On October 5, 2023 CEL-SCI Corporation (NYSE American: CVM) reported it has filed a request with the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) to discuss a pathway for approval of Multikine* (Leukocyte Interleukin, Injection) immunotherapy for the treatment of newly diagnosed head and neck cancer (Press release, Cel-Sci, OCT 5, 2023, View Source [SID1234635702]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

At the meeting, CEL-SCI will present MHRA with new results that demonstrate pre-surgical response rates and overall survival advantages that are superior to those published by CEL-SCI previously. These new results arose from an improved selection algorithm of the Multikine target population. The improvements in the selection algorithm were based on discussions and feedback from regulators and consultants. This improved selection algorithm is able to more accurately predict the patients who would benefit most from the Multikine therapy.

A statistical validation of outcomes in the new target population, based on the Phase 3 study data, was recently concluded and will be presented at the Conference of the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) which takes place October 20-24, 2023 in Madrid, Spain.

CEL-SCI is seeking a pathway towards approval of Multikine throughout the UK. CEL-SCI’s goal is to apply for marketing authorization in the UK as soon as possible, based on the data already generated. Just two weeks ago CEL-SCI filed a similar submission with the European Medicines Agency (EMA).

"We have a comprehensive global regulatory approval strategy," stated CEL-SCI’s CEO Geert Kersten. "Having received encouraging submission guidance from Health Canada, we plan to file for a NOC/C conditional approval there. This pathway would allow CEL-SCI to request immediate approval based on the data generated to date, and any additional studies if needed would be done post-market. With the European Medicines Agency and the MHRA, we hope to do the same. We are extremely excited about the results seen in the newly defined Multikine target population."

CEL-SCI’s pivotal Phase 3 study tested Multikine in newly diagnosed locally advanced head and neck cancer patients. The study demonstrated a nearly 4-year median overall survival benefit for Multikine treated patients who were treated with surgery and radiotherapy versus the control group who did not receive Multikine. The dire need for a new and effective treatment for newly diagnosed locally advanced primary head and neck cancer is widely recognized in the medical community.

On October 5, 2023 XNK Therapeutics AB reported that Anna-Karin Maltais, Chief Scientific Officer, will be speaking at the 2nd Annual Innate Killer Europe Summit in London on October 18 (Press release, XNK Therapeutics, OCT 5, 2023, View Source [SID1234635701]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The meeting is the second Innate Killer Europe Summit following last year’s first European version of the larger annual US Innate Killer Summit. The purpose of the meeting is to build community and collaboration to leverage innovative European R&D and transform the innate immune space. The summit gathers 80+ key European natural killer, natural killer T, neutrophil, gamma delta T and macrophage thought leaders to discuss how innate immunotherapies, through effective and scalable engineering, cell engager and combined modality strategies, can help bring safe, potent, and persistent innate immune therapies to patients in need.

On October 18, 2023, Dr. Maltais will present XNK and discuss how to harness autologous NK cells for personalized immunotherapy. She will discuss engineering vs non-engineering strategies, important aspects of repeat dosing as well as strategies to increase cell potency, targeting and persistence.

On October 5, 2023 Medivir AB (Nasdaq:MVIR) (Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that all patients in the ongoing phase 2a study in advanced hepatocellular carcinoma (HCC) has now dosed at least two treatment cycles and the treatment continues to show very promising clinical benefit (Press release, Medivir, OCT 5, 2023, View Source;lenvima-continues-to-show-promising-tumor-control-in-hcc-all-patients-have-now-dosed-at-least-two-treatment-cycles-301948293.html [SID1234635700]). The study evaluates safety and efficacy with the candidate drug fostrox in combination with Lenvima in patients for whom current first- or second-line treatment has proven ineffective or is not tolerable.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The study, which is an open-label, multi-center, dose-escalation and dose-expansion study, continues to show early and durable clinical benefit across the cohort, as measured by local review. Of the 13 patients with sustained tumor control at 3 months, 3 patients achieved Partial Response and 10 patients Stable Disease, providing 17% Overall Response Rate (ORR) and 72% Disease Control Rate (DCR). The patient who has benefited the longest remains on treatment after 13.5 months, with sustained partial response.

