CLINICAL AND REGULATORY
Medicenna reported confirmed partial response in pancreatic cancer in Phase 1/2
The confirmatory scan for this patient continues to show further tumor reduction compared to prior scans, suggesting durable anti-cancer activity following MDNA11 monotherapy. Overall, five of fourteen evaluable patients in the ABILITY study’s low and mid-stage dose escalation cohorts have achieved tumor control (PR or stable disease) with MDNA11 monotherapy. The observed tumor control rate of 36% in the low and mid-dose cohorts (n=14) in patients with advanced metastatic cancer further enhances our confidence in MDNA11’s monotherapy activity, consistent with our belief in its potential to selectively bolster cancer-fighting immune cells.
Werewolf initiated patient dosing in Phase 1 trial of WTX-124 for treatment of solid tumors
Werewolf Therapeutics announced that the first patient has been dosed in a Phase 1/1b clinical trial evaluating WTX-124, the Company’s lead INDUKINETM molecule targeting IL-2 for the treatment of solid tumors. The Phase 1/1b clinical trial is a first-in-human, multi-center, open-label trial that will evaluate WTX-124 as a monotherapy and in combination with Ketryda in patients with immunosensitive advanced or metastatic solid tumors who have failed standard of care, including checkpoint inhibitor therapy.
Nektar presented data for rezpegaldesleukin in patients with atopic dermatitis and psoriasis
Nektar announced data presentations from two Phase 1b, proof-of-concept studies of rezpegaldesleukin (NKTR-358) in patients with atopic dermatitis and plaque psoriasis at the 2022 European Academy of Dermatology and Venereology (EADV) Congress. Rezpegaldesleukin is a selective regulatory T-cell inducing IL-2 conjugate in development to treat autoimmune and inflammatory conditions. Data were presented at EADV from both a Phase 1b double-blind, randomized, placebo-controlled multiple-dose study evaluating the safety, tolerability, and pharmacokinetics of rezpegaldesleukin in patients with moderate-to-severe AD, as well as a Phase 1b double-blind, placebo-controlled study evaluating rezpegaldesleukin in patients with plaque psoriasis who are candidates for systemic therapy or phototherapy. The IL-2 conjugate Treg stimulator, LY3471851, had a safety profile at the doses studied that supports further clinical development of LY3471851 in patients with atopic dermatitis.
DEALS AND FINANCINGS
Roche to pay $250 million for Good Therapeutics’ PD-1-regulated IL-2 program
Roche has signed a definitive merger agreement for the acquisition of US-based biopharmaceutical company Good Therapeutics for an upfront payment of $250m in cash. Good Therapeutics focuses on the development of PD-1-regulated IL-2 drugs that are based on innovative conditionally active drug technology. With the takeover, Roche will attain rights to a conditionally active, PD-1-regulated IL-2 program of Good Therapeutics. Additionally, the company will gain the exclusive right to Good Therapeutics’ platform technology to develop PD-1-regulated IL-2 receptor agonist therapies.
Almirall and Simcere enter into a licensing agreement for IL-2 mutant fusion protein
Almirall will pay $15 million up front to Simcere Pharmaceutical in return for exclusive rights to develop and commercialize for all indications outside Greater China and Taiwan, where Simcere will retain rights. Simcere is also eligible for up to $492 million in milestones and low double-digit tiered royalties on global sales. The IL-2 mutant fusion protein, which is injected subcutaneously, selectively activates T regulatory cells and not effector T cells or NK cells. It is a compound intended to treat various autoimmune diseases. The candidate is IND-ready.
Medicenna announced clinical collaboration with Merck to evaluate MDNA11 with Keytruda
Medicenna Therapeutics announced that it has entered into a clinical trial collaboration and supply agreement with Merck to evaluate MDNA11, Medicenna’s “beta-only” long-acting IL-2 super-agonist in combination with Keytruda in the ongoing Phase 1/2 ABILITY Study. The ABILITY study is a Phase 1/2 trial designed to assess the safety, PK, PD and preliminary efficacy of MDNA11 as a monotherapy and in combination with Keytruda in patients with advanced/metastatic solid tumors. Medicenna will sponsor the study and Merck will supply Keytruda.