science

Tecemotide

Tecemotide is a science topic covered in the lgStudy science library. This page brings together a partial reference excerpt, illustrations, worked examples, real-world applications and a short study plan, so you can understand Tecemotide rather than just read about it. In short: Tecemotide (INN; emepepimut-S (USAN); formerly known as BLP25 or EMD 531444) is a synthetic lipopeptide that is used as antigen in an investigational therapeutic cancer vaccine (formerly known as Stimuvax, L-BLP25, BLP25 liposomal vaccine, or BLP25 liposome vaccine). The investigational therapeutic cancer vaccine is designed to induce a cellular immune response to cancer cells that express MUC1, a glycoprotein antig…

Key takeaways

Tecemotide belongs to science; place it in that map before memorising details.
Learn the definition first, then one example that makes the definition concrete.
Connect Tecemotide to a quantity you can measure, compute or draw — that is where exam questions come from.
Reproduce the core statement of Tecemotide from memory before moving on to harder problems.

Reference excerpt

Tecemotide (INN; emepepimut-S (USAN); formerly known as BLP25 or EMD 531444) is a synthetic lipopeptide that is used as antigen in an investigational therapeutic cancer vaccine (formerly known as Stimuvax, L-BLP25, BLP25 liposomal vaccine, or BLP25 liposome vaccine). The investigational therapeutic cancer vaccine is designed to induce a cellular immune response to cancer cells that express MUC1, a glycoprotein antigen that is widely over-expressed on common cancers such as lung cancer, breast cancer, prostate cancer, and colorectal cancer. The cellular immune response may lead to a rejection of tumor tissue expressing the MUC1 antigen.

Collaboration Tecemotide was developed – until Clinical trial phase II – by the Canadian biotech company Biomira Inc., which changed its company name to Oncothyreon Inc. in 2007. Oncothyreon is now located in Seattle, Washington, and it changed its name to SGEN after a merger and acquisition in March 2018. In 2001, Merck KGaA, of Darmstadt, Germany, entered into a collaboration and supply agreement with Biomira. In 2007, Merck KGaA acquired the exclusive worldwide marketing rights from Biomira, and Merck KGaA has since then been entirely responsible for the further clinical development of tecemotide. In 2008, Merck KGaA acquired the manufacturing rights for tecemotide from Oncothyreon. In 2011, Ono Pharmaceutical Company, of Japan, acquired a co-development and co-marketing license for tecemotide in Japan; Ono paid Merck KGaA 5 million euros.

Composition Tecemotide is a synthetic lipopeptide that is 27 amino acids long. Its molecular formula is C124H203N33O38, and its amino acid sequence is S T A PPAH G VTSAPDTRPAPGSTAPPKG. The first 25 amino acids of tecemotide are derived from the mucin 1 (MUC1, carcinoma-associated mucin, episialin, or CD227) sequence. The 26th modified amino acid, K, is palmityl-lysine (N6-(1-oxohexadecyl)-L-lysine), and the 27th is glycine.

Structure of the cancer vaccine

In the investigational therapeutic cancer vaccine (formerly known as Stimuvax, L-BLP25, BLP25 liposomal vaccine or BLP25 liposome vaccine), the antigen tecemotide is anchored — together with the adjuvant 3-O-deacyl-4′-monophosphoryl lipid A (MPL) — in the membrane of the liposome made from the lipids cholesterol, dimyristoyl phosphatidylglycerol (DMPG), and dipalmitoyl phosphatidylcholine. MPL is a derivative of the lipid A molecule found in the membrane of Gram-negative bacteria used as an adjuvant to initiate a non-specific immune stimulus, thereby stimulating the activation of antigen-presenting cells (APCs) through the toll-like receptor 4 (TLR-4) as well as macrophages. MPL is also used as an adjuvant in other vaccines, like Cervarix, a vaccine against certain types of cancer-causing human papillomavirus (HPV). The precise mixture of lipids in the vaccine, as well as providing the structure of the liposome, is also formulated to enhance the uptake of the vaccine by the aforementioned antigen-presenting cells. The cancer vaccine is a lyophilized powder, which is formulated to contain 300 μg of tecemotide and 150 μg of MPL per vial.

