Coherus Announces Clinical Collaboration with STORM Therapeutics to Evaluate STC-15 in Combination with LOQTORZI® (toripalimab-tpzi)
Coherus BioSciences (NASDAQ: CHRS) has announced a clinical collaboration with STORM Therapeutics to evaluate the combination of STC-15 (a METTL3 inhibitor) with LOQTORZI (toripalimab-tpzi), their next-generation PD-1 inhibitor. The first patient has been dosed in a Phase 1b/2 study targeting multiple cancer types including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma, and endometrial cancer.
The study will enroll up to 188 patients in the United States, with Phase 1b focusing on safety and efficacy of the combination, followed by Phase 2 expansion cohorts. Under the agreement, Coherus will supply LOQTORZI while STORM will sponsor the trial, with both companies retaining commercial rights to their respective compounds.
Coherus BioSciences (NASDAQ: CHRS) ha annunciato una collaborazione clinica con STORM Therapeutics per valutare la combinazione di STC-15 (un inibitore di METTL3) con LOQTORZI (toripalimab-tpzi), il loro inibitore PD-1 di nuova generazione. Il primo paziente è stato trattato in uno studio di Fase 1b/2 che coinvolge diversi tipi di cancro, tra cui il carcinoma polmonare non a piccole cellule (NSCLC), il carcinoma squamoso della testa e del collo (HNSCC), il melanoma e il cancro endometriale.
Lo studio arruolerà fino a 188 pazienti negli Stati Uniti, con la Fase 1b focalizzata sulla sicurezza e l'efficacia della combinazione, seguita dalle coorti di espansione della Fase 2. Secondo l'accordo, Coherus fornirà LOQTORZI mentre STORM sponsorizzerà lo studio, con entrambe le aziende che manterranno i diritti commerciali sui rispettivi composti.
Coherus BioSciences (NASDAQ: CHRS) ha anunciado una colaboración clínica con STORM Therapeutics para evaluar la combinación de STC-15 (un inhibidor de METTL3) con LOQTORZI (toripalimab-tpzi), su inhibidor PD-1 de próxima generación. Se ha dosificado al primer paciente en un estudio de Fase 1b/2 dirigido a múltiples tipos de cáncer, incluyendo cáncer de pulmón no microcítico (NSCLC), carcinoma de células escamosas de cabeza y cuello (HNSCC), melanoma y cáncer endometrial.
El estudio inscribirá hasta 188 pacientes en Estados Unidos, con la Fase 1b centrada en la seguridad y eficacia de la combinación, seguida por las cohortes de expansión de la Fase 2. Según el acuerdo, Coherus suministrará LOQTORZI mientras que STORM patrocinará el ensayo, y ambas compañías conservarán los derechos comerciales sobre sus respectivos compuestos.
Coherus BioSciences (NASDAQ: CHRS)는 STORM Therapeutics와 임상 협력을 발표하여 METTL3 억제제인 STC-15와 차세대 PD-1 억제제인 LOQTORZI(토리팔리맙-tpzi)의 병용 요법을 평가할 예정입니다. 비소세포폐암(NSCLC), 두경부 편평세포암(HNSCC), 흑색종, 자궁내막암 등 여러 암종을 대상으로 하는 1b/2상 임상시험에 첫 환자가 투여되었습니다.
미국 내 최대 188명 환자를 등록할 예정이며, 1b상은 병용 요법의 안전성과 효능에 중점을 두고, 이어서 2상 확장 코호트가 진행됩니다. 계약에 따라 Coherus는 LOQTORZI를 공급하고 STORM은 임상시험을 후원하며, 양사는 각자의 화합물에 대한 상업적 권리를 보유합니다.
Coherus BioSciences (NASDAQ : CHRS) a annoncé une collaboration clinique avec STORM Therapeutics pour évaluer la combinaison de STC-15 (un inhibiteur de METTL3) avec LOQTORZI (toripalimab-tpzi), leur inhibiteur PD-1 de nouvelle génération. Le premier patient a été traité dans une étude de phase 1b/2 ciblant plusieurs types de cancers, notamment le cancer du poumon non à petites cellules (NSCLC), le carcinome épidermoïde de la tête et du cou (HNSCC), le mélanome et le cancer de l'endomètre.
L'étude recrutera jusqu'à 188 patients aux États-Unis, la phase 1b se concentrant sur la sécurité et l'efficacité de la combinaison, suivie des cohortes d'expansion de la phase 2. Selon l'accord, Coherus fournira LOQTORZI tandis que STORM parrainera l'essai, les deux sociétés conservant les droits commerciaux sur leurs composés respectifs.
