Locally Advanced Melanoma

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.

The fast track designation will expedite the clinical development of the asset for melanoma treatment. Credit: yanishevska/Shutterstock. The US Food and Drug Administration (FDA) has granted its fast track designation to Innovent Biologics ‘ IBI363, a PD-1/IL-2 α-bias bispecific antibody fusion protein to treat advanced unresectable locally advanced or metastatic melanoma. The designation will expedite the clinical development and review process for IBI363, which is currently undergoing Phase I/II clinical trials in China, the US and Australia. The product blocks the PD-1/PD-L1 pathway and activates the IL-2 pathway, targeting melanoma patients who have progressed after systemic therapy, including a PD-1/L1 inhibitor. However, it is not aimed at treating choroidal melanoma. Promising results from ongoing clinical studies have shown that of 37 melanoma patients who had previously received immunotherapy, 11 achieved objective responses after being treated with 1mg/kg of IBI363. See Also: A guide to host-cell protein analysis services for biomanufacturers​ Chime looks to expand manufacturing capacity and establish European presence This includes one complete response and ten partial responses, with an objective response rate of 29.7% and a disease control rate (DCR) of 73%. Fast track status is a process that facilitates the development of assets addressing serious conditions with unmet medical needs. It allows for more frequent interactions with the FDA, which can lead to earlier approval for medicines. Innovent Biologics senior vice-president Dr Hui Zhou stated: “As a first in-class PD-1/IL-2 α-bias bispecific antibody fusion protein, IBI363 monotherapy has shown encouraging efficacy and a favourable safety profile in melanoma subjects who have previously received immunotherapy. “We will continue to explore the efficacy and safety of IBI363 in melanoma to provide more effective clinical treatment for patients with immune-resistant melanoma.” Innovent recently received approval from China’s National Medical Products Administration for its KRAS G12C inhibitor, Dupert (fulzerasib), for treating advanced non-small cell lung cancer in adults. This content was updated on 25 January 2024