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Two Small Great Biotechs Underestimated by the Market

  Tuesday, June 25, 2013

Seattle Genetics’ (SGEN) and ImmunoGen’s (IMGN) conjugated monoclonal antibody therapeutics for cancer are increasingly validating their superior safety and efficacy over other cancer products that are used without the antibody drug conjugates (ADC).  More...

ImmunoGen Offers New Hopes For Treatment Of Subtypes Of Squamous Cell Carcinomas And Other Difficult-To-Treat Cancers

  Friday, April 12, 2013

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IMMUNOGEN: TWO GOOD NEWS IN ONE ANNOUNCEMENT

  Monday, August 27, 2012

Targeted Antibody Payload (TAP) technology did not lie and we knew it and had never been skeptical about the fact that it is a superior technology for cancer treatment. Indeed, ImmunoGen’s (IMGN) lead TAP drug, trastuzumab emtansine for HER2 breast cancer continued to show its superiority over other cancer drugs and other delivery technologies that try to enhance oncology drugs’ efficacy, safety, or both. ImmunoGen’s TAP technology has demonstrated time and time again it improves both safety and efficacy and makes cancer drugs work after the same drugs fail to work when used alone, i.e., not within ImmunoGen’s targeted monoclonal antibody designed armed vehicle.  More...

Seattle Genetics: A powerful Approach For resistant Cancers Hits The Market

  Tuesday, August 23, 2011

We heard them all. We heard all they said, we mean the pessimist and the optimist following the approval of Seattle Genetics’ drug Adcentris™ (brentuximab vedotin) for Hodgkin lymphoma and for systemic anaplastic large cell lymphoma (ALCL). More...

Seattle Genetics: Adcentris Approved For Two Cancers

  Monday, August 22, 2011

Congratulations. A great technology, the antibody-drug conjugate (ADC) technology, which is perfected by the two biotech firms, Seattle Genetics (SGEN) and ImmunoGen (IMGN) has yielded the first approved drug. Yes, the FDA has granted accelerated approval of Adcentris™ (brentuximab vedotin) developed by Seattle Genetics (SGEN) for two indications:  More...

IMMUNOGEN: The TAP Technology

  Wednesday, June 15, 2011

Something to think about the fact that using ImmunoGen’s (IMGN) TAP technology makes targeted cancer drugs beat their own efficacy. This reality seems to be increasingly considered by cancer drug developers. Using ImmunoGen’s technology enables approved, or investigational targeted cancer drugs developed by pharmaceutical companies to gain extra-efficacy as first line treatments, in addition to overcoming cancer resistance in case of recurrences. The oncology drug developers would love to see their same products bring better safety and efficacy, cover more patients and succeed if recurrences occur. More...

ImmunoGen: No Exaggeration.

  Thursday, April 07, 2011

NO. It was not exaggerated, nor sophisticated what we wrote time and time again about the unparalleled safety and efficacy of the ImmunoGen’s Targeted Antibody Payload (TAP). It is no exaggeration announcing our conviction that cancer products based on Immunogen’s TAP   technology will generate billions of dollars in revenues. What we talked about has, indeed, become today’s great news.  More...

ImmunoGen: Steadfast Determination to Conquer Cancer

  Wednesday, April 06, 2011

The Program Committee of the 102nd Annual Meeting of the American Association for Cancer Research (AACR) taking place in Orlando, FL designated ImmunoGen’s (IMGN) cancer drug IMGN853 poster presentation “Highly Rated.” More...

ImmunoGen And The Second Lethal Virus

  Monday, August 30, 2010

Two lethal viruses plague general investors. The euphoria virus infects investors when the market stages sustained rallies. This virus makes investors buy and buy until the balloon becomes overstretched and eventually bursts. The fear virus causes hysteria in susceptible investors when their stocks go south and rush them to sell at ridiculously low prices. The fear virus also provokes vulnerable investors to immediately dispose of their stocks at the hint of unfavorable news, whether or not the negative news is indicative of weakness in the firms’ fundamentals. Healthy, rational investors usually take advantage to accumulate the battered stocks of firms with strong fundamentals at the new bargain price that results from sell-offs by the fearful.  More...

