On August 28, 2023 Cantex Pharmaceuticals, Inc., a clinical-stage pharmaceutical company focused on developing transformative therapies for cancer and other life-threatening medical conditions, reported the initiation of a Phase 2 clinical trial to assess the safety and effectiveness of Cantex’s azeliragon combined with stereotactic radiosurgery in patients with brain metastases (Press release, Cantex, AUG 28, 2023, View Source [SID1234634727]). Cantex’s azeliragon, currently also in Phase 2 development for the treatment of other major cancers, complications of cancer treatment and the treatment of other life-threatening illnesses, inhibits the receptor for advanced glycation end products (known as RAGE), is orally administered and is taken once daily.

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"We are very excited to initiate enrollment into this important clinical trial. With the initiation of this Phase 2 clinical trial, Cantex expands the cancer indications for which azeliragon is being investigated, which now include active Phase 2 clinical trials in glioblastoma, breast cancer, pancreatic cancer, and a phase 2/3 clinical trial in hospitalized COVID-19 patients to prevent acute kidney injury, accelerating azeliragon’s development as a treatment of very aggressive and difficult to treat cancers and other illnesses," said Stephen G. Marcus, M.D., Chief Executive Officer of Cantex.

Brain metastases are the most common type of cancer in the brain, with over 150,000 people each year developing brain metastasis from their primary cancer (most commonly from lung and breast cancer).

"Brain metastases are a common complication of cancer and often are treated with stereotactic radiosurgery in the upfront setting," said Rupesh Kotecha, M.D., principal investigator of the investigator-initiated trial and Chief of Radiosurgery and Director of Central Nervous System Metastasis at Miami Cancer Institute, part of Baptist Health South Florida. "This investigator-initiated Phase 2 clinical trial of azeliragon, with its differentiated mechanism of action, will offer patients a unique approach to the treatment of brain metastases that may protect against inflammation as well as enhance the effectiveness of radiation therapy."

Cantex’s azeliragon inhibits RAGE interactions with certain ligands, including HMGB1 and S100 proteins in the cancer microenvironment. S100A9, a protein released from cells within the microenvironment of brain metastasis, binds to RAGE receptors on the surface of cancer cells, making them resistant to the effectiveness of radiation treatments. Azeliragon blocks the interaction of S100A9 with RAGE, potentially restoring sensitivity to radiation therapy. In addition, interaction of RAGE with proteins that bind to it, triggers inflammatory responses, which may worsen brain swelling associated with radiation therapy. This clinical trial is designed to determine whether Cantex’s azeliragon, when administered in combination with stereotactic radiosurgery, can prevent or eliminate the need for a powerful steroid, dexamethasone, to control brain swelling as well as improve the effectiveness of radiation therapy to treat brain metastases.

About Azeliragon
Azeliragon is an orally administered capsule, taken once daily, that inhibits interactions of RAGE with certain ligands, including HMGB1 and S100 proteins in the tumor microenvironment. Azeliragon was discovered by and originally under development for Alzheimer’s disease by vTv Therapeutics Inc. (NASDAQ:VTVT) from whom Cantex licensed worldwide rights to azeliragon. Clinical safety data from these trials, involving more than 2000 individuals dosed for periods up to 18 months, indicate that azeliragon is very well tolerated. Cantex also has ongoing Phase 2 clinical trials in newly diagnosed glioblastoma, neoadjuvant therapy of breast cancer, and metastatic pancreatic cancer, and an ongoing Phase 2/3 clinical trial in hospitalized COVID-19 patients to prevent acute kidney injury. These trials are based on azeliragon’s robust pre-clinical data as well as its extensive clinical safety information from randomized placebo-controlled clinical trials.

On August 28, 2023 Harbour BioMed (the"Company", HKEX: 02142) reported that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its first antibody drug conjugate (ADC) program HBM9033 (Press release, Harbour BioMed, AUG 28, 2023, View Source [SID1234634726]).

