ADAP: Adaptimmune - Transforming T-Cell therapy

Adaptimmune Appoints Elliot Norry as Chief Medical Officer and Makes Changes to R&D Leadership

Organizational changes strengthen scientific and clinical development from early to late stage, and accelerate application of translational science learnings to therapeutic candidates and trials
https://ir.adaptimmune.com/news-releases/...chief-medical-officer-and
 

Ich würde mal sagen du/wir haben es verdient. Die letzten Wochen/Monate waren wirklich frustrierend. Und man sollte erst mal abwarten, wie es weitergeht - zumal der Dow auf Höchststand notiert.  

Start bei ü100%
https://www.ariva.de/...s_adr-aktie/chart?t=intraday&boerse_id=40
 

 

https://www.nasdaq.com/market-activity/stocks/adap
 

Für diese Erfolge gibt es bald noch öfter Aufmerksamkeit :)
"We look forward to presenting data from these trials at future scientific congresses."

https://ir.adaptimmune.com/news-releases/...platform-delivers-initial
 

Unglaubliches Volumen heute
 

Agreement covers the co-development and co-commercialization of up to three T-cell therapies -

- Agreement leverages Astellas’ Universal Donor Cell Platform and Adaptimmune’s stem-cell derived allogeneic T-cell platform -

- Astellas will pay Adaptimmune an upfront payment, research funding, development and commercial milestones, and royalties on net sales on co-commercialized products -

TOKYO, PHILADELPHIA and OXFORDSHIRE, United Kingdom, Jan. 14, 2020 (GLOBE NEWSWIRE) -- Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas"), through its wholly-owned subsidiary Universal Cells, Inc, and Adaptimmune Therapeutics plc (Nasdaq:ADAP), a leader in cell therapy to treat cancer, announced that they have entered into a co-development and co-commercialization agreement to bring new stem-cell derived allogeneic T-cell therapies to people with cancer.

Astellas and Adaptimmune will agree on up to three targets and co-develop T-cell therapy candidates directed to those targets. These targets will exclude target specific T-cell products in pre-clinical or clinical trials or those developed for other partners at Adaptimmune. The collaboration will leverage Adaptimmune's target identification and validation capabilities for generating target-specific T-cell Receptors (TCRs), chimeric antigen receptors (CARs), and HLA-independent TCRs that recognize surface epitopes independently of the HLA profile of the tumor cell. The collaboration will also utilize Astellas’ Universal Donor Cell and Gene Editing Platform it obtained through the acquisition of Seattle-based Universal Cells.

Adaptimmune has been collaborating with Universal Cells (now an Astellas Company) since 2015 on development of gene-edited iPSC cell lines, for which Adaptimmune has rights to develop and commercialize resulting T-cell therapy products using its proprietary process for generating T-cells from stem cells without the use of feeder cell lines.

Astellas will fund research up until completion of a Phase 1 trial for each candidate. Upon completion of the Phase 1 trial for each candidate, Astellas and Adaptimmune will elect whether to progress with co-development and co-commercialization of the candidate, or to allow the other Party to pursue the candidate independently through a milestone and royalty bearing licence, with the agreement allowing for either company to opt out. The companies will each have a co-exclusive licence covering the co-development and co-commercialization of the product candidates within the field of T-cell therapy. If a candidate is developed by one company only, the appropriate licences will become exclusive to the continuing party.

"Astellas positions immuno-oncology as one of its strategic areas of primary focus, and it is engaged in the development of novel therapies for cancer patients using a new modality/technology," stated Naoki Okamura, Representative Director Corporate Executive Vice President, Chief Strategy Officer and Chief Financial Officer, Astellas. "In addition to NK cells, T-cells are an important component of cell therapy for immuno-oncology, and we look forward that this agreement with Adaptimmune will enable us to create new stem-cell derived allogeneic T-cell therapies for a variety of cancers, including solid tumors, in the future. We will continue to dedicate our efforts in delivering novel treatments for diseases with high unmet medical needs, pursuing cutting-edge science and technological advances.”

