CLDN6

Context Therapeutics Submits IND Application to Evaluate CTIM-76 in Claudin 6-Positive Cancers

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星期一, 四月 1, 2024
Drug discovery, Cancer, Patient, CLDN6, Trial of the century, IND, Toxicology, Context, Physician, Food, Pharmaceutical industry

The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with Claudin 6 (CLDN6)-positive gynecologic and testicular cancers.

Key Points: 
  • The IND supports the initiation of a Phase 1 dose escalation and expansion clinical trial of CTIM-76 in patients with Claudin 6 (CLDN6)-positive gynecologic and testicular cancers.
  • “Our IND submission for CTIM-76 is a significant milestone for Context,” said Martin Lehr, CEO of Context.
  • The IND application includes extensive manufacturing, preclinical, and toxicology data to support a first-in-human trial.
  • I am incredibly proud of the entire Context team who worked tirelessly to complete this IND submission.

Context Therapeutics Reports Full Year 2023 Operating and Financial Results

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星期四, 三月 21, 2024
Research, Conference, Cancer, Immunotherapy, New Drug Application, Integral, CLDN6, Insurance, Society, Trial of the century, IND, CD3, SITC, Context, Annual general meeting, Food

PHILADELPHIA, March 21, 2024 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the year ended December 31, 2023, and reported on recent and upcoming business highlights.

Key Points: 
  • “During the fourth quarter of 2023, Context continued to advance our lead clinical candidate, CTIM-76, a Claudin 6 ("CLDN6”) x CD3 bispecific antibody, toward a first-in-human clinical study.
  • The preclinical data further support CTIM-76’s differentiated product profile, including its potential to address limitations of first-generation CLDN6-targeted clinical-stage therapies,” said Martin Lehr, CEO of Context.
  • In November 2023, Context presented preclinical data at the SITC 38th Annual Meeting that demonstrated CTIM-76 was well tolerated and induced dose-proportional tumor regressions in xenograft models of CLDN6-positive cancer.
  • Context reported a net loss of $24.0 million for 2023, as compared to $14.8 million for the same period in 2022.

Xencor Reports Fourth Quarter and Full Year 2023 Financial Results

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星期二, 二月 27, 2024
Biotechnology, Pharmaceutical, Health, Oncology, CD20, NSCLC, Cancer, J&J, Immune system, Alanine transaminase, Autoimmune disease, Research, ENPP3, Investment, ALT, PSMA, Cell, Antibody, Autoimmune hepatitis, Safety, Telephone, Vir, Lymphoid leukemia, Rash, Patient, PSA, RECIST, CLDN6, Diagnosis, Prostate-specific antigen, G&A, Workforce, CD28, Prostate cancer, Pharmaceutical industry

Both programs entered Phase 1 clinical development during the fourth quarter of 2023, and Xencor received $20 million in development milestones.

Key Points: 
  • Both programs entered Phase 1 clinical development during the fourth quarter of 2023, and Xencor received $20 million in development milestones.
  • In the fourth quarter of 2023, Xencor completed enrollment in subcutaneous dose-escalation cohorts of a Phase 1 study evaluating plamotamab.
  • Financial Results for the Fourth Quarter and Full Year Ended December 31, 2023
    Cash, cash equivalents, and marketable debt securities totaled $697.4 million as of December 31, 2023, compared to $584.5 million on December 31, 2022.
  • Total revenue for the fourth quarter ended December 31, 2023 was $44.7 million compared to $21.6 million for the same period in 2022.

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs  

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星期四, 二月 8, 2024
Acute leukemia, Therapy, BNTX, Patient, BioNTech, Entrepreneurship, CLDN6, American depositary receipt, Cooley LLP, Cancer, LLP, Pharmaceutical industry

In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

Key Points: 
  • In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.
  • “The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way.
  • "Furthermore, this collaboration grants us access to Autolus' precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."
  • “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, Chief Executive Officer of Autolus.

