On Wednesday, Shares of Bristol-Myers Squibb Co (NYSE:BMY), gained 1.00% to $68.99.
Seattle Genetics, Inc. (Nasdaq:SGEN) and Bristol-Myers Squibb (BMY), declared that the companies have initiated a phase 1/2 clinical trial of ADCETRIS (brentuximab vedotin) in combination with Opdivo (nivolumab) for patients with CD30-expressing relapsed or refractory B-cell and T-cell non-Hodgkin lymphomas (NHL), counting diffuse large B-cell lymphoma (DLBCL), peripheral T-cell lymphoma (PTCL) and cutaneous T-cell lymphoma (CTCL). This is the second of two trials being conducted under a formerly declared clinical trial partnershipagreement between Bristol-Myers Squibb Company and Seattle Genetics. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, a marker expressed on Hodgkin lymphoma (HL) and several types of NHL, which combines the targeting ability of a monoclonal antibody with a highly potent cell-killing agent. Recent preclinical data suggest that ADCETRIS causes immunogenic cell death of tumor cells, providing rationale for combination with Opdivo, a human antibody that targets and inhibits the programmed death receptor-1 (PD-1), resulting in T-cell activation. Opdivo is part of a new class of cancer immunotherapy treatments known as checkpoint inhibitors, which are designed to harness the body’s own immune system in fighting cancer by targeting distinct regulatory components of the immune system.
“This is the second corporate-sponsored clinical trial to evaluate ADCETRIS combined with a checkpoint inhibitor to determine if the combination can improve patient outcomes,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “This study is a part of a broad development program that comprises more than 70 ongoing clinical trials evaluating ADCETRIS in multiple lines of therapy for Hodgkin and non-Hodgkin lymphoma and as part of novel combinations that could result in improved clinical benefit with manageable safety profiles. Our aim is to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas.”
The phase 1/2 open-label, multi-center, clinical trial is designed to evaluate the safety, tolerability and antitumor activity of ADCETRIS in combination with Opdivo in patients with relapsed or refractory CD30-expressing NHL. The study will comprise of a phase 1 dose evaluation portion followed by a single-arm phase 2 portion that will expand enrollment to treat disease-specific cohorts with relapsed or refractory DLBCL, PTCL or CTCL at the recommended dose level and treatment plan. The primary endpoints are safety, tolerability and objective response rate of the combination of ADCETRIS with Opdivo. The secondary endpoints comprise duration of response, complete response rate with the combination regimen, duration of complete response, progression-free survival and overall survival. The trial is being conducted at multiple centers in the United States, Canada and Europe and is designed to enroll about 120 patients.
Bristol-Myers Squibb Company discovers, develops, licenses, manufactures, markets, distributes, and sells biopharmaceutical products worldwide. It provides chemically-synthesized drugs or small molecules, and biologics in various therapeutic areas, counting virology comprising human immunodeficiency virus infection (HIV); oncology; neuroscience; immunoscience; and cardiovascular.
Shares of Merrimack Pharmaceuticals Inc (NASDAQ:MACK), inclined 3.41% to $7.88, during its last trading session.
Merrimack Pharmaceuticals, declared it filed an amendment to its ongoing Phase 2 clinical study of MM-121 (seribantumab) in patients with heregulin-positive non-small cell lung cancer (NSCLC) with the U.S. Food and Drug Administration (FDA). The amendment comprises a change in primary endpoint to overall survival to enable a potential registration opportunity for MM-121.
“We believe MM-121 has the potential to address the pervasive clinical problem of resistance in cancer. This amendment is intended to accelerate development of this new treatment option for heregulin-positive non-small cell lung cancer patients who are resistant to standard-of-care therapies,” said Robert Mulroy, Merrimack’s President and CEO. “The financing we declared recently will allow us to independently advance and retain sole ownership of MM-121. In light of this amendment, we are focusing the development of MM-121 on this indication.”
MM-121 is a fully human monoclonal antibody targeting ErbB3. The ongoing clinical study in NSCLC is an open-label, biomarker–selected randomized study of MM-121 in combination with docetaxel or pemetrexed contrast to docetaxel or pemetrexed alone, in patients with heregulin-positive, locally advanced or metastatic NSCLC. Three prior Phase 2 clinical studies demonstrated that a subset of biomarker positive patients treated with MM-121 had a statically noteworthy reduction in the risk of progression, with hazard ratios in a range of 0.26 – 0.37.
Merrimack Pharmaceuticals, Inc., a biopharmaceutical company, engages in discovering, developing, and preparing to commercialize medicines paired with companion diagnostics for the treatment of cancer primarily in the United States. Its therapeutic oncology candidates in clinical development comprise MM-398, a nanotherapeutic encapsulation of the chemotherapy drug irinotecan, which is has accomplished Phase III clinical trials for the treatment of patients with metastatic pancreatic cancer whose cancer had progressed on treatment with the chemotherapy drug gemcitabine; in a Phase I clinical trial as a monotherapy in patients with glioma and in combination with cyclophosphamide in patients with pediatric solid tumors; and in a Phase 1 translational clinical trial designed to identify predictive biomarkers associated with MM-398.
Finally, Northwest Biotherapeutics, Inc (NASDAQ:NWBO), ended its last trade with -18.88% loss, and closed at $3.61.
Northwest Biotherapeutics (NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, declared that it has reached definitive agreements with healthcare focused institutional investors for a registered direct offering with gross proceeds of $12.6 million. In the offering, the Company is selling an aggregate of 3.5 million shares of common stock at a purchase price of $3.60 per share. The investors will also receive warrants to purchase up to 1.75 million shares of common stock with an exercise price of $4.50 per share. The warrants will become exercisable on the 6-month anniversary of issuance, and will have an exercise period of 5 years following the initial exercise date. The placement is predictable to close on or about December 29, 2015, subject to satisfaction of customary closing conditions.
Northwest Biotherapeutics, Inc., a biotechnology company, discovers and develops immunotherapy products to treat cancer in the United States and internationally. It is involved in the development of DCVax, a platform technology that uses activated dendritic cells to mobilize a patient’s own immune system to attack cancer.
DISCLAIMER:
This article is published by www.wsnewspublishers.com. The Content included in this article is just for informational purposes only. All information used in this article is believed to be from reliable sources, but we make no representations or warranties of any kind, express or implied, about the completeness, accuracy, or reliability with respect to this article.
All visitors are advised to conduct their own independent research into individual stocks before making a purchase decision.
Information contained in this article contains forward-looking information within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, counting statements regarding the predictable continual growth of the market for the corporation’s products, the corporation’s ability to fund its capital requirement in the near term and in the long term; pricing pressures; etc.
Any statements that express or involve discussions with respect to predictions, expectations, beliefs, plans, projections, objectives, aims, assumptions, or future events or performance may be forward looking statements. Forward-looking statements are based on expectations, estimates, and projections at the time the statements are made that involve a number of risks and uncertainties, which could cause actual results or events to differ materially from those presently anticipated. Forward looking statements may be identified with such words as expects, will, anticipates, estimates, believes, or by statements indicating certain actions may, could, should/might occur.