“We are delighted to establish this significant co-development partnership with Astellas, which builds upon and substantially extends an existing collaboration focused on gene editing of iPSC cells,” said Helen Tayton-Martin, Adaptimmune’s Chief Business Officer and Co-Founder. “This new collaboration may encompass both CAR-T and TCR T-cell approaches, including our novel HLA-independent TCR (“HiT”) platform. It brings together highly complementary skills and expertise across the two organizations, and will enable the accelerated development of new, off-the-shelf T-cell therapy products for people with cancer.”

Astellas will also have the right to select two targets and develop allogeneic cell therapy candidates independently. Astellas will have sole rights to develop and commercialize these products, subject to necessary licenses and the payment of milestones and royalties.

Under the terms of the agreement, Adaptimmune may receive up to $897.5 million in payments, including:

   an upfront payment of $50 million.
   development milestones totalling up to $73.75 million for each product if the collaboration product discovered in this partnership is co-developed and commercialized by both companies
   Up to $147.5 million in milestone payments per product and up to $110 million in sales milestones for products developed unilaterally by Astellas.

In addition, Adaptimmune will receive research funding of up to $7.5 million per year.

Finally, Adaptimmune would receive tiered royalties on net sales in the mid-single to mid-teen digits.

Under the terms of the agreement, Astellas may receive up to $552.5 million, including:

   Up to $147.5 million in milestone payments per product and up to $110 million in sales milestones for products developed unilaterally by Adaptimmune.

In addition, Astellas would receive tiered royalties on net sales in the mid-single to mid-teen digits.

To the extent that Astellas and Adaptimmune co-develop and co-commercialize any T-cell therapy, they will equally share the costs of such co-development and co-commercialization, with the resulting profits from co-commercialization also shared equally. Further details governing co-development and co-commercialization will be articulated in a product-specific commercialization agreement.

The impact of this transaction on Astellas’ financial results in the fiscal year ending March 31, 2020 will be limited.

About Adaptimmune
Adaptimmune is a clinical-stage biopharmaceutical company focused on the development of novel cancer immunotherapy products for people with cancer. The Company’s unique SPEAR (Specific Peptide Enhanced Affinity Receptor) T‑cell platform enables the engineering of T-cells to target and destroy cancer across multiple solid tumors. For more information, please visit http://www.adaptimmune.com.

About Astellas
Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. For more information, please visit our website at https://www.astellas.com/en

Adaptimmune Forward-Looking Statements
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (PSLRA). These forward-looking statements involve certain risks and uncertainties. Such risks and uncertainties could cause our actual results to differ materially from those indicated by such forward-looking statements, and include, without limitation: the success, cost and timing of our product development activities and clinical trials and our ability to successfully advance our TCR therapeutic candidates through the regulatory and commercialization processes. For a further description of the risks and uncertainties that could cause our actual results to differ materially from those expressed in these forward-looking statements, as well as risks relating to our business in general, we refer you to our Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on November 6, 2019, and our other SEC filings. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update such forward-looking statements to reflect subsequent events or circumstances.

Cautionary Notes Regarding Forward-Looking Statements (Astellas)
In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties.

Information about pharmaceutical products (including products currently in development) which is included in this press release is not intended to constitute an advertisement or medical advice.

Adaptimmune Contacts:

Media Relations:
Sébastien Desprez – VP, Communications and Investor Relations
T: +44 1235 430 583
M: +44 7718 453 176
Sebastien.Desprez@adaptimmune.com

Investor Relations:
Juli P. Miller, Ph.D. – Senior Director, Investor Relations
T: +1 215 825 9310  

Super, so eine Meldung nach der gestrigen. Kommt richtig Schwung rein.
Astellas wäre auch für MDG ein guter Partner (gewesen). Bis auf das teure co-/co- im ersten Satz der Meldung..

Meinen Teil-VK-Auftrag nehme ich erstmal wieder raus und warte auf die US-Reaktion nachher. Ohne finanzielle Details, bzw. jahrelanger geteilter Kosten könnte die allerdings niedriger ausfallen als erhofft.
 

Wobei die Upfront Zahlung in Höhe von rund 50 Mio die Notwendigkeit oder Höhe einer Kapitalerhöhung schmälern sollte  - oder?  

kurzfristig etwas ändern, fragt sich nur zu welchem Kurs. Ich denke unter $10 des letzten private placements geht da jetzt mit den Grossinvestoren NEA und MATRIX nix mehr.

