Immunome Presents Compelling Preclinical Data Demonstrating Robust Anti-Tumor Activity for IM-1021

On October 29, 2024 Immunome, Inc., a biotechnology company focused on developing first-in-class and best-in-class targeted cancer therapies, reported the company recently presented promising preclinical data for IM-1021 and the associated proprietary ADC payload HC74 (Press release, Immunome, OCT 29, 2024, View Source [SID1234647506]). The results were presented in a poster entitled "Preclinical evaluation of IM-1021, a ROR1-targeted antibody-drug conjugate with a novel topoisomerase I linker payload" at the 36th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics in Barcelona on October 24, 2024.

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The poster included preclinical results for IM-1021 in both liquid and solid tumors while also highlighting the enhanced ADME properties of HC74:

IM-1021 showed superior efficacy compared to zilovertamab vedotin in both the Jeko-1 mantle cell lymphoma model and the MDA-MB-468 triple negative breast cancer model. In the MDA-MB-468 study, 5 out of 8 animals achieved complete responses after three 5 mg/kg doses.
HC74 demonstrated superior potency (IC50=5nM) compared to deruxtecan (IC50=20nM) in a panel of 89 cancer cell lines.
HC74 showed faster hepatocyte clearance, higher permeability, and lower efflux than deruxtecan.
When evaluated in doxorubicin-resistant and vincristine-resistant cell lines, HC74 showed no reduction in potency compared to the parental NCI-H69 cell line.
Immunome expects to submit an IND for the IM-1021 program to the FDA in the first quarter of 2025.

"We believe that transformative ADCs require matching the target with the right combination of antibody, linker, and payload. Based on this data, we continue to believe that IM-1021 is a promising preclinical candidate," said Immunome’s Chief Scientific Officer Jack Higgins, Ph.D. "HC74’s differentiated profile, including substantial potency in chemo-resistant cell lines, provides intriguing opportunities for clinical development. We look forward to submitting the IM-1021 IND and starting clinical trials upon IND clearance to further validate these findings."

A copy of the poster is available in the "Events & Presentations" portion of Immunome’s website.

Owkin Announces MSIntuit ® CRC v2, a Next-Generation AI Diagnostic Aimed at Transforming Colorectal Cancer Detection and Treatment

On October 29, 2024 Owkin , the first end-to-end AI biotech company using cutting-edge causal AI to drive precision drug discovery, development and diagnostics, reported MSIntuit CRC v2 1 , a next-generation AI solution (Press release, Owkin, OCT 29, 2024, View Source [SID1234647505]). Designed to transform the detection and treatment of colorectal cancer (CRC), MSIntuit CRC v2 will initially launch as an RUO version in the United States on Roche’s navify Digital Pathology enterprise software.

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MSIntuit CRC v2 builds on the success of CE-IVD certified MSIntuit CRC by integrating Owkin’s industry-leading machine learning models with Roche’s unmatched expertise in oncology diagnostics. MSIntuit CRC v2 will now integrate resection and biopsy analysis, addressing a critical need in pathologists’ workflows.

This latest release features a new architecture with advanced machine learning models that significantly improve model performance. It also features enhanced staining techniques, including H&E (hematoxylin and eosin) and HES (hematoxylin, eosin, and saffron), further refining the product’s accuracy and reliability and expanding the solution’s accessibility to more labs.

Meriem Sefta, Owkin’s Chief Diagnostics Officer, said: "We are excited to bring the next innovations of MSIntuit CRC to pathology laboratories, marking a significant advancement in medical diagnostics. This innovation represents our commitment to pushing the boundaries of artificial intelligence in healthcare. By leveraging cutting-edge AI technology, we aim to provide more accurate diagnostic tools that will enable pathologists and oncologists to make more informed decisions. Our goal is to help deliver highly personalized treatment plans, improving patient outcomes and ensuring that each individual receives the most accurate care, tailored to their unique medical needs. This is just the first step in transforming the future of patient care through technology solutions and we look forward to expanding our collaboration with Roche Diagnostics as we pursue this critical mission."

These tools are designed to improve pathology knowledge, enabling cancer patients to benefit from precision medicine and targeted treatments. The RUO version of MSIntuit CRC v2 will soon be available in the United States on Roche’s navify Digital Pathology enterprise software, with additional platforms to come.

Exelixis Announces Third Quarter 2024 Financial Results and Provides Corporate Update

On October 29, 2024 Exelixis, Inc. (Nasdaq: EXEL) reported financial results for the third quarter of 2024, provided an update on progress toward achieving key corporate objectives, and detailed its recent and anticipated commercial, clinical and pipeline development milestones (Press release, Exelixis, OCT 29, 2024, View Source [SID1234647504]).

