CELL AND GENE THERAPY

AgeX Therapeutics Receives Stock Exchange Deficiency Letter

AgeX Therapeutics | November 24, 2021

AgeX Therapeutics Receives Stock Exchange Deficiency Letter
AgeX Therapeutics , Inc. a biotechnology company developing therapeutics for human aging and regeneration, announced that on November 17, 2021 it received a letter from the staff of the NYSE American indicating that AgeX does not meet certain of the Exchange’s continued listing standards as set forth in Section 1003(a)(i) and (ii) of the Exchange Company Guide in that AgeX has stockholders equity of less than $2,000,000 and has incurred losses from continuing operations and/or net losses during its two most recent fiscal years, and that it has stockholders equity of less than $4,000,000 and has incurred losses from continuing operations and/or net losses during three out of four of its most recent fiscal years. Pursuant to Section 1009 of the Exchange Company Guide and as provided in the Deficiency Letter, AgeX may provide the Exchange staff with a plan (the "Plan") by December 17, 2021 advising the Exchange staff of action AgeX has taken and will take that would bring AgeX into compliance with the Exchange’s continued listing standards by June 17, 2023. AgeX intends to submit a Plan by the December 17, 2021 deadline.

There is no assurance that the Exchange staff will accept the Plan. If the Exchange staff accepts the Plan, the Exchange staff will review AgeX’s compliance with the Plan on a quarterly basis and if AgeX does not show progress consistent with the Plan or is not in compliance with the Exchange’s continued listing standards by June 17, 2023, the Exchange will commence delisting procedures. If AgeX does not submit the Plan or if the Exchange staff does not accept the Plan, the Exchange staff will promptly initiate delisting proceedings.

AgeX intends to make arrangements to have its common stock quoted on an electronic interdealer quotation system if its common stock is delisted from the Exchange.

About AgeX Therapeutics
AgeX Therapeutics, Inc. is focused on developing and commercializing innovative therapeutics to treat human diseases to increase healthspan and combat the effects of aging. AgeX’s PureStem® and UniverCyte™ manufacturing and immunotolerance technologies are designed to work together to generate highly defined, universal, allogeneic, off-the-shelf pluripotent stem cell-derived young cells of any type for application in a variety of diseases with a high unmet medical need. AgeX has two preclinical cell therapy programs: AGEX-VASC1 (vascular progenitor cells) for tissue ischemia and AGEX-BAT1 (brown fat cells) for Type II diabetes. AgeX’s revolutionary longevity platform induced Tissue Regeneration (iTR™) aims to unlock cellular immortality and regenerative capacity to reverse age-related changes within tissues. HyStem® is AgeX’s delivery technology to stably engraft PureStem or other cell therapies in the body. AgeX is seeking opportunities to establish licensing and collaboration arrangements around its broad IP estate and proprietary technology platforms and therapy product candidates.

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Time-lapse imaging of DU145 prostate cancer spheroids. Cells were first cultured on Cell-able plates. After 4-7 days, media was switched with 100nM anti-cancer drug paclitaxel plus Caspase-3/7 (green stain indicating apoptosis) and ethidium homodimer-1 (red stain indicating necrosis). Cells were imaged on the ImageXpress Micro System every 30 minutes for 72 hours.

Spotlight

Time-lapse imaging of DU145 prostate cancer spheroids. Cells were first cultured on Cell-able plates. After 4-7 days, media was switched with 100nM anti-cancer drug paclitaxel plus Caspase-3/7 (green stain indicating apoptosis) and ethidium homodimer-1 (red stain indicating necrosis). Cells were imaged on the ImageXpress Micro System every 30 minutes for 72 hours.

