On September 25, 2024 Intas Pharmaceuticals Limited ("Intas") reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending approval of HETRONIFLY (serplulimab, approved as HANSIZHUANG in China), in European markets (Press release, Intas Pharmaceuticals, SEP 25, 2024, View Source [SID1234646867]).

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Serplulimab, a recombinant humanised anti-PD-1 monoclonal antibody (mAb) injection, is the first innovative monoclonal antibody developed by Henlius. It has been granted orphan drug status designation by the U.S. Food and Drug Administration (FDA) and the European Commission (EC) for the treatment of Small Cell Lung Cancer (SCLC).

Serplulimab will be commercialised by Intas through its subsidiary, Accord Healthcare Ltd (Accord), across more than 30 countries in Europe. As one of the key players in the global oncology market, Accord has a longstanding commitment to oncology with proven commercial capabilities and currently supplies around one in three injectable oncology medicines in Europe. This positive opinion from CHMP marks another step closer for both Henlius and Intas to provide serplulimab for patients in Europe.

Binish Chudgar, Vice-Chairman and Managing Director of Intas Pharmaceuticals, said, "The CHMP’s positive opinion on serplulimab is a pivotal moment in our mission to provide world-class cancer treatments to patients in Europe and across multiple geographies. This strengthens our differentiated oncology portfolio and reinforces Accord’s commitment to alleviating the global cancer burden by ensuring innovative high-quality affordable treatment for those in need."

Paul Tredwell, Executive Vice President of EMENA at Accord, said, " Accord are proud to be the leading generic oncology company in Europe, this approval highlights Accords’ continued strategy to build out its speciality business across the region, driving innovation in oncology."

Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius, stated: "The positive opinion from CHMP signifies a major milestone in our efforts to accelerate the global reach of our products, and further validates Henlius’ patient-centred R&D approach and commitment to global strategy. We look forward to the formal approval of this treatment in Europe, bringing more treatment options and hope to patients there and worldwide."

According to GLOBOCAN 2022, lung cancer is the most diagnosed and the first mortality cancer around the world. There were more than 2.48 million new cases of lung cancer worldwide in 2022, accounting for 12.4% of all new cancer cases. [1] Small cell lung cancer (SCLC) accounts for 15%–20% of the total number of lung cancer cases and is associated with early metastasis, rapid disease progression, and an extremely poor prognosis.

The positive opinion from CHMP is primarily based on ASTRUM-005, a randomized, double-blind, placebo-controlled international multi-centre clinical study, which evaluated the efficacy and adverse event profile of the PD-1 inhibitor serplulimab plus chemotherapy compared with placebo plus chemotherapy as first-line treatment in patients with ES-SCLC.

On September 25, 2024 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases, reported that it will participate at the 2024 Cell and Gene Meeting on the Mesa, to be held October 7-9, 2024 in Phoenix, AZ (Press release, ImmPACT-Bio, SEP 25, 2024, View Source [SID1234646866]).

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Sumant Ramachandra, M.D., Ph.D., ImmPACT Bio’s chief executive officer, will provide a corporate update on Tuesday, October 8, 2024 at 10:15 AM PT.

On September 25, 2024 AstraZeneca’s reported that Tagrisso (osimertinib) has been approved in the US for the treatment of adult patients with unresectable, Stage III epidermal growth factor receptor-mutated (EGFRm) non-small cell lung cancer (NSCLC) whose disease has not progressed during or following concurrent or sequential platinum-based chemoradiation therapy (CRT) (Press release, AstraZeneca, SEP 25, 2024, View Source [SID1234646865]). Tagrisso is indicated for patients with exon 19 deletions or exon 21 (L858R) mutations, as detected by a FDA-approved test.

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The approval follows a Priority Review by the Food and Drug Administration (FDA) that was based on results from the LAURA Phase III trial, which were presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and simultaneously published in The New England Journal of Medicine.

