ORIC Pharmaceuticals Announces Multiple Clinical Collaborations with Strategic Partners to Support Ongoing Trial Evaluating ORIC-944 in Combination with AR Inhibitors for the Treatment of Prostate Cancer
ORIC Pharmaceuticals (Nasdaq: ORIC) has announced multiple clinical collaborations to support its ongoing trial of ORIC-944, a potential best-in-class PRC2 inhibitor, in combination with AR inhibitors for prostate cancer treatment. The company has initiated dosing of ORIC-944 in combination with darolutamide and apalutamide in a Phase 1b trial for metastatic prostate cancer patients.
ORIC has entered into clinical trial collaboration and supply agreements with Bayer and Johnson & Johnson's Janssen Research & Development. These partnerships will provide darolutamide (NUBEQA®) and apalutamide (ERLEADA®) for the study, while ORIC maintains full global development and commercial rights to ORIC-944.
The combination approach is based on promising preclinical findings and emerging clinical data, demonstrating synergy in multiple prostate cancer models with a unique mechanism of reprogramming prostate cancer to revert to an AR-dependent state.
- Initiation of dosing for ORIC-944 in combination with darolutamide and apalutamide in Phase 1b trial
- Clinical collaborations secured with Bayer and Johnson & Johnson for drug supply
- ORIC maintains full global development and commercial rights to ORIC-944
- Preclinical data shows synergy between ORIC-944 and AR inhibitors in prostate cancer models
- ORIC-944 has demonstrated superior clinical half-life, robust target engagement, and favorable safety as a monotherapy
- None.
ORIC Pharmaceuticals' recent announcement of multiple clinical collaborations for ORIC-944 is significant for several reasons. The combination of ORIC-944 with androgen receptor (AR) inhibitors targets a well-known pathway in prostate cancer therapy. The trial's design includes both dose escalation and expansion cohorts, ensuring a comprehensive analysis of the drug's efficacy and safety profile when used in combination with existing treatments.
The involvement of Bayer and Johnson & Johnson through their supply agreements suggests confidence in ORIC-944’s potential. Darolutamide (NUBEQA®) and apalutamide (ERLEADA®) are established AR inhibitors and their integration into these trials highlights ORIC-944's promise. The preclinical data showing synergy is particularly noteworthy, as it suggests a novel mechanism of action that could offer improved outcomes for patients with metastatic castration-resistant prostate cancer (mCRPC).
For investors, the fact that ORIC maintains full development and commercial rights is crucial. This allows ORIC to potentially reap significant financial benefits if the trials are successful. Moreover, the collaborations could expedite the clinical development process, potentially bringing ORIC-944 to market more quickly. While the ongoing clinical trials are still in an early phase, the initial results are promising, with the combination showing superior clinical half-life and robust target engagement.
The strategic collaborations between ORIC Pharmaceuticals and industry giants Bayer and Johnson & Johnson indicate a strong validation of ORIC-944's potential from well-established players in the pharmaceutical market. These agreements could have a significant impact on ORIC's capital expenditure and operational efficiency by reducing costs associated with drug supply for trials.
From a financial perspective, maintaining global development and commercial rights to ORIC-944 is a strategic move. This ensures that ORIC can retain revenue streams if the drug is successful, rather than having to share profits with its collaborators. Given the high stakes involved in cancer treatment markets, this could translate into substantial financial gains.
However, it's important to note that the success of these trials is not guaranteed. The market has seen many instances where promising drugs failed in advanced phases. Investors should keep an eye on the progression of the Phase 1b trials and any emerging clinical data. Positive results could lead to a significant uptick in ORIC's stock, whereas any setbacks might dampen investor sentiment.
ORIC-944, a potential best-in-class PRC2 inhibitor, is being evaluated in combination with darolutamide and in combination with apalutamide in patients with mCRPC
ORIC entered into clinical trial collaboration and supply agreements with Bayer
and Johnson & Johnson
SOUTH SAN FRANCISCO, Calif. and SAN DIEGO, Calif., July 16, 2024 (GLOBE NEWSWIRE) -- ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, today announced it initiated dosing of ORIC-944, a potent and selective allosteric inhibitor of PRC2, in combination with darolutamide as well as in combination with apalutamide, in the first half of 2024 as part of the ongoing Phase 1b trial in patients with metastatic prostate cancer. Each combination cohort includes a dose escalation and expansion portion, evaluating the combination of ORIC-944 and NUBEQA® (darolutamide) or ORIC-944 and ERLEADA® (apalutamide).
The company also announced that it has entered into clinical trial collaboration and supply agreements with Bayer and Janssen Research & Development, LLC, a Johnson & Johnson company, to evaluate ORIC-944 in combination with NUBEQA®, Bayer’s androgen receptor (AR) inhibitor, and ERLEADA®, Johnson & Johnson’s AR inhibitor.
