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Woman in Chains32
4
Belangrijk jaar voor Onxeo met klinische data van DRIIV-1b (AsiDNA™ 600 mg + carboplatin + paclitaxel) in kleine kanker patiëntenpopulatie,
en ook voorlopige data voor einde van het jaar van fase 2 studie AsiDNA™ + niraparib (PARPi).


20-1-2020 shareholder letter

It is with great pleasure that I am addressing you at the beginning of this
year, after an eventful year in 2019, which Onxeo will be able to build on in 2020 to develop its key assets, notably AsiDNA™,our first tumor DNA repair inhibitor candidate at clinical stage.

What can we learn from 2019?
...and what can we expect from 2020?

First of all, 2019 was the year of the results of the first
administration in man of AsiDNA™ by IV route. The DRIIV clinical
study demonstrated the very good safety profile of AsiDNA™ and
genuinely proved the mechanism of its clinical action, with the
robust activation of biomarkers in tumor cells. 2019 will thus
remain the year that proved that AsiDNA™ is active and very well
tolerated when administered intravenously in humans.

Because of its mechanism of action, AsiDNA™ is an anti-cancer
agent that is particularly well suited for use in combination with
other agents that “break” tumor DNA. We, therefore, chose as
priority development the combination of AsiDNA™ first with
chemotherapy agents, and soon with a PARP inhibitor (PARPi) (=REVOCAN).

DRIIV-1b was thus initiated as soon as 2019 as the first combination
study of AsiDNA™ in patients eligible carboplatin and then
carboplatin + paclitaxel (DRIIV-1b) for advanced multi-treated cancers.
First
results are already available: a good safety profile confirmed, two of
the three patients in the first group included had their disease
"controlled", and tumor progression was stopped for a period longer
than that of previous treatments. The study continues with
additional results expected from the 1st quarter of 2020.


At the same time, the preparation of REVOCAN has mobilized the
R&D teams. Our objective: to demonstrate AsiDNA™'s ability to
overcome the acquired resistance of tumors to niraparib
(Tesaro/GSK PARPi). This study is particularly important because
acquired resistance to PARPi and more generally to targeted
therapies, enables the tumor to resume its progression despite
treatment, after a few weeks or months, which constitutes a real
hurdle today for the efficacy of these agents. Demonstrating the
capability of AsiDNA™ to counteract the resistance to PARPi would position our product as a leading treatment to avoid or delay this
type of resistance.


On the basis of preclinical data constantly showing such an effect
of AsiDNA™ in association with PARPi or other types of targeted
therapies, we are ready to start REVOCAN as early as early 2020, in
collaboration with a network of leading academic centers.
Preliminary results are expected before year end.


Finally, 2019 will also be remembered as the year of birth of
OX401, sourced from our platON™ platform which is dedicated to
designing agents that all share the same decoy agonist mechanism
as AsiDNA™. OX401 is a next generation PARP inhibitor, which both
inhibits PARP without inducing resistance and activates the STING
immune pathway. This approach is the focus of a great deal of
research, as it appears promising in terms of efficacy but poses real
problems in terms of tolerance. From the same family as AsiDNA™,
which has a good tolerance profile, OX401 could become a very
promising candidate when the preclinical proof of concept is
confirmed in 2020. Onxeo is thus positioned in two high-potential
areas, the DNA damage response and immuno-oncology.


Of course, these are only the key developments that are listed
here... the tip of the iceberg. Rest assured that all teams have been
and remain mobilized in 2020, in order to implement, despite a
sometimes difficult environment, the elements of success that
should enable us to confirm the value of our assets and the
Company more broadly.

On behalf of all the Onxeo teams, I thank you for your support and
interest in our company, our products and our work. We look
forward to keeping you informed as we move forward.
With kind regards,

Judith Greciet (CEO Onxeo)


"Demonstrating the capability of AsiDNA™ to overcome the resistance to PARPi would position our product as a leading treatment to avoid or delay this type of resistance".


www.onxeo.com/wp-content/uploads/2020...


2020
1) First efficacy signals expected from Q1 2020 (AsiDNA > DRIIV-1b)
2) Inclusion of the first patients in H1 2020, first results end 2020 (AsiDNA + niraparib > REVOCAN)
3) Preclinical proof of concept in 2020 (OX401, a next-generation PARPi
with double action)



Marktwaarde van kleine €40 miljoen, weinig liquide middelen (+/-€5 miljoen) maar wel een platON™ platform wat begint te leveren, middels AsiDNA en OX401. Eigen combi-studies in toekomst kan een gouden greep blijken, afhankelijk hoe goed deze 2 therapieën werken.
C200
0
Onxeo to Present Next-Generation PARP inhibitor, OX401, at PARP & DDR Inhibitors Summit 2020
 

The press release in PDF



Paris (France), January 28, 2020 – 5:45 pm CET – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, today announces that the Company’s Chief Scientific Officer, Françoise Bono, will present OX401, a next-generation PARP inhibitor (PARPi) of the Company, during an oral presentation at the PARP & DDR Inhibitors Summit 2020 held in Boston, MA on January 29-30, 2020.

