A Phase 3 Study to Evaluate the Efficacy and Safety of 3K3A-APC in Combination with Tissue Plasminogen Activator, Mechanical Thrombectomy, or Both in Subjects with Moderate to Severe Acute Ischemic Stroke

The purpose of this study is to evaluate the efficacy and safety of intravenous doses of 3K3A-APC, a recombinant variant of human activated protein C (APC), in the treatment of acute ischemic stroke following treatment with thrombolysis, mechanical thrombectomy or both.

Start Date01 Oct 2024

Sponsor / Collaborator

ZZ Biotech LLC

[+4]

NCT05039268

/ CompletedPhase 2IIT

A Phase 2 Open Label Trial of 3K3A-APC in Amyotrophic Lateral Sclerosis

Phase 2 open label trial to investigate the safety and potentially efficacy of 3K3A-APC in patients with Amyotrophic Lateral Sclerosis (ALS).

Start Date25 Nov 2021

Sponsor / Collaborator

Macquarie University

[+1]

NCT02222714

/ CompletedPhase 2

A Multi-center, Phase 2 Study Using a Continual Reassessment Method to Determine the Safety and Tolerability of 3K3A-APC in Combination With tPA, Mechanical Thrombectomy or Both in Moderate to Severe Acute Ischemic Stroke

The purpose of this study was to evaluate the safety, pharmacokinetics (PK) and preliminary efficacy of multiple ascending intravenous doses of 3K3A-APC, a Recombinant Variant of Human activated protein C (APC), in in the treatment of acute ischemic stroke following treatment with recombinant tissue plasminogen activator (tPA), mechanical thrombectomy or both.

Start Date01 Oct 2014

Sponsor / Collaborator

ZZ Biotech LLC

[+4]

100 Clinical Results associated with 3K3A-APC

100 Translational Medicine associated with 3K3A-APC

100 Patents (Medical) associated with 3K3A-APC

Literatures (Medical) associated with 3K3A-APC

01 Feb 2025·Blood Vessels, Thrombosis & Hemostasis

In vivo neuroprotection in ischemic stroke by activated protein C requires β-arrestin 2

Article

Author: Zlokovic, Berislav V ; Fernández, José A ; Kisler, Kassandra ; Wang, Yaoming ; Mack, William J ; Rust, Ruslan ; Griffin, John H ; Xiang, Biao

The protease activated protein C (APC) and its variants provide neuroprotection for murine ischemic stroke and mortality reduction for murine sepsis. For these actions, APC's in vivo mechanism of action, similar to in vitro studies using cultured cells, involves protease activated receptor 1 (PAR1)-mediated biased signaling. APC/PAR1 signaling in vitro requires β-arrestin 2, an intracellular scaffold protein, and β-arrestin 2-initiated signaling can alter diverse intracellular signaling pathways. This study used a proximal transient middle cerebral artery occlusion model to study the neuroprotective actions of the signaling-selective APC variant, 3K3A-APC, in β-arrestin 2-deficient (Arrb2 ^-/-) mice. Based on quantitation of brain injuries, 3K3A-APC significantly limited brain injury in control mice to relatively small, localized areas, whereas 3K3A-APC's protection was lost in Arrb2 ^-/- mice. Thus, the major in vitro mechanism of action that requires β-arrestin 2 for APC/PAR1 biased signaling is central to the in vivo mechanism of action for APC's neuroprotection.

01 Jan 2025·Journal of Trauma and Acute Care Surgery

Cytoprotective 3K3A-activated protein C and plasma: A comparison of therapeutics for the endotheliopathy of trauma

Article

Author: Ramser, Benjamin ; Moore, Ernest ; Mosnier, Laurent ; Cohen, Mitchell ; Stafford, Preston ; Hallas, William ; Stocker, Benjamin ; Mitra, Sanchayita ; Hansen, Kirk ; Gallagher, Lauren T. ; Schaid, Terry ; Thielen, Otto ; D′Alessandro, Angelo ; Griffin, John ; Kelher, Marguerite ; Debot, Margot ; Silliman, Christopher C.

