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Real Texture for Lab-grown Meat

Lab-grown or cultured meat could revolutionize food production, providing a greener, more sustainable, more ethical alternative to large-scale meat production. But getting lab-grown meat from the petri dish to the dinner plate requires solving several major problems, including how to make large amounts of it and how to make it feel and taste more like real meat. Now, researchers at the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS) have grown rabbit and cow muscles cells on edible gelatin scaffolds that mimic the texture and consistency of meat, demonstrating that realistic meat products may eventually be produced without the need to raise and slaughter animals. Kit Parker, the Tarr Family Professor of Bioengineering and Applied Physics at SEAS and senior author of the study, began his foray into food after judging a competition show on the Food Network. "The materials science expertise of the chefs was impressive," said Parker. "After discussions with them, I began to wonder if we could apply all that we knew about regenerative medicine to the design of synthetic foods. After all, everything we have learned about building organs and tissues for regenerative medicine applies to food: healthy cells and healthy scaffolds are the building substrates, the design rules are the same, and the goals are the same: human health. This is our first effort to bring hardcore engineering design and scalable manufacturing to the creation of food."

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Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Heron Therapeutics, Inc. | January 29, 2024

Heron Therapeutics, Inc. a commercial-stage biotechnology company announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration. "The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for ZYNRELEF and the Company," said Craig Collard, Chief Executive Officer of Heron. "We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures," said Bill Forbes, Executive Vice President, Chief Development Officer at Heron. "This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings." ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021. "Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use." Important Safety Information for Patients ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID. Cannot be used during heart bypass surgery. Can increase the risk of gastrointestinal bleeding, ulcers, and tears. ZYNRELEF should also not be used if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines. as a paracervical block, during childbirth. The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you. Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning. About ZYNRELEF ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.

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MedTech

Stevanato Group Launches EZ-fill® Kit and Laboratory Fill and Finish Service to Support Small Batch Drug Development and Commercialization

Stevanato Group | January 25, 2024

Stevanato Group S.p.A. a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC). In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases. The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration. Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier. As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024. Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy. “In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner," says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group. "Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.

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Medical

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine

Capricor Therapeutics | January 24, 2024

Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study. “We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.” Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.” About Capricor’s StealthX™ Vaccine The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication. About Capricor Therapeutics Capricor Therapeutics, Inc. is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.

Read More

Medical

Heron Therapeutics Announces FDA Approval of ZYNRELEF® Indication Expansion to Include Additional Orthopedic and Soft Tissue Procedures

