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AstraZeneca’s (AZ) Tagrisso (osimertinib) has been recommended by the European Medicines Agency’s human medicines committee as part of a combination treatment for a subset of advanced lung cancer patients.The Committee for Medicinal Products for Human Use (CHMP) has recommended that the epidermal growth factor receptor-mutated (EGFR)-tyrosine kinase inhibitor be authorised for use alongside pemetrexed and platinum-based chemotherapy as a first-line treatment for adults with locally advanced or metastatic EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose tumours have exon 19 deletions or exon 21 (L858R) mutations.The committee’s positive opinion was supported by results from the late-stage FLAURA2 trial, which randomised more than 500 patients to receive Tagrisso plus chemotherapy or Tagrisso monotherapy, the first-line global standard of care for these patients.The results showed the combination reduced the risk of disease progression or death by 38% compared to Tagrisso alone.The combination was shown to extend median progression-free survival by 8.8 months and progression-free survival by 9.5 months compared to Tagrisso monotherapy, AZ said, adding that while overall survival data remained immature at the time of the interim analysis, an “encouraging trend” towards overall survival benefit was observed with Tagrisso plus chemotherapy versus Tagrisso alone.More than 450,000 people are diagnosed with lung cancer every year in Europe and NSCLC accounts for up to 85% of all lung cancer cases.Up to 15% of NSCLC patients in Europe have an EGFR mutation, with this patient population particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor that blocks the cell-signalling pathways driving tumour cell growth.Tagrisso is already approved as monotherapy in more than 100 countries, with approved indications including for the first-line treatment of patients with locally advanced or metastatic EGFRm NSCLC, locally advanced or metastatic EGFR T790M mutation-positive NSCLC, and for the adjuvant treatment of early-stage EGFRm NSCLC.Read more: https://lnkd.in/gSHm3mCG

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The European Medicines Agency’s human medicines committee has recommended Valneva’s single-dose chikungunya vaccine for use in individuals aged 18 years and older.If approved by the European Commission, Ixchiq will become the first vaccine available in the EU against the chikungunya virus.Chikungunya is a mosquito-borne viral disease that often causes sudden large outbreaks with high attack rates, affecting one-third to three-quarters of the population in areas where the virus is circulating.Infection leads to symptomatic disease in up to 97% of people after three to seven days following the mosquito bite, with clinical symptoms including fever, joint and muscle pain, headache, nausea and rash.The recommendation from the Committee for Medicinal Products for Human Use (CHMP) was supported by positive results from a late-stage trial, which demonstrated a 98.9% seroresponse rate at 28 days after a single dose of the vaccine.This immune response was sustained for 24 months by 97% of study participants and was equally durable in younger and older adults, Valneva said.The company also recently shared further positive data for the vaccine in adolescents. The results showed that a single-dose generated a high and sustained immune response in an immunogenicity subset of adolescents who were chikungunya-negative at baseline, with a seroresponse rate of 99.1% after 180 days following vaccination compared to 98.8% after 29 days.The day 180 data also confirmed that a single dose of the vaccine was generally safe and well tolerated in adolescents, regardless of previous infection status.Read more: https://lnkd.in/ezxK6vh9

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Alligator Bioscience released positive data from its Phase Ib/II OPTIMIZE-1 study (NCT04888312) investigating itspancreatic cancermonoclonal antibody therapy, mitazalimab.The Sweden-headquartered company presented the Phase II readout at theAmerican Society of Clinical Oncology Annual Meeting(ASCO 2024), publishing the data in theLancet Oncologyon 3 June. Patients who took mitazalimab in combination with mFOLFIRINOX, demonstrated a confirmed objective response rate (ORR) of 40.4% with a median overall survival (mOS) of 14.3 months. This was an improvement compared to historical data from treatment with mFOLFIRINOX where patients typically achieve a 31.6% ORR and a mOS of 11.1 months.In an exclusive interview withPharmaceutical Technology, Alligator CEO Dr Søren Bregenholt says: “We believe that adding three months to the overall survival is clinically meaningful. It is definitely meaningful for the patients, and it is also a differential that is approvable in almost all major territories.”Bregenholt explains that for 80% of pancreatic cancer patients, the only option available for frontline and second-line treatment is chemotherapy. He adds that approved therapies are quite “mediocre” in terms of response rate and clinical benefit.Read more: https://lnkd.in/gwwwQQ6j

Soon afterSanofiannounced that the US Food and Drug Administration (FDA)acceptedits supplemental biologics licence application (sBLA) for priority review, the global pharma company announced positive results for the Phase III study of its Sarclisa (isatuximab) combination therapy for the treatment of multiple myeloma (MM).The results, which were shared at theAmerican Society of Clinical Oncology (ASCO)Annual Meeting, held from 31 May to 4 June, reported that Sarclisa in combination with standard-of-care bortezomib, lenalidomide and dexamethasone (VRd) reduced the risk of disease progression or death by 40% compared to treatment with the VRd active comparator arm.The randomised, multi-centre, open-label Phase III IMROZ study (NCT03319667) evaluated the treatment in 446 patients with newly diagnosed, transplant-ineligible MM. The study’s primary endpoint of progression-free survival (PFS) was met, with the estimated PFS at 60 months recorded at 63.2% in the treatment group versus 45.2% in the comparator arm. However, the regimen has not yet reached its trial median PFS.Read more: https://lnkd.in/gn6Qjeuu

