On March 29, 2023 Regeneron Pharmaceuticals, Inc. (NASDAQ: REGN) reported that the European Commission (EC) approved Libtayo (cemiplimab) in combination with platinum-based chemotherapy for the first-line treatment of adult patients with advanced non-small cell lung cancer (NSCLC) with ≥1% PD-L1 expression (Press release, Regeneron, MAR 29, 2023, View Source [SID1234629524]). This includes patients that have no EGFR, ALK or ROS1 aberrations and whose tumors are metastatic or locally advanced and not candidates for definitive chemoradiation.

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"Today’s approval considerably expands the number of people in Europe with advanced non-small cell lung cancer who are eligible for Libtayo-based first-line treatment, including those with PD-L1 expression ranges most commonly seen in real-world practice," said Israel Lowy, M.D., Ph.D., Senior Vice President, Translational and Clinical Sciences, Oncology at Regeneron. "We are proud that Libtayo continues to distinguish itself among PD-1 pathway blockers, as just one of two PD-1 inhibitors to be approved for use across squamous and non-squamous forms of advanced NSCLC in both combination and monotherapy settings. This marks the fifth approval for Libtayo in Europe."

Lung cancer is the leading cause of cancer death worldwide. In recent years, more than 2.2 million annual new cases have been diagnosed globally. Approximately 80-85% of all lung cancers are NSCLC, with 75% of these cases diagnosed in advanced stages.

"The Phase 3 EMPOWER-Lung 3 trial showed significant improvements across primary and key secondary endpoints, including overall survival in the cemiplimab plus chemotherapy arm," said Prof. Martin Reck, Head of Department of Thoracic Oncology, Lung Clinic Grosshansdorf, Germany. "As a treating physician of this patient population, I welcome a new treatment option for patients in Europe, as we continue to strive for better outcomes for patients with advanced non-small cell lung cancer."

"With lung cancer being the leading cause of cancer mortality globally, ongoing research is imperative to find more treatment options for people impacted by this disease," said Anne-Marie Baird, Ph.D., President, Lung Cancer Europe. "This approval highlights continued progress in first-line treatment options for people impacted by advanced lung cancer in Europe."

Libtayo is currently approved in the EU and other countries for the treatment of certain patients with advanced basal cell carcinoma (BCC), advanced cutaneous squamous cell carcinoma (CSCC), advanced NSCLC and advanced cervical cancer. The Libtayo combination was also approved by the U.S. Food and Drug Administration (FDA) for advanced NSCLC regardless of PD-L1 expression in November 2022.

About the Phase 3 Trial
The EC approval is based on data from the global Phase 3 EMPOWER-Lung 3 trial, a randomized, multicenter trial investigating a first-line combination treatment of Libtayo and platinum-doublet chemotherapy (Libtayo combination), compared to platinum-doublet chemotherapy alone. The trial enrolled 466 patients with locally advanced or metastatic NSCLC, as well as squamous or non-squamous histologies across all PD-L1 expression levels and with no EGFR, ALK or ROS1 aberrations. Notably, the trial was designed to closely resemble a patient population with varied disease presentations seen in everyday clinical practice. Among those enrolled, 43% had tumors with squamous histology, 15% had locally advanced disease and 7% had a history of brain metastases.

Patients were randomized 2:1 to receive either Libtayo 350 mg (n=312) or placebo (n=154) administered intravenously every 3 weeks for 108 weeks, plus platinum-doublet chemotherapy administered every 3 weeks for 4 cycles. The trial was stopped early based on a recommendation by the Independent Data Monitoring Committee after the Libtayo combination demonstrated a significant improvement in overall survival (OS). Results of the trial at the primary analysis were published in Nature Medicine in August 2022.

At the primary analysis (median follow-up: 16 months), the trial showed a statistically significant improvement in the primary endpoint of OS for patients treated with the Libtayo combination compared to chemotherapy alone in the overall population (hazard ratio [HR]: 0.71; 95% confidence interval [CI]: 0.53 to 0.93). Among the 70% of patients in the trial expressing PD-L1 ≥1% (n=327), efficacy results for the Libtayo combination arm (n=217) compared to chemotherapy alone (n=110) showed a:

22-month median OS versus 13 months, representing a 45% relative reduction in the risk of death (HR: 0.55; 95% CI: 0.39 to 0.78).
9-month median progression-free survival (PFS) versus 6 months (HR: 0.48; 95% CI: 0.36 to 0.63)
48% objective response rate (ORR) versus 23%
16-month median duration of response (DOR; range: 2 to 19+) versus 5 months (range: 2 to 19+)
At the time of the pre-specified final analysis (median follow up: 28 months), patients with PD-L1 expression ≥1% treated with the Libtayo combination continued to show clinically meaningful survival and PFS benefits compared to chemotherapy alone.

