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.

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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]).

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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.

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"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]).

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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.

On July 25, 2023, SQZ Biotechnologies Company (the "Company" or "SQZ") reported that F. Hoffmann-La Roche Ltd ("Roche Basel") and Hoffmann-La Roche Inc. ("Roche US", and together with Roche Basel, "Roche") determined that Roche will not exercise its option under the License and Collaboration Agreement, dated October 5, 2018, by and between the Company and Roche, to obtain an exclusive license to develop and commercialize the Company’s candidate targeting HPV 16 positive solid tumors under the Company’s SQZ-APC-HPV program (Press release, SQZ Biotech, JUL 25, 2023, View Source [SID1234633418]). The Company will regain full clinical development and future commercialization rights for its programs targeting HPV 16 positive tumors. The Company also announced that it intends to explore potential strategic alternatives to support the advancement of its oncology programs including HPV 16 positive tumors, in an effort to allow the Company to partner all its clinical and preclinical assets across all disease areas and indications. Potential strategic partnerships may include, but are not limited to, a partnership, acquisition, merger, business combination, or other transaction. There can be no assurance that this process will result in SQZ pursuing a transaction or that any transaction, if pursued, will be completed on attractive terms. SQZ has not set a timetable for completion of this process and does not intend to comment further unless or until the Board of Directors has approved a definitive course of action, the process is concluded, or it is determined that other disclosure is appropriate.

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