On March 31, 2022 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, and GenFleet Therapeutics (Shanghai), Inc. ("GenFleet"), a clinical-stage biotechnology company developing cutting-edge therapeutics in oncology and immunology, reported that the companies have entered into an exclusive license agreement that grants rights to SELLAS for the development and commercialization of GFH009, a highly selective small molecule cyclin-dependent kinase 9 ("CDK9") inhibitor, across all therapeutic and diagnostic uses worldwide outside of Greater China (mainland China, Hong Kong, Macau and Taiwan) (Press release, Sellas Life Sciences, MAR 31, 2022, View Source [SID1234611288]).

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GFH009, currently in Phase 1 clinical trials in the United States and China, is a highly selective next-generation CDK9 inhibitor. CDK9 activity has been shown to negatively correlate with overall survival in a number of cancer types, including hematologic cancers, such as acute myeloid leukemia ("AML") and lymphomas, as well as solid cancers, such as osteosarcoma, pediatric soft tissue sarcomas, and melanoma, and endometrial, lung, prostate, breast and ovarian cancer. As demonstrated in pre-clinical and clinical data, to date, GFH009’s high selectivity has the potential to reduce toxicity as compared to older CDK9 inhibitors and other next-generation CDK9 inhibitors currently in clinical development. The Company believes, based on the initial pharmacokinetic data of the ongoing Phase 1 dose-escalating clinical trial, that the administration of GFH009 leads to lower toxicity and more potent efficacy due to its unique mechanism of action. Thus far in the Phase 1 clinical trial, which is planned to enroll approximately 80 patients, including an expansion part 2 of the study, and which is at the fourth of six doses, stable disease has been observed in three patients and, in one AML patient, a bone marrow blast decrease from 40% to 20% was observed at 9 mg, which is the third of six dose levels.

"SELLAS’ license agreement with GenFleet marks a pivotal milestone for the Company as we expand and diversify our clinical pipeline with GFH009 and progress it toward commercialization," said Angelos Stergiou, M.D., Sc.D. h.c., President and CEO of SELLAS. "There is significant interest in CDK9 inhibitors in the industry, and we are extremely excited to have the opportunity to develop GFH009. Not only has GenFleet advanced the molecule to clinical trials, but the asset also has attributes that can potentially make it best-in-class. Working with GenFleet brings together two companies with complementary skill sets: GenFleet is a leader in cutting-edge drug discovery, and SELLAS’ focus and expertise is in clinical development and commercialization of oncology drugs for a range of indications, particularly hematological malignancies. In early 2023, we plan to initiate a Phase 2 clinical trial with GFH009 in combination with venetoclax in AML, a cancer we know quite well as it is the indication of our registrational study for galinpepimut-S ("GPS"), our lead asset. We also plan to initiate a Phase 1/2 basket study in pediatric soft tissue sarcomas in late 2022 or early 2023 where there is a pressing unmet medical need and where GFH009 could potentially contribute to extending the lives of the afflicted children."

Dr. Stergiou continued, "SELLAS and GenFleet both strive on a daily basis to meet the unmet medical needs of patients all over the world who are suffering from cancer, and this license agreement reflects our joint commitment to developing novel, more tolerable treatment options for these patients and their families/caregivers. Additionally, we believe GenFleet’s track record of success suggests that GFH009 has the potential to bring to SELLAS the ability to address many indications in a cost- and time-effective manner."

"SELLAS’ excellence in execution, as well as its expertise and capabilities in clinical development, especially in AML and other hematological and solid cancers, will help GenFleet to maximize the value of this asset," concluded Qiang Lu, PhD, Chairman of GenFleet Therapeutics. "We are pleased that GFH009, one of the leading assets in our first-in-class portfolio, will now be developed and commercialized on a worldwide basis, with numerous trials planned in 2023, thus potentially benefiting patients not only in China but also those throughout the world."

