On June 6, 2022 Cellworks Group, Inc., a world leader in Personalized Medicine in the key therapeutic areas of Oncology and Immunology, reported results from the myCare-024-04 study, which demonstrate that the Cellworks Singula Therapy Response Index (TRI) was strongly predictive of Overall Survival (OS) and Progression-Free Survival (PFS) for newly diagnosed Glioblastoma Multiforme (GBM) patients (Press release, Cellworks, JUN 6, 2022, View Source [SID1234615654]). In this study, Singula TRI provided patient-specific estimates of OS and PFS for 18 NCCN guideline GBM therapies and provided predictive value beyond physician-prescribed therapy, patient age, patient sex, and MGMT methylation status.

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The results from the myCare-024-04 clinical study were featured in a poster presentation with comments from Dr. Manmeet Ahluwalia, M.D., M.B.A., Chief of Medical Oncology, Chief Scientific Officer and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida, at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting June 3-7th during the Central Nervous Systems Tumors Session and available online as Abstract 2053.

"The molecular heterogeneity of GBM is a key driver for the inconsistent therapy response rates that we see in brain cancer patients and makes the disease difficult to treat," said Patrick Wen, MD, Director, Center for Neuro-oncology, Dana-Farber Cancer Institute; Professor, Neurology, Harvard Medical School; and Co-Principal Investigator for the myCare-024-04 clinical study. "But by using a patient’s NGS data and Cellworks Singula to biosimulate their individual therapy responses, we can potentially improve the ability to select the most effective therapy for each GBM patient and positively effect clinical outcomes for brain cancer patients."

"The significant differences in treatment response among GBM patients necessitates moving beyond population-based treatments to personalized multi-gene therapy predictions," said Dr. Manmeet Ahluwalia, M.D., M.B.A., Chief of Medical Oncology, Chief Scientific Officer and Deputy Director at Miami Cancer Institute, part of Baptist Health South Florida; and Co-Principal Investigator for the myCare-024-04 clinical study. "Using Cellworks Singula TRI, we can simulate the molecular effects of cell signaling, drugs and radiation on patient-specific in silico diseased cells prior to treatment and then identify the magnitude of disease control and survival for specific anti-tumor strategies. The findings from using this approach in the myCare-024-04 study suggest that biosimulating guideline GBM therapies for newly diagnosed GBM patients can positively effect clinical outcomes."

The Cellworks Biosimulation Platform simulates how a patient’s personalized genomic disease model will respond to therapies prior to treatment and identifies novel drug combinations for treatment-refractory patients. The platform is powered by the groundbreaking Cellworks Computational Omics Biology Model (CBM), a network of 7,000+ human genes, 30,000+ molecular species and 100+ signaling pathways. As part of the biosimulation process, personalized disease models are created for each patient using their cytogenetic and molecular data as input to the Cellworks CBM. The Cellworks platform analyzes the impact of specific therapies on the patient’s personalized disease model and generates a Singula biosimulation report with Therapy Response Index (TRI) scores from 0 to 100 that predict the efficacy of specific chemotherapies.

myCare-024-04 Clinical Study

Background

In this study, the Cellworks Singula Therapy Response Index (TRI) was used to prospectively predict the Overall Survival (OS) and Progression-Free Survival (PFS) in a retrospective cohort of 270 IDH wildtype GBM patients from the Cancer Genome Atlas (TCGA) with known clinical outcomes treated with physician prescribed therapies. The cohort included 162 males and 108 females with a median age of 57.5 years.

Methods

A mechanistic mulit-omcis biology model created for each patient using comprehensive genomic inputs allows biosimulation of downstream molecular effects of cell signaling, drugs and radiation on a patient’s personalized in silico disease model. Stratified random sampling was used to split the data into independent training (N=153) and validation (N=117) subjects. Multivariate Cox Proportional Hazard and Proportional Odds models were used to model OS and PFS as a function of the pre-defined Singula TRI and clinical thresholds. Cox Proportional Hazards (PH) regression and likelihood ratio (LR) tests were used on the independent validation subjects to assess the hypothesis that Singula is predictive of OS and PFS above and beyond standard clinical factors.

Results

Using Cellworks Personalized Therapy Biosimulation, Singula TRI was significantly predictive of OS and PFS in univariate analyses and remained significantly predictive in multivariate analyses, which included patient age, patient sex, MGMT methylation status and drug class.

