ImmunityBio announced updated data from an ongoing bladder cancer trial showing sustained complete response rates in patients with BCG-unresponsive non-muscle invasive carcinoma in situ bladder cancer (Cohort A). Of the 81 patients in the QUILT 3.032 study, 58 patients (72%) had a complete response (CR) at any time (three or six months) to intravesical BCG plus N-803 (Anktiva) with median duration of CR of 19.9 months. The data also showed a 59% probability (95% confidence interval; 43.1%, 71.2%) that responding patients would maintain a complete response for more than 12 months, based on Kaplan-Meier analysis. For the patients who had a CR within the first three months, the CR rate was 77%, with a 61% probability of remaining disease free at 18 months with the median duration of complete response having not yet been reached in that group. 85% of patients in the cohort avoided a cystectomy with a median duration of follow-up of 20.4 months. Of note, the therapy was extremely well tolerated with 0% treatment-related SAEs, 0% immune-related AEs and 0% grade 4 or 5 treatment-related AEs. In contrast, the currently approved checkpoint therapy for this indication is associated with an incidence of 21% immune-related adverse events.
IL-15 superagonist N-803 achieved strong antitumor activity in bladder cancer
DEALS AND FINANCING
Sanofi takes out Kadmon for $1.9 billion gaining marketed transplant drug and IL-15 fusion protein
Sanofi will acquire Kadmon Holdings. The acquisition will immediately add Rezurock (belumosudil) to its transplant portfolio. Rezurock is a recently FDA-approved, first-in-class treatment for chronic graft-versus-host disease for adult and pediatric patients 12 years and older who have failed at least two prior lines of systemic therapy. In the company’s pipeline lies anti-PD-L1/IL-15 fusion protein KD033, which is in Phase 1 testing for immuno-oncology. In 2019, Sanofi acquired Synthorx, which developed THOR-707, a variant of interleukin-2 (IL-2), is in clinical development in multiple solid tumor types.
Asher Bio closes $108M series B round to move IL-2 program to the clinic in 2022
Less than six months after closing a $55 million Series A round, Asher Biotherapeutics announced the closing of an oversubscribed Series B financing, which raised $108 million. The financing was led by Wellington Management Company LLP, and included new investors RA Capital Management, Janus Henderson Investors, Logos Capital, Marshall Wace and Alexandria Venture Investments, and, along with existing investors Third Rock Ventures, Invus, Boxer Capital of Tavistock Group, Mission BioCapital, and other undisclosed institutional investors. Asher Bio aims to advance a portfolio of cis-targeted therapies derived from diverse cytokines and cell-types, each designed to address the challenge of pleiotropy that limits the efficacy and tolerability of many immunotherapies. By engaging two receptors on the same cell for activation, an immunomodulatory receptor for therapeutic action and a specific target receptor for directing the therapy to the desired cell type, Asher Bio’s cis-targeted immunotherapies seek to offer a new level of selectivity, with the potential to deliver superior clinical outcomes and an improved safety profile.
Obsidian Therapeutics closed $115 million Series B and plans IPO
Cell and gene therapy play Obsidian Therapeutics Inc. looks set to seek a public listing after raising $115 million in a series B round led by The Column Group Crossover Fund. Other new investors included RA Capital, Surveyor Capital, Cowen Healthcare Investments, Deep Track Capital, Logos Capital, Pivotal BioVenture Partners, Samsara BioCapital and Soleus Capital. Existing investors Atlas Venture, Vertex Ventures HC, Amgen Ventures, BMS and Vertex Pharmaceuticals also participated. Obsidian’s lead tumor infiltrating lymphocyte (TIL) program, cytoTIL15, is expected to enter the clinic next year.