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"The favorable ruling on our cabozantinib intellectual property estate and recently announced zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of our business"

"The favorable ruling on our cabozantinib intellectual property estate and recently announced zanzalintinib development collaboration with Merck have generated important momentum to drive future growth across all components of our business," said Michael M. Morrissey, Ph.D., President and CEO, Exelixis. "We are increasing 2024 full year guidance for total and net product U.S. revenues based on the strong commercial performance of the cabozantinib franchise in the third quarter. We continue to execute on our plans for potential cabozantinib label expansions in neuroendocrine tumors and prostate cancer, with the final results from CABINET published in The New England Journal of Medicine in September and our partner Ipsen’s regulatory submission in Europe."

Dr. Morrissey continued: "Importantly, the zanzalintinib development program, which is now the subject of six ongoing or planned phase 3 pivotal trials, including two new renal cell carcinoma studies as part of our collaboration with Merck, headlines our emerging pipeline of novel agents with the potential to improve standards of care for patients with cancer. At the same time, we are accelerating our early-stage clinical pipeline with XL309, XB010 and XL495 in phase 1 development. I want to thank everyone at Exelixis for their hard work and dedication as we continue driving value for shareholders and innovating on behalf of the patients we serve."

Third Quarter 2024 Financial Results

Total revenues for the quarter ended September 30, 2024 were $539.5 million, as compared to $471.9 million for the comparable period in 2023.

Total revenues for the quarter ended September 30, 2024 included net product revenues of $478.1 million, as compared to $426.5 million for the comparable period in 2023. The increase in net product revenues was primarily due to an increase in sales volume and average net selling price.

Collaboration revenues, composed of license revenues and collaboration services revenues, were $61.5 million for the quarter ended September 30, 2024, as compared to $45.4 million for the comparable period in 2023. The increase in collaboration revenues was primarily related to an increase in milestone-related revenues recognized in the quarter and higher royalty revenues for the sales of cabozantinib outside of the U.S. generated by Exelixis’ collaboration partners, Ipsen Pharma SAS (Ipsen) and Takeda Pharmaceutical Company Limited, partially offset by a decrease in development cost reimbursements earned.

Research and development expenses for the quarter ended September 30, 2024 were $222.6 million, as compared to $332.6 million for the comparable period in 2023. The decrease in research and development expenses was primarily related to decreases in license and other collaboration costs.

Selling, general and administrative expenses for the quarter ended September 30, 2024 were $111.8 million, as compared to $138.1 million for the comparable period in 2023. The decrease in selling, general and administrative expenses was primarily related to decreases in corporate giving, stock-based compensation expenses and legal and advisory fees.

Impairment of long-lived assets for the quarter ended September 30, 2024 of $51.7 million was related to the non-cash asset impairment charge to certain of Exelixis’ leased facilities which are currently not in use and may be subleased.

Provision for income taxes for the quarter ended September 30, 2024 was $36.8 million, as compared to $4.8 million for the comparable period in 2023.

GAAP net income for the quarter ended September 30, 2024 was $118.0 million, or $0.41 per share, basic and $0.40 per share, diluted, as compared to GAAP net income of $1.0 million, or $0.00 per share, basic and diluted, for the comparable period in 2023. GAAP net income per share for the quarter ended September 30, 2024 was favorably impacted by lower weighted-average common shares outstanding for the quarter ended September 30, 2024, as compared to the comparable period in 2023, as a result of the stock repurchase programs.

Non-GAAP net income for the quarter ended September 30, 2024 was $135.7 million, or $0.47 per share, basic and diluted, as compared to non-GAAP net income of $32.1 million, or $0.10 per share, basic and diluted, for the comparable period in 2023.

Foresee Pharmaceuticals Announces Submission of the NDA to the U.S. FDA for the 3-month Version of CAMCEVI for the Treatment of Advanced Prostate Cancer

On October 29, 2024 Foresee Pharmaceuticals Co., Ltd. (TPEx: 6576), ("Foresee") reported that it has submitted a 505(b)(2) New Drug Application for the 3-month version of CAMCEVI, a ready-to-use 3-month depot formulation of leuprolide mesylate, to the U.S. Food and Drug Administration (FDA) (Press release, Foresee Pharmaceuticals, OCT 29, 2024, View Source [SID1234647503]). The application seeks approval for the use of this product for the palliative treatment of advanced prostate cancer.

