No one knows the needs of cancer patients as well as clinicians do. To take care of patients and ease the burden of their disease is at the core of their daily efforts. They are also the first ones to recognize the gaps in the current treatment offer for patients. The clinicians identify the resistance to treatment and recurrence of disease as the major hurdles to a lasting beneficial result of today’s cancer treatment.
The most recent breakthrough in cancer treatment associated with the introduction of immune checkpoint inhibitors has - by activation of the immune system - changed the outlook for many patients. Thousands of clinicians are now exploring how to extend the benefits of these new drugs to a larger population.
We are running clinical trials as part of this effort. Based on our innovative technology platform, we are developing an entirely new class of cancer drugs. All of our first-in-class drug candidates are off-the-shelf products that are appropriate for most patients with solid tumors, and at the same time enabling the unique nature of individual tumors to become an essential part of the healing process, making the resulting activation of the immune system highly personalized.
In our ongoing trials, our drug candidates are injected directly into the tumors, i.e., administered as intratumoral injections. Successful Human IntraTumoral ImmunoTherapy (HIT-IT) relies on precise and monitored execution of this administration method. When applied in superficial lesions, e.g., basal cell carcinomas, this procedure is easy and simple to perform. In subcutaneous tumors and deep-seated lesions, radiologists collaborate with experts in intratumoral treatment to optimize the distribution of the therapeutic compound in the tumor.
We realize that the need for optimal use of the limited resources available makes it important to develop new drugs and treatment schedules that exhibits simplicity and cost efficiency in cancer treatment. The use of our oncolytic molecules exhibits two major advantages.
The manufacturing of our drug candidates is far easier than most other personalized treatments, including all neoantigen-based alternatives.
When inducing immunogenic cell death, our oncolytic molecules release a broad specter of neoantigens and tumor-associated antigens, creating an immune response directed towards a wide range of tumor cells, responding to the heterogeneity of the tumors.
Our clinical pipeline is advanced, with one Phase II proof-of-concept study already completed and two other still ongoing.
In 2022 we completed the ATLAS-IT-04 study, a proof-of-concept study in advanced soft-tissue sarcoma patients. LTX-315 in combination with adoptive T-cell therapy demonstrated ability to enhance and widen the creation of tumor specific T cells and provide clinical benefit to patients.
While demonstrating the versatility of the technology, we have chosen to focus on skin cancers in the two ongoing Phase II studies.
In one of the two ongoing Phase II studies, ATLAS-IT-05, LTX-315 is given to patients with solid tumors in combination with the immune checkpoint inhibitor pembrolizumab (Keytruda), a leading market approved immunotherapeutic drug. The initial data from this study is expected during 2H 2023.
The second Phase II study is performed in basal cell carcinoma (BCC) patients by our partner Verrica Pharmaceuticals, a US-based dermatology-specialist company. In August 2020, Lytix announced it had entered into a worldwide license agreement enabling Verrica Pharmaceuticals Inc. to develop and commercialize LTX-315 for certain types of skin cancers. Verrica has now entered Part 2 out of the 3 Parts constituting this Phase II study.
The technology platform has demonstrated its ability to deliver several drug candidates.
Our second candidate in the pipeline, LTX-401, is a second-generation molecule developed for treatment of deep-seated solid tumors. We are at the final stage of preparations for a Phase I study within liver cancer with this compound.