Abpro and Celltrion Receive FDA Clearance for ABP-102 Clinical Trial
Abpro announced, together with its co-development partner Celltrion, that the U.S. Food and Drug Administration, FDA, has cleared the Investigational New Drug, IND, application for ABP-102 / CT-P72, Abpro's lead multispecific antibody oncology program. The IND clearance enables the initiation of a Phase 1 clinical trial evaluating the safety, tolerability, pharmacokinetics, and preliminary efficacy of ABP-102 / CT-P72 in patients with HER2-positive solid tumors. The Phase 1 clinical study will be led by Celltrion as part of the ongoing joint strategic collaboration to ensure the robust progression of the ABP-102 / CT-P72 program.
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Abpro Submits IND for ABP-102/CT-P72, Initiating Phase 1 Clinical Trial
- Clinical Trial Launch: Abpro, in collaboration with Celltrion, has submitted an IND application for ABP-102/CT-P72, with a phase 1 clinical trial anticipated to begin in 1H 2026 for patients with HER2-positive cancers, marking a significant advancement in the company's immuno-oncology efforts.
- Safety and Selectivity: Preclinical studies demonstrate that ABP-102/CT-P72 exhibits selective activity in HER2-high tumor models and shows good tolerability in non-human primates, indicating its potential advantages in clinical applications.
- Milestone in Collaboration: The submission of this IND application reflects the productive partnership between Abpro and Celltrion, further advancing Abpro's overall progress in the immuno-oncology pipeline and enhancing its competitive position in the market.
- Future Growth Potential: The successful advancement of this project not only addresses the treatment needs of HER2-positive tumor patients but also may provide new growth opportunities for Abpro's antibody therapy pipeline, elevating the company's standing in the biotechnology sector.
Abpro Submits IND Application for ABP-102/CT-P72, Targeting HER2-Positive Cancers
- Clinical Trial Milestone: Abpro, in collaboration with Celltrion, has submitted an IND application for ABP-102/CT-P72, marking its first phase 1 trial in solid tumors, anticipated to commence in 1H 2026, aimed at providing new treatment options for HER2-positive cancer patients.
- Safety and Selectivity: Preclinical studies demonstrate that ABP-102/CT-P72 exhibits selective activity in HER2-high tumor models and was well tolerated in non-human primates, indicating a potentially favorable therapeutic index in clinical studies.
- Collaborative Development Advantage: This IND submission reflects the productive collaboration between Abpro and Celltrion, further advancing Abpro's immuno-oncology pipeline and enhancing its competitive position in the market.
- Future Growth Potential: The development of ABP-102/CT-P72 not only offers hope for HER2-positive tumor patients but may also drive long-term growth for Abpro in the oncology treatment sector through its unique therapeutic mechanism.
Abpro Holdings Secures Nasdaq Compliance Extension Until 2026
- Compliance Plan Extension: Abpro has received formal notification from the Nasdaq Hearings Panel granting an extension to allow additional time for compliance, indicating the company's commitment to stabilize its business and build lasting momentum.
- Capital Strategy Optimization: The company has access to up to $44 million in equity financing to support operations and achieve long-term financial goals, enhancing stockholders' equity to maintain listing compliance.
- Significant Cost Optimization: By streamlining its structure, Abpro has achieved an estimated 60% reduction in operating expenses, improving financial health and laying a foundation for future growth.
- Pipeline Progress: Abpro's lead antibody candidate, ABP-102, is on track for first-in-human trials in 2026, showcasing the company's innovative potential and competitive edge in the biotechnology sector.
Stock Splits Scheduled for This Week (November 3 to November 7) – Keep Your Investments Active
Upcoming Stock Splits: Several companies are implementing stock splits or reverse stock splits from November 3 to November 7, including Abpro Holdings, ReTo Eco-Solutions, Aditxt, Chijet Motor Company, Fly-E Group, and Raytech Holding, primarily to comply with Nasdaq listing requirements.
Stock Split Mechanism: A stock split increases the number of shares while maintaining the company's overall value, making shares more accessible to retail investors, whereas a reverse stock split consolidates shares to raise the price per share, often to meet exchange listing standards.
Sitryx Names Adam Mostafa as CFO
Appointment of CFO: Sitryx Therapeutics has appointed Adam Mostafa as Chief Financial Officer, effective September 8, 2025, bringing over 25 years of experience in biotechnology capital markets and strategic leadership.
Adam Mostafa's Background: Mostafa has a strong track record in the biotech sector, having raised over $1 billion in capital and played key roles in financial strategies and partnerships at companies like X4 Pharmaceuticals and Abpro Holdings.
Company's Focus: Sitryx is a clinical-stage biopharmaceutical company developing novel oral therapies aimed at restoring immune balance in autoimmune and inflammatory diseases, with a promising pipeline including its lead candidate SYX-5219.
CEO's Statement: Iain Kilty, CEO of Sitryx, expressed confidence in Mostafa's expertise to drive the company's growth and advance its innovative clinical pipeline, which has the potential to significantly impact patient care.