Immune-mediated adverse reactions, which may be severe or fatal, can occur in any organ system or tissue during or after treatment with Libtayo. Among patients treated with the Libtayo combination evaluated for safety in the trial (n=312), adverse reactions occurring in at least 10% included anemia (44%), alopecia (37%), musculoskeletal pain (27%), nausea (25%), fatigue (23%), peripheral neuropathy (21%), hyperglycemia (18%), decreased appetite (17%), alanine aminotransferase increased (16%), aspartate aminotransferase increased (15%), neutropenia (15%), constipation (14%), dyspnoea (13%), rash (13%), thrombocytopenia (13%), vomiting (12%), diarrhea (11%), insomnia (11%), weight decreased (11%) and hypoalbuminemia (10%). Adverse reactions were serious in 25% of patients and led to permanent discontinuation of the Libtayo combination in 5% of patients.

In December 2022, Libtayo in combination with chemotherapy was added to the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Magnitude of Clinical Benefit Scale (score: 4 out of 5), for patients with advanced NSCLC across squamous and non-squamous histologies, and irrespective of PD-1 expression levels.

About Regeneron in Oncology
At Regeneron, we’re applying more than three decades of scientific innovation with the goal of developing paradigm-changing therapies for patients with cancer. Our oncology portfolio is built around two foundational approaches – our approved PD-1 inhibitor Libtayo and investigational bispecific antibodies – which are being evaluated both as monotherapies and in combination with emerging therapeutic modalities. Together, they provide us with unique combinatorial flexibility to develop potentially synergistic treatments for a wide range of solid tumors and blood cancers.

If you are interested in learning more about our clinical trials, please contact us ([email protected] or 844-734-6643) or visit our clinical trials website.

On March 29, 2023 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a clinical-stage biotechnology company developing novel LAG-3 immunotherapies for cancer and autoimmune disease, reported it has signed an agreement to expand the INSIGHT-003 trial evaluating the combination of eftilagimod alpha ("efti"), a soluble LAG-3 protein and first-in-class MHC class II agonist, in conjunction with standard-of-care combination of anti-PD-1 therapy and chemotherapy in 1st line nonsmall cell lung cancer (1L NSCLC) (Press release, Immutep, MAR 29, 2023, View Source [SID1234629523]).

INSIGHT-003 recently reached its initial enrolment target of 20 patients and will now be expanded to 50 patients across multiple sites. This expansion is based on favourable safety and strong initial efficacy results presented at SITC (Free SITC Whitepaper) 2022. Additional data from INSIGHT-003 is expected throughout calendar year 2023.

Prof. Dr. Salah-Eddin Al-Batran of the Institute of Clinical Cancer Research IKF and lead investigator noted: "We’re thrilled to expand the trial population for this triple combination therapy, which has demonstrated promising efficacy and safety in 1st line non-small cell lung cancer patients. We have seen the previous findings that are indicative of powerful synergies of efti’s immune system stimulation with anti-PD-(L)1 therapies and separately with chemotherapy across various solid tumors. As we continue to gather clinical data throughout the year, we eagerly anticipate discovering how this synergy translates in the INSIGHT-003 study, which combines all three modalities."

Initial results from the triple combination of efti, an anti-PD-1 therapy and chemotherapy in patients with 1L NSCLC show that the therapy is well-tolerated and provides promising early signals of therapeutic activity with an ORR of 72.7% and a Disease Control Rate (DCR) of 90.9%. Additionally, 82% of the eleven evaluable patients had a PD-L1 Tumour Proportion Score (TPS) of <50% and this group reported an encouraging 66.7% ORR and 88.9% DCR.

Patients with low to negative PD-L1 expression represent two-thirds of the 1L NSCLC patient population and are less responsive to anti-PD-(L)1 therapy compared to patients with a PD-L1 TPS of ≥50%. Unlike many dual immuno-oncology combinations (IO-IO) that focus solely on high PD-L1 expressing patients, compelling clinical results to date suggest that efti may be uniquely positioned to address the entire NSCLC patient population regardless of PD-L1 expression through chemo-free IO-IO combinations or IO-IO-chemo triple combinations as INSIGHT-003 is evaluating.

