Purple Biotech (PPBT) ehemals KTOV (Mkap $16 M) ( Cash $17 M) US Zulassungsantrag diesen Quartal (Seite 62)
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FeedbackEs passiert was - nur wann?
Die aktuelle Nicht-Kommunikation unseres CEO ist irgendwie strange und kann 2 Dinge bedeuten:1) Das Meeting mit Namensänderung war irrelevant
2) Es passt zum Drehbuch. Erst wenn die Namensänderung umgesetzt ist, wird kommuniziert
Ich tendiere zu 2) - wie würde dann der Zeitplan aussehen, sprich: Wann werden Big News kommuniziert?
Antwort auf Beitrag Nr.: 65.946.153 von Marclpet55 am 04.12.20 10:59:44TOP !!! 🙂🙂👍👍
Antwort auf Beitrag Nr.: 65.946.360 von 2brix am 04.12.20 11:12:46Gerne, allen ein schönes Wochenende!
Antwort auf Beitrag Nr.: 65.946.153 von Marclpet55 am 04.12.20 10:59:44super Zusammenfassung.
Vielen Dank 👏🎁
Vielen Dank 👏🎁
Danke Sven für den interessanten Artikel. Alles was man über NT219 wissen muß, steht in dem Artikel.
Ich fasse einmal das Wesentliche zusammen:
1. Das größte Problem der Krebsbekämpfung liegt darin, dass Krebs mutiert und nach einiger Zeit resistent wird gegen die verabreichten Medikamente und deren Wirkung daher immer geringer wird.
2. Inbesondere die Wirkungsmechanismen IRS1/2 und STAT3 befähigen Krebszellen resistent zu werden. Der Inhibitor NT219 setzt genau hier an und soll angeblich IRS1/2 blockieren und STAT3 neutralisieren.
3. Bemerkenswert ist dass die Resistenz ausgelöst durch IRS1/2 und STAT 3 bei sehr vielen Krebsarten auftritt, das Marktpotential ist daher riesig.
4. Positiv ist auch, dass es bisher wohl keine vergleichbaren Inhibitors gibt, das heißt Kitov ist die erste Firma, die an diesem Punkt forscht und entwickelt.
5. Kitov will kein Stand Alone Produkt entwickeln, sondern spätestens nach Phase 2 Partnerschaften eingehen, um die Phase 3 zu stemmen.
6. Es gibt einen Satz, der mir nicht gefällt.
NT-219 was found to be ineffective when used as a standalone drug.
Wen dem so ist, warum ist Teil der Phase 1 auch eine Monotherapie. Ich meine in einer PR von Kitov auch gelesen zu haben, dass auch die ersten Ergebnisse einer Monotherapie vielversprechend waren. Das ist irgendwie widersprüchlich.
7. In Phase1/2 wird an 85 Patienten und in mehreren Kliniken getestet. Bisher haben nur 2 Kliniken den Stats „Recruiting“. Das ist etwas enttäuschend, hängt vielleicht auch mit COVID zusammen.
Wie ich schon schrieb, war die HV und die Namenänderung ein Non-Event. Würde mich nicht wundern, wenn einige abspringen, weil sie auf eine große News gesetzt haben. Alles was zählt sind die Studienergebnisse und die werden wohl erst im 2. Halbjahr 2021 kommen. Vorher wird sich auch im Kurs nicht viel tun. Da die Börsen überfällig für eine Korrektur sind, könnte es auch noch einmal in Richtung 3USD gehen. In meinem Depot ist noch etwas Platz😀
Good luck!
Ich fasse einmal das Wesentliche zusammen:
1. Das größte Problem der Krebsbekämpfung liegt darin, dass Krebs mutiert und nach einiger Zeit resistent wird gegen die verabreichten Medikamente und deren Wirkung daher immer geringer wird.
2. Inbesondere die Wirkungsmechanismen IRS1/2 und STAT3 befähigen Krebszellen resistent zu werden. Der Inhibitor NT219 setzt genau hier an und soll angeblich IRS1/2 blockieren und STAT3 neutralisieren.
