On May 19, 2022 Mersana Therapeutics, Inc. (NASDAQ: MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation to XMT-2056, the company’s lead Immunosynthen STING-agonist ADC, for the treatment of gastric cancer (Press release, Mersana Therapeutics, MAY 19, 2022, View Source [SID1234614864]).

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According to the American Cancer Society, gastric cancer (also referred to as stomach cancer) accounts for approximately 1.5 percent of all new cancers diagnosed in the United States each year, with an estimated 26,560 new cases reported in 2021. The FDA grants orphan drug designation to a drug or biologic intended to treat a rare disease or condition impacting fewer than 200,000 individuals in the United States. This designation qualifies Mersana for potential incentives, including tax credits for certain trials, exemption from user fees and the potential for seven years of market exclusivity following approval (if granted).

"The FDA’s decision to grant orphan drug designation to XMT-2056 for the treatment of gastric cancer is an important recognition of its potential in this area of high unmet medical need," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics. "We are eager to bring XMT-2056 and its unique mechanism of action into the clinic mid-year to investigate its safety, tolerability and anti-tumor activity in gastric and other cancers."

XMT-2056 is designed to offer a differentiated and complementary therapeutic approach to existing and emerging solid tumor treatments. The company developed XMT-2056 leveraging a differentiated antibody that binds to a novel HER2 epitope, providing the opportunity, as demonstrated in preclinical studies, for treatment both as monotherapy and in combination with a variety of agents, including other anti-HER2 therapies. Mersana plans to initiate a Phase 1 trial of XMT-2056 in a range of HER2 expressing tumors, such as breast, gastric and non-small-cell lung cancers, in mid-2022.

On May 19, 2022 Coinciding with Melanoma Awareness Month, the Melanoma Research Alliance (MRA), the largest non-profit funder of melanoma research, reported funding for 27 research grants totaling $13,046,774 to support new research aimed at advancing melanoma prevention, diagnosis and treatment (Press release, Melanoma Research Alliance, MAY 19, 2022, View Source [SID1234614880]). Melanoma is the deadliest form of skin cancer and the fifth most common cancer in the United States.

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The grants will support 11 Team Science Awards, 10 Young Investigator Awards, and 6 Pilot Awards. MRA grant awards back development of innovative ideas that offer the promise of rapidly improving outcomes for melanoma patients.

This year’s grant awards focus on a variety of approaches, including the use of novel cellular barcodes to identify causes – and possible treatments – of resistant disease; research focused on rare melanoma subtypes ways to improve response to existing checkpoint immunotherapies; and two pilot awards co-funded with the Michael J. Fox Foundation to study the connection between melanoma and Parkinson’s Disease.

"These scientific proposals selected this year for funding by MRA’s expert Grant Review Committee are exceptional," said MRA Chief Executive Officer Marc Hurlbert, PhD. "We are at a pivotable moment in the fight against melanoma. We are thrilled to support this critical work with the hope of benefiting all patients and families dealing with melanoma, and preventing countless more from having to do so."

2022 Melanoma Research Alliance Grant Awards

Team Science Awards

Targeting Oncogenic Gaq in Uveal Melanoma
MRA Team Science Award
Boris Bastian, MD, The University of California, San Francisco

Identification & Validation of Novel Druggable Targets in Mucosal Melanoma
MRA Team Science Award
Genevieve Boland MD, PhD, Massachusetts General Hospital

Targeting Epigenetics to Enhance Anti-Melanoma Immunity
Leveraged Finance Fights Melanoma – MRA Team Science Award
Marcus Bosenberg MD, PhD, Yale University

Targeting RNA Processing to Enhance Mucosal Melanoma Immunotherapy
MRA Team Science Award
Rotem Karni PhD, Hebrew University of Jerusalem

Harnessing B Cell Checkpoints in Melanoma
MRA Team Science Award, collaboratively funded by Brigham and Women’s Hospital and The University of Texas MD Anderson Cancer Center
Vijay Kuchroo DVM, PhD, Brigham and Women’s Hospital, Inc.

Targeting Chromothripsis to Suppress Metastasis and Therapy Resistance
MRA Team Science Award
Roger Lo MD, PhD, The University of California, Los Angeles

Cellular Barcoding to Define Melanoma Drug Resistance and Cell of Origin
MRA Team Science Award for Women in Melanoma Research
Elizabeth E. Patton PhD, University of Edinburgh

Identifying Public Neoantigens, their TCRs and their Rules of Engagement
MRA Team Science Award
Yardena Samuels PhD, Weizmann Institute of Science

Improving Immunological Memory During Anti-PD-1 Immunotherapy
MRA Team Science Award, collaboratively funded by Harvard Medical School and Dana-Farber Cancer Institute
Arlene Sharpe MD, PhD, Harvard Medical School

Noninvasive Prediction of Severe Toxicity from Immune Checkpoint Blockade
MRA Team Science Award, collaboratively funded by Yale University, Washington University, and Stanford University
Mario Sznol MD, Yale University

