- Q3W schedule of CRB-701 (SYS6002) demonstrates a 43% ORR and 71% DCR at predicted therapeutically relevant doses
- All assessable nectin-4 positive study participants with mUC and cervical cancer treated at or above this dose demonstrated some level of disease control
- No dose limiting toxicities (DLTs) have been observed to-date up to 3.6 mg/kg (cohort 6) with further escalation at 4.5 mg/kg ongoing
- No cases of peripheral neuropathy or skin rash have been observed to date
- Cohort 6 is the first cohort selected for dose expansion
The poster is titled Phase 1 Dose Escalation of SYS6002(CRB-701), a Next Generation Nectin-4 Targeting Antibody Drug Conjugate by
Safety
- CRB-701 was well-tolerated with the majority of adverse events being grade one or two and reversible.
- No adverse events above grade three were observed.
- There have been no dose discontinuations or reductions in the study to date. There has been a singular participant that experienced a temporary dose interruption.
- The dose escalation is ongoing at cohort 7 (4.5 mg/kg).
- No cases of drug-related peripheral neuropathy or skin rash have been reported to date.
PK
- Single dose PK suggested that TAb, ADC and MMAE increase in an approximate dose proportional manner.
- No obvious accumulation was observed on cycle 3, day 1.
- When compared to the exposures achieved with enfortumab vedotin (EV) at 1.25 mg/kg Q1W x21 days, CRB-701 (SYS6002) consistently demonstrated lower free MMAE concentrations.
Efficacy
- Dose level 5 (2.7 mg/kg) and above represents the predicted therapeutically relevant doses based on allometric scaling.
- A mixed tumor population (n=7) receiving doses of 2.7 mg/kg or 3.6 mg/kg demonstrated an ORR of 43% (3 partial responses -2 unconfirmed and one non-responding participant with no-nectin-4 expression) and a disease control rate of 71%.
- The longest observed response to date is 11 cycles (~10 months) and ongoing.
- All nectin-4 positive mUC and cervical patients at doses ≥ 2.7 mg/kg that were assessable at the time of the
December 2023 data-cut off demonstrated levels of disease control and represent the CRB-701 (SYS6002) responsive population to date.
In reviewing the emerging profile of CRB-701 with one of the preeminent experts in GU cancers, Dr
Dose escalation and expansion are ongoing and additional data presentations are planned for later this year.
About CRB-701
CRB-701 (SYS6002) is a next-generation antibody-drug-conjugate (ADC) targeting nectin-4, that contains a site-specific, cleavable linker and a homogenous drug antibody ratio of 2, using MMAE as the payload. Nectin-4 is a clinically validated, tumor-associated antigen in urothelial cancer. The Nectin-4 ADC PADCEV® (enfortumab vedotin-ejfv) is approved for use in late metastatic urothelial cancer and recently received an expanded label under an accelerated approval from the
About Corbus
Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company's restructuring, trial results, product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management's current beliefs and assumptions.
These statements may be identified by the use of forward-looking expressions, including, but not limited to, "expect," "anticipate," "intend," "plan," "believe," "estimate," "potential,” "predict," "project," "should," "would" and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors on our operations, clinical development plans and timelines, which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company's filings with the
All product names, logos, brands and company names are trademarks or registered trademarks of their respective owners. Their use does not imply affiliation or endorsement by these companies.
INVESTOR CONTACT:
Chief Financial Officer
smoran@corbuspharma.com
Managing Director
bmackle@lifesciadvisors.com
Source:
2024 GlobeNewswire, Inc., source