Dominic Marasco

The collaboration between Virpax Pharmaceuticals Inc. (Nasdaq:VRPX) Pharmaceuticals and the National Center for Advancing Translational Sciences (NCATS) heralds a significant advancement in pain management research. Focused on the development of NES100, an intranasal peptide targeting acute and chronic non-cancer pain, this partnership utilizes innovative nanotechnology to enhance the delivery of enkephalin to the brain. By leveraging Molecular Envelope Technology (MET) and a specialized device, NES100 aims to provide analgesic effects without the adverse events commonly associated with opioids. This extended collaboration underscores the shift towards non-opioid alternatives for pain management, crucial in addressing the opioid crisis. The research aligns with the NIH’s HEAL initiative, emphasizing the national commitment to combat opioid addiction. The potential of NES100 lies in offering a non-addictive pain treatment, potentially transforming pain therapy and improving outcomes for individuals with chronic pain conditions. NES100's development presents a promising avenue for pain management, offering a safer alternative to traditional opioids. If proven effective in clinical trials, NES100 could emerge as a valuable tool for patients seeking pain relief. The intranasal delivery method not only enhances convenience but also holds the promise of improved patient adherence and treatment efficacy. 𝐑𝐞𝐚𝐝 𝐌𝐨𝐫𝐞: https://lnkd.in/dwMpJZf8 Gerald W. Bruce Matt Barnes

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ONO PHARMACEUTICAL CO., LTD. is set to make its largest acquisition yet, purchasing Deciphera Pharmaceuticals, an American cancer drug maker, for $2.4 billion. 💼 The move comes as Ono seeks to fuel #growth with new drug candidates, especially as key patents on its Opdivo #cancer immunotherapy are set to expire in 2028. 🌱 Established in 2003, Deciphera is the maker of the Qinlock cancer drug available in the U.S. and Europe. 🩺 Qinlock boasts a unique mechanism that inhibits enzymes critical for cancer cell proliferation. 🛑 Additionally, Deciphera holds promising new drug candidates. 🌟 One such candidate, a treatment for benign tumors in joints, is in the final stages of clinical trials in #Europe and the #US, with approval slated for 2024. 💉 Deciphera is also developing a drug to address complications in blood cancer treatment. 🩸 #Japan #Pharma #Pharmaceutical https://lnkd.in/dppfbjsy

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$100 million to develop covalent biologics for oncology ! Enlaza Therapeutics just secured $100 million in Series A funding, led by J.P. Morgan Asset Management’s Private Capital division, to advance its covalent biologic platform for novel protein drugs, particularly in oncology. ⚗️Safer and more tolerable tumor penetration : Enlaza's War-LockTM technology creates biologic drugs that bind irreversibly to disease targets, enhancing efficacy and safety. By promoting covalency, it improves therapeutic performance, reduces systemic exposure, and allows sustained biologic effects with minimal dosing. Using proprietary amino acids, Enlaza engineers precise biological medicines with enhanced properties, offering a versatile solution across different protein-drug formats. 💊Investors : J.P. Morgan led the funding round, joined by existing investors like Frazier Life Sciences and new ones including Amgen and Regeneron's investment arms.

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#AvalereExpert Mark Gooding moderated a panel at #BIO2024 on access and affordability considerations for patients and manufacturers in a post-#IRA world. Read highlights from his conversation with Anna Hyde, Valerie Reynolds, and Eric Gascho: https://lnkd.in/e_F3NZqM #patients #patientsupport #healthpolicy #healthcare #InflationReductionAct

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News Alert! Kairos Pharma announced the addition of City of Hope Cancer Center in Duarte, California to the Phase 2 clinical trial for ENV105 for castrate-resistant prostate cancer patients. City of Hope Cancer Center is the first of several planned new centers to be added in the coming weeks to support the Company’s randomized trial for patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The additional centers allow Kairos Pharma to test ENV105 in a broader patient population to identify blood markers that could help select patients expected to benefit most from ENV105 treatment. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI) Read the full release here: https://loom.ly/8Ood0Rs NYSE: KAPA #PharmaNews #PharmaStock #BioPharma #Invest #Investing

