GlobeNewswire

Active Biotech and NeoTX announce FDA Clearance of IND for Phase II Clinical Trial of Naptumomab

Share

Phase IIa trial in non-small cell lung cancer expected to begin enrollment in the US in the second half of 2021

Lund Sweden, April 19, 2021 - Active Biotech AB (publ) (NASDAQ STOCKHOLM: ACTI) and NeoTX today announced that they have received clearance from the U.S. Food and Drug Administration (FDA) for the Investigational New Drug (IND) application of the tumor targeted superantigen naptumomab estafenatox (Naptumomab).

The Phase IIa open label trial will evaluate naptumomab in combination with docetaxel in 35 patients with checkpoint inhibitor pretreated, advanced or metastatic non-small cell lung cancer. The primary endpoint is objective response rate as measured by RECIST 1.1 criteria.  The trial will also evaluate safety, duration of response, progression free survival, pharmacokinetics and pharmacodynamics.

Naptumomab treatment regimens have demonstrated preliminary safety and anti-tumor activity in early-stage clinical trials in solid tumors. Naptumomab binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating and expanding tumor specific immune cells.

“The FDA clearance of the IND for phase II clinical trial of naptumomab in non-small cell lung cancer marks a significant step in the continuing development of naptumomab as well as our collaboration with NeoTX. We are glad to receive the IND clearance and are excited to follow the progress of the development of naptumomab and the upcoming clinical Phase IIa trial” said Helén Tuvesson, CEO, Active Biotech AB.

See also www.neotx.com for NeoTX’s communication related to this information.

For further information, please contact:

Helén Tuvesson, CEO, +46 46 19 21 56, helen.tuvesson@activebiotech.com
Hans Kolam, CFO, +46 46 19 20 44, hans.kolam@activebiotech.com

Active Biotech AB (Corp. Reg. No. 556223-9227)
Box 724, 220 07 Lund, Sweden
+46 46-19 20 00
www.activebiotech.com

This information is information that Active Biotech AB is obliged to make public pursuant to the EU Market Abuse Regulation. This information was submitted for publication, through the agency of the contact person set out above, at 08.30 a.m. CET on April 19, 2021.


Active Biotech
Active Biotech AB (publ) (Nasdaq Stockholm: ACTI) is a biotechnology company that deploys its extensive knowledge base and portfolio of compounds to develop first-in-class immunomodulatory treatments for specialist oncology and immunology indications with a high unmet medical need and significant commercial potential. Following a portfolio refocus, the business model of Active Biotech aims to advance projects to the clinical development phase and then further develop the programs internally or pursue in partnership. Active Biotech currently holds three projects in its portfolio: Naptumomab, a targeted anti-cancer immunotherapy, partnered to NeoTX Therapeutics, is in a Phase I/II clinical program in patients with advanced solid tumors. The small molecule immuno-modulators, tasquinimod and laquinimod, both having a mode of actions that includes modulation of myeloid immune cell function, are targeted towards hematological malignancies and inflammatory eye disorders, respectively. Tasquinimod, is in clinical phase Ib/IIa for treatment of multiple myeloma. Laquinimod is advancing to phase II for treatment of non-infectious uveitis during second half of 2021. Please visit www.activebiotech.com for more information.

About NeoTX
NeoTX is a clinical-stage immuno-oncology company which is developing targeted anticancer immunotherapies utilizing its proprietary Tumor Targeted Superantigen (TTS) platform. TTS binds a genetically engineered bacterial determinant to the tumor surface while simultaneously activating and expanding tumor specific immune cells that are then redirected from the periphery to the tumor to mount an effective response. The company’s lead TTS molecule, naptumomab estafenatox is currently in clinical development for advanced solid tumors. For more information, please visit www.neotx.com.

Naptumomab was licensed from Active Biotech to NeoTX Therapeutics Ltd in 2016. NeoTX is responsible for the global development and commercialization of naptumomab for the treatment of cancer under the license agreement.

