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Invenra Highlights Exelixis’ Announcement: Initiation of Phase 1 Clinical Trial Evaluating XB010 in Patients with Advanced Solid Tumors

On August 7, 2024 Invenra’s collaboration partner, Exelixis, Inc. (NASDAQ: EXEL) reported the initiation of the dose-escalation stage of the first-in-human phase 1 clinical trial of XB010 in patients with locally advanced or metastatic solid tumors (Press release, Invenra, AUG 7, 2024, View Source [SID1234645519]).

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XB010, an antibody-drug conjugate (ADC) consisting of a monomethyl auristatin E payload conjugated to a monoclonal antibody targeting the tumor antigen 5T4, is the first custom ADC generated through Exelixis’ biotherapeutics collaboration network. XB010 was constructed using Catalent’s SMARTag site-specific bioconjugation platform, and its 5T4-targeting mAb was discovered in collaboration with Invenra.

Exelixis further announced that the dose-escalation stage of their phase 1, global, open-label study will evaluate XB010 as a single agent and in combination with pembrolizumab to inform the cohort-expansion stage. The expansion cohorts are designed to further assess the tolerability and activity of monotherapy and of the combination in specific indications.

Aadi Bioscience Announces Financial Results for the Second Quarter 2024 and Provides Corporate Update

On August 7, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI), a commercial-stage, precision oncology company focused on developing and commercializing therapies for cancers with alterations in the mTOR pathway, reported financial results for the second quarter ended June 30, 2024, and highlighted recent corporate progress (Press release, Aadi Bioscience, AUG 7, 2024, View Source [SID1234645518]).

"The second quarter saw quarter over quarter sales growth for FYARRO, as anticipated, and an increase in demand across both new and existing accounts, including from major oncology centers. Approximately 80 percent of accounts have ordered multiple times already this year, reflecting the clinical value of FYARRO for patients with advanced malignant PEComa," said Dave Lennon, President and CEO of Aadi Bioscience. "Looking ahead, we will provide the next interim update from PRECISION1, a tumor-agnostic study that enrolled any tumor type presenting with qualifying TSC1 or TSC2 inactivating alterations, later in the third quarter. With this study, nab-sirolimus has the potential to demonstrate a meaningful impact on the lives of patients who have already received standard therapies appropriate for their tumor type and stage of disease."

Recent Operational Highlights

FYARRO net product sales were $6.2 million in the second quarter, an increase of 15 percent from Q1 2024 and in line with the prior year period.
Two-thirds interim analysis of registration-intended PRECISION1 trial is planned for Q3 2024. PRECISION1 is exploring nab-sirolimus in solid tumors with TSC1 or TSC2 inactivating alterations. The trial is fully enrolled, and study completion is expected by year-end.
Enrollment into two additional Phase 2 trials is ongoing, with initial data expected by the end of the year. These tumor specific, open-label trials are investigating the potential of nab-sirolimus for difficult-to-treat mTOR-driven cancers: advanced or recurrent endometrioid-type endometrial cancer (EEC) in combination with letrozole, and neuroendocrine tumors (NETs) of the lung, gastrointestinal tract and pancreas.
Second Quarter 2024 Financial Results

Cash, cash equivalents and short-term investments as of June 30, 2024, were $78.6 million as compared to $108.8 million as of December 31, 2023, which is expected to fund operations into Q4 2025 based on current plans.
Total revenue for the quarter ended June 30, 2024, was $6.2 million, resulting from sales of FYARRO.
Net loss for the three months ended June 30, 2024, was $14.6 million as compared to $18.0 million for the three months ended June 30, 2023.
Conference Call Information

The Aadi management team is hosting a conference call and webcast today at 8:30 am EDT (5:30 am PDT) to provide a corporate update and discuss results for the second quarter 2024.

