Erik Halvorsen

Next week, partner Eva F. Yin, PhD, MPH, JD will join Rice Alliance for Technology and Entrepreneurship and BioHouston at their Texas Life Science Forum to participate on in the session "FDA & Healthcare Regulatory Considerations for Startups in Biotech & Medtech." The session will provide an overview of key FDA and healthcare regulatory considerations for #startups in the #lifesciences space as well as recent developments impacting the #biotech and #medtech industries. Learn more: https://lnkd.in/gcrR-pS7

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🧬 This week's Austin Bio & Health Roundup is a little quiet as the entire industry gears up for JPM, but there are some major milestones, data to dive into, and action across the Texas Bio Triangle! 🧬 🚀 Launches, Expansions, Milestones, and Wins Nuclein received FDA clearance and a CLIA waiver for their SARS-CoV-2 & Flu A/B test on their 15-minute point-of-care DASH Rapid PCR System. Huge congrats to Alan Blake, Charles Collins, & the entire team! 📊 Data Peter Walker’s analysis highlights AI’s growing slice in startup funding, with Bio & Health’s verticals being no different. • Healthtech: 24% of deals, 32% of cash raised • Med Device: 10% of deals, 15% of cash raised • Biotech: 13% of deals, 13% of cash raised 🤠 Texas Bio Triangle Houston: Indapta Therapeutics raised $22.5M to advance its cell therapy platform targeting cancer and autoimmune diseases. Harlingen: Frontier Direct Care secured a $20M Series B to expand its employer-sponsored healthcare offerings. Dallas: Highlander Health made its first acquisition, Target RWE, a longitudinal data company focused on numerous disease areas, with liver disease as its lead. Houston: CTMC - a joint venture between Resilience + MD Anderson Cancer Center announced a partnership with Syenex to scale their engineered T-cell therapies. What’s Next?

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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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We couldn't be happier for TechFW member Barricade Therapeutics, Corp., a bio-pharmaceutical company pioneering solutions for colorectal cancer, that has received a $14,005,035 grant from the Cancer Prevention and Research Institute of Texas (CPRIT). The funding will support the Phase 1 clinical development of Barricade’s innovative therapeutic candidate BT-1501 for APCmut advanced colorectal cancer (CRC) patients.   “This is a pivotal moment for Barricade. The feeling now is excitement and urgency as we position our drug candidate for testing in colorectal cancer patients where we plan to positively impact treatment options for this unmet medical need,” said CEO Neil Thapar.   Barricade has been a SmartStart member for six years and is a 2024 cohort member of the TMC innovation Factory – Accelerator for Cancer Therapeutics in Houston. It previously has raised $5.9M, including $3M from a previous CPRIT Seed grant award.  “CPRIT’s grant support has been invaluable toward enabling Barricade to declare BT-1501 as its clinical drug candidate. This product development grant award represents further validation that our drug class exhibits significant investigational merit, not only for colorectal cancer, but potentially for other difficult-to-treat cancers," Thapar said.   Thapar has leveraged TechFW's mentorship, community support, and program resources to support and refine Barricade’s groundbreaking research and development. “Over the years, TechFW has provided support and company building strategies that have been instrumental and a great asset for Barricade Therapeutics,” he said. Join us in congratulating Neil Thapar, John Walling and the entire Barricade Therapeutics, Corp. team on this fantastic development! We can't wait to see where this takes their research going into next year. 🔗: https://lnkd.in/gDHQcNTF Ryan Brown Sarah White Darlene Boudreaux Bruce Raben SJ Murdock, MSIMS Kaison Giles Create FW Fort Worth INC. Fort Worth Innovators Forum HSC Next BioNTX City of Fort Worth Economic Development Techstars Physical Health Fort Worth Accelerator Cowtown Angels

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Anavex Life Sciences (NASDAQ: AVXL) reports an impressive effect size for their Sigma-1 receptor agonist (activating autophagy), slowing Alzheimer's progression in a Ph2/3 study. https://lnkd.in/efc5r4kr https://lnkd.in/eWvWcQXG "Anavex Life Sciences (NASDAQ:AVXL) added ~13% in the premarket on Thursday after the neurology-focused drug developer said its lead asset blarcamesine (ANAVEX 2-73) slowed Alzheimer's disease progression by more than a third in a Phase 2/3 trial. Based on 48-week data from the trial, the New York-based biotech said blarcamesine, a once-daily oral therapy targeted at an Alzheimer's-linked protein called SIGMAR1, slowed clinical progression by 36.3% in terms of the primary endpoint. The effect was even more pronounced in a subgroup of patients identified as SIGMAR1 wild-type group, with blarcamesine slowing Alzheimer's progression by 49.8% at 48 weeks compared to the placebo group. The company remains on track to file regulatory submissions for the drug in Europe this year. Anavex (NASDAQ:AVXL) presented the data readout at a medical conference focused on Alzheimer's Disease in Madrid, Spain." Compared to Lecanimab, an FDA-approved anti-amyloid antibody (27% decline reduction on ADAS-Cog over 18 months vs. 38% (50 mg group), 26% (30 mg group), and 49% (Sigma 1 receptor WT subgroup). Lecanimab has significant side effects and is expensive compared to Anavex's small molecule.

