1stOncology™: Cancer Intelligence Service – Page 3547 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

GenScript ProBio Signs Viral Vector Manufacturing MOU With Curocell for Next-Generation CAR-T Therapy

On November 10, 2023 GenScript ProBio and specialized CAR-T therapy firm Curocell reported to have signed a strategic partnership MOU for the production of viral vectors necessary for the development of next generation of CAR-T therapy, marking another significant step in their ongoing collaboration (Press release, Curocell, NOV 10, 2023, View Source [SID1234637479]).

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!

This partnership will broaden the strategic cooperation between the two companies to encompass the entire project, including the development, production, and clinical trials of viral vectors for CAR-T therapy research and development.

Viral vectors are vehicles for drug delivery that utilize viruses to transport genetic material to the cellular interior. The demand for viral vectors is rapidly increasing due to the recent growth of the gene therapy market, which uses CAR-T therapy as its main active ingredient.

However, it has been noted that a shortage of GMP facilities producing viral vectors is causing delays in the development of gene therapies, including CAR-T therapy.

GenScript ProBio Chairman Patrick LIU, stating, "We are delighted to sign an MOU with Curocell, a local leader in CAR-T therapy, for the supply of viral vectors," and said that this partnership will "deepen our close collaboration to develop CAR-T therapy, not only in Korea but on a global scale."

Curocell CEO Gunsoo Kim said the partnership will allow the two companies to "establish a stable cooperative relationship spanning the entire process, from the developmental stage to the commercialization of CAR-T therapy." He also stated that "Curocell plans to grow as a global leader in cancer immunotherapies through its partnership with GenScript ProBio, a company expanding its global presence in the field of gene therapy."

Imvax to Present New Data on Lead Program, IGV-001, at 2023 SNO Annual Meeting

On November 10, 2023 Imvax, Inc., a clinical-stage biotechnology company developing personalized, whole tumor-derived immunotherapies, reported two poster presentations at the 2023 Society for NeuroOncology (SNO) 28th Annual Meeting in Vancouver, British Columbia, Canada, from November 15-19, 2023 (Press release, Imvax, NOV 10, 2023, View Source [SID1234637478]).

At the meeting, Imvax will present new data from its Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma (ndGBM), as well as information relating to the company’s ongoing randomized, multicenter, double-blind, placebo-controlled Phase 2b clinical trial of IGV-001 in patients with ndGBM.

On Friday, November 17, 2023, at 12:45 p.m. PT, Brad Elder, M.D., Director, Neurosurgical Oncology, and Associate Professor, Department of Neurological Surgery at The Ohio State University Wexner Medical Center, will present an Independent Support Session focused on the development of IGV-001 for the treatment of ndGBM.

The details of the two poster presentations are below:

Title: "Additional results from a Phase 1b study of IGV-001 in patients with newly diagnosed glioblastoma"
Number: CTIM-17
Timing: November 17, 2023, 7:30 p.m. – 9:30 p.m. PT
Presenter: Raul Perez-Olle, M.D., Ph.D.

Title: "A randomized, multicenter, double-blind, Phase 2b study of IGV-001, an autologous cell immunotherapy with antisense oligo IMV-001 targeting IGF-1R, vs placebo, in newly diagnosed glioblastoma patients"
Number: RTID-08
Timing: November 17, 2023, 7:30 p.m. – 9:30 p.m. PT
Presenter: Ian Y. Lee, M.D.

FDA Grants Orphan Drug Designation to MAIA Biotechnology for THIO as a Treatment for Glioblastoma

On November 10, 2023 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA" or the "Company"), a clinical-stage biopharmaceutical company developing telomere-targeting immunotherapies for cancer, reported that the U.S. Food and Drug Administration ("FDA") has granted orphan drug designation to its lead asset THIO, a cancer telomere-targeting agent, for the treatment of glioblastoma (Press release, MAIA Biotechnology, NOV 10, 2023, View Source [SID1234637476]). This is the third orphan drug designation granted to THIO, following the receipt of orphan drug designations for hepatocellular carcinoma (HCC) and small cell lung cancer (SCLC) in 2022.

