On August 11, 2024 Akeso, Inc. (HKEX: 9926.HK) ("Akeso,") reported two upcoming oral presentations of ivonescimab (PD-1/VEGF bispecific antibody) at the IASLC 2024 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer ("WCLC24"), taking place in San Diego, USA from September 7-10, 2024 (Press release, Akeso Biopharma, AUG 11, 2024, View Source [SID1234645701]). Among these is a late-breaking Presidential Symposium presentation featuring results from the HARMONi-2/AK112-303 study, which evaluated monotherapy ivonescimab against monotherapy pembrolizumab in patients with locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumors have positive PD-L1 expression (PD-L1 TPS ≥1%).

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The late-breaking result of HARMONi-2/AK112-303 will be presented by Professor Zhou Caicun, the principal investigator of HARMONi-2 and director in the Department of Medical Oncology at Shanghai Pulmonary Hospital, Tongji University.

Presentations during WCLC 2024

Abstract Title

Presentation Details

Phase 3 Study of Ivonescimab (AK112) vs. Pembrolizumab as First-line Treatment for PD-L1-positive Advanced NSCLC: Primary Analysis of HARMONi-2

Session: PL02 Presidential Symposium 1 (LIVESTREAMED)

Form: Plenary oral

Presenter: Caicun Zhou, MD. Ph.D, China Shanghai Pulmonary Hospital

Abstract release time: embargoed until the presentation day

A Phase 2 Study of Perioperative Ivonescimab Alone or Combined with Chemotherapy in Resectable Non-Small Cell Lung Cancer

Session: Perioperative Strategies 1—Early-Stage Non-Small Cell Lung Cancer

Sunday, September 8, 2024, 11:17 AM-11:27 AM

Form: Oral

Presenter: Xiaoliang Zhao, MD, China Tianjin Medical University Cancer Institute & Hospital

Abstract release time: August 14, 2024

Akeso will also participate as an exhibitor, actively engaging with professionals from diverse fields.

Milestones of ivonescimab:

May 2024:
Ivonescimab was granted marketing approval for the treatment of epidermal growth factor receptor ("EGFR") mutated locally advanced or metastatic non-squamous non-small cell lung cancer ("nsq-NSCLC"), making it the world’s first approved PD-1/VEGF bi-specific antibody.

May 31:
At a prespecified interim analysis conducted by an independent Data Monitoring Committee, ivonescimab demonstrated a statistically significant and clinically meaningful improvement in PFS by blinded independent radiology review committee (BICR) compared to pembrolizumab, and the hazard ratio (HR) was significantly better than expected. There are no known Phase III clinical trials in NSCLC which have shown a statistically significant improvement compared to pembrolizumab in a head-to-head setting.

June 01:
Interim result of the Phase III study of ivonescimab combined with platinum-doublet chemotherapy in patients with EGFR-mutant non-squamous non-small cell lung cancer who progressed on EGFR-TKIs treatment (HARMONi-A ), was presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, and the study was ranked as the top report on the TOP 10 list of lung cancer at ASCO (Free ASCO Whitepaper) by OncoAlert, an international cancer support organization. On the same day, the research findings were also published simultaneously in the JAMA journal.

July 25:
Akeso’s partner, Summit Therapeutics Inc. (NASDAQ: SMMT) ("Summit,") announced a strategic five-year collaboration agreement with The University of Texas MD Anderson Cancer Center (MD Anderson) for the purpose of accelerating the development in certain types of renal cell carcinoma, colorectal cancer, skin cancer, and breast cancer.

July 29:
The supplemental New Drug Application (sNDA) for ivonescimab as a monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic non-small cell lung cancer (NSCLC), has been accepted by the China National Medical Products Administration (NMPA). This new indication application for ivonescimab is based on the HARMONi-2 (AK112-303) study.

August 02:
The supplemental New Drug Application (sNDA) for ivonescimab monotherapy for first-line treatment of PD-L1 positive (PD-L1 TPS≥1%) locally advanced or metastatic NSCLC was accepted by China NMPA with priority review.

