VIEWS AND ANALYSIS, PHARMA TECH
Virpax Pharmaceuticals | December 15, 2022
Virpax® Pharmaceuticals, Inc. a company specializing in developing non-addictive products for pain management, post-traumatic stress disorder, central nervous system disorders and viral barrier indications, today announced that it has received pre-Investigational New Drug application guidance from the U.S. Food and Drug Administration for NobrXiol™, the Company’s product candidate for the delivery of cannabidiol in the management of epilepsy in children and adults. NobrXiol utilizes the Nanomerics Molecular Envelope Technology as its delivery system to cross the blood brain barrier, propelling the cannabidiol nanoparticles through the nose to the brain via the olfactory nerve.
The main purpose of a pre-IND 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 the IND.
“Virpax now has guidance on how to proceed with the IND enabling studies and possible regulatory pathways to pursue for NobrXiol. Based on the written responses from the FDA and its recommendations, we believe that we can proceed with the next steps in the process towards an IND application for this product candidate.”
Dr. Sheila A. Mathias, Chief Scientific Officer for Virpax
“This is a significant step forward for the NobrXiol project and we are very pleased with the outcome of the pre-IND meeting with the FDA,” said Anthony P. Mack, Chairman and CEO of Virpax. “We believe this product candidate has potential benefits over existing oral CBD treatments for epilepsy including Dravet Syndrome and Lennox-Gastaut Syndrome. We believe that by using the MET delivery system there may be significant advantages for patients including fewer side effects, avoidance of drug-to-drug interaction and lower dosing of CBD required,” concluded Mr. Mack.
Virpax has acquired the exclusive worldwide rights from Nanomerics to use Nanomerics' MET platform for the nasal delivery of cannabidiol or the management of epilepsy in children and adults. As part of this agreement, Nanomerics is developing an investigational formulation delivered via the nasal route to enhance CBD transport to the brain which could potentially eliminate any drug interaction issues and bypass the digestive system, possibly eliminating many of the side effects associated with the product currently in use on the market. Nanomerics demonstrated the ability of its platform technology to deliver CBD directly to the brain in an animal model.
About Virpax Pharmaceuticals
Virpax is developing branded product candidates for non-addictive pain management and neurological disorders using its proprietary technologies that optimize and target drug delivery. Virpax is initially seeking FDA approval of its three different patented drug delivery platforms. Epoladerm™ is a topical diclofenac spray film formulation being developed to manage pain associated with osteoarthritis of the knee. Probudur™ is a single injection long-acting liposomal bupivacaine formulation being developed to manage post-operative pain. Envelta™ is an intranasal Molecular Envelope Technology enkephalin formulation being developed for the management of acute and chronic pain, including pain associated with cancer, as well as post-traumatic stress disorder under the name PES200. MET technology is also used in AnQlar™, a candidate to inhibit viral replication caused by influenza or SARS-CoV-2. Virpax acquired global rights to NobrXiol™, a product candidate for the nasal delivery of a pharmaceutical-grade cannabidiol for the management of epilepsy in children and adults.
BUSINESS INSIGHTS, PHARMA TECH
Molecular Targeting Technologies, Inc. | December 07, 2022
Molecular Targeting Technologies, Inc. announces the issuance of Chinese Patent CN109153641B covering MTTI’s lead radiotherapeutic product, EBTATE™ and others in its EvaThera™ platform. Approval of “Chemical conjugates of Evans blue derivatives and their use as radiotherapeutic and imaging agents” follows issued patents in the US, Europe, Singapore, and Japan this past year.
EBTATE is a new generation of peptide receptor radiotherapeutic drug that has demonstrated potential clinical superiority over standard of care. It selectively targets and binds to somatostatin receptor 2 on neuroendocrine and other tumors, which are then killed by the radionuclide. EvaThera platform products were designed to bind to serum albumin, due to the Evans blue moiety, extending in vivo residence time, enabling lower, less frequent dosing of the radiopharmaceutical and reducing risk of renal injury vs. the current standard of care.
Our recent 3-year follow-up report on a 30-patient, ex-US, EBTATE study showed stable disease with progression-free survival of 43 months after three cycles of EBTATE. EBTATE treatment is effective and less toxic for neuroendocrine tumor patients. *
“This complements our IP portfolio, further protecting our EvaThera platform.” He added, “We’re continuing to bolster our position in radiotheranostics with planned clinical trials of our two platform products in multiple indications.”
