Post by lakers on Nov 13, 2015 13:52:53 GMT -5
The Leukemia & Lymphoma Society and MannKind Corporation Announce Collaborative Research Agreement
New Partnership under LLS's Therapy Acceleration Program to Advance Development of a Novel Targeted Therapy for T-Cell Leukemia and Lymphoma
WHITE PLAINS, N.Y. and VALENCIA, Calif., May 5 /PRNewswire-FirstCall/ -- The Leukemia & Lymphoma Society (LLS) and MannKind Corporation, (MNKD), today jointly announced the execution of a collaborative research arrangement funded through LLS's Therapy Acceleration Program (TAP).
TAP is an innovative program intended to advance therapies with high prospects of providing near-term benefit to patients suffering from blood cancers. The TAP funding will support MannKind's efforts to develop a novel and highly selective first-in-class targeted tyrosine kinase inhibitor for the treatment of T-cell leukemia and lymphoma. This early development work, if successful, will lead to the initiation of IND-enabling studies.
"The sponsorship of LLS will help MannKind to advance its development of a potential new blood cancer treatment," said Alfred Mann, Chairman and Chief Executive Officer of MannKind. "I am personally committed to taking innovative approaches to develop effective treatments for unmet medical needs. It is exciting and gratifying to be able to collaborate with a high-caliber organization that recognizes the importance of our research."
Louis J. DeGennaro, PhD, Chief Scientific Officer of LLS, added "Our partnership with MannKind is another example of LLS's commitment to support a select group of highly motivated, well positioned commercial organizations poised to bring effective therapies to blood cancer patients."
- See more at: investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=791873#sthash.SyzbLgL8.dpuf
The Latest Sales Figures in Oncology Drug Pipeline Update 2015
www.reportlinker.com/p02242592-summary/The-Latest-Sales-Figures-in-Oncology-Drug-Pipeline-Update.html
How May Drug Pipeline Update Be of Use?
* Show investors/board/management that you are right on top of drug development progress in your therapeutic area. * Find competitors, collaborations partners, M&A candidates etc. * Jump start competitive drug intelligence operations * Excellent starting point for world wide benchmarking * Compare portfolio and therapy focus with your peers * Speed up pro-active in-/out licensing strategy work
Compound Data
Compound type, Chemical name, CAS Number and molecular weight
Patent Data
Available patent information related to the drug is presented here.
Fillings and Approvals
Approvals and submissions
Analyst comments
Deals & Licensing
Collaborations and deals
Availability for licensing
Phase IV Data
Available Phase IV development data, developmental history and scientific data.
Phase III Data
Available Phase III development data, developmental history and scientific data.
Phase II Data
Available Phase II development data, developmental history and scientific data.
Phase I Data
Available Phase I development data, developmental history and scientific data.
Phase 0 Data
Available Phase 0 development data, developmental history and scientific data.
Preclinical Data
Available preclinical development data, developmental history and scientific data.
Discovery Data
Available discovery development data, developmental history and scientific data.
Identified drugs are linked to more than 86 different targets, divided into 27 classifications of molecular function:
- Acid phosphatase activity
- ATPase activity
- Catalytic activity
- Deaminase activity
- DNA topoisomerase activity
- DNA-methyltransferase activity
- G-protein coupled receptor activity
- Growth factor activity
- Isomerase activity
- Kinase activity
- Ligand-dependent nuclear receptor activity
- Ligase activity
- Lipid kinase activity
- Molecular function unknown
- Oxidoreductase activity
- Protein binding
- Protein serine/threonine kinase activity
- Protein threonine/tyrosine kinase activity
- Protein-tyrosine kinase activity
- Receptor activity
- Receptor binding
- Receptor signaling complex scaffold activity
- Structural constituent of cytoskeleton
- Transcription factor activity
- Transcription regulator activity
- Transmembrane receptor activity
- Transmembrane receptor protein tyrosine kinase activity
2015 Oncology Drugs in the Pipeline
www.healio.com/hematology-oncology/prostate-cancer/news/print/hemonc-today/%7B1ff53db9-a2b5-4833-bbc5-87113be3dc74%7D/2015-oncology-drugs-in-the-pipeline
The 2015 Oncology Drug Pipeline: Innovation Drives the Race to Cure Cancer
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489190/
Fast Pace of Cancer Drug Approvals Continues into 2015
By mid-May 2015, 4 new molecular entities or new biologics have already received FDA approval for various tumor types, as well as 2 new indications for drugs that were initially approved by the FDA ≤1 year earlier, as listed in Table 1. Of these, 2 approvals were for rare diseases with few treatment options.
