Antibody-drug conjugates

ADC Therapeutics Reports Second Quarter 2021 Financial Results and Provides Business Updates

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Tuesday, August 3, 2021

Biotechnology, FDA, Other Health, Health, General Health, Pharmaceutical, Oncology, Other Science, Research, Science, Clinical trials, Synaffix, Antibody-drug conjugates, Immunology, ZYNLONTA (loncastuximab tesirine-lpyl), ADC Therapeutics, ZYNLONTA (LONCASTUXIMAB TESIRINE-LPYL), ADC THERAPEUTICS

ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today reported financial results for the second quarter ended June 30, 2021 and provided business updates.

Key Points:

ADC Therapeutics SA (NYSE: ADCT), a commercial-stage biotechnology company improving the lives of those affected by cancer with its next-generation, targeted antibody drug conjugates (ADCs) for patients with hematologic malignancies and solid tumors, today reported financial results for the second quarter ended June 30, 2021 and provided business updates.
R&D expenses were $39.5 million for the quarter ended June 30, 2021, compared to $26.0 million for the same quarter in 2020.
During the second quarter of 2021, S&M expenses were $15.2 million, compared to $4.0 million for the same quarter in 2020.
ADC Therapeutics management will host a conference call and live audio webcast to discuss second quarter 2021 financial results and provide a company update today at 8:30 a.m. Eastern Time.

ADC Therapeutics to Host Second Quarter 2021 Financial Results Conference Call on August 3, 2021

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Wednesday, July 28, 2021

Biotechnology, General Health, Health, Oncology, Cancer treatments, Synaffix, Antibody-drug conjugates

A live webcast of the presentation will be available under Events and Presentations in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com .

Key Points:

A live webcast of the presentation will be available under Events and Presentations in the Investors section of the ADC Therapeutics website at ir.adctherapeutics.com .
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs).
The Company is advancing its proprietary PBD-based ADC technology to transform the treatment paradigm for patients with hematologic malignancies and solid tumors.
ADC Therapeutics is based in Lausanne (Biople), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey.

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

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Friday, July 9, 2021

The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.

Key Points:

The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin, said Roger Dansey, M.D., Chief Medical Officer, Seagen.
In clinical trials, 14% of the 680 patients treated with PADCEV developed hyperglycemia; 7% of patients developed Grade 3-4 hyperglycemia.
Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicenter, single-arm, phase 2 trial.

U.S. FDA Grants Regular Approval and Expands Indication for PADCEV® (enfortumab vedotin-ejfv) for Patients with Locally Advanced or Metastatic Urothelial Cancer

Retrieved on:

Friday, July 9, 2021

Clinical medicine, Cancer treatments, Drugs, Breakthrough therapy, Orphan drugs, Cancer immunotherapy, Monoclonal antibodies, Antibody-drug conjugates, Enfortumab vedotin, Transitional cell carcinoma, PD-1 and PD-L1 inhibitors, Atezolizumab

In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.

Key Points:

In 2019, the FDA granted accelerated approval for PADCEV for the treatment of adult patients with locally advanced or metastatic urothelial cancer who have previously received a PD-1/L1 inhibitor and a platinum-containing chemotherapy before (neoadjuvant) or after (adjuvant) surgery, or in a locally advanced or metastatic urothelial cancer setting.
The EV-301 trial compared PADCEV to chemotherapy in adult patients (n=608) with locally advanced or metastatic urothelial cancer who were previously treated with platinum-based chemotherapy and a PD-1/L1 inhibitor.
"PADCEV is the first and only FDA-approved therapy for patients with locally advanced or metastatic urothelial cancer who have received immunotherapy and cannot receive cisplatin," said Roger Dansey, M.D., Chief Medical Officer, Seagen.
Enfortumab vedotin after PD-1 or PD-L1 inhibitors in cisplatin-ineligible patients with advanced urothelial carcinoma (EV-201): a multicenter, single-arm, phase 2 trial.

DESTINY-Gastric04 Head-to-Head Phase 3 Trial of ENHERTU® Initiated in Patients with HER2 Positive Advanced Gastric Cancer

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Thursday, July 8, 2021

Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.

Key Points:

Locally advanced or metastatic HER2-positive gastric or gastroesophageal junction adenocarcinoma who have received a prior trastuzumab-based regimen.
In clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer treated with ENHERTU 5.4 mg/kg, ILD occurred in 9% of patients.
In DESTINY-Gastric01, of the 125 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma treated with ENHERTU 6.4 mg/kg, ILD occurred in 10% of patients.
The safety of ENHERTU was evaluated in 187 patients with locally advanced or metastatic HER2-positive gastric or GEJ adenocarcinoma in DESTINY-Gastric01.

