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Enhertu approved in China as first HER2-directed therapy for patients with HER2-mutant metastatic non-small cell lung cancer

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Approval based on DESTINY-Lung02 and DESTINY-Lung05 results which showed Enhertu demonstrated clinically meaningful efficacy in previously treated patients. Fourth approval in China for AstraZeneca and Daiichi Sankyo’s Enhertu across three different tumour types.

AstraZeneca and Daiichi Sankyo’s Enhertu (trastuzumab deruxtecan) has received conditional approval in China as a monotherapy for the treatment of adult patients with unresectable, locally advanced or metastatic non-small cell lung cancer (NSCLC) whose tumours have activating HER2 (ERBB2) mutations and who have received a prior systemic therapy.

The conditional approval by the National Medical Products Administration (NMPA) was based on the positive results of the DESTINY-Lung02 and DESTINY-Lung05 Phase II trials. Full approval for this indication will depend on the clinical benefit of a confirmatory trial.

Each year in China, more than one million people are diagnosed with lung cancer, accounting for more than 40% of the world’s lung cancer patients – the majority are diagnosed with advanced disease.1,2,3 Approximately 2% to 4% of patients with NSCLC have tumours with activating HER2 mutations.4,5

Ying Cheng, MD, PhD, Director of Jilin Lung Cancer Centre, China, and principal investigator of DESTINY-Lung05, said: “While there have been many advancements in the treatment of non-small cell lung cancer in China in recent years, patients with HER2-mutant disease have had few treatment options and none directed towards this specific type of lung cancer. This approval of Enhertu offers an important new targeted treatment for patients with this aggressive form of disease.”

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: “This approval of Enhertu represents the first HER2-directed therapy approved in China for the treatment of HER2-mutant metastatic non-small cell lung cancer, marking an important step forward in how the disease can be treated. It also reinforces the importance of testing for predictive biomarkers in lung cancer at the time of diagnosis, including HER2 mutations, to ensure patients can receive the most appropriate treatment for their specific disease.”

Kiminori Nagao, Head of the Asia, South & Central America Business Unit, Daiichi Sankyo, said: “Since our initial approval of Enhertu for patients with HER2-positive metastatic breast cancer in China last year, we have remained committed to bringing this innovative antibody drug conjugate to more patients in China, especially those that have previously not been eligible for treatment with a HER2-directed therapy. Today’s milestone marks the fourth approval of Enhertu in China and follows the recent approval for HER2-positive metastatic gastric cancer, reinforcing its benefit across multiple HER2-targetable tumours.”

In DESTINY-Lung02, which included patients from Japan, Korea and Taiwan (China), patients with previously treated HER2-mutant metastatic NSCLC treated with Enhertu (5.4mg/kg) showed a confirmed objective response rate (ORR) of 49.0% (95% confidence interval [CI] 39.0-59.1), as assessed by blinded independent central review (BICR). Median duration of response (DoR) was 16.8 months (95% CI 6.4-non-evaluable [NE]). Median progression-free survival (PFS) was 9.9 months (95% CI 7.4-NE) and median overall survival (OS) was 19.5 months (95% CI 13.6-NE).

In DESTINY-Lung05, Enhertu (5.4mg/kg) demonstrated a consistent clinically meaningful response in patients in China with previously treated HER2-mutant metastatic NSCLC. Treatment with Enhertu resulted in a confirmed ORR of 58.3% (95% CI 46.1-69.8), as assessed by independent central review (ICR).

The safety profile of Enhertu in DESTINY-Lung02 and DESTINY-Lung05 were similar and generally consistent with previous clinical trials of Enhertu in lung cancer with no new safety concerns identified.

Enhertu is a specifically engineered HER2-directed antibody drug conjugate (ADC) discovered by Daiichi Sankyo and being jointly developed and commercialised by AstraZeneca and Daiichi Sankyo.

Enhertu is already approved for the treatment of previously treated unresectable or metastatic HER2-mutant NSCLC in more than 45 countries, including the US, Japan and across the EU.