Cancer Drugs Approved by Mid-May 2015
One of these new approvals came on the heels of the other. On January 29, 2015, ibrutinib (Imbruvica) was the first cancer drug to receive a new indication this year, representing the first-ever medication to receive FDA approval for Waldenström's macroglobulinemia, a rare disease with few treatment options. On February 3, a new tyrosine kinase inhibitor (TKI), palbociclib (Ibrance), was approved for metastatic breast cancer.
On February 13, lenvatinib (Lenvima) became the newest TKI option for differentiated thyroid cancer, another rare disease. On February 17, lenalidomide (Revlimid) received a new indication for the first-line treatment of patients with multiple myeloma. On February 23, panobinostat (Farydak) became the first-ever histone deacetylase (HDAC) inhibitor to receive FDA approval, also for multiple myeloma.
On March 4, another immunotherapy, the first programmed cell death (PD)-1–blocking antibody, nivolumab (Opdivo), was approved by the FDA for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC).
This is a breathtaking list of new anticancer therapies, with promising outcomes demonstrated in early-stage clinical trials, and with many of the drugs receiving accelerated or priority regulatory reviews to facilitate early access to patients who may benefit from these promising therapies. It may be safe to presume that many of the cancer drugs approved last year will continue to receive second or third indications, or even more, and some will be further approved to facilitate enhanced outcomes within a combination regimen.
Of course, more new cancer drugs are expected to be approved in 2015. Of the 771 cancer drugs currently in development,6 several drugs are farther along in the process and are expected to be reviewed by the FDA between now and the end of 2015. These drugs potentially are:
Trabectedin (Yondelis), for chemotherapy-experienced soft-tissue sarcoma, is scheduled to be reviewed by the FDA for approval in July 2015
Cobimetinib, for melanoma, is scheduled for approval in August 2015
Gefitinib (Iressa), for first-line advanced or metastatic NSCLC with EGFR mutation; approval expected in September 2015
Sonidegib, for advanced basal-cell carcinoma, with approval expected in September 2015
Talimogene laherparepvec (T-VEC), for regionally or distally metastatic melanoma, is scheduled for approval in October
Necitumumab, for the first-line treatment of squamous NSCLC, with a scheduled date of December 2015
Trifluridine and tipiracil, for third-line therapy of refractory metastatic colorectal cancer, with approval expected by the end of the year.
Oncology Drugs Still a Pipeline Priority
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), 771 new drugs and vaccines are in development by US companies; these agents are currently in clinical trials or have been submitted to the FDA for review.6 According to PhRMA, of the 771 drugs and vaccines currently in the pipeline6:
98 are being developed for lung cancer
87 for leukemia
78 for lymphoma
73 for breast cancer
56 for skin cancer
48 for ovarian cancer.
Overall, 3137 clinical trials for cancer drugs are being conducted in the United States. Of these, 1313 are ongoing and are no longer enrolling new patients.6 Again, an impressive list of therapies, some with new mechanisms of action that may bring significant changes to cancer care.
Certain trends seen in the FDA approvals in 2014 appear to be continuing in 2015. Of the 41 new molecular entities and new biologics approved last year, 9 were for cancer drugs, including 5 new molecular entities and 4 new biologics. Moreover, several of the new drugs received a second indication in 2014 soon after their initial approval, with some receiving 2 or 3 new indications in succession within a few months. If the first half of 2015 is any indication, this approval trend may linger into 2016 and beyond, with increasing numbers of cancer drugs introducing new mechanisms of action, first-in-class options, or new options for rare cancers.
Several tumor types have attracted significant attention among pharmaceutical developers in recent years, resulting in a concentration of new therapies in the pipeline for specific cancers. Among the categories currently leading the race for FDA approval of new cancer therapies are melanoma, breast cancer, and lung cancer (Table 2) and hematologic malignancies (Table 3). In addition, several important emerging drugs are in a variety of other tumor types as shown in Table 4.
