of ADHD medication, according to her mother, Violet Vu.
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German pharmaceutical giant Bayer will look to make a significant investment in one of its U. S. plants. The U. S. Food and Drug Administration produces over-the-counter medicines.
Bayer said it will spend $43. 6 million to expand its facility in the city of Myersthe, Pennsylvania, a small town east of Harrisburg. Solar panels on the roof. The task is expected to be completed by 2025 and will create approximately 50 to 75 jobs.
With the global biologics market expected to succeed this year by nearly a fraction of a trillion dollars, new JAMA studies highlight the importance of immediate access to biosimilars, especially as fewer biosimilars enter the U. S. The U. S. population was “significantly higher” in the U. S. and monthly processing prices of biosimilars were “significantly higher” in the U. S. This is compared to Germany and Switzerland.
Among the 3 countries, the share of biosimilars market at the highest launch in Germany, however, grew at the fastest rate in the United States, authors from the University of Zurich Law Institute wrote today in JAMA Network Open.
Gilead is going on stage in some of the HIV projects it is funding through grants in a new series of films narrated through other people leading the projects.
The first 4 films and executives come from all over the United States: Arianna Lint in Florida and Puerto Rico, Cleve Jones in San Francisco, June Gipson in Mississippi and Kirk Myers in Texas. Network to offer high-quality fitness and social networks in underserved communities.
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The European Medicines Agency said Friday it is withdrawing from all European markets medicines containing folcodin, an opioid used in adults and children to treat dry coughs and in combination with other medicines for the treatment of colds and flu.
The decision to withdraw the drugs comes as the EMA questions the effects of the recent ALPHO study, which shows that the use of folcodine in the 12 months prior to anesthesia is linked to an anaphylactic reaction similar to neuromuscular blockers (NMBA). used (with an adjusted OR of 4. 2 and a 95% confidence period of 2. 5 to 6. 9).
Houston-based biotech Salarius Pharmaceuticals is revealing knowledge of an I/II trial for a drug that was lately on hold after a patient’s death, and the effects appear to have disappointed investors.
Salarius’ candidate, called seclidemstat, is an oral LSD1 inhibitor for the treatment of Ewing sarcoma and FET reassorted sarcomas in patients younger than 12 years. treated in mixture with topotecan and cyclophosphamide.
The FDA sought more information on four key areas before allowing Beam Therapeutics to conduct human trials for mobile treatment in a certain type of leukemia. It appears that biotechnology answered the agency’s questions.
The U. S. regulator The U. S. government authorized the ready-to-use, base-edited CAR-T, Beam said Friday morning, lifting a suspension this summer. Boston-area biotech said.
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