Following completion of the Phase 1 clinical trial and achievement of a maximum tolerated dose, SELLAS plans to commence a Phase 2 clinical trial of GFH009 in combination with venetoclax and azacitidine in AML patients with active disease. The current standard of care for the vast majority of AML patients, including older patients, is venetoclax in combination with a hypomethylating agent such as azacitidine. GFH009 has shown in preclinical models a strong synergy with venetoclax. The Company believes that GFH009 has the potential to improve response to venetoclax or possibly convert resistance to venetoclax into a response and that the program will not only be a synergistic, but also an integral complement to the Company’s program for GPS in AML patients. The Company also plans to commence a Phase 1/2 basket clinical trial of monotherapy GFH009 in pediatric soft tissue sarcomas, including Ewing’s sarcoma and rhabdomyosarcoma, in late 2022 or early 2023, which it expects to be completed by the end of 2023. Positive results from this program could ultimately provide the basis for a rare pediatric disease priority voucher. GenFleet plans to commence several Phase 2 studies in China for various hematological malignancies.

Under the financial terms of the agreement, SELLAS will pay to GenFleet (i) an initial payment of $10 million as an upfront license and technology transfer fee, a portion of which is payable within 30 days of the execution of the license agreement with the remainder due upon the completion of the technology transfer, (ii) development and regulatory milestone payments for up to three indications totaling up to $48 million in the aggregate, and (iii) milestone payments totaling up to $92 million in the aggregate upon the achievement of certain net sales thresholds of GFH009 in the United States and rest of the world other than Greater China in a given calendar year. SELLAS will also pay GenFleet tiered royalties based on a percentage of annual net sales of GFH009 ranging from the low to high single digits.

SELLAS plans to host a R&D Day for analysts, investors and media in the second quarter of 2022. More information will be provided soon.

On March 31, 2022 Portage Biotech Inc. (NASDAQ: PRTG) ("Portage" or the "Company"), a clinical-stage immuno-oncology company developing therapies to improve patient lives and increase survival by avoiding and overcoming cancer treatment resistance, reported its development goals for the remainder of 2022 (Press release, Portage Biotech, MAR 31, 2022, View Source [SID1234611304]).

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"We are pleased to report that as expected, Portage’s invariant natural killer T cell (iNKT) agonists, PORT-2 and PORT-3, were well tolerated in initial clinical studies," said Dr. Ian Walters, chief executive officer of Portage. "We believe that robust randomized trial design approaches for both PORT-2 and PORT-3 will allow us to rapidly evaluate efficacy signals in Phase 2. With our unique drug development strategy, experienced management team, burgeoning collaborations with academic and pharma partners and financial resources secured in 2021, Portage is well prepared and funded to leverage our product engine to deliver on important clinical milestones through the end of 2023."

Q2-Q4 2022 Development Focus

The Company remains focused on advancing its pipeline of novel immuno-oncology therapeutics designed to prevent and overcome cancer treatment resistance. Clinical trials were initiated in 2021 for both of Portage’s lead invariant natural killer T cell (iNKT) agonist programs, PORT-2 (a liposomal formulation iNKT agonist) and PORT-3 (a nanoparticle coformulation of Portage’s iNKT agonist packaged with an antigen to establish immune priming and boosting).

Preliminary Phase 1 data received to date suggests PORT-2 was well tolerated when administered as a monotherapy, with no related adverse events. This has enabled a plan to accelerate opening of the combination safety cohort with Keytruda, in parallel with the ongoing high dose monotherapy cohort. Detailed data will be submitted to congresses later this year.

With the enhanced management team, efficient organization, and financial resources obtained in 2021, Portage has decided to expand the PORT-2 study beyond the UK to accelerate clinical studies while addressing COVID-19 headwinds. The Company has hired a global clinical research organization (CRO-Parexel) and is preparing for regulatory submissions in other countries. By expanding the regions and sites contributing to the study, Portage will be enabled to accelerate enrollment in the planned Phase 2 portion of this trial.

