Carl Schoellhammer’s Post

🚀𝐀𝐜𝐜𝐞𝐥𝐞𝐫𝐚𝐭𝐢𝐧𝐠 𝐈𝐧𝐧𝐨𝐯𝐚𝐭𝐢𝐨𝐧: 𝐊𝐲𝐯𝐞𝐫𝐧𝐚 𝐒𝐞𝐜𝐮𝐫𝐞𝐬 𝐀𝐝𝐝𝐢𝐭𝐢𝐨𝐧𝐚𝐥 𝐅𝐃𝐀 𝐅𝐚𝐬𝐭 𝐓𝐫𝐚𝐜𝐤, 𝐈𝐏𝐎 𝐨𝐧 𝐭𝐡𝐞 𝐇𝐨𝐫𝐢𝐳𝐨𝐧 🌐 𝗜𝗻 𝗝𝗮𝗻𝘂𝗮𝗿𝘆 𝟮𝟬𝟮𝟰, Kyverna Therapeutics accelerates into another FDA fast track following IPO plans. As KYV-101 moves through the clinical trial stage, Kyverna will have more regular and convenient communication with U.S. regulators thanks to the fast track tag—this time for refractory progressive multiple sclerosis. Additionally, if and when Kyverna files a new #drug application, it allows the #business to request for priority review, which shortens the FDA approval review period to six months. Recently, Kyverna was able to obtain a fast-track tag for myasthenia gravis and approve the entry of its autologous CD19-targeting cell treatment into a phase 2 open-label trial for #patients suffering from #multiplesclerosis. 𝑳𝒐𝒐𝒌 𝒂𝒕 𝒐𝒖𝒓 𝑪𝒐𝒓𝒓𝒆𝒍𝒂𝒕𝒆𝒅 𝑹𝒆𝒑𝒐𝒓𝒕👉:https://bit.ly/3RPw6Qb #FDAFastTrack #IPOJourney #BiotechAdvancement #healthcareinnovation #acceleratingsuccess #biopharma #prophecymarketinsights

Wrapping up the 19th Annual HD Therapeutics Conference 2024 with enlightening insights! Here's a brief recap from the final day of the conference. Stay tuned for more updates! #HDResearch #HuntingtonsDisease #ScientificAdvancements #HDAfrica

Exciting news from Akero Therapeutics as they reveal more promising data for efruxifermin in the battle against metabolic dysfunction-associated steatohepatitis (MASH)! Despite previous challenges in the disease area, Akero’s latest findings mark a significant step forward, especially with the stock $AKRO soaring by up to 72% premarket following the announcement. Efruxifermin, now advancing through a Phase III program, has shown impressive results in improving histology status among MASH patients from week 24 to week 96. This comes after both doses of the drug previously met primary and secondary endpoints, showcasing remarkable efficacy in achieving MASH resolution without worsening of fibrosis. Moreover, the latest HARMONY Phase IIb data highlight a groundbreaking two-stage improvement in fibrosis for patients treated with efruxifermin, setting new records in response rates for this condition. The drug continues to demonstrate a manageable side effect profile, bolstering its position as a leading candidate in the race to address MASH effectively. As Akero presses forward with the SYNCHRONY program, including trials for a range of MASH severities, the spotlight also falls on the competitive landscape, with companies like 89bio and Boston Pharmaceuticals pushing forward with their FGF21 analogs. This breakthrough offers hope not just to patients but to the entire healthcare community, signaling a possible turning point in MASH treatment. Let’s keep an eye on efruxifermin’s journey and its potential to transform MASH care. #AkeroTherapeutics #Efruxifermin #MASH #FGF21 #PhaseIII #HARMONYstudy #biotech #healthcareinnovation #drugdevelopment #clinicaltrials #liverhealth #metabolicdisease #biopharma #stockmarket #medicalresearch

