On September 21, 2022 Helsinn Group ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets, reported that two scientific abstracts have been accepted for oral presentation at the upcoming EORTC CLTG (European Organisation for Research and Treatment of Cancer Cutaneous Lymphoma Tumors Group) Annual Meeting 2022, taking place in Madrid, Spain from the 22-24 September (Press release, Helsinn, SEP 21, 2022, View Source [SID1234619715]).

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Details on the presentations are below:

Presentations:

Title: A Post-hoc Analysis of Clinical Trial Data Shows that Prior Phototherapy Does Not Affect Response to Chlormethine Gel in Patients with Mycosis Fungoides

Authors: Chalid Assaf, Christiane Querfeld, Marta Scandurra, Marco Turini, Julia J. Scarisbrick

Date/Time: 23 September, 6:36pm CET

Presenter: Chalid Assaf, Prof. Dr. med., Chief Physician of the Clinic for Dermatology and Venerology, Helios Klinikum Krefeld, Germany

Title: Combination Therapy with Chlormethine Gel and Narrow-Band Ultraviolet B for Patients with Mycosis Fungoides: a Case Series

Authors: Laura Gleason, Daniel Joffe, Neda Nikbakht MD, PhD

Date/Time: 23 September, 5:12pm CET

Presenter: Laura Gleason, MD, Thomas Jefferson University, Department of Dermatology and Cutaneous Biology, Philadelphia, US

During the conference Helsinn will also be sponsoring a satellite symposium which will focus on chlormethine’s mechanism of action. The symposium, entitled "A multi-level analysis of chlormethine: from skin cells to clinical cases", will involve experts in the field of mycosis fungoides, including Prof. Pablo Ortiz-Romero, Head of Dermatology at University Hospital 12 de Octubre in Madrid, Spain and Prof. Emmanuella Guenova, Dermatologist at the Lausanne University Hospital, Switzerland and one of the leading researchers of the chlormethine molecule.

Satellite symposium

Title: A multi-level analysis of chlormethine: from skin cells to clinical cases

Date/Time: Thursday 22 September/1:30-2:30pm CET

Presenters: Emmanuella Guenova and Pablo Ortiz-Romero

Dr. Silvia Sebastiani, Group Head of Medical Affairs, commented: "It’s fantastic to see the growing body of data emerging from in vitro, clinical and case studies of LEDAGA/VALCHLOR for the treatment of this rare skin lymphoma. We’re pleased to be taking part in EORTC CLTG, sharing our own findings, as well as hearing the latest insights from across the cutaneous lymphoma research landscape. We remain committed to support the global MF-CTCL patient population."

Prof. Pablo Ortiz-Romero Head of Dermatology at University Hospital 12 de Octubre, added: "There is currently no cure for patients living with MF-CTCL and treatment goals are mainly aimed at reducing the abnormal appearance of the skin and to control any itching or other symptoms. I am delighted to Chair the Helsinn satellite symposium where emerging new data regarding chlormethine’s mode of action will be discussed, as well as interesting insights from Professor Guenova‘s clinical experience. The latest research further delineates the mechanism of LEDAGA/VALCHLOR in the treatment of this rare skin cancer."

Chlormethine gel 0.016%, also known as mechlorethamine gel, is approved in multiple countries, including the EU and US, and is marketed under the trade names LEDAGA and VALCHLOR. The authorized use for each country varies based on the design of the registrational trial and the individual health authority requirements. For more details, please refer to the approved product information for each respective jurisdiction.

On September 20, 2022 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the China National Medical Products Administration ("NMPA") has approved the supplemental new drug application ("sNDA") for toripalimab in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer ("NSCLC"). This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.

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"We are very pleased that toripalimab’s first indication for the treatment of lung cancer has been approved, which means we will be able to help more patients fight against malignant tumors with the highest incidence and mortality rates in China," said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. "We are particularly grateful to our patients, researchers, and R&D teams that participated in the clinical trials, whose efforts and contributions allowed our study to progress during the COVID-19 pandemic. We will continue to advocate for the use of toripalimab in the treatment of lung cancer as well as other cancers, and we hope to provide many more patients with better treatment options and greater survival benefits as soon as possible!"

Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimab’s performance in clinical trials. "In China, the number of lung cancer patients is massive and so is the demand for treatment. The CHOICE-01 study provided us with reliable and substantiating data, confirming that the addition of toripalimab to standard first-line chemotherapy can bring longer progression-free survival ("PFS") and overall survival ("OS") to patients with advanced NSCLC, regardless of PD-L1 expression and with a manageable safety profile. For patients with advanced non-squamous NSCLC, published data reveal that the 2-year OS rate is around 50%, and according to the CHOICE-01 study results, toripalimab in combination with chemotherapy is the only PD-(L)1 inhibitor combination in this field that can achieve a 2-year OS rate of more than 60%, not to mention a 50% decrease in risk of death, indicating that toripalimab plus standard chemotherapy can significantly increase survival benefits for patients. We are excited for toripalimab’s continuous contribution to the battle against lung cancer!"