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HBM9033 is an ADC drug candidate that specifically targets human mesothelin (MSLN), an upregulated tumor associated antigen in various solid tumors, including mesothelioma, ovary cancer, lung cancer, breast cancer, and pancreatic cancers. The fully human monoclonal antibody (mAb) in HBM9033, generated from the Harbour Mice platform, binds preferably to membrane bond MSLN over soluble MSLN, which minimizes the interference of the shedding MSLN on the binding and internalization of the membrane bond MSLN. HBM9033 utilizes a tumor specific cleavable linker with a novel topoisomerase inhibitor for improved stability and activity. The unique design for both mAb and linker-payload together has demonstrated superior potency and safety of HBM9033 in pre-clinical studies. This product was developed by the Company, in collaboration with MediLink Therapeutics. This phase I study is to evaluate the safety, tolerability, pharmacokinetics, and anti-tumor activity of HBM9033 in subjects with advanced solid tumors.

"HBM9033 is our first ADC asset that enters into clinical stage and it has the potential to be the best-in-class MSLN targeted therapeutics," said Dr. Jingsong Wang, Founder, Chairman and Chief Executive Officer of Harbour BioMed. " Building on the extensive applications of the HCAb PLUSTM platform in the ADC field, we have established an ecosystem of ADC that synergizes our in-house development with external collaborations. As evidenced by the rapid progress made by our partners and us, we will continuously strengthen our active presence in the ADC field globally."

On August 28, 2023 Harbour BioMed ("HBM", or the "Company"; HKEX: 02142), a global biopharmaceutical company committed to the discovery, development, and commercialization of novel antibody therapeutics focusing on oncology and immunology, reported its interim results for the six months ended June 30, 2023 (Press release, Harbour BioMed, AUG 28, 2023, View Source [SID1234634725]).

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Dr. Jingsong Wang, Founder, Chairman and CEO of Harbour BioMed commented, "In the first half of 2023, Harbour BioMed recorded a significant increase in its revenue, turning losses into profits. The outstanding performance demonstrated the Company’s excellent global business development capabilities and remarkable achievements in cost reduction and efficiency improvement. Our strategy on global innovation ensures we maintain a competitive edge in multiple fields of drug discovery, further creating favorable advantages for differentiated pipeline development and expansive international collaborations, thus unleashing a wider range of value. Despite the numerous challenges ahead, we will steadfastly promote the Company’s global strategy to drive sustainable growth on the base of innovation, thereby accelerating the advancement of our business."

With strong R&D capabilities, the Company has continued to optimize and upgrade its industry leading and globally patented antibody platforms to further implement its "Antibody+" business strategy. During the reporting period, the Company filed 268 patents, 12 of which had been granted invention patents by the China National Intellectual Property Administration with 174 in progress. Robust patent clusters provide effective protection for the Company’s products and new technology innovations, enabling the company to maintain an advantageous position in global biotech industry. Leveraging the unique antibody discovery technology, Harbour Therapeutics currently has over 10 innovative global programs in immuno-oncology and immunology, while Nona Biosciences further create value through global collaborations based on technology innovations.

The Company has achieved positive half-yearly revenue growth rates exceeding 40% for two consecutive years benefiting from its robust technology platform and cutting edge innovations in the field of Immuno-oncology and Immunology. The Company recorded revenues of over $40 million in the first half of 2023 and achieved its first interim profit of approximately $3 million. Turning to a profit verifies Harbour BioMed’s sustained and outstanding value creation ability. The out-licensing and collaboration of innovative products from Harbour Therapeutics’ portfolio, including HBM7008 and batoclimab (HBM9161), have significantly contributed to this growth. At the same time, the Company has also seen the positive contribution from Nona Biosciences to the earnings growth and profits during the period.

