On May 27, 2022 Transgene (Euronext Paris: TNG), a biotech company that designs and develops virus-based immunotherapies for the treatment of cancer, reported that an abstract reporting preliminary data from the two Phase I trials assessing TG4050, its individualized neoantigen cancer vaccine, has been selected for a poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting (Press release, Transgene, MAY 27, 2022, View Source [SID1234615173]). The conference will be held online and in-person in Chicago, IL, USA, from June 3 to 7, 2022.

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The abstract reports positive immunogenicity and clinical data generated from the two ongoing Phase I trials in patients with ovarian cancer and HPV-negative head and neck cancer (NCT03839524 and NCT04183166). The detailed data will be presented during a poster session on June 5, 2022, at the ASCO (Free ASCO Whitepaper) conference.

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
Session date and time: Sunday, June 5, 2022, 8:00 am-11:00 am CDT
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
The abstract can be accessed on the ASCO (Free ASCO Whitepaper) and Transgene websites.

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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. 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. In the USA, the trial is being led by Dr. 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. Dr. 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 Dr. 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.

On May 27, 2022 Invitae (NYSE: NVTA), a leading medical genetics company, reported that members of its management team will participate in the following investor conferences (Press release, Invitae, MAY 27, 2022, View Source [SID1234615172]):

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

42nd Annual William Blair Growth Stock Conference – Formal presentation on Tuesday, June 7, 2022, at 8:40 a.m. Central Time in Chicago.
43rd Annual Goldman Sachs Global Healthcare Conference – Fireside chat on Wednesday, June 15, 2022, at 2:40 p.m. Pacific Time in Rancho Palos Verdes, CA.
A live audio webcast of each presentation may be accessed by visiting the investors section of the company website at ir.invitae.com. Replays of the webcasts will be available shortly after the conclusion of each presentation.

On May 27, 2022 Gnubiotics Sciences, a biotech company pioneering immunomodulatory glycopeptides, reported that results from its GLAAD technology program in Colorectal Cancer (CRC) will be presented in a poster presentation at the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, scheduled for June 3-7, 2022 in Chicago, Illinois (USA) (Press release, Gnubiotics Sciences, MAY 27, 2022, View Source [SID1234615171]).

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The poster entitled Exploiting GLAAD molecules to drive an antitumor immune response in a colorectal cancer mouse model will be presented by Yemi Adesokan, Ph.D., Gnubiotics’s Chief Executive Officer, on June 5.

"We are thrilled to present compelling pre-clinical efficacy data in colorectal cancer. These findings nicely complement previous work in melanoma presented earlier this year at AACR (Free AACR Whitepaper). Our Glycopeptides with tumor-associated Antigen and Adjuvant Delivery (GLAAD) technology is designed to drive and boost immune responses directed against various solid tumors and we are excited that the technology continues to deliver promising preclinical data, paving the way for future clinical development. With our collaborators at the University of Zurich we demonstrated that our proprietary glycopeptide candidates were capable to control tumor growth either alone or in combination with existing treatment. We are convinced that glycan-based strategies like our GLAAD approach bear great potential for safe and effective immunotherapies and respond to the urgent need for new modalities for non-responding patients that are otherwise left with few alternative treatments," stated Yemi Adesokan, Ph.D., Gnubiotics’s Chief Executive Officer.

Abstract Title: Exploiting GLAAD molecules to drive an antitumor immune response in a colorectal cancer mouse model.

Abstract Number: 2565

Session Title: Developmental Therapeutics—Immunotherapy

Session Date and Time: Sunday, June 5, 2022, 8:00 AM-11:00 AM CDT

The Poster will also be made available for browsing on the first day of the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting. Viewers will have the possibility to e-mail questions and comments to the presenter.

On May 27, 2022 BeyondSpring Inc. (the "Company" or "BeyondSpring") (NASDAQ: BYSI), a clinical stage global biopharmaceutical company focused on developing innovative cancer therapies to improve clinical outcomes for patients who have a high unmet medical need, reported three poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting being held June 3-7, 2022, in Chicago, Illinois (Press release, BeyondSpring Pharmaceuticals, MAY 27, 2022, View Source;utm_medium=rss&utm_campaign=beyondspring-presents-new-clinical-data-in-the-chemotherapy-induced-neutropenia-and-nsclc-programs-at-the-2022-asco-annual-meeting [SID1234615169]).