Why Novavax Shares Are Trading Higher By Around 17%; Here Are 20 Stocks Moving Premarket
Novavax Vaccine Approval: Novavax, Inc. shares surged 16.6% to $7.84 in pre-market trading following the FDA's conditional approval of its COVID-19 vaccine for specific populations.
Market Movements: Several stocks experienced significant pre-market fluctuations, with Healthcare Triangle, Inc. rising 59.2%, while Affimed N.V. saw a decline of 35.5%.
Abpro Submits IND for ABP-102/CT-P72, Initiating Phase 1 Clinical Trial
- Clinical Trial Launch: Abpro, in collaboration with Celltrion, has submitted an IND application for ABP-102/CT-P72, with a phase 1 clinical trial anticipated to begin in 1H 2026 for patients with HER2-positive cancers, marking a significant advancement in the company's immuno-oncology efforts.
- Safety and Selectivity: Preclinical studies demonstrate that ABP-102/CT-P72 exhibits selective activity in HER2-high tumor models and shows good tolerability in non-human primates, indicating its potential advantages in clinical applications.
- Milestone in Collaboration: The submission of this IND application reflects the productive partnership between Abpro and Celltrion, further advancing Abpro's overall progress in the immuno-oncology pipeline and enhancing its competitive position in the market.
- Future Growth Potential: The successful advancement of this project not only addresses the treatment needs of HER2-positive tumor patients but also may provide new growth opportunities for Abpro's antibody therapy pipeline, elevating the company's standing in the biotechnology sector.
Abpro Submits IND Application for ABP-102/CT-P72, Targeting HER2-Positive Cancers
- Clinical Trial Milestone: Abpro, in collaboration with Celltrion, has submitted an IND application for ABP-102/CT-P72, marking its first phase 1 trial in solid tumors, anticipated to commence in 1H 2026, aimed at providing new treatment options for HER2-positive cancer patients.
- Safety and Selectivity: Preclinical studies demonstrate that ABP-102/CT-P72 exhibits selective activity in HER2-high tumor models and was well tolerated in non-human primates, indicating a potentially favorable therapeutic index in clinical studies.
- Collaborative Development Advantage: This IND submission reflects the productive collaboration between Abpro and Celltrion, further advancing Abpro's immuno-oncology pipeline and enhancing its competitive position in the market.
- Future Growth Potential: The development of ABP-102/CT-P72 not only offers hope for HER2-positive tumor patients but may also drive long-term growth for Abpro in the oncology treatment sector through its unique therapeutic mechanism.
Abpro Holdings Secures Nasdaq Compliance Extension Until 2026
- Compliance Plan Extension: Abpro has received formal notification from the Nasdaq Hearings Panel granting an extension to allow additional time for compliance, indicating the company's commitment to stabilize its business and build lasting momentum.
- Capital Strategy Optimization: The company has access to up to $44 million in equity financing to support operations and achieve long-term financial goals, enhancing stockholders' equity to maintain listing compliance.
- Significant Cost Optimization: By streamlining its structure, Abpro has achieved an estimated 60% reduction in operating expenses, improving financial health and laying a foundation for future growth.
- Pipeline Progress: Abpro's lead antibody candidate, ABP-102, is on track for first-in-human trials in 2026, showcasing the company's innovative potential and competitive edge in the biotechnology sector.
Stock Splits Scheduled for This Week (November 3 to November 7) – Keep Your Investments Active
Upcoming Stock Splits: Several companies are implementing stock splits or reverse stock splits from November 3 to November 7, including Abpro Holdings, ReTo Eco-Solutions, Aditxt, Chijet Motor Company, Fly-E Group, and Raytech Holding, primarily to comply with Nasdaq listing requirements.
Stock Split Mechanism: A stock split increases the number of shares while maintaining the company's overall value, making shares more accessible to retail investors, whereas a reverse stock split consolidates shares to raise the price per share, often to meet exchange listing standards.
Sitryx Names Adam Mostafa as CFO
Appointment of CFO: Sitryx Therapeutics has appointed Adam Mostafa as Chief Financial Officer, effective September 8, 2025, bringing over 25 years of experience in biotechnology capital markets and strategic leadership.
Adam Mostafa's Background: Mostafa has a strong track record in the biotech sector, having raised over $1 billion in capital and played key roles in financial strategies and partnerships at companies like X4 Pharmaceuticals and Abpro Holdings.
Company's Focus: Sitryx is a clinical-stage biopharmaceutical company developing novel oral therapies aimed at restoring immune balance in autoimmune and inflammatory diseases, with a promising pipeline including its lead candidate SYX-5219.
CEO's Statement: Iain Kilty, CEO of Sitryx, expressed confidence in Mostafa's expertise to drive the company's growth and advance its innovative clinical pipeline, which has the potential to significantly impact patient care.
Why Novavax Shares Are Trading Higher By Around 17%; Here Are 20 Stocks Moving Premarket
Novavax Vaccine Approval: Novavax, Inc. shares surged 16.6% to $7.84 in pre-market trading following the FDA's conditional approval of its COVID-19 vaccine for specific populations.
Market Movements: Several stocks experienced significant pre-market fluctuations, with Healthcare Triangle, Inc. rising 59.2%, while Affimed N.V. saw a decline of 35.5%.