BACKGROUNDBoth healthy plasma and cytoprotective aPC (3K3A-aPC) have been shown to mitigate the endotheliopathy of trauma (EoT), but optimal therapeutics remain unknown. Our aim was therefore to determine optimal therapies to mitigate EoT by investigating the effectiveness of 3K3A-aPC with and without plasma-based resuscitation strategies.METHODSElectric cell-substrate impedance sensing (ECIS) was used to measure real-time permeability changes in endothelial cells. Cells were treated with a 2-μg/mL solution of aPC 30 minutes prior to stimulation with plasma taken from severely injured trauma patients (ISS > 15 and BD < −6) (TP). Healthy plasma, or plasma frozen within 24 hours (FP24), was added concomitantly with TP. Cells treated with thrombin and untreated cells were included in this study as control groups.RESULTSA dose-dependent difference was found between the 5% and 10% plasma-treated groups when human umbilical vein endothelial cells were simultaneously stimulated with TP (μd, 7.346; 95% confidence interval [CI], 4.574–10.12). There was no difference when compared with TP alone in the 5% (μd, 5.713; 95% CI, −1.751 to 13.18) or 10% group (μd, −1.633; 95% CI, −9.097 to 5.832). When 3K3A-aPC was added to plasma and TP, the 5% group showed improvement in permeability compared with TP alone (μd, 10.11; 95% CI, 2.642 to 17.57), but there was no difference in the 10% group (μd −1.394; 95% CI, −8.859 to 6.070). The combination of 3K3A-aPC, plasma, and TP at both the 5% plasma (μd, −28.52; 95% CI, −34.72 to −22.32) and 10% plasma concentrations (μd, −40.02; 95% CI, −46.22 to −33.82) had higher intercellular permeability than the 3K3A-aPC preincubation group.CONCLUSIONOur data show that FP24, in a posttrauma environment, pretreatment with 3K3A-aPC can potentially mitigate the EoT to a greater degree than FP24 with or without 3K3A-aPC. Although further exploration is needed, this represents a potentially ideal and perhaps superior therapeutic treatment for the dysregulated thromboinflammation of injured patients.

01 Nov 2024·Journal of Stroke and Cerebrovascular Diseases

Effect of post thrombolytic intracerebral hemorrhage volume on 90-day outcomes in acute ischemic stroke patients

Article

Author: Gomez, Camilo R ; Qureshi, Adnan I ; Ma, Xiaoyu ; Huang, Yilun ; French, Brandi R ; Siddiq, Farhan ; Gillani, Syed A ; Fakih, Rami ; Lyden, Patrick D ; Bains, Navpreet K

BACKGROUND AND PURPOSEPost thrombolytic intracerebral hemorrhage (ICH) is associated with higher rate of death or disability in acute ischemic stroke patients. We investigated the relationship between post thrombolytic ICH volume and change in volume and death or disability at 90 days in acute ischemic stroke patients.METHODSWe analyzed 110 patents recruited in the Safety Evaluation of 3K3A-APC in Ischemic Stroke (RHAPSODY) trial who received intravenous tissue plasminogen activator (tPA) followed by mechanical thrombectomy (if indicated) and 3K3A-APC or placebo. ICH volume was measured at Day 2 and Day 7 using susceptibility weighted sequence (SWI) on magnetic resonance imaging (MRI). We also calculated the post thrombolytic ICH volume change between Day 2 and Day 7. Outcomes were determined by using utility weighted modified Rankin scale (UW-mRs) at 90-days, Outcomes were determined by using utility weighted modified Rankin scale (UW-mRS) at 90 days. To minimize interpretation bias, outcome assessors were blinded to the treatment allocation and clinical data.We adjusted for age, gender, National Institutes of Health Stroke Scale (NIHSS) score (<10,10-19 and ≥20), location of hemorrhage (single basal ganglia hemorrhage, single lobar, single cerebellum, and multiple sites) in multivariate regression analysis.RESULTSA total of 88 (80%) of 110 patients had post thrombolytic ICH (mean volume 28.3 ml ± SD 62 ml). The strata of ICH volume were not associated with UW-mRs at 90 days: <20 cc (regression coefficient (RC)-0.05, p= 0.58), 20-39 cc (RC-0.22, p=0.17), or ≥40 cc (RC-0.34, p= 0.083) compared with no ICH after adjusting for potential confounders. Change in ICH mean volume 26.78 ml ±59.68, 52 had increase in volume) between Day 2 and day 7 was not associated with UW-mRS at 90 days (RC -67.71, p= 0.06).CONCLUSIONSWe did not observe any independent effect of post thrombolytic ICH volume on death or disability in acute ischemic stroke patients. Although further studies must be done, our data suggest that strategies to prevent ICH expansion such as antifibrinolytic medications and reduction in ICH volume such as surgical evacuation may not reduce death or disability in acute ischemic stroke patients with post thrombolytic ICH.