SNDX-5613 Granted FDA Fast Track Designation for the Treatment of Relapsed/Refractory Acute Leukemias

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Monday, June 28, 2021

Leukemia, NPM1, Cancer, Clinical medicine, Acute myeloid leukemia, Antibody-drug conjugates, Branches of biology, Milatuzumab

In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit.

Key Points:

In preclinical models of MLLr acute leukemias, SNDX-5613 demonstrated robust, dose-dependent inhibition of tumor growth, resulting in a marked survival benefit.
SNDX-5613 is currently being evaluated in the Company's AUGMENT-101 Phase 1/2 open-label clinical trial for the treatment of relapsed/refractory (R/R) acute leukemias.
SNDX-5613 was granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of patients with AML, and Fast Track designation for the treatment of adult and pediatric patients with relapsed or refractory acute leukemias harboring a mixed lineage leukemia rearranged MLLr or NPM1 mutation.
MLLr leukemias, which are routinely diagnosed through currently available cytogenetic or molecular diagnostic techniques, occur in approximately 80% of infant acute leukemias and up to 10% of all acute leukemias.

ADC Therapeutics Announces Encouraging Interim Results from Pivotal Phase 2 Clinical Trial of Camidanlumab Tesirine (Cami) Presented at the 16th Annual International Conference on Malignant Lymphoma

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Tuesday, June 22, 2021

The pivotal Phase 2 study is intended to support the submission of a Biologics License Application.

Key Points:

The pivotal Phase 2 study is intended to support the submission of a Biologics License Application.
We also note that the incidence of GBS in Phase 2 is consistent with Phase 1.
We look forward to providing future updates on this pivotal program as the overall response rate and duration of response data continue to mature.
Cami (camidanlumab tesirine) is being evaluated in a late-stage clinical trial for relapsed or refractory Hodgkin lymphoma and in a Phase 1b clinical trial for various advanced solid tumors.

ADC Therapeutics Presents Updated ZYNLONTA™ (loncastuximab tesirine-lpyl) Clinical Data at 16th Annual International Conference on Malignant Lymphoma

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Friday, June 18, 2021

ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, announced today that posters on four ZYNLONTA (loncastuximab tesirine-lpyl) clinical trials were presented at the 16th Annual International Conference on Malignant Lymphoma (ICML).

Key Points:

ADC Therapeutics SA (NYSE:ADCT), a commercial-stage biotechnology company leading the development of novel antibody drug conjugates (ADCs) to treat hematological malignancies and solid tumors, announced today that posters on four ZYNLONTA (loncastuximab tesirine-lpyl) clinical trials were presented at the 16th Annual International Conference on Malignant Lymphoma (ICML).
As of the data cut-off date of March 1, 2021, all patients had completed treatment.
ADC Therapeutics CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
ADC Therapeutics is based in Lausanne (Biople), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey.

Debiopharm and Ubix Therapeutics Launch Research to Develop a New Anti-Cancer Modality - Antibody Degraducer® Conjugates

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Wednesday, June 16, 2021

Clinical medicine, Cancer treatments, Medical specialties, Immunology, Antibody-drug conjugates, Monoclonal antibodies, Antibody, Glycoproteins, Biotechnology, Antibody-drug conjugate, Antibody-oligonucleotide conjugate

The two companies are aiming to develop a new drug modality known as Antibody DegraducerConjugates (ADeC), by combining one of Ubix's Degraducer molecule, with Debiopharm's antibody drug conjugate linker Multilink.

Key Points:

The two companies are aiming to develop a new drug modality known as Antibody DegraducerConjugates (ADeC), by combining one of Ubix's Degraducer molecule, with Debiopharm's antibody drug conjugate linker Multilink.
Multilink is a new cleavable linker platform that allows the loading of multiple drug payloads on an antibody.
Combining these advanced biotechnology solutions offers the unique opportunity to produce new types of antibody conjugates with dual molecular targeting.
These antibody Degraducerconjugates could extend the range of therapeutic antibody conjugates available for the treatment of various cancers.

ADC Therapeutics Announces Presentations at the 16th Annual International Conference on Malignant Lymphoma

Retrieved on:

Wednesday, June 9, 2021

Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.

Key Points:

Once bound to a CD19-expressing cell, ZYNLONTA is internalized by the cell, where enzymes release a pyrrolobenzodiazepine (PBD) payload.
ADC Therapeutics (NYSE: ADCT) is a commercial-stage biotechnology company improving the lives of cancer patients with its next-generation, targeted antibody drug conjugates (ADCs).
ADC Therapeutics CD19-directed ADC ZYNLONTA (loncastuximab tesirine-lpyl) is approved by the FDA for the treatment of relapsed or refractory diffuse large B-cell lymphoma after two or more lines of systemic therapy.
ADC Therapeutics is based in Lausanne (Biople), Switzerland and has operations in London, the San Francisco Bay Area and New Jersey.