Chris Pak, MTTI’s President & CEO
About Molecular Targeting Technologies, Inc.
Molecular Targeting Technologies, Inc., is a privately held, rapidly growing, well financed, clinical-stage biotech company developing next-generation targeted radiotherapeutics and diagnostics for rare cancers. We are committed to building value by acquiring and translating innovative imaging, radiopharmaceutical and theranostics assets to improve human health, reduce healthcare costs and reward stakeholders. MTTI expects to be orchestrating multiple clinical trials in 2023.
VIEWS AND ANALYSIS, PHARMA TECH
Novavax, Inc. | December 16, 2022
Novavax, Inc. a biotechnology company dedicated to developing and commercializing next-generation vaccines for serious infectious diseases, today announced the pricing of an offering of $150 million aggregate principal amount of its 5.00% convertible senior notes due 2027. The notes are being offered and sold only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. In connection with the offering of the notes, Novavax has granted to the initial purchasers a 30-day option to purchase up to an additional $25.25 million aggregate principal amount of the notes. The offering of the notes is expected to close on December 20, 2022, subject to customary closing conditions.
The notes will represent senior unsecured obligations of Novavax and will accrue interest payable semi-annually in arrears and will mature on December 15, 2027, unless earlier converted, redeemed or repurchased. Novavax will settle conversions by paying or delivering, as applicable, cash, shares of its common stock, par value $0.01 per share or a combination of cash and shares of its common stock, at Novavax' election. The notes will be redeemable, in whole or in part for cash at Novavax' option at any time, and from time to time, on or after December 22, 2025, if the last reported sale price of common stock has been at least 130% of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period ending on and including the trading day immediately preceding the date on which Novavax provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus any accrued and unpaid interest to, but excluding, the redemption date.
The notes will be convertible at an initial conversion rate of 80.0000 shares of common stock per $1,000 principal amount of notes.
J.P. Morgan, Jefferies and Cowen are acting as joint book-running managers and representatives of the initial purchasers for the offering of the notes. J. Wood Capital Advisors served as financial advisor to the Company in relation to the offering of the notes.
Concurrently with the offering of the notes, Novavax also announced today the pricing of its previously announced underwritten public offering to sell up to 6,500,000 shares of its common stock at a public offering price of $10.00 per share, or $65 million worth of shares of its common stock. In connection with the common stock offering, Novavax granted the underwriters a 30-day option to purchase up to an additional 975,000 shares of its common stock at the public offering price, less underwriting discounts and commissions. The offering of the notes is not contingent upon the consummation of the concurrent common stock offering, and the concurrent common stock offering is not contingent upon the consummation of the offering of the notes. The concurrent common stock offering is expected to close on December 20, 2022, subject to customary closing conditions.
Novavax may use the net proceeds from the offering of the notes and, if consummated, the concurrent common stock offering, for general corporate purposes, including but not limited to the continued global commercial launch of Nuvaxovid, repayment or repurchase of a portion of the $325 million in outstanding principal amount of its 3.75% convertible senior unsecured notes due February 1, 2023, working capital, capital expenditures, research and development expenditures, clinical trial expenditures, repayments under its supply agreements, as well as acquisitions and other strategic purposes.
Novavax estimates that the net proceeds from the offering of the notes will be approximately $142.2 million after deducting the initial purchasers' discounts and estimated offering expenses payable by Novavax.
The offer and sale of the notes are not being registered under the Securities Act of 1933, as amended any state securities laws. The notes may not be offered or sold in the U.S. except pursuant to an exemption from the registration requirements of the Securities Act and any applicable state securities laws.
The notes are being offered only to persons reasonably believed to be qualified institutional buyers pursuant to Rule 144A under the Securities Act. The offer and sale of the notes and any shares of common stock issuable upon conversion of the notes have not been, and will not be, registered under the Securities Act or any other securities laws, and the notes and any such shares cannot be offered or sold absent registration or except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and any other applicable securities laws.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy the securities being offered, nor shall there be any sale of the securities being offered in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or other jurisdiction.