News (Medical) associated with 3K3A-APC

15 Nov 2023

·www.biospace.com

ZZ Biotech Hit with Data Manipulation Allegations Regarding Stroke Trial

Pictured: Doctor looking at brain scan images/iStock, Tippapatt Phase II data supporting ZZ Biotech’s investigational stroke therapy 3K3A-APC might have been doctored to make the candidate appear safer and more effective than it actually is, according to an investigative report by the journal Science, citing a small group of whistleblowers. The whistleblowers produced a 113-page dossier—which has already been submitted to the National Institutes of Health (NIH)—detailing a potentially higher rate of deaths in patients that received the experimental treatment compared to placebo. Those who were given 3K3A-APC also showed worse disability and dependency toward the end of the mid-stage study. Besides the Phase II data, the dossier obtained by Science also alleges that preclinical data had been tampered with, including papers that supported the human testing for 3K3A-APC. Overall, the whistleblowers flagged a total of 35 papers with manipulated data plus two publications in connection with 3K3A-APC’s Phase II trial, according to Science. Underpinning these data manipulation allegations is a “culture of intimidation” at the lab of Berislav Zlokovic, co-founder of Houston-based ZZ Biotech and chairman of its scientific advisory board. According to the whistleblowers, Zlokovic allegedly routinely pressured his scientists to tweak the data in favor of 3K3A-APC. Zlokovic would allegedly tell his scientists to “change lab notebooks” after experiments so that they “only contained the desired results,” according to Science. The University of Southern California (USC), where Zlokovic works as a professor of physiology and neuroscience, said that it will conduct a confidential review of the dossier and investigate its merits. Zlokovic declined to comment to Science but his lawyer said in a statement that the professor knows some of the dossier’s contents “to be completely incorrect.” In acute ischemic stroke, 3K3A-APC’s development is being supported by the NIH’s National Institute of Neurological Disorders and Stroke, which has awarded USC a $30 million grant to conduct a Phase III trial. The first tranche of this grant, amounting to $4 million, was disbursed in May 2022. 3K3A-APC is a genetically engineered variant of the activated protein C (APC) molecule, which is a serine protease with known anticoagulant and cell-protective activity. This mechanism of action allows the candidate to reduce bleeding and inflammation in the brain following a stroke episode, as well as prevent cell death in the neurons, glia and other cells in the brain. In its Phase II RHAPSODY study, 3K3A-APC treatment led to a significant reduction in intracranial hemorrhage rates versus placebo, as well as a substantial, but not significant, reduction in the total hemorrhage volume. The mid-stage trial also documented an estimated toxicity rate of 7%. Beyond stroke, 3K3A-APC is currently in a Phase II study for amyotrophic lateral sclerosis and is about to enter mid-stage development for diabetic wound healing, according to ZZ Biotech’s website. Tristan Manalac is an independent science writer based in Metro Manila, Philippines. He can be reached at tristan@tristanmanalac.com or tristan.manalac@biospace.com.

