Drug Hunter’s Post

EXO Biologics Received EMA Approval - https://ter.li/8juz04 In case you missed it, last month Exo Biologics received EMA approval to initiate a Phase 1/2 trial assessing the safety and efficacy of intratracheal administration of EXOB-001 in preventing Bronchopulmonary Dysplasia (BPD) in preterm newborns. The EVENEW Study is the first mesenchymal stromal cell (MSC)-derived extracellular vesicles trial approved by the EMA. Excitingly, Exo Biologics CEO, Hugues Wallemacq will be presenting at the 5th Exosome Based Therapeutics Summit in Boston in 2 weeks time. Download the full agenda here to discover the 35+ other World-Class expert speakers that will also be presenting & join 115+ of your peers at this industry-led forum. https://ter.li/y9oxjq I hope to see you soon in Boston, MA, to discuss this historic event and more! #exosomes #extracellularvesicles #advancedtherapies Hanson Wade Group Rachel McMahon

"Improved Assays & High Throughput Screens are the path to realizing the potential of TPD" Agree? The 2nd TPD Assay Development & Screening Summit returns to San Diego with 23 new speakers, 10+ more companies, 3 revamped discovery workshops, and 1 holistic agenda covering: - Ternary complex formation guided degrader discovery - Novel ligand binding ID and validation - Characterization of new E3s - High throughput proteomic approaches to understanding your degrader View the program here: https://ter.li/yex6w3 Join: Kymera Therapeutics Origami Therapeutics, Inc. Asha Therapeutics Monte Rosa Therapeutics Novartis The Janssen Pharmaceutical Companies of Johnson & Johnson UC San Diego Nurix Therapeutics Bristol Myers Squibb Entact Bio University of California, San Francisco Enveda Biosciences Baylor College of Medicine AbbVie The Structural Genomics Consortium (SGC) Plexium Lyterian Therapeutics A-Alpha Bio Pfizer NeoX Promega Corporation Orionis Biosciences NanoTemper Technologies View the program here: https://ter.li/yex6w3

EXO Biologics Received EMA Approval - https://ter.li/8juz04 In case you missed it, last month Exo Biologics received EMA approval to initiate a Phase 1/2 trial assessing the safety and efficacy of intratracheal administration of EXOB-001 in preventing Bronchopulmonary Dysplasia (BPD) in preterm newborns. The EVENEW Study is the first mesenchymal stromal cell (MSC)-derived extracellular vesicles trial approved by the EMA. Excitingly, Exo Biologics CEO, Hugues Wallemacq will be presenting at the 5th Exosome Based Therapeutics Summit in Boston in 2 weeks time. Download the full agenda here to discover the 35+ other World-Class expert speakers that will also be presenting & join 115+ of your peers at this industry-led forum. https://ter.li/y9oxjq I hope to see you soon in Boston, MA, to discuss this historic event and more! #exosomes #extracellularvesicles #advancedtherapies Hanson Wade Group Rachel McMahon

A NRF2 inhibitor selectively sensitizes KEAP1 mutant tumor cells to cisplatin and gefitinib by restoring NRF2-inhibitory function of KEAP1 mutants, Tahar Aboulkassim et al. Cell Reports Reports 2023. This is impressive. Conversely we have made molecules that repair the abberant binding v of Nrf2-KEAP1 due to somatic KEAP1 mutation. These mutations result in constitutively high Nrf2, and resistance to many cancer therapies, by virtue of the cytoptotective gene batter in regulates. This chemistry is advancing quickly; improving pritein-protein interaction.

[Clinical Trials] VYNE Therapeutics' phase 1b trial of VYN201 shows biological activity and positive effect on key biomarkers in nonsegmental vitiligo https://lnkd.in/gxestuXA Ferrer Internacional's phase 3 trial of FAB122 in amyotrophic lateral sclerosis fails to show significant benefit over placebo in disease progression https://lnkd.in/g5CwBDDw [Deals] Amgen Secures Exclusive Global Rights for Tepezza Subcutaneous Formulation in Xeris Pharmaceuticals Collaboration https://lnkd.in/gN5NaY6h Sermonix Pharmaceuticals Signs Exclusive Collaboration and License Agreement with Henlius Biopharmaceuticals for Lasofoxifene in China, Potentially Reaching $58M Milestone Payment https://lnkd.in/gJGfa2e3 Ji Xing Pharmaceuticals Shanghai Secures Global Development Rights for BIIB131 in Acute Ischemic Stroke Agreement from Biogen https://lnkd.in/gPGBtJHu