In addition to the Company’s late-stage clinical development efforts focused on 1L NSCLC with the combination of efti and anti-PD-1 therapy (IO-IO), the expansion of INSIGHT-003 will further inform planning for registrational studies. Importantly, this multi-center investigator-initiated trial will generate valuable data in a cost-efficient manner.

Immutep CEO, Marc Voigt, said: "We are grateful for the long-standing support of Dr. Al-Batran and the entire team at IKF. Our valuable relationship with this world-class institution has uncovered many positive attributes of efti and continues to help us cost-effectively advance this novel immunotherapy for patients with advanced solid tumours, including 1st line non-small cell lung cancer."

About INSIGHT-003
INSIGHT-003 is an investigator-initiated study conducted by the Institute of Clinical Cancer Research IKF. It is being run as the third arm (Stratum C) of the ongoing Phase I INSIGHT trial with Prof. Dr. Salah-Eddin Al-Batran as lead investigator. The study is evaluating a triple combination therapy in front line non-small cell lung cancer patients consisting of efti administered subcutaneously in conjunction with an existing approved standard-of-care combination of anti-PD-1 therapy (pembrolizumab) and chemotherapy (carboplatin and pemetrexed) delivered intravenously. The trial will assess the safety, tolerability, and initial efficacy of the combination.

About Eftilagimod Alpha (Efti)
Efti is Immutep’s proprietary soluble LAG-3 clinical stage candidate that is a first-in-class antigen presenting cell (APC) activator that stimulates both innate and adaptive immunity for the treatment of cancer. Efti is an agonist to major-histocompatibility index (MHC) Class II on antigen presenting cells (APCs) that binds to and uniquely activates these APCs via MHC II leading to activation/proliferation of CD8+ (cytotoxic) T cells, CD4+ (helper) T cells, dendritic cells, NK cells, and monocytes. It also upregulates the expression of key biological molecules like IFN-ƴ and CXCL10 that further boost the immune system’s ability to fight cancer.

Efti is under evaluation for a variety of solid tumours including non-small cell lung cancer (NSCLC), head and neck squamous cell carcinoma (HNSCC), and metastatic breast cancer. Its favourable safety profile enables various combinations, including with anti-PD-[L]1 immunotherapy and/or chemotherapy. Efti has received Fast Track Designation in 1st line HNSCC and in 1st line NSCLC from the United States Food and Drug Administration (FDA).

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On March 29, 2023 Thermo Fisher Scientific, the world leader in serving science, and Arsenal Biosciences, Inc. (ArsenalBio), a clinical-stage cell therapy company engineering advanced chimeric antigen receptor (CAR)-T cell therapies for solid tumors, reported an update to our strategic collaboration to further the development of manufacturing processes for new cancer treatments (Press release, Thermo Fisher Scientific, MAR 29, 2023, View Source [SID1234629522]). This research and process development-focused collaboration has enabled ArsenalBio to develop a robust manufacturing process for their next-generation, programmable autologous T cells for the treatment of cancer.

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ArsenalBio recently advanced its lead product candidate into clinical manufacturing of its autologous integrated circuit T cell (ICT) therapy for platinum-resistant ovarian cancer. ArsenalBio’s work to develop multi-functional CAR-T cell therapies is enabled by Thermo Fisher’s Cell Therapy Systems (CTS) portfolio of products, including the Gibco CTS Xenon Electroporation System and the Gibco CTS Rotea Counterflow Centrifugation System.

"Our programmable cell therapy technology holds the potential to help patients with aggressive and complex cancers who currently have few treatment options," said Ken Drazan, M.D., co-founder and chief executive officer, ArsenalBio. "To bring the promise of this technology to patients we’ll need to execute at speed and scale as we transition to clinical development. Our relationship with Thermo Fisher allows us to combine their fit-for-purpose solutions and internal expertise with our team’s innovative approach to clinical research and process development capabilities to manufacture ArsenalBio’s products and explore future therapeutic innovation."

Thermo Fisher began its collaboration with ArsenalBio in 2020 to help ArsenalBio overcome challenges associated with cell therapy manufacturing by working together to support development of a clinical-scale gene editing process. In addition, ArsenalBio received early access to Thermo Fisher’s latest instrumentation and reagents.

"By collaborating with ArsenalBio as they pioneer a new approach to treat solid tumors using engineered T cell therapies, we’re helping bring more options to those who are most in need of innovative treatments," said Betty Woo, vice president of cell, gene and advanced therapies, Thermo Fisher. "Through our Cell Therapy Collaboration Program, we are enabling the industry shift from reactive to proactive, applying our biological and technical expertise to improve the economics of therapy production, and moving toward expanded access to patients worldwide."

