The best news in biotech, October 21-17

In the biotech world, Boston rides the highs and lows more than anywhere else. When times are good, there are more raises and company creations than anywhere else in the world, however when times are bad there are more lay-offs and company closures. For the last 18 months, the number of great candidates in Boston not only on the job market, but struggling to find work for extended periods has been, quite frankly, astounding.?

Despite the headwinds and changes to the investing landscape, last week was a clear sign that Boston will continue to be? a key driver of growth and innovation in the next biotech cycle. 2/2 NewCo launches, 5/8 series A-C private raises, 4/7 research collaborations, 2/2 licensing deals, 1/1 IPOs and 2/3 public raises involved a biotech in Boston.

?Enjoy!?

?? New Biotech Launches …

• Boston based Passkey Therapeutics emerged from stealth with $20M seed financing and Bruce Beutel as CEO, announcing plans to develop a new class of molecules that modulate rare combinations of proteins that work together. Link
• Boston based Alyssum Therapeutics , led by CEO Richard Fahrner , came out of stealth adding $14.5M to raise a total of $26M in series A financing, and a clinical stage first in class small molecule CMTR2 inhibitor that converts immunologically cold tumors into hot and recruits a B cell-driven immune response against the tumor. Link ?

?? Private Raises…

• Boston based Fable Therapeutics , led by CEO Geoff MacKay , raised $53M to develop its AI platform for discovering new obesity drugs. Link
• After only launching in April, Boston based Seaport Therapeutics , led by CEO Daphne Zohar , raised an oversubscribed $225M series B financing to advance its pipeline of neuropsychiatric drugs designed with enhanced oral bioavailability and reduced metabolism and hepatotoxicity. Link
• Boston based AvenCell , led by CEO Andrew Schiermeier , raised $112M in a series B round to advance its early clinical pipeline of CAR-T cell therapies tan can be turned "on" once inside a patient. Link
• Boston based Be Biopharma , led by CEO Joanne Smith-Farrell ,? announced an $82M financing round to take its engineered B-cell therapies into clinic. Link
• Boston and Vancouver based Alpha-9 Oncology , led by CEO David Hirsch , raised a $175M oversubscribed series C financing to advance its discovery and clinical pipeline of radiopharmaceuticals to treat various cancers. Link
• Belgium based Agomab , led by CEO Tim Knotnerus , announced an $89M series D financing round to advance it phase 2a drug gut-restricted oral small molecule inhibitor of ALK5 (TGFβ1R) for the treatment of patients with fibrostenosing Crohn’s disease. Link
• Texas based March Biosciences , led by CEO Sarah Hein , raised a $28M oversubscribed series A to advance its clinical stage pipeline of CAR-T cell therapies. Link
• UK and Montreal based Epitopea , led by CEO Alan Rigby and CSO Jon Moore , closed a $31M pre-series A financing to develop its pipeline of off-the-shelf RNA-based immunotherapies for cancer. Link ?

?? New VC funds…

• New York based Dimension , led by Managing Partners Zavain Dar , Adam Goulburn and Nan Li , plan to raise $500M in its second fund, according to an SEC filing. Link ?

??Research collaborations…?

