JNJ-0631 / Zhejiang Medicine, J&J - LARVOL DELTA

Comprehensive understanding of the mutant 'giant' Arthrospira platensis developed via ultraviolet mutagenesis. (PubMed, Front Plant Sci) - "NCB001, which was isolated from freshwater and owned by NCell Co., Ltd. Transcriptome analysis revealed that these morphological differences resulted from changes in cell wall formation mechanisms and increased cell division. Our results show that NCB002 has outstanding industrial value and provides a comprehensive understanding of it."

Journal

Johnson & Johnson Completes Acquisition of Ambrx (Businesswire) - "Johnson & Johnson...announced today it has successfully completed the acquisition of Ambrx Biopharma, Inc...in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired, as announced on January 8, 2024...'We’re pleased to welcome Ambrx’s talented scientific team and proprietary ADC platform to Johnson & Johnson. We look forward to continuing the development of ARX517, which represents a potential first- and best-in-class PSMA-targeting ADC for the treatment of metastatic castration-resistant prostate cancer.'....The acquisition presents a distinct opportunity for Johnson & Johnson to design, develop and commercialize targeted oncology therapeutics."

M&A • Breast Cancer • Castration-Resistant Prostate Cancer • Gastric Cancer • Gastrointestinal Cancer • Genito-urinary Cancer • Hematological Malignancies • HER2 Breast Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Solid Tumor

Johnson & Johnson to Acquire Ambrx, Advancing Next Generation Antibody Drug Conjugates to Transform the Treatment of Cancer (Businesswire) - "Johnson & Johnson...announced today it has entered into a definitive agreement to acquire Ambrx Biopharma, Inc., or Ambrx...in an all-cash merger transaction for a total equity value of approximately $2.0 billion, or $1.9 billion net of estimated cash acquired...Ambrx is advancing a focused portfolio of clinical and preclinical programs designed to optimize efficacy and safety of its candidate therapeutics in multiple cancer indications, including ARX517, its proprietary ADC targeting PSMA for metastatic castration-resistant prostate cancer (mCRPC); ARX788, its proprietary ADC targeting human epidermal growth factor receptor 2 (HER2) for metastatic HER2+ breast cancer; and ARX305, its proprietary ADC targeting CD-70 for renal cell carcinoma....Building on a legacy of innovation in oncology and in prostate cancer, J&J scientists intend to work with Ambrx researchers, accelerating the Phase 1/2 APEX-01 study (NCT04662580) of ARX517 in advanced prostate cancer..."

M&A • Breast Cancer • Castration-Resistant Prostate Cancer • Genito-urinary Cancer • HER2 Breast Cancer • HER2 Positive Breast Cancer • Kidney Cancer • Metastatic Castration-Resistant Prostate Cancer • Oncology • Prostate Cancer • Renal Cell Carcinoma • Solid Tumor

Preclinical characterization of ARX305: A next-generation anti-CD70 antibody drug conjugate for the treatment of CD70-expressing cancers (ESMO 2023) - "Conclusions In summary, the highly selective and potent anti-tumor activity in multiple tumor types and wide pre-clinical therapeutic index of ARX305 support clinical evaluation of this next generation anti-CD70 ADC. ARX305 is currently in a phase 1 dose-escalation study in China."

Preclinical • Hematological Malignancies • Oncology • CD70

Ambrx to Present Preliminary ARX517 First-in-Human Safety, Efficacy, and Pharmacokinetics Data at ESMO 2023 (GlobeNewswire) - "Ambrx Biopharma Inc., Ambrx...announced the acceptance of four abstracts for poster presentation at the European Society for Medical Oncology (ESMO) Congress 2023, being held October 20-24, 2023 in Madrid, Spain. Posters will feature preliminary safety, efficacy, and pharmacokinetic (PK) data from APEX-01 (NCT04662580), evaluating Ambrx’s proprietary anti-PSMA antibody drug conjugate (ADC), ARX517, in metastatic castration resistant prostate cancer (mCRPC) patients. This will be the first presentation of clinical data regarding ARX517 at a medical congress."

P1/2 data • Preclinical • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Preclinical characterization of ARX305, a next-generation anti-CD70 antibody drug conjugate for the treatment of CD70-expressing cancers (AACR 2023) - "In summary, the highly potent anti-tumor activity in multiple tumor types and wide therapeutic index of ARX305 support clinical evaluation of this next generation anti-CD70 ADC. ARX305 is currently in a Phase 1 dose escalation study in China, and the IND in the United States is open."