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Presentation highlights:

Chemotherapy-induced neutropenia (CIN): Real-world CMS data showed that week 1 after chemotherapy still presents unmet medical needs with febrile neutropenia (FN) risk, even with prophylactic G-CSF, among patients with breast cancer after high FN–risk chemo
DUBLIN-3 (non-small cell lung cancer, NSCLC): Improved quality of life (QoL) in plinabulin/docetaxel combination vs. docetaxel alone in 2nd/3rd line EGFR-wild type NSCLC patients using the validated EORTC QLQ C30 and QLQ LC13 questionnaires
DUBLIN-3 (NSCLC): Subgroup analysis in patients with non-squamous, EGFR-wild type, 2nd/3rd line NSCLC from the global Phase 3 trial showed a superior survival benefit of 2.6 months in median overall survival (OS) in the plinabulin/docetaxel combination (11.4 months) vs. docetaxel alone (8.8 months), HR=0.75, p=0.023
"We continue to develop plinabulin as a potential ‘pipeline in a drug,’ in both CIN prevention and in NSCLC. We now present ‘real-world’ data demonstrating an unmet medical need with standard of care (SoC) G-CSF for CIN, primarily due to G-CSF’s slow-onset mechanism of action (MoA) that leaves patients unprotected in Week 1 of the chemotherapy cycle. Plinabulin has a fast-onset MoA acting within 24 hours of administration and when combined with G-CSF provided superior CIN protection throughout the entire cycle," said Dr. Ramon Mohanlal, executive vice president, research and development, and chief medical officer, at BeyondSpring. "In terms of the DUBLIN-3 Phase 3 data, patient QoL is an important factor for treatment decisions in 2nd/3rd line NSCLC. The improvement in QoL seen when plinabulin is added to SoC docetaxel vs docetaxel alone could be an important point of product differentiation. Whereas the mOS data in the overall intention to treat (ITT) population was positive, but somewhat modest, we now demonstrate a more robust mOS benefit (of 2.6 months) in a large subgroup of non-squamous 2nd/3rd line NSCLC patients. We continue to work with health authorities on a path to approval in the U.S. and in China."

Dr. Lan Huang, co-founder, chairman and chief executive officer at BeyondSpring, added, "Since we’ve started studying plinabulin, it has continued to show a strong potential to make a difference in a number of oncology indications. We’ve been able to demonstrate repeatedly how it has a two-pronged ability to help prevent CIN and treat cancer directly. We are pleased with the ongoing discussions with China NMPA on the NDA review of the plinabulin and G-CSF combination for the prevention of CIN and plan to file an NDA application to the NMPA for the use of plinabulin in NSCLC by year-end. I’m grateful to our team and partners over the years who have continued to do all the hard work at the bench and in clinical trials to fully understand what plinabulin has to offer for cancer patients. We continue to stay strongly committed to this work in the hopes of bringing plinabulin to patients around the globe."

Title: Real-world effectiveness of prophylactic granulocyte colony-stimulating factor (G-CSF) early (week 1) and late (weeks 2-3) in the cycle for the prevention of febrile neutropenia (FN) among patients (pts) with breast cancer (BC) after high FN–risk chemotherapy (chemo)

Abstract #: 599

Poster Session: Breast Cancer—Local/Regional/Adjuvant
Date/Time: June 6, 2022, 9 AM EDT

Presenter: Douglas W. Blayney, M.D., FASCO, Stanford University

The relative FN risk in Week 1 vs. Weeks 2-3 of the cycle with G-CSF is unknown. It was analyzed compared with no G-CSF in the real-world setting with high FN risk chemotherapy.
Using a CMS database of administrative claims representing 100% of fee-for-service Medicare, an analysis of breast cancer patients who initiated docetaxel (T), doxorubicin (A) or cyclophosphamide (C) monotherapy or combination therapy between 01/01/2015 – 12/31/2019 was performed.
Prophylactic G-CSF was highly effective for the prevention of FN in weeks 2-3 (only 0.8% of patients had FN) but relatively ineffective in Week 1 of cycle 1 (3.2% of patients had FN, which was not different from patients without G-CSF (3.6%)) in the real-world setting. This represents an unmet medical need in Week 1 of the cycle with SoC G-CSF.

Title: DUBLIN-3 results on quality of life (QoL) in second/third-line EGFR-wild type NSCLC patients (pts) receiving docetaxel (Doc) with or without plinabulin (Plin) using the validated EORTC QLQ C30 and QLQ LC13 questionnaires

Abstract #: 9091

Session: Lung Cancer—Non-Small Cell Metastatic
Date/Time: June 6, 2022, 9 AM EDT

Presenter: Trevor Feinstein, M.D., Piedmont Cancer Institute

In the ITT population of the DUBLIN-3 Phase 3 trial, the plinabulin/docetaxel combination had better quality of life versus docetaxel alone in second/third-line EGFR-wild type NSCLC patients (QTWiST, p=0.026).
EORTC QLQ C30 and QLQ LC13 scores were collected at baseline, Day 1 and Day 8 of each cycle.
Mean (SEM) change from baseline in cumulative C30 and LC13 were overall in favor of plinabulin/docetaxel. LC13 items in favor of plinabulin/docetaxel vs docetaxel alone were items 31 (coughing; p<0.05), 36 (sore mouth; p<0.01) and 37 (dysphagia; p<0.01).