Notes

HER2-mutant NSCLC          

Lung cancer is the most common form of cancer globally in both men and women.2 Each year there are approximately 2.5 million people diagnosed with lung cancer globally, with 80-85% diagnosed with NSCLC.2,6 Prognosis is poor for patients with metastatic NSCLC as only approximately 9% will live beyond five years after diagnosis.7

In China, lung cancer is the most commonly diagnosed cancer with more than one million cases diagnosed in 2022.1 It is also the leading cause of cancer-related deaths in China, with more than 733,000 deaths reported in 2022.1

HER2 is a tyrosine kinase receptor growth-promoting protein expressed on the surface of multiple tumour types. Certain HER2 (ERBB2) gene alterations (called HER2 mutations) have been identified in patients with non-squamous NSCLC as a distinct molecular target, and occur in approximately 2% to 4% of patients with this type of lung cancer.4,5 While HER2 gene mutations can occur in a range of patients, they are more commonly found in patients with NSCLC who are younger, female and have never smoked.8 HER2 gene mutations have been independently associated with cancer cell growth and poor prognosis, with an increased incidence of brain metastases.9 Next-generation sequencing has been utilised in the identification of HER2 (ERBB2) mutations.10

DESTINY-Lung02

DESTINY-Lung02 is a global, randomised Phase II trial evaluating the safety and efficacy of Enhertu in patients with HER2-mutant unresectable and/or metastatic NSCLC with disease recurrence or progression during or after at least one regimen of prior anticancer therapy that must have contained a platinum-based chemotherapy. Patients were randomised 2:1 to receive Enhertu 5.4mg/kg (n=102) or Enhertu 6.4mg/kg (n=50).

The primary endpoint of the trial is confirmed ORR as assessed by BICR. Secondary endpoints include disease control rate (DCR), DoR and PFS assessed by investigator and BICR, OS and safety.

DESTINY-Lung02 enrolled 152 patients at multiple sites, including Asia, Europe, Oceania and North America. For more information about the trial, visit clinicaltrials.gov.

DESTINY-Lung05

DESTINY-Lung05 is an open-label, single-arm Phase II trial evaluating the safety and efficacy of Enhertu (5.4mg/kg) in patients with HER2-mutant metastatic NSCLC with disease progression on or after at least one prior anticancer therapy.

The primary endpoint of the trial is confirmed ORR as assessed by ICR. Secondary endpoints include investigator-assessed confirmed ORR, as well as ICR and investigator-assessed DoR, DCR, PFS and safety.

DESTINY-Lung05 enrolled 72 patients at multiple sites in China. For more information about the trial, visit clinicaltrials.gov.

Enhertu

Enhertu is a HER2-directed ADC. Designed using Daiichi Sankyo’s proprietary DXd ADC Technology, Enhertu is the lead ADC in the oncology portfolio of Daiichi Sankyo and the most advanced programme in AstraZeneca’s ADC scientific platform. Enhertu consists of a HER2 monoclonal antibody attached to a number of topoisomerase I inhibitor payloads (an exatecan derivative, DXd) via tetrapeptide-based cleavable linkers.

Enhertu (5.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-positive (immunohistochemistry [IHC 3+ or in-situ hybridisation [ISH]+) breast cancer who have received a (or one or more)  prior anti-HER2-based regimen, either in the metastatic setting or in the neoadjuvant or adjuvant setting, and have developed disease recurrence during or within six months of completing therapy based on the results from the DESTINY-Breast03 trial.

Enhertu (5.4mg/kg) is approved in more than 65 countries worldwide for the treatment of adult patients with unresectable or metastatic HER2-low (IHC 1+ or IHC 2+/ ISH-) breast cancer who have received a prior systemic therapy in the metastatic setting or developed disease recurrence during or within six months of completing adjuvant chemotherapy based on the results from the DESTINY-Breast04 trial.

