The Weekly Roundup: Long-Acting Injectables, Diabetes Procedure Offers Hope, and More

The Weekly Roundup newsletter curates the top five - deals, pipeline, funding, and news from the past week.

The complete list is available here: Industry Updates

🤝Deals and Collaborations

1️⃣ DifGen Pharmaceuticals has acquired Aveva Drug Delivery Services, a company specializing in the development and manufacturing of transdermal delivery systems and oral dissolvable films. The acquisition will expand DifGen's capabilities in drug delivery technologies.

2️⃣ ALX Oncology has partnered with Sanofi to conduct a Phase l/ll clinical trial of evorpacept in combination with SARCLISA and dexamethasone for patients with relapsed or refractory multiple myeloma. The trial will evaluate the safety and efficacy of the combination therapy.

3️⃣ Daewoong Pharmaceutical has signed a global license agreement with Vitalli Bio for the development and commercialization of DWP213388, a new drug candidate for autoimmune disease. Under the agreement, Vitalli Bio has exclusive rights for the global market while Daewoong Pharmaceutical will retain rights in some Asian regions, including Korea.

4️⃣ Cartherics has granted Shunxi the license to develop, manufacture and commercialize its autologous CAR-T cell product, CTH-004, for multiple solid tumors including ovarian cancer in Greater China. The license agreement will enable Cartherics to expand its reach in the Chinese market for CAR-T cell therapy.

5️⃣ OBiO and CHINAGENE have signed a strategic agreement for contract development and manufacturing services for gene therapy products, including large-scale cGMP manufacturing service for clinical trials and commercial manufacturing, enabling CHINAGENE to expand its gene therapy product development capabilities.

⏫ Pipeline and Approvals

1️⃣ Anti-infective: Seres Therapeutics and Nestlé Health Science have received FDA approval for Vowst, a live biotherapeutic product for the prevention of recurrent C. difficile infection in adults. Vowst contains a blend of bacterial spores derived from the fecal microbiota of healthy donors.

2️⃣ Oncology: Futibatinib, developed by Taiho, has received backing from a European Union panel for the treatment of bile duct cancer in patients who have previously received at least one line of chemotherapy. Futibatinib is a selective and irreversible inhibitor of fibroblast growth factor receptor (FGFR) 4, which is often overexpressed in bile duct cancer.

3️⃣ Cardiology: Bristol Myers Squibb's Camzyos (mavacamten) has received a positive EMA committee recommendation for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (HCM). Camzyos is a first-in-class, oral, allosteric inhibitor of cardiac myosin that reduces excessive contractility of the heart muscle.

4️⃣ Vaccine: The EMA committee has recommended the approval of GSK's respiratory syncytial virus (RSV) vaccine for the prevention of lower respiratory tract disease (LRTD) caused by RSV in adults aged 60 years and older. The vaccine contains the recombinant RSV prefusion F glycoprotein antigen and is designed to elicit an immune response against RSV.

5️⃣ Dermatology: Novartis' Cosentyx (secukinumab) has received a positive recommendation from the CHMP for the treatment of hidradenitis suppurativa. The drug is a human monoclonal antibody that selectively binds to interleukin-17A (IL-17A), which plays a key role in the inflammatory response associated with hidradenitis suppurativa.

💰 Funding

1️⃣ Vedanta Biosciences has raised $106.5 million to advance its microbiome-based therapies, including VE303 for recurrent C. difficile infection. The financing will enable a pivotal Phase 3 study of VE303 to begin by 3Q 2023.

2️⃣ Orbital Therapeutics has raised $270 million to advance its research on next-generation RNA medicines, with a focus on vaccines, protein replacement, and immunomodulation. The startup's goal is to develop RNA-based therapies that offer advantages over currently available treatments.

3️⃣ Evommune has closed a $50 million Series B financing to advance its pipeline of therapies for chronic inflammatory diseases. The financing will support the development of EVO101, a novel small molecule inhibitor of the IRAK4, which is being evaluated in a Phase 2a proof-of-concept trial for atopic dermatitis, among other pipeline programs.

4️⃣ Therini Bio has raised funds to develop fibrin-targeted therapies for neurodegenerative and retinal diseases. The funding will enable the development of innovative therapies for these diseases, which currently have limited treatment options.

5️⃣ Adcentrx Therapeutics has completed a $38 million Series A financing, led by Eight Roads Ventures, to advance its pipeline of novel antibody-drug conjugates into clinical development. The funds will enable Adcentrx to progress its innovative therapies for the treatment of cancer and other diseases.

📰 Interesting News

1️⃣ Scientists have developed a mobile printer that can produce thumbnail-sized patches capable of delivering mRNA COVID-19 vaccines. The development aims to help immunize people in remote areas who may have limited access to healthcare facilities.

2️⃣ The development of long-acting injectables (LAI) for biologics is an area of increasing interest, with many products currently in the development phase. LAIs have the potential to improve patient compliance and reduce the frequency of injections. However, challenges in formulation development and delivery remain, making it crucial for collaboration between academia and industry to advance research in this area.

3️⃣ India has signed a pact with the Association of Korean Pharmaceutical Industry to export generic drugs to South Korea, a lucrative market in Northeast Asia after China and Japan. India's export of pharmaceuticals to South Korea has grown by 34% over the past financial year, reaching $166.94 million in 2022-23.

4️⃣ Brain organoids, lab-grown brain cells used to model and study neurodegenerative diseases, may soon power our computers. Emerging studies suggest that brain organoids are capable of learning, with a recent report from Melbourne showing that 800,000 brain cells were trained to play a computer game, indicating the potential for organoid intelligence to be used in computing technology.

5️⃣ A one-hour diabetes procedure that involves zapping part of the small intestine with controlled pulses of electricity has shown promise in helping people manage type 2 diabetes without insulin for up to a year. The procedure offers hope for those with type 2 diabetes who struggle to manage their condition with traditional insulin therapy.