Participants may access a live webcast of the call and the associated slide presentation on the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Photocure ASA: Results for the second quarter of 2024

On August 7, 2024 Photocure ASA (OSE: PHO), The Bladder Cancer Company, reported Hexvix/Cysview revenues of NOK 122.4 million in the second quarter of 2024 (Q2 2023: NOK 115.9 million) and EBITDA of NOK 27.8 million (NOK 23.4 million) (Press release, PhotoCure, AUG 7, 2024, View Source [SID1234645517]). Photocure reiterates its 2024 financial guidance of product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses. Photocure now expects new and upgraded Saphira installations in the U.S. in the range of 55 to 70 towers for the full year, up from the previous range of 40 to 70 towers.

"Photocure had a productive second quarter as we delivered Hexvix/Cysview revenue growth of 6% year-over-year and EBITDA of NOK 27.8 million. Year-to-date, we have reported 8% revenue growth, on track with our top-line guidance for the year. Once again, both our North American and European business segments had positive contributions during the period as we continue to grow revenues and contain our expenses. We also initiated key business development activities to accelerate our growth in the coming quarters and years," says Dan Schneider, President & Chief Executive Officer of Photocure.

Photocure reported total group revenues of NOK 145.4 million in the second quarter of 2024 (NOK 144.3 million), and EBITDA* of NOK 27.8 million (NOK 23.4 million), driven by revenue growth and a milestone payment from Asieris for the NDA acceptance of Cevira in China. Hexvix/Cysview revenues were NOK 122.4 million in the quarter (Q2 2023: NOK 115.9 million). The EBIT was NOK 20.7 million (NOK 16.8 million) and the cash balance at the end of the period was NOK 267.0 million.

"During the second quarter, 20 new Saphira towers were installed including 5 new account placements, 3 accounts that upgraded to Saphira, and 12 mobile BLC towers delivered to ForTec Medical. High-definition Saphira systems now represent approximately 46% of the installed base of rigid BLC towers in the U.S. In early June, we announced our mobile tower initiative in the U.S. market, aligned with an agreement between ForTec and Karl Storz to provide on-demand Saphira BLC equipment to ForTec’s vast network of hospital customers. ForTec is in the process of rolling out the program nationally, and we look forward to working with them to expand access to BLC procedures in the U.S.," Schneider adds.

At the end of the second quarter of 2024, the installed base of rigid BLC systems in the U.S. was 381, up 17% from the same period in 2023. This includes 18 mobile towers owned by ForTec Medical. In the U.S. 25 flexible BLC towers remain active. After the closing of the quarter, Photocure entered into an agreement with Richard Wolf to develop and globally commercialize a high-definition blue light flexible cystoscope.

"Turning to potential drivers of our long-term growth, we were very pleased to announce our partnership with Richard Wolf to develop and commercialize a state of the art high-definition flexible blue light system. Richard Wolf is a premier manufacturer of endoscopy equipment, and our partnership is focused on ensuring that physicians and patients have reliable access to state-of-the-art, high quality BLC in the surveillance setting. Given the number of new non-muscle invasive bladder cancer therapeutics that have, or are expected to enter the market, we believe that BLC technology will be more important than ever to properly identify, stage and manage bladder cancer patients. As we head into the second half of this year, we remain focused on accelerating the growth of our Hexvix/Cysview franchise, leveraging our established commercial infrastructure, and executing on the many initiatives and activities that can take Photocure to the next level," Schneider concludes.

Photocure believes that the benefits of Blue Light Cystoscopy with Hexvix/Cysview offering superior detection and management of bladder cancer will continue to be adopted and become the standard of care. The Company reiterates its 2024 financial guidance and continues to expect consolidated product revenue growth of 6% to 9% in constant currency and positive EBITDA excluding business development expenses. Photocure now expects new and upgraded Saphira installations in the U.S. in the range of 55 to 70 towers, up from the previous range of 40 to 70 towers for the full year.

Please find the full financial report and presentation enclosed.

EBITDA* and other alternative performance measures (APMs) are defined and reconciled to the IFRS financial statements as a part of the APM section of the second quarter 2024 financial report on page 25.