Enhertu (5.4mg/kg) is approved in more than 45 countries worldwide for the treatment of adult patients with unresectable or metastatic NSCLC whose tumours have activating HER2 (ERBB2) mutations, as detected by a locally or regionally approved test, and who have received a prior systemic therapy based on the results from the DESTINY-Lung02 and/or DESTINY-Lung05 trials.  Continued approval in China and the US for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu (6.4mg/kg) is approved in more than 45 countries worldwide for the treatment of adult patients with locally advanced or metastatic HER2-positive (IHC 3+ or 2+/ISH+) gastric or gastroesophageal junction (GEJ) adenocarcinoma who have received a prior trastuzumab-based regimen based on the results from the DESTINY-Gastric01, DESTINY-Gastric02 and/or DESTINY-Gastric06 trials. Continued approval in China for this indication will depend on whether a randomised controlled confirmatory clinical trial can demonstrate clinical benefit in this population.

Enhertu (5.4mg/kg) is approved in the US for the treatment of adult patients with unresectable or metastatic HER2-positive (IHC 3+) solid tumours who have received prior systemic treatment and have no satisfactory alternative treatment options based on efficacy results from the DESTINY-PanTumor02, DESTINY-Lung01 and DESTINY-CRC02 trials. Continued approval for this indication in the US may be contingent upon verification and description of clinical benefit in a confirmatory trial.

Enhertu development programme

A comprehensive global clinical development programme is underway evaluating the efficacy and safety of Enhertu monotherapy across multiple HER2-targetable cancers. Trials in combination with other anti-cancer treatments, such as immunotherapy, also are underway.

Daiichi Sankyo collaboration

AstraZeneca and Daiichi Sankyo entered into a global collaboration to jointly develop and commercialise Enhertu in March 2019 and datopotamab deruxtecan in July 2020, except in Japan where Daiichi Sankyo maintains exclusive rights for each ADC. Daiichi Sankyo is responsible for the manufacturing and supply of Enhertu and datopotamab deruxtecan.

AstraZeneca in oncology

AstraZeneca is leading a revolution in oncology with the ambition to provide cures for cancer in every form, following the science to understand cancer and all its complexities to discover, develop and delver life-changing medicines to patients.

The Company’s focus is on some of the most challenging cancers. It is through persistent innovation that AstraZeneca has built one of the most diverse portfolios and pipelines in the industry, with the potential to catalyse changes in the practice of medicine and transform the patient experience.

AstraZeneca has the vision to redefine cancer care and, one day, eliminate cancer as a cause of death.

AstraZeneca

AstraZeneca (LSE/STO/Nasdaq: AZN) is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca’s innovative medicines are sold in more than 125 countries and used by millions of patients worldwide. Please visit astrazeneca.com and follow the Company on social media @AstraZeneca

Contacts

For details on how to contact the Investor Relations Team, please click here. For Media contacts, click here.

References

  1. WHO. International Agency of Cancer Research. Cancer Today. China. 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/populations/160-china-fact-sheet.pdf. Accessed October 2024.
  2. WHO. International Agency of Cancer Research. Cancer Today. Lung. 2022. Available at: https://gco.iarc.who.int/media/globocan/factsheets/cancers/15-trachea-bronchus-and-lung-fact-sheet.pdf. Accessed October 2024.
  3. Fan H, et al. Incidence and survival of non-small cell lung cancer in Shanghai: a population-based cohort study. BMJ Open. 2015;5:e009419.
  4. Liu S, et al. Targeting HER2 Aberrations in Non–Small Cell Lung Cancer with Osimertinib. Clinical Cancer Research. 2018;24(11):2594-2604.
  5. Riudavets M, et al. Targeting HER2 in non-small-cell lung cancer (NSCLC): a glimpse of hope? An updated review on therapeutic strategies in NSCLC harbouring HER2 alterations. ESMO Open. 2021;6(5):100260.
  6. American Cancer Society. Key Statistics for Lung Cancer. Available at: https://www.cancer.org/cancer/types/lung-cancer/about/key-statistics.html. Accessed October 2024.
  7. American Cancer Society. Lung Cancer Survival Rates. Available at: https://www.cancer.org/cancer/types/lung-cancer/detection-diagnosis-staging/survival-rates.html. Accessed October 2024.
  8. Pillai RN, et al. HER2 mutations in lung adenocarcinomas: A report from the Lung Cancer Mutation Consortium. Cancer. 2017;123:4099-105.
  9. Offin M, et al. Frequency and outcomes of brain metastases in patients with HER2-mutant lung cancers. Cancer. 2019;125:4380-7.
  10. Hechtman J, et al. The Past, Present, and Future of HER2 (ERBB2) in Cancer: Approaches to Molecular Testing and an Evolving Role in Targeted Therapy. Cancer Cytopathology. 2019;127(7): 428-431
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SALE OF SHARES IN HUMANA AB (PUBL)