Coherus BioSciences (NASDAQ: CHRS) hat eine klinische Zusammenarbeit mit STORM Therapeutics angekündigt, um die Kombination von STC-15 (einem METTL3-Inhibitor) mit LOQTORZI (toripalimab-tpzi), ihrem PD-1-Inhibitor der nächsten Generation, zu evaluieren. Der erste Patient wurde in einer Phase 1b/2-Studie behandelt, die sich auf mehrere Krebsarten wie nicht-kleinzelliges Lungenkarzinom (NSCLC), Plattenepithelkarzinom des Kopf- und Halsbereichs (HNSCC), Melanom und Endometriumkarzinom konzentriert.
Die Studie wird bis zu 188 Patienten in den USA einschließen, wobei sich Phase 1b auf die Sicherheit und Wirksamkeit der Kombination konzentriert, gefolgt von Erweiterungskohorten in Phase 2. Im Rahmen der Vereinbarung wird Coherus LOQTORZI bereitstellen, während STORM die Studie sponsert, wobei beide Unternehmen die kommerziellen Rechte an ihren jeweiligen Wirkstoffen behalten.
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Insights
Clinical collaboration with STORM tests LOQTORZI with novel METTL3 inhibitor in multiple cancers, expanding Coherus' pipeline potential while limiting development costs.
Coherus BioSciences has initiated a strategic clinical collaboration with STORM Therapeutics that merits attention from the oncology research community. The collaboration centers on combining STORM's STC-15, a first-in-class METTL3 inhibitor, with Coherus' LOQTORZI (toripalimab-tpzi), an FDA-approved PD-1 inhibitor. The first patient has already been dosed in their Phase 1b/2 study, signaling operational momentum.
This trial design is particularly noteworthy for its comprehensive approach - starting with safety and efficacy assessment in Phase 1b before expanding into multiple cancer types including non-small cell lung cancer, head and neck squamous cell carcinoma, melanoma and endometrial cancer in Phase 2. The scope is substantial, potentially enrolling up to 188 patients across U.S. sites.
The underlying scientific rationale is compelling. METTL3 inhibitors represent a novel class targeting RNA modification, potentially complementing the established immune checkpoint inhibition mechanism of PD-1 blockers. This combination could potentially overcome resistance mechanisms seen with PD-1 monotherapy.
From a development perspective, Coherus has structured this deal intelligently - providing LOQTORZI while STORM sponsors the trial, effectively expanding their pipeline's potential without bearing full development costs. This aligns with their stated strategy of pursuing LOQTORZI indication expansion through partnership rather than solo development, demonstrating fiscal discipline while maintaining upside potential in additional cancer indications beyond the currently approved nasopharyngeal carcinoma (NPC).
– First patient dosed in a Phase 1b/2 study evaluating STC-15, a METTL3 inhibitor, in combination with LOQTORZI, a next-generation PD-1 inhibitor –
REDWOOD CITY, Calif., May 27, 2025 (GLOBE NEWSWIRE) -- Coherus BioSciences, Inc. (“Coherus,” NASDAQ: CHRS), today announced a clinical collaboration with STORM Therapeutics, Ltd. (“STORM”) to evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI (toripalimab-tpzi), a next-generation PD-1 inhibitor, in a Phase 1b/2 study for the treatment of non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), melanoma and endometrial cancer.
“We are excited to partner with STORM on the development of the LOQTORZI/STC-15 combination, with patient dosing underway in the Phase 1b/2 study,” said Theresa LaVallee, Ph.D., Chief Scientific and Development Officer of Coherus. “This collaboration is another example of our strategy for expanding potential LOQTORZI indications beyond NPC through cost-efficient drug supply agreements and evaluating LOQTORZI with novel mechanisms in prioritized tumor types such as NSCLC, HNSCC, and others.”
The phase 1b study will evaluate STC-15, a METTL3 inhibitor, in combination with LOQTORZI to determine the safety and efficacy of the combination. The phase 2 portion of the study will evaluate expansion cohorts in NSCLC, HNSCC, endometrial cancer and melanoma, in up to 188 patients in the United States. (NCT06975293)
Under the terms of the clinical trial collaboration and supply agreement, Coherus will provide LOQTORZI to STORM, which will be the sponsor of the Phase 1b/2 clinical combination trial. STORM and Coherus each retain all commercial rights to their respective compounds, including as monotherapies or as combination therapies.
