Since our patience is starting to grow weary, I figured I would remind everyone of the last 10Q's highlights and what's in store here soon:
Overview
During the first nine months of 2024, the Company continued its progress on multiple fronts, including the following.
MAA Application and Inspections. The Company has continued to work with multiple teams of expert consultants, the trial’s CRO (contract research organization) and Advent BioServices on the MAA process. The review of the application is ongoing, and inspections are being conducted in the U.K and the U.S. Each inspection involves pre-inspection requests from the inspectors for production of extensive documents and information, weeklong onsite inspections (including review of further documents, interviews of personnel, checking of facilities and procedures, etc.), and ongoing follow-up document and information requests after the onsite inspection. The inspections cover the sponsor, the CRO, the independent experts involved in the trial (such as the independent clinical database company, independent statisticians and others), selected trial site hospitals and their pharmacies, and others. As is typical, and as the Company has previously stated, the Company does not plan to make any interim announcements while its MAA is going through the regulatory process. The Company plans to announce the results when the regulatory review and decision-making is finished.
Reimbursement. The Company has evaluated and selected specialized, highly experienced consultants with whom to undertake preparations for a potential reimbursement review and evaluation process. The Company has executed the relevant contracts and is under way with the first stage of the process with the consultants. The preparations for the reimbursement process will involve several stages and include health economics and outcomes (HEO) analyses, analyses of the relevant clinical landscape, engagement with experts and stakeholders, and other steps.
Collaborations: Private Clinics. As previously reported, the Company has been working over the last couple of years and during this year to develop certain clinical collaborations. These include joint efforts by the Company and Advent BioServices to establish collaborations with several private clinics in the U.K. The collaborations with private clinics are designed to achieve several goals. One goal is to establish dedicated leukapheresis units which will be available for NWBio patients at all times. This is quite important for scale-up of the numbers of patients who can be handled for NWBio’s treatments, because there is a country-wide shortage of leukapheresis capacity in the U.K.
Another goal of the clinic collaborations is to potentially be able to conduct clinical trials with these private clinics as trial sites and be able to treat compassionate use patients – patients with diverse types of solid tumors, in addition to patients with brain cancer. The joint efforts have now reached or are reaching fruition. A contract has been executed with one private clinic for a dedicated leukapheresis unit there, and the focus is now on arrangements for the medical personnel and training. A Letter of Intent has been completed with a second private clinic, and the full contract is in process, for both a dedicated leukapheresis unit and treatment of patients. Arrangements have been made with a third private clinic for treatment of patients, and the first such patient is in process.
Collaborations: Complementary or Synergistic Technologies. The Company has also been pursuing ongoing efforts to identify and develop collaborations with other companies who have technologies that the Company believes may be complementary to the Company’s DCVax technologies (for example for combination treatment regimens) or may be synergistic with the Company’s technologies (for example, to enhance DCVax products). The Company completed negotiations and entered into a contract with a company that has a complementary immunotherapy agent, and the two companies have been engaged for a number of months in joint development of trial designs and selection of candidate cancers for a combination treatment clinical trial. The companies are particularly focusing on trial designs in which the primary endpoint will be tumor response (shrinkage), with potential timeframes in months, rather than time-to-event survival outcomes, with timeframes in years. The Company anticipates potentially being ready to submit an IND for such a combination trial to regulators during Q1 of next year.
The Company has also completed negotiations and entered into a contract with a company that has an immune booster agent that may have the potential to further increase the potency of DCVax products. The contract provides for material supply and in vitro testing of the booster agent with DCVax products. If the in vitro testing is successful, the parties plan to enter into a license of the booster agent to NWBio. The parties jointly designed the program of experiments, and the experiments were carried out and completed by the Flaskworks team. The parties are now evaluating the results and developing plans for further experiments.
Re-Start of the DCVax-Direct Clinical Program. As previously reported, preparations to restart clinical development of DCVax-Direct have been under way for quite a while. The Company currently anticipates that the DCVax-Direct program will be able to restart by the end of January. For the same reasons as described above in connection with the planned combination treatment trial, the Company plans to focus DCVax-Direct clinical trial designs on tumor response endpoints with potential timeframes of months rather than survival endpoints with timepoints of years. The preparations to date involve technology transfer to the U.K, development of new SOPs (Standard Operating Procedures) and regulatory documents, engineering runs and comparability testing. In addition, new development work has been carried out to develop a second version of DCVax-Direct because there is a worldwide shortage of one key ingredient of the original DCVax-Direct (an immune booster ingredient). The Company and Advent have been working together to evaluate other potential immune booster agents -- both their properties in the manufacturing process and their effects immunologically -- to identify an alternative booster agent that can be suitable and is available for production of new batches of DCVax-Direct. Advent is continuing to conduct final engineering runs for validation of the new SOPs, processes and formulation. The Company has entered into SOW 8 with Advent covering the work involved in restarting the DCVax-Direct program. SOW 8 is structured so that Advent only receives compensation for the work in the form of milestone payments and only after the applicable work has been successfully completed (see Note 13).
Ongoing and Expanded Phase 2 Clinical Trials Under the Roswell & Pittsburgh Portfolios. As previously reported, the Company entered into exclusive licenses from Roswell Park Cancer Center and the University of Pittsburgh, covering a large portfolio dendritic cell technologies developed over the course of more than 27 years of work by a leading team of dendritic cell experts, as well as 5 new patent families. The in-licensed technologies in the combined portfolios are currently in three Phase 2 clinical trials that are fully funded by grants and fully being carried out by the investigators. These Phase 2 trials are ongoing and one of them has been approved for a significant expansion in scope by the grant funding agency. That trial is testing an in-licensed dendritic cell treatment in melanoma that is refractory (unresponsive) to checkpoint inhibitor drugs. That dendritic cell treatment aims at a set of targets on abnormal blood vessels that are associated with tumors. As such, that dendritic cell treatment is anticipated to be tumor-agnostic and potentially applicable to most types of solid tumors. The expansion of the trial scope that has been approved is to add refractory lung, breast and bladder cancers to the trial in addition to refractory melanoma.
Intellectual Property. The Company’s intellectual property (IP) portfolio continued to grow during Q3 2024, complementing the Company’s growing pipeline. Patents from 3 different patent families developed by the Company were granted or allowed in several countries, particularly Europe. Patents from 2 different patent families which are part of the Roswell and Pittsburgh in-licenses were granted in the U.S. and elsewhere. New divisional applications were also filed to extend the scope of patents from 2 different patent families, in Europe and elsewhere. In regard to the Flaskworks technologies and IP, 5 new patents were allowed in the U.S. and elsewhere, from 4 different patent families, during Q3 2024. In addition, 4 new patents were issued in the U.S. during Q3 2024, which had been allowed during Q2 2024, and a 5th patent elsewhere was also issued. The Company believes that the ongoing expansion of its IP portfolio is an important and valuable part of building a leading franchise in dendritic cell technologies.
Litigation. In the Company’s lawsuit against certain market makers, the Company is awaiting the Magistrate’s Report and Recommendation on the last remaining element to be evaluated regarding the sufficiency of the Company’s Complaint: i.e., loss causation. The Magistrate and the Court already previously determined that all but this one of the required elements were sufficiently alleged in the Company’s Complaint, and the Court invited the Company to file expanded allegations about the loss causation element. The Company submitted expanded claims earlier this year, the parties’ filings were finished in June, and the parties are now waiting to receive the Magistrate’s recommendation.
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