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NOT FOR RELEASE, PUBLICATION OR DISTRIBUTION, IN WHOLE OR IN PART, DIRECTLY OR INDIRECTLY, IN OR INTO THE UNITED STATES, AUSTRALIA, CANADA OR JAPAN OR ANY OTHER JURISDICTION IN WHICH THE DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL.

THIS ANNOUNCEMENT DOES NOT CONSTITUTE AN OFFER TO SELL OR THE SOLICITATION OF AN OFFER TO BUY, NOR SHALL THERE BE ANY SALE OF THE SECURITIES REFERRED TO HEREIN, IN OR INTO ANY JURISDICTION WHERE SUCH OFFER, SOLICITATION OR SALE WOULD BE UNLAWFUL PRIOR TO REGISTRATION OR QUALIFICATION UNDER THE SECURITIES LAWS OF ANY SUCH JURISDICTION.

PLEASE REFER TO THE SECTION “IMPORTANT NOTICE” AT THE END OF THIS PRESS RELEASE.

SALE OF SHARES IN HUMANA AB (PUBL)

Press release, Nov 13th 2024

Team Olivia AB (“Team Olivia” or the “Seller”) has successfully completed the sale of 4 million ordinary shares in Humana AB (“Humana” or the “Company”), equal to approximately 7.7 per cent of the share capital of the Company (the “Sale”), at a price of SEK 35.7 per share.

The shares were sold to a limited number of Swedish and international institutional and other qualified investors.

Following the Sale, Team Olivia no longer holds any shares in the Company.

Carnegie acted as Sole Bookrunner on the Sale.

IMPORTANT NOTICE

THIS ANNOUNCEMENT IS NOT AN OFFER TO SELL, OR SOLICITATION OF AN OFFER TO BUY, ANY SECURITIES IN THE UNITED STATES. THE SECURITIES REFERRED TO HEREIN HAVE NOT BEEN, AND WILL NOT BE, REGISTERED UNDER THE U.S. SECURITIES ACT OF 1933, AS AMENDED (THE ”SECURITIES ACT”) AND MAY NOT BE SOLD IN THE UNITED STATES ABSENT REGISTRATION WITH THE UNITED STATES SECURITIES AND EXCHANGE COMMISSION OR AN EXEMPTION FROM REGISTRATION UNDER THE SECURITIES ACT. THERE IS NO INTENTION TO REGISTER ANY SECURITIES REFERRED TO HEREIN IN THE UNITED STATES OR TO CONDUCT A PUBLIC OFFERING OF SECURITIES IN THE UNITED STATES.

THIS ANNOUNCEMENT IS NOT AN OFFER OF SECURITIES OR INVESTMENTS FOR SALE OR A SOLICITATION OF AN OFFER TO BUY SECURITIES OR INVESTMENTS IN CANADA, JAPAN OR AUSTRALIA OR ANY JURISDICTION WHERE SUCH OFFER OR SOLICITATION WOULD BE UNLAWFUL. NO ACTION HAS BEEN TAKEN THAT WOULD PERMIT AN OFFERING OF THE SECURITIES OR POSSESSION OR DISTRIBUTION OF THIS ANNOUNCEMENT IN ANY JURISDICTION WHERE ACTION FOR THAT PURPOSE IS REQUIRED. PERSONS INTO WHOSE POSSESSION THIS ANNOUNCEMENT COMES ARE REQUIRED TO INFORM THEMSELVES ABOUT AND TO OBSERVE ANY SUCH RESTRICTIONS. ANY FAILURE TO COMPLY WITH THESE RESTRICTIONS MAY CONSTITUTE A VIOLATION OF THE SECURITIES LAWS OF ANY SUCH JURISDICTION.