Tagrisso reduced the risk of disease progression or death by 84% compared to placebo (hazard ratio 0.16; 95% confidence interval 0.10-0.24; p<0.001) as assessed by blinded independent central review. Median progression-free survival (PFS) was 39.1 months in patients treated with Tagrisso versus 5.6 months for placebo.

Overall survival (OS) results remain immature at this current analysis. The trial continues to assess OS as a secondary endpoint.

Each year in the US, there are more than 200,000 people diagnosed with lung cancer, and 80-85% of these patients are diagnosed with NSCLC, the most common form of lung cancer.1-3 Approximately 15% of NSCLC patients in the US have EGFR mutations.4 Nearly one in five people diagnosed with NSCLC has an unresectable tumour.5

Suresh Ramalingam, MD, Executive Director of Winship Cancer Institute of Emory University, Atlanta, US, and principal investigator in the trial, said: "This approval represents a major breakthrough for patients with Stage III, EGFR-mutated lung cancer who will now have the opportunity to benefit from osimertinib. Patients treated with osimertinib lived without disease progression by more than three years in the LAURA trial, and this impressive benefit underscores the importance of diagnosing and testing lung cancer patients as early as possible."

Dave Fredrickson, Executive Vice President, Oncology Business Unit, AstraZeneca, said: "The approval of Tagrisso for patients with Stage III, unresectable EGFR-mutated non-small cell lung cancer addresses a critical need for patients with these mutations who have never had the option of targeted therapy before. The results of the LAURA trial show the powerful impact Tagrisso can make as backbone therapy in this disease, and with this approval, patients across all stages of EGFR-mutated non-small cell lung cancer can now benefit."

The safety and tolerability of Tagrisso in the LAURA trial was consistent with its established profile and no new safety concerns were identified.

Tagrisso is approved for patients with EGFR mutations in the 1st-line metastatic setting as a monotherapy and in combination with chemotherapy, and as an adjuvant treatment for early-stage disease. Tagrisso is currently under review with regulatory authorities in other countries around the world for this indication.

Notes

Lung cancer
Each year, an estimated 2.4 million people are diagnosed with lung cancer globally.6 Lung cancer is the leading cause of cancer death among both men and women, accounting for about one-fifth of all cancer deaths.6 Lung cancer is broadly split into NSCLC and small cell lung cancer.2 The majority of all NSCLC patients are diagnosed with advanced disease.7

Approximately 10-15% of NSCLC patients in the US and Europe, and 30-40% of patients in Asia have EGFRm NSCLC.4,8-9 Patients with EGFRm NSCLC are particularly sensitive to treatment with an EGFR-tyrosine kinase inhibitor (EGFR-TKI) which blocks the cell-signalling pathways that drive the growth of tumour cells.10

LAURA
LAURA is a randomised, double-blind, placebo-controlled, multi-centre, global Phase III trial in patients with unresectable, Stage III EGFRm NSCLC whose disease has not progressed following definitive platinum-based CRT. Patients were treated with Tagrisso 80mg once-daily oral tablets until disease progression, unacceptable toxicity or other discontinuation criteria were met. Upon progression, patients in the placebo arm were offered treatment with Tagrisso.

The trial enrolled 216 patients in more than 145 centres across more than 15 countries, including in the US, Europe, South America and Asia. This is the analysis of the primary endpoint of PFS. The trial is ongoing and will continue to assess the secondary endpoint of OS.

Tagrisso
Tagrisso (osimertinib) is a third-generation, irreversible EGFR-TKI with proven clinical activity in NSCLC, including against central nervous system (CNS) metastases. Tagrisso (40mg and 80mg once-daily oral tablets) has been used to treat nearly 800,000 patients across its indications worldwide and AstraZeneca continues to explore Tagrisso as a treatment for patients across multiple stages of EGFRm NSCLC.

