KRONOS HEALTH

✨Exciting Times in Biotech: Latest Deals, Venture Raises, and Trends✨ Here’s a comprehensive look at the venture raises, M&A deals, and industry trends shaping the biotech landscape. Deals: 🤝 Ophthalmology: Merck acquires iBio, Inc. for $1.3B upfront, potentially reaching $3B, focusing on an ophthalmic tri-specific program targeting the Wnt pathway. 🤝 Immunology: Biogen buys HI-Bio, an immunology company, reflecting a trend towards acquiring mid to late-stage assets. 🤝 Renal Disease: Asahi Kasei takes over Calliditas Therapeutics for $1.1B, expanding in renal disease treatment with a de-risked product already in the market. 🤝 Dermatology: Johnson & Johnson Innovative Medicine acquires a bispecific molecule from Numab Therapeutics AG for $1.25B, targeting IL-4 receptor and IL-31 for atopic dermatitis. 🤝 Genetic Disorders: Maze Therapeutics & Shionogi Inc. (U.S.) form a partnership focused on Pompe disease. 🤝 Vaccines: Novavax & Sanofi collaborate on Novavax’s #COVID-19 vaccine, including a joint COVID-flu vaccine, with $500M upfront. 🤝 Neurology: Takeda & AC Immune strike a deal with $100M upfront for an immunotherapy targeting beta-amyloid for Alzheimer’s. 🤝 Muscular Dystrophy: Sanofi & Fulcrum Therapeutics partner with $80M upfront for a small molecule targeting FSHD, with Phase 3 data expected in Q4. Venture Raises: 📈 Late-Stage Antibodies: Zenas Biopharma raises $200M Series C for a bifunctional antibody in Phase 3. 📈 Hepatitis D: Blue Jay Therapeutics secures $182M Series C for its Hepatitis D program. 📈 Single-Domain Antibodies: Atovia raises $105M Series B for its platform pairing single-domain antibodies. 📈 Prader-Willi Syndrome: Aardvark Therapeutics acquires $85M Series C for a first-in-class treatment. Trends: 🚀 #Venture Capital: Increasing venture capital is flowing into early-stage biotechs, reflecting strong interest in novel therapeutic platforms and late-stage clinical assets. 🚀 #StrategicPartnerships: These partnerships continue to shape the biotech landscape, providing essential support for innovative therapies. 🚀 #RenalDisease Treatments: Increasing specificity in drug development for renal diseases with multiple billion-dollar acquisitions highlighting the focus on precise and effective treatments. 🚀 #Immunotherapy in Cold Tumors: Advances in immunotherapies are showing early signs of efficacy in cold tumors, particularly microsatellite-stable colorectal cancers, marking a promising trend in oncology. Is Pharma looking for later-stage assets to de-risk, esp. in Oncology? Does that mean Biotech will have to lean into investors for support? Does Biotech have to seriously consider pipeline expansion strategies and platform optionality to stay ahead of the game? Let’s stay connected and learn how to leverage new opportunities and drive transformative healthcare solutions. 🌐🔬

⭐It's a wrap at #BIO2024⭐ Grateful for the meaningful relationships, networking, and fun evenings with friends old and new. For those who took the time to connect, KRONOS HEALTH is ready to work together to drive towards common innovation goals for patients. The camaraderie and shared vision made this event truly special. The synergy BIO International Convention this year was nothing short of inspiring. The event truly highlighted the growing traction of partnerships in #Biotech, #LifeSciences, and #Pharma. Glad to say that I have been surrounded by so many brilliant leaders, executives, founders, and investors, all dedicated to shaping the future of #biopharma through groundbreaking collaborations. And never have I heard so many success stories fueled by collaboration and a shared vision for a healthier future! On the observed trends: ⚡ Oncology continues to be the leading therapeutic area in which BioPharma is invested (~37% of clinical stage pipeline is focussed on Oncology). However, there has been a decline in M&A deals in this area which were heavily discussed ⚡The pursuit of next-generation treatments across modalities such as ADCs, CAR-Ts, bispecifics, and precision medicine marked our discussions ⚡ Deal volumes in Immunology, Neurology and Rare Diseases have steadily increased. Discussion ensued around how Oncology vs. Non-Oncology and new modalities were fairing, across approvals, M&A, fundraising, IPOs, and alliances ⚡ Nearly half (48 percent) of biotech industry players predict their R&D spending to increase in the next one to two years ⚡ 60% of survey members from the Deerfield Management and Cure benchmark report said women's health is a very or extremely important factor when determining their interest level in particular therapeutic areas. ⚡ Attendees benefitted from perspectives from cutting-edge Biotechs, Big Pharma and VCs The future is truly calling and shining brighter for Biotech, Life Sciences, and BioPharma partnerships 🤝🔬🧬 #BIO2024 #LifeSciences #BioPharma #Innovation #Collaboration #FutureOfHealthcare