Attachment DeletedAttachment DeletedAttachment Deleted
Oncology Leading the Biosimilars Buzz
It is perhaps not surprising that the first-ever biosimilar to receive FDA approval (in March 2015) was a cancer drug, Zarxio (filgrastim-sndz), a biosimilar of the original drug Neupogen. What this means to curbing the costs of cancer care remains to be seen, but this approval has finally opened the way for biosimilar entry into the United States, trailing by several years behind Europe.
Several oncology biosimilars are currently in the pipeline and are expected to receive FDA approval in 2015, including:
Neupeg (pegfilgrastim), a biosimilar to Neulasta, is expected to be approved in August or September of this year
Grastofil, a second biosimilar to Neupogen, is expected to be approved in October
Retacrit (epoetin alfa), a biosimilar to Epogen and to Procrit, could be approved later in 2015.
This is likely just the beginning.
Abundance of Immunotherapies
Oncology continues to dominate the specialty drug pipeline, with recently introduced immunotherapies representing a variety of mechanisms of action, including the PD-1 antibodies; several anti-CD monoclonal antibodies; new HDAC inhibitors; novel agents targeting different proteins and mutations; new TKIs; and other multikinase inhibitors.
Therefore, despite the rising costs of cancer therapies, there is palpable excitement among those involved in cancer research, with a renewed sense that using human biology to fight cancer-producing cells may eventually move cancer from a death sentence and into the realm of chronic diseases, as in the case of HIV/AIDS. Perhaps not surprising, and similar to the case of HIV/AIDS, therapies that combine ≥2 drugs with several mechanisms of action are gaining more attention in cancer drug development. Combination therapies may indeed be the way of the future for cancer care, with the FDA continuing to approve new combination regimens that improve outcomes and prolong patients' lives.
But challenges remain with immunotherapies. Elaborating on the growing understanding of the role of immunotherapies in cancer care, Alise Reicin, Vice President of Clinical Research, Merck & Co, said, “We think the immune system does recognize cancer, and there is probably something called immune-editing going on, where the immune system finds the cancer and begins the process of trying to kill the tumor. But we're learning that tumors have developed ways to cloak themselves and deactivate the immune system. Tumors start to express a protein PD-L1 or PD-L2. These proteins interact with the protein on the T-cells, and they are able to deactivate the T-cells so that it no longer recognizes or kills the tumor.”
New Partnership under LLS's Therapy Acceleration Program to Advance Development of a Novel Targeted Therapy for T-Cell Leukemia and Lymphoma
WHITE PLAINS, N.Y. and VALENCIA, Calif., May 5 /PRNewswire-FirstCall/ -- The Leukemia & Lymphoma Society (LLS) and MannKind Corporation, (MNKD), today jointly announced the execution of a collaborative research arrangement funded through LLS's Therapy Acceleration Program (TAP).
TAP is an innovative program intended to advance therapies with high prospects of providing near-term benefit to patients suffering from blood cancers. The TAP funding will support MannKind's efforts to develop a novel and highly selective first-in-class targeted tyrosine kinase inhibitor for the treatment of T-cell leukemia and lymphoma. This early development work, if successful, will lead to the initiation of IND-enabling studies.
"The sponsorship of LLS will help MannKind to advance its development of a potential new blood cancer treatment," said Alfred Mann, Chairman and Chief Executive Officer of MannKind. "I am personally committed to taking innovative approaches to develop effective treatments for unmet medical needs. It is exciting and gratifying to be able to collaborate with a high-caliber organization that recognizes the importance of our research."
Louis J. DeGennaro, PhD, Chief Scientific Officer of LLS, added "Our partnership with MannKind is another example of LLS's commitment to support a select group of highly motivated, well positioned commercial organizations poised to bring effective therapies to blood cancer patients."
- See more at: investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=791873#sthash.SyzbLgL8.dpuf
The Latest Sales Figures in Oncology Drug Pipeline Update 2015
www.reportlinker.com/p02242592-summary/The-Latest-Sales-Figures-in-Oncology-Drug-Pipeline-Update.html
How May Drug Pipeline Update Be of Use?
* Show investors/board/management that you are right on top of drug development progress in your therapeutic area. * Find competitors, collaborations partners, M&A candidates etc. * Jump start competitive drug intelligence operations * Excellent starting point for world wide benchmarking * Compare portfolio and therapy focus with your peers * Speed up pro-active in-/out licensing strategy work
Compound Data
Compound type, Chemical name, CAS Number and molecular weight
Patent Data
Available patent information related to the drug is presented here.