3. Bemerkenswert ist dass die Resistenz ausgelöst durch IRS1/2 und STAT 3 bei sehr vielen Krebsarten auftritt, das Marktpotential ist daher riesig.
4. Positiv ist auch, dass es bisher wohl keine vergleichbaren Inhibitors gibt, das heißt Kitov ist die erste Firma, die an diesem Punkt forscht und entwickelt.
5. Kitov will kein Stand Alone Produkt entwickeln, sondern spätestens nach Phase 2 Partnerschaften eingehen, um die Phase 3 zu stemmen.
6. Es gibt einen Satz, der mir nicht gefällt.
NT-219 was found to be ineffective when used as a standalone drug.
Wen dem so ist, warum ist Teil der Phase 1 auch eine Monotherapie. Ich meine in einer PR von Kitov auch gelesen zu haben, dass auch die ersten Ergebnisse einer Monotherapie vielversprechend waren. Das ist irgendwie widersprüchlich.
7. In Phase1/2 wird an 85 Patienten und in mehreren Kliniken getestet. Bisher haben nur 2 Kliniken den Stats „Recruiting“. Das ist etwas enttäuschend, hängt vielleicht auch mit COVID zusammen.
Wie ich schon schrieb, war die HV und die Namenänderung ein Non-Event. Würde mich nicht wundern, wenn einige abspringen, weil sie auf eine große News gesetzt haben. Alles was zählt sind die Studienergebnisse und die werden wohl erst im 2. Halbjahr 2021 kommen. Vorher wird sich auch im Kurs nicht viel tun. Da die Börsen überfällig für eine Korrektur sind, könnte es auch noch einmal in Richtung 3USD gehen. In meinem Depot ist noch etwas Platz😀
Good luck!
Trading Spotlight
Antwort auf Beitrag Nr.: 65.944.893 von Sven_Bonn am 04.12.20 09:37:06nur zur Info..
NICHT AKTUELL! !
von Dec 17, 2018
NICHT AKTUELL! !
von Dec 17, 2018
auf boomberg:
https://sponsored.bloomberg.com/news/sponsors/kitov-pharmace…
Cancer Survival Hopes Raised by Kitov’s New Concept in Cancer Therapy
In the ongoing struggle to find better ways of treating cancer, a critical new development could improve the survival hopes of patients worldwide. Kitov Pharma, an innovative Israeli biopharmaceutical company, has developed a molecule that preclinical trials showed to be capable of removing the lethal ability of tumors to make themselves resistant to anti-cancer therapies.
The molecule, NT-219, was found to completely block the progression of various cancer tumors when used in combination with a wide array of anti-cancer therapies, including Keytruda®, a widely used immunotherapy drug based on the humanized antibody pembrolizumab. This potential therapeutic advance was achieved by blocking the ability of cancer cells to develop resistance to anti-cancer drugs.
Crucially, NT-219 was shown to be effective in neutering two different “escape” mechanisms that tumors use to resist anti-cancer therapies. These two pathways, IRS (Insulin Receptor Substrates) 1/2 and STAT3 (Signal Transducer and Activator of Transcription 3), can be triggered by the use of multiple anti-cancer drugs, rendering therapies ineffective.
The studies, conducted by Kitov Pharma, found that NT-219 blocked these pathways, preventing a tumor’s drug resistance. But malignancy was reduced only when NT-219 and the anti-cancer drugs were used in tandem, and was unaffected when the drugs were applied separately.
The findings could be highly significant. According to the World Health Organization, 9.6 million people died from cancers in 2018, and 18.1 million new cases were diagnosed.
“The problem of acquired resistance to cancer drugs is a well-known and huge problem worldwide,” says Isaac Israel, Kitov’s CEO. “In almost any drug therapy, the drug works initially, and then, after a certain amount of time, the tumor, which is much more sophisticated than we imagine, has the capacity to mutate and find a path to escape from the treatment.”
When used in combination with existing therapies in pre-clinical trials, NT-219 has demonstrated potent anti-tumor effects that could benefit patients with a range of cancers, including sarcoma, melanoma, pancreatic, lung, ovarian, head and neck, prostate and colon.