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This NDA submission is supported by a previously successful Phase 3 clinical study with a total of 144 advanced prostate cancer patients enrolled, in which treatment with leuprolide mesylate injection every 3 months was demonstrated to be effective, safe and well tolerated, with 97.9% of the subjects achieving the primary efficacy endpoint.

"Following the successful launch of CAMCEVI 6-month depot formulation in 2022, we are excited to announce the submission of the 3-month version of CAMCEVI NDA to the U.S. FDA. This marks a significant milestone in our efforts to expand treatment options for patients with advanced prostate cancer. We look forward to the regulatory approval from the FDA in 2025, and commercial launch in 2026, providing patients with its differentiated ready-to-use profile," said Dr. Ben Chien, Founder and Chairman of Foresee.

Fosun Pharma Announces 2024Q3 Financial Results

On October 29, 2024 Shanghai Fosun Pharmaceutical (Group) Co., Ltd. ("Fosun Pharma" or "the Group"; Stock Code: 600196.SH; 02196.HK), reported its operating performance for the first three quarters of 2024 (Press release, Fosun Pharma, OCT 29, 2024, View Source [SID1234647502]). From January to September 2024, Fosun Pharma achieved revenue of RMB30.91 billion, an increase of about 5.74% YoY after excluding COVID-related products. The net profit attributable to owners of the parent of the Group after deducting extraordinary gain or loss amounted to RMB1.84 billion, up by 24.58% YoY.

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In 2024, Fosun Pharma will further focus on innovative drugs and high-value devices, and continue to promote lean operations, cost reduction, efficiency improvement, and asset rationalization to optimize assets and financial structure, actively promote supply chain management and operational efficiency, and achieve healthy operating cash flow. In the first three quarters of 2024, the net cash flow from operating activities of Fosun Pharma was RMB2.99 billion, a year-on-year increase of 21.33%; the management expense ratio decreased by 0.15 percentage points YoY; excluding the impact of newly acquired companies, management expenses decreased by approximately RMB300 million on the same basis.

Focusing on advantageous therapeutic areas with innovative R&D pipelines continue to advance

In terms of innovative R&D, Fosun Pharma continues to focus on advantageous pipelines to achieve efficient results and continuous implementation of innovative products. In the first three quarters of 2024, Fosun Pharma’s R&D expenditure totaled RMB3.92 billion. In particular, R&D expenses were RMB2.65 billion. In addition to independent R&D, the Group fully implemented an open R&D model, and incubated and invested in R&D projects by initiating/managing industrial funds and other diversified ways, so as to ensure the sustainability of innovation and R&D.

Fosun Pharma’s innovative drug business mainly covers the core therapeutic areas of solid tumors, hematological tumors and immuno-inflammatory diseases, with emphasis on the enhancement of the core technology platforms of antibody/ADCs, cellular therapy and small molecules, to create an open and global innovative R&D system, continuously enhance pipeline value, and promote the development and commercialization of its products.

In the field of tumor immunotherapy, on September 13, 2024, Fosun Pharma announced it will acquire the 50% stake in Fosun Kite and will wholly own Fosun Kite (now renamed as "Fosun Kairos"). In the future, Fosun Kairos will serve as the core platform of Fosun Pharma’s cell therapy, continue to focus on the field of tumor immunotherapy, as well as to promote the development and commercialization of existing licensed products, Axi-Cel (i.e. Fosun Kite’s marketed product "Yi Kai Da") and Brexu-Cel (i.e. Fosun Kite’s pipeline project FKC889), in Chinese mainland, Hong Kong SAR and Macau SAR with Kite Pharma.

In the third quarter of 2024, Fosun Pharma’s multiple independently developed innovative products and pipeline clinical trial results were announced in industry conferences and journals, further consolidating its dominant position in the fields of hematological tumors, breast cancer, lung cancer and other tumors. Particularly, the interim analysis results of the Phase III study of Foritinib Succinate (SAF-189s), an innovative drug independently developed to treat ALK-positiveb advanced non-small cell lung cancer (NSCLC), were released during the 2024 World Conference on Lung Cancer ("WCLC"). The above-mentioned studies have found that the overall efficacy of Foritinib Succinate is good. Compared with crizotinib treatment, it can significantly improve PFS and reduce the risk of CNS progression. Its safety is controllable, and no new safety signals appeared after treatment. Faritinib Succinate is expected to break through the current clinical difficulties faced in the treatment of ALK-positive NSCLC and bring new treatment options to NSCLC patients.

