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  • Biotech & Pharma Updates | January 7 - 8, 2025

Biotech & Pharma Updates | January 7 - 8, 2025

Tenvie Therapeutics launches with $200M and neurological treatment assets acquired from Denali Therapeutics, Aspect Biosystems $115M Series B to fuel bioprinting tissue tech ambitions, Novo Nordisk & Valo Health expand $4.6B partnership to develop cardiometabolic drugs targeting obesity and diabetes, Galapagos splits in half (with 40% workforce reduction) + 32 more stories

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We have a triple-header of company launches today: from neurodegenerative disorders to rare disease to biopharma deal assessment. | Gif: europeanspaceagency on Giphy

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⬇️ The Good News ⬇️

THE GOOD
Business Development

Alpha Cognition out-licenses Asia (excluding Japan), Australia, and New Zealand rights of Alzheimer's drug Zunveyl (acetylcholinesterase inhibitor) to China Medical System Holdings Limited for $44M
Small molecule, Alzheimer’s disease - Read more

MOMA Therapeutics in-licenses MOMA-989 (selective PARP1 inhibitor), strengthening its DNA damage response portfolio
Small molecule, cancer - Read more

Alesta Therapeutics in-licenses hypophosphatasia hopeful OC-1/ALE1 (undisclosed target) from 1cBio
Small molecule, hypophosphatasia - Read more

THE GOOD
Clinical Trials

iECURE touts complete clinical response in infant dosed with gene editing therapy ECUR-506 to treat ornithine transcarbamylase deficiency as part of ongoing Ph1/2 trial
Gene editing, ornithine transcarbamylase deficiency - Read more

LB Pharmaceuticals' LB-102 (dopamine inhibitor) shows promise in Ph2 trial for treating schizophrenia
Small molecule, schizophrenia - Read more

Jasper Therapeutics' briquilimab (targeting c-Kit protein) delivers positive Ph1b/2a results for chronic spontaneous urticaria
Monoclonal antibody, chronic spontaneous urticaria - Read more

Vir Biotechnology's dual-masked T-cell engagers VIR-5818 (targeting HER2) and VIR-5500 (targeting PSMA) show delivers promising Ph1 data for solid tumors
T-cell engager antibody, prostrate cancer, solid tumor - Read more

BioInvent's BI-1910 (targeting TNFR2) delivers positive Ph1 data for solid tumors, including hepatocellular cancer
Monoclonal antibody, hepatocellular cancer, solid tumor - Read more

TaiMed Biologics showcases positive Ph2a data for TMB-365/TMB-380 combination therapy for HIV infections
Monoclonal antibody, human immunodeficiency virus infection - Read more

Anokion's KAN-101 (targeting pathogenic T cells) delivers positive Ph2 results for celiac disease treatment
Small molecule, celiac disease - Read more

MaaT Pharma's MaaT013 microbiome therapy demonstrates “unprecedented” efficacy in Ph3 trial for steroid-resistant gastrointestinal acute graft-versus-host disease
Microbiome therapy, graft-versus-host disease - Read more

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⬇️ More Good News ⬇️

THE GOOD
Company Launches

Tenvie Therapeutics launches with $200M and neurological treatment assets acquired from Denali Therapeutics
Small molecule, neurodegenerative disease, Alzheimer's disease, Parkinson's disease - Read more

Alesta Therapeutics launches with a €65M ($67M) Series A and rare disease aspirations, lead asset in-licensed from 1cBio
Small molecule, hypophosphatasia - Read more

Prudentia Sciences launches with $7M Seed and a software platform to help pharma companies evaluate deals
Deal-making, due diligence, AI - Read more

THE GOOD
Fundraises

Aspect Biosystems $115M Series B, developing 3D-bioprinting tissue tech & associated therapeutic pipeline
Bioprinting, tissue printing, metabolic disease, endocrine disease - Read more

Esphera SynBio $2M Seed, developing nanomedicines via in vivo production of engineered exosomes
Nanomedicine, exosomes, cancer, vaccine - Read more