About Coherus
Coherus is a fully integrated commercial-stage innovative oncology company with an approved next-generation PD-1 inhibitor, LOQTORZI® (toripalimab-tpzi), growing revenues and a promising pipeline that includes two mid-stage clinical candidates targeting liver, lung, head & neck, and other cancers. Our strategy is to grow sales of LOQTORZI in nasopharyngeal carcinoma and advance the development of new indications for LOQTORZI in combination with both our pipeline candidates as well as our partners’, driving sales multiples and synergies from proprietary combinations.
Coherus’ immuno-oncology pipeline includes multiple antibody immunotherapy candidates focused on enhancing the innate and adaptive immune responses to enable a robust antitumor response and enhance outcomes for patients with cancer. Casdozokitug is a novel IL-27 antagonistic antibody currently being evaluated in multiple Phase 1/2 and Phase 2 studies in patients with advanced solid tumors, including non-small cell lung cancer and hepatocellular carcinoma. CHS-114 is a highly selective cytolytic anti-CCR8 antibody currently in Phase 1b studies in patients with advanced solid tumors, including head and neck squamous cell carcinoma and gastric cancer.
For more information about LOQTORZI, including the U.S. Prescribing Information and important safety information, please visit www.loqtorzi.com.
Forward-Looking Statements
The statements in this press release include express or implied forward-looking statements within the meaning of Section 27A of the Securities Act and Section 21E of the Exchange Act about Coherus that involve risks and uncertainties relating to future events and the future performance of Coherus. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Words such as “will,” “could,” “would,” “should,” “expect,” “plan,” “anticipate,” “intend,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue,” “future,” “opportunity,” “likely,” “target,” variations of such words, and similar expressions or negatives of these words are intended to identify such forward-looking statements, although not all forward-looking statements contain these identifying words. You can also identify forward-looking statements by discussions of strategy, plans or intentions.
Examples of such forward-looking statements include, but are not limited to, express or implied statements regarding: the ability of Coherus’ pipeline to enhance outcomes for cancer patients; expectations about future synergies; projections about growth in sales; expectations for future enrollment in clinical trials; projections about the expansion of indications for LOQTORZI; and the assumptions underlying or relating to such statements.
These forward-looking statements are based on Coherus’ current plans, estimates and projections. By their very nature, forward-looking statements involve inherent risks and uncertainties, both general and specific, assumptions and changes in circumstances, many of which are beyond the control of Coherus. A number of important factors, including those described in this press release, could cause actual results to differ materially from those contemplated in any forward-looking statements. Factors that may affect future results and may cause these forward-looking statements to be inaccurate include, without limitation: uncertainties about the potential impact of unforeseen liabilities, future capital expenditures, revenues, costs, expenses, earnings, economic performance, indebtedness, financial condition and losses on Coherus’ prospects, business and operations in the future; risks and uncertainties in executing collaboration agreements and other joint ventures; risks and uncertainties of conducting clinical trials; the risks of Coherus’ dependence on an ability to raise funds, which may not be available on acceptable terms or at all; and risks and uncertainties of any litigation, regulatory actions and other legal proceedings.
While the foregoing list of factors presented here is considered representative, no list should be considered to be a complete statement of all potential risks and uncertainties. There can be no assurance that the transaction described above will in fact be consummated in the manner described or at all. For a further discussion of these and other factors that could cause Coherus’ future results to differ materially from any forward-looking statements see the section entitled “Risk Factors” in Coherus’ Quarterly Report on Form 10-Q for the period ended March 31, 2025, filed with the Securities and Exchange Commission (SEC) on May 12, 2025, as updated by Coherus’ subsequent reports filed with the SEC. Any forward-looking statements speak only as of the date of this press release and are made based on the current good faith beliefs and judgments of Coherus’ management, and the reader is cautioned not to rely on any forward-looking statements made by Coherus. Unless required by law, Coherus is not under any duty and undertakes no obligation to publicly update or revise any forward-looking statement to reflect changes in underlying assumptions or factors, of new information, data or methods, future events or other changes.
LOQTORZI® is a registered trademark of Coherus BioSciences, Inc.
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Coherus BioSciences Contact Information:
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IR@coherus.com
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FAQ
What is the purpose of Coherus (CHRS) and STORM Therapeutics' clinical collaboration?
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