Kymera Therapeutics, Inc. (KYMR Quick QuoteKYMR - Free Report) announced that its investigational New Drug (IND) application for pipeline candidate, KT-621, has been cleared by the FDA.

KT-621 is an investigational first-in-class once-daily, oral STAT6 degrader with dupilumab-like activity in preclinical models and the potential to address multiple allergic and atopic diseases, including atopic dermatitis, asthma, and chronic obstructive pulmonary disease.

KYMR’s Plans for KT-621

Following the IND clearance, KYMR expects to initiate dosing in a phase I study in healthy volunteers later in the month. The company expects to report data from the phase I study in the first half of 2025.

The phase I study will evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of single and multiple ascending doses of KT-621 compared to placebo.

Kymera believes that its oral STAT6 degrader, KT-621, has the potential to combine the complete pathway blockade of upstream biologics with the convenience of oral administration, which, in turn, can transform the current treatment paradigm for atopic and allergic diseases.

STAT6 is a historically undrugged essential transcription factor in the IL-4/IL-13 signaling pathways and the central driver of T helper type 2 (TH2) inflammation in allergic diseases.

Sanofi (SNY Quick QuoteSNY - Free Report) and Regeneron’s (REGN Quick QuoteREGN - Free Report) Dupixent (dupilumab), an injectable monoclonal antibody that blocks IL-4/IL-13 signaling, is an approved therapy for multiple allergic and atopic diseases. STAT6 targeting is therefore supported by both human genetics and clinical pathway validation.

Sanofi records Dupixent's global net product sales, while Regeneron records its share of profits/losses related to the drug’s global sales.

KYMR’s Pipeline Progress

Kymera recently raised $225 million from public offering of its shares that will be used to advance its pipeline of preclinical and clinical degrader programs.

In July, partner Sanofi informed Kymera about its intention to rapidly expand the ongoing mid-stage studies on KT-474 (SAR444656) toward pivotal studies. KT-474 (SAR444656) is a first-in-class IRAK4 degrader in development for the treatment of immune-inflammatory diseases with significant patient needs, such as hidradenitis suppurativa and atopic dermatitis.

Sanofi informed Kymera about the decision to expand the studies after a review of preliminary safety and efficacy data in these studies by an Independent Data Review Committee.

Sanofi collaborated with Kymera on the development of KT-474 outside of the oncology and immuno-oncology fields.

In June, Kymera shared new clinical data from its ongoing phase I study KT-253. The data showed strong evidence of mechanism and antitumor activity in multiple tumor types shown to be sensitive in preclinical models.

Dose escalation in the phase Ia study is ongoing in Arm A (solid tumors and lymphomas) and Arm B (high grade myeloid malignancies). KYMR expects to complete enrollment in the second half of 2024.

Kymera announced new data from its ongoing phase I study on KT-333, a first-in-class, potent, highly selective and heterobifunctional small molecule degrader of STAT3.

The candidate demonstrated antitumor responses in hematological malignancies, including relapsed/refractory classic Hodgkin’s lymphoma (cHL), cutaneous T-cell lymphoma and NK-cell lymphoma, at doses that were well-tolerated.  Complete responses in two patients with cHL were observed.

The phase Ia study is ongoing with enrollment focused on Hodgkin’s lymphoma based on encouraging clinical responses. KYMR is evaluating opportunities for future expansion into solid tumors, combined with immune checkpoint inhibitors and other targeted therapies. The company expects to complete enrollment of the phase Ia trial and share data in the second half of 2024.

The successful development of these promising candidates is important for Kymera.