Kura Oncology Reports First Patient Dosed in Trial of KO-2806 Plus Cabozantinib in Renal Cell Carcinoma
- Dosing of the first patient with KO-2806 in combination with cabozantinib in ccRCC cohort of FIT-001 trial.
- Significant milestone achieved in the next-generation FTI program of Kura Oncology.
- Focus on addressing resistance mechanisms and enhancing antitumor activity in cancer treatment.
- Innovative trial combining KO-2806 with targeted therapies to drive tumor regressions and improve antitumor response.
- Progress towards realizing the vision of broad application of KO-2806 as an ideal combination partner in cancer treatment.
- None.
Insights
From a medical perspective, the initiation of dosing with KO-2806 in combination with cabozantinib represents a promising step in the treatment of clear cell renal cell carcinoma (ccRCC). ccRCC is a subtype of kidney cancer that is known for its resistance to conventional chemotherapy, making advancements in targeted therapies particularly significant. The mechanism of action for KO-2806, as a farnesyl transferase inhibitor (FTI), involves blocking the farnesylation of proteins required for the proliferation of cancer cells. This approach can potentially inhibit tumor growth more effectively when combined with tyrosine kinase inhibitors (TKIs) like cabozantinib, which disrupt signaling pathways that cancer cells rely on to grow and spread.
Additionally, the focus on overcoming innate and adaptive resistance mechanisms is critical. Resistance to targeted therapies is a major hurdle in oncology and strategies that enhance the durability and depth of response could translate to better patient outcomes. The preclinical data suggesting tumor regression and enhanced antitumor response set a hopeful tone for the clinical trial outcomes. If positive, these results could lead to a new standard of care for ccRCC patients, who currently have limited treatment options.
The advancement of Kura Oncology's FIT-001 trial into human dosing is a notable event for stakeholders and could have implications for the company's valuation. The trial's design to assess KO-2806 both as a monotherapy and in combination with other targeted therapies provides a comprehensive evaluation of its therapeutic potential. The dual-track approach of monotherapy and combination therapy dose escalation allows for a more robust understanding of the drug's safety profile and efficacy. This strategy could accelerate the development timeline if the drug demonstrates positive results in either or both treatment modalities.
Moreover, the upcoming dosing in combination with adagrasib for KRASG12C-mutant NSCLC is particularly strategic, given the high unmet need in this patient population. KRAS mutations are common in NSCLC and have been historically challenging to target. The success of this combination therapy could open up a significant market opportunity for Kura Oncology. Investors should monitor the progression of these trials closely, as positive data could lead to substantial stock price movements and partnership opportunities for the company.
The oncology market is highly competitive, with numerous companies seeking to develop the next breakthrough in cancer treatment. Kura Oncology's focus on precision medicine and its pipeline of targeted therapies, such as KO-2806, positions it within a niche that is both highly sought after and lucrative. The potential broad application of KO-2806 as a combination partner enhances its marketability, as combination therapies are becoming increasingly common in oncology treatment regimens.
Investors often look for biopharmaceutical companies with innovative pipelines and clear strategies to address drug resistance, a current pain point in cancer therapy. Kura Oncology's emphasis on addressing mechanisms of innate and adaptive resistance could resonate well with investors looking for long-term growth prospects. The market impact of these developments will depend on the clinical outcomes; however, the initiation of dosing in a Phase 1 trial is an early yet positive indicator of the company's trajectory. The anticipation of dosing in NSCLC, a cancer with a higher prevalence than ccRCC, suggests a strategic move to target larger markets and could be a catalyst for future growth.
– Company anticipates dosing of KO-2806 in combination with adagrasib in KRASG12C-mutant NSCLC next quarter –
– Dose escalation of KO-2806 as a monotherapy continues in parallel –
SAN DIEGO, March 06, 2024 (GLOBE NEWSWIRE) -- Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, today announced dosing of the first patient with KO-2806, the Company’s next-generation farnesyl transferase inhibitor (FTI), in combination with the tyrosine kinase inhibitor (TKI) cabozantinib in the clear cell renal cell carcinoma (ccRCC) cohort of the Phase 1 portion of the FIT-001 trial.
“Dosing of the first patient in combination in our Phase 1 trial of KO-2806 marks a significant milestone for our next-generation FTI program,” said Stephen Dale, M.D., Chief Medical Officer of Kura Oncology. “This innovative, first-in-human trial builds upon our leadership position in the development of FTIs as well as a growing body of preclinical data demonstrating that combining KO-2806 with certain tyrosine kinase inhibitors, including cabozantinib, has the potential to address mechanisms of innate and adaptive resistance of targeted therapies, while driving tumor regressions and enhancing both duration and depth of antitumor response in preclinical models of ccRCC. With this achievement, we are now one step closer to realizing our vision for broad application of KO-2806 as an ideal combination partner to drive enhanced antitumor activity and address mechanisms of innate and adaptive resistance to targeted therapies.”