WITH RESPECT TO THE MEMBER STATES OF THE EUROPEAN ECONOMIC AREA (EACH A “RELEVANT MEMBER STATE”), NO ACTION HAS BEEN UNDERTAKEN OR WILL BE UNDERTAKEN TO MAKE AN OFFER TO THE PUBLIC OF THE SECURITIES REFERRED TO HEREIN REQUIRING THE PUBLICATION OF A PROSPECTUS IN ANY RELEVANT MEMBER STATE. AS A RESULT, THESE SECURITIES MAY ONLY BE OFFERED OR SOLD IN ANY RELEVANT MEMBER STATE PURSUANT TO AN EXEMPTION UNDER REGULATION (EU) 2017/1129 (AS AMENDED OR SUPERSEDED, THE “PROSPECTUS REGULATION”). THIS ANNOUNCEMENT IS ONLY ADDRESSED TO, AND DIRECTED AT, PERSONS IN RELEVANT MEMBER STATES WHO ARE “QUALIFIED INVESTORS” WITHIN THE MEANING OF ARTICLE 2 (E) OF THE PROSPECTUS REGULATION (“QUALIFIED INVESTORS”).

IN THE UNITED KINGDOM THIS ANNOUNCEMENT IS DIRECTED EXCLUSIVELY AT QUALIFIED INVESTORS AS DEFINED IN ARTICLE 2 OF THE PROSPECTUS REGULATION AS IT FORMS PART OF DOMESTIC LAW BY VIRTUE OF THE EUROPEAN UNION (WITHDRAWAL) ACT 2018 (”UK PROSPECTUS REGULATION”) WHO ARE (I) “INVESTMENT PROFESSIONALS” FALLING WITHIN ARTICLE 19(5) OF THE FINANCIAL SERVICES AND MARKETS ACT 2000 (FINANCIAL PROMOTION) ORDER 2005, AS AMENDED (THE “ORDER”); OR (II) PERSONS FALLING WITHIN ARTICLE 49(2)(A) TO (D) (“HIGH NET WORTH COMPANIES, UNINCORPORATED ASSOCIATIONS ETC”) OF THE ORDER, AND/OR (III) TO WHOM IT MAY OTHERWISE LAWFULLY BE COMMUNICATED UNDER THE ORDER, ALL SUCH PERSONS TOGETHER BEING REFERRED TO AS (“RELEVANT PERSONS”). UNDER NO CIRCUMSTANCES SHOULD PERSONS WHO ARE NOT RELEVANT PERSONS RELY OR ACT UPON THE CONTENTS OF THIS ANNOUNCEMENT. ANY INVESTMENT OR INVESTMENT ACTIVITY TO WHICH THIS ANNOUNCEMENT RELATES IN THE UNITED KINGDOM IS AVAILABLE ONLY TO, AND WILL BE ENGAGED ONLY WITH, RELEVANT PERSONS..

IN CONNECTION WITH THE SALE, CARNEGIE AND ANY OF ITS AFFILIATES ACTING AS AN INVESTOR FOR ITS OWN ACCOUNT MAY TAKE UP AS A PRINCIPAL POSITION ANY SHARES AND IN THAT CAPACITY MAY RETAIN, PURCHASE OR SELL FOR ITS OWN ACCOUNT SUCH SHARES. IN ADDITION, CARNEGIE OR ITS AFFILIATES MAY ENTER INTO FINANCING ARRANGEMENTS AND SWAPS WITH INVESTORS IN CONNECTION WITH WHICH CARNEGIE (OR ITS AFFILIATES) MAY FROM TIME TO TIME ACQUIRE, HOLD OR DISPOSE OF SHARES. CARNEGIE DOES NOT INTEND TO DISCLOSE THE EXTENT OF ANY SUCH INVESTMENT OR TRANSACTIONS OTHERWISE THAN IN ACCORDANCE WITH ANY LEGAL OR REGULATORY OBLIGATION TO DO SO.

