Alain Baron

The ZEPHYRUS-1 trial led by testing pamrevlumab (CTGF antibody) for #PulmonaryFibrosis published negative results yesterday, also discontinuing ZEPHYRUS-2. JAMA has a good editorial on challenges and ideas for improving predictive validity for #IPF clinical trials: - One is that the IPF label covers a heterogeneous patient population. Genetic risk factors could be used for targeting drugs, though that leaves >70% of patients with no treatment. Broader -omic characterization of patients & preclinical models could reveal which models best match patient subgroups. - Another is the FVC endpoint. Many physicians argue for more nuanced endpoints. But while we're using FVC we should think about how preclin assay map to this, given that it can't be measured in typical rodent models. Larger animals could give more direct comparisons, or when that's not feasible then we should think carefully about how anatomy and pathobiology of models reflect this endpoint. - Preclinical models for are much maligned, with high false positive rates for standard bleo mouse model. The editorial authors suggest focusing on human organoids, although this may be throwing out the baby with the bathwater: IPF is an inflammatory disease with a key role for immune cells, which aren't included in organoid/chip models (yet anyway)... We should also think about in vivo models that address the obvious limitations of the standard bleo mouse model: 1) fibrosis resolves spontaneously, instead of progressing. 2) IPF is strongly age-related, but the mice are usually young. Other species (even rats) have less spontaneous regression of fibrosis, and multiple types of injury might better capture patient exacerbations. And using older animals could capture both known and unknown mechanisms preventing normal regeneration in PF patients. Gordian Biotechnology's Vishwaraj Sontake thinks a lot about predictive validity for complex diseases like IPF. Mapping models to patients is key, and the basis for our 'Patient Avatars' concept. Trials are were biopharma spends the most dollars, so we think it's worth spending more on doing R&D in predictive models. Editorial: https://lnkd.in/gRUFQ5XK

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🚨 The #FDA's latest draft guidance on accelerated approvals takes aim at "dangling" approvals—products still marketed despite failed confirmatory trials. The agency is now mandating tighter timelines (2-4 years for oncology), more transparency in withdrawal processes, and public involvement. 🕵️‍♂️ This marks a shift from flexibility to rigor, signaling that the accelerated pathway is no longer a free pass. For #biopharma, it's both a challenge and an opportunity to align trial strategies earlier. Is this the FDA tightening the reins—or just evolution in regulatory science? FDA website: https://lnkd.in/gqc-z-5e #pharmanews #breakingnews

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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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David H. Crean and John Foley are thrilled to announce the creation of a new CEO Life Science peer-to-peer advisory group for San Diego CEOs with the leadership team at REF(Renaissance Executive Forum) San Diego. The focus of the REF group will be on more mature companies post-Series A funded companies including those nearing IPO’s and publicly traded companies. The new cohort is expected to begin in early 2025.   REF is a global organization that brings together business leaders in peer advisory groups to enhance their leadership skills and business strategies. Founded in the USA over 30 years ago, REF operates by assembling groups of 12 to 15 business leaders. These groups meet monthly, guided by a Forum Leader, to discuss strategic decisions and personal goals in a confidential environment. REF emphasizes the concept of "Collective Intelligence," where the diverse experiences and backgrounds of members are leveraged to foster better decision-making and personal growth. The organization serves as a hub for over 2,500 entrepreneurs, members, forum leaders, partners, ambassadors, and global speakers, providing a platform for sharing best practices and accessing new opportunities. This peer advisory model is considered more effective than traditional one-on-one coaching, as it builds lasting relationships and provides diverse perspectives that are crucial for both personal and professional development.   The partnership with REF is a recognition of the great work achieved by CEO360 with early-stage life sciences companies over the last 2.5 years plus a desire to take this platform to another level with a larger platform that REF offers for later stage companies. REF currently has a growing international footprint with an unmet need in Life Sciences well beyond the San Diego ecosystem. REF is well positioned to address those needs in 2025 and beyond.   CEO360 will stick to its core and not move away from its early-stage focus. The new REF cohort will be held in addition to the three CEO360 cohorts currently underway in San Diego, the Bay area, and via a new virtual group that will likely involve international leadership. The vision is to create a feeder program where qualified, seed-stage Life Sciences companies can benefit from the power of peer-to-peer advisory as they progress through the stages of funding - Seed, Series A, Series B, and all the way through IPO.   From a timing perspective, the new REF Life Sciences group has just started recruiting CEOs and Ambassadors in the sectors of therapeutics, pharmaceuticals, diagnostics, nutraceuticals, medical devices, and health tech.    Please stay tuned for updates as we embark on this new exciting journey and extend our mentoring support to later-stage Life Sciences CEOs. Below is a link to the REF website.    https://lnkd.in/gcgcgsBy   #Leadership #LifeSciences #CEOs #REF