Man bedenke der alte Deal mit Universal Cells vor der Übernahme durch Astellas sah überhaupt nur $45 Millionen an Meilenstein-Zahlungen VON Adaptimmune vor. Jetzt kriegen sie diese als upfront + die weitere Entwicklung einschliesslich der Phase 1 von Astellas finanziert und - noch wichtiger - sie behalten die Co-Entwicklungs / Vermarktungsoption!

Meine Meinung - KEINE Handelsempfehlung.  

Sorry, den Satz ziehe ich zurück:  "Ohne finanzielle Details, bzw. jahrelanger geteilter Kosten könnte die allerdings niedriger ausfallen als erhofft." Ich hatte die Meldung noch gar nicht bis zu Ende gelesen..
Stehen ja viele finanzielle Details drin  

"...Astellas will fund research through Phase 1 for each candidate. Afterward, the companies will decide whether to advance development and commercialization together or independently.

Under the terms of the agreement, ADAP will receive $50M upfront, up to $73.75M in milestones per candidate if co-developed/co-commercialized, up to $147.5M in development milestones and up to $110M in sales milestones per candidate in Astellas develops/commercializes alone, up to $7.5M per year in research funding and tiered mid-single-digit-to-mid-teens royalties on net sales.

ADAP up 24% premarket on average volume."
https://seekingalpha.com/news/...m=email&utm_source=seeking_alpha
 

Jetzt schon 30%..  :)
https://www.nasdaq.com/market-activity/stocks/adap/pre-market
-

(Sorry, ich hör jetzt auf damit.. Bin nur so erleichtert. Sollte m.M.n. auch auf MDG abstrahlen)

 

bei 23%, jetzt sind es schon 40,5% :/  

ihr der kurs steigt um 15:30 noch oder geht eher runter?  

January 14, 2020 06:55 AM ESTUpdated 09:13 AM Natalie Grover
New Adap­ti­m­mune man­age­ment scores con­fi­dence boost with up to $897M+ Astel­las deal
https://endpts.com/...confidence-boost-with-up-to-897m-astellas-deal/
--

Effectgreen; Das musst du schon selber entscheiden...oder abwarten  

Deal mit Astellas

https://www.fiercebiotech.com/biotech/...-create-car-ts-tcr-therapies

 

Der Wimpel ist natürlich bis jetzt hypothetisch. Könnte aber noch ein paar Tage hin-und her laufen bis zu einer Richtungs-Entscheidung.  M.E.n. aber nach Norden..

 

https://ir.adaptimmune.com/news-releases/...ublic-offering-american-0
 

ist jetzt positiv oder negativ zu bewerten?  

wobei der Preis und das Volumen sicher eine Rolle spielen dürften.
Ausserdem wird interessant sein, ob die bisherigen Hauptinvestoren - z.B. NEA und MATRIX - wieder dabei sein werden.
Meine Meinung  - Keine Handelsempfehlung.  

21 Mio. a' 4,--$
-----
https://seekingalpha.com/news/...m=email&utm_source=seeking_alpha
Adaptimmune +3% premarket after pricing equity offering
Jan. 22, 2020 8:57 AM ET|About: Adaptimmune Therapeutics plc (ADAP)|By: Mamta Mayani
Adaptimmune Therapeutics (NASDAQ:ADAP) has priced its public offering of 21M American Depositary Shares (ADSs) at $4.00 per ADS, for expected gross proceeds of ~$84M.

Underwriters' over-allotment is an additional ~3.2M ADSs.

Net proceeds will be used to advance clinical trials as well as for general corporate purposes.

Closing date is January 24.

Yesterday's close was $4.14.

Shares are up 3% premarket.  

zahlreichen Konkurrenten wie ALLOgene, CeLLectiS, FATE aber auch Partner GSK.

Guggenheim Healthcare Talks | Oncology Day
Date / Time
February 13, 2020 9:30 am EST

also Start in Deutschland ab 14 Uhr und Adaptimmune dann ab 15:30 Uhr  

mit reichlich Erfahrung an der NASDAQ und LSE durch seine Zeit bei Affymetrix bis zur Übernahme durch Thermo Fisher in 2016