Phase 2Clinical Result

21 Feb 2023

·www.prnewswire.com

Amyotrophic Lateral Sclerosis Pipeline Booms as 100+ Therapies Likely to Enter in the Treatment Domain | DelveInsight

The prevalence of amyotrophic lateral sclerosis has been rising over the past few years, which prompts the growing demand for treatment options. The increasing prevalence of amyotrophic lateral sclerosis and the growing research and development activities to develop novel therapies to treat amyotrophic lateral sclerosis to drive the market. The companies developing the potential therapies in the last stage of development include Biogen, AB Sciences, Helixmith, and several others. LAS VEGAS, Feb. 21, 2023 /PRNewswire/ -- DelveInsight's ' Amyotrophic Lateral Sclerosis Pipeline Insight – 2023 ' report provides comprehensive global coverage of available, marketed, and pipeline amyotrophic lateral sclerosis therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the amyotrophic lateral sclerosis pipeline domain. Key Takeaways from the Amyotrophic Lateral Sclerosis Pipeline Report DelveInsight's amyotrophic lateral sclerosis pipeline report depicts a robust space with 100+ active players working to develop 100+ pipeline therapies for amyotrophic lateral sclerosis treatment. Key amyotrophic lateral sclerosis companies such as Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others are evaluating new amyotrophic lateral sclerosis drugs to improve the treatment landscape. Promising amyotrophic lateral sclerosis pipeline therapies in various stages of development include BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others. In February 2023, NeuroSense Therapeutics Ltd. and QuantalX Neuroscience Ltd; the developer of Delphi-MD, a clinically objective neurodiagnostic medical device , announced a collaboration to improve early diagnosis and treatment of neurodegenerative diseases.In addition, the companies agreed that QuantalX's Delphi-MD would be used for early diagnosis and ongoing monitoring of trial participants in NeuroSense's planned future pivotal Phase III efficacy trial of PrimeC in people living with amyotrophic lateral sclerosis (ALS), pending the successful conclusion of its ALS Phase IIb trial. In February 2023, Amylyx Pharmaceuticals, Inc. announced the completion of enrollment in PHOENIX, a global, 48-week, randomized, placebo-controlled Phase III clinical trial of AMX0035 (sodium phenylbutyrate and taurursodiol [also known as ursodoxicoltaurine]) in people living with amyotrophic lateral sclerosis (ALS). Amylyx anticipates topline results in 2024. The study enrolled 664 participants living with ALS. In February 2023, UMass Chan Medical School signed a three-year sponsored research agreement with NeuShen Therapeutics Inc. to investigate a gene therapy treatment for amyotrophic lateral sclerosis, a rare neurological disease. Based in Shanghai and Boston, NeuShen is focused on developing innovative treatments for central nervous system disorders using adeno-associated virus-based gene therapy and small molecule delivery. In January 2023, Inflamed Pharma, part of the incubator and accelerator company Xlife Sciences, partnered with researchers at the University Medical Center Gottingen in Germany to develop its investigational therapy ProcCluster for the treatment of amyotrophic lateral sclerosis (ALS).The collaboration, led by Jan C. Koch, MD, a principal investigator at the university's Department of Neurology, will be focused particularly on investigating ProcCluster in cellular models of ALS. In January 2023, Amylyx Pharmaceuticals and Neopharm signed a license and distribution agreement to commercialize AMX0035 (sodium phenylbutyrate and ursodoxicoltaurine) to treat amyotrophic lateral sclerosis (ALS).Neopharm will commercialize the oral, fixed-dose medication in Israel, West Bank, Gaza, and the Palestinian