Indeed, Roche Filed NDA For T-DM1

  Wednesday, July 07, 2010
The First Conjugated Monoclonal Antibody From ImmunoGen’s (IMGN) Technology To Reach That Stage

In Today’s news, Genentech, a member of the Roche Group, announced that the company has, indeed, submitted a Biologics License Application (BLA) to the FDA for trastuzumab-DM1 (T-DM1). The drug’s technology is licensed from ImmunoGen (IMGN). The BLA is for approval of T-DM1 in people with advanced HER2-positive breast cancer who have previously received multiple HER2-targeted medicines and chemotherapies. This submission is based on the results of a Phase 2 study, which showed T-DM1 shrank tumors in one-third of women who had received on average seven prior medicines for advanced HER2-positive breast cancer.

This submission was expected and Prohost mentioned it time and time again, the latest was in Prohost Letter #303 posted on Prohost website on Tuesday when we wrote: “Seeing patients who became resistant to its drug herceptin respond to T-DM1, Roche became excited and motivated to ask the FDA for an early approval of the drug. Patients who had previously received, on average, seven different drugs for their advanced breast cancer had an objective response to treatment with T-DM1. Among the responders were a substantial number of patients with recurrent disease who became resistant to Roche’s blockbuster drug Herceptin. How could anybody believe that ImmunoGen, which has a pipeline of successfully conjugated drugs, be bad?”

The Prohost Letter wrote, “ImmunoGen’s weapon resides in its technological capability that succeeded for the first time in history in designing and developing safe and effective conjugated monoclonal antibody drugs. ImmunoGen’s lead drug Trastuzumab-DM1 (T-DM1) is a monoclonal antibody against HER2 neu breast cancer loaded with the cancer-cell killing agent, DM1. The drug has demonstrated efficacy in patients suffering from her2 neu recurrent resistant breast cancer patients.”

In Genentech/Roche press release, Hal Barron, M.D., executive vice president, Global Development and chief medical officer said: “While we’ve made great strides in treating HER2-positive breast cancer, there is a group of people whose breast cancer will come back after many treatments, leaving them with very limited options. Data from studies have shown that T-DM1 shrank tumors in these people, so we are excited to have submitted this application to the FDA in hopes of offering a potential new medicine to people with this type of breast cancer.”

T-DM1 is an antibody-drug conjugate (ADC), also known as an armed antibody, being studied for advanced HER2-positive breast cancer. T-DM1 attaches trastuzumab and the chemotherapy DM1 together using a stable linker, which is designed to keep T-DM1 in one piece until it reaches specific cancer cells. The antibody (trastuzumab) binds to the HER2-positive cancer cells, and is thought to block out-of-control signals that make the cancer grow while also calling on the body’s immune system to attack the cells. Then, once T-DM1 is absorbed into those cancer cells, it is designed to destroy them by releasing the DM1.

A Phase 2 study known as TDM4374g, designed to assess single-agent T-DM1 in 110 women with HER2-positive advanced breast cancer whose disease had worsened after receiving at least two prior HER2-targeted treatments Herceptin® (trastuzumab) and lapatinib) in the metastatic setting, as well as an anthracycline, a taxane and capecitabine, demonstrated the following results: 

-- T-DM1 shrank tumors in 33 percent of women with advanced HER2-positive breast cancer that had worsened following treatment with an average of seven prior medicines for metastatic disease.

-- Most side effects were mild (Grade 1-2) and similar to those observed in previous clinical trials of T-DM1.

More trials of T-DM1 are planned for the drug, either alone or in combination with other medicines.  An ongoing Phase 3 trial, known as EMILIA, is comparing T-DM1 to lapatinib in combination with capecitabine in people with advanced HER2-positive breast cancer whose disease has worsened after receiving initial treatment. Also, a planned Phase 3 study, MARIANNE, will compare both T-DM1 alone and T-DM1 in combination with pertuzumab to Herceptin in combination with a taxane chemotherapy in people with advanced HER2-positive breast cancer who have not been previously treated for advanced disease.

Genentech has opened a T-DM1 Patient Access Study in the United States to provide a specific group of people with advanced HER2-positive breast cancer access to T-DM1 while Genentech seeks U.S. approval.

Genentech licenses technology for T-DM1 from ImmunoGen (IMGN).

For the complete press release click: http://www.roche.com/media/media_releases/med-cor-2010-07-07.htm More...

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