Reported top-line outcomes from Phase 2 SIGNAL examine that signifies potential cognitive good thing about pepinemab in neurodegenerative illness. New Alzheimer’s examine anticipated to start enrollment in Q2
Phase 1/2 examine to judge pepinemab together with KEYTRUDA® in superior, recurrent or metastatic head and neck squamous cell carcinoma additionally anticipated to provoke enrollment in Q2
In first quarter 2021, raised $32 million in web proceeds via its pre-existing open sale market settlement
ROCHESTER, N.Y., March 16, 2021 (GLOBE NEWSWIRE) — Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology firm pioneering a differentiated strategy to treating most cancers and neurodegenerative illness via the inhibition of SEMA4D, at the moment introduced monetary outcomes for the fourth quarter and full yr ended December 31, 2020 and supplied a company replace.
“We had a productive fourth quarter, throughout which we offered topline knowledge from our SIGNAL section 2 examine in Huntington’s illness which indicated that remedy with pepinemab has a possible cognitive profit in sufferers with Huntington’s illness,” said Maurice Zauderer, Ph.D., president and chief government officer. “Looking ahead, throughout the second quarter of 2021 we anticipate initiating research of pepinemab in head and neck most cancers together with Merck’s KEYTRUDA® in addition to a brand new trial in Alzheimer’s illness, with monetary help from the Alzheimer’s Association and the Alzheimer’s Drug Discovery Foundation. Importantly, having raised $32 million within the first quarter of 2021 via our open sale market settlement with Jefferies, we imagine we’re effectively positioned to fund these trials, that are anticipated for completion in H2 2022/Q1 2023. Based on present medical knowledge, we’re hopeful that the outcomes will reveal the broad medical potential of SEMA4D inhibition and assist additional improvement of pepinemab in these vital indications.”
“With regards to our Huntington’s illness program, after finishing evaluation of the complete knowledge set, we imagine there’s a promising path ahead in mid-stage illness, and we’re at the moment engaged in potential partnering discussions to fund and execute a rigorously designed Phase 3 examine,” Dr. Zauderer concluded.
Pepinemab Clinical Updates:
- Alzheimer’s illness. Vaccinex beforehand introduced that it had been awarded a $750,000 improvement grant from the Alzheimer’s Association beneath the 2020 Part the Cloud Program, in addition to a $3 million award from the Alzheimer’s Drug Discovery Foundation. The awards have been based mostly partly on earlier findings that remedy with pepinemab prevented the attribute lack of glucose transport within the mind throughout underlying Huntington’s illness development as detected by typical FDG-PET imaging. Uptake of glucose, the principle supply of vitality within the mind, can be identified to say no with underlying illness development in Alzheimer’s illness. In specific, earlier research in AD have proven that decline in mind glucose transport correlates with cognitive decline and, extra lately, that FDG-PET is a superior indicator of cognitive efficiency in comparison with Aβ amyloid-PET in AD.
Dr. Eric Siemers, MD, previously senior medical director of the Alzheimer’s Disease Global Development Program at Eli Lilly and Company, will function Senior Medical Director of this randomized, placebo-controlled, multi-center medical examine which is anticipated to start enrolling sufferers in 2Q 2021.
- Head and Neck most cancers. In September 2020, Vaccinex introduced a medical collaboration with Merck to judge pepinemab together with Merck’s anti-PD-1 most cancers immunotherapy, KEYTRUDA® (pembrolizumab), in a Phase 2 examine for front-line remedy of superior, recurrent or metastatic head and neck squamous cell carcinoma. Multiple prior research counsel that inhibition of SEMA4D will increase immune infiltration and alters the stability of cytotoxic and immunosuppressive cells within the tumor microenvironment. As SEMA4D is very expressed in head and neck most cancers, we imagine there may be robust rationale for improvement on this indication.