“OX401 benefits from our accumulated insight into the unique decoy agonist mechanism already present in our clinical-stage DDR inhibitor AsiDNA™ and we are excited to present this very innovative PARP inhibitor to the world’s most recognized stakeholders in DNA Damage Response,” said Françoise Bono, Chief Scientific Officer of Onxeo. “We are in the process of building a strong preclinical data set for OX401, which was optimized to be potent on both PARP inhibition and STING response and to bypass resistance as well as homologous recombination deficiency requirements, two of the major hurdles faced by PARP inhibitors today.”

OX401 is the second candidate sourced from Onxeo's proprietary platform of decoy agonists, platON™. This new compound was optimized to maintain this unique mechanism of action, while targeting other DNA-binding proteins and other mechanisms involved in tumor growth, such as the immune response. Its properties position OX401 at the crossroads of two of the most active areas in oncology, DNA Damage Response and immunotherapy.
 
Session: Innovative Approaches to Targeting the DDR

Date: Thursday, January 30, 2019 - 2:30 pm EST
Location: Revere Hotel Boston Common, Boston, MA - USA

Oral presentation: Introducing OX401, a Next Generation PARP Inhibitor Able to Exploit Metabolic Vulnerabilities of Cancer Cells and Inducing a Potent STING Response

Introducing a ‘first-in-class’ Decoy Agonist candidate which sequesters and hyperactivates PARP Displaying selective activity in tumor cells versus healthy cells, regardless of HR status as OX401 does not induce DNA breaks or acquired resistance Exploiting a potentially synthetic lethal pathway in tumors with metabolic vulnerabilities by hyper-activating PARP and inducing NAD+ overconsumption Eliciting a potent STING response by inducing micronuclei induction
C200
1
Onxeo Enters Clinical Research Agreement with
Gustave Roussy to Conduct Clinical Trial of AsiDNA™
for Treatment of Relapsed Ovarian Cancer
The REVOCAN phase 1b/2 study, sponsored by Gustave Roussy, will evaluate
the effect of AsiDNA™ on the acquired resistance to PARP inhibitor niraparib
in 2nd line maintenance treatment of relapsed ovarian cancer
Paris (France), January 29, 2020 – 07:00 pm CET – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen:
ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the
development of innovative drugstargeting tumor DNA Damage Response (DDR), in particular against rare
or resistant cancers, today announces that the Company has entered into a Clinical Research Agreement
with Gustave Roussy (“Gustave Roussy”), the leading European cancer center, to conduct the REVOCAN1
phase 1b/2 study designed to evaluate the effect of AsiDNA™, Onxeo’s first-in-class DDR inhibitor, on
the acquired resistance to PARP inhibitor (PARPi) niraparib in its approved indication for 2
nd line
maintenance treatment of relapsed ovarian cancer.
“This is a major clinical milestone for Onxeo as we embark in this key study aiming to demonstrate that
the addition of AsiDNA™ abrogates the tumor resistance to PARP inhibitors, which would in turn improve
patients’ progression-free survival,” said Olivier de Beaumont, Chief Medical Officer of Onxeo. “We are
excited and honored to be collaborating with Gustave Roussy, one of the world’s leading academic
institutions, in a study that would open the way to AsiDNA™ becoming a must-have treatment to prevent
or abrogate resistance to targeted therapies in cancer treatment.”
C200
1
"Gustave Roussy and Onxeo will conduct an original proof-of-concept study of the reversion of the
mechanism of resistance to a major therapeutic class. If positive, this first study, labeled by the GINECO2
group, may pave the way for further combination studies with this therapeutic class, in ovarian cancer
but also in other pathologies, and offer patients who benefit from these treatments an additional
opportunity to control their disease," said Patricia Pautier, MD, oncologist, head of the Gynecological
Cancers Committee at Gustave Roussy and principal investigator of the study.
While niraparib significantly delayed cancer progression in both patients with and without a
BRCA mutation3
, treatment efficacy diminishes overtime as tumors establish new repair pathways and
resist to treatment. In preclinical studies, AsiDNA™ has consistently demonstrated its capacity to prevent
or abrogate the acquired resistance of the tumors to PARP inhibitors, regardless of tumor mutations.
Gustave Roussy and Onxeo have collaborated on REVOCAN multi-center trial design that Gustave Roussy
willsubmit, as study sponsor, to the French health authority (ANSM) and Ethics Committee in the coming
weeks, with the aim to start enrolling patientsin the first semester of 2020 and obtain preliminary results
before year-end.
C200
0
Kunnen we weer langzaam richting de Euro? Bovenstaand nieuws lijkt me toch heel mooi.
C200
0
Woman in Chains32
0
Ik ben de Franse taal niet machtig C200.

