On July 25, 2023 Anova Enterprises, Inc. (Anova), an organization dedicated to accelerating the development of promising treatments to market reported the FDA authorization of a Phase II clinical trial to re-assess a targeted treatment in light of newly discovered pharmacogenomic predictor data in patients with newly diagnosed high-grade glioma (HGG) (Press release, Denovo Biopharma, JUL 25, 2023, View Source [SID1234633424]).

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!

Anova reported the FDA authorization of an IND for a Phase II clinical trial under it’s management to re-assess a targeted treatment in light of newly discovered pharmacogenomic predictor data in patients with newly diagnosed high-grade glioma.

Tweet this
Denovo Biopharma LLC, a pioneer in applying precision medicine to develop innovative therapies, acquired Toca 511 and Toca FC (now collectively known as DB107) from Tocagen in 2020, with the aim of identifying one or more pharmacogenomic predictors for DB107 efficacy using its proprietary biomarker discovery platform.

In December 2021 Denovo Biopharma announced discovery of a novel genetic biomarker, Denovo Genomic Marker 7 (DGM7TM), by leveraging Tocagen’s randomized 403-patient Phase 3 study in recurrent HGG that had negative results overall, but that had subsets of patients who received clear benefit. DGM7 has been shown to be associated with increased overall survival with treatment of recurrent HGG, via retrospective analysis.

This year, Anova Enterprises, Inc. assembled a team of key opinion leaders from the University of California at San Diego (UCSD), University of California at San Francisco (UCSF), the University of Southern California (USC) and Denovo Biopharma to explore the best way to confirm the efficacy of DB107 in patients with HGG who have the DGM7 biomarker. The resulting Phase 2 study design has been authorized to proceed by the U.S. FDA, literally bringing a treatment "back from the dead" to help patients in need.

The Phase 2 study of DB107 will investigate the impact of giving multiple doses of DB107 both directly at time of surgery and intravenously (IV). The study also stratifies patients to more easily identify those individuals who benefit from treatment from those who do not. "FDA authorization of the study of DB107 is another important milestone for Denovo as we work to bring this retroviral replicating vector (RVV) back into clinical development" said Matthew A. Spear, M.D., Chief Medical Officer & Chief Development Officer, Denovo Biopharma. "Our dedicated team worked diligently to identify the biomarker which predicts response to DB107 and it will be exciting to potentially confirm our work in this prospective clinical trial."

Anova Enterprises, Inc. (Anova) will manage the study using its transformative AnovaOS technology. AnovaOS is the industry’s first collaborative ‘learning system’. "This is exactly the sort of opportunity Anova wants to deliver in the marketplace" said Martin Walsh, President at Anova. "We regularly see patients responding to treatments in studies that fail in large randomized patient populations. Identifying predictive biomarkers such as DGM7 and confirming results in smaller, targeted patient populations is the way toward better and more cost effective treatments."

The Phase 2 clinical trial is a multicenter, open-label study designed to confirm whether treatment DB107 when added to standard-of-care (SOC) provides clinical benefit to newly diagnosed HGG when compared to historical performance documented in well controlled clinical trials published in the peer reviewed literature. The trial is expected to enroll approximately 70 adult patients with newly diagnosed HGG, and the primary endpoint of the trial will be progression free survival (PFS).

"I am excited to see DB107 heading back into the clinic" said Noriyuki Kasahara, MD, PhD, Principal Investigator, Brain Tumor Research Center (BTRC) at University of California, San Francisco (UCSF). "Outcomes in patients newly diagnosed with HGG are essentially unchanged for 40 years and confirming DB107 works in patients with the DGM7 biomarker may change outcomes in those patients for the better"

"Our partnership with Denovo Biopharma, UCSD, UCSF and USC is another example of Anova’s commitment to improving access to promising new treatments for patients in need, in diseases where patients are often left with limited treatment options" said Chris Beardmore, CEO at Anova. "By fixing what is broken in clinical research we can conduct better studies and deliver the right treatments to the right patients."