About Ivonescimab (AK112/SMT112)
Ivonescimab is a novel global first-in-class PD-1/VEGF bi-specific immunotherapy drug independently developed by Akeso. Ivonescimab is known as SMT112 in Summit Therapeutics’ license territories, including the United States, Canada, Europe, Japan, Central America, South America, the Middle East and Africa. Ivonescimab was granted marketing approval by NMPA for the treatment of EGFR mutated locally advanced or metastatic non-squamous NSCLC patients who have progressed after EGFR TKI treatment. Currently, ivonescimab’s first indication has been approved in China, and Akeso is conducting 5 Phase III trials including 2 global MRCTs and 4 registrational trials versus anti-PD-1 therapeutics. The Company is also conducting multiple clinical trials of ivonescimab covering 16 indications including gastrointestinal cancer, hepatocellular carcinoma and colorectal cancer.

On August 9, 2024 GenScript reported its first quarter 2024 results (Presentation, GenScript, AUG 9, 2024, https://www.genscript.com/gsfiles/IPO/2024%2dInterim%2dResults%2dEN.pdf?v=0%2e2?1018088532 [SID1234647131]).

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On August 9, 2024 GenScript Biotech Corporation, a leading global technology and service provider of life science R&D and manufacture, reported its first half 2024 financial results for the six months ended June 30, showcasing impressive revenue growth, significant improvements in gross profit, and strategic advances across its business segments (Press release, GenScript, AUG 9, 2024, https://www.genscript.com/genscript-biotech-reports-first-half-2024-results.html [SID1234647130]). GenScript is also deepening its commitment to environmental, social, and governance (ESG) practices, marking a significant step towards sustainable development.

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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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Sherry Shao, GenScript’s rotating CEO, said, "In the first half of 2024, the Group showcased strong market adaptability and growth potential. With a diversified business strategy, exceptional innovation, and efficient operations, GenScript not only maintained solid profitability in the life sciences sector but also saw promising growth in cell therapy product sales. Our subsidiary, Bestzyme, has also outperformed the industry, thanks to years of hard work from the team. While the CDMO sector has been under pressure due to current investment challenges, we’re starting to see signs of recovery. We’re ready to accelerate our business in the second half of the year. GenScript will continue to strengthen its core competencies across all business lines and foster synergies across divisions to achieve shared growth with our global partners."

Strong Financial Performance
During the Reporting Period, GenScript generated revenue of approximately US$561.4 million, reflecting a robust 43.5% increase from US$391.3 million in the Prior Period. This growth was largely driven by the cell therapy segment, which saw a remarkable 156% increase, reaching approximately US$280.3 million compared to US$109.5 million previously. On the other hand, revenue from the non-cell therapy business was around US$281.1 million.

Gross profit surged to approximately US$307 million, a 75.4% increase from US$175 million in the Prior Period. The cell therapy segment was a key contributor to this growth, with its gross profit soaring by 323.4% to approximately US$175.3 million.

Improved Loss and Adjusted Net Loss
GenScript’s loss for the Reporting Period narrowed to approximately US$215.6 million, compared to US$245.8 million in the Prior Period. The adjusted net loss saw a significant improvement, decreasing to approximately US$69 million from US$162 million.

For the non-cell therapy business, the adjusted net profit before eliminations was approximately US$29.2 million, a 13.1% decrease from US$33.6 million. Meanwhile, the adjusted net loss for the cell therapy business before eliminations narrowed to approximately US$98.3 million from US$195.7 million.

