Cell and Gene Therapy

Hamilton and BioFluidica Pen Next Generation Liquid Biopsy Platform Co-Marketing Agreement

Hamilton and BioFluidica
Biofluidica, Inc., and Hamilton Company, announced a co-marketing agreement to bring advanced Liquid Biopsy capabilities to laboratories worldwide. Biofluidica has developed the next-generation liquid biopsy platform, enabling Hamilton liquid handlers to process biological samples to isolate extremely rare circulating tumor cells, circulating Leukemic cells, fetal cells, cfDNA, and exosomes. The Biofluidica platform, LiquidScan™, integrates seamlessly into the Hamilton pipetting robots. The high precision fluid control provided by the Hamilton automated pipetting channels is designed to avoid processing loss using the Biofluidica proprietary closed-loop pipetting interface with the Biofluidica microfluidic biomarker selection chips.

This announcement represents early commercialization for BioFluidica and a unique alliance for Hamilton Company. The STARlet offers a custom application-configurable liquid handling robot with sensitive programmable pneumatic features that enable walk-away automation for precision biological procedures. LiquidScan utilizes these features to isolate and enrich rare biomarker populations directly from biological samples such as a blood draw potentially replacing the need for surgical biopsies and making testing available for cancer types not previously amenable to surgical biopsy.

"LiquidScan is a novel platform that enhances the ability to perform diagnostic testing applied to many diseases, including several types of cancer, prenatal diagnostics, stroke, and infectious diseases. We have worked with Hamilton to ensure seamless automation allowing for high-throughput and lower-cost testing than current surgical biopsy procedures. There is a win-win scenario here for patients, physicians, and the healthcare system. Because LiquidScan uses a standard blood draw, and non-invasive screening, patients can receive closer monitoring of treatment regimens, and physicians can attain higher quality and earlier patient results. Expensive and time-consuming surgical procedures can be removed from the health-care system."

Rolf Muller, BioFluidica CEO

About Hamilton
Hamilton is a leading global manufacturer, providing automated liquid handling workstations and laboratory automation technology to the scientific community. With a focus on innovative design, Hamilton products incorporate patented liquid handling technologies into a portfolio that includes liquid handling platforms, standard application-based solutions, small devices, consumables, and OEM liquid handling solutions.
Known for advancing life science, clinical diagnostics, forensics, and biotechnology industries, Hamilton products offer reliability, performance, and flexibility. Ensuring a continuous commitment to quality, Hamilton utilizes state-of-the-art manufacturing at production facilities in Reno, Nevada, and Bonaduz, Switzerland and has earned a global ISO 9001 certification. Privately held, Hamilton maintains headquarters in Reno, Nevada; Franklin, Massachusetts; and Bonaduz, Switzerland, along with subsidiary offices throughout the world.

About BioFluidica
BioFluidica Inc. is a privately held biotechnology company that has developed a revolutionary liquid biopsy platform.

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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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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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Nimbus Therapeutics Announces Expansion of Its Immunology Drug Discovery Pipeline

Nimbus Therapeutics | January 08, 2024

Nimbus Therapeutics, LLC a biotechnology company that designs and develops breakthrough medicines through its powerful computational drug discovery engine, announced the advancement and expansion of its pipeline with the addition of discovery programs targeting innate immunity pathways. These programs, targeting the salt-inducible kinase (SIK) family and cyclic GMP-AMP synthase (cGAS), represent promising opportunities to leverage Nimbus’ industry-leading computational and structure-based drug design expertise to develop highly selective, potent medicines addressing areas of significant unmet need. "Building on the success of our TYK2 program, we are broadening our drug discovery engine to unlock new difficult-to-drug targets with compelling biology,” said Peter Tummino, Ph.D., Chief Scientific Officer of Nimbus. “SIK and cGAS are critical targets in highly prevalent diseases that are well suited to Nimbus’ structure-based drug design approach. We look forward to advancing our discovery and development programs across oncology, immunology, and metabolism to deliver transformative medicines to patients.” Nimbus is advancing its Phase 1/2 trial (NCT05128487) of NDI-101150, a small molecule inhibitor of hematopoietic progenitor kinase 1 (HPK1), and has reported positive dose escalation data showing potential monotherapy clinical benefit for patients with solid tumors. Furthermore, the company expects to initiate IND-enabling activities this year for its oncology program targeting Werner syndrome helicase (WRN). In collaboration with Eli Lilly and Company, Nimbus continues to progress the development of novel targeted therapies that activate AMPK to potentially treat a broad range of metabolic disorders. Nimbus continues to expand its platform capabilities with ongoing investments in cutting-edge technology for drug discovery. Alongside proprietary computational tools which the company has developed in-house, Nimbus’ platform leverages state-of-the-art technology through collaborations such as its recently announced partnership with Anagenex, a leader in generative AI for drug design. Jeb Keiper, M.S., MBA, Nimbus’ Chief Executive Officer, will provide an overview of the company’s progress and pipeline and anticipated milestones for 2024 and beyond at the 42nd Annual J.P. Morgan Healthcare Conference on Monday, January 8, 2024 at 7:30 am PT. About Nimbus Therapeutics Nimbus Therapeutics is a clinical-stage, structure-based drug discovery company developing novel small molecule medicines designed to act against well-validated but difficult-to-drug targets implicated in multiple human diseases. Nimbus combines leading-edge computational technologies with a tailored array of machine learning-based predictive modeling approaches. Nimbus’ pipeline includes a clinical-stage HPK1 inhibitor for the treatment of cancer (NCT05128487), as well as a diverse portfolio of preclinical programs focused on cancer, autoimmune conditions, and metabolic diseases. Nimbus is headquartered in Boston, Mass.

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