Attachment


About GlobeNewswire

GlobeNewswire
GlobeNewswire
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://globenewswire.com

GlobeNewswire is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Subscribe to releases from GlobeNewswire

Subscribe to all the latest releases from GlobeNewswire by registering your e-mail address below. You can unsubscribe at any time.

Latest releases from GlobeNewswire

Van Lanschot Kempen completes share buy-back programme6.5.2021 08:30:00 CEST | Press release

Amsterdam/’s-Hertogenbosch, the Netherlands, 6 May 2020 Van Lanschot Kempen today announced that it has successfully completed its share buy-back programme. In the last period, between 4 May 2021 and 5 May 2021, Van Lanschot Kempen repurchased 17,700 of its own shares (depositary receipts for Class A ordinary shares) at an average price of €24.21 per share for a total amount of €428,567. A total of 400,000 shares have been repurchased under the programme at an average price of €23.63 per share, representing a total amount of €9,451,734. The programme was announced on 25 February 2021. The repurchased shares will be used to cover the depositary receipts to be allocated to employees under existing remuneration policies and share plans. More information, including a detailed overview of all repurchase transactions under this programme, is available at www.vanlanschotkempen.com/sharebuyback. Media Relations: +31 20 354 45 85; mediarelations@vanlanschotkempen.com Investor Relations: +31 20

HOYLU AB: NUMBER OF USERS INCREASED 9% IN APRIL6.5.2021 08:30:00 CEST | Press release

Stockholm, Sweden, May 6, 2021 – Hoylu, a leader in visual collaboration solutions for distributed teams, today announced user numbers and Annual Recurring Revenue (“ARR)” as of the end of April 2021. The report for April 2021 is attached to this press release and is available on Hoylu's web site: (https://www.hoylu.com/investor-relations/financial-reports/). For more information, please contact: Stein Revelsby, CEO at Hoylu +1 213 440 2499 Email: sr@hoylu.com Karl Wiersholm, CFO at Hoylu +1 425 829 2316 Email: kw@hoylu.com About Hoylu Hoylu’s mission is to empower distributed teams to collaborate easily and seamlessly while always staying in sync. Hoylu’s Connected Workspaces™ helps enterprises as well as small and medium companies run projects, programs, and initiatives across time zones and continents with the same level of engagement and clarity as if everyone were working in the same room. For more information: www.hoylu.com Try Hoylu for free: https://www.hoylu.com/signup/ Ticker

HOYLU AB: ANTAL ANVÄNDARE ÖKADE MED 9% I APRIL6.5.2021 08:30:00 CEST | Pressemelding

Stockholm, Sverige, 6 maj 2021 – Hoylu, ledande inom visuella samarbetslösningar för distribuerade team, presenterade idag antal användare och Årliga återkommande intäkter (ARR) från och med slutet av april 2021. Rapporten för april 2021 bifogas detta pressmeddelande och finns tillgänglig på bolagets hemsida: (https://www.hoylu.com/investor-relations/financial-reports/). För mer information kontakta: Stein Revelsby, CEO at Hoylu +1 213 440 2499 Email: sr@hoylu.com Karl Wiersholm, CFO at Hoylu +1 425 829 2316 Email: kw@hoylu.com Om Hoylu Hoylus uppdrag är att ge distribuerade team möjlighet att samarbeta enkelt och sömlöst samtidigt som de alltid håller sig synkroniserade. Hoylus Connected Workspaces™ hjälper företag såväl stora som små att driva projekt, program och initiativ över olika tidszoner och kontinenter med samma engagemang och tydlighet som om alla arbetade i samma rum. För mer information: www.hoylu.com Testa Hoylu gratis: https://www.hoylu.com/signup/ Kortnamn: Hoylu Markna