CARNEGIE IS ACTING ON BEHALF OF THE SELLER AND NO ONE ELSE IN CONNECTION WITH THE SALE AND WILL NOT BE RESPONSIBLE TO ANY OTHER PERSON FOR PROVIDING THE PROTECTIONS AFFORDED TO CLIENTS OF CARNEGIE OR FOR PROVIDING ADVICE IN RELATION TO THE SALE.

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Rekordsnabba beslut inom bygglov – fler automatiserade beslut i Nacka

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I Nacka kommun fortsätter utvecklingen inom automatiserat beslutsfattande genom att nu låta en robot fatta beslut i ytterligare tre ärendekategorier. Därmed fattas automatiserade beslut i e-tjänster inom fem vanliga ärendetyper, vilket medför att 26% av besluten kan fattas på bara några minuter, istället för att ta dagar eller veckor.

Resultatet blir rekordsnabba, trygga besked för den som ansöker och en förbättrad arbetsmiljö för lovhandläggarna, som nu kan ägna sig åt mer kvalificerade uppgifter. 

Automatisering av arbetsflöden sker sedan flera år tillbaka i många av Nackas verksamheter. Målet är att låta systemen utföra vanligt förekommande repetitiva arbetsuppgifter för att frigöra tid för mänskliga möten på plats, via telefon och digitalt – med fokus på att vara tillgängliga när vi behövs och att kunna ge bästa service och råd.

Bättre arbetsmiljö för handläggarna

En av bygglovhandläggarna i Nacka är Sofie Hofvander (till vänster på bilden här ovanför), som har jobbat i hela 18 år med bygglov och hon kan nu se sina arbetsuppgifter utvecklas till att bli ännu mer serviceinriktade än någonsin – en utveckling som hon välkomnar:

– Jag tycker bäst om att jobba med ärenden från privatpersoner eftersom de ofta har mindre kunskaper om bygglovsprocessen, berättar hon och förklarar att mail inte är hennes favoritväg för att hålla kontakt med kunderna:

– Jag vill prata i telefon med kunden för att skapa en relation, kunna svara på frågor direkt, lösa problem och förklara ordentligt om det behövs, berättar hon.

Sofies erfarenhet och viljan att hela tiden förbättra den gemensamma servicen till kund har varit ovärderlig i enhetens utveckling, betonar gruppchefen för utveckling och service, Björn Rune (till höger på bilden här ovanför):

– Sofie har varit med och identifierat vilka beslut som bör automatiseras till förmån för andra ärenden som kan kräva mer hjälp och stöd till den som ska skicka in sin ansökan.

– Som bygglovhandläggare ska du kunna svara på alla inkommande ärenden, oavsett vilka frågor och synpunkter som kommer in, och våra handläggare har en hög kompetens och kan besvara frågor från både företag och privatpersoner som hör av sig, berättar Björn, som betonar att alla enhetens medarbetare bidrar till utvecklingen med olika perspektiv och erfarenheter.

Snabbare och effektivare service

Bygglovenheten i Nacka har sedan tidigare automatiserat beslut för installation av eldstad och anslutning till kommunalt vatten och avlopp. Med denna senaste utökning omfattas nu även beslut om slutbesked för utvändig ändring, slutbesked för anmälan om tillbyggnad samt slutbesked för marklov för trädfällning. Dessa ärendetyper står för en stor del av inkommande ärenden, som nu kan hanteras snabbt och säkert utan behov av en manuell bedömning, då de enbart kräver att alla nödvändiga handlingar har inkommit och är kompletta. Om inte alla handlingar redan finns på plats, så får den som ansöker upp kontrollfrågor som hjälper den fram till en färdig ansökan om slutbesked.

”Delegationen av beslut följer vår ambition”

– Automatiserat beslutsfattande är en fantastisk möjlighet för oss att kunna erbjuda Nackaborna en så effektiv och rättssäker service som möjligt. Vi har i nämnden haft en tydlig ambition redan från lagändringen 2022 att möjliggöra och utveckla det automatiska beslutsfattandet och nu kommer en fjärdedel av våra beslut att beslutas av en automatisk beslutsfunktion, förklarar Johan Krogh (C), ordförande i miljö- och stadsbyggnadsnämnden.

