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First Patient dosed in a Head-to-Head First-Line Bridging Study of HANSIZHUANG for ES-SCLC treatment in the US

On November 29, 2022 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the first patient was dosed in NCT05468489, a bridging head-to-head trial in the United States comparing HANSIZHUANG (serplulimab), an innovative anti-PD-1 monoclonal antibody (mAb) independently developed by the company to standard of care Atezolizumab (anti-PD-L1 mAb) (Press release, Shanghai Henlius Biotech, NOV 29, 2022, View Source [SID1234624565]). Based on the positive feedback of FDA Biologics license Application (BLA) submission for HANSIZHUANG for the treatment of extensive-stage small cell lung cancer (ES-SCLC) and the discussion results of the FDA’s Class C consultation meeting, Henlius plans to recruit 100 pairs of US patients with ES-SCLC to evaluate the efficacy of HANSIZHUANG.

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In April 2022, the company announced that US Food and Drug Administration (FDA) has granted Orphan-Drug Designation (ODD) for HANSIZHUANG for the treatment of small cell lung cancer (SCLC). The ODD granted by the FDA is beneficial for the continuous development of HANSIZHUANG and the enjoyment of certain policy support in terms of registration and commercialization in the United States. In China, the New Drug Application (NDA) of HANSIZHUANG in combination with chemotherapy for the first-line treatment of ES-SCLC has been accepted by the National Medical Products Administration (NMPA). At present, there is no anti-PD-1 mAb approved for the first-line treatment of SCLC worldwide. HANSIZHUANG is expected to become the world’s first anti-PD-1 mAb for the first-line treatment of SCLC and to fill the clinical gap in the next five years.

Innovate to further advance

SCLC is the most aggressive subtype of lung cancer, accounting for 15% to 20% of all lung cancer cases. SCLC exhibit high malignancy, strong invasiveness, early metastasis, fast disease progression, and a poor prognosis. At present, anti-PD-L1 mAbs combined with chemotherapy have been recommended by clinical practice guidelines abroad as the first-line treatment for ES-SCLC, but there is no anti-PD-1 mAb approved worldwide, suggesting the need for more effective treatments in this patient population.

Henlius has conducted an international multi-centre phase 3 study of HANSIZHUANG plus chemotherapy as first-line treatment for patients with ES-SCLC. The study has set up a total of 128 sites in various countries including China, Turkey, Poland, and Georgia, and enrolled 585 subjects who were screened from 114 sites, among whom 31.5% were White. The results of ASTRUM-005 were presented for the first time in an oral report at the 2022 ASCO (Free ASCO Whitepaper) annual meeting, and ASTRUM-005 went on to become the first immunotherapy clinical study of SCLC to be published in The Journal of the American Medical Association (JAMA, impact factor of 157.3), one of the top four medical journals in the world. As of data cutoff for the interim analysis (October 22, 2021), median overall survival (OS) was significantly longer in the serplulimab group (15.4 months) than in the placebo group (10.9 months), forming a new world record. In addition, the study showed good safety and consistent efficacy over time.

Comprehensive Layout

HANSIZHUANG is the first innovative mAb developed by Henlius. Up to date, 2 indications are approved for marketing in China, 2 NDAs have been accepted by the NMPA. Since launched in March 2022, HANSIZHUANG has been approved by the NMPA for the treatment of MSI-H solid tumours and squamous non-small cell lung cancer, benefiting more than 9,700 Chinese patients. Its synergy with in-house products of the company and innovative therapies are forging ahead. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 11 clinical trials on immuno-oncology combination therapies in a wide variety of indications, such as lung cancer, esophageal carcinoma, head and neck squamous cell carcinoma and gastric cancer, etc., and covering the full range of first-line treatments of lung cancers. As of now, HANSIZHUANG has enrolled more than 3,100 subjects around the world, and the proportion of White is over 30% in two MRCTs including ASTRUM-005. Such a large amount of global clinical data is also expected to bolster the marketing approval of HANSIZHUANG in overseas markets such as the European Union and to lay a foundation for global clinical application. The bridging trial carried out in the United States will also further promote the global development of HANSIZHUANG.

In the future, the company will continue to emphasize unmet clinical needs, actively promote the progress of this bridging study and the combination immunotherapy of serplulimab, offering high-quality, affordable, and innovative medicines to patients worldwide.