The quarterly report and presentation will be published at 08:00 CEST and will be publicly available at www.photocure.com. Dan Schneider, CEO and Erik Dahl, CFO, will host a live webcast at 14:00 CEST.

The presentation will be held in English and questions can be submitted throughout the event. The streaming event is available through https://channel.royalcast.com/landingpage/hegnarmedia/20240807_1/

The presentation is scheduled to conclude at 14:45 CEST.

PeproMene Bio announced study demonstrating strong polyfunctionality of novel chimeric antigen receptor (CAR) T cells

On August 7, 2024 PeproMene Bio, Inc., a clinical-stage biotech company developing novel therapies for cancers and immune disorders, reported that City of Hope-developed BAFF-R CAR T, known as PMB-CT01, demonstrated better polyfunctionality than CD19 CAR T cells, which are used in current Food and Drug Administration-approved CAR T cell therapies, according to a correlative study published in Blood Advances (Press release, PeproMene Bio, AUG 7, 2024, View Source [SID1234645516]).

Researchers used a single-cell platform, which found that PMB-CT01 CAR T cells, had more polyfunctionality, which is T cells’ ability to perform several functions at the same time, than CD 19 CAR T cells. PMB-CT01 cells also produced more stimulatory cytokines, which can spur the immune system, and effector cytokines, which can directly kill cancer cells.

Using the City of Hope-developed assay, researchers tested a BAFF-R CAR T cell product from a 57-year-old man with relapsed mantle cell lymphoma. The patient had not achieved remission with prior CD19 CAR T cell therapies. After receiving one infusion in City of Hope’s Phase 1 trial using PMB-CT01 and experiencing minimal side effects, the man has been in complete remission over 18 months and continues to have undetectable cancer by sensitive molecular tests for minimal residual disease.

The study reported robust indicators of polyfunctionality, which correlated with successful CAR T cell expansion post-infusion and the patient’s ongoing remission. Researchers plan to use the assay to test CAR T cell products from five other patients in the trial, all of whom have experienced similar remissions to PMB-CT01.

"We developed BAFFR-CAR T therapy as another treatment option for a significant number of patients with lymphomas and leukemias who relapse after receiving commercial CD19 CAR T cell therapy, and our results so far represent the ideal maximal efficacy with minimal toxicity," said Larry W. Kwak, M.D., Ph.D., vice president and deputy director of City of Hope’s Comprehensive Cancer Center and PeproMene’s scientific founder and compensated chair of its Scientific Advisory Board. Kwak has an equity interest in PeproMene. "We have developed a robust and reliable polyfunctional assay for CAR T cell products, with the potential to predict patient outcomes and accelerate the development of effective CAR T cell therapies."

Elizabeth Budde, M.D., Ph.D., the trial’s principal investigator, an associate professor of hematology and hematopoietic cell transplantation and the executive medical director for the Immune Effector Cell Therapy Program at City of Hope, presented initial trial results at the American Society of Hematology (ASH) (Free ASH Whitepaper)’s conference in December 2023.

"It’s exciting to say that five patients with non-Hodgkin lymphoma and one with B-cell acute lymphoblastic leukemia have been treated with PMB-CT01 and 100% have demonstrated durable responses," Dr. Budde said. "Many of the trial patients relapsed had after CD19 CAR T therapy and/or were CD19 negative. PMB-CT01 could present a viable option for other patients who also face this dilemma."

"This assay can be applied to current and future clinical trials to guide the development of PMB-CT01. PeproMene remains committed to the ongoing scientific and clinical development of this potentially promising new cell therapy" said Hazel Cheng Ph.D., COO of PeproMene Bio.

