SAN DIEGO, June 9, 2021 (GLOBE NEWSWIRE) – eFFECTOR Therapeutics, Inc., a leader in the development of selective translational regulation inhibitors (STRIs) for the treatment of cancer, announced today that it is the first patient with non-small cell lung cancer (NSCLC) was dosed in a phase 2b study with tomivosertib in combination with KEYTRUDA® (pembrolizumab). KICKSTART is a randomized, double-blind, placebo-controlled clinical trial evaluating the efficacy and safety of tomivosertib in combination with pembrolizumab, a US Food and Drug Administration (FDA) -approved PD-1 inhibitor, as a combination therapy of first choice or as Extension of first-line therapy with the first radiographic progression of the disease with pembrolizumab alone. Patients enrolled in this study demonstrated> 50% PD-L1 biomarker expression as determined by an FDA-approved diagnostic test. These NSCLC patients generally respond best to immunotherapy and for whom treatment with checkpoint inhibitors as monotherapy is the standard of treatment.
“In our Phase 2a study with tomivosertib in combination with checkpoint inhibitors, we observed that the addition of tomivosertib after the disease had progressed was correlated with an identified change in tumor progression and long-term treatment benefit, which indicates the potential of our product candidate to reverse the Resistance to checkpoint inhibitors. In addition, a retrospective analysis of the Phase 2a data showed that PD-L1 positivity correlated with duration of benefit, which supports the use of PD-L1> 50% as a biomarker for patient selection at KICKSTART, ”said Steve Worland , Ph.D., President and CEO of eFFECTOR. “Based on these encouraging results, which have greatly expanded patient benefit from immunotherapy, we are introducing KICKSTART to focus on both frontline and frontline extension settings in combination with pembrolizumab. We developed tomivosertib to downregulate several immune-suppressing factors and to reprogram T cells to improve the immune response and fight tumors, and ultimately hope to provide a new and improved treatment option for cancer patients. “
Around 120 participants in two cohorts are to be included in the KICKSTART study. Cohort One is a first-line extension cohort that investigates the efficacy and safety of adding tomivosertib to the regimen in combination with pembrolizumab in patients who initially benefited from therapy and then developed radiographic progression on treatment with pembrolizumab alone. Cohort two will evaluate the safety and efficacy of tomivosertib in combination with pembrolizumab at the start of treatment as a first-line therapy. Both cohorts in the study will have a control arm with placebo in combination with pembrolizumab. The primary endpoint of the study is progression-free survival (PFS) in each of the frontline extension and frontline settings. In addition, PFS in the combined population of both cohorts, overall survival (OS), and overall response rate (ORR) are assessed as secondary endpoints. For more information on the study, visit www.clinicaltrials.gov under the registration number NCT04622007.
About tomivosertib (eFT508)
Tomivosertib is eFFECTOR’s 100%, highly selective translational regulation inhibitor that targets MNK1 and MNK2 (MNK1 / 2). The oral, small molecule drug candidate has been shown to improve T cell killing of tumor cells, delay T cell exhaustion / dysfunction, and improve T cell central storage pool, in part by downregulating several checkpoint proteins, including PD 1, PD-L1, TIM-3 and LAG-3. Tomivosertib is being evaluated in KICKSTART, eFFECTOR’s randomized, double-blind, placebo-controlled phase 2b study in NSCLC in combination with pembrolizumab. The KICKSTART study builds on results from an earlier study of tomivosertib as an extension of checkpoint inhibitor treatment in patients who have inadequate response to an FDA-approved checkpoint inhibitor alone.
For more information on ongoing clinical trials with tomivosertib, please visit www.clinicaltrials.gov.
eFFECTOR is a next generation oncology company developing a new class of targeted therapies called STRIs. Tomivosertib, eFFECTOR’s MNK1 / 2 inhibitor, is being investigated in KICKSTART, a randomized, double-blind, placebo-controlled phase 2b study in NSCLC in combination with pembrolizumab. Zotatifin, eFFECTOR’s inhibitor of eIF4A, is in a Phase 1/2 dose escalation study, with the Phase 2a expansion cohorts expected to open in the second half of 2021. eFFECTOR partners with Pfizer to develop inhibitors of eIF4E.