Conclusions

Cellworks Singula TRI facilitates selection of optimal personalized therapies by providing patient-specific estimates of OS and PFS for 18 NCCN guideline GBM therapies. This information may be used to estimate increases in OS and PFS when comparing Singula TRI recommended therapies verses standard care. These positive results suggest the utility of biosimulation-informed therapy selection to improve survival of GEA patients.

On June 6, 2022 Shanghai Henlius Biotech, Inc. (2696.HK) reported that an international randomized phase 3 study (ASTRUM-005) of HANSIZHUANG (serplulimab), an anti-PD-1 mAb independently developed by Henlius, as first-line treatment for extensive-stage small-cell lung cancer (ES-SCLC) has been orally presented at 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (Press release, Shanghai Henlius Biotech, JUN 6, 2022, View Source [SID1234615670]). Serplulimab is the first China-developed anti-PD-1 mAb in first-line treatment of lung cancer that was presented orally at ASCO (Free ASCO Whitepaper) Annual Meeting. The leading principal investigator is Professor Ying Cheng from Jilin Cancer Hospital.

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Professor Ying Cheng said, "ASTRUM-005 is the first and largest ES-SCLC international multi-center clinical study led by Chinese researchers for anti-PD-1 mAb. A total of 114 sites’ subjects were screened around the globe, with 31.5% being Caucasian. The study results demonstrated that serplulimab in combination with chemotherapy can significantly extend the median OS to 15.4 months when compared to the control group in first-line SCLC, gaining global recognition while leapfrogging immunotherapy treatment for SCLC patients."

Mr. Jason Zhu, President of Henlius, said, "HANSIZHUANG is an innovative mAb independently developed by Henlius. Based on the large number of unmet clinical needs, the company has implemented a comprehensive first-line treatment strategy for lung cancer with multiple clinical trials. Previously, the NDA of HANSIZHUANG for the treatment of ES-SCLC has been accepted by NMPA, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. We are hoping that the approval comes soon to mend the gap and bring a new treatment option to patients living with ES-SCLC. Going forward, we will proactively promote more clinical research, thereby benefiting more patients around the world."

ASTRUM-005 has set up a total of 128 sites in China, Turkey, Poland, Georgia, etc. and enrolled 585 subjects from 114 sites, among whom 31.5% were Caucasian. In December 2021, ASTRUM-005 met its primary study endpoint of the overall survival (OS) in the interim analysis and demonstrated HANSIZHUANG with a manageable safety profile. The global clinical data lays a solid foundation for future applications across the world. ASTRUM-005 results are as follows:

Title

Serplulimab, a novel anti-PD-1 antibody, plus chemotherapy versus chemotherapy alone as first-line treatment for extensive-stage small-cell lung cancer: An international randomized phase 3 study (Abstract No. 8505)

Study design

This randomized, double-blind, international, multicenter, phase 3 clinical study aimed to compare the efficacy and safety of serplulimab with placebo when combined with chemotherapy (carboplatin-etoposide) in previously untreated patients with ES-SCLC. Enrolled patients were randomized 2:1 to receive intravenous infusion of either serplulimab or placebo in combination with chemotherapy every three weeks until disease progression, death, intolerable toxicity, withdrawal of informed consent or other reasons specified in the protocol (whichever occurred first). The primary endpoint of this study was overall survival (OS). The secondary endpoints included progression-free survival (PFS), objective response rate (ORR), duration of response (DOR), safety, pharmacokinetic characteristics, and immunogenicity.

Results

As of October 22, 2021, 585 eligible patients were randomized (serplulimab group, n=389; placebo group, n=196), with a median follow-up duration of 12.3 months. The median OS in the serplulimab group and the placebo group were 15.4 (95% CI 13.3–NE) and 10.9 (95% CI 10.0–14.3) months, respectively, with a hazard ratio (HR) of 0.63 (95% CI 0.49–0.82; p<0.001). The 24-month OS rate in the two treatment groups were 43.1% and 7.9%, respectively. Median PFS assessed by the independent radiology review committee (IRRC) per RECIST v1.1 was 5.7 months in the serplulimab group and 4.3 months in the placebo group (HR 0.48, 95% CI 0.38–0.59). Efficacy improvements were also observed in ORR (80.2% vs. 70.4%) and DOR (median, 5.6 vs. 3.2 months) as assessed by IRRC per RECIST v1.1.

Grade ≥3 treatment related adverse events (TRAEs) related to serplulimab or placebo were reported by 129 (33.2%) and 54 (27.6%) patients in the respective groups. Incidence of immune-related adverse events (irAEs) was higher in the serplulimab group compared to the placebo group (37.0% vs. 18.4%), and was similar to the approved PD-1/PD-L1 antibodies.