BioNTech and Autolus Announce Strategic CAR-T Cell Therapy Collaboration to Advance Pipeline and Expand Late-Stage Programs 

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星期四, 二月 8, 2024
Acute leukemia, Therapy, BNTX, Patient, BioNTech, Entrepreneurship, CLDN6, American depositary receipt, Cancer, Pharmaceutical industry

In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.

Key Points: 
  • In connection with the strategic collaboration, the companies entered into a license and option agreement and a securities purchase agreement.
  • “The collaboration with Autolus enables us to expand our BNT211 program into trials for multiple cancer indications in a cost-efficient way.
  • “Furthermore, this collaboration grants us access to Autolus' precise cell targeting tools to further support BioNTech’s development of in vivo cell therapy and antibody-drug conjugate candidates."
  • “We see a remarkable opportunity to leverage our core capabilities, accelerate pipeline programs, realize cost-efficiencies and expand opportunities beyond autologous cell therapies,” said Dr. Christian Itin, CEO of Autolus.

Orphan designation: Humanised IgG1 monoclonal antibody against CLDN6 conjugated to monomethyl auristatin E via a cathepsin hydrolysable dipeptide VC linker Treatment of ovarian cancer, 08/11/2023 Positive

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星期日, 二月 4, 2024
Immunoglobulin G, COMP, IRIS, EMA, European Commission, Patient, Ovarian cancer, CLDN6, Committee, Pharmaceutical industry

Key facts

Key Points: 
  • Key facts
    - Active substance
    - Humanised IgG1 monoclonal antibody against CLDN6 conjugated to monomethyl auristatin E via a cathepsin hydrolysable dipeptide VC linker
    - Intended use
    - Treatment of ovarian cancer
    - Orphan designation status
    - Positive
    - EU designation number
    - EU/3/23/2854
    - Date of designation
    - Sponsor
    Insight Drug Regulatory
    Patients' organisations
    For contact details of patients’ organisations whose activities are targeted at rare diseases, see:
    European Organisation for Rare Diseases (EURORDIS), a non-governmental alliance of patient organisations and individuals active in the field of rare diseases.
  • EU register of orphan medicines
    The list of medicines that have received an orphan designation in the EU is available on the European Commission's website:
    EMA list of opinions on orphan medicinal product designation
    EMA publishes information on orphan medicinal product designation adopted by the Committee for Orphan Medicinal Products (COMP) on the IRIS online platform:

BioNTech Outlines 2024 Strategic Priorities at the 42nd Annual J.P. Morgan Healthcare Conference

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星期二, 一月 9, 2024
Entrepreneurship, Roche, Influenza, Patient, CD40, Pfizer–BioNTech COVID-19 vaccine, ADC, RNA, Science, Pfizer, Drug discovery, BioNTech, PD-L1, BNTX, NSCLC, Infection, Investment, Food, Conference, COVID-19, Safety, Lung cancer, FDA, Webcast, Cancer, Investigational New Drug, Messenger, CLDN6, Pharmaceutical industry

Ended 2023 with approximately €17.5 billion (unaudited) in cash, cash equivalents and security investments

Key Points: 
  • Ended 2023 with approximately €17.5 billion (unaudited) in cash, cash equivalents and security investments
    Presentation and webcast at the 42nd Annual J.P. Morgan Healthcare Conference on Tuesday, January 9, 2024, at 6:00 p.m. CET/ 12:00 p.m.
  • ET
    Mainz, Germany, January 9, 2024 (GLOBE NEWSWIRE) -- BioNTech SE (Nasdaq: BNTX, “BioNTech” or “the Company”) provided its full year 2024 revenue guidance as part of its outlined 2024 strategic priorities today at the 42nd Annual J.P. Morgan Healthcare Conference in San Francisco, California.
  • The replay of the webcast will be archived on the Company’s website for 30 days following the conference.
  • BioNTech plans to initiate a pivotal Phase 2 trial in relapsed/refractory germ cell tumors in 2024.

