CLDN6

Xencor Reports Fourth Quarter and Full Year 2023 Financial Results

Retrieved on: 
Tuesday, February 27, 2024

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  

Retrieved on: 
Thursday, February 8, 2024

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 

Retrieved on: 
Thursday, February 8, 2024

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

Retrieved on: 
Sunday, February 4, 2024

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

Retrieved on: 
Tuesday, January 9, 2024

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

Retrieved on: 
Thursday, November 9, 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.

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

Retrieved on: 
Tuesday, November 7, 2023

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

Retrieved on: 
Tuesday, October 31, 2023

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.

Xencor Presents Preclinical Data from Multiple XmAb® Research Programs at the SITC Annual Meeting

Retrieved on: 
Friday, November 3, 2023

We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”

Key Points: 
  • We are also developing additional CD3 and CD28 T cell engaging bispecific antibodies against solid tumor targets.”
    Posters will be available in the poster hall and virtually to registrants of the SITC Annual Meeting.
  • In the poster hall, odd-numbered posters will be displayed on Friday, November 3, and even-numbered posters will be displayed on Saturday, November 4.
  • Xencor’s posters will be archived under "Events & Presentations" in the Investors section of the Company's website located at www.xencor.com .
  • To enhance the anti-tumor activity, Xencor engineered multi-specific NK cell-engaging antibodies that simultaneously target MICA/B antigens and an orthogonal activating receptor on NK cells, NKp46.

BioNTech Presents Positive Phase 1/2 Data Update for CAR-T Cell Therapy Candidate BNT211 in Advanced Solid Tumors at ESMO Congress 2023

Retrieved on: 
Monday, October 23, 2023

The data show encouraging signs of clinical activity and an increased persistence of cancer-specific CAR-T cells when combined with CARVac.

Key Points: 
  • The data show encouraging signs of clinical activity and an increased persistence of cancer-specific CAR-T cells when combined with CARVac.
  • “Our goal is to unlock the potential of CAR-T for solid tumors and to help improve the outcomes for a broad range of hard-to-treat tumors,” said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech.
  • “BNT211 aims to address two of the key limitations of CAR-T cell approaches in solid tumors, namely the lack of suitable cancer-specific cell surface targets and the limited persistence of CAR-T cells.
  • Patients with germ cell tumors (n=16), ovarian cancer (n=17) and other solid tumor types (n=11) were treated.