Vaccinex Announces the KEYNOTE B84 Phase Ib Combined Study of Keytruda® and Pepinemab in Patients … | Nation / World


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The phase 1b segment assessed the safety and tolerability of the combination

Paving the way for expansion and acceleration of enrollments in the Phase 2 segment of the study

ROCHESTER, NY, January 04, 2022 (GLOBE NEWSWIRE) – Vaccinex, Inc. (Nasdaq: VCNX, Vaccinex, the Company), a clinical-stage biotechnology company pioneering a differentiated approach to the treatment of cancer and neurodegenerative diseases by inhibition of SEMA4D, today announced positive intermediate safety data in the phase Ib “safety run-in” segment of the KEYNOTE B84 combination study from Keytruda® (Merck, NYSE: MRK, known as MSD name outside the United States and Canada) and pepinemab (Vaccinex) in patients with advanced, recurrent or metastatic squamous cell carcinoma of the head and neck (R / M HNSCC). The Phase 2 segment of the study is now expected to begin recruitment and is expected to accelerate patient accumulation.

The phase Ib “safety run-in” segment of the trial (NCT04815720) aimed to assess the safety and tolerability of pipinemab (20 mg / kg) in combination with Keytruda (anti-PD-1 treatment from Merck, pembrolizumab, 200 mg Q3W / every three weeks) to determine a recommended phase 2 dose (RP2D) for the dose extension phase of the study enrolling patients with R / M HNSCC. The interim safety analysis has been completed by the Data Safety Monitoring Board and signals the start of the Phase 2 expansion segment.

“We are very pleased that interim safety data for KEYNOTE B84 has indicated that the combination of pipinemab and Keytruda appears to be well tolerated,” said Maurice Zauderer, Ph.D., President and CEO. “Vaccinex hopes that the combination of pipinemab and anti-PD-1 therapy for the treatment of advanced R / M HSNCC may improve the benefits for patients. There is a strong rationale for the development of HNSCC as these tumors express very high levels of SEMA4D and we believe that preclinical data has indicated that this contributes to the pathology of the disease. We look forward to making progress in recruiting the Phase 2 segment of the trial. “

About the KEYNOTE B84 study:

The KEYNOTE B84 combined study of Keytruda® (anti-PD-1 treatment by Merck, pembrolizumab) and pepinemab (SEMA4D inhibitory monoclonal antibody by Vaccinex) is underway for the first-line treatment of patients with squamous cell carcinoma. advanced, recurrent or metastatic head and neck (R / M HNSCC). The study has two parts:

  • Segment 1: The final segment of Phase 1b “Preparing for Safety” assessed the safety and tolerability of the combination and defined a Phase 2 Recommended Dose (RP2D) in 3 to 6 subjects. After recruiting the first three subjects, the Data Safety Monitoring Board determined that the RP2D dose of pipinemab (20 mg / kg) and Keytruda (200 mg Q3W) was safe and well tolerated.
  • Segment 2: The “expansion” segment of Phase 2 is now expected to begin recruiting up to 62 subjects at 19 trial sites in the United States. The main objective of this segment is to assess the objective response rate (ORR) by response endpoint in solid tumors (RECIST) 1.1 of the combination in immunotherapy-naïve patients with R / M Advanced HNSCC.

The secondary objectives of the study are to assess progression-free survival (PFS) according to RECIST 1.1, overall survival (OS) and duration of response (DOR).

The study is also expected to assess a number of exploratory measures including pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity of the combination and a number of biomarkers and genomic tumor signatures.

Additional information on the study is available at the following address: KEYNOTE B84 Link clinictrials.gov. Vaccinex anticipates interim results for the primary efficacy endpoint, ORR, in the second half of 2022.

Vaccinex will sponsor the study which is being carried out in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc.

Vaccinex owns the global commercial and development rights for pipinemab.

Keytruda® is a registered trademark of Merck.

About Pépinémab

Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates chronic inflammation in the tumor microenvironment. Preclinical / clinical data show that pepinemab promotes infiltration / activation of dendritic cells / CD8 + T cells and reverses immunosuppression within the tumor.

The results of a phase 1b / 2 study to evaluate the combination of pipinemab with a checkpoint inhibitor, BAVENCIO®, (with Merck KGaA) were presented by Dr. Shafique, MD, assistant professor of thoracic oncology , Moffitt Cancer Center, in an oral poster and discussion at ASCO 2020 and was featured in the July 2021 publication from Clinical Cancer Research. Vaccinex reported that the results of the Phase 1b / 2 CLASSICAL-Lung trial showed an overall response rate (ORR) of 25 to 33% for patients with difficult-to-treat weak / negative PD-L1 tumors treated with association, while ORR has been reported for similar patients. treated with anti-PD-L1 monotherapy is approximately 10 to 15%. The study report also indicated that pipinemab did not increase the immune toxicities of BAVENCIO, but increased the penetration of cytotoxic T cells. The publication is available electronically at: Clinical cancer research.

About Vaccinex, Inc.

Vaccinex, Inc. is pioneering a differentiated approach to the treatment of cancer and slowly progressing neurodegenerative diseases through the inhibition of 4D semaphorin (SEMA4D). The Company’s lead drug candidate, pipinemab, blocks SEMA4D, a potent biological effector that it claims prevents immune infiltration into tumors and triggers chronic inflammation in the brain. The Company also intends to leverage its proprietary drug discovery platform, ActivMAb®, to create opportunities for future pipeline expansion and strategic collaborations, in particular by leveraging its unique ability to select antibodies. of high value against important multi-pass membrane receptors including GPCR and ion channels.

Forward-looking statements

To the extent that the statements contained in this presentation are not descriptions of historical fact concerning Vaccinex, Inc. (“Vaccinex”, “we”, “us” or “our”), they are forward-looking statements reflecting the current management beliefs and expectations. Such statements include, but are not limited to, statements about our plans, expectations and objectives regarding the results and timing of our clinical trials of pipinemab in various indications, the use and potential benefits of pipinemab in Huntington’s disease. and Alzheimer’s and other indications, and other statements identified by words such as “may”, “will”, “will appear”, “expect”, “hope”, “planned”, “anticipate” “,” Estimate “,” intend “,” hypothesis “,” “potential”, “suggest”, “advance” and similar expressions or their negative aspects (as well as other words and expressions referring to future events, conditions or circumstances). Forward-looking statements involve substantial risks and uncertainties that could cause the results of our preclinical research and development programs, clinical development programs, results to fu trends, performances or achievements differ materially from those expressed or implied by forward-looking statements. These risks and uncertainties include, among others, the uncertainties inherent in the execution, cost and completion of preclinical and clinical trials, uncertainties related to regulatory approval, risks related to our reliance on our flagship product candidate, pepinemab, the impact of the COVID-19 pandemic. , and other matters which could affect our development plans or the commercial potential of our product candidates. Except as required by law, we assume no obligation to update these forward-looking statements. For a further discussion of these and other factors that could cause future results to differ materially from any forward-looking statement, see the section entitled “Risk Factors” in our periodic reports filed with the Securities and Exchange Commission ( “SEC”) and the other risks and uncertainties described in the Company’s most recent year-end annual report on Form 10-K and subsequent filings with the SEC.

Investor contact

John mullaly

LifeSci Advisors, LLC

617-429-3548

[email protected]

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