Team Science Academic-Industry Partnership Award

Analytical and Clinical Validation of a Multiplex IF Biomarker for Anti-PD1
MRA Team Science Academic-Industry Partnership Award
Janis Taube MD, Johns Hopkins University School of Medicine

Young Investigator Awards

New Genetic Tools to Understand the Role of M6A in Melanomagenesis
MRA Young Investigator Award
Claudio Alarcon PhD, Yale University, School of Medicine

Decipher the Epigenetic Code Regulating Cellular Dynamics in Acral Melanoma
MRA Young Investigator Award
Junyue Cao PhD, The Rockefeller University

Targeting Anti-Tumor Immunity in Anatomically Distinct Mucosal Melanomas
MRA Young Investigator Award for Women in Melanoma Research
Kasey Couts PhD, University of Colorado Denver

Investigating Lipid Kinase Pip4k2c in Regulating Anti-Tumor Immunity
Bristol Myers Squibb – MRA Young Investigator Award
Karen Dixon PhD, Brigham and Women’s Hospital

Mechanisms and Relevance of Treg Expansion after PD-1 Blockade in Melanoma
Bristol Myers Squibb – MRA Young Investigator Award
Francesco Marangoni PhD, The University of California, Irvine

Interfering with Early Cell State Transitions to Prevent Drug Tolerance
The Wayne Stinchcomb Big Orange Melanoma Foundation – MRA Young Investigator Award
Florian Rambow PhD, Essen University Hospital

Interrogating Epigenetic Regulation of PD1 in Melanoma-Infiltrating T Cells
Leveraged Finance Fights Melanoma – MRA Young Investigator Award in memory of Michael Konigsberg
Debattama Sen PhD, Massachusetts General Hospital

Tumor-Stroma Metabolic Crosstalk in Melanoma Brain Metastases
Tara Miller Melanoma Foundation – MRA Young Investigator Award
Inna Smalley PhD, H. Lee Moffitt Cancer Center & Research Institute

Investigating the role of FGL1/LAG-3 Axis in Melanoma Immunity
Bristol Myers Squibb – MRA Young Investigator Award
Jun Wang PhD, New York University School of Medicine

mRNA-Based Re-Programming of Terminally Differentiated TILs
MRA Young Investigator Award
Yochai Wolf PhD, The Sheba Fund for Health Service and Research

Pilot Awards

A Strategy to Identify the Basis of Melanoma and Parkinson’s Comorbidity
The Michael J. Fox Foundation – MRA Pilot Award
Deanna L. Benson PhD, Icahn School of Medicine at Mount Sinai

Investigating ARID2 as a Suppressor of Melanoma Metastasis
MRA Pilot Award for Women in Melanoma Research
Emily Bernstein PhD, Icahn School of Medicine at Mount Sinai

Combined Intrathecal Immunotherapeutic Strategies for Melanoma LMD
MRA Pilot Award
Sherise Ferguson MD, University of Texas MD Anderson Cancer Center

Novel Mouse Models of Uveal Melanoma
MRA Pilot Award
Florian Karreth PhD, H. Lee Moffitt Cancer Center & Research Institute, Inc

The Role of APC Mutations in Melanoma Brain Metastasis
Leveraged Finance Fights Melanoma – MRA Pilot Award
James Robinson PhD, The University of Minnesota, Twin Cities

Alpha-Synuclein’s Role in Melanoma Formation and Metastasis
The Michael J. Fox Foundation – MRA Pilot Award
Vivek Unni MD, PhD, Oregon Health & Science University

On May 19, 2022 Ryvu Therapeutics (WSE: RVU), a clinical-stage drug discovery and development company focusing on novel small molecule therapies that address emerging targets in oncology, reported that the Company will participate in the following upcoming investors’ conferences (Press release, Ryvu Therapeutics, MAY 19, 2022, View Source [SID1234614897]):

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UBS Global Healthcare Conference
Format: Corporate overview presentation and one-on-one investor meetings
Date: Monday, May 23rd, 2022, in New York, NY
Presentation Time: 11:30 AM EST

H.C. Wainwright Global Investment Conference
Format: Corporate overview presentation and one-on-one investor meetings
Date: Wednesday, May 25th, 2022, in Miami, FL
Presentation Time: 4:30 PM EST

Erste CEE Technology & Innovation Conference
Format: One-on-one, and group investor meetings
Date: Wednesday, May 25th, 2022, Virtual

IPOPEMA CEE Days
Format: Group investor meeting and Q&A session
Date: Wednesday, June 1st, 2022, Warsaw, Poland
Meeting Time: 2 PM CEST

Pekao Technology Conference
Format: One-on-one investor meetings
Date: Wednesday, June 8th, 2022, Virtual

During the UBS 2022 Global Healthcare Conference and the 2022 H.C. Wainwright Global Investment Conferences, Vatnak Vat-Ho, Chief Business Officer of Ryvu Therapeutics will give a corporate overview and participate in investor meetings. The presentations will be available to conference registrants on-demand. Broader Ryvu management team will be available for meetings during Erste, Ipopema, and Pekao conferences.