The multicenter real-world study of Fosun Pharma’s self-developed serplulimab-based immunochemotherapy for extensive-stage small cell lung cancer was released at the 2024 WCLC. The ASTRUM-005R study provides additional empirical evidence to support the therapeutic value of serplulimab plus chemotherapy and complements the pivotal data from the ASTRUM-005 clinical trial. Additionally, during the reporting period, the Committee for Medicinal Products for Human Use ("CHMP") of the European Medicines Agency (EMA) issued a positive opinion recommending approval for Fosun Pharma’s self-developed serplulimab injection in combination with carboplatin and etoposide for the first-line treatment of adult patients with extensive-stage small cell lung cancer (ES-SCLC). The CHMP’s opinion will be submitted to the European Commission (EC) as a reference for marketing authorization approval.

Results of the phase 2 study of HLX22, an innovative anti-HER2 monoclonal antibody (mAb), in combination with Han Qu You (trastuzumab) and chemotherapy for the first-line treatment of HER2-positive advanced gastric/gastroesophageal junction (G/GEJ) cancer were presented on 2024 ESMO (Free ESMO Whitepaper) Gastrointestinal Cancers Congress (ESMO GI) and MED, a flagship clinical and translational research monthly journal by Cell Press. The results showed that add HLX22 to HLX02 (trastuzumab) and chemotherapy as first-line therapy improved efficacy in HER2-positive G/GEJ cancer patients with manageable safety.

In September 2024, Fosun Pharma announced the Biologics License Application ("BLA") for the licensed product RT002 (DaxibotulinumtoxinA-lanm, Chinese trademark: 达希斐) for the temporary improvement in the appearance of moderate to severe glabellar lines associated with corrugator and/or procerus muscle activity in adult patients, was approved by the National Medical Products Administration ("NMPA"), becoming the first DaxibotulinumtoxinA-lanm approved for marketing in Chinese mainland. Additionally, the results of a Phase III multicenter, double-blind, placebo-controlled study conducted in China for the treatment of moderate to severe glabellar lines were published in the Journal of Plastic, Reconstructive & Aesthetic Surgery (JPRAS). The study demonstrates that the product provides durable efficacy and high safety in Chinese patients with moderate to severe glabellar lines.

Actively implementing share repurchases and increasing holdings with continuous efforts on enhancing ESG

Fosun Pharma, a company listed on both the A-share and H-share markets, and its controlling shareholder Fosun High Tech have actively engaged in share repurchases and increased holdings this year, demonstrating confidence in the Company’s future development and further boosting market confidence. In the first three quarters of 2024, Fosun Pharma spent approximately RMB127 million and approximately HKD66.9 million to repurchase around 5.68 million A shares and 5.47 million H shares respectively. As of now, the H Share Repurchase Plan is still valid. In addition, the controlling shareholder Fosun High Tech, has spent a total of approximately RMB101 million to increase its holdings of around 4.30 million A shares of Fosun Pharma, under the latest Shareholding Increase Plan.

Founded in 1994 and with three decades of development, Fosun Pharma has grown into a global innovation-driven pharmaceutical and healthcare industry group. The Company always regards innovation as its primary social responsibility, consistently focusing on unmet clinical needs, prioritizing innovative R&D, advancing the launch of innovative products, promoting drug accessibility and affordability, and driving high-quality corporate growth. Fosun Pharma maintained an A grade rating in MSCI ESG Ratings for three consecutive years and an A- rating in HSI ESG, ranking among the top tier in the healthcare industry for pharmaceuticals and biotechnology. It was also selected as a constituent of the Hang Seng (China A) Corporate Sustainability Benchmark Index ("HSCASUSB"), Hang Seng (China A) Corporate Sustainability Index ("HSCASUS"), and Hang Seng (Mainland and HK) Corporate Sustainability Index ("HSMHSUS").

With its sustained excellence in innovation and global operational capabilities, Fosun Pharma has been recognized by multiple authoritative institutions in innovative R&D, ESG and other areas. The Company ranked in the top four of China’s 2023 Top 100 Pharmaceutical Industry, was included in the "China Best Managed Companies" List (BMC) for the second consecutive year and was listed in Forbes 2024 China ESG 50. In addition, the Company has actively introduced its independently developed artemisinin-based innovative products to Africa, providing a Chinese solution to the global fight against malaria. This initiative highlights the inclusive, diverse, and open nature of ESG and earned Fosun Pharma recognition as an "Inspirational ESG Case", serving as a model for corporate ESG practices.