#Switzerland #Onward Therapeutics #Emercell #OT-C001 #Epalinges

Innovative Developments in Cancer Therapy from Onward Therapeutics

Onward Therapeutics SA, a dynamic player in the biotechnology sector, has recently made significant strides in the realm of cancer treatment. The company has announced that its subsidiary, Emercell SAS, has received crucial approval from the European Medicines Agency (EMA) to launch a Phase 1 clinical trial for its allogeneic NK cell therapy, known as OT-C001. This therapy will be tested in combination with Rituximab, an established anti-CD20 monoclonal antibody, targeting patients suffering from diffuse large B-cell lymphoma (DLBCL) who have either relapsed or are refractory to CAR-T cell therapies.

Background on the Trial

The forthcoming trial, designated C00101, aims to evaluate the efficacy and safety of OT-C001 across several dosage levels. It will also investigate cellular kinetics and potential biomarkers that could shed light on the mechanisms behind the therapy's therapeutic responses. According to Dr. C. Grace Yeh, the Chairman and CEO of Onward Therapeutics, reaching this milestone represents an essential step, fueled by strategic investments in Emercell since 2021.

Dr. Yeh stated, “This Phase 1 trial may validate Emercell's patented platform technology for meaningful clinical outcomes,” emphasizing the importance of these advancements in creating promising treatment options. The trial's outcomes could lay the groundwork for future partnerships and the ongoing optimization of the industrial manufacturing processes associated with OT-C001.

Unique Aspects of OT-C001

OT-C001 is distinctive due to its use of multiple umbilical cord blood (UCB) samples. This approach not only provides a diverse product but also ensures consistency across Good Manufacturing Practice (GMP) batches. Dr. Patrick Henno, the founder of Emercell, highlighted this aspect by noting that unlike many engineered cell therapies, the production of OT-C001 offers a scalable and safe solution to address significant unmet medical needs in targeted indications.

“OT-C001 represents a groundbreaking therapy in one of the most aggressive forms of non-Hodgkin lymphoma,” commented Dr. Alain Herrera, President of Emercell and Chief Medical Officer of Onward Therapeutics. Dr. Herrera expressed excitement about the initiation of this multicenter trial, which could play a pivotal role in providing novel therapeutic options for patients suffering from DLBCL.

Mechanism and Effectiveness of OT-C001

OT-C001 functions by administering allogeneic NK cells that have been highly activated and expanded through a patented process. These cells target tumor cells directly and indirectly, especially when coupled with monoclonal antibodies that attach to tumor-specific antigens. Preclinical studies, which include in vitro and in vivo models, have demonstrated that OT-C001 is well-tolerated and possesses promising anti-tumor properties.

About Onward Therapeutics and Emercell

With its headquarters in Switzerland, Onward Therapeutics is at the forefront of clinical-stage biotechnology, focusing on the development of innovative cancer therapies. Its comprehensive portfolio also includes a bispecific antibody, OT-A201, among other promising candidates. Emercell, located in Montpellier, France, specializes in off-the-shelf allogeneic NK cell therapies and has garnered financial support under initiatives aimed at accelerating biotherapies and innovative therapies in France.

As Onward Therapeutics enters this new chapter in cancer treatment, the biotech community remains eager to see how the outcomes of the Phase 1 trial will shape future cancer therapies and potentially offer hope to patients in need of novel treatment strategies.