The combination remains tolerable with no unexpected new safety events and adverse events are transient and manageable. Continued lower need for dose reductions or interruptions than expected. The observed tolerability is of outmost importance as patients with HCC often have an increased sensitivity to drugs in general due to impaired liver function.

"Overall, the consistent early and durable signals of clinical benefit and the favorable safety profile are very encouraging. Patients with advanced HCC, who have progressed on at least one line of treatment, are a very difficult-to-treat population with few effective treatment options. The overall response rate of 17% already at 2nd scan is very encouraging and indicates a higher share of responders than historically seen in second line treatment of HCC. We can also see that for many patients, their target lesions continue to shrink with longer follow-up," says Dr. Pia Baumann, CMO at Medivir.

Medivir plans to provide an update in connection with the company’s upcoming quarterly results presentation on Friday October 27. This will include a more comprehensive update of local review data as most of the patients will have had the opportunity to have at least three scans, with each scan scheduled to take place every 6 weeks. In addition to the data update, the company will also provide further context what these more mature data could mean for future clinical practice in second line HCC, a patient population for whom there are no approved medical treatments today.

On October 5, 2023 ProfoundBio, a clinical-stage biotechnology company focused on the development of novel antibody-drug conjugate therapeutics for cancer, reported that management will be participating in one-on-one meetings at Bank of America’s Healthcare Trailblazers Private Company Conference on Thursday, October 26, 2023 (Press release, ProfoundBio, OCT 5, 2023, View Source [SID1234635699]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We look forward to participating in the BofA conference to speak with selected potential investors in advance of our upcoming data presentations at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting in November 2023, where we will present data on our ADC programs, including interim Phase 1 data for our lead anti-folate receptor alpha ADC program, rinatabart sesutecan." said Baiteng Zhao, PhD, CEO of ProfoundBio. "We believe our innovative ADC technology platforms have the potential to lead to highly differentiated ADC therapeutics with improved clinical outcomes, and we’re excited to share our emerging clinical data."

On October 5, 2023 Aadi Bioscience, Inc. (NASDAQ: AADI), a biopharmaceutical company focused on developing and commercializing precision therapies for patients with mTOR pathway alterations, reported that two posters will be presented at the upcoming North American Neuroendocrine Tumor Society (NANETS) Multidisciplinary NET Medical Symposium, taking place October 4-6, 2023, in Montreal, Canada (Press release, Aadi Bioscience, OCT 5, 2023, View Source [SID1234635698]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Details of the poster presentations are below:

Title: "Phase 2 study of nab-sirolimus in patients with well-differentiated and advanced or metastatic neuroendocrine tumors of the gastrointestinal tract, lung, or pancreas"
Date/Time: Thursday, October 5, 2023, 5:15 pm – 7:00 pm EDT
Presentation Location: Poster Gallery Location, Square Dorchester
Presenter: Scott Paulson, MD
Authors: Michael J. Demeure, MD; Allen L. Cohn, MD; Tara Seery, MD; Li Ding, MS, MA; Usman Aziz, MD; Willis Navarro, MD; Scott Paulson, MD

Highlights:

The PI3K/AKT/mTOR pathway has been implicated in the pathogenesis and progression of NETs, though the use of oral mTORis as a treatment for NETs is limited by low bioavailability and the heterogeneity of the disease
nab-Sirolimus is a nanoparticle albumin-bound mTORi designed to preferentially target tumors and overcome the limitations of oral sirolimus
nab-Sirolimus is currently approved in the United States for the treatment of malignant perivascular epithelioid cell neoplasms
The efficacy and safety of nab-sirolimus in patients with advanced or metastatic NETs will be evaluated in this phase 2, multicenter, open-label, single-arm, US-based study
The study, NET-202 (NCT05997056), will enroll up to 21 efficacy evaluable patients at approximately three US centers. Enrollment for the study is planned to begin in the third quarter of 2023, with completion expected within 12–18 months
An encore presentation titled, "Phase 2, Multicenter, Open-label Basket Trial of nab-Sirolimus for Malignant Solid Tumors Harboring Pathogenic Inactivating Alterations in TSC1 and TSC2 (PRECISION1)" will also be presented on Thursday, October 5, 2023.

More information can be found on the North American Neuroendocrine Tumor Society (NANETS) website.