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ADAP Down 46% This Month, CLVS Abuzz, ADRO Awaits Data In Nov.


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(RTTNews.com) - The following are some of the pharma/biotech stocks that posted the biggest percentage decline today.

1. Adaptimmune Therapeutics plc ( ADAP )

Adaptimmune is a clinical-stage biopharmaceutical company developing novel cancer immunotherapy products.

Lost 29.83% to close Monday's (Oct.22) trading at 7.55.

Pipeline:

The Company is developing engineered T cell therapies like MAGE-A10, MAGE-A4, AFP and NY-ESO.

-- The MAGE-A4 SPEAR T-cell therapy is under a phase I, open label, dose escalation study in certain patients with urothelial (bladder) cancers, melanoma, head and neck cancer, ovarian cancer, NSCLC, esophageal cancer and gastric cancers. -- The MAGE-A10 TCR therapy is under phase I testing in certain patients with lung cancer, bladder, melanoma and head and neck cancers. -- The AFP SPEAR T-cell therapy is under a phase I study in patients with hepatocellular carcinoma.

News: On October 20, the Company presented initial data from the first two cohorts of the ongoing studies with its MAGE-A10 and MAGE-A4 SPEAR T-cells.

The preliminary data support continued investigation of MAGE-A4 and MAGE-A10 SPEAR T-cells in the respective study populations, according to the Company.

2. Aduro BioTech Inc. (ADRO)

Aduro is an immunotherapy company focused on developing therapies that are intended to transform the treatment of challenging diseases. Its product candidates are based on STING (stimulator of interferon genes) Pathway Activators and B-select monoclonal antibody technologies.

Lost 29.46% to close Monday's trading at $4.43.

News: Aduro shares took a hit in response to clinical trial news of Merck & Co's (MRK) STING agonist MK-1454.

According to preliminary results, in a phase I trial, Merck's MK-1454 as a monotherapy was unable to elicit any complete or partial responses when administered to patients with advanced solid tumors or lymphomas. However, MK-1454 when used in combination with Merck's Keytruda, achieved partial responses of 24%, and median reductions of 83 percent in the size of both target-injected and non-injected tumors.

Aduro's ADU-S100 (MIW815), an intratumoral STING agonist, is in phase I trial in patients with advanced solid tumors or lymphomas. Preliminary clinical data from this trial are expected to be reported on November 9, 2018.

3. Anixa Biosciences Inc. (ANIX)

Anixia, formerly known as ITUS Corp., is a biotechnology company focused on using the body's immune system to fight cancer.

Lost 28.24% to close Monday's trading at $4.32.

News: The Company announced that it has completed a pre-IND (Investigational New Drug) meeting with the FDA for a novel CAR-T therapy to address ovarian cancer. Assuming the FDA approves the IND, the Company anticipates beginning the trial as early as the summer of 2019.

Recent event:

On October 15, the Company filed an IVD pre-submission with the FDA for use of its Cchek artificial intelligence based cancer detection technology, as a prostate cancer test.

A face-to-face meeting with the FDA has been sought by the Company to discuss the agency's feedback on the proposed preclinical and clinical performance testing plan required to support a pre-market application, and to determine the appropriate regulatory path for Cchek.

4. Clovis Oncology Inc. (CLVS)

Lost 19.88% to close Monday's trading at $21.12.

News: The Company's shares took a hit on competitors', (AstraZeneca and Merck), promising PARP inhibitor clinical trial news.

In a phase III trial, which is testing AstraZeneca and Merck's LYNPARZA 300 mg tablets twice daily as a maintenance treatment for patients with newly-diagnosed advanced BRCA-mutated (BRCAm) ovarian cancer, 60% of patients receiving LYNPARZA remained progression-free at 3 years compared to 27% on placebo following platinum-based chemotherapy.

LYNPARZA is an ADP-ribose polymerase (PARP) inhibitor approved in the U.S. since 2014, and is indicated for the maintenance treatment of recurrent ovarian cancer in response to platinum-based chemotherapy regardless of BRCA mutation status, and for the treatment of advanced ovarian cancer patients with a germline BRCA mutation previously treated with three or more lines of chemotherapy. The drug is not currently FDA-approved for advanced BRCAm ovarian cancer treatment in the first-line maintenance setting.

Clovis Oncology's PARP inhibitor drug is Rubraca, which is indicated for the treatment of patients with deleterious BRCA mutation-associated epithelial ovarian, fallopian tube, or primary peritoneal cancer who have been treated with two or more chemotherapies; and for the maintenance treatment of adult patients with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who are in a complete or partial response to platinum-based chemotherapy.

A phase III trial evaluating Rubraca plus Opdivo as first-line maintenance treatment in newly diagnosed patients with stage III/IV high-grade ovarian, fallopian tube or primary peritoneal cancer was initiated as recently as August of this year.


Read the original article on RTTNews (http://www.rttnews.com/2946010/adap-down-46-this-month-clvs-abuzz-adro-awaits-data-in-nov.aspx)


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This article appears in: Stocks
Referenced Symbols: ADAP ,



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