Statkraft AS: Result for the first quarter6.5.2021 08:00:00 CEST | Press release

Record-high operating result (Oslo, 6 May 2021) Higher power prices and increasedgeneration resulted in a record-high underlying operating result. Statkraft continued to deliver on its strategy and initiated new renewable projects in the quarter. The underlying EBIT was NOK 7.2 billion in the quarter, an increase of NOK 3.1 billion from the first quarter last year. “The underlying operating result was the best ever achieved in a single quarter, following higher Nordic power prices and successful energy management”, says CEO Christian Rynning-Tønnesen. The average Nordic system price was 42.3 EUR/MWh, an increase of 26.9 EUR compared with the low price in the first quarter of 2020. Total power generation increased by 16 per cent to 20.6 TWh. A strengthening of NOK against EUR had a positive effect on net financial items, which ended at NOK 1.5 billion. Net profit was NOK 4.8 billion, an increase of NOK 6.7 billion compared with the result in the first quarter last year. Cash flow from o

Bayport Management Limited Appointment of Board Chairperson6.5.2021 08:00:00 CEST | Press release

APPOINTMENT OF BOARD CHAIRPERSON The Board of Bayport Management Ltd (“BML” or the “Company”) wishes to apprise its shareholders and the general public that Nicholas Haag has been appointed as the Chairperson of the Board of the Company, from April 2021. Mr. Haag has served as an Independent Non-Executive Director of the Company since 2016. Mr. Haag has had a 30- year career in the finance industry with various institutions including Barclays, ABN AMRO and the Royal Bank of Scotland. Most recently, Mr. Haag was a member of the Boards of TBC Bank Group PLC and Citadele Bank Group. Mr. Haag holds a First-Class Honours Degree from the University of Oxford. By order of the Board 6 May 2021 For additional information, please contact: David Rajak Investor Relations Executive (investor@bayportfinance.com / +27 11 236 7300) This information is information that Bayport Management Ltd is obliged to make public in accordance with the EU Market Abuse Regulation. The information was submitted for p

Statkraft AS: Resultat for første kvartal6.5.2021 08:00:00 CEST | Pressemelding

Rekordhøyt driftsresultat (Oslo, 6.mai 2021) Høyere kraftpriser og -produksjon ga Statkraft et rekordhøyt underliggende driftsresultat. Statkraft fortsetter å levere på strategien, og initierte flere nye fornybarprosjekter i kvartalet. Underliggende driftsresultat var 7,2 milliarder kroner i kvartalet, en forbedring på 3,1 milliarder kroner sammenlignet med samme kvartal i fjor. - Det underliggende driftsresultatet er det beste i et enkeltstående kvartal noensinne og er et resultat av høyere nordiske kraftpriser og vellykket energidisponering, sier konsernsjef Christian Rynning-Tønnesen. Den gjennomsnittlige nordiske systemprisen var 42,3 EUR/MWh. Det er en økning på 26,9 EUR/MWh sammenlignet med de lave prisene i første kvartal 2020. Samlet kraftproduksjon var 20,6 TWh, en økning på 16 prosent. En styrking av norske kroner mot euro hadde en positiv effekt på netto finansposter som endte på 1,5 milliarder kroner. Resultat etter skatt endte på 4,8 milliarder kroner, en forbedring på 6,7

Changes in Marimekko’s management – Jussi Siitonen steps down from Marimekko’s Board6.5.2021 07:45:00 CEST | Press release

Marimekko Corporation, Stock Exchange Release, 6 May 2021 at 8.45 a.m. Changes in Marimekko’s management – Jussi Siitonen steps down from Marimekko’s Board Jussi Siitonen has announced that he will resign immediately from his position as a member of the Board of Directors of Marimekko. Siitonen was today appointed CFO of Fiskars as of 3 November 2021 at the latest, which creates a conflict of interest with his duties as a Board member in Marimekko. According to the Articles of Association, Marimekko’s Board of Directors comprises a minimum of four and a maximum of seven ordinary members. As of today, the Board consists of Elina Björklund, Carol Chen, Mika Ihamuotila, Mikko-Heikki Inkeroinen, Catharina Stackelberg-Hammarén and Tomoki Takebayashi. The Board is chaired by Mika Ihamuotila and vice-chaired by Elina Björklund. MARIMEKKO CORPORATION Corporate Communications Anna Tuominen Tel. +358 40 5846944 anna.tuominen@marimekko.com DISTRIBUTION: Nasdaq Helsinki Ltd Key media Marimekko is