Automatiserade beslut kortar alla handläggningstider

– När vi nu går vidare med att automatisera tre ytterligare ärendetyper som har höga volymer och tydliga riktlinjer kan vi korta ner handläggningstiden för enklare beslut avsevärt, något som direkt bidrar till att korta den totala handläggningstiden – även för mer komplexa ärenden som kräver mer manuell handläggning när handläggarna inte måste ägna tid åt återkommande enklare arbetsmoment, säger Maria Melcher, biträdande klimat- och miljödirektör med ansvar för bygglovenheten.

Hon förklarar vidare hur ärenden valts ut för automatiserat beslutsfattande:

– Automatisering passar särskilt bra för ärenden med höga volymer och tydliga riktlinjer. Vi har under de senaste två åren börjat med lågt hängande frukter och kommer att fortsätta automatisera beslut där det är möjligt.

Nöjda kunder

Bygglovenheten arbetar med tjänstedesign i utvecklingen av sina e-tjänster och samlar in feedback från kunder genom både uppföljande telefonsamtal och fritextsvar. Synpunkterna bidrar direkt till utvecklingen av tjänsterna. 
Responsen från Nackabor som använt e-tjänster med automatiserade beslut har varit mycket positiv.

Flera användare har uttryckt sin uppskattning för hur smidigt och snabbt processen fungerar: ”Fantastiskt snabbt och bra. Imponerande att Nacka är framstående i den digitala utvecklingen,” skriver en av dem. ”Toppen! Detta var nytt för mig, så jag blev mycket positivt överraskad,” säger en annan.

Bakgrund

Nacka kommun har länge varit i framkant när det gäller digitalisering och automatisering av arbetsflöden. När lagändringen sommaren 2022 öppnade för att kommuner skulle kunna fatta automatiserade beslut inom bygglov så blev Nacka först ut i Sverige och några kommuner har följt efter sedan dess.

De automatiserade besluten för installation av eldstad och anslutning till kommunalt VA följdes upp och visade att de varit 100% korrekta beslut. Nu är det dags för ytterligare tre beslutstyper att automatiseras, vilket är ett viktigt steg i kommunens strävan att möta morgondagens behov och krav på effektivitet. Precis som tidigare, så kommer även dessa beslut att följas upp manuellt för att säkerställa att beslutsfattandet är korrekt.

Med denna utökade automatisering fortsätter Nacka kommun sin väg som föregångare inom digitalisering och effektivisering av kommunal service, och möjliggör därmed en modern och tillgänglig samhällsbyggnadsprocess.

Fakta: Nacka kommuns resa inom automatiserat beslutsfattande

2022

Kommunallagen ändrades och öppnade möjligheten för automatiserade beslut i kommuner. Sedan decennier har lagen medgivit automatiserade beslut i statliga myndigheter.

2023

Nacka blev först i Sverige med automatiserade beslut inom bygglov för eldstad och VA, med 100 procent korrekthet i utfallet.

2024

Automatiseringen utökades till fler beslutstyper. Totalt hanteras nu 26% av besluten på bygglovenheten automatiskt, medan övriga ärenden än så länge kräver manuell handläggning.

Effekt

Handläggningstiden för dessa ärenden har reducerats från i vissa fall flera veckor eller dagar till bara några minuter! Bekräftelse på inskickat ärende kommer till kund via SMS, oftast precis innan SMS om att slutligt beslut har fattats – allt för att hålla kunden uppdaterad.

Maria Melcher
Biträdande klimat- och miljödirektör Nacka kommun och ansvarig för bygglovenheten
maria.melcher@nacka.se
Tel: 070-456 21 27

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Stayble Therapeutics’ STA363 receives positive phase 1b results

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Stayble Therapeutics AB (”Stayble” or the ”Company”) announces positive results from the Company’s clinical phase 1b study in lumbar disc herniation (LDH). The study met its primary safety and tolerability endpoint. Additionally, STA363-treated patients showed a statistically significant reduction in disc volume compared to placebo-treated patients.

The study met its primary endpoint with an established favorable safety profile. Only a few adverse events (AE) and no sustained serious adverse events (SAE) related to STA363 were recorded during the study.