 🔍Are you an investor or a collaborator evaluating a Liquid Biopsy asset 🩸? Consider this: Recent advances have propelled Liquid Biopsies to their full potential. Here are reasons why your team should be investigating liquid biopsy companies in your clinical or investment plans: Summarized from an Inside PMx article (link in comments) 👉In addition to #NGS, Droplet Digital PCR (ddPCR) has made precise characterization of low-abundance biomarkers in liquid biopsies possible, enabling absolute quantification of nucleic acid molecules 👉ctDNA analyses can offer deeper and more accessible insights into intra- and inter-tumor heterogeneity of solid tumors than traditional biopsy alone. This can also make up around 60-90% of the total circulating DNA in the blood 👉Increase in usage by clinical practice is closing the gap in standardization in sample collection, processing, and analysis methods, which can affect the reliability and reproducibility of results 👉Comfort level by clinicians has increased in leveraging liquid biopsies as a screening tool to assess both pre-adjuvant and primary treatment efficacy Case(s) in point: ➡️In the recent CHRONOS trial, use of ddPCR technology guided second-line treatment selection for metastatic colorectal cancer patients, allowing for anti-EGFR rechallenge in patients with wildtype RAS/RAF/EGFR mutations, providing a valuable alternative to standard late-line therapeutic options (limited efficacy and significant toxicities). ➡️In a “plasma first” study 49 patients with radiological evidence of advanced lung cancer, 11 were able to begin targeted treatment based on NGS molecular testing of plasma samples prior to receiving molecular testing results from tissue biopsies. ➡️The median time to results for patients who underwent plasma ctDNA analysis was 9 days, compared to 25 days for standard-of-care tissue tests Spotlight: 👉Nucleosomes, released from cells undergoing apoptosis, may serve as more sensitive cancer biomarkers compared to ctDNA, as they are more stable in the blood In addition to what you are detecting (cfDNA, EVs, Proteins, Nucleosomes) based on the disease area, What technology is used to detect it (ELISA, Proteomics, PCR, MassSpec)? Do you have a strong commercial value proposition? April is #CancerPrevention & #EarlyDetection month. Are you up to date with your personal preventive and screening plan? Article 🔗 : https://lnkd.in/e9y86Pbx     ______________________________________________________________________________ Find this useful? Follow us, hit the 🔔 At Kronos, we support teams with bench-to-market portfolio strategy, market assessment, early commercialization strategy, stakeholder pitch approach, and business development. If you want an initial intake and analysis of your needs, DM sangeetha@kronos-health.com  