COVID-19 vaccine makers said data from animals studies showed their 2024-25 shots targeting the JN.1 variant that was dominant earlier this year could neutralize newer subvariants such as KP.2 much better than the older shots.This was disclosed in presentations by the companies ahead of a meeting of the U.S. Food and Drug Administration's advisers on Wednesday.The FDA panel will vote to recommend if companies should target the JN.1 variant when the companies update their vaccines for 2024-25 immunization campaign.Pfizerand its partner BioNTech will be ready to supply the updated vaccines immediately upon approval, while Moderna and Novavax forecast a timeline for August, the companies said.Focus will be on whether advisers will recommend JN.1 strain or KP.2, which is now the dominant strain in the United States.Pfizer and Moderna said they are ready to supply vaccines that target either JN.1 or KP.2. Novavax has said it would be able to offer a vaccine in the United States this autumn if regulators accept the shot it started manufacturing to target the JN.1 variant.Read more: https://lnkd.in/envNwESe

Eli Lilly has entered into an exclusive licence agreement worth over $620m to gain rights to QurAlis’ investigational precision therapy for neurodegenerative diseases including amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD).The deal gives Lilly global rights to develop and commercialise QRL-204, a splice-switching antisense oligonucleotide (ASO) designed to restore the function of the UNC13A gene, and other UNC13A-targeting compounds.In exchange, QurAlis will receive an upfront payment of $45m and will be eligible for future milestone payments of up to $577m, plus tiered royalties on net sales.UNC13A is an essential regulator of neurotransmitter release at synapses and is implicated in approximately 63% of ALS cases and 33% of FTD cases.Andrew Adams, senior vice president, neurodegeneration research, and director, Lilly Institute for Genetic Medicine, said: “Genetic precision medicines like QRL-204 that target specific causal components of disease pathology hold great promise for delivering meaningful advances against a range of neurodegenerative diseases like ALS and FTD.”Preclinical data recently presented at this year’s International Conference on Alzheimer’s and Parkinson’s Diseases and Related Neurological Disorders demonstrated that QurAlis’ UNC13A splice-switching ASOs modulate UNC13A splicing and restore normal synaptic activities in ALS and FTD.The agreement will also see the companies collaborate to identify and develop additional candidates targeting UNC13A using QurAlis’ proprietary FlexASO splice modulator platform.Kasper Roet, chief executive officer and co-founder of QurAlis, said: “This partnership enables QRL-204 to rapidly move toward the clinic, while we continue to advance our other lead programmes.“We look forward to combining our complementary strengths to uncover additional candidates that target UNC13A that have the potential to transform the treatment of neurodegenerative diseases like ALS and FTD and beyond.”Read more: https://lnkd.in/epGDC4mAStay in touch with all the leading stories, events and opportunities by subscribing to our LinkedIn Newsletter:https://bit.ly/3RbdKtcor joining some of the largest groups most relevant to you:https://bit.ly/4caKquL(A-Z list)

BioNTech SE, an immunotherapy company pioneering novel therapies for cancer and other serious diseases, and NanoTag Biotechnologies, a biotechnology company developing single-domain antibodies, have announced Research Collaboration and exclusive License Agreement aimed at evaluating NanoTag’s target labeling system ALFA across indications in oncology and infectious diseases, in both preclinical and clinical settings.The ALFA System, featured in Nature Communications in 2019, employs high-affinity single-domain antibodies (nanobodies) that recognize a rationally designed 14 amino acid epitope tag, ALFA. This technology, developed and patented by NanoTag, has become an essential tool for academic researchers to label and study proteins of interest (POI). The precision and adaptability of the ALFA system are expected to drive significant advancements in biomedicine and diagnostics.According to the press release, the collaboration will explore the high specificity of the ALFA tag-antibody binding in various applications, including potential drug delivery methods that BioNTech is eager to pursue.NanoTag Biotechnologies GmbH is a German company founded in 2015, primarily focused on the development, production, and application of single-domain antibodies (sdAbs). NanoTag leverages its expertise in biotechnology to produce these specialized antibodies on a large scale using recombinant cell cultures, thereby minimizing animal use. The company's core activities include the discovery and validation of sdAbs, aiming to support research, diagnostics, and therapeutic applications. Additionally, NanoTag is involved in the creation of novel sdAb-based reagents and tools. They focus on improving the production, properties, and applications of these antibodies in various biomedical fields, aiming to enhance the speed and reproducibility of sdAb discovery and development.Under the terms of the initial agreement signed in 2022, NanoTag will now receive an option exercise fee of EUR 1 million from BioNTech for the use of the ALFA system in its candidate development, and potential additional development, regulatory and commercial milestone payments, and royalty payments. BioNTech may advance any number of products under the licensing agreement.Read more: https://bit.ly/3yCfeoV