On July 25, 2023 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the Company has received approval to conduct clinical trial of its second generation pan-TRK inhibitor zurletrectinib (ICP-723) to treat pediatric patients (2 to 12 years old) in China (Press release, InnoCare Pharma, JUL 25, 2023, View Source [SID1234633423]). This is following the clinical trial of zurletrectinib for adolescent patients (12 to 18 years old) after showing good safety and efficacy in adult patients.

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!

Zurletrectinib was developed to treat advanced or metastatic solid tumors harboring NTRK fusion genes, including breast cancer, colorectal cancer, lung cancer, thyroid cancer, sarcoma, etc., and for patients resistant to the first generation of TRK inhibitors.

Dr. Jasmine, the Co-founder, Chairwoman and CEO of InnoCare, said, "NTRK gene fusion is more common among pediatric patients. By now, our clinical study with zurletrectinib has covered NTRK fusion patients at all ages. We will continue to accelerate the clinical trials of zurletrectinib, looking forward to providing better treatment options for patients early."

On July 25, 2023 Clinical stage Australian biotech company HaemaLogiX Ltd reported that it has entered into a co-development agreement with the world leading Peter MacCallum Cancer Centre (Peter Mac) to conduct the first in human Phase I trial of HaemaLogiX’s CAR-T immunotherapy, KMA.CAR-T, for kappa-type multiple myeloma (Press release, HaemaLogiX, JUL 25, 2023, View Source [SID1234633422]).

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!

KMA.CAR-T is a novel immunotherapy that targets a receptor called Kappa Myeloma Antigen (KMA) found only on the surface of myeloma cells in kappa-type multiple myeloma patients and not on normal immune cells, which means normal immune cells are not damaged by the treatment.

The agreement sees the HaemaLogiX and Peter Mac Centre of Excellence in Cellular Immunotherapy continue to co-develop KMA.CAR-T, following a collaborative preclinical research project that demonstrated compelling proof of concept. Preclinical data shows the anti-KMA CAR-T cells selectively killed KMA-expressing myeloma cell lines and demonstrated potent anti-myeloma activity in a xenograft mouse model.

Dr Rosanne Dunn, HaemaLogiX Director| Chief Scientific Officer and Founder, said: "CAR-T cell therapy is now a realistic option for myeloma patients who have failed standard of care treatments. We’re excited to progress KMA.CAR-T to the clinic in collaboration with Peter Mac, a renowned Australian cancer hospital and research institute that has been involved in the development of many of the CAR-T therapies now approved as treatments."

Professor Simon Harrison, Director of the Peter Mac Centre of Excellence in Cellular Immunotherapy, said: "CAR-T cell therapy is a game-changer in the treatment of certain blood cancers, such as multiple myeloma. We are delighted to continue our project with HaemaLogiX to translate the preclinical potential of KMA.CAR-T into a novel first-in-human clinical trial therapy."

Under the agreement, HaemaLogiX brings its patented KappaMab technology to the collaboration with Peter Mac to develop the technology, method of manufacturing and conduct the trial.

The proof of concept trial will be conducted initially in six patients, with the possibility of expanding to twelve patients.

On July 25, 2023 Illumina Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, and Pillar Biosciences Inc., the pioneers of Decision Medicine, reported a strategic partnership to make Pillar’s suite of oncology assays commercially available globally as part of the Illumina portfolio of oncology products (Press release, Illumina, JUL 25, 2023, View Source [SID1234633421]). The agreement will result in an unprecedented offering of complementary next-generation sequencing solutions that will enhance the efficiency, accuracy, and cost-effectiveness of oncology testing through advanced sequencing techniques, improving patient access to personalized cancer treatment options.

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 are proud to partner with Pillar to provide products that will improve care for patients with advanced and high-risk cancer," said Phil Febbo, chief medical officer of Illumina. "By leveraging Pillar’s targeted sequencing technology alongside Illumina’s state-of-the-art sequencing and bioinformatics solutions, we will enable rapid and focused genomic profiling of tumors, which is essential to facilitate personalized therapy in healthcare systems across the globe."

