Cancer treatments

Advaxis Reports Second Quarter Ended April 30, 2021 Financial Results and Provides a Business Update

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Monday, June 14, 2021

Cancer treatments, Clinical medicine, Drugs, Bayer, Kenilworth, New Jersey, Merck & Co., Schering-Plough, Cancer immunotherapy, Pembrolizumab, Merck, Fiscal year, NASDAQ

PRINCETON, N.J., June 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announces its financial results for the second quarter ended April 30, 2021 and provides a business update.

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PRINCETON, N.J., June 14, 2021 (GLOBE NEWSWIRE) -- Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products today announces its financial results for the second quarter ended April 30, 2021 and provides a business update.
Second Quarter Ended April 30, 2021 Financial Results
Research and development expenses for the second quarter of fiscal year 2021 were$4.34 million, compared with$3.92 for the second quarter of fiscal year 2020.
General and administrative expenses for the three months ended April 30, 2021 were at $3.35 million, compared to$2.65 millionin the same three-month period in fiscal 2020.
KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, N.J., USA.

Model Suggests Surgery Should Come Before Chemotherapy for Select Patients with Aggressive Ovarian Cancer

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Monday, June 14, 2021

Medicine, Clinical medicine, Cancer, Oncology, Gynaecology, Cancer treatments, Gynaecological cancer, Ovarian cancer, Chemotherapy, Debulking, Malignancy, Hyperthermic intraperitoneal chemotherapy

Ovarian cancer is the 8th most common cancer and cancer death in women worldwide, and HGSC constitutes roughly 70 percent of ovarian malignancies and has the worst prognosis.

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Ovarian cancer is the 8th most common cancer and cancer death in women worldwide, and HGSC constitutes roughly 70 percent of ovarian malignancies and has the worst prognosis.
Patients with the condition typically undergo surgery and chemotherapy, but there has been long-standing controversy over the best order of treatment.
The researchers found that in patients who are well enough for surgery, debulking provides better results because it has the best chance of removing cancer cells resistant to chemotherapy.
For patients who are too ill for debulking surgery, the study suggests that a shorter period of initial chemotherapy, rather than the currently recommended interval, might provide a greater benefit.

Istari Oncology Announces FDA Granted Fast Track Designation to PVSRIPO for the Treatment of Advanced Melanoma

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Monday, June 14, 2021

In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.

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In addition to Fast Track designation, FDA granted Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma earlier this year.
Treatment-resistant, advanced melanoma patients have very poor survival rates, with less than 30% of metastatic melanoma patients surviving 5 years1.
Fast Track is an FDA program designed to facilitate the expedited development of drugs to treat serious conditions and address an unmet medical need.
We are thrilled with FDAs decision to grant both Fast Track and Orphan Drug Designation to PVSRIPO for the treatment of advanced melanoma, said Matt Stober, President and Chief Executive Officer at Istari Oncology.

DESTINY-Breast09 Head-to-Head First-Line Phase 3 Trial of ENHERTU® Initiated in Patients with HER2 Positive Metastatic Breast Cancer

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Monday, June 14, 2021

This is the first trial to evaluate ENHERTU in the first-line metastatic setting in patients with HER2 positive breast cancer.

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This is the first trial to evaluate ENHERTU in the first-line metastatic setting in patients with HER2 positive breast cancer.
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 clinical studies, of the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU 5.4mg/kg, a decrease in neutrophil count was reported in 62% of patients.
In the 234 patients with unresectable or metastatic HER2-positive breast cancer who received ENHERTU, two cases (0.9%) of asymptomatic LVEF decrease were reported.

Exelixis Announces Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Evaluate XL092 in Combination with Immuno-oncology Therapies in Advanced Solid Tumors

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Monday, June 14, 2021

Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.

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Exelixis, Inc. (Nasdaq: EXEL) today announced a clinical trial collaboration and supply agreement with Bristol-Myers Squibb Company (NYSE: BMY) for STELLAR-002, a new phase 1b trial evaluating XL092 in combination with immuno-oncology therapies in advanced solid tumors.
Exelixis is sponsoring STELLAR-002 and Bristol Myers Squibb will provide nivolumab, ipilimumab and bempegaldesleukin for use in the trial.
STELLAR-002 will begin with a dose-escalation phase to determine the recommend dose for each of the XL092 combination therapies: XL092 in combination with nivolumab, XL092 in combination with nivolumab and ipilimumab and XL092 in combination with nivolumab and bempegaldesleukin.
XL092 is the first internally discovered Exelixis compound to enter the clinic following the companys reinitiation of drug discovery activities.