Title: Subgroup analysis in patients (pts) with non-squamous (N-Sq), EGFR-wild type (wt), second/third-line NSCLC from the global phase (Ph) 3 trial DUBLIN-3 with the plinabulin/docetaxel (Plin/Doc) combination versus Doc alone

Abstract #: 9090

Session: Lung Cancer—Non-Small Cell Metastatic
Date/Time: June 6, 2022, 9 AM EDT

Presenter: Baohui Han, M.D., Department of Pulmonary Medicine, Shanghai Chest Hospital, Shanghai Jiao Tong University

With PD-1/PD-L1 inhibitors moving to first line in NSCLC, 2nd/3rd line NSCLC represents a severe unmet medical need, dominated by docetaxel-based therapies with >40% severe neutropenia and limited survival.
In the ITT population of the DUBLIN-3 Phase 3 trial, the plinabulin/docetaxel combination had superior efficacy, safety and quality of life versus docetaxel alone in EGFR-wild type, second/third-line NSCLC patients.
In this subgroup analysis of the non-squamous (N-Sq) subgroup, the addition of plinabulin to docetaxel was superior to docetaxel alone for efficacy (mOS 11.4 vs. 8.8 months, HR=0.75, p=0.023) and safety (Grade 4 neutropenia rate 13.9% vs 37.9%, p<0.001).

About DUBLIN-3

The DUBLIN-3 Phase 3 trial is a randomized, single blinded, active-controlled global trial that enrolled 559 patients with 2nd/3rd line NSCLC, EGFR wild type, with a measurable lung lesion. Patients were treated on a 21-day cycle with an infusion of docetaxel (75 mg/m2 on day 1) and plinabulin (30 mg/m2 on days 1 and 8) vs. docetaxel alone (75 mg/m2, day 1). The primary endpoint was overall survival. Secondary endpoints include ORR, PFS, grade 4 neutropenia, 2 year and 3 year OS rate and quality of life analysis. Plinabulin in combination with docetaxel (DP) showed statistically significant overall survival improvements compared to docetaxel alone (D) for the ITT population (DP: n=278; D: n=281).

On May 27, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported the publication of three abstracts related to its OncoMimcs pipeline, including EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy, ahead of poster presentations at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, taking place June 3-7, 2022 in Chicago and virtually (Press release, Enterome, MAY 27, 2022, View Source [SID1234615168]).

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Enterome will present clinical proof-of-concept data from its most advanced OncoMimics drug candidate, EO2401, a therapeutic cancer vaccine candidate currently in clinical development for the treatment of patients with first progression/recurrence of glioblastoma (ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (SPENCER trial, EOADR1-19).

A third poster describing the Phase 1/2 trial (SIDNEY, EONHL1-20) with Enterome’s second OncoMimics vaccine, EO2463, in non-Hodgkin lymphoma will also be presented at ASCO (Free ASCO Whitepaper).

Details of the poster presentations and session are as follows:

ROSALIE Trial (EOGBM1-18)

Title: EO2401, a novel microbiome-derived therapeutic vaccine for patients with recurrent glioblastoma
Track: Central Nervous System Tumors
Abstract number: #2034
Date and Time: Sunday, June 5, 8:00 AM-11:00 AM CDT
Presenter: Professor Wolfgang Wick, Universitätsklinikum Heidelberg and German Cancer Research Center, Heidelberg, Germany
Authors: Wick, W. et al
SPENCER Trial (EOADR1-19)

Title: EO2401, a novel microbiome-derived therapeutic vaccine for patients with adrenocortical carcinoma (ACC)
Track: Genitourinary Cancer—Kidney and Bladder
Abstract number: #4596
Date and Time: Saturday, June 4, 1:15 PM-4:15 PM CDT
Presenter: Professor Vivek Subbiah, The University of Texas MD Anderson Cancer Center (MDACC), Houston, TX
Authors: Baudin, E. et al
SIDNEY Trial (EONHL1-20)

Title: A novel microbial-derived peptide therapeutic vaccine (EO2463) as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma
Poster session: Hematologic Malignancies/Lymphoma and Chronic Lymphocytic Leukemia
Poster number: #TPS7586
Date and Time: Saturday, June 4, 8:00 -11:00 AM CDT
Authors: Zinzani, P.L et al

About OncoMimics Peptides

OncoMimics peptides are gut microbiome-derived peptides that closely mimic antigens expressed by tumor cells. In contrast to tumor antigens, however, OncoMimics peptides are recognized by the immune system as "non-self" and can generate a strong human cytotoxic CD8+ response steming from memory T cells, offering enormous potential to create a new class of cancer vaccines targeting solid and liquid tumors.

Enterome’s pioneering work on its OncoMimics pipeline leverages the fundamental understanding that the gut is the largest lymphoid organ in the body and is home to most of its memory T-cells. As a result, there is constant interaction and presentation of peptides and proteins secreted by gut bacteria to the body’s immune system, resulting in the formation of a pool of effector memory T cells protecting the human body against bacterial invasion. In the event that the bacterial antigens are mimics of tumor antigens, this process leads to the generation of circulating effector memory T cells with a preserved ability to recognize tumor antigens.