Heron Therapeutics, Inc. | January 29, 2024

Heron Therapeutics, Inc. a commercial-stage biotechnology company announced that the U.S. Food and Drug Administration (the "FDA") has approved its supplemental New Drug Application ("NDA") for ZYNRELEF® extended-release solution to expand the indication for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. ZYNRELEF was previously approved for foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures in adults. This expanded indication for ZYNRELEF will now cover an estimated 13 million procedures annually, an estimated increase of 86% over prior indicated procedures. To obtain this labeling expansion, Heron successfully conducted studies for cesarean section, spinal surgery, augmentation mammoplasty, and total shoulder arthroplasty. No unique safety issues were identified from the new clinical trials, and the bupivacaine and meloxicam blood concentrations were consistent with previous experience following ZYNRELEF administration. "The expanded indication is poised to have a transformative impact on patient care, providing healthcare professionals with a versatile and effective solution for managing postoperative pain across an even wider range of surgical procedures. The new label expansion and recent partnership with CrossLink, combined with the potential approval of the Vial Access Needle ("VAN") later this year, are expected to have a significant positive impact for ZYNRELEF and the Company," said Craig Collard, Chief Executive Officer of Heron. "We're excited for the opportunity to give even more healthcare providers and patients a new, safe and effective option for achieving long-lasting non-opioid pain control after painful surgical procedures," said Bill Forbes, Executive Vice President, Chief Development Officer at Heron. "This new approval further reinforces our commitment to providing meaningful solutions to address unmet medical needs in the acute care and oncology settings." ZYNRELEF is the first and only therapy for postoperative pain management to be rigorously tested in Phase 3 studies and demonstrate superiority to bupivacaine solution, the current standard-of-care. ZYNRELEF demonstrated superiority compared to bupivacaine with lower pain scores, fewer patients experiencing severe pain, and lower opioid consumption. ZYNRELEF was initially approved by the FDA in May 2021 and received approval of the first supplemental NDA for an expanded label in December 2021. "Patients undergoing orthopedic procedures often experience severe pain, slowing down their recovery time and potentially leading to other complications. Reducing patients' pain within the first three days is critical for patient satisfaction, and having a product like ZYNRELEF now available for additional orthopedic procedures is a great benefit to have in my practice," said Alexander Sah, M.D., orthopedic surgeon at Sah Orthopaedic Associates. "ZYNRELEF helps my patients recover fully, be discharged sooner, and have significantly less pain, with little to no opioid use." Important Safety Information for Patients ZYNRELEF contains an NSAID (non-steroidal anti-inflammatory drug), a type of medicine which Can increase the risk of a heart attack or stroke that can lead to death. This risk increases with higher doses and longer use of an NSAID. Cannot be used during heart bypass surgery. Can increase the risk of gastrointestinal bleeding, ulcers, and tears. ZYNRELEF should also not be used if you are allergic to any component of ZYNRELEF, similar local anesthetics, aspirin or other NSAIDs (such as ibuprofen or naproxen), or have had an asthma attack, hives, or other allergic reaction after taking any of these medicines. as a paracervical block, during childbirth. The most common side effects of ZYNRELEF are soft tissue procedures: vomiting and orthopedic procedures: constipation and headache. The medicines in ZYNRELEF (a local anesthetic and an NSAID) may affect the nervous and cardiovascular system; may cause liver or kidney problems; may reduce the effects of some blood pressure medicines; should be avoided if you have severe heart failure; may cause adverse effects on cartilage; may cause a rare blood disorder, or life-threatening skin or allergic reactions; may harm your unborn baby if received at 20 weeks of pregnancy or later; and may cause low red blood cells (anemia). Tell your healthcare provider about all your medical conditions and about all the medicines you take including prescription or over-the-counter medicines, vitamins, or herbal supplements to discuss if ZYNRELEF is right for you. Talk to your healthcare provider for medical advice about side effects. Report side effects to Heron at 1-844-437-6611 The information provided here is not comprehensive. Please see full Prescribing Information, including Boxed Warning. About ZYNRELEF ZYNRELEF is the first and only dual-acting local anesthetic that delivers a fixed-dose combination of the local anesthetic bupivacaine and a low dose of nonsteroidal anti-inflammatory drug meloxicam. ZYNRELEF is the first and only extended-release local anesthetic to demonstrate in Phase 3 studies significantly reduced pain and significantly increased proportion of patients requiring no opioids through the first 72 hours following surgery compared to bupivacaine solution, the current standard-of-care local anesthetic for postoperative pain control. ZYNRELEF was initially approved by the U.S. Food and Drug Administration (the "FDA") in May 2021 for use in adults for soft tissue or periarticular instillation to produce postsurgical analgesia for up to 72 hours after bunionectomy, open inguinal herniorrhaphy and total knee arthroplasty. In December 2021, the FDA approved an expansion of ZYNRELEF's indication to include foot and ankle, small-to-medium open abdominal, and lower extremity total joint arthroplasty surgical procedures. On January 23, 2024, the FDA approved ZYNRELEF for soft tissue and orthopedic surgical procedures including foot and ankle, and other procedures in which direct exposure to articular cartilage is avoided. Safety and efficacy have not been established in highly vascular surgeries, such as intrathoracic, large multilevel spinal, and head and neck procedures. ZYNRELEF was granted a marketing authorization by the European Commission in September 2020 and by the United Kingdom Regulatory Authority in January 2021. In August 2023, we cancelled the ZYNRELEF U.K. marketing authorization and, in October 2023, we cancelled the ZYNRELEF European Union (EU) marketing authorization, as we do not plan to commercially launch ZYNRELEF in the U.K. or the EU. About Heron Therapeutics, Inc. Heron Therapeutics, Inc. is a commercial-stage biotechnology company focused on improving the lives of patients by developing and commercializing therapeutic innovations that improve medical care. Our advanced science, patented technologies, and innovative approach to drug discovery and development have allowed us to create and commercialize a portfolio of products that aim to advance the standard-of-care for acute care and oncology patients.

Read More

MedTech

Stevanato Group Launches EZ-fill® Kit and Laboratory Fill and Finish Service to Support Small Batch Drug Development and Commercialization

Stevanato Group | January 25, 2024

Stevanato Group S.p.A. a leading global provider of drug containment and delivery solutions to the pharmaceutical, biotechnology, and life sciences industries, unveiled today two new offerings for efficient small batch pharmaceutical manufacturing: the EZ-fill® Kit and the non-GMP laboratory fill and finish service at its Technology Excellence Centers (TEC). In a context where reducing time-to-market is key, Stevanato Group’s new EZ-fill® Kit offers fast access to a customizable and versatile solution to pharma and biotech companies needing to efficiently fill small batches with high-quality injectable formulations during clinical trials or commercial phases. The surge the industry has seen in biopharmaceuticals treating various diseases in several therapeutical areas may signal a significant growth potential for pharmaceutical companies. Injectables, comprising more than 60% of the over 21,000 drugs currently in development, of which 44% are biopharmaceuticals, require high-performance primary packaging and delivery technologies for proper storage and administration. Stevanato Group’s EZ-fill® Kit builds on its existing ready-to-use platform of pre-sterilized containment solutions – vials, cartridges, and syringes – allowing customers to effectively screen different primary packaging in combination with drug products. The kit will be available as a modular box made up of glass ready-to-use drug containers and add-on components on request, shipped by courier. As a result, the platform can bring enhanced levels of quality and safety to patients across the entire drug life cycle and improve the rate at which new drugs enter the market. EZ-fill® Kit will be presented at Pharmapack and is expected to be available commercially beginning in the second quarter of 2024. Additionally, to better support customers, Stevanato Group has introduced a non-GMP laboratory filling and finishing service at its Technology Excellence Centers (TEC) in Boston, USA, and Piombino Dese, Italy. This new service allows customers to assess and identify the possible effects of the fill-and-finish process on their product performance as early as the container selection stage, thus de-risking processes and enhancing development and commercialization strategy. “In the race to bring new advanced biopharmaceutical products to market and to patients, Stevanato Group is tackling the challenge of supporting customers with flexible drug containment and filling solutions in a timely manner," says Fabio Bertacchini, Senior Director EZ-fill® Vials & Cartridges at Stevanato Group. "Stevanato Group remains focused on developing new offerings that can help raise pharmaceutical manufacturing standards. By leveraging the expertise provided by our global TEC Centers, we aim to support customers' innovation, helping them face tests and de-risking processes and making right-the-first-time choices throughout their drug development journey.” About Stevanato Group Founded in 1949, Stevanato Group is a leading global provider of drug containment, drug delivery and diagnostic solutions to the pharmaceutical, biotechnology and life sciences industries. The Group delivers an integrated, end-to-end portfolio of products, processes and services that address customer needs across the entire drug life cycle at each of the development, clinical and commercial stages. Stevanato Group’s core capabilities in scientific research and development, its commitment to technical innovation and its engineering excellence are central to its ability to offer value added solutions to clients.