Other preclinical trials of NT-219 have shown it reverses tumor resistance to drugs such as Tarceva® or Tagrisso® in fighting head and neck cancer and lung cancer, desensitizes pancreatic cancer to chemotherapy, and prevents acquired resistance of thyroid cancer malignancies to the anti-cancer drug Trametinib (Mekinist®).
Kitov will submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA), and aims to initiate clinical trials of NT-219 in 2019.
These clinical trials will help determine how NT-219 can be used in combination with other anti-cancer therapies, for example studying the drug’s impact on pancreatic cancer patients when used alongside gemcitabine (Gemzar®), and its effect on non-small cell lung cancer patients when used in conjunction with osimertinib (Tagrisso®).
The NT-219 story begins with Dr. Hadas Reuveni, a specialist in anti-cancer drug discovery and the founder and Chief Technology Officer of TyrNovo, a subsidiary of Kitov. NT-219 emerged from research that Dr. Reuveni undertook with world-renowned biochemist Professor Alexander Levitzki from the Hebrew University of Jerusalem, is a Wolf Prize in Medicine laureate in 2005 for his work developing anti-cancer agents.
After founding TyrNovo, Dr. Reuveni focused on bringing NT-219 to clinical trial. The resistance of tumors to anti-cancer therapies is “the most serious problem we face today in oncology,” says Dr. Reuveni, who was formerly head of R&D at American biopharmaceutical company Keryx, where she developed agents for use in oncology, and for treating diabetes and cardiovascular diseases.
NT-219 was found to be ineffective when used as a standalone drug, but in combination with other therapies it converts non-responsive tumors to responsive and induces regression of highly aggressive tumors, by inhibiting two feedback mechanisms, IRS1/2 and STAT3. “The paradox is that these survival pathways are unexpectedly activated by many anti-cancer drugs, preventing cancer cell death and leading to drug resistance," she says. This is true for many targeted oncology drugs as well as for chemotherapy. This is the name of the game here, because inhibiting only one of the pathways is not enough.”
Applying what Dr. Reuveni describes as “a new concept in cancer therapy,” NT-219 has been found to remove one of the pathways and neutralize the other. “NT-219 is a small molecule that eliminates IRS1/2 from the cells in a unique mechanism that we haven’t seen in other oncology drugs, and it shuts down STAT3 effectively and for a long term. The combination of these activities in one molecule makes it first-in-class,” she says.
In addition, STAT3 has a major role in the immune evasion of the tumor, and blockage of STAT3 may sensitize the tumor to anti-cancer immune attack. Many cancer patients do not respond to immuno-oncology therapies, since additional mechanisms, like enhanced STAT3, prevent cell death.
The Kitov study found that NT-219 converted nonresponsive tumors to responsive ones, enabling Keytruda® to do its job of helping the immune system destroy the cancer cells.
The success of preclinical trials of NT-219 marks an important moment for Kitov, which acquired a majority holding in TyrNovo in January 2017, and has a proven track record of drug development leading to FDA approval. Founded in 2010, Kitov is based in Tel Aviv and Washington, D.C., where former FDA staff are on its team. The company made its IPO on NASDAQ in 2015, and has a market capitalization of $21.1 million (as of Nov. 2018).
Dr. J.Paul Waymack, Chairman of Kitov’s board of directors and its Chief Medical Officer, is a former FDA medical officer with a history of bringing oncology drugs to approved status. “Kitov is excited with the results of the latest preclinical trials of NT-219”, he says. “We are focused on advancing this highly promising therapeutic candidate to clinical trials as quickly as possible in order to provide enhanced treatment options to cancer patients,” he says.
The progress toward clinical trials of NT-219 is part of the diverse pipeline of drugs being developed and brought to market by Kitov. The company’s flagship drug, Consensi™, used for the simultaneous treatment of osteoarthritic pain and hypertension, was approved for marketing by the FDA in May 2018.
