FDA Grants Moderna/Merck Therapy Breakthrough Status

On 22 February 2023,Moderna and its partner Merck announced that Moderna's MRNA cancer vaccine MRNA-4517/V940 and Merck's Keytruda(R) cancer therapy have been granted breakthrough therapy status by the U.S. Food and Drug Administration.That means the FDA will fast-track its review of the new combination therapy.The Moderna cancer vaccine,when administered with Merck's Keytruda(R) cancer therapy following complete surgical resection,prevented recurrence of advanced melanoma skin cancer (stage III/IV) in 44% of patients in a Phase 2b clinical trial.Preliminary breakthrough designations are given when evidence indicates that the product may demonstrate substantial improvement over available therapies on at least one clinically significant endpoint. The new therapy is given for the adjuvant (prevention of cancer returning) treatment of patients with high-risk melanoma following complete surgical resection (removal).The two companies are to begin a Phase 3 clinical trial of the novel therapy.Moderna and Merck want to investigate the new therapy as an adjuvant treatment for other forms of cancer,including non-small cell lung cancer.* Earlier,the FDA granted breakthrough status to Moderna's MRNA vaccine against respiratory syncitial virus (RSV) which proved highly effective (more than 80%) at preventing RSV in a clinical trial.RSV is a serious threat primarily to children younger than five and older adults.RSV is the leading cause of hospitalization of babies.In the US,it kills an estimated 100-500 children a year and about 14,000 adults a year,but the estimate is suspected to be lowball.* Merck & Co Inc (MRK),Moderna Inc (MRNA)

MedImmune Joins Forces With Cancer Vaccine Collaborative

The structure of cancer research can be complex,even as the disease itself is.As a case in point,consider that MedImmune,the biotech division of British pharmaceutical titan AstraZeneca,has agreed to contribute three of its monoclonal antibodies to a research effort of the Cancer Vaccine Collaborative,or CVC.The CVC is in turn a project sponsored by a philanthropic organisation called the Cancer Research Institute and also by the Ludwig Institute for Cancer Research.The CVC is a network of clinical immunologists and oncologists with expertise in immunotherapy programs.
MedImmune's three antibodies will be incorporated into the CVC's portfolio of cutting edge clinical research and development,which utilises the expertise of its global network of clinicians and scientists to identify new immunotherapy combinations and launch clinical trials that help to bring the new treatments to cancer patients faster.
MedImmune's antibodies will be combined with other primary agents available to the CVC or accessed through additional partnerships to develop a more powerful generation of smarter immunotherapy drugs to better manage cancer patients' disease over the long term.Such combinations enable scientists to attack a particular cancer on multiple fronts,increasing the effectiveness of immune system response to cancer.
A monoclonal antibody is a protein produced from a single cell clone that can bind to substances such as tumor cells or other proteins,thus stimulating a person's immune system,modifying its regulatory checkpoints to make it more effective in responding to cancer.MedImmune intends to continue its research on these antibodies on an individual basis while the CVC combination studies proceed.
No financial terms of the joint effort with the CVC were revealed.
MedImmune employs about 3500 people worldwide.Its headquarters are in Gaithersburg,Maryland.
AstraZeneca(AZN)

Federal Rules Impel SAIC To Split Itself Up

Federal conflict of interest rules are forcing SAIC,the former Science Applications International Corporation,to divide into two separate companies.The rules make it harder for a company that combines services and solutions functions as SAIC does to compete for contracts.Under the leadership of new CEO General John P. Jumper,US Air Force retired,the IT-oriented research group will spin off its 4 billion dollar a year services business from the larger 7 billion a year solutions business.
The services business will provide systems engineering and technical assistance,plus financial analysis and program office support.The solutions business will offer science and technology for national security,engineering and health projects such as communications,intelligence,logistics and electronic warfare initiatives.
SAIC was founded by a small group of scientists led by physicist J. Robert Beyster,PhD in 1969.The FORTUNE 500 company addresses complex and critical technology-related needs such as cancer research at its SAIC-Frederick subsidiary in Maryland.SAIC-Frederick develops and applies advanced technologies to translational research,accelerating the delivery of new cancer and AIDS treatments.The activity supports the National Institutes of Health's Frederick National Laboratory for Cancer Research,employing nanotechnology,genomics and biomedical imagery in both basic and applied research.
SAIC employs about 40,000 people at locations from Virginia to Saudi Arabia,Bahrain and the United Arab Emirates.
SAIC,Inc(SAI)