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TheraVet Announces Its Participation in the 2022 ESVOT Congress With 3 Scientific Communications

TheraVet SA | September 19, 2022

TheraVet a pioneering company in the management of osteoarticular diseases in pets, announced today its participation in the annual congress of the European Society of Veterinary Orthopaedics and Traumatology which will be held from 21 to 24 September at the Acropolis in Nice, France. With nearly 1000 participants, this event is the largest specialised congress in veterinary orthopaedics and traumatology in Europe, bringing together high-quality international speakers and therefore represents a prime showcase for the Company. ESVOT is chaired by Pr. Marc Balligand, who is also the President of the Scientific Advisory Board of TheraVet. About TheraVet SA TheraVet is a veterinary biotechnology company specialising in osteoarticular treatments for companion animals. The Company develops targeted, safe and effective treatments to improve the quality of life of pets suffering from joint and bone diseases. For pet owners, the health of their pets is a major concern and TheraVet’s mission is to address the need for innovative and curative treatments. TheraVet works closely with international opinion leaders in order to provide a more effective response to ever-growing needs in the field of veterinary medicine. TheraVet is listed on Euronext Growth® Paris a with a US subsidiary in Texas. About BIOCERA-VET In close collaboration with an international scientific board, THERAVET® has developed a new line of calcium-phosphate and biological bone substitutes, BIOCERA-VET®. BIOCERA-VET® is a full range of innovative, easy-to-use, efficient & cost-effective bone substitutes indicated in bone surgeries where a bone graft is required and as a palliative alternative in the management of canine osteosarcoma. Based on extremely promising clinical results, this line offers the possibility of a better, more convenient and more efficient orthopedic surgery.

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CELL AND GENE THERAPY

Intravacc announces additional favorable preclinical and toxicology data for Avacc 10®, an intranasal SARS-CoV-2 candidate vaccine

Intravacc | September 12, 2022

Intravacc, a world leader in translational research and development of preventive and therapeutic vaccines, today announced additional favorable preclinical and toxicology data for Avacc 10®, the company's SARS-CoV-2 intranasal candidate vaccine. These results demonstrate a reduction in upper respiratory tract viral load, broad cross protection against circulating variants of concern. and a good safety profile, allowing progression towards a phase I clinical study. "Based on our additional pre-clinical data, Avacc 10® has the potential to reduce the spreading of the virus as well as providing broad protection against circulation variants. Combined with the favorable toxicological safety data, this puts us a good position for our Phase I clinical trial, which will commence in Q4 2022." Dr. Jan Groen, Intravacc's Chairman & CEO The first set of pre-clinical studies of Avacc 10®, published in Frontiers of Immunology in December 2021, demonstrated high levels of spike-binding immunoglobulin G (IgG) and A (IgA) antibodies in serum, and the nose and lungs after two intranasal vaccinations 3 weeks apart. Avacc 10® vaccinated hamsters challenged with SARS-CoV-2 were protected from weight loss and viral replication in the lungs and histopathology showed no lesions in lungs 7 days after challenge. The objectives of the additional pre-clinical and toxicology study of Avacc 10® were to study the dosing, cross neutralization and safety of the intranasal vaccine. For the dosing study, mice were vaccinated intranasally with two doses of various concentrations of OMV and Spike protein. Three weeks after the last vaccination neutralizing antibodies against the SARS-CoV-2 Wuhan strain and variants of concern Delta, Gamma and Omicron were determined in the sera. High virus neutralizing antibody titers were detected against all the variant viruses. Syrian hamsters were used to study viral replication after challenge with SARS-CoV-2. A reduced viral load in throat and lungs and highly reduced lung lesions were observed in Avacc 10® vaccinated animals exposed to placebo vaccinated, challenged animals. Furthermore, delayed transmission of Avacc 10® vaccinated, challenged animals to placebo vaccinated animals was observed. The purpose of the repeated dose toxicity study was to assess the safety and tolerability of Avacc 10® when administered through the intranasal route in New Zealand White Rabbits. Animals were vaccinated 3 times with Avacc 10® , and control animals with OMV only, or saline buffer. Toxicity was monitored until 2 weeks after the final vaccination. No clinical signs of toxicity nor morbidity/mortality were found in any of the groups, and no gross pathological changes were observed, demonstrating the safety of OMV based vaccine. All Avacc 10® vaccinated animals showed high IgG antibodies levels against Spike as well as virus neutralizing antibodies. Based on the outcome of the Phase I trial, Intravacc will seek manufacturing and commercialization license partners. About Intravacc's OMV platform technology For the development of vaccines, Intravacc has designed and developed a platform based on outer membrane vesicles (OMVs) - spherical particles with intrinsic adjuvant properties. The OMVs can be rigged with immunogenic peptides and/or proteins that stimulate effective adaptive immunity. The OMV carrier has been optimized to induce a more effective immune response against these newly introduced antigens. Intravacc has also developed genetic tools to increase the yield of OMVs, reduce the toxicity and achieve the desired antigenic composition. Intravacc's OMV platform is fully scalable and allows rapid and efficient modification of the antigen composition, either through genetic modification of the bacterial host or by associating antigens with stored OMVs. About Intravacc Intravacc, located at Utrecht Science Park Bilthoven in the Netherlands, is a leading global contract development and manufacturing organization for infectious diseases and therapeutic vaccines. As an established independent CDMO with many years of experience in the development and optimization of vaccines and vaccine technologies, Intravacc has transferred its technology world-wide for many vaccines including polio-, measles-, DPT-, Hib- and influenza. Around 40% of childhood disease vaccines are based on Intravacc's know-how and proprietary technology. Intravacc offers a wide range of expertise for independent vaccine development, from concept to Phase I/II clinical studies for partners around the world, including universities, public health organizations biotech and pharmaceutical companies.