Wat ik verder nog wel interessant vindt aangaande Onxeo: ze zoeken actief naar partnership voor AsiDNA.

Zie investor meeting januari 2020 pagina 25-28 voor de outlook en bewoordingen als 'ready for partnership' & 'ready for licensing'.

www.onxeo.com/wp-content/uploads/2020...


Klinische data van DRIIV-1b in Q1 2020 kan belangrijke doorbraak betekenen al is patiëntenpopulatie van zes zeer beperkt.

Gezien grote huidige markt voor PARPi, en mogelijkheden combi AsiDNA, kan een partnership veel betekenen. Wel belangrijk dat dit een grote oncologie-speler is.
Eerdere samenwerking met Spectrum was een farce.

Met tevens een next generatie PARPi in preklinische ontwikkeling heeft Onxeo nog genoeg te bieden.

De urgentie is wel zeer hoog gezien slinkende liquide positie.




C200
0
Dank WIC32,

De liquide positie baart mij inderdaad zorgen. Als er nieuw geld aangetrokken moet worden kan dit de koers hard doen dalen. Ik blijf dan ook zeer beperkt in Onxeo maar het blijft een interessant bedrijf.
rationeel
0
Afwachten of het aandeel hogere bodems en toppen gaat laten zien.

Als laatste low 0,50.

En high 0,663.
Woman in Chains32
0
11-2-2020

ONXEO ENTERS INTO SETTLEMENT AGREEMENT WITH SPEPHARM AND SPEBIO

> Settlement agreement fully resolves long-lasting litigation between the parties and all related proceedings

> Settlement terms have no impact on Onxeo’s expected cash runway

Paris (France), February 11, 2020 – 7:00 pm CET – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, today announces it has entered into an agreement to settle (“the Settlement Agreement”) the remaining actions in the litigation which began in 2009 between Onxeo on the one hand and SpePharm and SpeBio B.V. on the other hand. SpeBio B.V. is a joint-venture managed by SpePharm, which was dedicated to the distribution in Europe of Loramyc®, a product sold by Onxeo to Vectans Pharma in July 2017.

Two remaining actions were pending following the decision of the Paris Court of Appeal in December 2018. On the one hand, Onxeo had appealed this decision before the French Supreme Court. On the other hand, the proceedings before the Court of Arbitration of the International Chamber of Commerce (ICC), which had been suspended whilst awaiting the decision of the French Courts, had resumed.

The Settlement Agreement includes immediate complete and final withdrawal of these last two pending actions as well as any and all future claims or causes of action between the parties linked to their previous disputes.

In return, Onxeo immediately sells its shares in SpeBio to SpePharm at their nominal value, thereby transferring its share of the cash of the joint venture amounting to approximately €3.5m and will pay 15 to 20% of net cash received on future commercial agreements concerning Onxeo’s R&D assets for a total cumulative amount of €6m within the next 4 years.

As SpeBio’s cash was not taken into account in Onxeo’s cash position, the Settlement Agreement’s terms have no impact on the Company’s cash runway of Q3 2020, nor on Onxeo’s current operational plan.
This agreement settles a dispute which had no more relation to the Company’s current activities and strategy and will enable the Company to focus on the development of its assets in the field of DNA Damage Response.

Accounting impacts

The signing of this agreement after the end of the 2019 financial year will result in the recognition of the following provisions in the consolidated accounts at December 31, 2019:
- A provision for depreciation of equity securities in the amount of 3.6 million euros, as a result of the sale of SpeBio shares at their nominal value.
- A provision for risks of 6 million euros, corresponding to the additional payments linked to the Group's future license agreements.
The total charge will be booked under “other operating income and expenses”.

www.onxeo.com/onxeo-enters-into-settl...
Woman in Chains32
0

3 aspecten omtrent bovenstaand persbericht:

1) onzekerheid over cash-impact behoort tot het verleden. Deze overeenkomst kost indirect geld, echter vindt er nu geen uitstroom van cash plaats.