ALX Oncology Announces Update on ASPEN-03 and ASPEN-04, the ALX148 Phase 2 Head and Neck Cancer Studies

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Monday, June 14, 2021

Cancer treatments, Clinical medicine, Medicine, Cancer immunotherapy, Immune system, Antineoplastic drugs, Breakthrough therapy, Orphan drugs, Pembrolizumab, Checkpoint inhibitor, Myelodysplastic syndrome, Oncology

The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study.

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The two randomized Phase 2 studies, ASPEN-03 and ASPEN-04, are potentially registrational with patient enrollment unimpacted in either study.
ALX Oncology is advancing ALX148 into two randomized Phase 2 studies in subjects with HNSCC in combination with pembrolizumab, marketed as KEYTRUDA, the market leading anti-programmed cell death protein-1, or PD-1, checkpoint inhibitor, with or without chemotherapy.
ALX Oncology intends to continue clinical development of ALX148 for the treatment of multiple solid tumor indications and hematologic malignances, including AML and myelodysplastic syndromes (MDS).
Except to the extent required by law, ALX Oncology undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

TILT Biotherapeutics Submits IND for Phase I Trial of Immunotherapeutic TILT-123 in Ovarian Cancer

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Monday, June 14, 2021

Biotechnology, Health, Pharmaceutical, Clinical trials, Oncology, Cancer treatments, Clinical medicine, Medicine, Virotherapy, Biotechnology, Experimental cancer treatments, Cancer immunotherapy, Adenoviridae, Pembrolizumab, Oncolytic adenovirus, Oncolytic virus, Akseli Hemminki

TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, today announces that it has submitted an IND for its Phase I trial of immunotherapeutic TILT-123 in ovarian cancer.

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TILT Biotherapeutics, a clinical-stage biotechnology company developing cancer immunotherapeutics, today announces that it has submitted an IND for its Phase I trial of immunotherapeutic TILT-123 in ovarian cancer.
The trial will evaluate the companys adenoviral cancer immunotherapy TILT-123, a double cytokine armed oncolytic adenovirus, in combination with KEYTRUDA (pembrolizumab), MSDs anti-PD-1 therapy, in a dose escalation trial in platinum resistant or refractory ovarian cancer patients.
During the first month of the trial, patients will receive TILT-123 monotherapy, and thereafter TILT-123 in conjunction with pembrolizumab.
TILT Biotherapeutics also announces changes to the board of directors, with Jyrki Liljeroos, formerly a board advisor, appointed as Chairman.

Longer-term Data for Kite’s Yescarta® in Relapsed or Refractory Follicular Lymphoma Demonstrate Substantial Survival Improvement Over Current Therapies in Comparative Analysis

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Saturday, June 12, 2021

We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.

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We are very encouraged by these data that suggest a significant and sustained survival benefit with Yescarta even after multiple rounds of prior treatment.
In an indolent disease like follicular lymphoma, longer-term data that demonstrate durable responses are critical.
The continued durable benefit demonstrated by axicabtagene ciloleucel at nearly two years is exciting, and the substantial survival benefit over current therapies that were seeing in the SCHOLAR-5 analysis is encouraging.
Adult patients with relapsed or refractory follicular lymphoma (FL) after two or more lines of systemic therapy.

eFFECTOR Therapeutics Doses First Patient in Phase 2b KICKSTART Clinical Trial

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Wednesday, June 9, 2021

Cancer treatments, Drugs, Clinical medicine, Orphan drugs, Breakthrough therapy, Lung cancer, Cancer immunotherapy, Pembrolizumab, Placebo-controlled study, Non-small-cell lung carcinoma, Atezolizumab

The KICKSTART trial is designed to enroll approximately 120 participants in two cohorts.

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The KICKSTART trial is designed to enroll approximately 120 participants in two cohorts.
Tomivosertib is being evaluated in KICKSTART, eFFECTORs randomized, double-blind, placebo-controlled Phase 2b study in NSCLC in combination with pembrolizumab.
Tomivosertib, eFFECTORs MNK1/2 inhibitor, is being evaluated in KICKSTART, a randomized, double-blind, placebo-controlled Phase 2b trial in NSCLC in combination with pembrolizumab.
Neither LWAC nor eFFECTOR gives any assurance that either LWAC or eFFECTOR or the combined company will achieve its expectations.

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

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Wednesday, June 9, 2021

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

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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.