About PMB-CT01

PMB-CT01 is a first-in-class, BAFF-R-targeted, autologous CAR T cell therapy. BAFF-R (B- Cell Activating Factor Receptor), a member of the tumor necrosis factor (TNF) receptor superfamily, is the main receptor for BAFF and is expressed almost exclusively on B cells. Since BAFF-R signaling promotes normal B-cell proliferation and appears to be required for B-cell survival, tumor cells are unlikely to escape therapy via loss of the BAFF-R antigen. This unique characteristic makes BAFFR CAR T therapy a highly promising option for treating B-cell malignancies. The BAFFR CAR was constructed using anti-BAFF-R single-chain fragment variable (scFv) antibodies and second-generation signaling domains CD3ζ and 4-1BB. Our research has demonstrated that BAFFR-CAR T cells effectively kill human lymphomas and leukemias both in vitro and in animal models. PeproMene Bio has licensed the intellectual property of PMB-CT01 from City of Hope.

WestGene to Advance Clinical Trials Following Dual IND Approvals for World’s First EB Virus-Related mRNA Therapeutic Cancer Vaccine

On August 7, 2024 WestGene Biopharma reported that its mRNA therapeutic cancer vaccine, WGc-043, has received dual IND approvals from China’s National Medical Products Administration (NMPA) and the US FDA (Press release, WestGene Biopharma, AUG 7, 2024, View Source [SID1234645515]). This unprecedented achievement marks the world’s first IND-approved mRNA vaccine for EBV-related cancers in both the United States and China.

Groundbreaking milestone in cancer immunotherapy

On 6 August, the Center for Drug Evaluation (CDE) of the NMPA approved the clinical trial application for WGc-043 injection, allowing the initiation of Phase I clinical trials. This dual approval further validates WestGene’s expertise in core mRNA technologies such as delivery vectors and sequence design, and accelerates the commercialisation of effective and low-toxicity anti-tumour mRNA vaccines worldwide.

Revolutionary technology

WGc-043 is part of WestGene’s portfolio of more than 20 mRNA vaccine candidates. The innovative aspects of WGc-043 include

1. AI-assisted antigen screening: The use of AI to select the broadest and safest protein sequences with the introduction of a globally unique immuno-enhancer (IE) into the mRNA molecule. This design activates the patient’s anti-tumour immunity, generating cytotoxic T-cells (CTLs), antigen-specific antibodies and memory T-cells, providing highly effective anti-cancer effects comparable to combined CAR-T and monoclonal antibody therapies, and preventing tumour recurrence.

2. Advanced delivery system: The newly developed LNP delivery system, patented in China, the US, Europe, Canada, Australia and South Africa, has demonstrated safety and delivery efficiency in clinical trials of three of WestGene’s proprietary products.

Significant market potential and Innovative immunotherapy for EBV-related cancers

The EBV, classified as a Group 1 carcinogen by the International Agency for Research on Cancer (IARC), infects more than 90% of the world’s population and is associated with more than ten malignancies, including nasopharyngeal carcinoma, lymphoma, gastric cancer, lung cancer, liver cancer, esophageal cancer, breast cancer and cervical cancer. WGc-043 is now approved in both countries for treating EBV-positive solid tumors and hematologic malignancies. This new immunotherapy option, backed by high-quality preliminary data, is expected to demonstrate excellent safety and anti-tumor activity in upcoming clinical trials.

WGc-043 has completed investigator-initiated trials (IITs) in nasopharyngeal carcinoma and natural killer T-cell lymphoma, demonstrating superior safety and efficacy compared to existing mRNA cancer vaccines. Its launch is expected to be a major breakthrough in mRNA immunotherapy for EBV-positive tumours.

Comprehensive pipeline and commercialisation progress

Building on its scientific achievements, WestGene has established five R&D platforms. WestGene’s pipeline includes more than 20 products, including mRNA cancer vaccines, mRNA preventive vaccines for infectious diseases, and therapeutic drugs for conditions such as obesity and ageing. In addition to the IND approval for its cancer product, WestGene’s novel nano-adjuvant WGa01 received EUA in China last year, marking a significant milestone in domestic production.

As WestGene moves forward, its pioneering spirit and commitment to innovation promise to revolutionise the field of mRNA technology and cancer therapy. WestGene is currently open to various forms of commercial collaboration, including but not limited to pipeline licensing, co-development and technology licensing.