Mike Powell

Despite challenges in the IPO market in 2021, the biotechnology sector is resilient and showing signs of recovery. Tempus led the way last week. Congratulations to all stakeholders at Tempus! This period of turbulence urges biotech firms to strategically focus on building strong data foundations, which will not only attract investments but also pave the way for sustainable growth and innovation. Embracing uncertainty as an opportunity for innovation and skill development could redefine leadership in biotech, fostering a culture of resilience and adaptability crucial for sustained success in a rapidly evolving industry landscape. #Biotech #Leadership

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16July: How does Orum Therapeutics plan to replace chemo with the targeted conditioning agents for gene editing therapies that it will work to develop with Vertex Pharmaceuticals? Read about the collaboration in my latest for Genetic Engineering & Biotechnology News: https://lnkd.in/epKWDUbZ

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Epoch 16: Sweat Equity - Your Weekly Biotech News Fix Designed to be consumed as a quick scroll with underlying links for more detail 👉 How to deal with biopharma layoff stress 👉 Series A biotech funding surges in Q1 👉 RNAi is coming $ARWR 👉 #AACR24 most exciting oncology biotechs 👉 $DTIL $LLY terminamos 👉 GLP-1 for sleep apnea $LLY 👉 Degrader momentum $ARVN $PFE $NVM 👉 New VC funds! Caanan & $REGEN 👉 Update on neuroscience / neuropsych 👉 Massive Obesity newco announced And more! https://lnkd.in/dEkBy2bY

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Biotech Sector is Bouncing Back

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Great piece, Alex Philippidis! One cannot help but notice that 9 of these 10 companies are pursuing various approaches involving irreversible genetic changes in patients, with the attendant and in my estimation substantial risks of off-target genetic toxicity. Only one, Wave Life Sciences, is editing genes at the level of RNA, where the safety risk is a priori lessened but the reversible nature of the editing event (by RNA turnover and drug wash-out). Arguably, it would behoove the investment and pharma + biotech community to rebalance so as to increase emphasis on RNA editing. Wave Life Sciences is way out in front of this field and has a extraordinary head of steam.

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IVIEW Therapeutics Inc. Announces Dosing of First Patient in Phase 1/2 Clinical Trial of IVW-1001 for Dry Eye Disease [Cranbury, New Jersey, June 25, 2024] – IVIEW Therapeutics Inc., a clinical stage biotechnology company advancing innovative treatments for ocular diseases, proudly announces the dosing of the first patient in the Phase 1/2 clinical trial of IVW-1001 Ophthalmic Eyelid Wipe. This milestone marks the initiation of the clinical evaluation of IVW-1001, a novel TRPM8 agonist designed to treat signs and symptoms of dry eye disease. The commencement of patient dosing in the Phase 1/2 trial represents a significant advancement in IVIEW Therapeutics' mission to develop innovative solutions for individuals suffering from dry eye disease, particularly those inadequately managed by artificial tears. This first-in-human (FIH) trial aims to rigorously assess the safety, tolerability, and preliminary efficacy of IVW-1001. Dry eye disease is a prevalent and burdensome condition affecting millions worldwide. IVW-1001, developed by IVIEW Therapeutics, offers promising potential as a therapeutic intervention through its TRPM8 agonist mechanism, targeting the underlying causes of dry eye. The innovative delivery route via an ophthalmic eyelid wipe further distinguishes IVW-1001 as a potentially groundbreaking treatment. Houman Hemmati, MD, PhD, Chief Medical Advisor, leading the clinical development of the IVW-1001 program, stated, "Dosing the first patient in our Phase 1/2 clinical trial is an exciting and critical step forward. Our focus remains on thoroughly evaluating the safety and potential efficacy of IVW-1001. This investigational TRPM8 agonist offers an innovative approach to treating dry eye diseases, and we are committed to advancing this program to address the unmet needs of patients worldwide." Bo Liang, PhD, MBA, Co-founder, Chairman, and CEO of IVIEW Therapeutics Inc., added, "We are thrilled to initiate the clinical development of IVW-1001 with the dosing of our first patient. This milestone underscores our commitment to pioneering treatments for dry eye diseases and highlights the potential of our novel TRPM8 activation mechanism. We look forward to the progress of this trial and the insights it will provide."

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Epoch 17: Sweat Equity - Your Weekly Biotech News Fix Designed to be consumed as a quick scroll + links to the source articles 👉 Biopharma hirings & VISAs 👉 $MRNA working with OpenAI ChatBots 👉 $BIIB PPD drug estimated $500M PYS 👉 David Baker desings peptide-like drugs 👉 $BIIB update on M&A strategy 👉 $DAWN accelerated approval for pediatric cancer 👉 Japan biotech pharma collaboration 👉 Xaira launches with $1B financing 👉 MASSIVE BMS RIF 👉 $REGN gene editing deal with Mammoth 👉Endeavor $132M financing for fibrosis 👉Neurocrine with major breakthrough in MDD And more! https://lnkd.in/dEkBy2bY