Preclinical • Hematological Malignancies • Oncology • CD70

Ambrx Presents New Preclinical Data on ARX517 and ARX305 at the 2023 AACR Annual Meeting (GlobeNewswire) - "In a renal cell carcinoma (RCC, 786-OS3) xenograph model, ARX305 dose-dependently inhibited tumor growth and outperformed sunitinib. In another RCC (Caki-1) xenograph model, weekly administration of ARX305 resulted in significant, dose-dependent, anti-tumor activity. Pharmacokinetic studies of ARX305 in mice confirms the high ADC stability in circulation with a long terminal half-life of 16.5 days. GLP toxicity study in monkey predicted a clear therapeutic index in human. In summary, ARX305 preclinical data demonstrated ADC stability, strong anti-tumor activity in two RCC models, increased survival of animals in a multiple myeloma disseminated model, and tolerance in non-human primates indicating a wide therapeutic index."

Preclinical • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma

Ambrx to Present Preclinical Data on ARX517 and ARX305 at the 2023 AACR Annual Meeting (GlobeNewswire) - "Ambrx Biopharma Inc., or Ambrx...announced the presentation of three posters featuring preclinical data at the upcoming 2023 American Association for Cancer Research (AACR) Annual Meeting in Orlando, Florida, from April 14 to 19, 2023. The two preclinical posters will provide data from Ambrx’s preclinical studies of ARX517 (anti-PSMA ADC) and ARX305 (anti-CD70 ADC). Further, a clinical trial in progress poster will be presented from APEX-01 (NCT04662580), the Company’s Phase 1, first-in-human, open label dose escalation and dose expansion trial of ARX517 enrolling patients with advanced prostate cancer whose tumors have progressed on at least two prior FDA-approved treatments. "

Preclinical • Trial status • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ambrx Announces NovoCodex’s Dosing of First Patient with ARX305, Ambrx’s Investigational Antibody Drug Conjugate Targeting CD70 (Businesswire) - "Ambrx Biopharma Inc...announced the first patient has been dosed by Ambrx’s partner, NovoCodex Biopharmaceuticals, Inc. (NovoCodex) in its Phase 1 trial of ARX305 in patients with advanced solid tumors....According to their development agreement, NovoCodex and Ambrx will collaborate in the development of ARX305 up until the completion of Phase 1 clinical trials. Under the terms of the development agreement, Ambrx is eligible to receive up to $4.0 million in clinical milestones, as well as tiered royalties in the low teens percentage range of aggregate net sales of ARX305 in China from NovoCodex. As a result of the first patient being dosed in NovaCodex’s Phase 1 clinical trial in China, Ambrx will now receive a significant portion of the $4.0 million milestones payments.... Following the completion of NovoCodex’s Phase 1 clinical trial, Ambrx’s Phase 1a clinical trial for ARX305 is expected to initiate in the second half of 2023."

Licensing / partnership • New P1 trial • Oncology • Solid Tumor

Ambrx Biopharma Inc. Announces Strategic Reprioritization and Provides Corporate Update (GlobeNewswire) - "Anticipated Near Term Pipeline Milestones: 2H 2023: Ambrx sponsored globally (U.S.) Interim Phase 1a safety data for ARX517, leading to a recommended dose that would allow Ambrx to initiate a Phase 1b/2 trial; 2H 2023: Initiation of Ambrx sponsored globally (U.S.) Phase 1a trial for ARX305 (subject to results from NovoCodex sponsored trial); 1H 2024: IND submission for ARX102 (subject to results from Sino Biopharm sponsored trial)."

IND • New P1 trial • New P1/2 trial • P1 data • Oncology • Solid Tumor

Ambrx Biopharma Inc. Announces Strategic Reprioritization and Provides Corporate Update (GlobeNewswire) - "Ambrx will prioritize the progression of ARX517 through the clinic as the company’s new lead asset. The company believes ARX517 has the potential to be the first ADC therapy that specifically targets Prostate Specific Membrane Antigen (PSMA) to treat prostate cancer....Due to changes in the HER2 competitive landscape, Ambrx will no longer directly pursue our anti-HER2 antibody-drug conjugate (ADC) asset ARX788 as its lead clinical asset. As such, the company will pause development of Ambrx-sponsored clinical trials involving ARX788. Instead, Ambrx will continue to work collaboratively with NovoCodex and seek a development partner(s) ex-China to progress ARX788; Ambrx highly values its global partners and plans to continue working collaboratively with NovoCodex (ARX788, ARX305), Sino Biopharm (ARX102) and BeiGene (research collaboration); Additional pipeline programs, ARX305 (anti-CD70 ADC) and ARX102 (smart PEG-IL2), will continue in development."

Pipeline update • Breast Cancer • Genito-urinary Cancer • Oncology • Prostate Cancer • Solid Tumor

Ambrx Biopharma Inc. Reports 1H 2022 Financial Results and Provides Corporate Update (Businesswire) - "In July, Ambrx’s partner in China, NovoCodex, announced that it had received drug clinical trial approval notice for ARX305 and intends to initiate a Phase 1 trial in China in the second half of 2022....Sponsored by Quantum Leap, I-SPY 2.2 is an adaptive Phase 2 clinical trial that evaluates emerging targeted agents, allowing those agents to either be combined with less toxic chemotherapeutic regimens or to replace cytotoxic chemotherapy entirely. The first patient was dosed with ARX788 in August 2022."