Consensi™, which is also based on the principle of using therapies in combination and combines the drugs celecoxib and amlodipine in a single pill, could be used to treat a vast number of patients worldwide. In the US alone, 103.3 million people are classified as having hypertension according to a new guideline released by the American College of Cardiology and American Heart Association in November 2017.
Unlike Consensi™, which Kitov developed as a complete product, NT-219 is viewed as an add-on that the company believe will improve a patient’s response to existing therapies and extends the duration of treatment. “We are not required to develop or manufacture NT-219, together with Keytruda or any other existing therapy, as a single product,” says Isaac Israel. “It’s about developing NT-219 and providing it in the right combination with previously approved drugs.”
He believes that the potential market for NT-219, which is expected to be administered to patients via intravenous infusion, is huge. “The beauty of NT-219 is that it’s been found, in pre-clinical trials, to be very effective in a wide range of combinations of therapies,” Mr. Israel says. “So the market is enormous.”
He noted that Merck & Co.’s Keytruda®, for example, has already reached “blockbuster” status — generating more than $4 billion in annual sales — despite the fact that the drug shows an effective response rate of about 40 percent in certain indications. “If one can increase the effectiveness of Keytruda® by even 10 percent, this would be a major advance, and this is just one specific drug”, continued Mr. Israel.
“Kitov is looking to partner with other companies in order to test NT-219 in combination with other therapies,” he says.
Kitov plans to submit the application for IND in 2019. Should the safety and efficacy of NT-219 be shown in human trials, Kitov will look for a partner to take the product to market. “Our current strategy is to license the drug to players that have the resources to further develop this exciting drug in a phase 3 clinical trial and get it approved,” Mr Israel explains.
The vital struggle between cancerous tumors and cancer drugs goes on. But Dr. Reuveni says her fellow cancer scientists have reacted positively to her presentation of data on NT-219 at international conferences. “NT219 presents a new concept in anti-cancer therapies. There aren’t any other dual inhibitors of IRS and STAT3 in development, and the effects are very compelling,” she says.
Written by Ian Burrell, for Bloomberg Media Studios
https://sponsored.bloomberg.com/news/sponsors/kitov-pharmace…
Cancer Survival Hopes Raised by Kitov’s New Concept in Cancer Therapy
In the ongoing struggle to find better ways of treating cancer, a critical new development could improve the survival hopes of patients worldwide. Kitov Pharma, an innovative Israeli biopharmaceutical company, has developed a molecule that preclinical trials showed to be capable of removing the lethal ability of tumors to make themselves resistant to anti-cancer therapies.
The molecule, NT-219, was found to completely block the progression of various cancer tumors when used in combination with a wide array of anti-cancer therapies, including Keytruda®, a widely used immunotherapy drug based on the humanized antibody pembrolizumab. This potential therapeutic advance was achieved by blocking the ability of cancer cells to develop resistance to anti-cancer drugs.
Crucially, NT-219 was shown to be effective in neutering two different “escape” mechanisms that tumors use to resist anti-cancer therapies. These two pathways, IRS (Insulin Receptor Substrates) 1/2 and STAT3 (Signal Transducer and Activator of Transcription 3), can be triggered by the use of multiple anti-cancer drugs, rendering therapies ineffective.
The studies, conducted by Kitov Pharma, found that NT-219 blocked these pathways, preventing a tumor’s drug resistance. But malignancy was reduced only when NT-219 and the anti-cancer drugs were used in tandem, and was unaffected when the drugs were applied separately.
The findings could be highly significant. According to the World Health Organization, 9.6 million people died from cancers in 2018, and 18.1 million new cases were diagnosed.
“The problem of acquired resistance to cancer drugs is a well-known and huge problem worldwide,” says Isaac Israel, Kitov’s CEO. “In almost any drug therapy, the drug works initially, and then, after a certain amount of time, the tumor, which is much more sophisticated than we imagine, has the capacity to mutate and find a path to escape from the treatment.”
When used in combination with existing therapies in pre-clinical trials, NT-219 has demonstrated potent anti-tumor effects that could benefit patients with a range of cancers, including sarcoma, melanoma, pancreatic, lung, ovarian, head and neck, prostate and colon.
