Vicentra BV aims to make its Kaleido 2 insulin patch pump and automated insulin delivery system even smaller than its current device, already amongst the smallest, lightest and most precise insulin device on the market, new CEO Tom Arnold told BioWorld. As the company works to meet growing demand for its product, Kaleido has the potential to transform diabetes care, he said.

Kadimastem Ltd. and Itolerance Inc. have held a type B pre-IND meeting with the FDA regarding the development of ITOL-102, an investigational biologic for the treatment and potential cure of type 1 diabetes that would not require life-long chronic immune system suppression. It comprises Kadimastem’s allogenic human stem cell-derived pancreatic islets (Isletrx cells) combined with Itolerance’s immunomodulator, ITOL-100.

Cour Pharmaceuticals Development Co. Inc. has obtained IND clearance from the FDA for CNP-103, a nanoparticle in development to address the underlying autoimmunity of type 1 diabetes. A first-in-human phase Ib/IIa trial will begin later this year and will enroll adults (aged 18-35 years) and pediatric patients (aged 12-17) who have stage III or newly diagnosed (within the last 6 months) type 1 diabetes as well as C-peptide >0.2 ng/mL.

Sana Biotechnology Inc. CEO Steve Harr said “cool and transformative science” led to his firm’s latest strides in type 1 diabetes, and the “very generalizable [clinical] result” cheered Wall Street, which led shares of the Seattle-based firm (NASDAQ:SANA) to close Jan. 8 at $4.30 up $2.65, or 160.6%. “I believe we now have all of the pieces in place to move forward rapidly,” Harr said.

As recently as last month, Lexicon Pharmaceuticals Inc. was holding out hope regarding the NDA for Zynquista (sotagliflozin) as an adjunct to insulin therapy for glycemic control in adults with type 1 diabetes (T1D) and chronic kidney disease (CKD), with analysts mulling the potential label.

During a busy day of dealmaking, Cour Pharmaceutical Development Co. Inc. entered a pact with Roche Holding AG’s Genentech unit to advance tolerogenic nanoparticle treatments for an autoimmune disease indication, garnering up to $940 million in up-front and milestone payments. Cour’s partnership with Genentech is its biggest to date, and the largest deal announced by a biopharma company on Dec. 3. A total of seven deals amounted to a combined single-day deal value of $3.67 billion.

Astrazeneca plc has selected a candidate to progress under its type 1 diabetes regulatory T cell (Treg) therapy program with Quell Therapeutics Ltd. The company has exercised its exclusive option to license the therapy for further development and commercialization, resulting in a milestone payment to Quell of $10 million.