On March 22, 2023 Virpax Pharmaceuticals, Inc. ("Virpax" or the "Company") (NASDAQ: VRPX), a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system (CNS) disorders and viral barrier indications, reported its financial results for the twelve months ended December 31, 2022, and other recent developments (Press release, Virpax Pharmaceuticals, MAR 22, 2023, View Source [SID1234629192]).

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"We continue to make progress in our drug candidate programs as well as in our efforts to secure non-dilutive funding. Additionally, we have attracted leading physicians to advise on trial design, regulatory pathway and patient recruitment, as well as world-class partners to support our global sub-licensing plans for selected pipeline assets," commented Anthony P. Mack, Chairman and Chief Executive Officer of Virpax.

"The work on developing an improved formulation for Probudur, our leading drug product for postoperative pain management, has been completed. With this new formulation, we expect to demonstrate longer duration, manufacturing efficiencies and extended patent protection. We are working with Lipocure to scale up production of Probudur in anticipation of initiating Investigational New Drug Application (IND) enabling toxicity studies. It is currently expected that we will engage one of our CROs to initiate our pre-clinical animal studies towards the end of 2023.

"We recently announced that Dr. Neil Singla, a leading pain expert, will be working with Virpax to assist in the design and support of the clinical development strategy for Probudur. In addition, Dr. Singla will work with us on patient recruitment and establishing relationships with patient advocacy groups as well as submissions for potential grants and additional cooperative research and development agreements (CRADAs)," continued Mr. Mack.

"The Molecular Envelope Technology (MET) that we have in-licensed from Nanomerics Ltd. is serving as the foundation for our other two Rx programs, Envelta and NobrXiol. As stated previously, we expect to be able to reference the same MET preclinical data for both submissions, potentially saving us valuable time and money. With Envelta, the Company is working under our grant program with the National Center for Advancing Translational Sciences (NCATS) to scale up manufacturing in anticipation of an IND filing in 2024.

"With NobrXiol, we recently received our pre-IND guidance from the Food and Drug Administration ( FDA) to help guide us as we advance this drug candidate. To support our overall development plan, we have engaged two leading physicians experienced in pediatric epilepsy, Dr. Kenneth Sommerville and Dr. Lawrence Fried. Additionally, we have identified grant opportunities for NobrXiol and anticipate that Dr. Sommerville and Dr. Fried will assist our team in our grant and CRADA submissions," added Mr. Mack.

"We are moving forward with our non-dilutive financing strategy with both grants and licensing opportunities. Our grant team, in conjunction with outside experts, identifies and evaluates grant opportunities and CRADAs where we believe we have a strong chance of success. We have applications in process, as well as pending applications and will continue to pursue this strategic approach.

"Finally, we have engaged exclusive advisors for our partnering and licensing efforts in key global markets. New England Investors is leading our effort for Envelta in the People’s Republic of China. Before they could begin their work, we were required to obtain a patent in China, which we obtained this past November. To date, we are encouraged by the initial interest and responses they have received.

"Destum Partners, whom we have engaged to lead our global strategic partnering and licensing efforts for our two potential OTC products (EpoladermTM, indicated for osteoarthritis pain, and AnQlar, an intranasal mucosal viral barrier) and Probudur for the animal health market, have begun their outreach efforts. They are starting with Probudur and have identified several animal health care companies that have expressed initial interest. While these types of licensing deals take time to complete, we are optimistic based upon the level of interest to date.

"I believe we have a highly experienced and motivated team working to help us enter first-in-human trials. We have a solid strategy in place and expect that we will achieve some significant drug development milestones in 2023 as well as important regulatory milestones in 2024," concluded Mr. Mack.

RECENT DEVELOPMENTS

On December 8, 2022, Virpax received Pre-Investigational New Drug (PIND) application guidance from the FDA for NobrXiol. The main purpose of a PIND submission is to obtain FDA guidance on the overall development plan for a new drug and to identify any need for further data prior to submitting an IND.