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Marc-Henry PITTY, MD, CEO of Oregon Therapeutics, "To date, our first-in-class #metabolicinhibitor, XCE853, has exhibited robust preclinical efficacy in both in vitro and in vivo models across multiple #cancer types. Lantern’s (NASDAQ: LTRN) #RADR®AI platform will leverage the in vitro and in vivo data to potentially advance XCE853 development in a highly targeted manner and will help inform disease indications and #biomarker signatures that can aid in the design of future #clinicaltrials and in the pursuit of combination therapies with other approved cancer drugs. Our team is looking forward to efficiently selecting among the landscape of ideal development options and efficiently de-risking future clinical development decisions." https://lnkd.in/g8XPQSsa #biotech #france #texas #oncology #artificialIntelligence

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What a day for biotech financings! CatalYm GmbH, one of four companies who raised a megaround today, snagged an $150-million series D to move its GDF-15 inhibitor visugromab into first-line lung cancer patients. The protein plays a key role in fetomaternal tolerance, but cancer can hijack that mechanism to avoid immune detection, CEO Phil L'Huillier told me. Targeting GSF-15 also has another benefit -- it can reduce the nausea and vomiting triggered by other cancer treatments. “When we neutralise GDF-15 to treat cancer, not only are we treating the cancer through the immune mechanism, but we’re also treating the sickness that’s often associated with chemotherapies, radiotherapies, and ADCs ,” L'Huillier explained. For more on CatalYm's clinical plans and the American Society of Clinical Oncology (ASCO) data that triggered Tuesday's round, read the story here: https://lnkd.in/gDcHZQUm

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Appreciate John Glasspool’s op/ed in the Boston Business Journal. He brings the perspective of a CEO of a Cambridge-based #biotech, MassBio member Anthos Therapeutics, to the debate over the White House’s plans to use Bayh-Dole as a blunt instrument to force price controls. The reality is that any effort to use “march in” rights like this would hurt innovation, chill the collaborative relationship between research institutes and small biotechs (which are the lion’s share of Massachusetts’ industry) when it comes to advancing early science, and do nothing to address the price of drugs. You can’t argue with Bayh-Dole’s success: 6 million jobs, $2 trillion in economic output, thousands of startups, and 200+ drugs and vaccines. As John points out, we can’t go back to a time when science sat on shelves instead of getting into medicine cabinets. https://lnkd.in/ezkNndKA cc: The Bayh-Dole Coalition

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The Innovation Imperative: Pioneering New Modalities for Therapeutic Leadership -- great report from Revvity Signals, creators of the ChemDraw software I used to operate for many years during my research career. Grateful for featuring BioPharmaTrend.com's article "The Explosion of Therapeutic Modalities: Small Molecules, Biologics, and Everything in Between!" "New drug modalities encompass a broad spectrum of therapeutic strategies, each distinct in its action mechanism and target specificity. These span from monoclonal antibodies (mAbs) and RNA-based therapies to advanced gene editing techniques and cell therapies. The classification of these modalities is multifaceted, considering both their therapeutic mechanisms and stages of development. Established methods like mAbs coexist with emerging frontiers like CRISPR and CAR-T cell therapies, illustrating the breadth and depth of this field." A noteworthy trend within the small-moleculemodality is the reemergence of PROteolysis TArgeting Chimeras (PROTAC) although they were first described in 2001. This class within small molecule therapeutics Targeted Protein Degraders (TPDs), along with covalent inhibitors, and macrocycles represent an exciting frontier in small molecule therapy. TPDs, for instance, are designed to harness the body’s own protein disposal systems to eliminate disease-causing proteins, a strategy that could offer a new therapeutic angle for challenging targets. Covalent inhibitors, with their ability to form permanent bonds with target proteins, offer enhanced specificity and potency. Macrocycles, characterized by their large, ringshaped structures, present a unique balance of specificity and stability, enabling them to interact with complex protein surfaces that were previously inaccessible." Links to report and article in the comments 👇 #medicinalchemistry #drugdiscovery #biotech #biologics #biopharmatrend Image credit: Revvity Signals

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Great investment panel kicking off at SynBioBeta with Packy McCormick at Not Boring, Omri Amirav-Drory at NFX, Brigid O'Brien at RA Capital Management , Jenny Rooke at Genoa Ventures and Ursheet P. at Mayfield Fund Main take homes: 1. Constraints bring focus 2. Make the minimum viable products 3. Ideally you want to redefine an existing Category 4. Path to Profitability is Key 5. Margins matter A LOT 6. If B2B what are the KPI's of your buyer? 7. Success is a high bar "Chickens are VERY cost effective in food production" Omri 8. "Do the Math" If you can't have a performance or cost advantage you're not a viable business - Brigid 9. "For VC, you have to talk about the math of exits for making VC investments" Jenny 10. One of the challenges in SynBio is who are the buyers? Most don't have have very high margins. You have to build a cash engine to get a buyer interested" Ursheet 11. "If you're competing with a public company, you can read their public reports" Brigid 12. "In the end you have to make something and sell it for money" Omri 13. "You can't get away from negative gross margins" Omri 14. "Don't spend VC on CapEx" Jenny 15. "What innovations are you excited about?" Packy AI, Longevity, Glowing plant, Can you get to cost parity in climate tech without government subsidies?