Additional information and where to find it
On May 26, 2021, eFFECTOR closed with Locust Walk Acquisition Corp. (NASDAQ: LWAC), a purpose acquisition company, and Locust Walk Merger Sub, Inc., entered into a definitive agreement and plan (the “Merger Agreement”). a wholly owned subsidiary of LWAC.
In connection with the Merger Agreement, LWAC intends to file a registration statement with the SEC on Form S-4, which will contain a document that will serve as the prospectus and proxy statement of LWAC, which will be referred to as the proxy statement / prospectus. A proxy declaration / prospectus will be sent to all LWAC shareholders. LWAC will also file other documents with the SEC relating to the Merger Agreement and the proposed transactions (the “Transactions”). LWAC investors and securityholders are urged to read the Registration Statement, Proxy Statement / Prospectus and any other relevant documents that will be filed with the SEC in connection with the Transactions or will be filed as they become available prior to voting, as it contains important information about the transactions, including the terms of the transactions, the parties involved and the risks associated with the transactions.
Investors and securityholders can obtain free copies of the registration statement, proxy statement / prospectus, and all other relevant documents filed or filed by LWAC with the SEC through the SEC-maintained website at www.sec.gov. receive . Alternatively, if available, these documents can be called toll-free by the LWAC upon written request to Locust Walk Acquisition Corp., c / o eFFECTOR, 11120 Roselle Street, Suite A, San Diego, CA 92121, z (858) 925-8215.
Participant in the tender
LWAC and eFFECTOR and their respective directors and officers may be considered participants in the solicitation of proxies from LWAC shareholders in connection with the Transactions. A list of the names of the directors and officers of LWAC and information regarding their interest in the Transactions will be included in the Proxy Statement / Prospectus, if available. You can obtain free copies of these documents as described in the previous paragraph.
No Offer or request
This announcement does not constitute an offer to sell or a solicitation of an offer to buy any securities, or a solicitation of a vote or approval, nor will any sale of securities be made in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such other jurisdiction.
This press release contains certain forward-looking statements within the meaning of the federal securities laws. All statements contained in this press release that are not historical facts, including statements about the design and expectations of the KICKSTART clinical trial and the timing of the Zotatifin Phase 2a expansion cohorts, the potential of eFFECTOR’s product candidates to benefit patients, and the proposed business combination of eFFECTOR and LWAC, are forward-looking statements. These forward-looking statements are subject to a number of risks, uncertainties, and assumptions including, but not limited to: potential delays in initiating, enrolling, and completing clinical trials; Interruption of the operations of eFFECTOR due to the COVID-19 pandemic, including the delay or other interruption of clinical trials, manufacturing and the supply chain; eFFECTOR’s dependence on third parties in connection with product manufacturing and clinical trials; the results of preclinical studies and early clinical studies are not necessarily predictions of future results; the success of eFFECTOR’s clinical trials and preclinical studies for its product candidates; unexpected side effects or inadequate effectiveness of the product candidates from eFFECTOR, which could limit their development, regulatory approval and / or commercialization or lead to recalls or product liability claims; Risks associated with the proposed business combination, including the risk that the transaction may not be completed on time or at all; and the risks associated with eFFECTOR’s business and business combination set out in the appendix to the investor presentation submitted as Appendix 99.3 to the current report on Form 8-K filed by LWAC on May 27, 2021, are exposed to risks and uncertainties by some of which cannot be predicted or quantified, and some of which are beyond the control of LWAC and eFFECTOR, you should not rely on these forward-looking statements as predictions of future events. The foregoing list of factors is non-exclusive and you should carefully consider the foregoing factors and the other risks and uncertainties described in the “Risk Factors” section of the LWAC Annual Report on Form 10-K for the year filed December 31, 2020 The SEC on March 29, 2021 consider the registration statement on Form S-4 discussed above, and other documents filed by LWAC with the SEC from time to time. These filings identify and address other important risks and uncertainties that could cause actual events and results to differ materially from those contained in the forward-looking statements, including the risk that the terms of the merger agreement will not be met. Forward-looking statements only apply at the time of their publication. Readers are cautioned not to place undue reliance on forward-looking statements except as required by law. LWAC and eFFECTOR assume no obligation and do not intend to update or revise these forward-looking statements as a result of new information, future events or for any other reason. Neither LWAC nor eFFECTOR make any representation that either LWAC or eFFECTOR or the combined company will meet their expectations.
Westwicke, an ICR company
Heidi Chokeir, Ph.D.