About NCT05468489

This randomised, open-label clinical study aims to compare the efficacy and safety of serplulimab with atezolizumab (anti-PD-L1 mAb) when combined with chemotherapy (carboplatin-etoposide) in previously untreated US patients with extensive-stage small cell lung cancer (ES-SCLC). Eligible patients will be randomised 1:1 to receive intravenous infusion of either serplulimab (300 mg) or atezolizumab (1200 mg) in combination with chemotherapy every 3 weeks. The primary objective of this study is to compare the efficacy of the two treatment regimens in previously untreated US ES-SCLC patients. Secondary objectives are to evaluate the efficacy, safety, pharmacokinetics, and immunogenicity of serplulimab in combination with chemotherapy. The primary endpoint is overall survival (OS). Secondary endpoints include progression-free survival (PFS), PFS2, objective response rate (ORR), duration of response (DOR), safety, pharmacokinetic characteristics, and immunogenicity.

BostonGene to Present at the 2022 San Antonio Breast Cancer Symposium

On November 29, 2022 BostonGene reported that four abstracts have been accepted for poster presentations for the 2022 San Antonio Breast Cancer Symposium (SABCS), which will be held December 6 – 9, 2022, at the Henry B. Gonzalez Convention Center in San Antonio, Texas (Press release, BostonGene, NOV 29, 2022, View Source [SID1234624564]). BostonGene will also exhibit at booth 107.

"The data we will present at SABCS demonstrates the clinical utility of BostonGene‘s AI-based molecular and immune profiling and analytics to advance and optimize outcomes for cancer patients," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "Our findings highlight the importance of a multifaceted approach to understand the composition and activity of the tumor and the microenvironment."

Details about the abstracts selected for presentation can be found below:

Abstract Number: 1304759
Title: A molecular classification system for basal-like breast cancer based on the tumor microenvironment is prognostic for survival
Date and Time: Thursday, December 8 | 7:00 AM – 8:15 AM
Location: Poster Session 4 – Hall 1
Poster Number: P4-09-02
Speaker: Nikita Kotlov, BostonGene

Using whole-transcriptome data clustering techniques, BostonGene uncovered five distinct basal-like breast cancer molecular functional portraits prognostic for survival using gene signatures from the tumor microenvironment.

Abstract Number: 1310282
Title: An HRD scoring system based on long-focal copy number alterations predictive of PARP inhibitor response
Date and Time: Thursday, December 8 | 5:00 PM – 6:15 PM
Location: Poster Session 5 – Hall 1
Poster Number: P5-02-45
Speaker: Nikita Kotlov, BostonGene

BostonGene developed and validated a new homologous recombination deficiency (HRD) scoring system for breast cancer patients. This novel HRD score, which uses long-focal copy number alterations and ploidy rather than relying on germline mutations in the homologous recombination pathway, was predictive of PARP inhibitor response.

Abstract Number: 1310386
Title: AI-based prediction of tertiary lymphoid structures and lymphocyte immune infiltration in breast carcinomas
Date and Time: Friday, December 9 | 7:00 AM – 8:15 AM
Location: Poster Session 6 – Hall 1
Poster Number: P6-04-15
Speaker: Ekaterina Postovalova, PhD, BostonGene

Leveraging a convolutional neural network, BostonGene trained and validated an image analysis platform capable of detecting tertiary lymphoid structures and the lymphocyte immune-infiltrated area on breast carcinoma H&E slides. This AI-based approach may be used to automate the traditional pathology workflow.

Abstract Number: 1310481
Title: TRK inhibitor in a patient with metastatic triple-negative breast cancer and NTRK fusions identified via cell-free DNA analysis.
Date and Time: Thursday, December 8 | 5:00 PM – 6:15 PM
Location: Poster Session 5 – Hall 1
Poster Number: P5-02-13
Speaker: Jennifer C. Keenan, Mass General Cancer Center

In this case report, BostonGene’s Tumor Portrait next-generation sequencing test provided orthogonal validation for two NTRK fusions, including one novel fusion, detected by cell-free DNA analysis in a metastatic triple-negative breast cancer patient.

Research conducted with Mass General Cancer Center

For more information, please visit the 2022 San Antonio Breast Cancer Symposium website. The abstracts will be published in the Abstracts2View online database at the conclusion of the symposium.