The Company expects to start enrollment of as much as 65 sufferers within the second quarter of 2021. The examine is designed to evaluate whether or not mixture remedy can considerably enhance responses to KEYTRUDA® on this inhabitants. Key endpoints of the examine are anticipated to incorporate goal response, development free survival and general survival.
- Huntington’s illness. In September 2020, Vaccinex reported topline knowledge from its Phase 2, double-blind, placebo-controlled SIGNAL trial of pepinemab in sufferers with early manifest and prodromal Huntington’s illness (HD). The examine had two co-primary endpoints, a household of two cognitive assessments from the Huntington’s Disease Cognitive Assessment Battery and Clinical Global Impression of Change (CGIC).
Although the examine didn’t meet the above pre-specified co-primary endpoints, we imagine the outcomes of every of the 2 cognitive assessments in sufferers with early manifest illness demonstrated a robust development for helpful change (OTS, p=0.028 and PTAP, p=0.06, 1-sided). Given the favorable development of outcomes, an exploratory endpoint, the HD-CAB composite rating encompassing the complete set of 6 totally different cognitive assessments was additionally evaluated and is believed to point extremely vital treatment-related profit (p=0.007). Similarly, the treating physicians’ analysis of CGIC in these sufferers didn’t present a statistically vital distinction between the placebo and pepinemab-treated teams. However, given the issue of detecting modifications in CGIC on the high of the practical capability scale (TFC 12-13), a subpopulation evaluation of sufferers who have been considerably extra superior in illness development at baseline (TFC 11) indicated an improved end result (p=0.04, 1-sided), albeit in a smaller inhabitants that was not powered for statistical significance. Beneficial results of pepinemab remedy have been supported by imaging evaluation. Exploratory volumetric MRI evaluation of mind in sufferers with early manifest illness demonstrated statistically vital treatment-related discount in atrophy of the mind caudate, a key mind area in early HD development. In addition, FDG-PET evaluation of metabolic exercise indicated that remedy resulted in a statistically vital enhance in glucose transport within the majority of mind areas examined.
Overall, we imagine that the outcomes of the SIGNAL trial counsel that pepinemab might assist shield in opposition to cognitive decline throughout HD development. Vaccinex is actively exploring partnering pepinemab for a big pivotal Phase 3 HD trial in collaboration with a biopharmaceutical accomplice.
- Other Trials. Pepinemab can be being evaluated in a number of investigator-sponsored trials (ISTs) being performed by the Winship Cancer Institute of Emory University to judge pepinemab together with checkpoint inhibitors in “Window of Opportunity” research in colorectal, pancreatic, head and neck most cancers and melanoma.
Other Recent Accomplishments:
- Entered into multi-project offers with two main pharmaceutical corporations targeted on leveraging Vaccinex’s ActivMAb® antibody discovery and novel viral show platform to find medicine in opposition to advanced membrane receptors resembling GPCRs and ion channels.
- Announced that Surface Oncology will probably be exercising its choice to license the anti-CCR8 antibody found through Vaccinex’s ActivMAb® platform. The phrases of settlement with Surface Oncology supplied that Surface Oncology pay know-how entry and licensing charges along with analysis funding, and that Vaccinex will qualify for improvement milestone funds and royalties on business gross sales.
- Subsequent to the tip of the fourth quarter, the Company raised $32 million in web proceeds via its present open sale market settlement, or ATM.
Upcoming Anticipated Milestones:
- Q2 2021 – Planned initiation of a Phase 1b/2 medical trial of pepinemab together with KEYTRUDA® for the remedy of sufferers with HNSCC
- Q2 2021 – Expected initiation of Alzheimer’s illness Phase 1/2 trial
- H2 2022 – Data anticipated from open head and neck most cancers trial of mixture immunotherapy with KEYTRUDA®
- Late 2022/Q1 2023 – Data anticipated from randomized Alzheimer’s trial
Financial Results for the Three and Twelve Months Ended December 31, 2020:
Revenue. Revenue for the yr ended December 31, 2020 was $625,000 as in comparison with $523,000 for the yr ended December 31, 2019. The Company’s revenues have been generated primarily from a grant awarded beneath the Part the Cloud Program from the Alzheimer’s Association.