Fillings and Approvals
Approvals and submissions
Analyst comments
Deals & Licensing
Collaborations and deals
Availability for licensing
Phase IV Data
Available Phase IV development data, developmental history and scientific data.
Phase III Data
Available Phase III development data, developmental history and scientific data.
Phase II Data
Available Phase II development data, developmental history and scientific data.
Phase I Data
Available Phase I development data, developmental history and scientific data.
Phase 0 Data
Available Phase 0 development data, developmental history and scientific data.
Preclinical Data
Available preclinical development data, developmental history and scientific data.
Discovery Data
Available discovery development data, developmental history and scientific data.
Identified drugs are linked to more than 86 different targets, divided into 27 classifications of molecular function:
- Acid phosphatase activity
- ATPase activity
- Catalytic activity
- Deaminase activity
- DNA topoisomerase activity
- DNA-methyltransferase activity
- G-protein coupled receptor activity
- Growth factor activity
- Isomerase activity
- Kinase activity
- Ligand-dependent nuclear receptor activity
- Ligase activity
- Lipid kinase activity
- Molecular function unknown
- Oxidoreductase activity
- Protein binding
- Protein serine/threonine kinase activity
- Protein threonine/tyrosine kinase activity
- Protein-tyrosine kinase activity
- Receptor activity
- Receptor binding
- Receptor signaling complex scaffold activity
- Structural constituent of cytoskeleton
- Transcription factor activity
- Transcription regulator activity
- Transmembrane receptor activity
- Transmembrane receptor protein tyrosine kinase activity
2015 Oncology Drugs in the Pipeline
www.healio.com/hematology-oncology/prostate-cancer/news/print/hemonc-today/%7B1ff53db9-a2b5-4833-bbc5-87113be3dc74%7D/2015-oncology-drugs-in-the-pipeline
The 2015 Oncology Drug Pipeline: Innovation Drives the Race to Cure Cancer
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4489190/
Fast Pace of Cancer Drug Approvals Continues into 2015
By mid-May 2015, 4 new molecular entities or new biologics have already received FDA approval for various tumor types, as well as 2 new indications for drugs that were initially approved by the FDA ≤1 year earlier, as listed in Table 1. Of these, 2 approvals were for rare diseases with few treatment options.
Cancer Drugs Approved by Mid-May 2015
One of these new approvals came on the heels of the other. On January 29, 2015, ibrutinib (Imbruvica) was the first cancer drug to receive a new indication this year, representing the first-ever medication to receive FDA approval for Waldenström's macroglobulinemia, a rare disease with few treatment options. On February 3, a new tyrosine kinase inhibitor (TKI), palbociclib (Ibrance), was approved for metastatic breast cancer.
On February 13, lenvatinib (Lenvima) became the newest TKI option for differentiated thyroid cancer, another rare disease. On February 17, lenalidomide (Revlimid) received a new indication for the first-line treatment of patients with multiple myeloma. On February 23, panobinostat (Farydak) became the first-ever histone deacetylase (HDAC) inhibitor to receive FDA approval, also for multiple myeloma.
On March 4, another immunotherapy, the first programmed cell death (PD)-1–blocking antibody, nivolumab (Opdivo), was approved by the FDA for the treatment of patients with metastatic squamous non–small-cell lung cancer (NSCLC).
This is a breathtaking list of new anticancer therapies, with promising outcomes demonstrated in early-stage clinical trials, and with many of the drugs receiving accelerated or priority regulatory reviews to facilitate early access to patients who may benefit from these promising therapies. It may be safe to presume that many of the cancer drugs approved last year will continue to receive second or third indications, or even more, and some will be further approved to facilitate enhanced outcomes within a combination regimen.
Of course, more new cancer drugs are expected to be approved in 2015. Of the 771 cancer drugs currently in development,6 several drugs are farther along in the process and are expected to be reviewed by the FDA between now and the end of 2015. These drugs potentially are:
Trabectedin (Yondelis), for chemotherapy-experienced soft-tissue sarcoma, is scheduled to be reviewed by the FDA for approval in July 2015
Cobimetinib, for melanoma, is scheduled for approval in August 2015
Gefitinib (Iressa), for first-line advanced or metastatic NSCLC with EGFR mutation; approval expected in September 2015
Sonidegib, for advanced basal-cell carcinoma, with approval expected in September 2015
Talimogene laherparepvec (T-VEC), for regionally or distally metastatic melanoma, is scheduled for approval in October
Necitumumab, for the first-line treatment of squamous NSCLC, with a scheduled date of December 2015
Trifluridine and tipiracil, for third-line therapy of refractory metastatic colorectal cancer, with approval expected by the end of the year.