Preliminary safety data for repeat dosing of PORT-3, a nanoparticle co-formulation of PORT-2 and NY-ESO-1 immunogenic peptides developed for the treatment of NY-ESO-1 positive solid tumors, is also favorable. The Company expects to submit data to a scientific congress for PORT-3 later this year.

New Collaborations with Academic Partners to Enhance Strategic Goals

As part of its broader research and development strategy, Portage is partnering with experts and companies that could bring additional expertise and insights to help advance the science and open new avenues for development. New collaborations include a partnership with Dr. Francis Mussai and Dr. Carmela De Santo at University of Birmingham on iNKTs. Dr. Mussai and colleagues will be analyzing samples for immune markers and helping Portage to understand both the pro-inflammatory markers induced by iNKT agonists as well as the impact on suppressive cells that can impair immune based attacks.

Portage is also initiating a second collaboration with Dr. Robert Negrin and his team at Stanford University to evaluate the use of PORT-2 with iNKT cell therapies in animals. This work will evaluate if an agonist co-administered with expanded or transformed iNKT cells can further activate the transplanted and endogenous cells inside the patient. The Stanford collaboration will also study the impact iNKT agonists have on driving an adaptive immune response and correcting the suppressive tumor microenvironment.

Clinical Development Goals for the Remainder of 2022

Generate safety and efficacy data on all products currently in clinical trials
PORT-2: iNKT agonist to treat melanoma and non-small cell lung cancer (NSCLC) (Phase 1/2); initial efficacy data anticipated by the end of 2022
PORT-3: iNKT agonist co formulated in a nanoparticle with NY-ESO-1 peptide vaccine in tumors that express NY-ESO-1 (Phase 1/2); preliminary efficacy data in patients expected year end, going into 2023
PORT-1: intratumoral amphiphilic formulation, developed in collaboration with our affiliate Intensity, being evaluated as a monotherapy and in combination with Keytruda and Yervoy to treat multiple solid tumors (Phase 2); multiple readouts expected in 2H 2022
Prepare additional compounds to enter clinical studies
PORT-5: Systemically delivered STING agent developed in collaboration with our affiliate Stimunity, is progressing towards the clinic. Preclinical data has been recently published and was selected for a late breaker presentation at the 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting. This compound is a next generation, systemically delivered, targeted STING approach differentiated from others in this area.
Continue to explore collaboration opportunities for all of our assets and evaluate new opportunities to expand immuno-oncology product portfolio
"We are grateful to the patients and families who have enrolled in our studies and are helping us to better understand cancer and ways to improve care. While the COVID pandemic has certainly created challenges for everyone, Portage is optimistic moving in to 2022 that we can resume more normal activities in our day-to-day business. The Company’s focus for this year is on data generation and ways to accelerate the studies that were initially managed by third parties. With this lean structure, our current financial runway is sufficient to support progress through the end of 2023 including the release of many key data points from our ongoing trials," concluded Dr. Walters.

On March 31, 2022 Gnubiotics Sciences SA, a biotech company pioneering immunomodulatory glycopeptides reported a poster presentation on the use of Glycopeptides to promote anti-cancer immune response against solid tumors at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, scheduled for April 8-13, 2022 in New Orleans, Louisiana (USA) (Press release, Gnubiotics Sciences, MAR 31, 2022, View Source [SID1234611322]).

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"Our poster presentation at the AACR (Free AACR Whitepaper) will showcase the immunomodulatory and therapeutic potential of our proprietary glycopeptide assets to boost directed anti-tumor immune responses in anti-PD-1 resistant solid tumors. Our innovative Glycopeptides with Tumor and Antigen Associated Delivery (GLAAD) technology has been shown to have the power, through molecular mimicry, to reduce tumor size, either in combination with existing anti-PD-1 treatment or as a monotherapy. The pre-clinical study carried out in collaboration with the University of Zurich indicates that GLAAD treatment may be a safe and effective strategy to potentiate immune checkpoint inhibitor (ICI) therapies in a resistant setting. We expect our GLAAD approach to have a broader utility in immuno-oncology treatments, for example in enabling the efficacy of CAR-T therapies against solid tumors." stated Yemi Adesokan, Ph.D., Gnubiotics` Chief Executive Officer.