FIT-001 is a first-in-human, multicenter, open-label study to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary antitumor activity of KO-2806 when administered as monotherapy and in combination with targeted therapies. Concurrent with the monotherapy dose escalation, Kura is evaluating KO-2806 in dose-escalation combination cohorts with other targeted therapies, beginning with cabozantinib in ccRCC. The Company expects to begin dosing in combination with adagrasib in KRASG12C-mutant non-small cell lung cancer (NSCLC) next quarter. For more information regarding FIT-001, please visit www.clinicaltrials.gov (identifier: NCT06026410).
About KO-2806
KO-2806 is a next-generation inhibitor of farnesyl transferase designed to improve upon the potency, pharmacokinetic and physicochemical properties of earlier FTI drug candidates. At the 2023 AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics, Kura presented promising preclinical data supporting the rationale for combining KO-2806 with distinct classes of targeted therapies, including tyrosine kinase inhibitors, KRASG12C inhibitors and KRASG12D inhibitors. Additional information about clinical trials for KO-2806 can be found at https://kuraoncology.com/clinical-trials/#farnesyl-transferase-inhibitor.
About Kura Oncology
Kura Oncology is a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer. The Company’s pipeline consists of small molecule drug candidates that target cancer signaling pathways. Ziftomenib is a once-daily, oral drug candidate targeting the menin-KMT2A protein-protein interaction for the treatment of genetically defined AML patients with high unmet need. Kura is currently enrolling patients in a Phase 2 registration-directed trial of ziftomenib in NPM1-m R/R AML (KOMET-001). The Company is also conducting a series of studies to evaluate ziftomenib in combination with current standards of care, beginning with ven/aza and 7+3 in NPM1-m and KMT2A-r newly diagnosed and R/R AML (KOMET-007) and with the FLT3 inhibitor gilteritinib, FLAG-IDA or LDAC in NPM1-m and KMT2A-r R/R AML (KOMET-008). Tipifarnib, a potent and selective FTI, is currently in a Phase 1/2 trial in combination with alpelisib for patients with PIK3CA-dependent HNSCC (KURRENT-HN). Kura is also evaluating KO-2806, a next-generation FTI, in a Phase 1 dose-escalation trial as a monotherapy and in combination with cabozantinib in ccRCC and with adagrasib in KRASG12C-mutated NSCLC (FIT-001). For additional information, please visit Kura’s website at www.kuraoncology.com and follow us on X and LinkedIn.
Forward-Looking Statements
This news release contains certain forward-looking statements that involve risks and uncertainties that could cause actual results to be materially different from historical results or from any future results expressed or implied by such forward-looking statements. Such forward-looking statements include statements regarding, among other things, the efficacy, safety and therapeutic potential of KO-2806, potential benefits of combining KO-2806 with appropriate standards of care and expected timing for enrollment in the NSCLC cohort of the FIT-001 trial. Factors that may cause actual results to differ materially include the risk that compounds that appeared promising in early research or clinical trials do not demonstrate safety and/or efficacy in later preclinical studies or clinical trials, the risk that Kura may not obtain approval to market its product candidates, uncertainties associated with performing clinical trials, regulatory filings, applications and other interactions with regulatory bodies, risks associated with reliance on third parties to successfully conduct clinical trials, risks associated with Kura’s cash needs, the risks associated with reliance on outside financing to meet capital requirements, and other risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics, and in the endeavor of building a business around such drugs. You are urged to consider statements that include the words “may,” “will,” “would,” “could,” “should,” “believes,” “estimates,” “projects,” “promise,” “potential,” “expects,” “plans,” “anticipates,” “intends,” “continues,” “designed,” “goal,” or the negative of those words or other comparable words to be uncertain and forward-looking. For a further list and description of the risks and uncertainties the Company faces, please refer to the Company's periodic and other filings with the Securities and Exchange Commission (SEC), including the Company’s Form 10-K for the quarter ended December 31, 2023 filed with the SEC on February 27, 2024, which are available at www.sec.gov. Such forward-looking statements are current only as of the date they are made, and Kura assumes no obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
Contacts
Investors:
Pete De Spain
Executive Vice President, Investor Relations &
Corporate Communications
(858) 500-8833
pete@kuraoncology.com
Media:
Alexandra Weingarten
Associate Director, Corporate Communications &
Investor Relations
(858) 500-8822
alexandra@kuraoncology.com
FAQ
What is the significance of dosing the first patient with KO-2806 in the ccRCC cohort of FIT-001 trial?
What is the focus of Kura Oncology's trial involving KO-2806?
Which targeted therapy is KO-2806 being evaluated in combination with for ccRCC?
When is Kura Oncology expected to begin dosing in combination with adagrasib in KRASG12C-mutant NSCLC?
Where can more information about the FIT-001 trial be found?
