Compugen's Cancer Trial, And Other News: The Good, Bad And Ugly Of Biopharma
Summary
- Compugen's triple therapy for solid tumors is cleared for IND.
- Abiomed's heart pump for COVID-19 receives emergency authorization.
- Eli Lilly's cyramza gets another expanded label.
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Compugen Received FDA Clearance of IND Application
Compugen (NASDAQ:CGEN) announced that the FDA has given its clearance for the Investigational New Drug for Phase 1/2 study of its Triple combination therapy for cancer. The company expects to initiate the trial during the second half of the year. The trial is expected to provide a push to the company’s DNAM axis hypothesis as well as to biomarker based approach for treating advanced solid tumors.
Compugen reported that it plans to start an open-label Phase 1/2 trial under this IND. The trial will aim to assess the safety, tolerability and preliminary antitumor activity of COM701 in conjunction with Opdivo® and BMS-986207. Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "The encouraging clinical data from the ongoing COM701 Phase 1 study evaluating our discovered target PVRIG, and the emerging clinical validation of the TIGIT pathway, leave us increasingly enthusiastic about our science-driven clinical approach evaluating these two complementary yet distinct pathways in combination with PD-1.” Bristol Myers Squibb has already determined the dose levels for Opdivo® and BMS-986207 combinations in prior testing.
COM701 is a humanized antibody and works by binding with PVRIG and blocking the interaction with PVRL2. Preclinical data has demonstrated that control of PVRIG may trigger a strong anti-tumor immune response. It has also shown to have synergistic impact when taken in combination with inhibitors of TIGIT and/or PD-1. Currently, the drug candidate is being tested in a Phase 1 clinical trial. It has shown positive safety profile and the potential of anti-tumor activities.
COM701 has been tested as a monotherapy as well and provided partial response. It has also been assessed in combination with nivolumab for patients suffering from difficult to treat cancers. The company is working on the premises that PVRIG and PD-1 are two distinct pathways and controlling them together may result in significant benefits for the patients. However, the triple combination takes this hypothesis to the next level. Henry Adewoye, M.D., Senior Vice President and Chief Medical Officer of Compugen said, “The triple combination will further test our science-driven hypothesis that PVRIG, TIGIT, and PD-1 are non-redundant inhibitory pathways and that their simultaneous blockade is expected to further enhance anti-tumor immune responses and broaden the patient population responsive to cancer immunotherapies. We look forward to collaborating with Bristol Myers Squibb on this important study."
Compugen is a clinical stage company and is mainly focused on developing immunotherapies for cancer. COM701 is its lead drug candidate and is a first in class anti-PVRIG antibody for treating solid tumors. The company has a solid development pipeline with a variety of products in different stages. COM902 is another antibody targeted at TIGIT. The drug candidate is currently in Phase 1 clinical study phase. Apart from these, Compugen also has early stage immune-oncology programs which are mainly focused on myeloid targets.
Compugen shares have defied the markets to record positive returns on Year to Date basis. The stock has shown over 110 percent growth so far this year. However, it should be noted that the stock is currently trading close to its 52 weeks high.
Abiomed Receives Emergency Authorization for Heart Pump Use for COVID-19
Abiomed Inc. (ABMD) announced that the company has received an emergency use authorization from the FDA for its Impella RP heart pump. The authorization allows the pump to be used for treating certain COVID 19 patients including the ones suffering from heart failure. The device is already approved for treating right ventricular failure in cases of acute myocardial infarction and after cardiac surgery. The device may also be used for providing biventricular cardiac support when used in combination with left-side Impella devices.
Abiomed claimed that the product has been used by clinicians for treating COVID 19 patients with acute blood clots in the pulmonary artery. The pump may be deployed using minimally invasive techniques. Michael R. Minogue, Abiomed’s Chairman, President and Chief Executive Officer said, “We appreciate the work of physicians and healthcare providers to treat these difficult patients and thank the FDA for its emergency use authorization for Impella RP. We are committed to helping our customers improve the outcomes of their patients with our percutaneous heart pumps during these COVID-19 times.” The Impella system is a catheter based temporary heart pump and works by picking up blood from the vena cava.
The FDA has stated that based on reported clinical experience and extrapolation of data, the regulatory body has concluded that the system may prove to be effective in offering temporary right ventricular support. It is also believed that the system may provide support in the pulmonary embolism, which has been recognized as one of the manifestations of COVID 19. The emergency authorization allows the system to be used in the hospital setting by healthcare providers. Impella 2.5, Impella CP and Impella CP with SmartAssist are already CE marked in Europe.
Eli Lilly Receives Positive Split Decision From FDA for Cyramza
Eli Lilly & Company (LLY) announced receiving the FDA approval for Cyramza as the first-line treatment of metastatic non-small cell lung cancer in patients with EGFR mutation. The drug now is approved for six indications for treating certain types of stomach, lung and liver cancers. The company has also filed a supplemental biological license application for the use of Cyramza in conjunction with Tarceva for this indication. The FDA decision was given after 6-5 voting by the Oncologic Drugs Advisory Committee.
The company used the data from Phase 3 Relay trial for supporting its application. The data demonstrated that the drug may reduce the risk of disease progression or death by 40 percent when used in conjunction with Tarceva vis a vis the use of Tarceva alone. Patients who were administered the combo lived a median 19.4 months without disease progressing, compared with 12.4 months for those on Tarceva plus placebo. Lilly Oncology’s late-phase development chief Maura Dickler said, “We believe doctors should have options when they’re discussing therapy with patients,” she recently told FiercePharma, adding that the seven-month progression-free advantage the regimen has delivered is “clinically meaningful.”
Cyramza is a VEGF receptor 2 antagonist and has proved to be a blockbuster drug for Eli Lilly. It generated $239 million for the first quarter of 2020, up 21 percent on Year over Year basis. The company also stated that at the point of the data cutoff, 26 percent of the patients in the treatment arm had died. However, for the purpose of carrying out survival analysis, 300 fatalities are required. The FDA advisory meeting had suggested that Relay study with its 440 enrolments was not big enough for providing a clear overall survival benefit. Cyramza will be competing with Tagrisso which has created a niche market for itself in the EGFE segment.
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