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How do we minimize the number of protocol amendments and increase the operational feasibility of our clinical trials? This article below points out the benefits of using data, conversations and real world data to enhance the feasibility of the protocol design and inclusion/exclusion criteria: 1) Are we being too strict on our criteria in order to "control" for data variability? 2) Do are criteria allow for the intended patient population in the real world (if not, they need to) 3) How realistic is your design in how the study sites actually work? How they see and treat patients? How is your company ensuring the design meets these requirements? https://lnkd.in/gzJzFd-3

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Proud to have raised about $2.5 for our portfolio companies in 2024 Seegnal VVT Medical NurExone Biologic (OTCQB:NRXBF) (TSXV: NRX) (FSE: J90) Israeli health tech thrives amid global challenges, attracting $1.2 billion in 2024 From AI-driven diagnostics to cutting-edge medical devices, Israeli companies are paving the way in health innovation.  Israel's health tech sector remained resilient in 2024, securing $1.2 billion in private funding despite ongoing global economic challenges. The Health Tech Top 100 map, compiled by Startup Nation Central’s Finder platform, underscores Israel’s key role in biopharma, digital health, and medical devices. While total funding decreased slightly from $1.6 billion in 2023, the sector saw a notable increase in the average deal size, which reached $4.6 million across 102 funding rounds—more than double the previous year’s median of $2.16 million. Digital health emerged as the leading sector, attracting $545 million, followed by medical devices ($380 million) and pharma/biotech ($262 million). https://lnkd.in/dPzCZiAc

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Thoughtful perspective on the medtech industry..

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Fabulous to be on the investor panel for Mintz’s Life Sciences Pitch Event today, on yet another glorious fall day in Boston. ☀️🍁 Key feedback shared by our panel: 🔹 Ensure your target market is clear - especially when the population for your relevant indication is highly heterogenous 🔹 Share your current assumptions about how your product may be used (e.g., chronically vs. episodically) and open questions 🔹 If you're exploring a range of commercial use cases, share how you anticipate prioritizing across them over time 🔹 If your GTM strategy requires you to displace heavily entrenched solutions and/or processes, share how you will enable these transitions 🔹 Note the specific set of milestones to be achieved with investment 🔹 Always include target timelines and potential paths to exit Thank you to the incredible lineup of entrepreneurs who pitched today, and please stay in touch! Thank you to Dean Farmer and Charlie C. for facilitating today's event. Thank you to panelists David Fogel, CPA, Ben Littauer (he/him), Molly Hoult, and Richard Wagner for your contributions. Great to meet you, and thank you for all of your help, Emily (Krasowski) Yanachkov and Diana Malkin. #lifesciences #pitchevent #investor #panel #boston

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In September, the results of the Phase III trial of biospecific antibody Ivenescimab delivering a meaningful improvement over Merck’s Keytruda in lung cancer sent Summit Therapeutics (NASDAQ: SMMT) stock soaring. However, few paid attention to the originator of the PD-1/VEGF targeting asset, Chinese biotech Akeso Bio. Akeso represents a cohort of emerging innovative drug companies from China, working at impressive speed to deliver advancements in patient care and next-generation therapeutics with global ambition. #deeptech #chinesedeeptech #bosonventures #Ivenescimab #biotech #immuology

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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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The health tech industry is entering 2025 with a cautiously optimistic outlook. While funding environments remain selective, the focus is shifting toward technologies and solutions that address critical healthcare needs with clear paths to impact. Investors are increasingly prioritizing scalability, clinical relevance, and robust commercialization strategies over speculative ventures. This trend underscores a maturing of the health tech sector, where the emphasis is on delivering transformative outcomes rather than following short-term market trends. This cautious yet focused funding climate presents both challenges and opportunities. Companies with differentiated platforms and a commitment to addressing unmet medical needs may find themselves well-positioned to secure support, even in a competitive environment. For the broader industry, this shift could lead to more impactful innovations reaching patients faster. Read more in this article in Endpoints News: https://lnkd.in/eTru3AcJ #HealthTech #Biotech #Innovation #FundingTrends #HealthcareSolutions

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Nice short article on medtech ups and downs. Don’t need a subscription on this one! Reduced biopharma funding could slow medical device growth—50% of revenue in life sciences comes from biopharma. Physician visits suggest fewer surgeries—impacting demand for surgical devices. FDA LDT rules could raise costs & limit competition in diagnostics. R&D spending & clinical trials remain strong, a high number of device approvals & active clinical trials — 756 as of May 2024 — point to a promising future. Automation & supply chain optimization can improve margins during lower sales periods. Data can optimize inventory management, logistics, and geographic footprint. How can MedTech companies adapt further? #FutureOfWork #MedTech #RandD