Harbour Therapeutics: Advanced pipeline with exciting advancements

Batoclimab (HBM9161) ‘s positive results on its phase III clinical trial for the treatment of generalized myasthenia gravis (gMG) were announced during 1H2023. Batoclimab resulted in a higher rate of sustained MG-ADL improvement in adult patients with gMG than placebo, and sustained improvement were observed in the second cycle. As the most advanced asset in the portfolio, this marks a major milestone for Harbour BioMed as it is the first positive readout of a registrational trial since its establishment. Also, as the first anti-FcRn product with a complete data set in Greater China, this result of batoclimab has significant positive impact on the development of effective therapeutics for patients with gMG in China.

Porustobart (HBM4003) is a next-generation fully human heavy chain only anti-CTLA-4 antibody generated from the Harbour Mice HCAb platform. It has showcased promising efficacy and safety profile in multiple clinical trials in patients with melanoma, neuroendocrine neoplasms and hepatocellular carcinoma, demonstrating the potential to be developed as a cornerstone therapy in immuno-oncology. Data released in 1H2023 showed that the overall objective response rate (ORR) was 36.8% in its phase Ib clinical trial of porustobart in combination with toripalimab in patients with advanced high-grade neuroendocrine neoplasms, and in its phase Ib clinical trial of porustobart in combination with toripalimab in patients with hepatocellular carcinoma, the ORR hit 46.7%. The Company is poised for the first pivotal trial of porustobart in the next 6 months and plans to expand in multiple new indications including colorectal cancer.

HBM1020 is a first-in-class therapeutic monoclonal antibody against B7H7/HHLA2 entering clinical development globally. It obtained U.S. FDA clearance for phase I trial in January 2023 and completed the first patient dosing in June 2023. As a newly discovered member of the B7 family, B7H7/HHLA2 expression is found non-overlapping with PD-L1 expression in multiple tumor types, which indicates an alternative immune evasion pathway besides PD-(L)1. Preclinical data demonstrated its immune activation and anti-tumor functional activities, showing great potential to address huge unmet medical needs in patients with advanced malignancies.

HBM9033 is an antibody-drug conjugate-based (ADC) drug that specifically targets human mesothelin (MSLN), a TAA that is upregulated in various solid tumors, including mesothelioma, ovary cancer, lung cancer, breast cancer, and pancreatic cancers. HBM9033 is the first ADC product of the Company, which is generated from the Company’s patented ADC platform and has obtained the IND Clearance by U.S. FDA for phase I trial in August 2023.

The collaboration with industry partners on product development has provided more diversified avenues and enriched resources for Harbour Therapeutics’ portfolio advancement, which is an integral part of the strategy that the Company will continue to implement and optimize. Regional and global business collaborations are accelerating the development of numerous programs including HBM7022, HBM7008 and HBM9378. These efforts have verified our innovation ability and recognized the value of the product portfolio of the Company.

Nona Biosciences: Unleashing platform value to shape the second growth curve

As a pioneer in innovative antibody platform technology, the Company continues to advance the "Antibody+" strategy based on its unique advantages of Harbour Mice technology and develop its strengths in cutting-edge research areas such as bispecific antibody, ADC, mRNA, CAR-T, artificial intelligence and protein engineering, providing strong momentum for breakthroughs in innovative technologies. Nona Biosciences, a wholly-owned subsidiary of the Company, as a pivot of value realization and business expansion, is committed to providing global partners with innovative antibody solutions, continuously developing the global cooperation network, and constantly exploring diverse business areas to promote sustainable business growth. With its world-leading technology innovation, the Company’s second growth curve is steadily gaining momentum.

In the field of ADC development, the Company disclosed its ADC technology platform patent as early as 2021 to invest strong R&D efforts ahead of the curve. Not only is Harbour Therapeutics advancing its ADC program HBM9033 generated from the ADC platform from Nona Biosciences, it has successively entered into strategic cooperation with global ADC leaders with rich technology expertise and has generated substantial financial returns through technology licensing and product partnerships.