New P1 trial • Trial status • Breast Cancer • Oncology • Solid Tumor

ARX305, a subsidiary of Zhejiang Medicine (600216.SH), was approved for clinical trials [Google translation] (Zhitong Finance) - "Zhitong Finance APP News, Zhejiang Pharmaceutical (600216.SH) issued an announcement. Recently, Zhejiang Xinma Biopharmaceutical Co., Ltd. (referred to as 'Xinma Bio'), a subsidiary of the company, received the approval issued by the State Drug Administration. The Anti-CD70 Monoclonal Antibody-AS269 Conjugate (ARX305) 'Drug Clinical Trial Approval Notice' approved the clinical trial of this product as a single drug in patients with advanced tumors."

New trial • Oncology • Solid Tumor

"$AMAM Ambrx Biopharma Inc. Announces Submission of IND Application for ARX305 with the U.S. FDA https://t.co/ElNpEGNKdd" (@stock_titan)

Ambrx Biopharma Inc. Announces Submission of IND Application for ARX305 with the U.S. FDA (Businesswire) - "Ambrx Biopharma...announced it received a 'Study May Proceed' letter from the U.S. Food and Drug Administration (FDA) related to an Investigational New Drug (IND) application for ARX305, an antibody drug conjugate (ADC) designed to target CD70 to treat a broad range of solid and hematologic tumors such as renal cell carcinoma....The clinical study cleared by the FDA, ARX305-01, is a first in human, Phase 1, multicenter, open-label, dose-escalation, and dose-expansion study to evaluate the safety, pharmacokinetics and preliminary anti-tumor activity of ARX305 in adults with clear cell renal cell carcinoma who are resistant or refractory to prior standard therapies."

IND • New P1 trial • Genito-urinary Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Solid Tumor • Urothelial Cancer

Ambrx Biopharma Inc. Reports 1H 2021 Financial Results and Provides Corporate Update (Businesswire) - "Anticipated Near-Term Milestones: (i) Additional data from the Phase 1 clinical study of ARX788 (ACE-Breast-01) in patients with HER2+ metastatic breast cancer in 2H 2021; (ii) Submit an Investigational New Drug (IND) application for ARX305 in patients with cancer (renal cell carcinoma (RCC) and other cancers) in 1H 2022."

IND • P1 data • Breast Cancer • Genito-urinary Cancer • HER2 Positive Breast Cancer • Kidney Cancer • Oncology • Renal Cell Carcinoma • Urothelial Cancer

Targeting CD70 with Cusatuzumab Eliminates Acute Myeloid Leukemia Stem Cells in Humans (ASH 2019) - P1/2; "Elderly or unfit AML patients not eligible for intensive chemotherapy are treated in a palliative setting with hypomethylating agents (HMA) or low dose Ara-C, but responses are modest and not durable...The therapeutic potential of targeting CD70-expressing LSCs in presence and absence of HMA was assessed using the anti-CD70 ADCC-optimized monoclonal antibody (mAb), cusatuzumab, and an effector-dead anti-CD70 mAb in colony formation and re-plating assays as well as patient-derived xenograft models (Silence et al, 2014)...In combination with azacitidine, cusatuzumab induced CR/CRi in 10 out of 12 patients...Conclusions Blocking CD70/CD27-signaling and targeting CD70-expressing LSCs by the ADCC-optimized mAb, cusatuzumab, eliminated LSCs in vitro and in xenotransplantation experiments. In a phase 1 study promising activity of cusatuzumab in combination with HMA was observed in AML patients, in which translational data indicate that cusatuzumab selectively eliminates..."

IO biomarker • Acute Myelogenous Leukemia • Hematological Disorders • Hematological Malignancies • Leukemia • CD27 • CD34 • CD38 • CD70 • GS

Novel auristatins with high activity on efflux-positive models and demonstrable bystander activity (AACR 2018) - "...Anti-CD70 ADCs demonstrated high in vivo efficacy in a 786-O xenograft and complete remissions (CRs) in the efflux-positive renal cell carcinoma model. Anti-CD30 ADCs were dosed in a CD30+ and CD30- admixed Karpas/Karpas-35R xenograft model to demonstrate proof-of-concept in vivo bystander activity. In summary, these novel auristatins showed potential across multiple indications as ADC payloads."

Renal Cell Carcinoma

Novel Anti-CD70 Antibody Drug Conjugate for the Treatment of Adult T-Cell Leukemia (ATL). (PubMed, Anticancer Res) - "The anti-CD70 ADC offers some chemotherapeutic potential for the treatment of ATL."

Clinical • Journal • Hematological Malignancies • Leukemia • Oncology • Transplantation