On May 19, 2022 Enterome, a clinical stage biopharmaceutical company developing first-in-class immunomodulatory drugs based on its bacterial Mimicry drug discovery platform, reported that it will present for the first time proof-of-concept data from clinical trials with EO2401, its first-in-class off-the-shelf OncoMimics cancer immunotherapy 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 19, 2022, View Source [SID1234614848]).

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OncoMimics peptides – generating strong CD8+ T-cell responses derived from pre-existing memory cells

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.

To-date, Enterome has generated a repertoire of OncoMimics peptides correlating to tumor antigens across a wide range of solid and liquid tumor types. From this, the Company is creating a pipeline of off-the-shelf cancer immunotherapies designed to act via the same novel mode of action. The first candidates include EO2401 (in clinical trials for glioblastoma and adrenal malignancies), EO2463 (in clinical development for liquid tumors) and EO4010 (in development for colorectal cancer, and targeted to enter clinical trials in 2023).

Enterome’s lead candidate EO2401 combines three OncoMimics peptides that closely mimic IL13Ra2, BIRC5 and FOXM1, all of which are known driver antigens present on aggressive solid tumors and generate strong human CD8+ responses. In addition, EO2401 contains a CD4 helper peptide UCP4.

At ASCO (Free ASCO Whitepaper), in the first two abstracts, Enterome will present, for the first time, clinical proof-of-concept data from Phase 1/2 clinical trials of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo), for the treatment of patients with first progression/recurrence of glioblastoma (the ROSALIE trial, EOGBM1-18) and for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma (the SPENCER trial, EOADR1-19).

In a third abstract, the Company will present the use of its second therapeutic vaccine program, EO2463 as monotherapy and in combination with lenalidomide and rituximab, for treatment of patients with indolent non-Hodgkin lymphoma (the SIDNEY trial, EONHL1-20). EO2463 combines four OncoMimics peptides that exhibit molecular mimicry with the B cell markers CD20, CD22, CD37, and CD268 (BAFF-receptor), respectively.

Jan Fagerberg, Chief Medical Officer of Enterome said, "As a proof-of-concept for the entire Mimicry platform, we have put in action a clinical development strategy for EO2401 that is designed to identify a clinical efficacy signal in various tumor types that have in common the same tumor antigens (IL13Ra2, BIRC5 and FOXM1). In both the ROSALIE and SPENCER trials, EO2401 in combination with checkpoint blockade generated strong systemic immune responses directed against human tumor antigens. We look forward to sharing these very promising clinical data at ASCO (Free ASCO Whitepaper) while continuing to progress these trials, with the aim of providing a more mature set of data at ESMO (Free ESMO Whitepaper), Europe’s leading medical oncology conference, later in the year."

Enterome’s Mimicry Platform

Enterome’s Mimicry drug discovery platform is based on its unique ability to decode the interaction between the gut microbiome and the immune system. The Mimicry platform uses best-in-class biocomputational tools and bioassays to identify novel therapeutics from its proprietary database of 21 million full-length gut microbiome peptides and proteins.

The Mimicry platform is highly productive and has already generated first-in-class small protein and peptide drug candidates targeting multiple therapeutic areas that modulate the immune system by closely mimicking the structure, effect or actions of specific human antigens, hormones or cytokines.

"We are thrilled to be able to present the first clinical data demonstrating the potential of our unique OncoMimics pipeline at ASCO (Free ASCO Whitepaper) this year. We are using our Mimicry platform to generate mutliple pipelines of transformative drug candidates, targeting a broad range of therapeutic areas. Presently we are advancing two pipelines of distinct drug candidates – OncoMimics and EndoMimics – which have the potential to address cancer, inflammatory and autoimmune diseases," said Pierre Belichard, CEO of Enterome. "We believe that our unique platform has the potential to create effective new medicines that make a real difference to patients. Our corporate strategy is designed to advance the development of these new therapies as quickly and robustly as possible while generating significant value for our shareholders. Enterome’s future has never looked so exciting."

On May 19, 2022 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors and viruses, reported that Walter Klemp, President and Chief Executive Officer of Moleculin, will present at the H.C. Wainwright Global Investment Conference being held May 23-26, 2022 in Miami, FL and virtually (Press release, Moleculin, MAY 19, 2022, https://moleculin.com/moleculin-to-present-at-the-h-c-wainwright-global-investment-conference/ [SID1234614865]).

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In addition to the presentation, management will be available to participate in virtual one-on-one meetings with qualified members of the investor community who are registered to attend the conference. For more information, please visit the conference website.

A video webcast of the presentation will be available for viewing on-demand beginning Tuesday, May 24, 2022, at 7:00 AM ET for those registered for the event and will be accessible on the Events page in the Investors section of the Company’s website (www.moleculin.com). The webcast replay will be archived for 90 days following the event.