Clinical trials

Overview and results of all trials Tecemotide clinical trials (as of September 2, 2014) sorted by (estimated) primary completion date:

Overview of completed trials Overview of completed tecemotide trials (as of September 2, 2014) where results have been published, sorted by primary completion date:

Discontinued development On August 18 and September 12, 2014, Oncothyreon and Merck KGaA, respectively, reported that a randomized Phase 1/2 study, EMR 63325–009, of tecemotide compared to a placebo in Japanese patients with Stage III non-small cell lung cancer did not meet its primary endpoint of an improvement in overall survival, and no treatment effect was seen in any of the secondary endpoints (progression-free survival, time to progression, or time to failure). Merck made the recommendation to stop the investigational treatment of patients in the EMR 63325-009 study in Japan. Furthermore, Merck KGaA announced its decision to discontinue the Phase III START2 and INSPIRE studies, and all other Merck-sponsored clinical trials with tecemotide in NSCLC, worldwide. Merck will continue to supply tecemotide for ongoing investigator-sponsored trials in other indications in accordance with their agreements with the sponsors of these studies.

Drug development risks Risks that could affect the further development of tecemotide published in the annual reports of Oncothyreon (grantor of the license) and Merck KGaA (license holder; responsible for clinical development, marketing and manufacturing) are listed in the following sections.

Efficacy As published so far, primary end points have not been met in the clinical studies, and tecemotide has shown treatment effects only in statistical analyses of certain subgroups.

Patent situation Oncothyreon's patent protection for tecemotide in the U.S. was scheduled to expire in 2018.

Human resources In 2013, Merck KGaA reported problems with recruiting and retaining qualified employees: "Sourcing, recruiting and retaining specialists and talent at Merck are among the company's top priorities. Nevertheless, employee-related risks that affect business activities are likely, even though their impact is difficult to assess. Merck rates this as a medium risk." Merck KGaA further reported with respect to its pharma division, Merck Serono: "Over 80% of the Merck Serono senior management positions [have been] replaced since 2011 [as of September 2014]."

Novel technologies Tecemotide is based on novel technologies, which may raise new regulatory issues that could delay or complicate regulatory approval. Additionally, as of 2013, the FDA had approved for commercial sale in the United States only one active vaccine designed to stimulate an immune response against cancer. Consequently, there is limited precedent for the successful development or commercialization of products based on these technologies in this area.

… excerpt ends here. Continue reading the full article.

Worked examples

Example 1 — a first encounter with Tecemotide

Start with the simplest possible case. Write down what Tecemotide claims or describes in one sentence, then invent the smallest concrete situation in which that sentence is true. In science, the smallest case is usually a single object, a single equation or a single measurement. Check that every symbol or term in your sentence has a meaning in that case.

Example 2 — changing one variable

Take the situation from Example 1 and change exactly one quantity: double it, halve it, or set it to zero. Predict what should happen to Tecemotide before you calculate. Comparing your prediction with the result is the fastest way to find out whether you understand the idea or only the words.

Example 3 — an exam-style question

Typical questions about Tecemotide ask you to (a) state it precisely, (b) apply it to given data, and (c) explain a limitation. Practise writing all three answers in under five minutes; the third part is what separates a full-mark answer from an average one.

Applications of Tecemotide

In research: Tecemotide appears in science research whenever the underlying quantities have to be modelled precisely. Papers usually cite it as a starting assumption and then explore where it breaks down.
In technology and industry: Engineering practice reuses Tecemotide in design rules, simulations and safety margins. Knowing the idea lets you read a specification sheet and understand why the numbers look the way they do.
In the classroom: Tecemotide is common in secondary-school and first-year university syllabi. It links to neighbouring topics Cancer vaccines, Drugs developed by Merck, Experimental cancer treatments, so understanding it makes those chapters shorter.
In everyday life: Look for Tecemotide outside the textbook — in sport, cooking, traffic, electronics or the sky above you. An example you found yourself is remembered far longer than one you were given.

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How to study Tecemotide in 20 minutes

Read the reference excerpt below once, without taking notes.
Close the page and write down what Tecemotide means in your own words.
Compare your version with the excerpt and mark what you missed.
Work through the three examples above with pen and paper.
Explain Tecemotide out loud to somebody else — or to Teacher Smith in the lgStudy chat.

Frequently asked questions

What is Tecemotide in simple terms?

Why does Tecemotide matter?

Because it connects several science ideas at once: it gives you a definition you can apply, a quantity you can calculate, and a way to check whether a result is plausible.

How should I study Tecemotide?

Read the excerpt, restate it from memory, then work through the examples and applications listed on this page. The five-step study plan above takes about twenty minutes.

What does this page cover?

It gives you a compact reference excerpt plus original lgStudy explanations, examples, applications and study material on Tecemotide.