Conclusions

The results demonstrated that serplulimab in combination with carboplatin-etoposide significantly improved OS as first-line treatment in ES-SCLC patients. The safety profile was consistent with previous studies. Serplulimab, as the first anti-PD-1 antibody showing OS benefit in untreated ES-SCLC patients, possess the potential to provide an alternative treatment option for this patient population worldwide.

About HANSIZHUANG

HANSIZHUANG (recombinant humanized anti-PD-1 monoclonal antibody injection, generic name: serplulimab injection) is the first innovative monoclonal antibody developed by Henlius. Up to date, 1 indication is approved for marketing in China, 2 NDAs have been accepted by the NMPA, and 9 clinical trials are ongoing across the world.

HANSIZHUANG was approved by the NMPA for the treatment of MSI-H solid tumors in March 2022 and actively promotes its synergy with in-house products of the company and innovative therapies. It has successively obtained clinical trial licenses in China, the United States, the European Union and other countries and regions to initiate 9 clinical trials on immuno-oncology combination therapies worldwide 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, the company has enrolled more than 2,800 subjects in China, Turkey, Poland, Georgia and other countries and regions, and the proportion of Caucasian is over 30% in two MRCTs, making HANSIZHUANG an anti-PD-1 mAb with one of the largest global clinical data pools. The NDAs of the treatment for squamous non-small cell lung cancer (sqNSCLC) and the first-line treatment of extensive small-cell lung cancer (ES-SCLC) have been accepted by the NMPA. Furthermore, HANSIZHUANG was recommended by the 2022 CSCO Guidelines for Diagnosis and Treatment of Small Cell Lung Cancer (SCLC) for the treatment of ES-SCLC and was also granted orphan drug designation by the FDA for treatment of SCLC. The MAA of ES-SCLC is expected to be filed in the EU in 2022, which makes HANSIZHUANG potentially the world’s first anti-PD-1 mAb for the first-line treatment of SCLC. In the field of esophageal squamous cell carcinoma, the phase 3 clinical trial of HANSIZHUANG in combination with chemotherapy has met the co-primary endpoints.

On June 6, 2022 PureTech Health plc (Nasdaq: PRTC, LSE: PRTC) ("PureTech" or the "Company"), a clinical-stage biotherapeutics company noted that its Founded Entity, Akili Interactive Labs, Inc. ("Akili"), a leading digital medicine company pioneering the development of cognitive treatments through game-changing technologies, reported that industry veteran Matt Franklin will join the company in the newly created role of President and Chief Operating Officer, effective June 21, 2022 (Press release, PureTech Health, JUN 6, 2022, View Source [SID1234615605]).

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As President and COO, Franklin will join Eddie Martucci, Akili’s Chief Executive Officer, and the company’s executive leadership team to scale the organization and bring Akili’s diverse pipeline of cognitive treatments to market, with an initial focus on the commercial launch of EndeavorRx. He will lead the day-to-day operations of the company, and oversee Commercial, Product, Engineering, Medical and People Operations.

Franklin brings more than two decades of experience across business, commercial and strategic marketing in the diagnostics, life sciences and technology industries leading and evolving innovation. Most recently, Franklin served as General Manager of the Precision Oncology business unit at Exact Sciences. Previously, Franklin was the Chief Commercial Officer at Thrive Earlier Detection Corp, where he led the go-to-market strategy development for their ground-breaking multi-cancer early detection assay. In addition, Franklin served as the Chief Business Officer for ArcherDX, a growth-stage molecular diagnostics company, where he was responsible for establishing and scaling the global sales, customer support, marketing, market access, business development and corporate development teams. Prior to ArcherDX, Franklin served as the Senior Vice President of Global Marketing and Clinical Product Strategy at Foundation Medicine where he led the global launch of three products in three years, including the company’s first liquid biopsy offering and the first FDA-approved, CMS-covered, comprehensive genomic profiling companion diagnostic test. Franklin held progressive leadership roles overseeing novel interventional medical devices at Boston Scientific, culminating in his running global strategic planning, product development and marketing for the company’s cardiovascular division.

On June 6, 2022 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL inhibitors for severe unmet medical needs, reported that presentation of a poster at the ASCO (Free ASCO Whitepaper) Annual Meeting to be held from 3rd – 8th June 2022 (Press release, BerGenBio, JUN 6, 2022, View Source [SID1234615622]).