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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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Reminder to come by Plus Therapeutics at the SNO Annual Meeting in Houston at Booth #317/319 Plus Therapeutics is a clinical-stage pharmaceutical company developing targeted radiotherapeutics for difficult-to-treat cancers of the central nervous system with the potential to enhance clinical outcomes for patients. Combining image-guided local beta radiation and targeted drug delivery approaches, the Company is advancing a pipeline of product candidates with lead programs in recurrent glioblastoma (GBM) and leptomeningeal metastases (LM). Learn more at https://bit.ly/4hUvWBV #BrainMets #BrainCancer #BreastCancer #LungCancer #raredisease #cancer #oncology #metastatic #radiotherapy #therapeutics #diagnostics $PSTV

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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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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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The top regional #healthcare and #biotech news for December 16th via the Big4Bio newsletters: San Diego: Candid Therapeutics' Deals With Ab Studio, EpimAb Biotherapeutics, Inc.; Approval for Neurocine; Crinetics Pharmaceuticals Names Exec; Boundless Bio Shares Dip https://lnkd.in/ggzmSCBv SF Bay: Executive Hires; Collabs and Deals; Gritstone bio's Asset Sale https://lnkd.in/gXi_NDMk Seattle: BioLife Solutions, Inc. Leadership Update; Bill & Melinda Gates Foundation's TB R&D Funding Contribution; Upcoming Events https://lnkd.in/geZKjNxH Los Angeles: Cedars-Sinai Secures $35M Donation;  Adagio Medical Inc.'s New CEO and Director; enVVeno Medical's Preclinical Study Success; ImmunityBio, Inc. Shares Drop https://lnkd.in/gMBrJrvi Boston: Exec Hires; Foghorn Therapeutics Inc. Drops Candidate; Nona Biosciences, Candid Therapeutics Collab; More on Bicycle Therapeutics, Editas Medicine, Repare Therapeutics https://lnkd.in/gHUtrVYv Philadelphia: Palvella Therapeutics, Pieris Pharmaceuticals Close Merger; Incyte Scraps Anemia Program; Roche Drops Phase 3 Spark Gene Therapy https://lnkd.in/gbmuBkE6 Capital Region: Novavax Meets $50M Milestone; Emergent BioSolutions Lands BARDS Contract; Upcoming Events https://lnkd.in/gjibvdac NYC: Amarin Corporation Appoints CFO; Catalent Pharma Solutions-Novo Holdings Deal Goes Through; Outlook Therapeutics, Inc. Layoffs; Bristol Myers Squibb Trims Portfolio https://lnkd.in/gNKn-zzc

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Excellent way to spend 1 minute, 30 seconds. DSO shares via an embedded video in the article below how Modality.AI is making an impact with patients. It is wonderful to have NIH SEED as a partner on this journey. Relentless Venture Fund David "DSO" Suendermann-Oeft #Neurotech #AI #BIO2024 #precisionmedicine #clinicaltrials #healthtech #healthcare #digitalhealth

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Watch this video to review options for enrolling patients in the NRG-GU009 (PREDICT-RT trial) and the NRG-GU010 (GUIDANCE) phase III RCTs, which both require risk stratification using Veracyte, Inc.'s #DecipherProstate Genomic Classifier. 

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See how PRIMR is helping Decipher by Veracyte build educational content for providers and patients enrolling on the NRG ONCOLOGY #prostatecancer #clinicaltrials Make your clinical trial easy to understand with PRIMR: https://lnkd.in/e6zPbmG3

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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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There's a deep personal history for me with this major acquisition today. Incyte (Rich Levy) had the vision at the time (2016) to let me design a very bold #phase2 #clinicaltrial with topical #ruxolitinib which ended up being the first FDA-approved JAK inhibitor in dermatology as OPZELURA® (ruxolitinib) HCP. Incyte acquires John E. Harris, MD, PhD's Villaris Therapeutics backed by Medicxi to go after #vitiligo. John E. Harris, MD, PhD and I are co-founders of Alys Pharmaceuticals which is going after #urticaria #itch #vitiligo and beyond again backed by Medicxi. In parallel in 2019, we publish an early and key paper in the journal Immunity (Meixiong et al. Immunity 2019) with Xinzhong Dong who discovered MRGPRX2 (actually, the entire family). I then start advising Escient Pharmaceuticals with the most bullish optimism about MRGPRX2 as target for #skin #diseases and witness a brilliant execution by Veena Viswanath et al. Incyte makes a bargain acquisition today for $750 million to transform skin disease in #dermatology and #allergy. The key point here is that MRGPRX2 antagonist will NOT be competing IMO with other more moderate-to-severe assets in #CSU like #barzolvolimab. They will mutually grow the market for #CSU across the mild to severe spectrum in a disease that is growing in incidence and poorly penetrated even by great drugs like #omalizumab. Keep in mind, #antihistamines are >$2 billion annual sales for #itch, which it does not even work for that well! This will accelerate new treatments for #urticaria and much beyond. Great for our patients.

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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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