NobrXiol is the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults that utilizes Nanomerics’ Molecular Envelope Technology (MET) as its delivery system to cross the blood brain barrier, propelling the cannabidiol nanoparticles through the nose to the brain via the olfactory nerve.
On January 4, 2023, Virpax announced that it has engaged two leading physicians experienced in childhood epilepsy, Dr. Kenneth W. Sommerville and Dr. Lawrence Fried, to support the overall development plan for NobrXiol. Their involvement with this program is expected to include advising on trial design, regulatory pathway development and patient recruitment. Additionally, it is anticipated that they will support Virpax with patient advocacy groups and grant applications.
On January 10, 2023, Virpax announced that that the Company has engaged Destum Partners, Inc. to serve as the exclusive advisor for the Company’s partnering and licensing efforts in strategic global markets. This initial engagement will encompass the Company’s OTC product candidates, Epoladerm, indicated for osteoarthritis pain, and AnQlar, an intranasal mucosal viral barrier. Additionally, Destum Partners will work with Virpax on identifying a partner in the animal health market for its Rx product candidate, Probudur, a long-acting local anesthetic indicated for postoperative pain management.
On January 18, 2023, Virpax announced that it will utilize leading pain expert, Dr. Neil K. Singla, to assist in the design and support of the clinical development strategy for Probudur. Probudur is Virpax’s post-operative, long-acting anesthetic injection product candidate that is being developed to significantly reduce or eliminate the need for opioids after surgery in approved indications.
On January 31, 2023, Virpax announced the Company has engaged New England Investors, LLC to serve as the out-licensing advisor for Envelta in the People’s Republic of China. Envelta is Virpax’s non-opioid pain product candidate for acute and chronic pain including non-cancer pain that is being funded under an in-kind grant from NCATS, part of the National Institutes of Health (NIH).
On February 13, 2023, Virpax announced that the Company has completed FDA required preclinical toxicology studies for its licensed Molecular Envelope Technology. The Company believes MET may enhance the delivery of Virpax’s Envelta and NobrXiol product candidates. MET is also utilized in the Company’s AnQlar product candidate. These preclinical toxicology studies were performed to evaluate the safety of the MET platform and support the IND submission of each product candidate.
FINANCIAL RESULTS FOR THE YEARS ENDED DECEMBER 31, 2022 AND 2021

Twelve Months Ended December 31, 2022

Operating Expenses

General and administrative expenses increased by $3,896,078, or 54%, to $11,082,463 for the year ended December 31, 2022, from $7,186,385 for the year ended December 31, 2021. The primary reasons for the increase in general and administrative costs were (i) an increase in legal costs associated with litigation defense efforts of $3,417,321, including a $2,000,000 estimated litigation liability, (ii) an increase in salaries and wages and employee benefits of $257,438, (iii) an increase in insurance costs related to directors’ and officers’ insurance of $216,134, (iv) an increase in non-executive board compensation of $181,667, and (v) an increase in grant writing and grant consulting fees of $114,973. This was offset by a decrease in stock-based compensation of $316,768.

Research and development expenses increased by $5,923,555, or 122%, to $10,762,670 for the year ended December 31, 2022, from $4,839,115 for the year ended December 31, 2021. The increase was primarily attributable to (i) an increase in preclinical activity of $3,826,920 related to AnQlar’s ongoing IND enabling studies and regulatory consulting, in addition to an increase in milestone payments of $500,000 made to Nanomerics related to AnQlar, (ii) an increase in NobrXiol of $599,800 mainly due to a milestone payment of $500,000 paid to Nanomerics upon achieving the study aim contained within a pre-clinical animal study,(iii) increases in preclinical and regulatory activity related to Epoladerm of $513,517, and (iv) an increase in preclinical work related to Probudur of $487,573 related to ongoing formula optimization.

Cash Flows

Operating Activities

For the year ended December 31, 2022, cash used in operations was $17,846,708 compared to $14,542,592 for the year ended December 31, 2021. The increase in cash used in operations was primarily the result of the increase in net loss offset by a decrease in prepaid expenses and current assets as well as an increase in current liabilities.

Financing Activities

Cash provided by financing activities was $51,329,788 during the year ended December 31, 2021, attributable primarily to net proceeds received from our initial public offering in February 2021 of $15,834,087 and the underwritten offering in September 2021 of $36,999,465, after deducting underwriting discounts and offering expenses. These proceeds were offset by the repayment in full of our RRD Note of $493,480 in February 2021 and repayments of our promissory notes and the unforgiven portion of the PPP Loan of an aggregate of $1,503,764. No financing activities took place during the year ended December 31, 2022.

At December 31, 2022, Virpax had cash of approximately $19.0 million.