Other preclinical trials of NT-219 have shown it reverses tumor resistance to drugs such as Tarceva® or Tagrisso® in fighting head and neck cancer and lung cancer, desensitizes pancreatic cancer to chemotherapy, and prevents acquired resistance of thyroid cancer malignancies to the anti-cancer drug Trametinib (Mekinist®).
Kitov will submit an investigational new drug (IND) application to the U.S. Food and Drug Administration (FDA), and aims to initiate clinical trials of NT-219 in 2019.
These clinical trials will help determine how NT-219 can be used in combination with other anti-cancer therapies, for example studying the drug’s impact on pancreatic cancer patients when used alongside gemcitabine (Gemzar®), and its effect on non-small cell lung cancer patients when used in conjunction with osimertinib (Tagrisso®).
The NT-219 story begins with Dr. Hadas Reuveni, a specialist in anti-cancer drug discovery and the founder and Chief Technology Officer of TyrNovo, a subsidiary of Kitov. NT-219 emerged from research that Dr. Reuveni undertook with world-renowned biochemist Professor Alexander Levitzki from the Hebrew University of Jerusalem, is a Wolf Prize in Medicine laureate in 2005 for his work developing anti-cancer agents.
After founding TyrNovo, Dr. Reuveni focused on bringing NT-219 to clinical trial. The resistance of tumors to anti-cancer therapies is “the most serious problem we face today in oncology,” says Dr. Reuveni, who was formerly head of R&D at American biopharmaceutical company Keryx, where she developed agents for use in oncology, and for treating diabetes and cardiovascular diseases.
NT-219 was found to be ineffective when used as a standalone drug, but in combination with other therapies it converts non-responsive tumors to responsive and induces regression of highly aggressive tumors, by inhibiting two feedback mechanisms, IRS1/2 and STAT3. “The paradox is that these survival pathways are unexpectedly activated by many anti-cancer drugs, preventing cancer cell death and leading to drug resistance," she says. This is true for many targeted oncology drugs as well as for chemotherapy. This is the name of the game here, because inhibiting only one of the pathways is not enough.”
Applying what Dr. Reuveni describes as “a new concept in cancer therapy,” NT-219 has been found to remove one of the pathways and neutralize the other. “NT-219 is a small molecule that eliminates IRS1/2 from the cells in a unique mechanism that we haven’t seen in other oncology drugs, and it shuts down STAT3 effectively and for a long term. The combination of these activities in one molecule makes it first-in-class,” she says.
In addition, STAT3 has a major role in the immune evasion of the tumor, and blockage of STAT3 may sensitize the tumor to anti-cancer immune attack. Many cancer patients do not respond to immuno-oncology therapies, since additional mechanisms, like enhanced STAT3, prevent cell death.
The Kitov study found that NT-219 converted nonresponsive tumors to responsive ones, enabling Keytruda® to do its job of helping the immune system destroy the cancer cells.
The success of preclinical trials of NT-219 marks an important moment for Kitov, which acquired a majority holding in TyrNovo in January 2017, and has a proven track record of drug development leading to FDA approval. Founded in 2010, Kitov is based in Tel Aviv and Washington, D.C., where former FDA staff are on its team. The company made its IPO on NASDAQ in 2015, and has a market capitalization of $21.1 million (as of Nov. 2018).
Dr. J.Paul Waymack, Chairman of Kitov’s board of directors and its Chief Medical Officer, is a former FDA medical officer with a history of bringing oncology drugs to approved status. “Kitov is excited with the results of the latest preclinical trials of NT-219”, he says. “We are focused on advancing this highly promising therapeutic candidate to clinical trials as quickly as possible in order to provide enhanced treatment options to cancer patients,” he says.
The progress toward clinical trials of NT-219 is part of the diverse pipeline of drugs being developed and brought to market by Kitov. The company’s flagship drug, Consensi™, used for the simultaneous treatment of osteoarthritic pain and hypertension, was approved for marketing by the FDA in May 2018.
