MC1R

Alpha-9 Oncology has raised $175m in a Series C funding round to advance its pipeline of radiopharmaceuticals. Credit: eamesBot via Shutterstock. Alpha-9 Oncology is the latest radiopharma to raise funds, drawing in $175m in Series C financing, to advance its radiopharmaceutical candidates through clinical trials and expand its research and development (R&D) capabilities. Vancouver, Canada-based Alpha-9 shared that it will advance its pipeline of preclinical candidates to the “clinic-ready” stage. While the company has not disclosed which of its assets in particular will be advanced, the company has several preclinical programs targeting MC1R, PSMA, GRPR, CXCR4, and B1R, as per GlobalData’s Pharma Intelligence Center. In May 2024, Alpha-9 announced the dosing of the first patient in its Phase I study for the MC1R programme, dubbed A9-3202. This peptide-based radiopharmaceutical targets the melanocortin 1 receptor for imaging locally advanced or metastatic melanoma. The trial is evaluating A9-3202’s tumour uptake and distribution in normal tissue among participants with melanoma. This latest financing comes after a flood of investment into the radiopharma arena over the last few years. Earlier this month, Aktis Oncology raised $175m to support the development of its new radiopharmaceuticals, including a first-in-class Nectin-4-targeted miniprotein radioconjugate. Big pharma has jumped on the radiopharma train too, with Bristol Myers Squibb (BMS), Novartis , and Eli Lilly signing acquisition deals worth $4.2bn , $1.75bn , and $1.4bn, respectively. Alpha-9’s Series C – co-led by Lightspeed Venture Partners and Ascenta Capital – builds on a $75m Series B in December 2022, and a $8.9m Series A in 2021, three years after the company spun-out from the University of British Columbia. Other participating investors in this round included a16z Bio + Health, RA Capital Management, Janus Henderson Investors and Samsara BioCapital. See Also: UPFs fuelling ‘alarming rise of chronic diseases’ in india FDA grants ODD to Modalis’ MDL-101 to treat LAMA2-CMD Alpha-9 said its funding will also support ongoing investments in its discovery capabilities, as well as the expansion of manufacturing and isotope supply partnerships. The company recently completed the construction of a manufacturing facility in Vancouver, Canada. Last month, Telix Pharmaceuticals paid $230m upfront to acquire US-based radioisotope manufacturer RLS Radiopharmacies to expand its manufacturing footprint in the US. Venture financing for innovative radiopharmaceutical drugs has witnessed an approximately 550% increase from $63m in 2017 to $408m in 2023 YTD (year-to-date) total deal value in the US, according to GlobalData’s Pharma Intelligence Center Deals Database. GlobalData is the parent company of Pharmaceutical Technology. In the announcement accompanying the financing, Alpha-9’s CEO David Hirsch said: “Over the last few years, Alpha-9 has built a leading radiopharmaceutical company with a deep pipeline and robust infrastructure.”

Another private radiopharmaceutical biotech has raised big money. Alpha-9 Oncology revealed on Wednesday that it’s put together a $175 million Series C, aiming to fund clinical trials for programs that are ready to be tested in humans and to advance preclinical candidates to the “clinic-ready” stage. The raise highlights the continuation of a strong interest in radiopharmaceuticals from large pharma companies, startups and venture capital. Alpha-9’s $175 million raise matches a Series B by Aktis Oncology last month, with multiple firms contributing to both rounds. It’s not immediately clear which of Alpha-9’s programs are expected to enter the clinic with the new fundraise. Execs previously told Endpoints News in 2022 that the company had five programs going after the cancer targets PSMA, MC1R, CXCR4, B1R and GRPR, with the PSMA program furthest along. But this past May, Alpha-9 announced the first patient had been dosed in a Phase 1 study for the MC1R program, called A9-3202. That trial is researching the compound’s effect in locally advanced or metastatic melanoma. Alpha-9 hasn’t previously announced any other trial launches, and a company spokesperson would only say that “multiple programs” have entered the clinic since the Series B. Wednesday’s financing was co-led by Lightspeed Venture Partners and Ascenta Capital. Other participating investors included a16z Bio + Health, RA Capital Management, Janus Henderson Investors and Samsara BioCapital.

In early-stage trials called dose escalation studies, drug developers usually want to test progressively higher doses of their therapies. Not Perspective Therapeutics. The radiopharma biotech announced Friday morning that it is planning to explore an even lower dose of its radioactive lead-based drug after Phase 1/2a results in 10 melanoma patients showed that those who got the low dose did better than those who got the high one. The company said there were no dose-limiting toxicities or adverse safety events that led to drug discontinuation, which are typical reasons for companies to test lower doses in early-stage studies. Perspective is studying an experimental treatment called [²¹²Pb]VMT01, which uses radioactive lead and is targeted at a receptor overexpressed in melanoma called MC1R. The first cohort of the trial included three patients who received 3.0 millicurie doses of Perspective’s therapy, while the second cohort had seven patients who received 5.0 millicurie doses of the drug. Patients in each cohort received a median of five prior lines of systemic therapy, Perspective said, meaning the patients had already tried a lot of treatments. In the cohort that got the low dose, one patient had a partial response, and the treatment staved off cancer progression for 13 months. All three patients completed all three cycles of therapy, which were given eight weeks apart. The two other patients in that cohort had stable disease at nine and 11 months from the start of treatment. Meanwhile, in the high-dose cohort, three patients progressed after the first cycle of treatment, while four progressed after the second cycle. Perspective CEO Thijs Spoor told Endpoints News that those patients saw progression-free survival times that “seemed to track the disease, without any major change that we could see either up or down.” Typically for these patients, the median PFS ranges from two to four months. Perspective’s shares $CATX fell about 12% on Friday morning. The company is part of a wave of biotech companies that is testing radiopharma assets that use so-called alpha emitters, one of which is the highly sought-after isotope actinium. Perspective now plans to test its lead-based radiopharma drug at 1.5 millicurie doses alone and in combination with Bristol Myers Squibb’s checkpoint inhibitor Opdivo. By combining the radiopharma drug with the checkpoint inhibitor, the idea is that the radiopharma drug could stimulate an immune response. Chief innovation officer Frances Johnson said that a key goal with radiation-based treatments is “to see if you can get the effect you want with as little radiation as possible,” which also explains why the safety monitoring committee recommended studying a lower dose. The company may also move to test even lower doses. “There’s a sweet spot here,” Spoor said. “And these patients’ immune systems are so compromised. So trying to push up for monotherapy at a higher dose in patients where there’s so much going on already doesn’t seem to make as much sense, especially given the animal data when we get such extraordinary responses in combination at lower doses.” In the study, there were four cases of grade 3 adverse events that were deemed unrelated to treatment.