On March 22, 2023 Marengo Therapeutics, Inc., a company pioneering novel immuno-therapeutics targeting the T cell receptor (TCR) Vβ repertoire to fight cancer and other diseases, reported that the company will present a late-breaking abstract at the upcoming American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, held April 14-19 in Orlando, Florida (Press release, Marengo Therapeutics, MAR 22, 2023, View Source [SID1234629191]). Building on recent scientific insights into Marengo’s lead asset, STAR0602, which selectively activates and expands Vβ6 T cells, Marengo will present new data revealing the broad utility of targeting different T cell subsets expressing distinct Vβ TCRs utilizing its STAR (Selective T Cell Activation Repertoire) platform to remodel the adaptive immune response to refractory solid tumors.

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"As we continue to explore the hidden reactivities of the germline TCR repertoire using our proprietary libraries of anti-TCR antibodies, we are uncovering exciting immunology with potential broad therapeutic application across a range of cancers and other immune-related diseases," said Andrew Bayliffe, Ph.D., Chief Scientific Officer of Marengo Therapeutics. "Importantly, we also find that Marengo’s anti-TCR antibody constructs transform Vβ T cells towards a novel phenotype that drives potent anti-tumor activity in vivo via a mechanism of action that is both unique and distinct from anti-PD1 immunotherapy."

Details of the presentation are as follows:

Title: A novel class of T cell-activators targeting germline encoded TCR β chains promotes antitumor activity in PD1-refractory models through expansion of a clonally diverse effector memory T cell subset
Authors: Jacques Moisan, Madan Katragadda, Jonathan Hsu, Jessica Lowry, Wei Huang, Jian Tang, Roya Servattalab, Gurkan Guntas, Raj Chopra, Zhen Su, and Andrew Bayliffe
Session Title: Late-Breaking Research: Immunology 3
Session Date and Time: Wednesday Apr 19, 2023, 9:00 AM – 12:30 PM
Poster Section: 3
Poster Number: 6
Abstract Presentation Number: LB338

On March 22, 2023 XNK Therapeutics AB reported its extensive participation at the 8th Annual Innate Killer Summit in La Jolla, San Diego, CA, March 28-30 (Press release, XNK Therapeutics, MAR 22, 2023, View Source [SID1234629189]).

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The Annual Innate Killer Summit is the largest and leading technical, industry-focused, end-to-end innate immune cell therapy meeting to explore frontiers in immunobiology, genetic modification, clinical translation, scalable manufacturing, cryopreservation, and CMC. Over 200 experts from both pharmaceutical industry and academia participate to advance the clinical and phase development of NK, macrophage, γδT and NKT cell therapies for liquid and solid tumors.

On March 29, XNK’s CMO Peter Hovstadius, M.D., Ph.D. will discuss the potential risks and benefits of repeat dosing in NK cell therapy.

On March 29, XNK’s Head of Manufacturing and Engineering Paul Do, will discuss how a tailor-made in-house GMP facility can provide a fast track to ensure efficient process development and robust manufacturing capability.

On March 30, there is a panel discussion with the title ‘What does the future of innate therapies look like? Is it out-patient care?’. Johan Liwing, CEO of XNK, will discuss this important topic with Daniel Teper CEO at Cytovia Therapeutics and Peter Flynn, COO at Artiva Bio.

"We are very excited to have been invited to participate at this prestigious conference. Discussing key topics like clinical development aspects, manufacturing processes as well as the future landscape of NK-cell therapies shows that XNK is at the forefront of NK cell therapy today," said Johan Liwing, CEO.

On March 22, 2023 Jacobio Pharma (1167.HK) reported it has entered into a clinical collaboration with Merck & Co., Inc., Rahway, NJ, USA to evaluate the combination of Jacobio’s CD73 monoclonal antibody JAB-BX102 in combination with Merck & Co., Inc., Rahway, NJ, USA’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) (Press release, Jacobio Pharmaceuticals, MAR 22, 2023, View Source [SID1234629188]).

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The clinical study will evaluate the clinical effect of JAB-BX102 in combination with KEYTRUDA for the treatment of advanced solid tumors. Under the terms of the agreement, Merck & Co., Inc., Rahway, NJ, USA will provide KEYTRUDA.