Between April 2, 2019 to August 5, 2020, the CHOICE-01 study enrolled a total of 465 NSCLC patients in 63 centers in China, among which 245 non-squamous NSCLC patients were randomly allocated in the ratio of 2:1 to receive toripalimab/placebo in combination with pemetrexed and cisplatin/carboplatin. After disease progression, eligible control subjects could receive crossover treatment with toripalimab monotherapy. Previously, the latest research results of the CHOICE-01 study were announced at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Plenary Series March Program and the ASCO (Free ASCO Whitepaper) annual meeting. The study data showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy in the first-line treatment of patients with advanced NSCLC without EGFR/ALK mutations can significantly improve the PFS and the OS of patients with a manageable safety profile regardless of PD-L1 expression status.

As of October 31, 2021, in 245 non-squamous NSCLC patients, the median PFS of toripalimab in combination with chemotherapy was 9.7 months, which was 4.2 months longer than placebo in combination with chemotherapy (HR = 0.48 [95% CI: 0.35-0.66], p < 0.0001); the median OS of toripalimab in combination with the chemotherapy group has yet to be reached, while OS benefits had already been observed, reducing the risk of death by 52% (HR=0.48 [95%CI: 0.32-0.71]).

About NSCLC
Lung cancer is currently the second most prevalent malignant tumor with the highest mortality rate in the world[1], and the most prevalent with the highest mortality rate in China[2]. According to data released by the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000 and accounted for 17.9% of all new cancer cases in China[2]. In the same year, the number of lung cancer deaths in China amounted to 715,000 and accounted for 23.8% of all cancer deaths in China[2]. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases[3]. Non-squamous NSCLC patients account for approximately 70% of all NSCLC patients[4]. Existing domestic and overseas studies have shown that the use of anti-PD-(L)1 monoclonal antibodies as monotherapy or in combination with chemotherapy has already become new standard for the first-line treatment of advanced driver gene-negative NSCLC.

(Press release, Shanghai Junshi Bioscience, SEP 20, 2022, View Source [SID1234663442])

On September 20, 2022 Shanghai Junshi Biosciences Co., Ltd ("Junshi Biosciences", HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies, reported that the China National Medical Products Administration ("NMPA") has approved the supplemental new drug application ("sNDA") for toripalimab in combination with pemetrexed and platinum as the first-line treatment in EGFR mutation-negative and ALK mutation-negative, unresectable, locally advanced or metastatic non-squamous non-small cell lung cancer ("NSCLC"). This is the sixth indication approved for toripalimab in China and will bring more treatment options to Chinese patients with advanced NSCLC.

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Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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"We are very pleased that toripalimab’s first indication for the treatment of lung cancer has been approved, which means we will be able to help more patients fight against malignant tumors with the highest incidence and mortality rates in China," said Dr. Jianjun Zou, Global Research and Development President at Junshi Biosciences. "We are particularly grateful to our patients, researchers, and R&D teams that participated in the clinical trials, whose efforts and contributions allowed our study to progress during the COVID-19 pandemic. We will continue to advocate for the use of toripalimab in the treatment of lung cancer as well as other cancers, and we hope to provide many more patients with better treatment options and greater survival benefits as soon as possible!"

Professor Jie Wang from the Cancer Hospital, Chinese Academy of Medical Sciences elaborated on toripalimab’s performance in clinical trials. "In China, the number of lung cancer patients is massive and so is the demand for treatment. The CHOICE-01 study provided us with reliable and substantiating data, confirming that the addition of toripalimab to standard first-line chemotherapy can bring longer progression-free survival ("PFS") and overall survival ("OS") to patients with advanced NSCLC, regardless of PD-L1 expression and with a manageable safety profile. For patients with advanced non-squamous NSCLC, published data reveal that the 2-year OS rate is around 50%, and according to the CHOICE-01 study results, toripalimab in combination with chemotherapy is the only PD-(L)1 inhibitor combination in this field that can achieve a 2-year OS rate of more than 60%, not to mention a 50% decrease in risk of death, indicating that toripalimab plus standard chemotherapy can significantly increase survival benefits for patients. We are excited for toripalimab’s continuous contribution to the battle against lung cancer!"

Between April 2, 2019 to August 5, 2020, the CHOICE-01 study enrolled a total of 465 NSCLC patients in 63 centers in China, among which 245 non-squamous NSCLC patients were randomly allocated in the ratio of 2:1 to receive toripalimab/placebo in combination with pemetrexed and cisplatin/carboplatin. After disease progression, eligible control subjects could receive crossover treatment with toripalimab monotherapy. Previously, the latest research results of the CHOICE-01 study were announced at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) ("ASCO") Plenary Series March Program and the ASCO (Free ASCO Whitepaper) annual meeting. The study data showed that compared to chemotherapy alone, toripalimab in combination with chemotherapy in the first-line treatment of patients with advanced NSCLC without EGFR/ALK mutations can significantly improve the PFS and the OS of patients with a manageable safety profile regardless of PD-L1 expression status.