During the period, there were more than 30 projects ongoing with over 20 new projects initiated by Nona Biosciences. The ongoing platform upgrade driven by Nona is broadening the frontiers of applications in challenging fields including immune cell engager, G protein-coupled receptor (GPCR), mRNA, etc. and more platform-based global bio-innovation is expected to continue to emerge.

On August 28, 2023 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer, reported that, in partnership with Moffitt Cancer Center, it has commenced treatment of the third patient in the ongoing clinical trial of Anixa’s novel chimeric antigen receptor T-cell (CAR-T) therapy for ovarian cancer (Press release, Anixa Biosciences, AUG 28, 2023, View Source [SID1234634724]).

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The study (NCT05316129), which is being conducted at Moffitt Cancer Center, is a dose-escalation Phase 1 trial to evaluate the therapy’s safety; determine the maximum tolerated dose of T-cells targeting the follicle stimulating hormone receptor (FSHR); and preliminarily assess clinical activity. All patients being enrolled in the trial have disease that is progressing and have failed at least two, but often more, therapeutic interventions.

The third patient received the same dose of engineered T-cells as the first and second patients in the trial. Assuming safety is validated in the third patient, as was the case for the first two patients, Anixa expects to begin treatment of the second cohort in the fourth quarter of 2023. Patients enrolled in this second cohort will receive approximately three times the cell dose compared to the first cohort.

The CAR-T approach used for Anixa’s therapy is known as chimeric endocrine receptor T-cell (CER-T) since the target of the engineered T-cells is an endocrine receptor. While CAR-T therapy has shown efficacy in some hematological tumors, reproducing the same results with solid tumors, such as ovarian cancer, has proven challenging. One of the reasons for this difficulty is that effective CAR-T therapy needs to attack a specific antigen present only on targeted cells to avoid negatively affecting healthy cells. The cell therapy being evaluated in Anixa’s Phase 1 study differs from traditional CAR-T therapy in that it targets the FSHR, which research indicates is exclusively expressed on ovarian cells in healthy adult females.

Dr. Robert Wenham, Principal Investigator of the trial and Chair of the Gynecologic Oncology Program at Moffitt Cancer Center, stated, "We are pleased that the Phase 1 clinical trial evaluating this CAR-T therapy for ovarian cancer continues to progress. We are looking forward to analyzing the safety data from the first cohort, and look forward to escalating the dose in the following cohort."

"Though enrollment of patients in this trial has been slow, which is common for clinical studies of this type, we are pleased to have completed the first cohort," stated, Dr. Amit Kumar, Chairman and CEO of Anixa Biosciences. "Assuming there are no safety issues with this third patient, we look forward to advancing to the next higher dose cohort."

About Anixa’s CER-T Approach (Follicle Stimulating Hormone Receptor-Mediated CAR-T technology)

Anixa’s chimeric antigen receptor T-cell (CAR-T) technology approach is an autologous cell therapy comprised of engineered T-cells that target the follicle stimulating hormone receptor (FSHR). FSHR is found at immunologically relevant levels exclusively on the granulosa cells of the ovaries. Since the target is a hormone (chimeric endocrine) receptor, and the target-binding domain is derived from its natural ligand, this technology is known as CER-T (chimeric endocrine receptor T-cell) therapy, a new type of CAR-T.

On August 28, 2023 Illumina, Inc. (NASDAQ: ILMN) reported that its executives will be speaking at the following investor conference (Press release, Illumina, AUG 28, 2023, View Source [SID1234634723]):

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Morgan Stanley 21st Annual Global Healthcare Conference on September 11, 2023
Fireside chat at 9:55am Pacific Time (12:55pm Eastern Time)

The webcast can be accessed through the Investor Info section of Illumina’s website at investor.illumina.com. A replay will be posted on Illumina’s website after the event and will be available for at least 30 days following.