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Blijkbaar interpreteren veel aandeelhouders het anders dan ze voor ogen hadden
Nieuwsbrief is wel in het Frans..
https://mailchi.mp/atcg-partners/lettre ... 53d87fd19c
- And its gone!
- Forum actieveling
- Berichten: 773
- Lid geworden op: 30 mei 2018 21:25
- waarderingen: 337
Marseille, September 15, 2020
Dear members of the Club Innate en actions,
Following the publication of our half-year results on September 8, many of you have contacted us and asked us questions about the monalizumab program, licensed from our AstraZeneca partner.
I will therefore come back to you today to clarify various points concerning the clinical progress and the financial conditions relating to this program:
The decision to enter Phase 3, announced in October 2019, was taken by AstraZeneca on the basis of data from the study launched by Innate Pharma at the end of 2015, testing monalizumab in combination with cetuximab in squamous cell cancers of the head and neck ( Cohort 1 ).This study , which did not have a control arm, involved 40 patients. Of these, only 17 had been previously treated with immunotherapy, the population in which the combination will be tested in Phase 3.
Going straight from Phase 1b / 2 to Phase 3 has the potential to accelerate development. monalizumab as the program continues to carry the intrinsic risk of clinical development.
AstraZeneca took the necessary steps to launch the Phase 3 trial. At the same time, we continued to evaluate this combination and generate additional data.
40 patients with squamous cell carcinoma of the head and neck and previously treated with immunotherapy were thus recruited (Cohort 2 ). The preliminary results of this cohort were shared with ASCO in June 2020. They confirmed the data from the Cohort 1 study on the primary endpoint of the study, namely an overall objective response rate, as well. than tolerance.
During the summer, we started to accumulate longer-term data on Cohort 2. These enabled us to refine the clinical profile of monalizumab. These data, which will be made public at a forthcoming scientific congress, confirm the interest of launching a Phase 3 in squamous cell cancers of the head and neck pretreated by immunotherapy, an indication where the medical need is important.
However, since the strategy of going immediately to Phase 3 is bold, Innate has agreed to review the sharing of the risks associated with it, adjusting the terms of the milestone payment initially planned, while maintaining the overall amount. of $ 100 million:
We will collect $ 50 million upon inclusion of the first patient, expected in 2020
And $ 50 million to the results of a planned interim analysis showing that the combination reaches a predefined threshold of clinical activity that will take place 18 to 24 months after the start of the study. It should be remembered that this type of intermediate analysis is standard in clinical trials for registration purposes.
We accepted this amendment because we have confidence in the monalizumab program and are satisfied with the commitment of our partner, demonstrated by the start of this Phase 3 trial and by a consequent payment which will bring the amounts received by Innate  . As a reminder, the Company will co-finance 30% of Phase 3, subject to an overall cap.
In conclusion, we are very pleased to see the first active product produced by Innate Pharma's research entering Phase 3 . To our knowledge, this is the first trial to test the combination of cetuximab with an immunodulatory antibody of 2 ndgeneration. This is also the first Phase 3 in the head and neck targeting patients already treated with immunotherapy
Finally, let's quickly come back to the combination testing monalizumab, cetixumab and durvalumab in patients with relapsed or metastatic head and neck cancer. who have never received anti-PD- (L) 1 immunotherapy ( Cohort 3 ). We announced that during the second quarter of 2020, we had extended the recruitment from 20 to 40 patients, as planned in the protocol and on the basis of the first data. We are delighted to share that the recruitment of these 40 patients is now complete and the data is expected in 2021 .
The monalizumab program is therefore progressing significantly.The 50 million euros that we will receive by the end of 2020 will strengthen an already solid financial situation, guaranteeing the financing of our operations until the end of 2022 . This allows us to focus on delivering the lacutamab program and the rest of our proprietary portfolio.
I would also like to take this letter to inform you of our forthcoming communications to individual investors:
We are going to relaunch Club Innate in action in a slightly different form. A first newsletter is in preparation for the month of October.
You are also used to meeting us every year at the Actionaria fair. The current sanitary conditions make it difficult to hold such an event. Also, we are working to offer you a new space for dialogue in the near future that will guarantee everyone's health security.
If you have any further questions on this subject, our Investor Relations team is at your disposal.
Thank you for your confidence in Innate Pharma,
Dr Mondher Mahjoubi, Chairman of the Management Board
 $ 250 million upon signing in 2015, $ 100 million upon unwinding of the option in 2018, $ 50 million for the first patient dosed in the first Phase 3 in 2020
Op 10 september heeft hij 10.000 aandelen gekocht aan 3,43€
Is niet veel maar hij probeert de koers toch een beetje te ondersteunen
- Forum actieveling
- Berichten: 309
- Lid geworden op: 02 mar 2018 15:26
- waarderingen: 64
to "buy" from "hold", saying the current share price
offers an attractive entry point into a company with "strong
** The broker points out the negative market reaction
following the announcement of an amendment to the agreement
signed with AstraZeneca on monalizumab seems overdone
** Monalizumab, co-developed by AstraZeneca and Innate
Pharma, will enter phase III in H2 as planned
** The brokerage says the development of lacutamab is back
on track and the rate of new Lumoxiti patients, which has slowed
due to COVID-19, does not impact the potential of the product
over the long-term
** It adds the company has a well-balanced portfolio of
immuno-oncology drugs against cancer and a robust cash position
to finance the development of monalizumab
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