• Boston based Editas Medicine and Vancouver based Genevant Sciences entered a licensing an collaboration agreement to develop novel mRNA-LNP gene editing therapies using Editas' CRISPR Cas12a genome editing systems with Genevant’s proprietary LNP technology. Genevant will receive $238M in upfront and milestone payments. Link
• As part of an ongoing 5 year collaboration, 拜耳 entered an exclusive license agreement with Dewpoint Therapeutics for a biomolecular condensate targeting program to treat dilated cardiomyopathy patients. The deal is worth up to $424, including upfront and milestone payments. Link
• AbbVie and Hungary based Gedeon Richter Pharma GmbH announced new collaboration for the discovery and development of novel targets for neuropsychiatric conditions in a deal worth $25M upfront, plus milestone payments, building on a 20 year partnership. Link
• Boston based Dyno Therapeutics , led by Founding CEO Eric Kelsic , announced a deal with Roche worth $50M upfront and over $1B in milestone payments to design and develop next generation AAV gene therapies for neurological diseases. Link
• Boston and Shanghai based Eccogene received a $60M milestone payment from 阿斯利康 following the dosing of the first patient in the global phase 2b program of ECC5004/AZD5004 for the Treatment of Obesity and Type 2 Diabetes. Link
• Evotec and 百时美施贵宝 expanded their proteomics collaboration of molecular glue degraders in fields beyond oncology, triggering a $50M milestone payment to Evotec. Link
• France based TreeFrog Therapeutics entered a research collaboration with the University of Pittsburgh focused on the potential of tertiary lymphoid structures (TLS) in immuno-oncology. Link

??Licensing deals…

• Boston based Monte Rosa Therapeutics , led by CEO Markus Warmuth , announced a global development and commercialization license agreement with 诺华 to Advance T and B-cell-modulating molecular glue degraders, inlcuding its lead phase 1 program. The deal is worth $150M upfront and up to $2.1B in milestone payments. Link
• Monopar Therapeutics Inc. is to acquire a late stage Wilson program from Alexion Pharmaceuticals, Inc. for an undisclosed fee. Link

?? M&A…

• CA based Lyell Immunopharma will acquire ImmPACT Bio $30M in cash plus up to 50 million shares of Lyell common stock.? ImmPACT’s lead program, IMPT-314, is a CD19/20-targeting CAR T-cell therapy that Lyell will continue to develop for hematologic malignancies, among a pipeline reprioritization. Link
• Clinical stage rare disease and Texas based Lumos Pharma will go private after being acquired by Double Point Ventures , led by managing partner Daniel Yadegar MD FACC RPVI , for $38M. Link
• Merck Group is to acquire CT based Modifi Bio , led by founding team Kingson Lin Seth Herzon , Kevin Rakin and Ranjit Bindra , for $30M upfront with up to $1B in milestone payments, for its novel class of small molecules that target cancer cells lacking expression of a key DNA repair protein. Link

?? IPO News…

• Several weeks after announcing its initial IPO plans, during which it moved its first GPCR targeting programs into clinic, CA based Septerna , led by CEO Jeff Finer , announced the pricing of a $288M IPO, which was upsized from its initial pricing of $157M. Link ?

?? Other Public Raises…

• Boston and Montreal based enGene , led by CEO Ron Cooper, announced a $60M PIPE to fund continued clinical development of its non-viral locally delivered gene therapy for the treatment of various cancers. Link
• Switzerland based Molecular Partners announced plans to raise $20M in an underwritten offering for development and expansion of its radiopharmaceutical pipeline and platform. Link
• Boston and Netherlands based ProQR Therapeutics raised a $75M in a public offering to fund further development of its RNA pipeline.? Link

?? Other investments and expansions…

• 荷商葛蘭素史克藥廠 announced plans to spend $800M expanding its medicines and vaccines manufacturing in Pennsylvania, its largest manufacturing investment in the US. Link