"The CD73 monoclonal antibody is Jacobio’s first large molecule project to enter the clinic. CD73 is an important target in the tumor immune pathway. We believe the combination of CD73 and anti-PD-1, an inhibitor on the same tumor immune pathway, can potentially relieve immunosuppression in the tumor microenvironment, stimulate the proliferation and activation of killer immune cells, enhance tumor immunity," said Dr. WANG Yinxiang, Chairman and CEO at Jacobio. "We look forward to exploring the potential benefit of CD73 in combination with an anti-PD-1 in tumor immunotherapy through this collaboration with Merck & Co., Inc., Rahway, NJ, USA and potentially giving patients new treatment options."

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

About JAB-BX102

JAB-BX102 is a humanized CD73 monoclonal antibody developed by Jacobio that was granted approvals for clinical trials in the U.S. and China in October 2021 and March 2022. Jacobio is currently initiating a Phase I/IIa, multi-center, open study of the safety, tolerability, pharmacokinetics and preliminary anti-tumor efficacy of JAB-BX102 alone and in combination with pablizumab to treat advanced solid tumors in China and the U.S. Current published clinical data show that CD73 in combination with PD-(L)1 significantly prolongs survival of patients with non-small cell lung cancer.

On March 22, 2023 Flare Therapeutics Inc., a biotechnology company targeting transcription factors to discover precision medicines for cancer and other diseases, reported a $123 million Series B financing co-led by GordonMD Global Investments LP and Pfizer Ventures, with participation from existing investors Boxer Capital, Casdin Capital, Eventide Asset Management, Invus Financial Advisors, Nextech Invest and Third Rock Ventures and new investors Agent Capital, Eli Lilly and Company, Memorial Sloan Kettering Cancer Center (MSK), Novartis, Pavilion Capital and ShangBay Capital (Press release, Flare Therapeutics, MAR 22, 2023, View Source [SID1234629187]). In conjunction with the financing, Craig D. Gordon, M.D., Founder, Chief Executive Officer and Chief Investment Officer of GordonMD Global Investments LP, and Irena Melnikova, Ph.D., Partner at Pfizer Ventures, have joined the Flare Therapeutics Board of Directors.

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"Our investor support is testament to the rapid progress our team has made since launch in advancing the only company focused on rationally designing transcription factor targeting therapies," said Amit Rakhit, M.D., MBA, President and Chief Executive Officer of Flare Therapeutics. "This will be a pivotal year for Flare as we progress our first precision oncology program, FX-909, into the clinic, continue to expand our collection of druggable transcription factor targets, and build a pipeline of potentially first-in-class therapies against genetically validated transcription factor targets for cancer."

Proceeds from the financing will support a planned clinical trial in 2023 for FX-909, a small molecule inhibitor targeting the PPARG transcription factor, in patients with advanced urothelial cancer, as well as the advancement of a pipeline of novel transcription factor targets in oncology, including nomination of at least one additional development candidate from the company’s research pipeline in 2024.

"Transcription factors have long been viewed as prime therapeutic targets playing a key role in a broad range of diseases, particularly cancers, where they represent one-third of all oncogenes. While targeting transcription factors has the potential for incredible impact, their complex structure makes them notoriously difficult to drug, requiring a new approach and new thinking," said Rob Sims, Ph.D., Co-founder and Chief Scientific Officer of Flare Therapeutics. "From the very beginning, we knew this would require a world-class, cross-disciplinary team to not only think creatively about how to design the platform, but also how to apply translational insights to ensure efficient drug development at scale."

The Flare drug discovery platform is a powerful engine driving the systematic identification of switch sites, or druggable pockets within transcription factor complexes that dictate conformation and function. This is achieved through a broad and comprehensive approach that layers chemoproteomics, functional biochemistry, covalent chemistry and genetic insights to gain a deeper understanding of the structural underpinnings driving transcription factor function, and a proprietary library of compounds designed to modulate transcription factor behavior.

"Flare has taken on one of the most formidable challenges in drug discovery – drugging transcription factors," said Craig D. Gordon, M.D., Founder, Chief Executive Officer and Chief Investment Officer of GordonMD Global Investments LP. "The company is making impressive strides enabled by its platform, which to date has successfully identified more than 150 switch sites across the majority of transcription factor families, providing opportunities to treat a broad range of diseases."

"We believe Flare’s differentiated and comprehensive approach to uncovering, targeting and systematically drugging switch sites on transcription factors may unlock the therapeutic potential of this class of targets, not only in oncology but in other indications as well," said Irena Melnikova, Ph.D., Partner at Pfizer Ventures. "As a member of the board, I look forward to supporting the company in their mission to bring new medicines to patients in need."