News and Comments

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: More...

Investors’ Rush To Buy ImmunoGen IMGN

  Friday, March 19, 2010

IMGN soared on Thursday, as investors did not miss the parts related to ImmunoGen in the article Robert Langreth, a senior editor at Forbes wrote about the pharmaceutical company Roche’s status and plans. In the article, Severin Schwan, Roche’s chief executive remind of his firm’s dominant position in the cancer drug market, stressing the fact that Roche’s cancer drug Avastin is hard to beat, regardless of what other pharmaceutical companies claim about their upcoming competing drugs. “In cancer, we are at the beginning,” Schwan told Forbes in an interview yesterday. “The barrier to beat our established drugs is very high. It is extremely difficult to find something better than Avastin whose sales approached $6 billion last year.”

The part related to ImmunoGen, though, came when the article described Roche’s plans. He wrote, “Roche is testing drugs called armed antibodies that combined targeted therapy with traditional toxic cell-killing drugs. The idea is that the antibody will deliver the toxic chemotherapy directly to the tumor, maximizing effectiveness and limiting side effects.” Is this not ImmunoGen’s drug? Indeed it is as investors who read the article confirmed their notion when it mentioned the armed antibody by name “T-DM1”, described it as much as possible, and confirmed that ImmunoGen is the developer of the drug.

Motivating IMGN’s rally yesterday is the part where the writer said, “Roche is in late stage testing of T-DM1 that chemically links Herceptin to a potent chemotherapy toxin. If the drug works, patients will take one drug for breast cancer instead of two or three. Roche, presumably, could charge a higher price for the two-in-one combo, especially if it has fewer side effects.”

Further exciting ImmunoGen’s fans was the part of the text that said, “Schwan swears there are no big more mergers in Roche’s future because we think it destroys a lot of value. We are going for targeted midsize acquisitions.”

Well, well, well. Reading the article’s description of ImmunoGen’s T-DM1 drug was enough for informed investors to connect the dots. ImmunoGen typically fits the description of what Roche is interested in. If taken over, the firm, which is a small size, the premium to be paid in case of acquisition would turn it into a midsize firm. In addition, investors know that ImmunoGen is not a single cancer drug firm, but has a pipeline of several conjugated monoclonal antibodies developed for several cancers. More important, it owns the TAP technology that made possible what defied other firms’ previous attempts, i.e., designing and developing monoclonal antibodies that carry highly toxic payloads, yet leave the normal cells intact because they released their toxic ammunition only inside the cancer cells.


Recent Postings