Authority, subject to regulatory review and clearance.According to the agreement, Amylyx will grant exclusive rights to Neopharm for commercializing the therapy in the covered territory. In January 2023, uniQure N.V. and Apic Bio announced that they have entered into a global licensing agreement for APB-102 to treat superoxide dismutase 1 (SOD1) amyotrophic lateral sclerosis (ALS), a rare, genetic form of ALS. Under the agreement, uniQure acquires global rights for the development and commercialization of APB-102, adding to its pipeline of gene therapies to treat neurological disorders. Request a sample and discover the recent advances in amyotrophic lateral sclerosis drug treatment @ Amyotrophic Lateral Sclerosis Pipeline Report The amyotrophic lateral sclerosis pipeline report provides detailed profiles of pipeline assets, a comparative analysis of clinical and non-clinical stage amyotrophic lateral sclerosis drugs, inactive and dormant assets, a comprehensive assessment of driving and restraining factors, and an assessment of opportunities and risks in the amyotrophic lateral sclerosis clinical trial landscape. Amyotrophic Lateral Sclerosis Overview Amyotrophic Lateral Sclerosis (ALS) is a rare neurological disease that affects the nerve cells (neurons) that control voluntary muscle movement (those muscles we choose to move). Voluntary muscles are responsible for movements such as chewing, walking, and talking. The disease is progressive, which means that the symptoms worsen over time. There is currently no cure for ALS and no effective treatment to slow or reverse the disease's progression. Muscle weakness or stiffness are common early ALS symptoms. Individuals gradually lose strength and the ability to speak, eat, move, and even breathe as all voluntary muscles are affected. Most people with ALS die from respiratory failure, usually within 3 to 5 years of the onset of symptoms. However, approximately 10% of people with ALS live for ten years or more. There is no single test that can definitively diagnose ALS. A detailed history of the symptoms observed by a physician during physical examination, as well as a review of the individual's full medical history and a series of tests to rule out other diseases, are used to make the ALS diagnosis. Find out more about drugs for amyotrophic lateral sclerosis @ New Amyotrophic Lateral Sclerosis Drugs A snapshot of the Amyotrophic Lateral Sclerosis Pipeline Drugs mentioned in the report: Learn more about the emerging amyotrophic lateral sclerosis pipeline therapies @ Amyotrophic Lateral Sclerosis Clinical Trials Amyotrophic Lateral Sclerosis Therapeutics Assessment The amyotrophic lateral sclerosis pipeline report proffers an integral view of amyotrophic lateral sclerosis emerging novel therapies segmented by stage, product type, molecule type, mechanism of action, and route of administration. Scope of the Amyotrophic Lateral Sclerosis Pipeline Report Coverage: Global Therapeutic Assessment By Product Type: Mono, Combination, Mono/Combination Therapeutic Assessment By Clinical Stages: Discovery, Pre-clinical, Phase I, Phase II, Phase III Therapeutics Assessment By Route of Administration: Oral, Parenteral, Intravenous, Subcutaneous, Topical Therapeutics Assessment By Molecule Type: Monoclonal Antibody, Peptides, Polymer, Small molecule, Gene therapy Therapeutics Assessment By Mechanism of Action: RNA interference, Superoxide dismutase 1 expression inhibitors, Angiogenesis inhibitors, Colony stimulating factor inhibitors, Coronavirus-3C-like-proteinase inhibitors, Endopeptidase Clp inhibitors, Focal adhesion protein-tyrosine kinase inhibitors, Lyn protein-tyrosine kinase inhibitors, Macrophage colony-stimulating factor receptor modulators, Mast cell inhibitors, Platelet-derived growth factor receptor antagonists, Protein tyrosine kinase inhibitors, Proto