On April 30, 2024 Anixa Biosciences, Inc. ("Anixa" or the "Company") (NASDAQ: ANIX), a clinical-stage biotechnology company focused on the treatment and prevention of cancer, reported its participation in the Sidoti Micro-Cap Virtual Conference, taking place May 8-9, 2024 (Press release, Anixa Biosciences, APR 30, 2024, View Source [SID1234642457]). Anixa Chairman and CEO Dr. Amit Kumar will present an overview of the Company and its clinical programs including vaccines to prevent cancer and a CAR-T cell therapy to treat cancer.

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Conference details:

Presentation: Thursday, May 9, 2024, at 11:30 am ET*
Presentation link: Click here to register; available via Zoom
Conference registration: Available on the conference website
1×1 meetings: Open to all investors upon conference registration

Dr. Kumar will discuss Anixa’s preventative breast cancer vaccine, currently in Phase 1 clinical trials, that is showing strong positive data. Additional data releases expected in the coming months, and a Phase 2 trial is expected to commence in early 2025. Anixa’s CAR-T cell therapy treatment for ovarian cancer is also in a Phase 1 trial and showing positive data. Anixa has a capital efficient business model, with greater than two years cash, no debt, and a clean cap table.

*The presentation date and time are subject to change. Participants should refer to the final program agenda for up-to-date information.

On April 30, 2024 Photocure ASA (OSE: PHO), the Bladder Cancer Company, reported its participation in the American Urological Association Annual Congress (AUA 2024) to be held May 3-6, 2024 in San Antonio, TX, USA (Press release, PhotoCure, APR 30, 2024, View Source [SID1234642444]).

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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

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Two AUA program highlights will feature Blue Light Cystoscopy with Cysview study data:

On Sunday, May 5th, Dr. Sanjay Das will present the study, "Use of Blue Light Cystoscopy Among Non-Muscle Invasive Bladder Cancer Patients and Outcomes in an Equal Access setting: A Propensity Scored Matched Analysis"
The study, known as BRAVO (Bladder Cancer Recurrence Analysis in Veterans and Outcomes), is a retrospective, propensity score matched analysis that evaluated oncologic outcomes following BLC compared to WLC alone in patients from the Veterans Affairs (VA) Healthcare System.

(PD48: Bladder Cancer: Non-invasive III,
Sunday, May 5, 2024 1:00 PM to 3:00 PM, room 304A)
Monday, May 6th, Poster presentation by Dr. Hailong Hu: "Blue Light Cystoscopy versus White Light Cystoscopy for the Detection of Bladder Cancer using modern HD 4K equipment: An Analysis of Pivotal Trial and Real-World Data". This pooled meta-analysis includes data from a randomized clinical trial and a supporting real-world evidence study conducted in China.

(MP71: Bladder Cancer: Non-invasive IV,
Monday, May 6, 2024 9:30 AM to 11:30 AM, room 302B)

AUA Congress attendees can meet the Photocure team on booth number 601 and gain hands-on experience in the blue light cystoscopy with Cysview procedure using the Saphira HD equipment.

Note to editors:

All trademarks mentioned in this release are protected by law and are registered trademarks of Photocure ASA.
This press release may contain product details and information which are not valid, or a product is not accessible, in your country. Please be aware that Photocure does not take any responsibility for accessing such information which may not comply with any legal process, regulation, registration or usage in the country of your origin.

About Bladder Cancer

Bladder cancer ranks as the 8th most common cancer worldwide – the 5th most common in men – with 1 949 000 prevalent cases (5-year prevalence rate)1a, 614 000 new cases and more than 220 000 deaths in 2022.1b
Approx. 75% of all bladder cancer cases occur in men.1 It has a high recurrence rate with up to 61% in year one and up to 78% over five years.2 Bladder cancer has the highest lifetime treatment costs per patient of all cancers.3
Bladder cancer is a costly, potentially progressive disease for which patients have to undergo multiple cystoscopies due to the high risk of recurrence. There is an urgent need to improve both the diagnosis and the management of bladder cancer for the benefit of patients and healthcare systems alike.
Bladder cancer is classified into two types, non-muscle invasive bladder cancer (NMIBC) and muscle-invasive bladder cancer (MIBC), depending on the depth of invasion in the bladder wall. NMIBC remains in the inner layer of cells lining the bladder. These cancers are the most common (75%) of all BC cases and include the subtypes Ta, carcinoma in situ (CIS) and T1 lesions. In MIBC the cancer has grown into deeper layers of the bladder wall. These cancers, including subtypes T2, T3 and T4, are more likely to spread and are harder to treat.4

1 Globocan. a) 5-year prevalence / b) incidence/mortality by population. Available at: View Source, accessed [February 2024].
2 Babjuk M, et al. Eur Urol. 2019; 76(5): 639-657
3 Sievert KD et al. World J Urol 2009;27:295–300
4 Bladder Cancer. American Cancer Society. View Source

About Hexvix/Cysview (hexaminolevulinate HCl)

Hexvix/Cysview is a drug that preferentially accumulates in cancer cells in the bladder, making them glow bright pink during Blue Light Cystoscopy (BLC). BLC with Hexvix/Cysview, compared to standard white light cystoscopy alone, improves the detection of tumors and leads to more complete resection, fewer residual tumors, and better management decisions.
Cysview is the tradename in the U.S. and Canada, Hexvix is the tradename in all other markets. Photocure is commercializing Cysview/Hexvix directly in the U.S. and Europe and has strategic partnerships for the commercialization of Hexvix/Cysview in China, Chile, Australia, New Zealand and Israel. Please refer to View Source for further information on our commercial partners.