"We are pleased to receive a third orphan drug designation for THIO, further highlighting FDA’s recognition of THIO’s potential in the treatment of multiple cancer indications, including rare ones such as glioblastoma," said Vlad Vitoc, M.D., MAIA’s Chairman and Chief Executive Officer. "Each year, globally, more than 300,000 people are diagnosed with brain tumors, of which, 25,000 are in the United States. Glioblastoma represents the majority of these cases in the U.S., with 15,000 new patients diagnosed and more than 10,000 deaths yearly, making it an orphan indication. Given this prevalence there is significant room for growth in the $2.2 billion glioblastoma market, which is expected to reach $3.2 billion globally in the next three years.1 We consider this ODD an important milestone for our development strategy and for glioblastoma patients who could benefit from a potentially revolutionary therapy."

"In the data presented to the FDA, THIO successfully penetrated the blood brain barrier (BBB) in syngeneic and humanized mouse models of telomerase-expressing brain cancers. Treatment with THIO resulted in potent anticancer activity and significant expansion of the animal lifespan for several difficult to treat cell lines and xenograft mouse models," added Sergei Gryaznov, Ph.D., MAIA’s Chief Scientific Officer. "These results stem from THIO’s remarkable mechanism of action and its BBB penetrating property that allows for direct targeting of brain tumors in vivo and potentially in glioblastoma patients."

"Glioblastoma is the most aggressive and most common type of cancer that originates in the brain. With very limited treatment options available, glioblastoma patients have exceptionally short survival durations, and only 7% remain alive five years after being diagnosed with the condition,"2 said Mihail Obrocea, MD, MAIA’s Chief Medical Officer. "We are optimistic about our telomere-targeting agent’s ability to provide clinical benefit in patients with glioblastoma, and we look forward to studying THIO for the treatment of this highly unmet medical indication in a future trial."

Enrollment is ongoing in a Phase 2 trial of THIO, THIO-101, evaluating the drug candidate in patients with advanced non-small cell lung cancer (NSCLC). THIO is the only direct telomere targeting agent currently in clinical development.

About Orphan Drug Designation

The FDA’s Orphan Drug Act of 1983 was designed to incentivize the development of therapies that demonstrate promise for the treatment of rare (orphan) diseases or conditions. A disease is classified as "rare" if it affects fewer than 200,000 people total in the U.S., or if the cost of developing a drug and making it available in the U.S. for such diseases will exceed any potential profits from its sale due to the small target population size. The FDA’s ODD program provides multiple incentives to make orphan drug development more financially possible for companies to pursue, such as up to seven years of market exclusivity for the approved orphan drug, up to 20 years of 25% federal tax credit for expenses incurred in conducting clinical research within the U.S. and waiver of Prescription Drug User Fee Act (PDUFA) fees for orphan drugs, a value of approximately $2.9 million in 2021.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to an anti-PD1 agent will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

FORE Biotherapeutics Announces Oral Presentation of Phase 1/2a Plixorafenib Data at the Society for Neuro-Oncology 2023 Annual Meeting

On November 10, 2023 FORE Biotherapeutics reported an oral presentation highlighting updated Phase 1/2a clinical data for plixorafenib (FORE8394; PLX8394), the company’s novel, investigational, small-molecule, next-generation, orally available selective inhibitor of BRAF alterations, will be given at the Society for Neuro-Oncology (SNO) 2023 Annual Meeting, taking place November 15-19, 2023, in Vancouver, Canada (Press release, Fore Biotherapeutics, NOV 10, 2023, View Source [SID1234637475]). The data being presented continue to demonstrate that plixorafenib has a favorable safety profile and results in durable responses in adults with primary central nervous system tumors with BRAF V600 alterations.

Details for the SNO 2023 Oral Presentation:

Title: Efficacy of BRAF inhibitor plixorafenib (FORE8394) in recurrent, primary central nervous system tumors (PCNST)
Presenter: Macarena I. de la Fuente, MD, University of Miami, Sylvester Comprehensive Cancer Center
Abstract number: CTNI-76
Session: Clinical Trials – Non-immunologic
Presentation date and time: Friday, Nov 17, 2023, 3:55-4:05 p.m. PT

About Plixorafenib (FORE8394)

Plixorafenib is an investigational, novel, small-molecule, next-generation, orally available selective inhibitor of mutated BRAF. It was designed to target a wide range of BRAF mutations while sparing wild-type forms of RAF. Nonclinical studies and clinical trials have shown that its unique mechanism of action effectively inhibits not only the constitutively active BRAF V600 monomers targeted by first-generation BRAF inhibitors but also disrupts constitutively active dimeric non-V600 BRAF alterations (class 2 mutants, fusions, splice variants and others). Unlike first- and second-generation BRAF inhibitors, plixorafenib does not induce paradoxical activation of the MAPK pathway. This not only yields the potential for an improved safety profile, but also avoids the need to combine with a MEK inhibitor. As a "paradox breaker," plixorafenib could therefore yield improved safety and more durable efficacy than earlier generation BRAF inhibitors and have activity in settings of acquired resistance to current RAF inhibitors.