oncogene protein c-kit inhibitors, Proto-oncogene protein c-fyn modulators, Type 3 fibroblast growth factor receptor antagonists, Angiogenesis inducing agents, Gene transference, Hepatocyte growth factor expression stimulants, G protein-coupled receptor modulators, HSP90 heat-shock protein modulators, Ion channel modulators, Antioxidants, NAD(P)H dehydrogenase (quinone) modulators, CD40 ligand inhibitors, Complement C1 inhibitors, Cyclo-oxygenase 2 inhibitors, DNA gyrase inhibitors Key Amyotrophic Lateral Sclerosis Companies: Biogen, Ionis Pharmaceuticals, Ferrer Internacional S.A., AbbVie, Calico Life Sciences LLC, Genuv Inc., Kadimastem, Corcept Therapeutics, AL-S Pharma, Rapa Therapeutics LLC, Cytokinetics, MediciNova, Retrotope, Inc. Woolsey Pharmaceuticals, Sanofi, PTC Therapeutics, Helixmith Co., Ltd., Annexon, Inc., Denali Therapeutics Inc., Revalesio Corporation, Clene Nanomedicine, Ashvattha Therapeutics, Inc., Apellis Pharmaceuticals, Inc., Procypra Therapeutics, Knopp Biosciences, InFlectis BioScience, AI Therapeutics, Inc., Cellenkos, ZZ Biotech, LLC, QurAlis Corporation, Alector Inc., NeuroSense Therapeutics Ltd., Novartis Pharmaceuticals, Eledon Pharmaceuticals, and others. Key Amyotrophic Lateral Sclerosis Pipeline Therapies: BIIB067, FAB122, ABBV-CLS-7262, Trametinib, BIIB105, AstroRx, Dazucorilant, AP-101, RAPA-501, ION-363, Reldesemtiv, MN-166, RT001, Fasudil, SAR443820, PTC857, ANX005, DNL343, RNS60, BIIB100, CNMAu8, 18F-OP-801, Pegcetacoplan (APL-2), Cu(II)ATSM, KNS-760704, IFB-088, LAM-002A, CK 0803, 3K3A-APC, QRL-201, Dexpramipexole, AL001, PrimeC, BLZ945, AT-1501, and others. Dive deep into rich insights for new drugs for amyotrophic lateral sclerosis treatment; visit @ Amyotrophic Lateral Sclerosis Medications Table of Contents For further information on the amyotrophic lateral sclerosis pipeline therapeutics, reach out @ Amyotrophic Lateral Sclerosis Drug Treatment Related Reports Amyotrophic Lateral Sclerosis Epidemiology Amyotrophic Lateral Sclerosis Epidemiology Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted amyotrophic lateral sclerosis epidemiology in the 7MM, i.e., the United States, EU5 (Germany, Spain, Italy, France, and the United Kingdom), and Japan. Amyotrophic Lateral Sclerosis Market Amyotrophic Lateral Sclerosis Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key amyotrophic lateral sclerosis companies including Helixmith, Sanofi, Denali Therapeutics, Alector, GSK, NeuroSense Therapeutics, Biogen, among others. Duchenne Muscular Dystrophy Market Duchenne Muscular Dystrophy Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key Duchenne muscular dystrophy companies including Edgewise Therapeutics, Pfizer, Daiichi Sankyo, among others. Nonsense Mutation Duchenne Muscular Dystrophy Pipeline Nonsense Mutation Duchenne Muscular Dystrophy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key nonsense mutation Duchenne muscular dystrophy companies, including Taiho Pharmaceutical, Solid Biosciences, Capricor, Nippon Shinyaku, among others. Becker Muscular Dystrophy Pipeline Becker Muscular Dystrophy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key becker muscular dystrophy companies, including Epirium Bio, Ultragenyx, Strykagen, among others. Facioscapulohumeral Muscular Dystrophy PIpeline Facioscapulohumeral Muscular Dystrophy Pipeline Insight – 2023 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key facioscapulohumeral muscular dystrophy companies, including miRecule, Arrowhead Pharmaceuticals, Fulcrum Therapeutics, among others. 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It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Connect with us on LinkedIn |Facebook|Twitter Additionally, get in touch with our business executive to explore @ Healthcare Due Diligence Services Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