Nanobodies can be a powerful tool to help streamline design of novel therapeutics. Advantages include: ✅ Smaller size for better tissue penetration/payload delivery ✅ Simplified manufacturing due to a single functional VHH ✅ Faster discovery of HCAbs with our RenNano® mice! Our progress boasts functional HCAbs for targets like TFR1 and 4-1BB, with our "Nano 100 Project" underway to discover nanobodies for 100+ targets. Visit our TFR1 poster at the CNS Drug Delivery Summit or reach out to explore our nanobody assets: bd-licensing@biocytogen.com. (Image created with BioRender) #Nanobodies #tfr1 #drugdiscovery #DrugDevelopment

We are pleased to share Quince Therapeutics by Dirk Thye, MD, CEO & CMO from the 7th Annual Neuroscience Innovation Forum #Sachs_NIF View here: https://lnkd.in/dra2qH_c Short Company Profile 👇 Quince is a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology to deliver innovative and life-changing therapeutics to those living with rare diseases. The company’s lead asset, EryDex, which is being developed for the treatment of a rare neurodegenerative disease, Ataxia-Telangiectasia (A-T), is expected to begin a pivotal Phase 3 clinical trial in the second quarter of 2024. Currently, there are no approved treatments for A-T and the market represents a $1+ billion estimated peak sales opportunity globally. EryDex utilizes a highly differentiated technology platform for autologous intracellular drug encapsulation (AIDE). Its proprietary AIDE technology is designed to optimize the biodistribution of dexamethasone sodium phosphate (DSP; a pro-drug) by using an A-T patient’s own red blood cells to deliver the sustained therapeutic over a once monthly treatment period. It is also designed to allow for the chronic administration of the therapeutic. Quince’s flexible and expandable AIDE technology platform is designed to deliver a variety of therapeutics, ranging from small to large molecules, as well as biologics. The company intends to investigate additional potential applications of the AIDE technology platform as it provides Quince with opportunities for future indication expansion.

Viking Therapeutics Shakes Up Weight-Loss Drug Arena: The Rise of VKTX Viking Therapeutics, with its groundbreaking obesity medication, stole the spotlight this week, sending its shares soaring by an impressive 121%. In a promising Phase II study, the biotech company reported that its drug helped patients shed up to 14.7% of their weight in just 13 weeks, outperforming competitors' offerings. While there's still a journey ahead in Phase III trials, the market's enthusiasm underscores the soaring demand for innovative weight-loss treatments. Viking's bold leap into this arena is reshaping the landscape and capturing investors' attention. #VikingTherapeutics #ObesityMedication #biotechinnovation #stockmarket

United Therapeutics v. Liquidia Join us on November 28th, wherein Dr. Roshan Shreshta explores the Enablement, Written Description, and Anticipation: Takeaways from United Therapeutics v. Liquidia

VHHs – Hitting the sweet spot for affinity! Despite VHHs’ small size, their high affinity and specificity rival that of the classic IgG. In fact, VHHs are able to get into those hard-to-reach places that larger molecules simply cannot, giving them the edge. At Isogenica, we use the biggest synthetic VHHs libraries out there to routinely isolate binder panels ~20 nM  or below, with some VHHs straight out of our libraries giving BLI measurements in the pM range.  For most partners, this level of affinity is the “sweet spot”, especially for therapeutics development. Do you have a project you want to integrate VHHs into? Discuss your research needs with our Business Development team: https://lnkd.in/et2yAhqT  and read more about VHHs here: https://lnkd.in/ePnYvrFf  #affinity #vhhs #antibody #biotherapeutics #drugdiscovery #insideisogenica

Amidst the doom and gloom around whether DTx is going to make it as a field, Mark Wuttke thinks digital solutions are inevitable and here to stay. For that and more, check out our latest episode.

🔊 Are you attending NeurIPS next week? 🤖🧬🖥️ Interested in transforming Drug Disvovery? 📧📝 Connect with our very own Thomas Gaudelet and our Executive Chair Charles Campbell Roberts and find out how we are doing exactly that at Relation Therapeutics #cause2cure #patientiswaiting