The authors on the poster are: Marianne R. Spalinger, Romain Wyss, Sara Vidal, Yong Miao, Michael Scharl, Yemi Adesokan.

The Poster, abstract number 5600, will be made available for browsing on April 8, the first day of the AACR (Free AACR Whitepaper) Annual Meeting 2022 and will remain available for viewing through July 13. Viewers will have the possibility to e-mail questions

On March 31, 2022 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in cell and gene therapy, reported a business and strategy update and reported 2021 financial results (Press release, Abeona Therapeutics, MAR 31, 2022, View Source [SID1234611234]).

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"We are committed to developing novel cell and gene therapies for patients with rare diseases with no approved treatment options," said Vish Seshadri, Ph.D., Chief Executive Officer of Abeona. "We are focused on EB-101 and, having recently achieved target enrollment in our pivotal Phase 3 VIITAL study, have increased confidence that we will share topline results in the third quarter of 2022. We also expect animal proof-of-concept data from our preclinical eye programs beginning in the second half of 2022 that could support pre-IND meetings with the FDA. We believe the strategic steps announced today reflect the operating discipline needed to extend our cash runway beyond these near-term catalysts."

Strategy and Business Update

●Following a comprehensive portfolio review, Abeona announced today that it is focusing research and development (R&D) resources on the topline data readout for its EB-101 pivotal Phase 3 VIITAL study while the Company actively pursues a potential commercialization partner for EB-101.
●Target enrollment was achieved in Abeona’s EB-101 pivotal Phase 3 VIITAL study for recessive dystrophic epidermolysis bullosa (RDEB). The Company anticipates topline results for the co-primary endpoints related to wound healing and pain reduction measured at 24 weeks post treatment in the third quarter of 2022. Abeona received positive feedback from the U.S. Food and Drug Administration (FDA) related to a Type B meeting on the proposed Chemistry, Manufacturing and Controls (CMC) requirements of the EB-101 development program, gaining alignment on the characterization and validation plans that could support a potential Biologics License Application (BLA) for EB-101 in RDEB.

●In connection with its shift in priorities, the Company has intensified its pursuit of a strategic partnership to take over development activities for ABO-102, and has ceased build-out of additional AAV manufacturing space. As part of the FDA’s feedback on the Transpher A Statistical Analysis Plan (SAP) in January 2022, the agency recommended that all participants be followed to an age of at least 60 months, which would shift timing of the neurocognitive outcomes data readout to late-2024/early-2025, as compared to the Company’s prior projection of the second quarter of 2023.
●As part of the Company’s portfolio prioritization, Abeona will discontinue development of ABO-101 for MPS IIIB.
●Abeona plans to continue development of AAV-based gene therapies designed to treat ophthalmic and other diseases and next-generation AAV-based gene therapies using the novel AIM capsid platform and internal AAV vector research programs. Abeona will present results from testing of novel AAV capsids in non-human primates at the Association for Research in Vision and Ophthalmology (ARVO) 2022 Annual Meeting being held on May 1-4, 2022 in Denver, CO. The preclinical data could support pre-IND meetings with the FDA for Abeona’s undisclosed eye gene therapy indications. The Company previously reported preclinical data showing the potential for AIM AAV vectors to efficiently target the photoreceptor and retinal epithelium cell layers after intravitreal injection, creating the potential for new pipeline candidates that can address multiple ophthalmic disorders.
●The strategic changes will reduce the Company’s operating expenses and extend the estimated runway of current cash resources to mid-2023.
●In December 2021, Abeona raised approximately $17.5 million in aggregate gross proceeds, before underwriting discounts and commissions and other offering expenses, from an underwritten public offering of common stock.
●Joseph Vazzano was appointed as Chief Financial Officer (CFO) at Abeona, and will serve as the Company’s principal financial officer and principal accounting officer effective March 31, 2022. Mr. Vazzano previously served as CFO of Avenue Therapeutics, Inc. (Nasdaq: ATXI), where he secured multiple equity financings for Avenue and served in a leadership role for signing a complex, two-stage acquisition of the company with future contingent value rights.