Novavax, Inc. is a biotechnology company that promotes improved health globally through the discovery, development, and commercialization of innovative vaccines to prevent serious infectious diseases. The company's proprietary recombinant technology platform harnesses the power and speed of genetic engineering to efficiently produce highly immunogenic nanoparticles designed to address urgent global health needs. The Novavax COVID-19 vaccine has received authorization from multiple regulatory authorities globally, including the U.S. Food and Drug Administration, the European Commission, and the World Health Organization.
BUSINESS INSIGHTS, PHARMACY MARKET
insitro | December 02, 2022
insitro, a machine learning-powered drug discovery and development company announced that Philip Tagari has been appointed as chief scientific officer. Tagari joins insitro following a 24-year career at Amgen, where he has led the organization's research platforms for over a decade as vice president, research - therapeutic discovery.
“I am deeply excited to partner with Philip on insitro’s journey to build a transformative biology platform for the efficient discovery and development of effective medicines for patients in need. Philip brings unparalleled experience in drug development, including building and utilizing cutting-edge platforms, profound scientific expertise across therapeutic areas and modalities, and most importantly, the humility and courage to transcend the drug discovery status quo and do things differently.”
Daphne Koller, Ph.D., founder and CEO of insitro
Tagari joins a cross-functional team of experts in biology and technology at insitro, part of a uniquely collaborative culture that spans the boundaries of both fields. “Philip’s inspiring track record of fusing science and technology to build innovative platforms and leading therapeutic programs from bench to approval will guide us in the next step of insitro’s journey, as we deploy our expertise to identify exciting new targets and design therapeutic molecules,” said Koller.
“insitro is completely redefining our understanding of disease biology and developing novel therapeutic strategies for a variety of grievous illnesses. Using machine learning on genetics and multi-modal phenotypic data at scale from human cohorts and cellular systems, their cutting edge laboratories are rapidly generating differentiated approaches to currently intractable unmet needs,” Tagari said. “I’m thrilled to partner with Daphne and insitro’s world-class scientists and technologists in achieving a patient-driven vision brought to life in a different kind of drug company.”
Tagari joins insitro in early 2023 from Amgen, where he has held a variety of roles since 1998, and served as vice president, research - therapeutic discovery, since 2012. During his time at Amgen, Tagari built and led a global organization of over 600 scientists that delivered numerous experimental and marketed therapies in neurology, inflammation, cardiovascular disease and oncology. Throughout his career, which includes a decade at Merck and research positions at McGill University and Oxford University, Tagari made significant contributions toward multiple first-in-class, disease-modifying, life-changing therapies including Lumakras, Repatha, Singulair, Aimovig, Evenity, Tarlatamab, Acapatamab, Efavaleukin alfa, and AMG 133.
With more than 30 years of research experience, he brings expertise across neurobiology, metabolic disease, hematology/oncology, immunology and inflammation, cell and molecular biology, antibody discovery and biologics engineering, medicinal, peptide and oligonucleotide chemistry, analytical chemistry and biochemistry, structural biology, pharmacokinetics, safety pharmacology, laboratory automation and information technologies. Tagari has published or contributed to more than 70 peer-reviewed publications.
“I had the privilege of working with Philip for more than 15 years, first at Merck, and thereafter at Amgen, and can say unequivocally that he ranks among the most accomplished, and most innovative, scientific leaders in the industry,” said Roger M. Perlmutter, M.D., Ph.D., currently president, chief executive officer, and chairman of Eikon Therapeutics, Inc., (formerly EVP R&D both at Amgen and at Merck), and is a member of insitro’s Board of Directors. “With Philip as chief scientific officer and partner to Daphne, insitro will be well positioned to ensure that insights from its machine learning-enabled discovery platform contribute to the development of important new medicines that will make a meaningful difference for patients.”
insitro is a data-driven drug discovery and development company using machine learning and data at scale to transform the way that drugs are discovered and developed for patients. insitro is developing predictive machine learning models to discover underlying biologic states based on human cohort data and in-house generated cellular data at scale. These predictive models are being brought to bear on key bottlenecks in pharmaceutical R&D to advance novel targets and patient biomarkers, design therapeutics and inform clinical strategy. insitro is advancing a wholly owned and partnered pipeline of biologic insights and molecules in metabolism and neuroscience. Since formation in mid 2018, insitro has raised over $700 million from top tech, biotech, and crossover investors, and from collaborations with pharmaceutical partners.