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𝐂𝐞𝐥𝐥 & 𝐆𝐞𝐧𝐞 𝐓𝐱 𝐒𝐭𝐚𝐫𝐭𝐮𝐩𝐬 𝐛𝐲 𝐒𝐭𝐚𝐭𝐞 🧬 We screened our database of >1,000 cell & gene therapy companies & identified the states with the most CGT startups*. (see graph 📊) Message me for our free list of all 1k+ CGT companies 𝐈𝐧𝐭𝐞𝐫𝐞𝐬𝐭𝐢𝐧𝐠 𝐅𝐢𝐧𝐝𝐢𝐧𝐠𝐬: - Surprised that NY & FL have so many. - Not surprisingly, CA and MA top the list. - A bit surprised that MD has so many more than NC. *Companies with 50 or less employees See comment to get access to our list of over 1,000s companies developing cell & gene therapy products. 👇

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🧑‍💼 The Business of Biotech (5th Edition):🌱➡️🪙 The New Era Of Biotech Funding ⚡Cytonics is disrupting the traditional biotech funding model to accelerate research and development for the net benefit of humanity. The success of securing funding in biotech is a massively challenging task that is necessary for transforming innovative research into life-changing therapies. Cytonics is at the forefront, utilizing both traditional funding mechanisms and pioneering methods like equity crowdfunding. Here’s how each stage of funding contributes to our progress and offers strategic benefits to investors: https://lnkd.in/ehnwmUHr #biotechnology #arthritis #osteoarthritis #investing #crowdfunding #venturecapital #healthcare #drugdevelopment #clinicaltrials #regenerativemedicine #orthopedics #orthopaedics #surgery #investor #FDA #medicine #lifesciences #researchanddevelopment #capitalmarkets

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Congratulations to Cerevance on its initial $47M Series B-1 Extension closing – bringing the total Series B-1 raise to $98M. Bioluminescence Ventures is proud to have co-led this round with Agent Capital and Double Point Ventures, with participation from MQB Partners, LifeRock Ventures, Gates Frontier, GV (Google Ventures), and Lightstone Ventures. Kouki Harasaki, PhD, MBA (Founder and Managing Partner at Bioluminescence Ventures) and Campbell Murray, MD, MPP, MBA (Partner at Agent Capital) will join the company’s Board of Directors. The Series B-1 financing will support the upcoming Phase 3 clinical trial for CVN424, a first-in-class, non-dopaminergic compound that acts as an inverse agonist of the novel target G Protein-Coupled Receptor 6 (GPR6). CVN424 shows promise in improving both motor and non-motor symptoms of Parkinson's disease and may also have disease-delaying effects. The proceeds will also aid the advancement of a pipeline of novel treatments for other CNS disorders, including Alzheimer’s disease, Amyotrophic lateral sclerosis, and frontotemporal dementia. At Bioluminescence Ventures, we are committed to financing transformative platform technologies and breakthrough innovations that will translate to much-needed therapies for patients. We believe that the field of neurology is currently experiencing a golden age of discovery, with many subfields of research converging together to create increasingly holistic models of major CNS pathologies. Cerevance continues to advance the field by identifying novel target proteins that are either exclusive to specific circuits in the brain or differentially expressed in various disease states via its proprietary NETSseq (Nuclear Enriched Transcript Sort sequencing) Platform. Using an extensive and growing collection of over 15,000 human brain tissue samples, Cerevance has generated an unprecedented catalog of the most promising next-generation targets for major CNS diseases. Cerevance is revolutionizing the treatment of CNS diseases and transforming the lives of afflicted patients. We are excited to partner with Cerevance in this next phase of development.

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Indaptus Therapeutics (NASDAQ: INDP) CEO, #JeffreyMeckler, and CMO, #RogerWaltzman, sat down to discuss a few key takeaways from their recent presentation at #ASCO2024. In this video, they cover: • Decoy20 Strategy: Discover how their novel approach stimulates both the innate and adaptive immune systems, with a remarkable tolerability profile thanks to a significant reduction in LPS. • Conference Highlights: Learn about the promising developments in CAR therapies for solid tumors and how Decoy20 could potentially enhance these treatments. • Reinforcement of Their Approach: Hear about other studies, like Eikon Therapeutics’ EIK1001 + Pembro, that support our broad immune activation strategy. #immunotherapy #checkpointinhibitors #biotech #cancerresearch #lifesciences #merck #keytruda

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We started out Q1 with cautious optimism and the numbers continue to show the confidence was warranted. Biopharma M&A activity more than doubled nationally during the year’s first three months, coinciding with a rebound in venture capital deals as well as a flurry of IPOs. These are all good signs that the drug development cycle is normalizing and should translate into additional funding being available at the seed and Series A stages. Certain to be on the minds of funders and startups attending #AlignSummit24 on Thursday! https://lnkd.in/erEiJm6S  

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