Full Year 2021 Financial Results

Cash, cash equivalents, restricted cash and short-term investments totaled $50.9 million as of December 31, 2021, compared to $96.0 million as of December 31, 2020. Net cash used in operating activities was $65.7 million for the full year of 2021, including a $20 million payment in November 2021 in accordance with a settlement agreement with REGENXBIO. Net cash used in operating activities was $35.0 million for the full year of 2020.

License and other revenues for the full year of 2021 were $3.0 million, compared to $10.0 million in 2020. The revenue in 2021 resulted from a clinical milestone achieved in December 2021 under a sublicense agreement with Taysha Gene Therapies for ABO-202 for CLN1 disease.

R&D expenses were $34.3 million for the full year of 2021, compared to $30.1 million in 2020. General and administrative (G&A) expenses were $22.8 million for the full year of 2021, compared to $23.8 million in 2020.

Net loss was $84.9 million for the full year of 2021, or a $0.86 basic and diluted loss per common share as compared to a net loss of $84.2 million, or a $0.91 basic and diluted loss per common share, in 2020. The net loss in 2021 included a non-cash goodwill impairment charge of $32.5 million. The impairment charge has no impact on the Company’s cash position, cash flow from operating activities, and does not have any impact on future operations.

Conference Call Details

Abeona Therapeutics will host a conference call and webcast today, Thursday, March 31, 2022 at 8:30 a.m. ET, to discuss its full year 2021 financial results and business update. To access the call, dial 877-545-0320 (U.S. toll-free) or 973-528-0002 (international) and Entry Code: 851784 five minutes prior to the start of the call. A live, listen-only webcast and archived replay of the call can be accessed on the Investors & Media section of Abeona’s website at www.abeonatherapeutics.com. The archived webcast replay will be available for 30 days following the call.

On March 31, 2022 Vaccinex, Inc. (Nasdaq: VCNX), a clinical-stage biotechnology company pioneering a differentiated approach to treating cancer and neurodegenerative disease through the inhibition of SEMA4D, reported financial results for the year ended December 31, 2021 and provided a corporate update on key events since the start of 2021 (Press release, Vaccinex, MAR 31, 2022, View Source [SID1234611268]).

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"I am pleased to report that the last 15 months have been extremely productive for Vaccinex. We are advancing the development of pepinemab for oncology and neurodegenerative disease and have made good progress in each of the clinical programs in these diseases. These programs build on a comprehensive body of prior preclinical and clinical studies that provide a strong foundation of understanding of the mechanism of action of this novel immunomodulator," said Maurice Zauderer, Ph.D., President and Chief Executive Officer of Vaccinex.

Dr. Zauderer continued, "In the open label, Phase 1b/2 KEYNOTE-B84 trial of pepinemab in combination with KEYTRUDA (pembrolizumab) as first-line treatment for recurrent or metastatic head and neck cancer, we observed two complete responses (CRs) in the first three patients enrolled. We will review details of those responses and promising Phase 1b safety results that opened enrollment into the Phase 2 expansion of this study at the American Society for Cancer Research (AACR 2022) on Monday, April 11, 2022."