Novartis Honored By Fortune Magazine

Swiss health care firm Novartis was honored by Fortune magazine as its Most Admired pharmaceutical company for 2011.It recieved an overall score of 7.02,folowed by Merck at 6.80 and Johnson&Johnson at 6.72.Last year,Novartis came in third.
The rank was decided by a survey of pharmaceutical executives,directors and analysts.They used nine criteria such as investment value and social responsibility.
Novartis is the world's third-largest pharmaceutical firm by sales.
One of its leading products is Gleevec(imatinib),a pill for patients with certain forms of chronic myeloid leukemia(CML) and gastrointestinal stromal tumors(GIST).Gleevec is also approved in the U.S.,EU and Japan for a form of acute lymphoblastic leukemia(ALL) and other blood disorders.It has helped many patients stay in remission for several years.
Novartis also owns the OTC brands Theraflu and Comtrex.The company has an assistance program for uninsured or underinsured patients.
Novartis AG(NVS)

MedImmune Licenses Pfizer Cancer Care Candidate

MedImmune has licensed a Pfizer CTLA-4 monoclonal antibody,tremelimumab,for exploration in a number of potential cancer treatments.Under the agreement,Pfizer will retain the rights to use tremelimumab with specified types of combination therapies while MedImmune assumes global development rights of the antibody.
The acquisition for MedImmune's oncology pipeline exemplifies MedImmune's continued commitment to embracing this new era of cancer care,according to Dr.Bahija
Jallal,PhD,Executive Vice President of Research and Development.
CTLA-4 is a protein that has an important role in regulating the immune system.There is growing interest in potential therapeutic benefits of blocking this protein with antibodies such as Pfizer's tremelimumab,as a means of inhibiting immune system tolerance of carcinogenic tumors,thus providing a potential new immunotherapy for cancer patients.
MedImmune is a division of London-based pharma titan AstraZeneca.The Gaithersburg,Maryland biotech firm has a staff of around 3500 workers worldwide.MedImmune is the inventor of the iconic FluMist vaccine,as well as pediatric respiratory therapy Synagis.
AstraZeneca(AZN),Pfizer(PFE)

Pfizer Cancer Therapies Move Forward in Europe

The European Medicines Agency has accepted Pfizer's regulatory submissions for review of two investigational compounds.One of them,crizotinib,targets a form of advanced non-small cell lung cancer(NSCLC);the other,bosutinib,is aimed at newly diagnosed chronic myeloid leukemia.Both compounds are believed to inhibit signaling in cancer cells that allows them to grow,survive and reproduce.
Pfizer Oncology says its pipeline is focused on identifying and translating the best scientific breakthroughs into clinical applications across a wide range of cancers.It has biologics and small molecules in clinical development and more than 100 clinical trials underway.
With its wide array of research partners,ranging from individual researchers to academic institutions,Pfizer Oncology strives to deliver the right drug for each patient at the right time to cure or control cancer.
Pfizer is listed on the London and New York stock exchanges under the ticker symbols PFZ and PFE,respectively.CEO Ian Read heads the New York-based company.

Cheap Diabetes Drug May Help Cancer Patients

Metformin,an inexpensive and commonly prescribed diabetes drug,may hold promise as part of a treatment regimen for certain cancer patients,including breast cancer sufferers,a new study suggests.
The Anglo-American team of researchers was led by Professor Michael Lisanti of the University of Manchester,who said they have showed that the food cancer cells consume is crucial to how well a patient does and what treatment they need.If cancer cells are consuming high energy foods,ketone and lactate,this makes a tumor more aggressive and harder to treat.However,patients could benefit from metformin,which cuts off this fuel supply.There is much work to do,but a test to identify these patients could be an important new way of tailoring treatments to a patient's needs,across a wide range of cancers.
The research team,from the Breakthrough Cancer Research Unit at the University of Manchester and Thomas Jefferson University in Philadelpia,found that breast cancer patients whose cancer cells consumed high energy foods were more likely to suffer recurring and metastatic,or spreading,cancers.These patients were identified by a certain gene signature.This signature may show which individuals could benefit from taking metformin,the generic diabetes medication.
Anthony Howell,another University of Manchester professor and director of the Breakthrough Cancer Research Unit,thinks the study marks another step towards personalised medicine,as it shows the best way to treat individual cancer patients.

Human Genome Sciences Sets Cancer Goals

Human Genome Sciences has set its oncology and immunology goals for 2011.The therapies at the center of these goals are in the mid and early stage pipelines.The firm's oncology portfolio is centered around its expertise in the programmed cell death approach.
Human Genome's monoclonal antibody mapatumumab is being studied in combination with Nexavar as a treatment for advanced hepatcellular cancer.At the same time,The company's HGS1029 is being evaluated as a treatment for solid and advanced lymphoid tumors.
HGS1029 is one of a new class of compounds that block IAP proteins from protecting cancer cells.HGS1029 will be studied both alone and in combination with other agents,such as mapatumumab.HGS will initiate and continue the clinical trials of these oncology therapies in 2011.
CEO Thomas H. Watkins announced these and other goals on January 10 at the 29th Annual JP Morgan Healthcare Conference in San Francisco.Human Genome Sciences is based in Rockville,Maryland and has more than a billion dollars of cash and investments in its war chest.That is considered a lot for a young biotech concern such as Human Genome.
Human Genome Sciences(HGSI)