Phase 3License out/inPhase 2

25 May 2022

·www.biospace.com

Money on the Move: Biotechs Target Cancers, Dermatology and Strokes

Private investors, governmental institutions and longtime life sciences investors provided funding to develop therapies for cancers, dermatological problems and acute ischemic strokes. Unnamed private investors, governmental institutions and longtime life sciences investors supported these biotech companies with funding to develop therapies for hard-to-treat cancers, dermatological problems and acute ischemic strokes. Senti Biosciences Leading gene circuit company Senti Biosciences announced $5.175 million in funding from Leaps by Bayer, the impact investment arm of Bayer AG . The funding comes in the form of a Note Subscription Agreement for an unsecured, convertible promissory note. In December, Senti and Dynamics Special Purpose Corp announced a business combination to create a public company dedicated to gene therapies and gene circuit-engineered cells. When the deal is closed, the Note Subscription Agreement will be canceled and exchanged for DYNS Class A common stock at a conversion price of $10.00 per share. In early 2021, Senti Bio’s Series B financing was led by Leaps by Bayer and totaled around $105 million. The funding boosted the company’s off-the-shelf chimeric antigen receptor natural killer (CAR-NK) cell therapies for difficult-to-treat cancers, such as acute myeloid leukemia, colorectal cancer and hepatocellular carcinoma. Now, the extra $5.175 million from Leaps by Bayer will help bolster the CAR-NK programs as Senti hopes to submit Investigational New Drug (IND) applications next year. ZZ Biotech and the Keck School of Medicine ZZ Biotech and researchers at the Keck School of Medicine at the University of Southern California (USC) are working together on ZZ Biotech’s drug, 3K3A-APC. The drug is an experimental treatment for acute ischemic stroke. The two organizations announced that because of the success in the drug’s previous Phase II Raphsody clinical trial, the National Institute of Neurological Disorders and Stroke (NINDS), part of the U.S. National Institutes of Health (NIH), will award them a $30 million grant. The grant will fund a Phase III trial of 3K3A-APC. On Tuesday, ZZ Biotech and the Keck School of Medicine received $4 million as the first tranche. The rest of the $30 million will be given in tranches over the six years of the grant, pending the accomplishment of milestones. Patrick Lyden, M.D., professor of physiology and neuroscience and neurology at the Keck School of Medicine, said, “In addition to funding the upcoming Phase III trial, the grant is a recognition by the NINDS of the great need to find a suitable treatment that produces better patient outcomes while reducing the burdensome healthcare costs associated with ischemic stroke, the third leading cause of death and the most common cause of disability in industrialized nations.” Inceptor Bio Founded in 2020, Inceptor Bio just closed its Series A financing , gathering a solid $37 million. The North Carolina-based company focuses and developing therapies for difficult-to-treat cancers. The financing, led by Kineticos Venture, will fund two of Inceptor Bio’s imminent goals: first, to advance Inceptor’s CAR-T lead program to a Phase I clinical trial, and second, to finish building Inceptor’s new 29,000-square-foot facility in Gainesville, Florida. When complete, the facility will be a state-of-the-art cell and gene therapy GMP manufacturing site. Exavir Therapeutics Exavir Therapeutics, a company creating modality-agnostic antiviral treatments for HIV and other viral infections, closed a seed financing round worth $4 million. The seed funding was led by AlleyCorp and included participation from Gilead Sciences. With over $30 billion spent annually on antiretroviral HIV therapies worldwide, HIV treatment is a high-need, high-paying market. “We are thrilled to have the support of AlleyCorp and Gilead Sciences, a pioneer and leader in antiviral drug development,” said Alborz Yazdi, co-founder and president of Exavir. “With this financing, we are one step closer to our goal of bringing Exavir’s broad portfolio of long-acting antivirals to communities around the world affected by some of the most challenging viruses.” Biofrontera Dermatological product company Biofrontera closed a private placement worth $9.4 million. Roth Capital Partners and The Benchmark Company acted as the exclusive placement agents for the private offering with a single institutional investor. The transaction consisted of 3,419,000 shares of Biofrontera Inc. common stock, or common stock equivalents, with a warrant to purchase a single share at $2.75. The warrants’ exercise price is $2.77 per share. The funds will sustain Biofrontera through three clinical trials running in parallel on its flagship product Ameluz. Oviva Therapeutics Oviva Therapeutics, a Cambrian Biopharma pipeline company, announced $11.5 million in seed funding from Cambrian Biopharma. The announcement also included an in-licensing agreement with Massachusetts General Hospital (MGH) of a family of patents. Oviva, a biotech company focused on women’s health, aims to develop first-in-class therapeutics to improve healthspan – the period of life spent in good health - in women. The seed funding will go toward one of Oviva’s first goals, which is to work on ovarian aging. The company hopes to take research on Anti-Müllerian Hormone (AMH) genes in ovaries from pre-clinical studies to in-vivo clinical testing.