"In addition, phase 1 has been completed and enrollment is underway in Phase 2a expansion of the SIGNAL-AD trial in early Alzheimer’s Disease. Looking ahead to 2022 and early 2023, we expect to complete enrollment in the KEYNOTE-B84 and SIGNAL-AD trials. Data from these studies will help to guide the regulatory and product development path for the pepinemab programs. We look forward to continue to update the clinical community and investors on our progress at other medical conferences in 2022."

Pepinemab Clinical Updates:

Oncology: Head and Neck Cancer

Enrollment is underway in the Phase 1b/2 clinical trial evaluating pepinemab in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for first-line treatment in recurrent or metastatic head and neck cancer.

Multiple prior studies suggest that inhibition of SEMA4D increases immune infiltration and alters the balance of cytotoxic and immunosuppressive cells in the tumor microenvironment. As SEMA4D is highly expressed and has been shown to promotes immunosuppression in head and neck cancer, there is strong rationale for development in this indication.

In January 2022, Vaccinex reported that, based on data from the phase 1b segment, the Data Safety Monitoring Board approved the recommended phase 2 dose and initiation of enrollment into the Phase 2 expansion segment of the trial. Importantly, two complete responses were observed among the three patients enrolled in phase 1b.

Vaccinex expects to report further data from this study (Abstract CT-111) at the AACR (Free AACR Whitepaper) 2022 on Monday, April 11, 2022 in the Phase II Clinical Trials session.

The KEYNOTE-B84 study is expected to enroll up to 65 subjects across 18 U.S. trial sites and will assess whether immunotherapy with pepinemab in combination with pembrolizumab can improve responses in the front-line setting. The primary outcome of the study is objective response, and additional outcomes include progression free survival and overall survival.

Vaccinex anticipates that study enrollment will conclude in 2023. The Company expects to continue to provide additional updates from this open label trial at medical conferences in 2022 and results for the primary outcome in 2023.

Other Oncology Trials. Pepinemab is also being evaluated in multiple investigator-sponsored trials (ISTs) in pancreatic and breast cancer and in "window of opportunity" studies, including head and neck cancer and melanoma to evaluate pepinemab in several combination treatments.

Neurodegenerative Disease:

Alzheimer’s Disease. Enrollment continues in the Phase 1/2a SIGNAL-AD trial of pepinemab as a single agent in early Alzheimer’s disease. This trial is being funded in part by the Alzheimer’s Drug Discovery Foundation and by the Alzheimer’s Association under the 2020 Part the Cloud Program.

The randomized, double-blind, placebo-controlled, multi-center safety and biomarker study of pepinemab in early AD is planned to enroll 40 subjects across 15 U.S. trial sites. Vaccinex anticipates topline data from this study in 2023.

Huntington’s disease. The Phase 2 double-blind, placebo-controlled SIGNAL trial of pepinemab in patients with early Huntington’s disease (HD) has been completed, and Vaccinex believes the program is Phase-3 ready.

While the Phase 2 study did not meet the prespecified primary endpoints, we believe that multiple exploratory and post-hoc analyses support the potential cognitive benefit of treatment with pepinemab in early manifest HD patients, particularly those with evidence of mild cognitive or functional deficits at baseline including:

Highly significant improvement (p=0.007) in the Huntington’s Disease Cognitive Assessment Battery (HD-CAB) Composite score, a measure comprised of 6 different cognitive assessments that has also been employed in other HD trials.
Significant benefit in reducing apathy severity (p=0.017, 1-sided), a problem behavior that has previously been correlated with cognition in both HD and AD.
Reduced atrophy (p=0.017) in caudate region of striatum, a brain region known to degenerate early in HD progression, along with a striking increase in brain metabolic activity as measured by FDG-PET in most brain regions. Decline in FDG-PET signal has been reported to correlate with cognitive decline and clinical progression in several studies of AD.
The Company continues to actively explore advancing pepinemab into a Phase 3 HD trial in collaboration with biopharmaceutical partners.