Segment Highlights
Life-Science Services and Products: Revenue in this segment grew by 9.6% to approximately US$222.4 million, driven by major upgrades in platforms and automation, especially in molecular biology, peptide, and protein technologies. Enhanced manufacturing efficiency in Singapore, Mainland China, and the U.S., along with strong commercial operations in the U.S. and Europe, fueled this growth. Adjusted gross profit increased by 8.5% to approximately US$119.9 million, maintaining a stable margin. Adjusted operating profit rose significantly by 23.8% to approximately US$47.8 million.
Biologics Development Services: This segment saw a revenue decline of 37.9% to approximately US$40.4 million, impacted by reduced demand and increased competition. Adjusted gross profit fell by 69.7% to approximately US$5.9 million, with the adjusted gross profit margin decreasing to 14.7%. Adjusted operating loss widened to approximately US$18.9 million, driven by higher operating costs related to U.S. expansion and strategic investments. The Company plans to refine pricing strategies and enhance global market presence to address these challenges.
Industrial Synthetic Biology Products: Revenue increased by 43.4% to approximately US$26.1 million, driven by a market rebound and growing demand in Mainland China and beyond. Adjusted gross profit rose by 52.8% to approximately US$11 million, with the adjusted gross profit margin improving to 42.2%. Adjusted operating profit improved to approximately US$2.3 million, reflecting higher capacity utilization and process improvements.
Cell Therapy: Revenue from the cell therapy segment grew by 155.7% to approximately US$280.5 million. This growth was fueled by collaboration revenue from CARVYKTI sales under the Janssen Agreement and increased license revenue from agreements with Janssen and Novartis Pharma AG. The adjusted operating loss narrowed to approximately US$119.4 million from US$205.9 million. The Company invested approximately US$196.3 million in research and development, focusing on cilta-cel and solid tumor programs, and incurred approximately US$52.4 million in adjusted selling and distribution expenses and US$49.1 million in adjusted administrative expenses.
Deepening ESG Commitment
In addition to its financial achievements, GenScript is advancing its commitment to sustainability and ESG practices. This year, the Company officially joined the United Nations Global Compact (UNGC), underscoring its commitment to adhere to ten sustainable development principles and drive more responsible, inclusive, and sustainable global business practices.

The Group has also been recognized for its ESG performance, ranking in the top 35% in EcoVadis’ sustainability assessments. This recognition highlights the Company’s efforts in environmental protection, labor rights, supply chain management, fair operations, and the execution of sustainable development strategies. Further demonstrating its dedication, the Company has joined the Science Based Targets initiative (SBTi) and submitted its Science-Based Targets Commitment, reflecting its proactive stance on global climate change and commitment to aligning with the Paris Agreement’s temperature goals.

In environmental management, GenScript is focused on optimizing its carbon footprint through international certifications such as ISO 14064, ISO 14001, and ISO 50001. These certifications enhance energy efficiency and cut greenhouse gas emissions. Additionally, the Company has earned ISO 27001 certification, ensuring top-notch data security and customer privacy protection.

On August 9, 2024 Oncolys BioPharma reported non-consolidated Financial Results for the Six Months Ended June 30, 2024 (Press release, Oncolys BioPharma, AUG 9, 2024, View Source [SID1234646913]).

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On August 9, 2024 Ono Pharmaceutical Co., Ltd. and Bristol-Myers Squibb reported the submission of supplemental application of Ono’s anti-PD-1 antibody, Opdivo (generic name: nivolumab) Intravenous Infusion ("Opdivo") and BMSKK’s anti-CTLA-4 antibody, Yervoy (generic name: ipilimumab) Injection ("Yervoy") in combination therapy in Japan, to expand the use for the treatment of unresectable hepatocellular carcinoma (HCC) (Press release, Ono, AUG 9, 2024, View Source [SID1234646251]). This application is related to the additional indication for a partial change in approved items of the manufacturing and marketing approval in Japan.

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 This application is based on the results from interim analysis of the CheckMate -9DW study, a global multi-center Phase 3 clinical study (CA209-9DW: ONO-4538-92), evaluating Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy for patients with unresectable HCC who have not received prior systemic therapy. In this study, Opdivo plus Yervoy met its primary endpoint of overall survival (OS), demonstrating a statistically significant and clinically meaningful improvement in OS compared to lenvatinib or sorafenib monotherapy. The safety profile of Opdivo plus Yervoy was consistent with previously reported data, with no new safety signals identified.

About CheckMate -9DW Study (CA209-9DW: ONO-4538-92)
 CheckMate -9DW study is a global multicenter randomized open-label Phase 3 study evaluating the combination of Opdivo plus Yervoy compared to investigator’s choice of lenvatinib or sorafenib monotherapy in patients with advanced hepatocellular carcinoma who have not received prior systemic therapy.
 668 patients were randomized to receive Opdivo plus Yervoy (Opdivo 1 mg/kg plus Yervoy 3 mg/kg Q3W for up to four doses, followed by Opdivo monotherapy 480 mg Q4W) infusion, or single agent lenvatinib or sorafenib as oral capsules in the control arm. The primary endpoint of the study is overall survival (OS) and key secondary endpoints include objective response rate (ORR) and time to symptom deterioration (TTSD).