2) Onxeo heeft geen recht meer op deel cash van SpeBio B.V. Het aandeel betrof €3,5 miljoen

3) Komende 4 jaar, gerekend vanaf 11-2-2020 m.i., is Onxeo nog maximaal €6 miljoen verschuldigd aan SpePharm, inhoudende 15-20% van netto geld wat Onxeo realiseert middels toekomstige commerciële overeenkomsten aangaande R&D moleculen (AsiDNA en OX401). Dit omhelst dus partnerships/in-licentiename t.b.v. toekomstige commercialisatie.


Gisteren negatieve reactie; vandaag sterk positieve reactie van de koers.
Liquide middelen nog goed voor max. 7 maanden. Eens zien wat het management gaat klaarspelen omtrent partnership.

Het is 5 voor 12, maar moleculen bieden veel combi-mogelijkheden voor kankertherapieën dus neem aan dat de opties goed zijn verkend.
Heinz
0
quote:

Woman in Chains32 schreef op 13 februari 2020 12:53:


Het is 5 voor 12, maar moleculen bieden veel combi-mogelijkheden voor kankertherapieën dus neem aan dat de opties goed zijn verkend.


Dank voor de duiding! Ik hoop dat je gelijk hebt vwb je laatste opmerking; dit is wel een moment voor het management om zich te bewijzen.
rationeel
0
Paris (France), February 27, 2020 – 5:45 pm CET – Onxeo S.A. (Euronext Paris, NASDAQ Copenhagen: ONXEO), (“Onxeo” or “the Company”), a clinical-stage biotechnology company specializing in the development of innovative drugs targeting tumor DNA Damage Response (DDR), in particular against rare or resistant cancers, today announces that the Company will present first preclinical results on OX401, its next-generation PARP inhibitor (PARPi), during a poster session at the ESMO-TAT1 Congress 2020 dedicated to the research on targeted cancer therapies, to be held in Paris, France, on March 2-4, 2020.

“Based on our proprietary platform platON™, OX401 benefits from our accumulated experience on the original decoy agonist mechanism that it shares with AsiDNA™, our clinical-stage DDR inhibitor. We are excited to present the first results on OX401, including its high affinity with PARP that leads to DDR inhibition, metabolic exhaustion and activation of the innate immune response, specifically in tumoral cells,” said Françoise Bono, Chief Scientific Officer of Onxeo. “These data establish OX401 in the current cutting-edge areas of research and open up promising therapeutic prospects, by exploiting both its ability to exhaust the tumor cell without inducing resistance and its value in combination with immunotherapies.”

OX401 is the second candidate sourced from Onxeo’s proprietary platform of decoy agonists, platON™. It was optimized to maintain this unique mechanism of action, while specifically targeting PARP and immune response. Its properties position OX401 at the crossroads of two of the most active areas in oncology, DNA damage repair and immunotherapy.

Poster presentation: OX401, a new generation of PARP interfering drug for cancer treatment
Poster ID: 21P (ID 224)
Date: Monday, March 2, 2020 - 5:30 pm CET
Location: Palais des congrès – Place de la porte Maillot – Paris (France) - Hall Bordeaux
RW1963
0
Al die lappen Engels lezen vind ik lastig.
Is er ook een korte bondige Nederlandse samenvatting?

Onxeo zou eens iets moeten hebben tegen het Coronavirus en honderden procenten omhoog schieten :-)
rationeel
0
quote:

RW1963 schreef op 28 februari 2020 14:09:


Al die lappen Engels lezen vind ik lastig.
Is er ook een korte bondige Nederlandse samenvatting?

Onxeo zou eens iets moeten hebben tegen het Coronavirus en honderden procenten omhoog schieten :-)


Ze zijn actief in een andere tak van sport.

Maar de bedrijven die in die richting werken doen hun best.

Ik heb gisteren 2 namen van bedrijven gepost die zelf in ieder geval vinden dat ze goed op weg zijn.
rationeel
0
quote:

RW1963 schreef op 28 februari 2020 14:09:


Al die lappen Engels lezen vind ik lastig.
Is er ook een korte bondige Nederlandse samenvatting?

Onxeo zou eens iets moeten hebben tegen het Coronavirus en honderden procenten omhoog schieten :-)


Hier is de aanleiding voor het pb:

today announces that the Company will... present... first preclinical results on OX401,... its... next-generation... PARP inhibitor (PARPi),... during a poster session at the... ESMO-TAT1 Congress 2020 ...dedicated to the research on targeted cancer therapies, to be held in... Paris, France,... on... March 2-4, 2020...

Daar ontmoeten ze elkaar, en kunnen misschien zaken doen;)
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