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LSX Nordic Congress 2018 - Presentation Oncology Venture Swe 18-09-14 08:54
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Ökat intresse Oncology Venture Swe 18-03-30 20:35
Sedermera Köpenhamn 2018-03-13 Oncology Venture Swe 18-03-13 08:18
Räcker... Oncology Venture Swe 18-03-02 18:28
Sweet... Oncology Venture Swe 18-02-12 10:55
Här var det Oncology Venture Swe 18-01-30 07:07
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2020-05-14 09:58 IP: gVeqdNxzz
Är du nu här inne och smutsar ner. Tidigare idag var du inne och klankade ner på en annan aktie... Var inte så jävla bitter... England håller på att öppna upp igen...
Oncology Venture / Northern Arizona University initiates COVID-19 testing projecT / Northern Arizona University initiates COVID-19 testing project
2020-04-27 23:07 IP: gVeqdNxzz

” The initiative calls for the cancer drug 2X-121 to be the first therapy tested against the COVID-19 virus at the CTSC, researchers indicated, adding the drug was developed by the Danish firm Oncology Venture, which recently signed a joint research agreement with PMI and NAU to evaluate 2X-121.”
Redigerades 2020-04-27
2020-04-15 12:54 IP: aTJZdvmqy
Precision Oncology News...

Second Chance for Dovitinib: Oncology Venture to Seek Approval for Once-Failed TKI in Kidney Cancer
Apr 14, 2020 | Caroline Hopkins
NEW YORK – After a recent meeting with the US Food and Drug Administration, the Denmark-headquartered biotech Oncology Venture said it plans to file a new drug application for dovitinib as a third-line option for patients with renal cell carcinoma (RCC) who are deemed likely to benefit based on the company"s proprietary drug response predictor, or DRP, tool.

Dovitinib, originally a product of Novartis, was once regarded as a failed therapeutic based on its inability to outperform sorafenib (Bayer"s Nexavar) in clinical trials. But this time around, Oncology Venture is hoping that its predictive DRP tool can turn the drug"s "failure" on its head.

"If and when we"re successful, we"ll be the first company able to utilize an algorithm-based AI tool as a diagnostic predictor in combination with an approved therapeutic that could treat a pretty challenging disease," said Oncology Venture CEO Steve Carchedi. The company plans to submit data on the drug and predictive tool at the same time, enabling the FDA to review dovitinib and the DRP simultaneously, according to Carchedi.

A recent meeting with the FDA was encouraging for Oncology Venture, though the company remained cautious in its statement about the interaction: "The FDA’s feedback provides guidance only and the review process is unpredictable and may or may not lead to a formal approval."

"Reinvigorating" dovitinib

When Oncology Venture bought the pan-tyrosine kinase inhibitor dovitinib from Novartis in 2018, the company was just beginning to transition into therapeutics from its previous standing as a pure diagnostic development company.

"Around 2017, 2018, we went on what I"ll call a "shopping spree" to identify compounds that had demonstrated levels of effectiveness for treating various cancers, but for whatever reason fell just short by way of statistical significance for their indications," said Carchedi.

Dovitinib, having demonstrated a median progression-free survival of 3.7 months versus 3.6 months for sorafenib, had not met its primary endpoint in its Phase III trial. But Oncology Ventures saw an opportunity in that more-or-less equivalent PFS result. While the drug hadn"t proven itself any better than sorafenib, it had clinically demonstrated that it was safe, and that it did have activity in RCC. Oncology Venture, accordingly, bought dovitinib from Novartis with the goal of using its DRP to determine the patients for whom the drug would show a higher response rate.

Oncology Ventures "had confidence in our ability to reinvigorate drugs," said Carchedi. "We developed a DRP for the molecule, and what we found was that we could identify those patients that would likely respond with upwards of 80 percent accuracy."

"More than a diagnostic"

Oncology Venture"s DRP tool, which Carchedi said will go "hand-in-glove" with dovitinib if approved, uses a proprietary algorithm-based AI technology to pinpoint which patients have a high likelihood of responding to the drug.

To develop the algorithm underlying the DRP tool for dovitinib, the company used cell lines treated with dovitinib, then trained the AI to pick up specific tumor biology and genomic tumor features associated with treatment response or resistance. The company did not disclose what, exactly, those specific tumor biology and genomic tumor features were.

In developing the DRP, Carchedi said, other information was used as well, such as gene expression from a large number of human tumors in their microenvironments. When applying DRP"s AI algorithm to analyze tumor samples, the tool uses the expression of 58 genes that have been gleaned using DNA arrays.

To validate the DRP for dovitinib, Oncology Venture used anonymized biopsy data from Novartis" Phase III trial.

"It really is more than a diagnostic," said Carchedi. "I use the term diagnostic loosely, but it"s really a drug-specific diagnostic platform."

If approved, Carchedi said, included on the label for dovitinib would be the fact that the drug is approved specifically for patients with renal cell carcinoma who are shown likely to respond based on the DRP screening tool. In practice, Carchedi explained, the DRP would be used on a patient"s tumor sample and then roughly one week later, the requesting oncologist would receive a report containing a prediction as to whether a patient is likely to respond to dovitinib.

"At the end of the day, the FDA wants to narrow the patient population … and we"re doing it with a tool that is not a basic tool for patients," Carchedi said.

Using data from more than 2,500 patients, Oncology Venture claims to have ultimately shown that the dovitinib DRP was able to identify responders, resulting in a two- to fourfold higher response rate among those deemed likely to respond by the DRP tool than among the group that had not been run through the DRP.

Approval on the basis of non-inferiority

In accordance with guidance from the FDA, Oncology Venture plans to package the DRP tool together with the data-mining results based on Novartis" Phase I, II, and III clinical trials when it files its NDA seeking approval for dovitinib based on non-inferiority compared with sorafenib.