As of October 31, 2021, in 245 non-squamous NSCLC patients, the median PFS of toripalimab in combination with chemotherapy was 9.7 months, which was 4.2 months longer than placebo in combination with chemotherapy (HR = 0.48 [95% CI: 0.35-0.66], p < 0.0001); the median OS of toripalimab in combination with the chemotherapy group has yet to be reached, while OS benefits had already been observed, reducing the risk of death by 52% (HR=0.48 [95%CI: 0.32-0.71]).

About NSCLC
Lung cancer is currently the second most prevalent malignant tumor with the highest mortality rate in the world[1], and the most prevalent with the highest mortality rate in China[2]. According to data released by the World Health Organization, in 2020, the number of new lung cancer cases in China amounted to 816,000 and accounted for 17.9% of all new cancer cases in China[2]. In the same year, the number of lung cancer deaths in China amounted to 715,000 and accounted for 23.8% of all cancer deaths in China[2]. NSCLC is a major subtype of lung cancer, accounting for approximately 85% of all cases[3]. Non-squamous NSCLC patients account for approximately 70% of all NSCLC patients[4]. Existing domestic and overseas studies have shown that the use of anti-PD-(L)1 monoclonal antibodies as monotherapy or in combination with chemotherapy has already become new standard for the first-line treatment of advanced driver gene-negative NSCLC.

[1] View Source
[2] View Source
[3] Rosell R, Karachaliou N. Large-scale screening for somatic mutations in lung cancer. Lancet, 2016, 387(10026): 1354-1356. doi: 10.1016/S0140-6736(15)01125-3
[4] Gridelli C, et al. Nat Rev Dis Primers. 2015;1:15009

About Toripalimab
Toripalimab is an anti-PD-1 monoclonal antibody developed for its ability to block PD-1 interactions with its ligands, PD-L1 and PD-L2, and for enhanced receptor internalization (endocytosis function). Blocking PD-1 interactions with PD-L1 and PD-L2 promotes the immune system’s ability to attack and kill tumor cells. In China, toripalimab was the first domestic anti-PD-1 monoclonal antibody approved for marketing in 2018 (approved in China as TUOYI). Currently, there are six approved indications for toripalimab in China.

(Press release, Shanghai Junshi Bioscience, SEP 20, 2022, View Source [SID1234663439])

On September 20, 2022 Affirma Biotech reported the closing of its seed capital round with a total of 600,000 Euros that the company will invest in the optimization of its preclinical candidates. During the past year a total amount of 960.000 Euros in funding has been raised by the company from several business angels with extensive experience in the biotech industry. The lead investors of this round are Alfons Hidalgo (founder of Infinitec), Luis Ruiz Avila and Reig Jofre Investments among others. Affirma Biotech also has Start-up Capital grant from Acció.

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The company discovered a new family of orally administered drugs that are currently being optimized and that will be developed as new antivirals for the treatment of chronic hepatitis B virus infection, as well as other unresolved infections. Chronic hepatitis B is currently the most prevalent viral infection worldwide. More than 290 million patients are chronically infected with this virus that is currently the main cause of liver cancer, one of those with the worst prognosis. The burden of the disease is estimated at approximately 1 million deaths each year.

Maribel Berges, founder and CEO of the company, emphasizes the importance of developing new therapeutic tools against viral infections «that will contribute to solve these increasingly urgent global sanitary challenges. We think that our innovative approach will be key to improve the treatment of diseases that today do not have a complete medical solution». The company’s goal is to start clinical trials within the next two years.

(Press release, Affirma Biotech, SEP 20, 2022, View Source [SID1234662179])

On September 20, 2022 Integra Therapeutics reported the company has been awarded €1-million grant from Eurostars, the largest funding programme of the European Commission that supports innovative SMEs in developing collaborative transnational projects geared towards the market (Press release, Integra Therapeutics, SEP 20, 2022, View Source [SID1234654531]). The company applied for the call as part of a consortium with Caszyme, a Lithuanian company that specialises in CRISPR technology and molecular tools development and application.

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The funding of the project submitted by Integra Therapeutics and Caszyme will go towards discovery, characterisation and execution of in vivo studies on the 2.0 version of the Integra Therapeutics FiCAT gene-writing platform.

The key difference between FiCAT 1.0 and FiCAT 2.0 will be the addition of novel nucleases discovered by Caszyme, which have different characteristics from the Cas9 nucleases and expand their potential uses in advanced therapies. During the execution of the project, Integra and Caszyme will enhance the functionality of novel nucleases in human cells.

The partnership between Integra Therapeutics and Caszyme will unite scientific know-how and technology from top academic and industrial biomedical research. The founders of Caszyme are Prof. Virginijus Šikšnys, Dr. Giedrius Gasiūnas and Dr. Monika Paule, the first scientists to prove that CRISPR-Cas9 can be used to program DNA double-strand breaks in a genome of interest, opening a new era in gene editing.

The project is scheduled to kick off on the 1st of November 2022 and finish at the end of 2025.

The Eurostar programme is part of Horizon Europe and is managed by Eureka with a network of national coordinators from the 37 participating countries, which from Spain is the Centre for the Development of Industrial Technology (CDTI).