Upcoming Anticipated Milestones:

Oncology:

Phase 1b/2 Keynote B84 Trial: Open label head and neck cancer trial of pepinemab in combination with KEYTRUDA/pembrolizumab. Multiple interim data read-outs expected in 2022. Enrollment is expected to be completed and primary outcome data presented in 2023.
AACR Presentation: Monday, April 11 in the Phase II Clinical Trials 1 between 9:00 a.m. and 12:30 p.m. CST.
Neurodegenerative Disease:

Phase 1/2a Alzheimer’s Disease Trial: Topline data are expected in 2023.
ActivMAb Updates:

As previously announced, the Company has entered into several collaborations with pharmaceutical and biotechnology companies employing the unique capabilities of our ActivMAb antibody discovery platform to address difficult to drug multi-pass membrane receptors including G-protein Coupled Receptors (GPCRs) and ion channels known to be strongly associated with diseases.

Financial Results for the Twelve Months Ended December 31, 2021:

Cash and Cash Equivalents and Marketable Securities. Cash and cash equivalents and marketable securities on December 31, 2021 were $8.6 million, as compared to $10.6 million as of December 31, 2020. In January, 2022, the Company sold 3,115,197 shares of its common stock at a weighted average price of $1.16 through the Open Market Sale Agreement, and 8,747,744 shares of the Company’s common stock at a price of $1.11 through a private placement sale.

Research and Development Expenses. Research and development expenses for the year ended December 31, 2021 were $17.2 million as compared to $21.5 million for the comparable period in 2020.

Research and Development expenses are lower in 2021 compared to 2020 primarily attributed to a smaller number of patients enrolled in clinical trials, especially the CLASSICAL-Lung and SIGNAL studies.

General and Administrative Expenses. General and administrative expenses for the year ended December 2021 were $6.2 million as compared to $7.4 million for the comparable period in 2020.

The difference in general and administrative expenses is primarily attributable to planned cost reductions, as part of cost control measures.

Comprehensive loss/Net loss per share. The Comprehensive Loss and Net loss per share for the year ended December 31, 2021 was $22.4 million and $0.78 compared to $28.9 million and $1.54 for the comparable period in 2020.

Financial results are included below. For further details on Vaccinex’s financials, refer to its Form 10-K filed March 31, 2022 with the Securities and Exchange Commission.

About Pepinemab
Pepinemab is a humanized IgG4 monoclonal antibody that inhibits SEMA4D, which regulates chronic inflammation in the tumor microenvironment. Preclinical and clinical data show that pepinemab promotes infiltration of activated immune cells while reducing immune suppression in tumors and repair or prevention of neurological damage in neuroinflammatory and neurodegenerative diseases.

Results of a Phase 1b/2 study were presented at ASCO (Free ASCO Whitepaper) 2020 and were highlighted in the July 2021 publication of Clinical Cancer Research. The Company believes that results of this Phase 1b/2 CLASSICAL-Lung trial supports increased benefit of combination immunotherapy relative to historical results for checkpoint inhibitor alone as a treatment for immunotherapy naïve patients with PD-L1 low non-small cell lung cancer (NSCLC). In addition, the Company believes that its recently completed phase 2 study of single agent pepinemab in Huntington’s disease indicated both cognitive benefit and a reduction in brain atrophy and reversal of disease-associated loss of brain metabolic activity. Topline data for the SIGNAL Phase 2 trial was reported in September 2020 and more detailed analysis of the data was presented at medical conferences in April and September of 2021.

Vaccinex has global commercial and development rights to pepinemab and is the sponsor of SIGNAL trials for HD and AD, as well as the KEYNOTE-B84 study which is being performed in collaboration with Merck Sharp & Dohme Corp, a subsidiary of Merck and Co, Inc. Kenilworth, NJ, USA. Additional information about the study is available at: clinicaltrials.gov link.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co. Inc., Kenilworth, NJ, USA.