MK-0616: “I Was Told.. an Oral PCSK9 Inhibitor is Impossible” | https://lnkd.in/gmYxYD43 -2023 Molecule of the Year Nominee (#1/10)- Merck's macrocyclic PCSK9 protein-protein interaction (PPI) inhibitor, MK-0616, is a once-daily PCSK9-lowering and LDL-cholesterol-lowering small molecule that has recently demonstrated antibody-like efficacy as an oral agent in the clinic. The program highlights numerous technical achievements at the forefront of modern drug discovery, from mRNA display screening to the use of lipidic permeation enhancer formulations, and will set a standard for modern “classics in drug discovery” for some time. In this case study, we review the drug discovery campaign leading to MK-0616 from hit-finding to clinical development, highlighting why this molecule continues to be a “big deal” and a standard for modern “classics in drug discovery.” Article | https://lnkd.in/gmYxYD43

As per DelveInsight, in 2022, the total prevalent cases of Age-related Macular Degeneration (AMD) were approximately 53 million in the 7MM. The AMD market size was found to be approximately USD 9.4 billion in 2022, and it is anticipated to grow at a significant CAGR by 2032. Some of the leading pharma and biotech giants such as Opthea, Kodiak Sciences., REGENXBIO Inc., Alkahest, Inc., Evergreen Therapeutics, Inc., Alkeus Pharmaceuticals, Inc., Ribomic USA Inc, Outlook Therapeutics, Inc., UNITY Biotechnology, PanOptica, Inc., Clearside Biomedical, Inc., Alexion Pharmaceuticals, Inc., AstraZeneca, Alkeus Pharmaceuticals, Inc., Stealth BioTherapeutics, Regenerative Patch Technologies, Allegro Ophthalmics, LLC, Annexon Biosciences, NGM Biopharmaceuticals, Ionis Pharmaceuticals, Inc., Apellis Pharmaceuticals, Iveric Bio, An Astellas Company, Gyroscope Therapeutics, Novartis, and others are developing novel AMD drugs which are anticipated to enter the market in the near future. Find out more key insights, at: https://lnkd.in/dxzjbXZ4 #healthcare #biotechnology #lifesciences #market #marketforecast #marketanalysis #fda #healthcaremarket #healthcareindustry #marketoutlook #agerelatedmaculardegeneration #AMD

As a science-led biotechnology firm developing prescription digital therapeutics, Click Therapeutics recognizes the important role that FDA plays to ensure that patients receive safe and effective treatments. Recently, FDA published a perspective on navigating the regulatory landscape and specifically referenced digital therapeutics, sharing that “Digital therapeutics is another area of novel therapy development that holds the potential for increased, and potentially rapid, access for patients.” We are thrilled to see the team at FDA supportive of the potential of digital therapeutics to increase access to high-quality therapies for patients. To read more on this perspective, visit: https://lnkd.in/eq9eTUwv #DigitalTherapeutics

Targeted protein degraders (TPDs), such as PROTACs and certain molecular glues, have garnered increasing attention in late-stage research and clinical trials recently. Kymera Therapeutics is slated to unveil interim phase 1 results of their STAT3 degrader, KT-333, during the Late-Breaking Research Poster session at the upcoming AACR 2024 conference (April 5-10) in San Diego. Check link for more detail: https://www.aacr.org While most of TPD are small molecules, there's a growing buzz surrounding Degrader-antibody conjugates (DACs) in recent times. Orum Therapeutics’s ORM-6151, a phase 1 stage anti-CD33 antibody-enabled GSPT1 degrader, has recently been acquired by Bristol Myers Squibb. Firefly Bio and Nurix Therapeutics also have their own DACs in development.   Additionally, the 2024 Annual Conference of our society, featuring numerous novel modalities of biologics, will convene in Cambridge, MA, USA on Saturday, May 11, 2024. Registration for the conference is now open via the following link. https://lnkd.in/ecmFPA4v #antibodydiscovery #antibodydrugconjugates #annualmeeting #annualconference #aacr #targetedproteindegrader #degraderantibodyconjugates

It’s Molecule Monday and today’s post is about a Molecule of the Future: Milvexian #chemistry #moleculemonday #acs ------------- Milvexian (CAS Reg. No. 1802425-99-5) is a developmental oral drug for preventing blood clots. It inhibits factor X1a (FX1a), an enzyme in the clot-forming coagulation cascade. Janssen Pharmaceuticals and Bristol-Myers Squibb (BMS) completed Phase 2 clinical trials on milvexian early this year. ------------- In April, Simon Wagschal, Diego Broggini, and 35 colleagues at worldwide locations of Janssen and BMS reported a major advance toward the commercial synthesis (https://lnkd.in/emTA95FB) of milvexian. They scaled up the reaction sequence for making the right-hand portion of the molecule (see image), which contains a 12-membered ring. ------------- In June, Surasak Wichaiyo and co-workers at Mahidol University (Bangkok) reviewed the potential clinical benefits of small-molecule FXIa inhibitors for preventing arterial thrombosis. They focused on milvexian and another anticoagulant, asundexian (CAS Reg. No. 2064121-65-7), along with mentions of other drug candidates in earlier stages of development. They concluded that small-molecule FXIa inhibitors have the advantages of rapid action, oral availability, and lower bleeding risks (https://lnkd.in/eFGH8Gq7) when compared with currently available anticoagulants.