Resilience to Establish a Biomanufacturing Partnership with AstraZeneca and Purchase AstraZeneca’s Manufacturing Site in West Chester, Ohio

On November 29, 2022 National Resilience, Inc. (Resilience) and AstraZeneca PLC reported that the companies will establish a long-term biomanufacturing relationship in support of AstraZeneca’s portfolio (Press release, National Resilience, NOV 29, 2022, View Source [SID1234624563]). Under the agreement, AstraZeneca will have strategic access to Resilience’s end-to-end capabilities. Resilience will purchase AstraZeneca’s manufacturing facility located in West Chester, Ohio and will manufacture select AstraZeneca medicines at the facility as part of a multi-year supply agreement. The companies anticipate completing the transaction in early 2023, subject to receipt of regulatory approvals and the satisfaction of other customary closing conditions. Upon closing, Resilience will acquire the West Chester site’s operations and physical assets, retain the site’s leadership and employees, and continue to invest in the workforce and facility.

The West Chester site is a commercial-scale, 580,000 square-foot facility with a strong record of regulatory and commercial drug supply performance in numerous global markets. The site is equipped with end-to-end drug product manufacturing capabilities, including aseptic filling, inspection, packaging, labeling, and cold-chain operations for vials, cartridges, pre-filled syringes, and autoinjectors, as well as a virtual reality training center.

The West Chester site and its talented and experienced workforce will service multiple product types for commercial or public health needs, with capacity available immediately for new projects upon closing of the transaction. West Chester’s access to Resilience technology and its integration with the Resilience biomanufacturing network are expected to deliver greater benefits to patients and customers. With the acquisition, Resilience will provide nearly two million square feet of end-to-end drug substance and drug product capacity and solutions for the process and analytical development and GMP biomanufacturing of biologics, vaccines, nucleic acid, cell therapy, and gene therapy modalities.

"We envision the West Chester site as our global center of excellence for commercial drug product manufacturing that will produce a wide range of life-saving medicines," said Rahul Singhvi, Sc.D., Chief Executive Officer of Resilience. "This partnership is an exciting step toward our mission of broadening patient access to complex medicines and protecting domestic biopharmaceutical supply chains."

"As part of our long-term strategy to ensure our global supply network remains fit for the future, we are continuously optimising our manufacturing footprint to meet the evolving needs of our pipeline and portfolio," said Andrew Wirths, Senior Vice President, Americas Supply Region, AstraZeneca. "The transfer of our West Chester site to Resilience will enable the continued supply of AstraZeneca medicines to patients, as well as the continued employment for more than 500 people working at the West Chester site. I’m encouraged by Resilience’s plans to transform the site into their drug product centre of excellence."

Eikonoklastes Therapeutics and Forge Biologics Announce Viral Vector Contract Development and AAV Manufacturing Partnership

On November 29, 2022 Eikonoklastes Therapeutics, a preclinical biotech company developing treatments for today’s most challenging diseases, and Forge Biologics, a gene therapy-focused contract development and manufacturing organization, reported a manufacturing partnership that will advance Eikonoklastes’ AAV-based gene therapy, ET-101, into clinical trials for the treatment of patients with amyotrophic lateral sclerosis (ALS) (Press release, Eikonoklastes Therapeutics, NOV 29, 2022, View Source [SID1234624562]).

Forge will provide adeno-associated viral (AAV) process development and manufacturing services for ET-101. Eikonoklastes will utilize Forge’s platform process including its proprietary HEK 293 suspension Ignition Cells and pEMBR adenovirus helper plasmid. All development and AAV manufacturing activities will occur at the Hearth, Forge’s 200,000 square foot gene therapy facility in Columbus, Ohio.

"Eikonoklastes is conducting promising research into treating patients with ALS, and we are honored to work together with them during this critical phase of development to help ET-101 enter clinical trials," said Timothy J. Miller, Ph.D., CEO, President, and Co-Founder of Forge Biologics. "Our primary goal is to deliver the AAV resources, scale, technology, and expertise for our partners to help patients living with diseases like ALS with no known cure."

ALS is a rare neurological disease with significant socioeconomic impact, whose patients are desperate for novel, safe and effective therapies. ALS is the lead indication for Eikonoklastes’ ET-101, which has just received Orphan Drug Designation from the FDA—an important regulatory milestone reflecting the compelling data underlying the ET-101 program and its potential as a first-in-class treatment option for both familial and sporadic ALS.