Thermo Fisher’s CTS portfolio of products are cGMP manufactured, designed to meet applicable cell therapy standards, and include traceability and regulatory documentation to help customers transition from research to clinical production.

For more information about Thermo Fisher’s cell therapy collaboration partnership program, please visit thermofisher.com/collabcenterpartnership.

On March 29, 2023 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported that management will present and participate in the following investor conferences (Press release, Tyra Biosciences, MAR 29, 2023, View Source [SID1234629521]).

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Cantor’s The Future of Oncology Virtual Symposium

Todd Harris, CEO of TYRA, will participate virtually in a fireside chat on Tuesday, April 4, 2023, at 2:15 pm ET
Bank of America 2023 Healthcare Conference

Mr. Harris will present on Thursday, May 11, 2023, at 9:35 am PT
A live and archived webcast of the Bank of America event will be available via the For Investors page on the Investor section of the TYRA website.

On March 29, 2023 Transcenta Holding Limited ("Transcenta") (HKEX: 06628), a clinical stage biopharmaceutical company with fully-integrated capabilities in discovery, research, development and manufacturing of antibody-based therapeutics, reported that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to Osemitamab (TST001), its high affinity humanized ADCC-enhanced anti-Claudin18.2 monoclonal antibody, for the treatment of patients with pancreatic cancer (Press release, Transcenta, MAR 29, 2023, View Source [SID1234629520]). This is the second Orphan Drug Designation for Osemitamab (TST001), following its designation in 2021 for the treatment of gastric cancer and gastroesophageal junction cancer.

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Orphan drugs are used for the prevention, treatment, and diagnosis of rare diseases. The ODD granted by the US FDA is applicable to drugs and biologics for rare diseases with less than 200,000 patients in the United States each year. The drugs that have been certified can potentially enjoy tax incentives in the United States, a seven-year market exclusivity period after listing, as well as other policy incentives.

Pancreatic cancer is one of the most challenging cancers to treat, as it is often diagnosed at an advanced stage with typically poor outcomes to available therapies. The 5-year survival rate at diagnosis is around 10% and the median overall survival barely exceeds 9 months for advanced or metastatic disease. According to the data from National Institutes of Health, it is estimated that in 2022 approximately 62,200 people will be diagnosed with pancreatic cancer and approximately 50,000 will die from the disease.

Previously Transcenta presented preliminary anti-tumor activity data in pancreatic cancer of Osemitamab (TST001) at the 2022 International Gastric Cancer Congress, the data indicated that monotherapy treatment with Osemitamab (TST001) led to a prolonged partial response in a Claudin18.2 low expressing pancreatic cancer patient who progressed from multiple cycles of chemotherapy. In preclinical studies, Osemitamab (TST001) has shown potent anti-tumor activities in Claudin18.2 expressing pancreatic cancer tumor models independent of Kras mutation status.

"Osemitamab (TST001) is currently being evaluated for the treatment of different Claudin18.2 positive indications. We believe it also has the potential to be transformative for advanced pancreatic adenocarcinoma who lack effective therapeutic options. We look forward to progressing our program in this indication." said Dr. Caroline Germa, Transcenta’s Executive Vice President, Global Medicine Development and Chief Medical Officer.

About Osemitamab (TST001)

Osemitamab (TST001) is a high affinity humanized anti- CLDN18.2 monoclonal antibody with enhanced antibody-dependent cellular cytotoxicity ("ADCC") and complement-dependent cytotoxicity ("CDC") activities and potent anti-tumor activities in tumor xenograft models. Osemitamab (TST001) is the second most advanced CLDN18.2 targeting antibody being developed globally. Osemitamab (TST001) is generated using Transcenta’s Immune Tolerance Breaking Technology (IMTB) platform. Osemitamab (TST001) kills CLDN18.2 expressing tumor cells by mechanisms of ADCC and CDC. Leveraging advanced bioprocessing technology, the fucose content of Osemitamab (TST001) was significantly reduced during the production, which further enhanced NK cells mediated ADCC activity of Osemitamab (TST001). Clinical trials for Osemitamab (TST001) are ongoing in the U.S. and China (NCT04396821, NCT04495296/CTR20201281). Osemitamab (TST001) was granted Orphan Drug Designation in the U.S. by FDA for the treatment of patients with gastric or gastroesophageal junction (G/GEJ) cancer.