UniQure $75 million public offering, gene therapy biotech with broad pipeline
Gene therapy, hemophilia B, Huntington's disease, epilepsy, amyotrophic lateral sclerosis, Fabry disease - Read more

THE GOOD
IPOs

Maze Therapeutics files for IPO, hoping for a warm public reception of its kidney disease ambitions
Small molecule, APOL1 kidney disease, chronic kidney disease, phenylketonuria - Read more

THE GOOD
Mergers & Acquisitions

ActiGraph acquires Biofourmis' life sciences division, expanding its clinical trial capabilities with additional health monitoring software and tools
Digital health, clinical trial data collection, wearable - Read more [Paywall]

THE GOOD
Partnerships

Novo Nordisk, Valo Health expand $4.6B partnership to develop cardiometabolic drugs targeting obesity and diabetes
Small molecule, obesity, type 2 diabetes, cardiometabolic disease, drug development - Read more

Araris Biotech, Chugai Pharmaceutical partner to develop novel ADCs using Araris' AraLinQ platform with Chugai's antibodies
Antibody-drug conjugate, research, cancer - Read more

Tochigi Cancer Center, J-Pharma partner to study LAT1 inhibitor for biliary tract cancer treatment
Small molecule, biliary tract cancer, research - Read more [Press release in Japanese]

Biocytogen, Acepodia partner to develop dual-payload bispecific antibody-drug conjugates targeting complex tumors
Bispecific antibody-drug conjugate, solid tumor, cancer, drug development - Read more

Mirror Biologics, Merck KGaA clinical collab in Phase II trial combining AlloStim (off-the-shelf immune cell immunotherapy) and Bavencio (anti-PD-L1) for metastatic colorectal cancer treatment
Cell therapy, colorectal cancer, allogeneic cell therapy, monoclonal antibody - Read more

Ryght AI, QPS partner to automate clinical trials using AI technology for global research optimization
Clinical trial workflow, clinical trial automation, AI - Read more

THE GOOD
Regulatory

FDA releases guidance on evaluating AI models used in drug approval submissions, addressing growing use of AI in pharmaceutical development
Drug development, clinical trial management, manufacturing, AI - Read more

THE GOOD
Research

AI model SCORPIO predicts cancer immunotherapy success using routine blood tests, outperforming FDA-approved biomarkers
Cancer, therapy prediction, blood test, AI - Read more

AI model developed by Penn State researchers predicts autoimmune disease progression with significantly higher accuracy than existing methods
Autoimmune disease, disease pathway prediction, AI - Read more

Scientists develop the first nanobody inhibitors to fight deadly Ebola virus, hoping to address current 50% fatality rate
Nanobody, ebola virus infection - Read more

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⬇️ The Bad News ⬇️

THE BAD
Clinical Trials

Astellas Pharma discontinues Ph1 trial of ASP2802, a cell therapy targeting CD20-positive B cell lymphomas
Cell therapy, lymphoma, CAR-T - Read more

THE BAD
Layoffs

Galapagos splits into two companies, cutting 40% of workforce (and ends Gilead partnership)
Cell therapy, cancer - Read more

Cassava Sciences cuts 10 jobs (1/3rd of workforce) after disastrous 2024 (remember simufilam?) in an attempt to regroup
Small molecule, Alzheimer’s disease - Read more

Resilience plans to permanently cut 120 jobs at its Durham, NC facility
CDMO, manufacturing - Read more

Gotta break some eggs? Scribe Therapeutics cuts 20% of workforce in push to move cardiometabolic assets into the clinic
CRISPR-based therapy, severe hypertriglyceridemia, familial chylomicronemia syndrome - Read more

THE BAD
Regulatory

FDA raises concerns ahead of Seikagaku's condoliase injection adcomm
Biologic, radic­u­lar leg pain as­so­ci­at­ed with lum­bar disc her­ni­a­tion - Read more [Paywall]

⬇️ The Ugly News ⬇️

THE UGLY
Adverse Events

FDA mandates GSK and Pfizer to add Guillain-Barré syndrome warning labels on their RSV vaccines
Vaccine, respiratory syncytial virus, Guillain-Barré syndrome - Read more

You’re all caught up on the latest Pharma & Biotech News!

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