"We are excited to advance ET-101, our novel treatment for neurodegenerative diseases, towards a first-in-human clinical trial in ALS patients. Partnering our AAV manufacturing with Forge will further our ability to advance into clinical trials," said Bruce Halpryn, Ph.D., Chair, CEO, and Co-Founder of Eikonoklastes Therapeutics. "With their end-to-end platform supporting AAV therapies, Forge is accelerating our development to reach patients suffering from ALS."

About Amyotrophic Lateral Sclerosis (ALS)

ALS, also known as Lou Gehrig’s Disease, is a rare, progressive, debilitating, and universally fatal neurodegenerative disease affecting the motor neurons connecting the brain and spinal cord. Degeneration of these neurons leads to paralysis as the brain loses its ability to control muscle movement. Most people with ALS succumb to respiratory failure, usually within three to five years from when symptoms first appear. An estimated 10 percent of ALS is familial and caused by genetic mutations that are inherited. The 90%+ of sporadic ALS may be due to a combination of environment and genetic risk factors. There is currently no cure for either familial or sporadic ALS.

Novocure’s Optune® Approved in Canada for the Treatment of Newly Diagnosed and Recurrent Glioblastoma

On November 29, 2022 Novocure (NASDAQ: NVCR) reported that Health Canada has approved Optune for the treatment of newly diagnosed and recurrent glioblastoma (GBM) (Press release, NovoCure, NOV 29, 2022, View Source [SID1234624561]). GBM is the most common and one of the most aggressive forms of primary brain cancer . Optune is the first treatment for glioblastoma approved in Canada in over 12 years.

"We are proud to have reached this milestone as a company and are committed to making our therapy available to all the patients who may benefit throughout the world."

Optune is a medical device that works by creating Tumor Treating Fields (TTFields), which are electric fields that disrupt cancer cell division. Optune delivers TTFields therapy to the region of the tumor. Optune is small and light, weighing 2.7 pounds. This makes Optune wearable and portable, so continuous treatment can be received almost anywhere. Globally, more than 25,000 patients have been treated with Optune, to date.

"We’re very happy that Health Canada has approved Optune for the treatment of GBM," said Jovan Antunovic, Country Manager of Novocure Canada. "We are grateful for the rapid and diligent review of our submission and for Health Canada’s approval of Optune. This is an important achievement in order to bring our therapy to more patients throughout Canada who can benefit."

"It is well established that glioblastoma treatment is a high unmet medical need," said Dr. David Roberge, Professor of Radiology, Radiation Oncology & Nuclear at the CHUM Research Centre and Future President of the Canadian Association of Radiation Oncology. "Patients with GBM have very few effective therapeutic options. The approval of Optune can offer a real benefit to Canadian patients."

Each year in Canada, 1,600 people are diagnosed with GBM. Novocure’s phase 3 pivotal EF-14 trial compared Optune plus temozolomide to temozolomide alone in 695 patients with newly diagnosed GBM. Patients treated with Optune plus temozolomide experienced overall survival of 20.9 months versus 16 months for patients treated with temozolomide alone (HR, 0.63; 95 percent Cl, 0.53-0.76; P<.001). Optune was safely used together with temozolomide with no significant increase in serious adverse events compared with temozolomide alone. The most common side effect related to Optune was mild to moderate skin irritation. Optune is commercially available as a treatment for GBM in multiple countries in North America, Europe and Asia.

"With Health Canada’s approval of Optune, the Brain Tumour Foundation of Canada (BTFC) is excited that another treatment option will soon be available for patients with GBM," said Shannon LaHay, CEO of BTFC. "There are many GBM patients and their caregivers looking forward to the availability of Optune in Canada."

The next critical milestone will be securing reimbursement. Novocure is actively working on this important step in order to ensure that patients have access to Optune for GBM across Canada.

"We are working to ensure that both public and private payers provide access and full reimbursement for Optune as soon as possible," said Pritesh Shah, Novocure’s Chief Commercial Officer. "We are proud to have reached this milestone as a company and are committed to making our therapy available to all the patients who may benefit throughout the world."

About Optune
Optune is a noninvasive, antimitotic cancer treatment for glioblastoma (GBM). Optune delivers Tumor Treating Fields (TTFields) therapy to the region of the tumor.

Tumor Treating Fields therapy uses electric fields to disrupt cell division. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with GBM and in the U.S. for MPM, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.