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The poster presentation provides clinical data from a Phase 1 dose escalation and expansion study of bemcentinib (BGB324) in combination with docetaxel in patients with previously treated advanced non-small cell lung cancer (NSCLC). The data presented indicate that bemcentinib in combination with docetaxel shows evidence of anti-tumor activity, with 35% of patients achieving a partial response and 47% attaining stable disease, and a manageable safety profile in previously treated, advanced NSCLC.

Cristina Oliva, Chief Medical Officer at BerGenBio, commented: "While the data are limited, they suggest a mechanism by which treatment with bemcentinib could delay resistance to and potentiate the effects of chemotherapy treatment in NSCLC patients."

The full abstract is available on the ASCO (Free ASCO Whitepaper) website here: View Source

On June 6, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that it presented updated preliminary Phase I data on TG4050, its individualized neoantigen cancer vaccine, in a poster session at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Transgene JUN 6, 2022, View Source [SID1234615638]). TG4050 is based on Transgene’s myvac platform and powered by NEC’s cutting-edge AI capabilities.

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These additional positive initial data, including molecular (ctDNA) response, have been generated from the first patients with ovarian cancer and HPV-negative head and neck cancer enrolled in the two ongoing Phase I trials assessing TG4050. They were presented in-person in Chicago, IL, June 5, 2022.

"These new results, though early, are very encouraging" said Dr. Maud Brandely, MD, PhD, Chief Medical Officer of Transgene. "So far we accumulated promising preliminary data with TG4050: good tolerability, consistent immunogenicity and encouraging molecular response. We are particularly impressed by the effective priming of the immune system and the early signs of clinical activity. These results suggest that our individualized vaccine, TG4050, has the potential to extend the remission period, thus providing a new hope for cancer patients. In addition, the information we gather from the two ongoing Phase I studies will be pivotal in designing the Phase II trial of TG4050 which could start as early as 2023."

Prof. Jean-Pierre Delord, MD, PhD, General Manager of IUCT Oncopole of Toulouse and first author of the poster, added: "Neoantigen vaccination such as TG4050 is a relevant strategy for the treatment of patients with high risk of cancer relapse for whom the medical need is particularly high. In this setting, the vaccine is expected to deliver clinical benefit by controlling the residual disease. To date, this non-invasive treatment is well tolerated by the patients and although preliminary, the data presented at ASCO (Free ASCO Whitepaper) clearly suggest that TG4050 could become a new treatment option for cancer patients. I am looking forward to seeing this potential game-changing therapy moving forward."

For the first time, ctDNA data were generated following treatment with TG4050

Liquid biopsies were performed to measure the circulating tumor DNA (ctDNA) levels. ctDNA is an emerging modality that is used to detect subclinical disease or asymptomatic relapse in an increasing number of indications. Use of such highly sensitive and specific marker seeks to identify patients whose disease is very likely to relapse in the near future, before their disease becomes detectable with current standard methods such as imaging. Moreover, it allows a non-invasive monitoring of treatment effectiveness. For instance, in at least one ovarian cancer patient in the study, a decline in ctDNA was concomitant with CA-125 normalization and disease control. Analyses are ongoing in more recently included patients.

Clinical follow-up data continue to demonstrate the potential of TG4050 in ovarian and head and neck cancer patients

In the head and neck cancer trial, patients were randomized to immediately receive vaccination with TG4050 (early treatment arm, arm A) or at relapse (delayed vaccination arm, arm B). All evaluable patients randomized to arm A (n=8) are still in complete response as of mid-May 2022. In arm B (n=8), two patients have experienced relapse.

In the ovarian cancer trial (n=5), a fifth patient initiated her treatment with TG4050 recently. One patient treated after an elevation of CA-125 experienced a normalization of CA-125 without clinical progression for 9 months until death from an unrelated chronic illness. Another patient was treated upon onset of radiological evidence of relapse and remained stable for 11.4 months.

To date, the vaccine has been well tolerated and no related Serious Adverse Events have been reported across the two studies.

In both clinical studies, enrollment and patient dosing are progressing in line with our expectations. Overall, Transgene plans to treat 13 patients in the ovarian cancer trial and 30 patients in the head and neck cancer trial.

Immune cell response data demonstrated an effective priming of the immune system which is associated with disease regression

Transgene presented a comprehensive set of immunological data at ASCO (Free ASCO Whitepaper). Circulating immune cells quantification (in particular monocytes, DC, NK cells, subcells of CD8, CD4, Treg) and expression of immune checkpoints (ICOS and PD1) suggest that the vaccine is able to effectively induce innate and adaptive immune responses in patients.