Oncology Drugs Still a Pipeline Priority
According to the Pharmaceutical Research and Manufacturers of America (PhRMA), 771 new drugs and vaccines are in development by US companies; these agents are currently in clinical trials or have been submitted to the FDA for review.6 According to PhRMA, of the 771 drugs and vaccines currently in the pipeline6:
98 are being developed for lung cancer
87 for leukemia
78 for lymphoma
73 for breast cancer
56 for skin cancer
48 for ovarian cancer.
Overall, 3137 clinical trials for cancer drugs are being conducted in the United States. Of these, 1313 are ongoing and are no longer enrolling new patients.6 Again, an impressive list of therapies, some with new mechanisms of action that may bring significant changes to cancer care.
Certain trends seen in the FDA approvals in 2014 appear to be continuing in 2015. Of the 41 new molecular entities and new biologics approved last year, 9 were for cancer drugs, including 5 new molecular entities and 4 new biologics. Moreover, several of the new drugs received a second indication in 2014 soon after their initial approval, with some receiving 2 or 3 new indications in succession within a few months. If the first half of 2015 is any indication, this approval trend may linger into 2016 and beyond, with increasing numbers of cancer drugs introducing new mechanisms of action, first-in-class options, or new options for rare cancers.
Several tumor types have attracted significant attention among pharmaceutical developers in recent years, resulting in a concentration of new therapies in the pipeline for specific cancers. Among the categories currently leading the race for FDA approval of new cancer therapies are melanoma, breast cancer, and lung cancer (Table 2) and hematologic malignancies (Table 3). In addition, several important emerging drugs are in a variety of other tumor types as shown in Table 4.
Attachment DeletedAttachment DeletedAttachment Deleted
Oncology Leading the Biosimilars Buzz
It is perhaps not surprising that the first-ever biosimilar to receive FDA approval (in March 2015) was a cancer drug, Zarxio (filgrastim-sndz), a biosimilar of the original drug Neupogen. What this means to curbing the costs of cancer care remains to be seen, but this approval has finally opened the way for biosimilar entry into the United States, trailing by several years behind Europe.
Several oncology biosimilars are currently in the pipeline and are expected to receive FDA approval in 2015, including:
Neupeg (pegfilgrastim), a biosimilar to Neulasta, is expected to be approved in August or September of this year
Grastofil, a second biosimilar to Neupogen, is expected to be approved in October
Retacrit (epoetin alfa), a biosimilar to Epogen and to Procrit, could be approved later in 2015.
This is likely just the beginning.
Abundance of Immunotherapies
Oncology continues to dominate the specialty drug pipeline, with recently introduced immunotherapies representing a variety of mechanisms of action, including the PD-1 antibodies; several anti-CD monoclonal antibodies; new HDAC inhibitors; novel agents targeting different proteins and mutations; new TKIs; and other multikinase inhibitors.
Therefore, despite the rising costs of cancer therapies, there is palpable excitement among those involved in cancer research, with a renewed sense that using human biology to fight cancer-producing cells may eventually move cancer from a death sentence and into the realm of chronic diseases, as in the case of HIV/AIDS. Perhaps not surprising, and similar to the case of HIV/AIDS, therapies that combine ≥2 drugs with several mechanisms of action are gaining more attention in cancer drug development. Combination therapies may indeed be the way of the future for cancer care, with the FDA continuing to approve new combination regimens that improve outcomes and prolong patients' lives.
But challenges remain with immunotherapies. Elaborating on the growing understanding of the role of immunotherapies in cancer care, Alise Reicin, Vice President of Clinical Research, Merck & Co, said, “We think the immune system does recognize cancer, and there is probably something called immune-editing going on, where the immune system finds the cancer and begins the process of trying to kill the tumor. But we're learning that tumors have developed ways to cloak themselves and deactivate the immune system. Tumors start to express a protein PD-L1 or PD-L2. These proteins interact with the protein on the T-cells, and they are able to deactivate the T-cells so that it no longer recognizes or kills the tumor.”
