1stOncology™: Cancer Intelligence Service – Page 16634 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

Molecular Templates and ImClone Systems Form Oncology Drug Discovery and Translation Research Collaboration

On July 6th, 2010 Molecular Templates reported that it has entered into a collaborative oncology drug discovery and translation research agreement with ImClone Systems, a wholly-owned subsidiary of Eli Lilly and Company (Press release Molecular Templates, JUL 6, 2010, View Source [SID:1234500725]).
Under the terms of the agreement, Molecular Templates will identify Engineered Toxin Bodies (ETBs) against an undisclosed oncology target of interest selected by ImClone. ImClone will conduct preclinical studies utilizing the ETBs to evaluate their therapeutic potential in oncology. Upon completion of the evaluation of the ETBs, Molecular Templates and ImClone have the option to continue exclusive development of selected ETBs by ImClone for potential commercialization by Lilly. Molecular Templates will receive upfront, milestone and royalty payments if any of the ETBs are selected for further development and commercialization. Financial terms of the agreement were not disclosed. "We are excited to partner with a premier biologics innovator like ImClone," said Eric Poma, president and chief executive officer of Molecular Templates. "We look forward to collaborating with ImClone to identify novel oncology therapies by leveraging our ETB technology. Given ImClone’s depth in the oncology and biologics arena, we view this partnership as validation of our novel platform and its potential to be used to discover and develop the next generation of targeted biologic medicines."
ETBs represent a new class of small biologic therapeutics derived from modified bacterial toxins that retain the potent direct cell-kill properties, internalization capabilities, and predictable pharmacokinetics of the parent toxins, but have significantly reduced immunogenicity. These features confer a host of advantages over traditional biologic and small molecule approaches and allow for discovery of therapeutic targets that may be uniquely accessible by ETBs. Molecular Templates has created a vast library (>10^15) of ETBs, each with distinct binding affinities, that can be directly screened for cell-kill ability to rapidly identify promising therapeutic candidates based on both specificity and efficacy to a given target.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

Tumor specific vaccination therapy for advanced/recurrent ovarian cancer using HLA-A*2402 restricted Specific Epitope Peptides Cocktail derived from Tumor genome/Tumor related Angiogenetic factors genome

Cancer, ovarian
It is in a Phase I/II tumor specific vaccination therapy for advanced/recurrent ovarian cancer using HLA-A*2402 restricted specific epitope peptides cocktail derived from tumor genome/tumor related angiogenetic factors genome (Clinical trial, Trial ID:UMIN000003862, UMIN, JUL 2, 2010, View Source [SID1234520548]). Advanced/recurrent ovarian cancer with the conditions of unremoval by surgery, or refractory, chemo-resistant disease. Objective 1: To elcidate the feasibility and efficacy of HLA-A*2402 restricted Specific Epitope Peptides Cocktail of FOXM1,MELK,HJURP,VEGFR(vaacular endotherial growth factor receptor)-1 and VEGFR2. Objective 2: Safety,Efficacy.

FDA: Pfizer Voluntarily Withdraws Cancer Treatment Mylotarg From U.S. Market

On June 21, 2010 Pfizer Inc. reported the voluntary withdrawal from the U.S. market of the drug Mylotarg (gemtuzumab ozogamicin) for patients with acute myeloid leukemia (AML), a bone marrow cancer (Press release, Pfizer, JUN 21, 2010, View Source [SID1234634976]). The company took the action at the request of the U.S. Food and Drug Administration after results from a recent clinical trial raised new concerns about the product’s safety and the drug failed to demonstrate clinical benefit to patients enrolled in trials.

Mylotarg was approved in May 2000 under the FDA’s accelerated approval program. This program allows the agency to approve a drug to treat serious diseases with an unmet medical need based on a surrogate endpoint – a laboratory measurement or a physical sign used as a substitute for a clinically meaningful endpoint that directly measures how a patient feels, functions, or survives.

Under accelerated approval, the company is required to conduct additional clinical trials after approval to confirm the drug’s benefit. If those trials fail to confirm clinical benefit to patients, or if the company does not pursue the required confirmatory trials with due diligence, the FDA can withdraw the drug from the market using expedited procedures.

Mylotarg was approved to treat patients ages 60 years and older with recurrent AML who were not considered candidates for other chemotherapy. The initial approval was based on the surrogate endpoint of response rate (i.e., the percentage of patients whose leukemia decreased or disappeared in laboratory tests), observed in 142 patients with AML across three clinical trials.