There is an extensive body of evidence supporting the use of Tagrisso as standard of care in EGFRm NSCLC. Tagrisso improved patient outcomes in early-stage disease in the ADAURA Phase III trial, locally advanced disease in the LAURA Phase III trial, late-stage disease in the FLAURA Phase III trial, and with chemotherapy in the FLAURA2 Phase III trial.

As part of AstraZeneca’s ongoing commitment to treating patients as early as possible in lung cancer, Tagrisso is also being investigated in the neoadjuvant setting in the NeoADAURA Phase III trial with results expected later this year and in the early-stage adjuvant resectable setting in the ADAURA2 Phase III trial.

The Company is also researching ways to address tumour mechanisms of resistance through the SAVANNAH and ORCHARD Phase II trials, and the SAFFRON Phase III trial, which test Tagrisso plus Orpathys (savolitinib), an oral, potent and highly selective MET TKI, as well as other potential new medicines.

On September 25, 2024 Phio Pharmaceuticals Corp. (NASDAQ: PHIO), a clinical stage biotechnology company whose proprietary INTASYL siRNA gene silencing technology is designed to make immune cells more effective in killing tumor cells, reported it is presenting data about INTASYL, its patented technology platform at the 20th Annual Oligonucleotide Therapeutics Society (OTS) Meeting (Press release, Phio Pharmaceuticals, SEP 25, 2024, View Source [SID1234646864]). The conference will be held from October 6th-9th in Montreal, bringing together leading experts in oligonucleotide research.

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Phio’s presentation will focus on how INTASYL can enhance the ex vivo expansion process to improve the functionality and outcomes of adoptive cell therapies such as NK, TIL, or CAR-T. An advantage of the INTASYL technology is its simplified chemical composition, designed to reduce toxicity and improve both tolerability and efficacy, which are concerns in therapeutic development.

Presentation Details are as follows:

Title: INTASYL Self-Delivering RNAi: a Flexible Platform for Cancer Treatment
Poster Number: P180
Poster Session: II
Presenting Author: Melissa Maxwell
Date and Time: October 8 at 3:45-6:45 PM
Location: Centre Mont-Royal, 2000 Mansfield St, Montreal, Quebec

On September 25, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported the filing of a new patent application protecting MDG2021, a T cell receptor engineered T cell (TCR-T) therapy targeting Kirsten rat sarcoma viral oncogene homologue (KRAS) G12D with human leukocyte antigen (HLA)-A*11, for the TCR-T therapy alone as well as in combination with the Company’s PD1-41BB costimulatory switch protein (CSP) technology to the European Patent Office (Press release, MediGene, SEP 25, 2024, View Source [SID1234646863]). MDG2021 marks the second candidate within the KRAS library targeting KRAS G12D (HLA-A*11) for which the Company announced lead selection in June 2024. The addition of MDG2021 to Company’s KRAS targeting TCR library significantly impacts the addressable patient population with the combination of KRAS G12V and KRAS G12D mutations comprising ~50% of all KRAS mutations in all tumors (pan-cancer), or even >70% in pancreatic adenocarcinoma. (Yang et al., J Clin Med 2023)

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"We are pleased to announce the patent filing for MDG2021, our optimal affinity 3S (sensitive, specific and safe) TCR targeting KRAS G12D (HLA-A*11), alone and in combination with our PD1-41BB armoring and enhancement CSP," said Selwyn Ho CEO at Medigene. "This filing reaffirms our commitment to broaden our intellectual property for TCRs targeting both neoantigens and cancer testis antigens that have potential utility in multiple TCR-guided treatment modalities including TCR-T therapies such as MDG2021, as well as TCR-guided T cell engager therapies (MDG3010) and TCR-natural killer cell therapies."

Medigene continually extends and strengthens its patent portfolio with new technologies and expands existing patents into additional jurisdictions. The Company maintains 29 different patent families worldwide covering applications protecting Medigene’s 3S TCRs as well as its exclusive E2E Platform technologies.