Gene TherapyLicense out/inPhase 1Phase 2Phase 3

100 Deals associated with 3K3A-APC

R&D Status

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Wound Infection	Phase 1	-	ZZ Biotech LLC	-
Ischemic stroke	Preclinical	-	ZZ Biotech LLC	01 Oct 2024
Ischemic stroke	Preclinical	-	University of Southern California	01 Oct 2024
Ischemic stroke	Discovery	-	ZZ Biotech LLC	01 Oct 2024
Ischemic stroke	Discovery	-	University of Southern California	01 Oct 2024
Amyotrophic Lateral Sclerosis	Discovery	Australia	ZZ Biotech LLC	25 Nov 2021

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT05039268 (CTgov)	Phase 2	Amyotrophic Lateral Sclerosis	16	3K3A-APC Protein (15mg Dose Group)	jqnopgziat(ntshnrvalj) = gwfjkdbqcw ywzoiyfrpm (ynpvkigxxf, wjlnocsdzg - bgdhdbwsde) View more	-	11 Oct 2023
				3K3A-APC Protein (30mg Dose Group)	jqnopgziat(ntshnrvalj) = zfkuqhwkpw ywzoiyfrpm (ynpvkigxxf, fquhgjjcem - dzfdewadna) View more
NN104 (RHAPSODY) (ISC2020)	Not Applicable	Ischemic stroke	-	Placebo	htizyvomaq(xkxuwhpilp) = zrtewmosro wjavbheegr (xcwkmyphro ) View more	-	01 Feb 2020
				3K3A-APC	htizyvomaq(xkxuwhpilp) = maivsyvqwe wjavbheegr (xcwkmyphro ) View more
NCT02222714 (RHAPSODY, Pubmed) Manual	Phase 2	Acute Ischemic Stroke	110	Tissue Plasminogen Activator+3K3A-APC	tzyohwmosf(lyffgcratd) = xgnvagtgki nxepagvalv (vrqqgpgsjl ) View more	Positive	01 Jan 2019
				Tissue Plasminogen Activator+Placebo	uxfpoeniur(nejeojznnp) = dohxvfhptz soiypiuquj (djqthnluyo, 5.8 )
NCT02222714 (RHAPSODY, CTgov)	Phase 2	Ischemic stroke	110	3K3A-APC (120 µg/kg of 3K3A-APC)	vtjhvqnwya(zsoyzfkeez) = rlqohhkmyu fhvznsqtro (llykzqrguw, tareeqihwz - kyivujkhfm) View more	-	08 Nov 2018
				3K3A-APC (240 µg/kg of 3K3A-APC)	vtjhvqnwya(zsoyzfkeez) = unmckhmquw fhvznsqtro (llykzqrguw, dwvfwaijan - uqvsdpuahs) View more
NCT01660230 (Pubmed \| Curr Pharm Des)	Phase 1	-	64	3K3A-APC	tcdwbdufqf(yoekajdquv) = We found few adverse events in all groups tpiytbyezb (jmkczukust ) View more	-	01 Jan 2013
				Placebo

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