A confirmatory, post approval clinical trial was begun by Wyeth (now Pfizer) in 2004. The trial was designed to determine whether adding Mylotarg to standard chemotherapy demonstrated an improvement in clinical benefit (survival time) to AML patients. The trial was stopped early when no improvement in clinical benefit was observed, and after a greater number of deaths occurred in the group of patients who received Mylotarg compared with those receiving chemotherapy alone.

At initial approval, Mylotarg was associated with a serious liver condition called veno-occlusive disease, which can be fatal. This rate has increased in the postmarket setting.

"Mylotarg was granted an accelerated approval to allow patient access to what was believed to be a promising new treatment for a devastating form of cancer," said Richard Pazdur, M.D., director, Office of Oncology Drug Products, part of FDA’s Center for Drug Evaluation and Research. "However, a confirmatory clinical trial and years of postmarketing experience with the product have not shown evidence of clinical benefit in patients with AML."

As a result of the withdrawal, Mylotarg will not be commercially available to new patients. Patients who are currently receiving the drug may complete their therapy following consultation with their health care professional. Health care professionals should inform all patients receiving Mylotarg of the product’s potential safety risks.

Following the withdrawal, any future use of Mylotarg in the United States will require submission of an investigational new drug application to FDA.

Mylotarg is manufactured by New York City-based Pfizer.

For more information:

Pfizer: Mylotarg Withdrawal

View Source

FDA: Access to Investigational Drugs

View Source

OXFORD BIOMEDICA ANNOUNCES AMENDMENT TO 5T4 LICENCE AGREEMENT WITH CRT AND ISSUE OF SHARES

On June 18, 2010 Oxford BioMedica (LSE:OXB), a leading gene therapy company, announced today that it has signed an amendment to its licence agreement with Cancer Research Technology (CRT) covering the use and exploitation of the 5T4 antigen used in TroVax, Oxford BioMedica’s therapeutic cancer vaccine, the antibody being developed by Pfizer, and other potential applications (Press release, Cancer Research Technology, JUN 18, 2010, View Source [SID1234523526]).

Under the amended agreement, royalty payments that had been due to CRT relating to amounts received under the sanofi-aventis TroVax agreement (signed March 2007 and terminated April 2009) will now be settled.

To find out more, read the Oxford BioMedica press release.

CrystalGenomics Initiates Phase I Study of CG200745, its Novel Molecular Targete

On May 31, 2019 CrystalGenomics, Inc. (www.cgxinc.com), a leading biopharmaceutical company developing novel small molecule therapeutics reported that it has received an approval from the Korea Food & Drug Administration (KFDA) to begin Phase I clinical study of CG200745, its novel molecular targeted cancer therapeutic (Press release, CrystalGenomics, MAY 31, 2010, View Source;id=836&page=8&num=51&nowpos=1017&type=&sermun=&qu=&tb_name=eng_news&rt_page=/en/news/news.php [SID1234539171]). This KFDA approval makes it CrystalGenomics’ second recent announcement of initiating clinical trials as it has only been 20 days since its previous announcement on plans to initiate the Phase I Multiple Ascending Dose Study for CG400549, its novel antibiotic candidate for MRSA.

CG200745 is being developed to potentially overcome negative side effect profiles of traditional cancer therapies. One of the major flaws of traditional oncology agents is the severe toxicity issue as current agents tend to target and kill even the normal healthy cells that are around the cancerous cells. Because CG200745 has been designed to specifically target the cancerous cells, it is also referred to as a "Molecular Targeted Cancer Therapeutic" that will not harm the non-cancerous cells.

While being designed to test human safety as its primary objective, this Phase I study will also attempt to collect efficacy profiles of CG200745 on various types of cancers and also, its effects of combination therapy to see if CG200745’s co-administration will result in synergic effect of increasing effectiveness of existing cancer therapies. It is anticipated that CG200745 will be developed to treat cancer types of high incidences such as colon cancer, breast cancer, gastric cancer, and hematological cancers including lymphoma, leukemia and multiple myeloma.

Preclinical study results have confirmed CG200745’s safety profile done in Europe, and its efficacy was also demonstrated against various cancer cell lines. It was also observed that CG200745 had better efficacy profile than Merck’s recently approved Zolinza.

"We are excited to conduct our study at the Seoul Asan Medical Center, a premier hospital with one of the highest standards in Korea. We are highly optimistic moving forward and look forward to the opportunity to provide new hope and improved quality of life for many suffering cancer patients," commented Dr. Joong Myung Cho, President & CEO of CrystalGenomics.