Under the terms of the collaborations, ORIC® will continue to conduct and sponsor the ongoing Phase 1b trial, and Bayer and Johnson & Johnson will provide darolutamide and apalutamide, respectively, for the study. ORIC maintains full global development and commercial rights to ORIC-944.
“We are pleased to enter into these clinical collaborations to investigate the broader potential of ORIC-944 in combination with AR inhibitors, a combination approach that we believe is particularly promising based on our preclinical findings as well as emerging clinical data,” said Jacob M. Chacko, M.D., president and chief executive officer. “As reported at the AACR Annual Meeting earlier this year, the combination of ORIC-944 and AR inhibitors demonstrated synergy in multiple prostate cancer models with a unique mechanism of reprogramming prostate cancer to revert to an AR-dependent state. Together with the emerging clinical profile of ORIC-944, which has already demonstrated superior clinical half-life, robust target engagement and favorable safety as a monotherapy, the combination of ORIC-944 with an AR inhibitor has the potential to become a novel treatment paradigm for patients with prostate cancer.”
About ORIC-944
ORIC-944 is a potent and selective allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the embryonic ectoderm development (EED) subunit. ORIC-944 was initially evaluated as a single agent in a Phase 1b trial in patients with advanced prostate cancer and demonstrated potential best-in-class drug properties, including clinical half-life of approximately 20 hours, robust target engagement and a favorable safety profile.
About ORIC Pharmaceuticals, Inc.
ORIC Pharmaceuticals is a clinical stage biopharmaceutical company dedicated to improving patients’ lives by Overcoming Resistance In Cancer. ORIC’s clinical stage product candidates include (1) ORIC-114, a brain penetrant inhibitor designed to selectively target EGFR and HER2 with high potency against exon 20 insertion mutations, being developed across multiple genetically defined cancers, (2) ORIC-944, an allosteric inhibitor of the polycomb repressive complex 2 (PRC2) via the EED subunit, being developed for prostate cancer, and (3) ORIC-533, an orally bioavailable small molecule inhibitor of CD73, a key node in the adenosine pathway believed to play a central role in resistance to chemotherapy- and immunotherapy-based treatment regimens, being developed for multiple myeloma. Beyond these three product candidates, ORIC is also developing multiple precision medicines targeting other hallmark cancer resistance mechanisms. ORIC has offices in South San Francisco and San Diego, California. For more information, please go to www.oricpharma.com, and follow us on X or LinkedIn.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, statements regarding the continued clinical development of ORIC-944, including the various Phase 1b combination cohorts; potential combination benefits of ORIC-944 with an AR inhibitor; ORIC-944 clinical data, which may materially change as patient enrollment continues or more patient data become available; the development plans for ORIC-944 and ORIC’s other product candidates; the potential advantages of ORIC-944 and ORIC’s other product candidates and programs; plans underlying ORIC’s clinical trials and development; and statements by the company’s chief executive officer. Words such as “believes,” “anticipates,” “plans,” “expects,” “intends,” “will,” “goal,” “potential” and similar expressions are intended to identify forward-looking statements. The forward-looking statements contained herein are based upon ORIC’s current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results could differ materially from those projected in any forward-looking statements due to numerous risks and uncertainties, including but not limited to: risks associated with the process of discovering, developing and commercializing drugs that are safe and effective for use as human therapeutics and operating as an early clinical stage company; ORIC’s ability to develop, initiate or complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in ORIC’s plans to develop and commercialize its product candidates; the potential for clinical trials of ORIC’s product candidates to differ from preclinical, initial, interim, preliminary or expected results; negative impacts of health emergencies, economic instability or international conflicts on ORIC’s operations, including clinical trials; the risk of the occurrence of any event, change or other circumstance that could give rise to the termination of ORIC’s license and collaboration agreements; the potential market for ORIC’s product candidates, and the progress and success of competing therapeutics currently available or in development; ORIC’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; ORIC’s reliance on third parties, including contract manufacturers and contract research organizations; ORIC’s ability to obtain and maintain intellectual property protection for its product candidates; the loss of key scientific or management personnel; competition in the industry in which ORIC operates; general economic and market conditions; and other risks. Information regarding the foregoing and additional risks may be found in the section titled “Risk Factors” in ORIC’s Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (the “SEC”) on May 6, 2024, and ORIC’s future reports to be filed with the SEC. These forward-looking statements are made as of the date of this press release, and ORIC assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law.
Contact:
Dominic Piscitelli, Chief Financial Officer
dominic.piscitelli@oricpharma.com
info@oricpharma.com
FAQ
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