In an ovarian cancer patient, clinical resolution and biological responses (CA-125 and ctDNA responses) were concomitant to an immune response against multiple epitopes and to the onset of markers of an effective immune response (switch in circulating CD4 and CD8 cells toward an effector phenotype, increase in CD16neg NK cells; peak in circulating cytokines).

All evaluable patients developed a robust T-cell response against multiple targeted neoantigens (median of 10 positive responses per patient). T-cell responses were observed for class I and class II epitopes, they consisted of de novo responses and amplifications of preexisting responses.

Poster title: Phase 1 studies of personalized neoantigen vaccine TG4050 in ovarian carcinoma (OC) and head and neck carcinoma (HNSCC)

Abstract number: 2637
Session title: Developmental Therapeutics—Immunotherapy
Authors: J.P. Delord, M. Block, C. Ottensmeier, G. Colon-Otero, C. Le Tourneau, A. Lalanne, O. Lantz, KL. Knutson, G. Lacoste, A. Tavernaro, M. Brandely, N. Silvestre, B. Grellier, Y. Yamashita, O. Kousuke, N. Yamagata, Y. Tanaka, B. Malone, E. Quemeneur, K. Bendjama

About the clinical trials

TG4050 is being evaluated in two Phase I clinical trials for patients with ovarian cancer (NCT03839524) and HPV-negative head and neck cancers (NCT04183166).

In a first Phase I trial, TG4050 is being administered to patients with HPV-negative head and neck cancer. A personalized treatment is created for each patient after they complete surgery and while they receive an adjuvant therapy. Half of the participants receive their vaccine immediately after they complete their adjuvant treatment. The other half is given TG4050 as an additional treatment at the time of recurrence of the disease as an additional treatment to SoC. This randomized study is evaluating the treatment benefits of TG4050 in patients who have a high risk of relapse. Up to 30 patients will receive TG4050 in France, in the UK and in the USA. The principal investigator of the trial is Prof. Christian Ottensmeier, MD, PhD, Consultant Medical Oncologist at the Clatterbridge Cancer Centre and Professor of Immuno-Oncology at the University of Liverpool. In France, the clinical trial is being conducted at Institut Curie, Paris by Prof. Christophe Le Tourneau, MD, PhD, Head of the Department of Drug Development and Innovation (D3i), and at the IUCT-Oncopole, Toulouse by Prof. Jean-Pierre Delord, MD, PhD. In the USA, the trial is being led by Yujie Zhao, MD, PhD, at the Mayo Clinic. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.

In parallel, a Phase I clinical trial of TG4050 is enrolling patients with ovarian cancer. This second trial is including patients at the time of asymptomatic relapse after surgery and first-line chemotherapy. Matthew Block, MD, PhD, Consultant Medical Oncology, Consultant Immunology and Associate Professor of Oncology at the Mayo Clinic (USA) is the principal investigator of the trial; in France, the trial is being conducted by Prof. Le Tourneau, MD, PhD, at Institut Curie and by Alexandra Martinez, MD, Associate Head of Surgical Department, at IUCT-Oncopole. Endpoints of the trial include safety, feasibility and biological activity of the therapeutic vaccine.

The first preliminary clinical data generated from the first patients treated with TG4050 were very encouraging.

About myvac

myvac is a viral vector (MVA – Modified Vaccinia Ankara) based, individualized immunotherapy platform that has been developed by Transgene to target solid tumors. myvac-derived products are designed to stimulate the patient’s immune system, recognize and destroy tumors using the patient’s own cancer specific genetic mutations. Transgene has set up an innovative network that combines bioengineering, digital transformation, established vectorization know-how and unique manufacturing capabilities. Transgene has been awarded "Investment for the Future" funding from Bpifrance for the development of its platform myvac. TG4050 is the first myvac-derived product being evaluated in clinical trials.

Click here to watch a short video on myvac.

About TG4050

TG4050 is an individualized immunotherapy being developed for solid tumors that is based on Transgene’s myvac technology and powered by NEC’s longstanding artificial intelligence (AI) expertise. This virus-based therapeutic vaccine encodes neoantigens (patient-specific mutations) identified and selected by NEC’s Neoantigen Prediction System. The prediction system is based on more than two decades of expertise in AI and has been trained on proprietary data allowing it to accurately prioritize and select the most immunogenic sequences.

TG4050 is designed to stimulate the immune system of patients in order to induce a T-cell response that is able to recognize and destroy tumor cells based on their own neoantigens. This individualized immunotherapy is developed and produced for each patient.