Plixorafenib is currently being evaluated in Phase 1/2a clinical trial in adults and children with advanced solid tumors (including brain and spinal cord tumors) with activating BRAF alterations. Interim clinical data presented at ESMO (Free ESMO Whitepaper) 2022, ASCO (Free ASCO Whitepaper) 2023, and SNO 2023 provide evidence of durable anti-tumor single-agent activity in patients with BRAF-mutated cancers.

Novocure Announces Presentations on Tumor Treating Fields Therapy, Including New Clinical Data and Real-World Evidence, at 2023 Society for Neuro-Oncology Annual Meeting

On November 10, 2023 Novocure (NASDAQ: NVCR) reported that research on Tumor Treating Fields (TTFields) therapy, including new data from the phase 2 2-THE-TOP trial and real-world evidence from patients diagnosed with glioblastoma (GBM) and other central nervous system tumors (CNS), will be presented at the 2023 Society for Neuro-Oncology (SNO) Annual Meeting from Nov. 16 to Nov. 19 in Vancouver, Canada (Press release, NovoCure, NOV 10, 2023, View Source [SID1234637474]).

Novocure’s presence at the SNO Annual Meeting will include medical booths, sponsored symposia and scientific presentations spanning preclinical, clinical and real-world outcomes research underscoring the safety and efficacy of TTFields therapy, as well as patient and healthcare provider satisfaction with the therapy.

"The SNO Annual Meeting is the largest annual conference focused on neuro-oncology and an ideal forum for sharing new data on the use of immunotherapy and TTFields therapy in the treatment of GBM as well as our largest real-world study to date and additional insights about the safety and efficacy of TTFields therapy," said Frank Leonard, President of Novocure’s U.S. CNS Cancers Franchise. "We are eager to engage with the neuro-oncology community as we strive to extend survival in some of the most aggressive forms of cancer."

Highlights include:

an oral presentation of data from the 2-THE-TOP trial, suggesting TTFields therapy had an enhanced effect with pembrolizumab in patients with newly diagnosed GBM. 2-THE-TOP is an investigator-sponsored phase 2 clinical trial of TTFields therapy plus pembrolizumab plus maintenance temozolomide.

an oral presentation of the final results of Novocure’s largest non-interventional real-world evidence study to date, the TTFields in Germany in Routine Clinical Care (TIGER) study in patients with newly diagnosed glioblastoma (GBM). A striking 82% of the 710 patients surveyed opted to use TTFields therapy and demonstrated sustained health-related quality of life, except for more itchy skin, consistent with results from the randomized, phase 3 EF-14 clinical study.
Novocure is also sponsoring an Independent Supported Session, titled Tumor Treating Fields vs. GBM —The Evidence and Experience, on Friday, Nov. 17, from 12:45-1:45 p.m. PST in Room 208-209, Vancouver Convention Centre.

A CME/Industry Sponsored Symposium, PeerView Live at SNO 2023, Shattering the Barriers to Glioblastoma Care: Revolutionary Advances With Innovative Technologies and Modern Systemic Approaches (in collaboration with the American Brain Tumor Association), will be held Thursday, Nov. 15 at 5:30-6:30 p.m. PST in Room 205-207, Vancouver Convention Centre.

The 2023 SNO Annual Meeting will also mark the debut of Novocure’s new Optune Gio brand. Optune, Novocure’s FDA-approved treatment for newly diagnosed and recurrent GBM, will be renamed Optune Gio on Nov. 15.

Presentations include:

Final efficacy and correlative analyses of 2-THE-TOP: A pilot study of TTFields (Optune) plus pembrolizumab plus maintenance temozolomide in patients with newly diagnosed glioblastoma (ndGBM). Presenter: David D. Tran. 8:06 p.m. PST on Friday, Nov. 17.
Treatment decision and quality of life of patients with newly diagnosed glioblastoma (ndGBM) receiving Tumor Treating Fields (TTFields) therapy in routine clinical care: First results of the TIGER study. Presenter: Martin Glas. 8:35 a.m. PST on Saturday, Nov. 18
Demographics, prescribing patterns, and satisfaction of healthcare professionals who prescribe Tumor Treating Fields (TTFields) therapy to patients with glioblastoma. Presenter: Elena Palmesino. 7:30 p.m. PST on Friday, Nov. 17.
Tumor Treating Fields (TTFields) therapy in glioblastoma (GBM): relationship between patient experience, global region, and age. Presenter: Eleni T. Batzianouli. 7:30 p.m. PST on Friday, Nov. 17.
Long-term global post-marketing surveillance data from pediatric, adult and elderly patients with central nervous system malignancies treated with Tumor Treating Fields (TTFields) therapy. Presenter: Maciej M. Mrugala. 7:30 p.m. PST on Friday, Nov. 17.
Real world experience with TTFields with emphasis on therapy compliance. Presenter: Claudius Jelgersma. 7:30 p.m. PST on Friday, Nov. 17.
Prolonged follow-up of an oligodendroglioma patient with history of Tumor Treating Fields (TTF) as post chemo-radiation maintenance therapy. Presenter: Xiao-Tang Kong. 7:30 p.m. PST on Friday, Nov. 17
Distant progression to the posterior fossa in supratentorial glioblastoma: A report of three cases during Tumor Treating Fields therapy. Presenter: Juri Kiyowaka. 7:30 p.m. PST on Friday, Nov. 17
Advanced MRI Biomarkers Predict Early Response to Tumor Treating Fields in Glioblastoma. Presenter: Kathleen Schmainda. 7:30 p.m. PST on Friday, Nov. 17
Investigating safety and efficacy of TTFields prior and concomitant to radiotherapy in newly diagnosed glioblastoma – first results of the PriCoTTF phase I/II trial. Presenter: Sied Kebir. 7:30 p.m. PST on Friday, Nov. 17
The pivotal METIS (EF-25) study of Tumor Treating Fields (TTFields) therapy for brain metastases from non-small cell lung cancer (NSCLC) following radiosurgery. Presenter: Minesh P. Mehta. 7:30 p.m. PST on Friday, Nov. 17
The pivotal TRIDENT study of Tumor Treating Fields (TTFields) therapy with chemoradiation, followed by maintenance TTFields therapy/temozolomide (TMZ), in newly diagnosed glioblastoma (ndGBM). Presenter: Wenyin Shi. 7:30 p.m. PST on Friday, Nov. 17
Adopting Tumor Treating Fields (TTFields) therapy for glioblastoma and other solid cancers: challenges and opportunities. Presenter: Leonardo Lustgarten. 7:30 p.m. PST on Friday, Nov. 17
Tumor Treating Fields: Real-World Survival and Quality of Life Outcomes on the XCELSIOR Platform. Presenter: Joshua Palmer. 7:30 p.m. PST on Friday, Nov. 17
Development of Tumor Treating Fields (TTFields) arrays for treatment of head tumors in mice models. Presenter: Moshe Giladi. 7:30 p.m. PST on Friday, Nov. 17
Molecular characterization of glioma tissue after TTFields treatment. Presenter: Christian Mawrin. 7:30 p.m. PST on Friday, Nov. 17
Dielectric properties of intracranial tumors – role of myelin content. Presenter: Martin A. Proescholdt. 7:30 p.m. PST on Friday, Nov. 17
About Tumor Treating Fields Therapy

Tumor Treating Fields (TTFields) are electric fields that exert physical forces to kill cancer cells via a variety of mechanisms. TTFields do not significantly affect healthy cells because they have different properties (including division rate, morphology, and electrical properties) than cancer cells. The multiple, distinct mechanisms of TTFields therapy work together to selectively target and kill cancer cells. Due to its multimechanistic actions, TTFields therapy can be added to cancer treatment modalities in approved indications and demonstrates enhanced effects across solid tumor types when used with chemotherapy, radiotherapy, immune checkpoint inhibition, or targeted therapies in preclinical models. TTFields therapy provides clinical versatility that has the potential to help address treatment challenges across a range of solid tumors. To learn more about Tumor Treating Fields therapy and its multifaceted effect on cancer cells, visit tumortreatingfields.com.

About Optune

Optune is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). Optune delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.

TTFields therapy uses electric fields to disrupt cell division. TTFields therapy does not stimulate or heat tissue and targets dividing cancer cells of a specific size. TTFields therapy takes advantage of the special characteristics and geometrical shape of dividing cells, which make them susceptible to the effects of the alternating electric fields. TTFields therapy causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. TTFields therapy is approved in certain countries for the treatment of adults with glioblastoma, malignant pleural mesothelioma and pleural mesothelioma, some of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.