About Hepatocellular Carcinoma
 Liver cancer is the third most frequent cause of cancer death worldwide. It is estimated that there were approximately 866,000 new cases of liver cancer worldwide in 2022, with an estimated approximately 758,000 deaths1) . In Japan, it is estimated that there were approximately 41,000 new cases of liver cancer in 2022, with an estimated approximately 26,000 deaths1) . Hepatocellular carcinoma (HCC) is the most common type of primary liver cancer and accounts for 90% of all liver cancers2) . HCC is often diagnosed in an advanced stage, where effective treatment options are limited and are usually associated with poor outcomes.
 Up to 70% of patients experience recurrence within five years, particularly those still considered to be at high risk after surgery or ablation3) . While most cases of HCC are caused by hepatitis B virus (HBV) or hepatitis C virus (HCV) infections, metabolic syndrome and nonalcoholic steatohepatitis (NASH) are rising in prevalence and expected to contribute to increased rates of HCC.

Globocan 2022: Available at: View Source
Kim E, Viatour P. Hepatocellular carcinoma: old friends and new tricks. Exp Mol Med. 2020; 52: 1898–07.
Forner A, Reig M, Bruix J. Hepatocellular carcinoma. Lancet. 2018; 391: 1301–14.
About Opdivo
 Opdivo is a programmed death-1 (PD-1) immune checkpoint inhibitor that is designed to uniquely harness the body’s own immune system to help restore anti-tumor immune response by blocking the interaction between PD-1 and its ligands. By harnessing the body’s own immune system to fight cancer, Opdivo has become an important treatment option across multiple cancers since the approval for the treatment of melanoma in Japan in July 2014. Opdivo is currently approved in more than 65 countries, including Japan, South Korea, Taiwan, the US and European Union.
 In Japan, Ono launched Opdivo for the treatment of unresectable melanoma in September 2014. Thereafter, Opdivo received an approval for additional indications of unresectable advanced or recurrent non-small cell lung cancer in December 2015, unresectable or metastatic renal cell carcinoma in August 2016, relapsed or refractory classical Hodgkin lymphoma in December 2016, recurrent or metastatic head and neck cancer in March 2017, unresectable advanced or recurrent gastric cancer which has progressed after chemotherapy in September 2017, unresectable advanced or recurrent malignant pleural mesothelioma which has progressed after chemotherapy in August 2018, microsatellite instability high (MSI-High) unresectable advanced or recurrent colorectal cancer that has progressed following chemotherapy and unresectable advanced or recurrent esophageal cancer that has progressed following chemotherapy in February 2020, cancer of unknown primary in December 2021, adjuvant treatment of urothelial carcinoma in March 2022, malignant mesothelioma (excluding malignant pleural mesothelioma) in November 2023 and unresectable advanced or recurrent malignant epithelial tumors in February 2024.
 In addition, Ono has been conducting clinical development program including hepatocellular carcinoma, etc.

About Yervoy
 Yervoy is a recombinant, human monoclonal antibody, and binds to the cytotoxic T-lymphocyte-associated antigen-4 (CTLA-4). CTLA-4 is a negative regulator of T-cell activation. Yervoy binds to CTLA-4, and blocks the interaction of CTLA-4 with its ligands, CD80/CD86. Blockade of CTLA-4 has been shown to augment T-cell activation and proliferation, including the activation and proliferation of tumor infiltrating T-effector cells. Inhibition of CTLA-4 signaling can also reduce T-regulatory cell function, which may contribute to a general increase in T-cell responsiveness, including anti-tumor immune response. On March 25, 2011, the U.S. Food and Drug Administration (FDA) approved Yervoy 3 mg/kg monotherapy for patients with unresectable or metastatic melanoma. Yervoy is now approved in more than 50 countries. There is a broad, ongoing development program in place for Yervoy spanning multiple tumor types. In Japan, Yervoy was approved for the indication of unresectable malignant melanoma in July 2015.

About Ono and Bristol Myers Squibb Collaboration
 In 2011, through a collaboration agreement with Bristol Myers Squibb (BMS), Ono granted BMS its territorial rights to develop and commercialize Opdivo globally except in Japan, South Korea and Taiwan, where Ono had retained all rights to Opdivo except the US at the time. In July 2014, Ono and BMS further expanded the companies’ strategic collaboration agreement to jointly develop and commercialize multiple immunotherapies – as single agent and combination regimens – for patients with cancer in Japan, South Korea and Taiwan.