Consensi™, which is also based on the principle of using therapies in combination and combines the drugs celecoxib and amlodipine in a single pill, could be used to treat a vast number of patients worldwide. In the US alone, 103.3 million people are classified as having hypertension according to a new guideline released by the American College of Cardiology and American Heart Association in November 2017.
Unlike Consensi™, which Kitov developed as a complete product, NT-219 is viewed as an add-on that the company believe will improve a patient’s response to existing therapies and extends the duration of treatment. “We are not required to develop or manufacture NT-219, together with Keytruda or any other existing therapy, as a single product,” says Isaac Israel. “It’s about developing NT-219 and providing it in the right combination with previously approved drugs.”
He believes that the potential market for NT-219, which is expected to be administered to patients via intravenous infusion, is huge. “The beauty of NT-219 is that it’s been found, in pre-clinical trials, to be very effective in a wide range of combinations of therapies,” Mr. Israel says. “So the market is enormous.”
He noted that Merck & Co.’s Keytruda®, for example, has already reached “blockbuster” status — generating more than $4 billion in annual sales — despite the fact that the drug shows an effective response rate of about 40 percent in certain indications. “If one can increase the effectiveness of Keytruda® by even 10 percent, this would be a major advance, and this is just one specific drug”, continued Mr. Israel.
“Kitov is looking to partner with other companies in order to test NT-219 in combination with other therapies,” he says.
Kitov plans to submit the application for IND in 2019. Should the safety and efficacy of NT-219 be shown in human trials, Kitov will look for a partner to take the product to market. “Our current strategy is to license the drug to players that have the resources to further develop this exciting drug in a phase 3 clinical trial and get it approved,” Mr Israel explains.
The vital struggle between cancerous tumors and cancer drugs goes on. But Dr. Reuveni says her fellow cancer scientists have reacted positively to her presentation of data on NT-219 at international conferences. “NT219 presents a new concept in anti-cancer therapies. There aren’t any other dual inhibitors of IRS and STAT3 in development, and the effects are very compelling,” she says.
Written by Ian Burrell, for Bloomberg Media Studios
Guten Morgen zusammen,
tja.. da hat unser Isaac ja mal wieder nur das Nötigste gesagt. Böse Zungen behaupten, dass es das Meeting garnicht gab und die Ergebnisse vorher schon feststanden.
Anyway.. dass es so sachlich und ohne Hype durchgeführt wurde, macht es noch merkwürdiger. Würde Purple den Weg alleine gehen wollen, hätte man sicher mehr daraus gemacht.
Ich denke, wir müssen nun einfach auf dem "Masterplan" warten und Geduld zeigen.. und dann ist es hoffentlich PAY-tience...
Momentan würde es auch keinen Sinn mehr machen, unter dem alten Brand Kitov etwas zu veröffentlichen. Die hoffentlich bahnbrechenden News werden sicher alle unter dem Brand PURPLE veröffentlicht werden, in welcher Form auch immer...
Herzlichen Gruß
Sven
tja.. da hat unser Isaac ja mal wieder nur das Nötigste gesagt. Böse Zungen behaupten, dass es das Meeting garnicht gab und die Ergebnisse vorher schon feststanden.
Anyway.. dass es so sachlich und ohne Hype durchgeführt wurde, macht es noch merkwürdiger. Würde Purple den Weg alleine gehen wollen, hätte man sicher mehr daraus gemacht.
Ich denke, wir müssen nun einfach auf dem "Masterplan" warten und Geduld zeigen.. und dann ist es hoffentlich PAY-tience...
Momentan würde es auch keinen Sinn mehr machen, unter dem alten Brand Kitov etwas zu veröffentlichen. Die hoffentlich bahnbrechenden News werden sicher alle unter dem Brand PURPLE veröffentlicht werden, in welcher Form auch immer...
Herzlichen Gruß
Sven
Antwort auf Beitrag Nr.: 65.943.321 von 2brix am 04.12.20 07:30:15Geduld wird sich auszahlen. Einfach liegen lassen, wenn Du von der Pipeline überzeugt bist!
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