Pillar’s targeted assays help oncologists and researchers identify mutations that drive tumor growth. This knowledge is pivotal in making informed decisions about cancer treatment. By gaining an understanding of the genomic landscape of the tumor, clinicians can tailor treatment options such as targeted therapies and immunotherapies to suit each patient’s needs. This personalized approach has the potential to result in more effective and precise interventions.

"Pillar Biosciences is committed to enabling global access to our high-value genomic profiling assays to empower better-informed precision patient treatment," said Randy Pritchard, CEO of Pillar Biosciences. "This agreement will facilitate seamless integration between Pillar Biosciences assays and Illumina sequencers, delivering a streamlined workflow and complementary product offerings and leading to faster turnaround times for patients."

Pillar’s suite of oncology assays can be used on any of Illumina’s sequencers. Assay offering will depend on the region. Commercial availability of Pillar’s assays through Illumina is set to begin this month.

On July 25, 2023 Mabwell (688062.SH), an innovative biopharmaceutical company with entire industry chain, reported that clinical trial data from phase I/II study for advanced solid tumor of Nectin-4-targeting ADC (9MW2821), and phase III study of Long-Acting Recombinant Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor (I) Fusion Protein (8MW0511) will be presented orally and as a poster respectively at ESMO (Free ESMO Whitepaper) Congress 2023, which will be held in Madrid, Spain, from Oct. 20th to 24th, 2023 (Press release, Mabwell Biotech, JUL 25, 2023, View Source [SID1234633420]).

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!

ESMO Congress is one of the most influential oncology conferences in the world. Please pay close attention to Mabwell’s reports during ESMO (Free ESMO Whitepaper) Congress 2023.

Oral Presentation

Abstract Title:
Preliminary results from a phase I/II study of 9MW2821, an antibody-drug conjugate targeting Nectin-4, in patients with advanced solid tumors

Abstract Number:
4613

Poster Presentation

Abstract Title:
MW05, a Novel, Long-Acting Recombinant Human Serum Albumin/Human Granulocyte-Colony Stimulating Factor (I) Fusion Protein for the Management of Chemotherapy-Induced Neutropenia: Results of a Phase III Trial

Abstract Number:
3602

About 9MW2821

Developed by Mabwell’s ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, 9MW2821 is the first clinical stage Nectin-4-targeting ADC developed by Chinese company. The site-specific modification of antibody is based on the coupling technology linker and optimized ADC coupling process with independent intellectual property rights. 9MW2821 received IND clearance from NMPA and FDA on Oct.19th, 2021 and Jul. 28th, 2022, respectively. Clinical trial application of combination therapy has also been approved by NMPA on Apr. 14th, 2023. The multiple ongoing clinical studies to evaluate safety, tolerability, pharmacokinetics, and preliminary antitumor activity of 9MW2821 show positive therapeutic signals in different types of advanced solid tumors and good safety profile at the recommended phase II dose (RP2D).

About 8MW0511

8MW0511 is a novel, long-acting G-CSF (highly active modified cytokine) with independent intellectual property rights of Mabwell. It is intended to reduce the incidence of infection characterized by febrile neutropenia(FN) in the adult patients with non-myeloid malignant tumors, when they are treated with antitumor therapies that are susceptible to FN. 8MW0511 is produced by fusion of N terminal of modified G-CSF genes with C terminal of human serum albumin(HSA) through gene fusion technology, which can significantly inhibit the G-CSF receptor-mediated clearance pathway, prolong the half-life period, decrease the frequency of administration in clinical use, reduce the suffering of patients, and improve the treatment compliance. Meanwhile, 8MW0511 is produced by yeast-expression system, which brings better homogeneity. It is expected to reduce the cost by avoiding the complex PEG modifications and simplifying production process. The phase III clinical trial of 8MW0511 has been completed, and we are moving forward with the preparations of NDA.