Research and Development Expenses. Research and improvement bills for the three months ended December 31, 2020 have been $4.2 million as in comparison with $4.4 million for the comparable interval in 2019. For the complete yr 2020, analysis and improvement bills have been $21.5 million as in comparison with $25.7 million for the complete yr 2019. Research and improvement expense decreased in comparison with the prior yr durations primarily on account of decreased spend related to the Huntington Disease trial.
General and Administrative Expenses. General and administrative bills for the three months ended December 31, 2020 have been $1.8 million as in comparison with $1.9 million for the comparable interval in 2019. For the complete yr 2020, normal and administrative bills have been $7.4 million as in comparison with $6.7 million for the complete yr 2019. The elevated expense versus the prior yr was primarily pushed by elevated D&O insurance coverage premiums.
Cash and Cash Equivalents and Marketable Securities. Cash and money equivalents and marketable securities on December 31, 2020 have been $10.6 million, as in comparison with $2.8 million as of December 31, 2019. Subsequent to the tip of the fourth quarter 2020, the Company raised $32 million in web proceeds via its pre-existing ATM.
About Vaccinex, Inc.
Vaccinex, Inc. is pioneering a differentiated strategy to treating most cancers and slowly progressive neurodegenerative illnesses via the inhibition of semaphorin 4D (SEMA4D). The Company’s lead drug candidate, pepinemab, blocks SEMA4D, a potent organic effector that stops immune infiltration into tumors and triggers continual irritation within the mind. The Company moreover intends to leverage its proprietary drug discovery platform, ActivMAb®, to create alternatives for future pipeline growth and strategic collaborations, significantly by exploiting its distinctive functionality to pick excessive worth antibodies in opposition to vital multi-pass membrane receptors together with GPCR and ion channels.
Forward Looking Statements
To the extent that statements contained on this presentation are usually not descriptions of historic info relating to Vaccinex, Inc. (“Vaccinex,” “we,” “us,” or “our”), they’re forward-looking statements reflecting administration’s present beliefs and expectations. Such statements embody, however are usually not restricted to, statements about our plans, expectations and aims with respect to the outcomes and timing of our medical trials of pepinemab in numerous indications, the use and potential advantages of pepinemab in Huntington’s and Alzheimer’s illness and different indications, and different statements recognized by phrases resembling “might,” “will,” “seems,” “count on,” “exploratory,” “deliberate,” “anticipate,” “estimate,” “intend,” “speculation,” “promising,” “potential,” “hopeful,” “advance,” and related expressions or their negatives (in addition to different phrases and expressions referencing future occasions, situations, or circumstances). Forward-looking statements contain substantial dangers and uncertainties that would trigger the result of our analysis and pre-clinical improvement packages, medical improvement packages, future outcomes, efficiency, our historical past of working losses and want to lift extra capital to proceed as a going concern, or achievements to vary considerably from these expressed or implied by the forward-looking statements. Such dangers and uncertainties embody, amongst others, uncertainties inherent within the execution, price and completion of preclinical and medical trials, uncertainties associated to regulatory approval, dangers associated to our dependence on our lead product candidate pepinemab, the impression of the COVID-19 pandemic, and different issues that would have an effect on our improvement plans or the business potential of our product candidates. Except as required by legislation, we assume no obligation to replace these forward-looking statements. For an additional dialogue of those and different elements that would trigger future outcomes to vary materially from any forward-looking assertion, see the part titled “Risk Factors” in our periodic experiences filed with the Securities and Exchange Commission (“SEC”) and the opposite dangers and uncertainties described in our Form 10-Okay dated March 9, 2020 and subsequent filings with the SEC.
LifeSci Advisors, LLC
Cait Williamson, Ph.D.
LifeSci Communications, LLC