On April 30, 2024 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that Roche issued an Investor Update regarding anti-cancer agent/ALK inhibitor Alecensa (alectinib). The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended to approve Alecensa monotherapy as adjuvant treatment following complete tumor resection for adult patients with anaplastic lymphoma kinase (ALK)-positive non-small cell lung cancer at high risk of recurrence (Press release, Chugai, APR 30, 2024, View Source;category= [SID1234642443]).
*Stage IB (tumours ≥ 4 cm) – IIIA non-small cell lung cancer (UICC/AJCC 7th edition)

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Please refer to the link below for details of the Investor Update:

CHMP recommends EU approval of Roche’s Alecensa as the first adjuvant treatment for resected ALK-positive early-stage lung cancer
View Source

On April 29, 2024 Bright Biologics reported the company and Asieris Pharmaceutical have signed a collaboration agreement to advance the development of next-generation bispecific and trispecific antibody-drug conjugates (ADCs) (Press release, Bright Biologics, APR 29, 2024, View Source [SID1234656214]). This partnership will combine Asieris’ proprietary linker-payload technology with Bright’s innovative bispecific and trispecific antibodies to create and commercialize novel ADC therapies for cancer treatment.

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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

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On April 29, 2024 Molecular Partners AG (SIX: MOLN; NASDAQ: MOLN), a clinical-stage biotech company developing a new class of custom-built protein drugs known as DARPin therapeutics, reported a comprehensive, peer-reviewed publication of preclinical data supporting MP0533’s proposed unique mechanism of action (MoA) for the treatment of acute myeloid leukemia (AML) in Cancer Immunology Research, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) (Press release, Molecular Partners, APR 29, 2024, View Source [SID1234655797]). The publication collates and discusses multiple studies undertaken to characterize MP0533’s preclinical profile and evaluate its therapeutic potential.

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Developing safe and efficacious targeted therapies for patients with AML has proven challenging as AML cells share many of the relevant target antigens with healthy cells. Through its unique MoA, MP0533 was designed to simultaneously target the proteins CD33, CD123, and CD70, which are commonly co-expressed on AML cells and rarely on healthy cells. MP0533’s binding strength increases with the number of target proteins present, leading to increased engagement of T cells when at least two of the targets are present. This results in preferential killing of AML cells.

The data published by Bianchi et al in Cancer Immunology Research in collaboration with the University of Bern build on the results presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition in December 2021 and 2022, and support MP0533’s intended MoA. MP0533 induces selective T cell-mediated killing of AML cell lines, as well as patient bone marrow-derived AML blasts and leukemic stem cells (LSCs) expressing two or three of the target antigens, while sparing healthy hematopoietic stem cells, blood and endothelial cells. MP0533 also demonstrated reduced risk of T cell fratricide observed with other CD70-targeting agents related to CD70’s upregulation on activated T cells. MP0533 was equivalent to non-CD70 targeting therapies in terms of impact on T cell count and viability, further supporting its potentially favorable on-target, off-tumor profile.

MP0533 led to tumor-localized T-cell activation and efficacious tumor regression in an antigen-dependent manner across different in vivo models. Notably, when compared to other T cell engagers that target single antigens, MP0533 led to lower levels of cytokine release, findings that were confirmed through in vitro, in vivo, and ex vivo studies. This included IL-6, a cytokine known as a primary driver of cytokine release syndrome, a systemic toxicity that has so far limited the development of T cell engagers as potential treatment options of AML. Finally, an evaluation of MP0533 in combination with azacitidine and venetoclax, two chemotherapeutic drugs used in AML, suggest the MoAs may be synergistic in terms of LSC killing.

MP0533 is currently being evaluated in a Phase 1/2a trial in patients with relapsed/refractory AML or myelodysplastic syndrome (MDS/AML), and the Company presented positive initial data from the first four dosing cohorts at the ASH (Free ASH Whitepaper) Annual Meeting and Exposition in December 2023. The trial is currently dosing patients in cohort 7. The Company expects to present an update from the study in H1 2024.

For more information about the publication, visit:

The CD33xCD123xCD70 Multispecific CD3-Engaging DARPin MP0533 Induces Selective T Cell–Mediated Killing of AML Leukemic Stem Cells

Reference:
Bianchi M et al. Cancer Immunol Res 2024. Epub ahead of print April 29, 2024.

About MP0533
MP0533 is a novel tetra-specific T cell-engaging DARPin, which simultaneously targets the antigens CD33, CD123 and CD70 on AML cells as well as the immune activator CD3 on T cells. AML cells commonly co-express at least two of the three target antigens, whereas most healthy cells only have one or none. MP0533 binds with increasing avidity as the number of its target antigens present increases, dramatically favoring binding to AML cells over healthy cells. This unique avidity-driven mode of action is designed to enable T cell-mediated killing of AML cells while preserving a therapeutic window that minimizes damage to healthy cells.

About DARPin Therapeutics
DARPin (Designed Ankyrin Repeat Protein) therapeutics are a new class of custom-built protein drugs based on natural binding proteins that open new dimensions of multi-functionality and multi-target specificity in drug design. The flexible architecture, intrinsic potential for high affinity and specificity, small size and high stability of DARPins offer benefits to drug design over other currently available protein-based therapeutics. DARPin candidates can be radically simple, with a single DARPin unit acting as the delivery vector to a specific target; or multispecific, with the possibility of engaging more than five targets, and combining multiple and conditional functionalities in a unique DARPin drug candidate. The DARPin platform is a rapid and cost-effective drug discovery engine, producing drug candidates with optimized properties and high production yields. DARPin therapeutics have been clinically validated across several therapeutic areas and developed through to the registrational stage.