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May 6 2024 - 10 Notable Articles To Read Article: ‘Next wave of IPOs’ will arrive in summer, predicts biotech-focused VC partner Takeaway: The partner at Medicxi anticipates a surge in biotech initial public offerings (IPOs) during the summer. Source: Fierce Biotech Link: https://lnkd.in/d8XZHcKs Article: SVB Financial to sell VC business SVB Capital Takeaway: Pinegrove Capital Partners is set to purchase the venture capital enterprise, a newly formed entity supported by both Brookfield Asset Management and Sequoia Capital Heritage. Source: Reuters Link: https://lnkd.in/dDX5gP7F Article: Eye On AI: After Q4 Slowdown, AI-Related M&A Picked Back Up In Q1 Takeaway: In Q1 2024, there was an uptick in M&A exits, with 55 startups being acquired, marking an increase from Q4 2023. Source: Crunchbase Link: https://lnkd.in/dYbcfimk Article: Roark Capital completes $9.6bn Subway deal Takeaway: A private equity firm specializing in leveraged buyout investments within the franchise restaurant and food sectors has finalized the acquisition of Subway. Source: Private Equity Insights Link: https://lnkd.in/d88rwqYZ Article: Bolt closes €220M revolving credit facility: a step towards IPO Takeaway: The company aims to expedite the shift from individual car ownership to shared mobility, providing superior alternatives for various needs as part of its journey towards an IPO. Source: Tech.eu Link: https://lnkd.in/d_q7nCGK Article: The Stock Market Will Rise Nearly 10% More This Year, Money Managers Predict in Barron’s Latest Poll Takeaway: Numerous individuals anticipate that a stable economy will result in a more robust performance in the stock market. Source: Barron's Link: https://lnkd.in/d3tet-GY Article: Private equity firms step up plans to edge banks out of low-risk lending Takeaway: Apollo Global Management, Inc. issued a historic $40 billion in loans, reflecting a similar expansion seen among competitors such as KKR and Blackstone, as they raise long-term projections within this strategy. Source: Financial Times Link: https://lnkd.in/dv6AUJtb Article: Insight Partners’ Hinkle: M&A Is The Key To Unlocking Startup Liquidity This Year Takeaway: Many believe that the existing liquidity shortage stems from a dearth of exits in the startup market, leaving VCs with numerous illiquid assets. Source: Crunchbase Link: https://lnkd.in/dPvFPSMi Article: Rite Aid Closes a Quarter of Stores as It Navigates Bankruptcy Takeaway: At the time it filed for Chapter 11, the store was operational in 17 states and shuttered 520 locations within a span of seven months. Source: Bloomberg Link: https://lnkd.in/dhTUyf78 Article: Mubadala Capital plans $13.5bn biofuels investment in Brazil Takeaway: The fund also supported initiatives to establish a new stock exchange in Brazil and is augmenting its investments in the country. Source: Financial Times Link: https://lnkd.in/d4uUK6Pt #news #research #business

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The pandemic was a challenging period for all. But it also offered us opportunities! The concept of Jupiter is a great example. Jupiter Bioventures, a product of virtual brainstorming with friends (Ned David, Ned Sharpless and Steve Tregay) to enable Mayo Clinic’s insatiable desire to create the next generation of Cures, is now a powerhouse of drug development that has attracted value-aligned investors and academic partners to join forces in the best interest of patients everywhere…. Congratulations Jupiter team! May the patients win….. Norman Sharpless Nathaniel David Steve Tregay Nirdesh K Gupta, PhD Steven VanNurden Peter Noseworthy, MD Vijay Shah Heidi Dieter Andy Danielsen Mayo Clinic Ventures James Rogers Clark Otley Olayemi (Yemi) Sokumbi, M.D. Pankaj Jay Pasricha Waleed Brinjikji Janani Reisenauer Justin Butler Geoff Johnson, MD, PhD Melissa Noel, MBA, MSE, Johannes Fruehauf, Owen Garrick, MD, Jeanette Caban Cheryl Willman, M.D. #venture, #biopharma, #capital, #venturecapital #accelerator, #drug #drugdevelopment, #development, #technology, #commercialization, #technologytransfer, #research, #clinicaltrial, #patient, #cure, #transform, #venturestudio, #disease, #cancer

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Has Izervay been a successful medication? We can debate whether Izervay is clinically meaningful. But there is another way to look at its success or failure. Astellas Pharma paid $5.9 B to acquire Iveric Bio. In their latest quarter, Q1 24, Izervay sales were $85M. Prorated, that’s $340M annually. The Free Cash Flow (FCF) margin for Astellas has averaged 15% over the last 5 years. For Izervay, that’s a current FCF of $51M annualized. At a generous discount rate of 10% and terminal rate of 2%, Astellas has to grow its revenue by a compounded rate of 34% for 10 consecutive years to be valued at 5.9B today. That is simply impossible for a medication that has no tangible benefit observed by patients. My guess is Astellas Pharma assumed that Izervay would capture a significant portion of the Total Addressable Market (TAM) for dry AMD. Watch for a write down in their goodwill very soon. #pharmaceuticals #Retina #ophthalmology #finance

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