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CELL AND GENE THERAPY

Sesen Bio and Carisma Therapeutics Announce Merger Agreement

Sesen Bio and Carisma Therapeutics | September 22, 2022

Sesen Bio, Inc. and Carisma Therapeutics Inc. a privately held, clinical stage biopharmaceutical company focused on discovering and developing innovative immunotherapies, announced that they have entered into a definitive merger agreement to combine the companies in an all-stock transaction. The combined company will focus on the advancement of Carisma’s proprietary cell therapy platform that utilizes engineered macrophages and monocytes to potentially transform the treatment of cancer and other serious disorders. Carisma is pioneering the development of chimeric antigen receptor macrophage therapies and is believed to be the only company developing CAR-M therapies with demonstrated proof of mechanism and safety data in clinical trials. The combined company is expected to operate under the name Carisma Therapeutics Inc. and trade on Nasdaq under the ticker symbol “CARM”. 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Carisma is focused on delivering cutting-edge technology for patients in a way that has never been done before, and we look forward to advancing this important mission.” Steven Kelly, President and Chief Executive Officer of Carisma “This transaction represents the result of a thoughtful and careful review of strategic alternatives over the past four months, during which Carisma’s clinical programs, management team, and corporate strategy stood out amongst the 42 bids reviewed,” said Dr. Thomas Cannell, President and Chief Executive Officer of Sesen Bio. “Carisma is an exciting clinical-stage company with groundbreaking science and an impressive management team, which we believe makes them the optimal partner to provide value for our shareholders. 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Immediately prior to the closing of the proposed merger, Sesen Bio stockholders of record will be issued a contingent value right (CVR) for each outstanding share of Sesen Bio common stock held by such Sesen Bio stockholder as of such date, representing the right to receive certain cash payments from proceeds received by Sesen Bio related to the Roche Asset Purchase Agreement, if any, subject to customary deductions, including for expenses and taxes. SVB Securities is acting as exclusive financial advisor to Sesen Bio for the transaction and Hogan Lovells US LLP is serving as its legal counsel. Evercore Group LLC is serving as lead financial advisor to Carisma for the transaction and BofA Securities, Inc. is also serving as financial advisor to Carisma for the transaction. Wilmer Cutler Pickering Hale and Dorr LLP is serving as legal counsel to Carisma. BofA Securities, Inc. and Evercore Group L.L.C. are serving as co-placement agents for Carisma’s concurrent financing and Shearman & Sterling LLP is serving as the placement agents’ legal counsel. About Sesen Bio Sesen Bio, Inc. is a late-stage clinical company focused on targeted fusion protein therapeutics for the treatment of patients with cancer. Sesen Bio’s most advanced product candidate, Vicineum™, also known as VB4-845, is a locally-administered targeted fusion protein composed of an anti-epithelial cell adhesion molecule antibody fragment tethered to a truncated form of Pseudomonas exotoxin A for the treatment of non-muscle invasive bladder cancer. On July 15, 2022, Sesen Bio made the strategic decision to voluntarily pause further development of Vicineum in the US. 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