Biotech Briefs: Encoded Therapeutics, Solstice Oncology, TwoStep Therapeutics & More 

The latest from small and Emerging Pharma companies featuring Encoded Therapeutics, Solstice Oncology, TwoStep Therapeutics, Superluminal, and Medicus Pharma. 

For news on the large and mid-sized bio/pharmaceutical companies, see Global Briefs

* Encoded Therapeutics Raises $275 M To Support Gene-Therapy Neurological Pipeline 
* Solstice Oncology Raises $225 M for Biologic Colon Cancer Drug 
* TwoStep Therapeutics Raises $62.5 M for Peptide-Drug Conjugate; Gets FDA OK for IND
* Superluminal Raises $60 M To Support Genetic Obesity Drug
* Medicus Pharma Gains Rights to Early-Stage ADC from Pfizer


Encoded Therapeutics Raises $275 M To Support Gene-Therapy Neurological Pipeline 
Encoded Therapeutics, a South San Francisco, California-based clinical-stage bio/pharmaceutical company developing precision genetic medicines for neurological disorders, has announced the close of a $275 million financing. 

Proceeds will support the study of ETX101, a gene therapy for treating SCN1A-positive Dravet syndrome, a rare and severe form of genetic epilepsy, in infants and young children as well as an expansion study in children and adolescents up to 18 years of age. Funding will also support commercial scale-up of internal GMP manufacturing capabilities and pipeline advancement, including for ETX301, a gene therapy for treating chronic neuropathic pain caused by lower limb post-amputation neuroma, toward an investigational new drug application submission in 2027.  

Source: Encoded Therapeutics 


Solstice Oncology Raises $225 M for Biologic Colon Cancer Drug 
Solstice Oncology, a Boston-based clinical-stage bio/pharmaceutical company focused on treating cancer early in the neoadjuvant setting, raised $225 million in Series A financing. The funding will support the advancement of its lead candidate, porustobart, a Fc-enhanced cytotoxic T-lymphocyte-associated protein 4 (CTLA-4) antibody, across two clinical indications, one in microsatellite-stable (MSS) colon cancer and a second, undisclosed indication. A Phase II trial is evaluating porustobart in combination with pembrolizumab in the neoadjuvant setting for the treatment of MSS clinical Stage II-III colon cancer. 

Source: Solstice Oncology 


TwoStep Therapeutics Raises $62.5 M for Peptide-Drug Conjugate; Gets FDA OK for IND 
TwoStep Therapeutics, a San Carlos, California-based bio/pharmaceutical company developing multi-specific targeted therapies for solid tumors, has raised $62.5 million in an oversubscribed Series A financing and gain clearance by the US Food and Drug Administration (FDA) of its investigational new drug (IND) application for TS-104, the company’s lead multi-specific peptide-drug conjugate.  

The IND clearance enables TwoStep to initiate a first-in-human Phase I clinical trial of TS-104, with patient enrollment expected to begin in late 2026. 

Source: TwoStep Therapeutics 


Superluminal Raises $60 M To Support Genetic Obesity Drug  
Superluminal Medicines, a Boston-based bio/pharmaceutical company integrating aritificial intelligence/machine learning, protein dynamics, and structural biology for G protein-coupled receptor (GPCR) targets, has raised $60 million in an oversubscribed Series B financing.  

Proceeds will support advancing Superluminal’s lead program for rare genetic forms of obesity and hypothalamic obesity, a rare and severe medical condition caused by damage to or dysfunction of the hypothalamus, the part of the brain that regulates hunger, satiety (feeling full), and energy metabolism, advancing additional pipeline programs, and further expanding the company’s portfolio of small-molecule GPCR-targeted therapies for endocrine and cardiometabolic diseases. Superluminal’s lead clinical program is a selective, biased MC4R agonist being developed for rare genetic forms of obesity and hypothalamic obesity, with a Phase I clinical trial expected to begin by the end of 2026. 

Source: Superluminal Medicines 


Medicus Pharma Gains Rights to Early-Stage ADC from Pfizer 
Medicus Pharma, a Philadelphia, Pennsylvania-based bio/pharmaceutical company, and Pfizer have entered an agreement under which Pfizer granted Medicus a license to develop, manufacture and commercialize PF-08046031 (CD228V), an early clinical-stage antibody-drug conjugate targeting melanotransferrin (CD228).  

Under the agreement, Medicus paid Pfizer an upfront payment of $12 million and is obligated to pay an additional payment of $15 million on the first anniversary of the effective date. In addition, Pfizer paid Medicus a payment of $2 million, which Medicus is required to apply solely to fund development activities for CD228V and products incorporating it.

Pfizer is also eligible to receive development and regulatory milestone payments of over $1 billion, assuming achievement of all applicable milestones across multiple indications and commercial thresholds, and low double-digit royalties on net sales per calendar year. 

Source: Medicus Pharma