Shiny objects have blind spots as well In the linked article, Targeted Oncology sheds light on #ADCs, while reducing off-target side effects, present tolerability challenges, requiring careful monitoring and management of ADC-specific toxicities Important translational Due Diligence check boxes for ADCs : Have the cohorts with AEs been genomically analyzed for their #Biomarker profiles? 🌈 Are the clinical data sets heterogeneous? Can you, as an investor, help expand the trial to more heterogeneous populations? 🤝 Is there a collaboration with selected clinical sites on patient data insights? AI integration for trial management is a step up. This could help important cohort selection criteria and appropriate dose modifications. 🧬🩸Can Biomarker tests utilized in the clinical trial setting be standardized across sites? Have the data sets been retained? Is an MRD process possible or has it been implemented (even better). Patients homogenous for UGT1A1*28 allele in Trodelvy's trials, had a 58% incidence of grade 3/4 neutropenia compared with 49% who were heterozygous. Also think Elahere's FRα-positive test for testing methodology. Gilead Sciences AbbVie ⚖️Has the SOC shifted and benchmarked in the TPP? Are SOC guidelines unmanageable due to quality measure incentives? Think Zevalin and Retuxan! Not all ADCs are the same and ADC toxicities can vary widely Target differentiation, testing methodologies and incorporation of genomics in cohort analysis are three critical steps that can make or break your ADC translational strategy and due diligence. 🔍📈 Article 🔗: https://lnkd.in/e3h8p36W #drugdevelopment #precisiononcology #oncology --- Kronos Health provides consulting services to biopharma for bench-to-market strategy. If you'd like to discuss your translational strategy, if you are either preparing for a registration trial or a investor/stakeholder approach send us a message

Is there an appetite for Advanced Therapeutics in Oncology Solid Tumors? 📰 Earlier this year Janux Therapeutics’s candidates in metastatic castration-resistant #prostatecancer cancer and late-stage solid tumors sent the San Diego–based biotech’s stock soaring 172% 🎣Followed by Merck’s $680 million acquisition of T Cell engager Harpoon Therapeutics in January. 🧬In January, Ferring Pharmaceuticals Pharma launched the first CGT therapy in unresponsive non-muscle invasive #bladdercancer. 53% high-grade recurrence rate survival in patients with BCG unresponsive disease in the latest launched CGT in #bladdercancer Advances in research technologies have led to a sustained increase in solid tumor clinical trials in next-generation therapeutics. There are a few key reasons for taking a second take: ➡️ Better adenoviral vector constructs for solid tumor membrane penetration ➡️ Advancements in highly tumor-specific targets, reducing off tumor, off target toxicities. ➡️ Focus on genes that encode proteins linked to T-cell exhaustion ➡️ Novel administration considerations and role in clinical workflow Other factors to be considered? PS: Slides made with Beautiful.ai. a great tool Analytics and insights from Kognitic, Inc. – a cutting edge Oncology and Biomarker predictive platform #oncoly, #pharma #biotech CARsgen TherapeuticsA2 PHARMA Telix Pharmaceuticals Limited Perspective Therapeutics Viewpoint Molecular Targeting, Inc.

https://lnkd.in/dxsUHiud

https://lnkd.in/eHXJwhnP

As many have observed, the historic milestone of 2 FDA-approved gene editing treatments for sickle cell disease—Casgevy at $2.2M and Lygenia at $3.1M (List Price), was dovetailed by bluebird bio (Lyfgenia) down 40% and CRSP also experiencing a decline. 📉 Bluebird's market position plummeted from $115 per share in 2018 to about $2.86 per share. As predicted by healthcare financiers, this will likely bounce back when future programs move forward. However, these questions arise: 📉💡Is this a harbinger that the return on investment for breakthrough science is going to be marginal? 💭This scenario prompts reflection on the importance of commercial input into early pipeline development. Does it underscore the significance of data gathering, evidence, and partnerships with health plans early-on? 🌐👥Could this be an indication of early breakthrough entrants pricing, which will taper off, paving the path for more? 🏛️And how might potential new pricing policies impact state-of-the-art investments in the biotech industry? In any case, with approximately 100MM in the US saddled with healthcare debt (Per a KFF poll, 41% of US adults carry medical debt), alongside the increased costs of medical services, it becomes crucial for manufacturers and innovators to not be the sole carriers of solutions to this problem. Let’s perhaps not go down the road of Pharma cost-sharing, to ensure innovation isn't crippled. As we wrap up at #ASH23 #ash2023 and prepare for a new year, these are pressing questions for all of us in #biotech Innovation ecosystem. Fostering stakeholder collaborations for #PatientDriven innovations to communities and solving for a greater economic problem in healthcare 💡is paramount in the new era of #healthcare  #sicklecelldisease #innovation #crispr #biotechinnovation #genetherapy Image: Cell&Gene Feb 2023