Read More

Medical

Capricor Therapeutics Announces Collaboration with the National Institutes of Health for Clinical Trial of Novel Exosome-Based Multivalent Vaccine

Capricor Therapeutics | January 24, 2024

Capricor Therapeutics a biotechnology company developing transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases, today announced that Capricor’s proprietary StealthX™ exosome-based multivalent vaccine (StealthX™ vaccine) for the prevention of SARS-CoV-2 has been selected to be part of Project NextGen, an initiative by the U.S. Department of Health and Human Services to advance a pipeline of new, innovative vaccines providing broader and more durable protection for COVID-19. As part of Project NextGen, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, will conduct a Phase 1 clinical study with Capricor’s StealthX™ vaccine, subject to regulatory approval. NIAID's Division of Microbiology and Infectious Diseases (DMID) would oversee the study. “We are extremely pleased with the external support from the NIH, which highlights the clinical potential of our StealthX™ exosome platform technology and provides non-dilutive support for the advancement of our vaccine candidate,” said Linda Marbán, Ph.D., Capricor’s chief executive officer. “Our proprietary vaccine is multivalent, delivering both the highly mutagenic S protein (Spike) and the more stable N protein (Nucleocapsid) which potentially may offer broader and longer lasting immunity against SARS-CoV-2. We view the NIH SARS-CoV-2 project as the first clinical step towards development of a next generation vaccine platform that may be extended to other infectious diseases. Our platform is designed to combine the speed of response of an mRNA vaccine with the potential efficacy of a protein vaccine. Further, our StealthX™ vaccine is free of both adjuvant and lipid nanoparticles and in preclinical studies has generated a strong immune response at low doses. We believe our StealthX™ vaccine may offer a clinically meaningful alternative for highly mutating or novel infectious agents.” Dr. Marbán continued, “This is the opportunity we have been waiting for as it allows the exosome technology to be brought into the clinic as we continue to focus our resources on CAP-1002 for the treatment of Duchenne muscular dystrophy. Beyond SARS-CoV-2, we look forward to exploring the potential therapeutic utility of this platform, and more broadly, expanding our pipeline into therapeutics and future partnership opportunities.” About Capricor’s StealthX™ Vaccine The StealthX™ vaccine is a proprietary vaccine developed internally by Capricor utilizing exosomes that were engineered to express either spike or nucleocapsid proteins on the surface. Preclinical results from murine and rabbit models published in Microbiology Spectrum, showed the StealthX™ vaccine, resulted in robust antibody production, potent neutralizing antibodies, a strong T-cell response and a favorable safety profile. These effects were obtained with administration of only nanogram amounts of protein and without adjuvant or synthetic lipid nanoparticles (LNPs). Exosomes offer a new antigen delivery system that potentially could be utilized to rapidly generate multivalent protein-based vaccines. Exosomes, first identified as extracellular vesicles, are small vesicles enriched in specific subsets of proteins, RNAs and lipids and responsible for cell-to-cell communication. About Capricor Therapeutics Capricor Therapeutics, Inc. is a biotechnology company focused on the development of transformative cell and exosome-based therapeutics for the treatment and prevention of rare diseases. Capricor’s lead candidate, CAP-1002, is an allogeneic cardiac-derived cell therapy currently in Phase 3 clinical development for treating Duchenne muscular dystrophy (DMD). Further, Capricor has entered into a partnership for the exclusive commercialization and distribution of CAP-1002 for DMD in the United States and Japan with Nippon Shinyaku Co., Ltd. (U.S. subsidiary: NS Pharma, Inc.), subject to regulatory approval. Capricor is also developing its exosome technology as a potential next-generation therapeutic platform. Our proprietary StealthX™ exosome platform has potential for a broad range of new therapeutic applications in the field of vaccinology as well as targeted oligonucleotide, protein and small molecule therapeutics to treat or prevent a variety of diseases.

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