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The top regional #healthcare and #biotech news for January 10th via the Big4Bio newsletters: San Diego: Timberlyne Therapeutics Launches With $180M; Shoreline Biosciences, Inc. Cuts Staff; Belharra Therapeutics Hires CSO https://lnkd.in/gP4pb3wY SF Bay: Exec Hires; Ouro Medicines, Kardigan Launch; Layoffs at IGM Biosciences, Inc.; Biotech Ecosystem Venture Fund https://lnkd.in/gGbr4gvn Seattle: Transcarent, Accolade, Inc. $621M Deal; Slaoui & Phelan Join Achieve Life Sciences Board; AGC Biologics, Pandorum Technologies Collab https://lnkd.in/gAhtyWxk Los Angeles: Biocom California's New Directors; TAE Life Sciences & Kyoto University Breakthrough BNCT Results; UC Irvine's Bioluminescent RNA https://lnkd.in/gHWSiS92 Boston: Exec Changes; City Therapeutics, etherna, HARBOUR BIOMED Strike Deals; Restructuring at Repare Therapeutics, Intellia Therapeutics, Inc. https://lnkd.in/g_M8nQBp Philadelphia: Kardigan Launches; RhyGaze AG Raises $86M; How Fungi Make a Key Medicinal Molecule https://lnkd.in/g-ydsewW Capital Region: VERALOX Therapeutics to Acquire Nudge; Danaher Corporation, Innovaccer Partnership; Hot Investor Mandates; More on Vanda Pharmaceuticals NYC: Kardigan Launches; Pacira BioSciences, Inc.'s Five-year Plan; Pfizer Prospect Beats Incumbent; More on Johnson & Johnson https://lnkd.in/gP-cTPRZ

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Great day for California Life Sciences (CLS) attending Physicians for a Healthy California, Health Equity Leadership Summit! Panelist, Maria Jison, MD, (Executive Director, Global Clinical Head, Fasenra) of member company AstraZeneca spoke to the strides they've made using their AIRE Mobile Unit as a “clinic on wheels” that brings trial screenings directly to patients in diverse communities. The mobile unit is equipped with exam rooms and staffed with healthcare professionals who are ready to pre-screen patients and book both an appointment and transportation for patients to visit the clinical trial site they’re referred to. Per Maria, "You can't be successful without community engagement and building trust. It's not enough to just show up in a bus.....you really need to be part of the community. A multi-pronged engagement campaign is required. Outreach alone isn't enough — you need to partner with other organizations that are part of the community and trusted." #EquitableResources #PhysiciansForAHealthyCalifornia #HealthEquity

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Diakonos Oncology CFO Anthony Baldor is at #BIO24 this week to make a company presentation and meet with potential partners and investors. For those interested in learning more about Diakonos’ unique dendritic cell vaccines for cancer, we can be reached through the BIO ONE Partnering System. Mr. Baldor’s company presentation takes place on Tuesday, June 4th at 3:00 pm PT in Company Presentation Theater 2 at the San Diego Convention Center. Mr. Baldor’s presentation will include a review of Diakonos’ highly differentiated double-loaded autologous dendritic cell vaccines for cancer, and an operational update on the company’s plans for growth, including clinical development outlook and expansion of its leadership team. Diakonos recently completed a Phase 1 trial of DOC1021, its lead vaccine for glioblastoma multiforme (GBM), and is planning a Phase 2 study. The US Food and Drug Administration has granted Fast Track and Orphan Drug status for DOC1021. Two other clinical trials are under way with dendritic cell vaccines targeting pancreatic cancer and angiosarcoma. “We are very excited about the results of our Phase 1 trial for GBM,” Mr. Baldor said. “Data observed to date give us great confidence in our dendritic cell vaccines and their potential to treat a broad range of solid tumor cancers, including the most deadly. Twelve month survival is currently at 90% for evaluable patients, and the therapy is well tolerated.” Diakonos’ dendritic cell vaccines activate robust cytotoxic TH1 cell signaling pathways that better harness a patient's immune system to target and eliminate cancer cells by initiating a natural immune response. This is achieved without any genetic modification of the patient’s immune cells, which greatly simplifies the manufacturing process and significantly reduces costs when compared to leading cell therapy approaches. Visit our we site: diakonosoncology.com to learn more. #cancerresearch #cancer #biopharma #clinicaltrials https://lnkd.in/dET5pqbD

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Tomorrow, October 2nd, G&L experts will sit on the 'Maximize Your Drug Asset Value & Commercial Success' panel at Biocom California's offices in San Diego. Dr. Steven Hildemann, MD, PhD, R&D Physician at G&L, will be joined by industry experts including Krishna Allamneni, Executive Vice President, Chief Development Officer at Concarlo Therapeutics, Inc., and @Dr. Michael J. Nowak, Managing Partner, Nowak Ventures, LLC. With a focus on integrating regulatory, clinical, and commercial expertise, this discussion will help you develop novel strategies that set your asset apart. If you're in discovery, pre-clinical, or mid-phase clinical development, this is a must-attend event for gaining insights on increasing valuation at key inflection points. ***Please note, this event is now taking place at Biocom California's offices in San Diego - 10996 Torreyana Rd, San Diego, California 92121*** #HealthcareAdvisors #RegulatoryAffairs #QualityAssurance #ThoughtLeadership #Biopharma

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Great article Adam Fein . Thanks for your insight Benjamin Hinton II, PharmD, RPh ! “Adding a manufacturing arm brings undeniable advantages for PBMs, from better cost control to smoother supply chain dynamics. Payer-production entities can align an entire product distribution chain in their favor, excluding competitors and preferring their designated agents. But how will these integrated powerhouses impact the industry?”