"When we acquired the asset, [Novartis] had done all the heavy lifting that a company would have to go through in order to get a drug approved," said Carchedi. "We inherited all of that, so our clinical studies are done. Now, we are working on packaging the data on our DRP and the data on its activity with dovitinib to create a very robust package to file to the FDA."

Because the clinical data that the company will package within its NDA comes from the original trial comparing dovitinib and sorafenib, and that trial essentially showed that dovitinib was non-inferior to the comparator, this will become the basis on which Oncology Venture seeks approval. Although "non-inferiority" was not originally written into the protocol for the Novartis trial, Oncology Venture discussed with the FDA using PFS as an endpoint to seek approval based on non-inferiority. The FDA indicated that the NDA would be referred to the Oncologic Drugs Advisory Committee for review once submitted, and that it would not be necessary for the company to conduct any additional pre-clinical, safety, or clinical testing, for dovitinib.

According to Oncology Venture, dovitinib would address a significant unmet need for improved therapies in RCC. Globally, there are more than 342,000 new RCC diagnoses each year, and metastatic kidney cancer has a five-year survival rate of just 12 percent. Currently, sorafenib — possibly together with a PD-1 inhibitor — is standard of care for patients with stage III or IV RCC. Unlike other TKIs that exist as standard of care for advanced kidney cancer, including sorafenib, one of the targets that dovitinib inhibits is FGFR, shown to be associated with RCC progression.

Going forward, Oncology Venture plans to develop its DRP for use with other assets in its pipeline, too, including a PARP inhibitor, 2X-121, which is currently in Phase II clinical trials for patients with advanced ovarian cancer. Similar to how the company is packaging the DRP with dovitinib, Oncology Venture plans to refine its development of a specific 2X-121 DRP to predict patients who are highly likely to respond to the PARP inhibitor
2020-01-22 15:20 IP: 5fsAyK8As
Uppe och touchar på 3:an nu...
Oncology Venture / Ledande befattningshavare i Oncology Venture deltar i bolagets pågående nyemission / Ledande befattningshavare i Oncology Venture deltar i bolagets pågående nyemission
2019-05-02 14:52 IP: gVeqdNxzz
Ledande befattningshavare i Oncology Venture deltar i bolagets pågående nyemission (GlobeNewswire)
2019-05-02 13:00

Hoersholm, Danmark och Cambridge, MA, USA, 2 maj 2019 – Oncology Venture A/S meddelar idag att Duncan Moore, styrelseordförande, Peter Bul Jensen, vd, (genom Buhl Krone Holding ApS), Niels Laursen, CFO, och Claus Frisenberg Pedersen, CCO, kommer delta i den pågående nyemissionen genom teckning av aktier till ett totalt belopp om cirka SEK 2 miljoner.

Handel med teckningsrätter återupptas fredagen den 3 maj 2019 och avslutas den 8 maj 2019. Teckning av aktier kan ske till och med den 10 maj 2019.

För ytterligare information, vänligen kontakta:
För investerarfrågor
Ulla Hald Buhl
IR & Communications
Telefon +45 21 70 10 49

För mediafrågor
Thomas Pedersen
Carrotize PR & Communications
Telefon +45 60 62 93 90
Oncology Venture Swe / LSX Nordic Congress 2018 - Presentation / LSX Nordic Congress 2018 - Presentation
2018-09-14 08:54 IP: gVeqdNxzz
2018-06-29 17:17 IP: gVeqdNxzz

2018-06-29 16:56
STOCKHOLM (Direkt) Oncology Venture och Medical Prognosis Institute har för avsikt att på kvartalsbasis publicera kliniska uppdateringar gällande bolagets projekt och aktiviteter. Den första uppdateringen kommer genom pressmeddelande på måndagen den 2 juli efter klockan 12.

Det framgår av ett pressmeddelande.

I mars meddelades att Oncology Venture hade kommit överens om en fusion med Medical Prognosis Institute.

Johan Lind +46 8 5191 7954

Nyhetsbyrån Direkt

2018-05-15 11:54 IP: 3TJvtt1uk
Tror att så fort första affären är i hamn och man ser värdet på den så kliver upp ordentligt. Marknaden behöver bara få det svart på vitt.

Arbete pågår givetvis fortlöpande och vi kan inte kräva PM stup i kvarten.
2018-03-30 20:35 IP: gVeqdNxzz
Får ju hoppas att fler BP fått upp ögonen för OV efter BIO-Europe... Man bör ju dock inrikta sig på att komma till avslut med Liplacis och TKI innan man tar på sig fler projekt... Tufft för oss aktieägare att ställa upp med cash två gånger om året...
Oncology Venture Swe / Presentation / Sedermera Köpenhamn 2018-03-13
2018-03-13 08:18 IP: RmtHfhAcw
10:30 - 11:00 är det OV som ska köra.
2018-03-02 18:28 IP: gVeqdNxzz
För mig att har gör ett utspel innan Juli...


Det är Claus på OV. Vi har boxat ett avtal för TKI som ger OV 3,6 miljarder upfront plus royalties.


2018-02-12 10:55 IP: aU5FDNXA6
Då säljer vi LiPlaCis till Kina, tar lite av pengarna och köper loss andelen i TKI som S&L sitter på. Därefter kränger vi TKI för många pengar och köper MPI.

Tjoff tjoff allt i samma bolag...
2018-01-30 07:07 IP: nNlqWgl+C
Helt dött...

Dax för att steppa upp med resultat av LiPlaCis, teckningsgrad i emissionen etc.
Tror att första halvan på 2018 blir intressant och förhoppningsvis kommer även det att resultera i en stigande aktiekurs.

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