Data show a statistically significant volume-decreasing effect compared to placebo already after 1 month, with a maximum reached after 3 months with a sustained decrease at the 6-month follow-up. These results correlate with previously generated data from the phase 2b STA363 study in Degenerative Disc Disease and add valuable insights regarding the onset of volume changes. Moreover, the STA363-induced disc volume reduction is similar to what is available in publications, which correlates to a significant pain-relieving effect in patients with herniated discs.

Improvements in pain scores, functionality, and overall satisfaction were demonstrated in both groups. The study was not powered to detect a difference between the STA363-treated and placebo-treated patients; hence, this result is entirely in line with the study’s expectations.

CEO Andreas Gerward, comments

I am thrilled to present positive results from our study, with the results meeting the primary endpoint in establishing an acceptable safety and tolerability profile. In addition, I am excited that the results clearly demonstrate a STA363 effect on the disc as intended, with statistically significant changes in volume at all follow-up visits, i.e., an effect already after 1 month. This finding may indicate that we will be able to demonstrate an effect on the many times excruciating pain that patients with disc herniation suffer from when we continue the development of STA363 in LDH patients. We have gained important knowledge on efficacy endpoints, setting a solid foundation for the next phase of development. With these results supporting further development, we look forward to advancing preparations for a phase 2b study and intensifying our partnering activities. Finally, I would like to thank our team, collaboration partners, and shareholders for their dedication, support, and persistence.

 

For more information

Andreas Gerward, CEO of Stayble Therapeutics AB

Mail: andreas.gerward@stayble.se

Phone: +46 730 808 397

 

This information is the type of information that Stayble Therapeutics AB is obliged to publish pursuant to the EU Market Abuse Regulation. The information was submitted for publication through the agency of the contact person set out above on November 13, 2024.

 

About the clinical STA363 phase 1b study

The study “A Prospective, Randomized, Double-blinded, Placebo-controlled Study Investigating the Safety and Tolerability of STA363 in Patients with Radiculopathy Caused by Lumbar Disc Herniation”, was a multicenter, double-blind, placebo-controlled study in 25 LDH patients conducted at three sites in Poland. Patients were randomized to either treatment with STA363 or placebo with a ratio of 2:1. All patients received a single injection of STA363 or placebo and were followed for 6 months with follow-up visits at 1 week, 1 month, 3 months, and 6 months. MRI was performed at screening, 1, 3 and 6 months to gather valuable objective measurements regarding safety, volume changes and type of herniation. The study was primarily aimed at assessing the safety and tolerability of STA363, and secondly, the hypothesis that STA363 reduces the disc volume of the herniated disc was tested. A reduced disc volume should decrease the size of the hernia and the pressure on nerve roots, and thereby relieving pain. Treatments that reduce disc and hernia volume have been shown to reduce nerve root pain caused by herniated discs. [1],[2], [3]

 

About Stayble Therapeutics AB

Stayble is a clinical pharmaceutical company developing the injection treatment STA363 for lumbar disc herniation (LDH). Stayble’s vision is to offer patients a simple and effective treatment that targets the underlying cause of the patient’s chronic pain and provides lasting pain relief and increased physical function. The treatment is aimed at patients who are not helped by physical therapy and painkillers and is a single injection that is expected to last a lifetime and requires minimal rehabilitation. After convincing data from previous pre-clinical and clinical studies (phase 1b and 2b) in degenerative disc disease, which show a volume reduction of the discs, the Company has successfully completed a phase 1b study for the treatment of herniated discs.

The company’s Certified Adviser is Svensk Kapitalmarknadsgranskning AB.

[1] Splendiani et al. MR assessment of lumbar disk herniation treated with oxygen-ozone diskolysis: the role of DWI and related ADC versus
  intervertebral disk volumetric analysis for detecting treatment response. 2013

[2] Bitz et al. An evaluation of narrowing following intradiskal injection of chymopapain. 1977

[3] Murphy et al. Percutaneous Treatment of Herniated Lumbar Discs with Ozone: Investigation of the Mechanisms of Action. 2016

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