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Oragenics, Inc Partners with Avance Clinical for Phase II Concussion Trial in Australia SARASOTA, Fla., May 07, 2024 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN), a pioneer in developing innovative intranasal pharmaceuticals for neurological disorders, today announced a partnership with Avance Clinical, a leading Contract Research Organization (CRO), to conduct a Phase II clinical trial in Australia. This trial aims to evaluate Oragenics' lead drug candidate, ONP-002, for mild Traumatic Brain Injury (TBI), commonly known as concussion. ONP-002, a novel chemical entity (NCE), is delivered through a unique intranasal device and designed to maximize drug delivery directly to the brain. Avance Clinical, renowned for its clinical trial management capabilities and quality of service in Australia, New Zealand, and North America, brings over two decades of expertise in navigating the Therapeutic Goods Administration, Food and Drug Administration, and European Medicines Agency regulatory landscapes. An Oragenics Phase I clinical trial, recently completed in Australia under the management of Avance Clinical, demonstrated that ONP-002 is safe and well-tolerated. "Concussion remains a significant unmet medical need," said Dr. Jorgen Mould, Senior Director of Scientific and Regulatory Services at Avance Clinical. "Oragenics is poised to address this challenge, and we are delighted to be part of the team, especially given Australia's high incidence of sports-related concussions." Read the full Press Release 👇 https://lnkd.in/geAB5kMV #AvanceClinical #CRO #Concussion #Biotech #DrugDevelopment #Oragenics #TraumaticBrainInjury #TBI #SportsInjuries #Australia #AustralianAdvantage #ClinicalTrials #ClinicalResearch

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Association of Northern California Oncologists (ANCO)’s ASCO24 highlights panel discussion with Eric Small American Society of Clinical Oncology (ASCO) #ANCO #ASCO #ASCO24 #Cancer #OncoDaily #Oncology

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𝐌𝐞𝐭𝐬𝐞𝐫𝐚 𝐑𝐞𝐩𝐨𝐫𝐭𝐬 𝐏𝐨𝐬𝐢𝐭𝐢𝐯𝐞 𝐏𝐡𝐚𝐬𝐞 𝟐𝐚 𝐑𝐞𝐬𝐮𝐥𝐭𝐬 𝐟𝐨𝐫 𝐔𝐥𝐭𝐫𝐚-𝐋𝐨𝐧𝐠 𝐀𝐜𝐭𝐢𝐧𝐠 𝐆𝐋𝐏-𝟏𝐑𝐀 𝐌𝐄𝐓-𝟎𝟗𝟕𝐢 Metsera, Inc. Metsera announced positive Phase 2a data for MET-097i, its once-monthly, ultra-long acting GLP-1 receptor agonist (RA), showing up to 11.3% placebo-adjusted weight loss at 12 weeks with no plateau observed and strong tolerability. The 12-week trial enrolled 120 participants with obesity or overweight and demonstrated: Dose-dependent weight loss of up to 20% in some individuals. Statistically significant weight loss across all doses. Flexible dosing options, including titration-free weekly and monthly schedules. Mild, short-lived side effects, primarily gastrointestinal, improving with titration. Results reinforce MET-097i’s potential as a foundational obesity therapy with monthly dosing feasibility supported by its 15-16 day half-life. Phase 2b trials are fully enrolled, with topline results expected mid-2025. “These data highlight MET-097i’s potential to deliver powerful, sustained weight loss and flexible dosing options,” said Steve Marso, M.D., Chief Medical Officer. Metsera plans to explore monthly dosing and expand studies into Type 2 diabetes populations, with Phase 3 trials anticipated soon after. #Metsera #WeightLoss #ObesityTreatment #GLP1RA #ClinicalTrials #Biopharma #MetabolicHealth #ObesityCare #DiabetesResearch #PharmaInnovation

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#PRIMR produces doctor-approved videos for trustworthy trial content. The RadiCaL Study is enrolling kidney cancer patients with bone metastases to explore if adding Ra-223 to cabozantinib improves patient outcomes. PI: Rana McKay UC San Diego Alliance for Clinical Trials in Oncology See IRB-approved video below 👇 https://lnkd.in/d97fj9dj #kidneycancer #kidneycancerawareness #cabozantinib #radium223 #radiopharmaceuticals #clinicaltrials #cancer #clinicalresearch #DEI #digital #health #immunotherapy #kidneycancer #men #menshealth #metastatickidneycancer #oncology #patienteducation #video #women #womenshealth #digital

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