?? Positive clinical development updates…

• North Carolina based Precision BioSciences, Inc. became the first company to move an in-vivo gene editing program into clinical trials for the treatment of HBV, with acceptance of their CTA in Moldova. Link
• San Deigo based Adcentrx Therapeutics , led by President and CEO Hui Li and CSO Pia Challita-Eid , announced FDA clearance of its IND for a potential first-in-class ADC targeting STEAP1 for the treatment of Advanced Solid Tumors. Link
• New data from a phase 3 trial for Arexvy, 荷商葛蘭素史克藥廠 's respiratory syncytial virus vaccine, showed potential to help protect a broader group of adults at increased risk for RSV disease. Link
• 礼来 's IL-13 inhibitor EBGLYSS (lebrikizumab-lbkz) demonstrated meaningful improvement in skin clearance and itch reliefin a phase 3 trial in the majority of patients with moderate-to-severe atopic dermatitis who discontinued dupilumab. Link
• Sanofi teased positive data to be presented at ACAAI for Dupixent as a treatment for chronic spontaneous urticaria, teeing up a resubmission and the potential for the first new targeted treatment for people living with chronic spontaneous urticaria in more than 10 years. Link
• 强生公司 's TREMFYA? (guselkumab) was shown to effectively clear overlooked and undertreated plaque psoriasis in a phase 3b study. Link
• Biogen presented positive results from phase 2 study of felzartamab in IgA Nephropathy at ASN kidney week 2024. Link
• 诺和诺德 's oral semaglutide demonstrated a 14% reduction in risk of major adverse cardiovascular events in adults with type 2 diabetes in a phase 3 trial. Link
• 诺华 's oral Fabhalta? (iptacopan) sustained clinically meaningful results at one year in a Phase 3 C3 glomerulopathy (C3G) trial. Link
• Intellia Therapeutics, Inc. presented positive phase 2 results from its In-Vivo CRISPR Gene Editing treatment for Hereditary Angioedema (HAE). Link
• CA based IDEAYA Biosciences announces positive interim phase 1 expansion data of IDE397 in MTAP-Deletion Urothelial and Lung Cancer. Link
• CA based Arcus Biosciences announced positive interim clinical data for its phase 1/1b HIF-2a Inhibitor for the treatment of Metastatic Kidney Cancer. Link
• California based BridgeBio , led by CEO Neil Kumar , shared positive data from high dose cohort of phase 1/2 CANaspire Study of gene therapy BBP-812 for Canavan Disease at ESGCT 2024. Link
• Otsuka announced positive phase 3 data for its cytokine targeting drug for IgAN. Link
• CA based Annexon Biosciences presented positive phase 2 data for its Dry AMD program. Link
• MD based REGENXBIO presented positive data for its phase 2 Wet AMD gene therapy. Link

?? Regulatory Recommendations…

• 阿斯利康 and Ionis Pharmaceuticals, Inc. 's RNA silencer Wainzua (eplontersen) was recommended for approval in the EU by CHMP for the treatment of adult patients with polyneuropathy associated with hereditary transthyretin-mediated amyloidosis. Link
• The Advisory Committee on Immunization Practices (ACIP) recommended 辉瑞 's 20-Valent Pneumococcal Conjugate Vaccine PREVNAR20 for Adults Aged 50 and Older. Link
• CDC’S ACIPa also recommended Merck Group 's CAPVAXIVE? (Pneumococcal 21-valent Conjugate Vaccine) for Pneumococcal vaccination in adults 50 years of age and older. Link

?? Regulatory Approvals

• 阿斯利康 's antibody drug Fasenra (benralizumab) was approved for another indication, this time in the EU for patients with eosinophilic granulomatosis with polyangiitis. Link
• The US FDA approved Pfizer's RSV vaccine ABRYSVO for adults aged 18-59 at increased risk for disease. Link
• 礼来 's Kisunla? (donanemab-azbt) receiveed marketing authorization in Great Britain for the treatment of mild cognitive impairment and mild dementia due to alzheimer's disease in adult patients who are apolipoprotein E Ε4 heterozygotes or non-carriers. Link
• 强生公司 's DARZALEX? (daratumumab)-SC based quadruplet regimen was approved by the European Commission for patients with newly diagnosed multiple myeloma who are transplant-eligible. Link
• Ireland based Iterum Therapeutics plc received U.S. FDA approval of ORLYNVAH? (oral sulopenem) for the treatment of uncomplicated urinary tract infections. Link ?

That's all for this week, thanks for tuning in. Subscribe for alerts to the latest positive news in the biotech industry delivered to your inbox every Monday ????

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About the author: Max Robinson is an ex-scientist turned talent leader in the biotechnology industry, and currently Global Head of Discovery, Preclinical & Translational Research at Proclinical .