Context Therapeutics Reports Third Quarter 2023 Operating and Financial Results

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星期四, 十一月 9, 2023
Annual general meeting, Food, IND, Insurance, CLDN6, Research, Immunotherapy, New Drug Application, Conference, Trial of the century, SITC, Toxicity, Context, Society, CD3, Cryptocurrency, Pharmaceutical industry, Vaccine

PHILADELPHIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the third quarter ended September 30, 2023, and reported on recent and upcoming business highlights.

Key Points: 
  • Cash and cash equivalents of $21.7 million as of September 30, 2023
    PHILADELPHIA, Nov. 09, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced its financial results for the third quarter ended September 30, 2023, and reported on recent and upcoming business highlights.
  • Research and development (“R&D”) expenses were $4.5 million for the third quarter 2023, as compared to $2.1 million for the same period in 2022.
  • General and administrative expenses were $1.7 million for the third quarter 2023, as compared to $2.0 million for the same period in 2022.
  • Context reported a net loss of $5.9 million for the third quarter 2023, as compared to $3.9 million for the same period in 2022.

Xencor Reports Third Quarter 2023 Financial Results

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星期二, 十一月 7, 2023
Oncology, Health, Clinical Trials, Research, Science, Pharmaceutical, Biotechnology, CLDN3, Ovarian cancer, CD28, Telephone, STEAP1, OMERS, CLDN4, Sale, Vir, ESMO, Amgen, Cytokine, Gilead Sciences, Antibody, Part, Safety, Cancer, Investment, Patient, Congress, G&A, Prostate cancer, CTA, ENPP3, CLDN6, Liver disease, Genentech, European Society for Medical Oncology, CLDN9, Tafasitamab, IND, CD3, Colorectal cancer, R, Environment, Ravulizumab, Lung cancer, PARP, Vaccine, Pharmaceutical industry, Medical imaging, Rare-earth element, Cryptocurrency, Omeros, Janssen, MorphoSys, Alexion, Astellas Pharma

Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a review of recent business and clinical highlights.

Key Points: 
  • Xencor, Inc. (NASDAQ:XNCR), a clinical-stage biopharmaceutical company developing engineered antibodies and cytokines for the treatment of patients with cancer and autoimmune diseases, today reported financial results for the third quarter ended September 30, 2023 and provided a review of recent business and clinical highlights.
  • Total revenue for the third quarter ended September 30, 2023 was $59.2 million, compared to $27.3 million for the same period in 2022.
  • Decreased net loss in the third quarter of 2023 compared to 2022 is primarily due to additional income earned.
  • ET (1:30 p.m. PT) to discuss the third quarter 2023 financial results and provide a corporate update.

Context Therapeutics Announces Preclinical Data Demonstrating Differentiated and Active Profile of its Claudin 6-Targeted Bispecific Antibody CTIM-76

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星期二, 十月 31, 2023
IND, CD3, Lehr, Context, CLDN6, SITC, Immunotherapy, Annual general meeting, Benchmarking, Path integral molecular dynamics, Society, Patient, Drug discovery, Toxicity, Abstract, Fine chemical, Pharmaceutical industry

PHILADELPHIA, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced encouraging preclinical data regarding the Company’s preclinical asset, CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.

Key Points: 
  • PHILADELPHIA, Oct. 31, 2023 (GLOBE NEWSWIRE) -- Context Therapeutics Inc. (“Context” or the “Company”) (Nasdaq: CNTX), a biopharmaceutical company advancing medicines for solid tumors, today announced encouraging preclinical data regarding the Company’s preclinical asset, CTIM-76, a Claudin 6 (CLDN6) x CD3 T-cell engaging bispecific antibody.
  • Findings from Context’s research team, in conjunction with development partner Integral Molecular, illustrate the potential of CTIM-76 to treat CLDN6-positive tumors.
  • Notably:
    CTIM-76 was shown to have high potency and target selectivity in both binding and cytotoxicity assays.
  • “The preclinical data at this year's SITC meeting will illustrate the potential of CTIM-76 to target CLDN6,” said Lehr.