On June 4, 2020 OncoSec Medical Incorporated (NASDAQ:ONCS) (the "Company" or "OncoSec"), a company developing late-stage intratumoral cancer immunotherapies, reported that Daniel J. O’Connor, President and Chief Executive Officer of OncoSec, will present a company overview at the Virtual Summer Investor Summit on Tuesday, June 9th at 9:45 a.m. Eastern Time (Press release, OncoSec Medical, JUN 4, 2020, View Sourcepress-releases/detail/2050/oncosec-to-present-at-virtual-summer-investor-summit" target="_blank" title="View Sourcepress-releases/detail/2050/oncosec-to-present-at-virtual-summer-investor-summit" rel="nofollow">View Source [SID1234560828]).

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A live audio webcast of the presentation will be available on the Investors section of OncoSec’s website at View Source, where it will be archived for approximately 30 days.

On June 4, 2020 GlaxoSmithKline (GSK) plc reported new data from its DREAMM (DRiving Excellence in Approaches to Multiple Myeloma) clinical trial programme of belantamab mafodotin in relapsed/refractory multiple myeloma will be presented at the upcoming virtual edition of the 25th European Hematology Association (EHA) (Free EHA Whitepaper) Annual Congress from 11-21 June 2020 (Press release, GlaxoSmithKline, JUN 4, 2020, View Source [SID1234560827]).

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Sixteen presentations in total will be shared at the meeting, including new analyses from the pivotal DREAMM-2 study evaluating belantamab mafodotin in heavily pre-treated patients with relapsed/refractory multiple myeloma. Key presentations include:

DREAMM-1 and DREAMM-2 Pooled Data: Safety and Tolerability of Single-agent Belantamab Mafodotin in Heavily Pre-Treated Patients With Relapsed/Refractory Multiple Myeloma (ePoster #EP948; Trudel S)
DREAMM-2: Assessing Efficacy Via Indirect Comparison of Single-agent Belantamab Mafodotin Versus Selinexor Plus Dexamethasone Combination in Anti-CD38 Exposed Relapsed/Refractory Multiple Myeloma (ePoster #EP1016; Popat R)
DREAMM-4: Evaluating Safety and Clinical Activity of Belantamab Mafodotin in Combination With Pembrolizumab in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) (ePoster #EP955; Trudel S)
Dr Axel Hoos, Senior Vice President and Head of Oncology R&D, GSK said: "In today’s challenging environment we are committed to helping address the COVID-19 pandemic, while also progressing our scientific research to deliver innovative treatments for patients with cancer. We are proud to present data at EHA (Free EHA Whitepaper) from our extensive DREAMM clinical trial programme as we continue to advance belantamab mafodotin in various relapsed/refractory multiple myeloma treatment settings."

Belantamab mafodotin is an investigational humanised, anti-BCMA (antibody-drug conjugate against B-cell maturation antigen).[1] BCMA is a cell-surface protein that plays an important role in the survival of plasma cells and is universally expressed in patients with multiple myeloma.[2] A Biologics License Application (BLA) and Marketing Authorisation Application (MAA), are currently under review by the US Food and Drug Administration and European Medicines Agency, respectively. Data from the DREAMM-2 study of single-agent belantamab mafodotin in patients with RRMM who had received a median of seven prior lines of treatment and whose disease was progressing despite treatment with an immunomodulatory drug, a proteasome inhibitor, and an anti-CD38 antibody, serve as the basis for the BLA and MAA.

Additional GSK presentations can be found below.

Belantamab mafodotin

Abstract Name

Presenter

Presentation Details

DREAMM-2 Pivotal Study: Analysis of the Lyophilized Presentation Cohort of Single-Agent Belantamab Mafodotin for Relapsed/Refractory Multiple Myeloma

Richardson P

ePoster #EP1048

DREAMM-2: Single-Agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma RRMM–Outcomes by Prior Therapies

Lonial S

ePoster #EP937

DREAMM-2: Belantamab Mafodotin Effect on Disease Symptoms and Health-Related Quality of Life in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Popat R

ePoster #EP1746

DREAMM-1: Patient Perspectives From the First-in-Human Study of Single-Agent Belantamab Mafodotin for Relapsed and Refractory Multiple Myeloma (RRMM)

Eliason L

Abstract #PB2064

DREAMM-2: Single-Agent Belantamab Mafodotin in Relapsed/Refractory Multiple Myeloma Refractory to PIs, Immunomodulatory Agents, and Refractory and/or Intolerant to Anti-CD38 mAbs

Lonial S

ePoster #EP970

DREAMM-2: Single-Agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and High-Risk (HR) Cytogenetics

Trudel S

ePoster #EP1037

DREAMM-2: Single-agent Belantamab Mafodotin in Patients With Relapsed/Refractory Multiple Myeloma (RRMM) and Renal Impairment

Lee H

ePoster #EP1006

DREAMM-3: A Phase III, Open-label, Randomized Study of Single-Agent Belantamab Mafodotin Versus Pom/Dex in Relapsed/Refractory Multiple Myeloma (RRMM)

Weisel K

Abstract #PB2041

DREAMM-5 Platform Trial: Belantamab Mafodotin in Combination With Novel Agents in Patients With Relapsed/Refractory Multiple Myeloma (RRMM)

Richardson P

Abstract #PB2065

DREAMM-6: Safety and Tolerability of Belantamab Mafodotin in Combination with Bortezomib/Dexamethasone in Relapsed/Refractory Multiple Myeloma (RRMM)

Popat R

ePoster #EP1031

DREAMM-9: Phase III Study of Belantamab Mafodotin Plus VRd vs. VRd Alone in Transplant-Ineligible Newly Diagnosed Multiple Myeloma (TI NDMM)

Usmani S

Abstract #PB2038

Relapsed/Refractory Multiple Myeloma

Abstract Name

Presenter

Presentation Details

Characteristics, Treatment Patterns, and Outcomes Among Patients with Relapsed/Refractory Multiple Myeloma in Europe

Casey V

ePoster #EP971

Estimating the Number of US Patients with Multiple Myeloma at Different Lines of Therapy

Nikolaou A

ePoster #EP963

About multiple myeloma
Multiple myeloma is the third most common blood cancer and is generally considered treatable, but not curable.[3] Research into new therapies is needed as multiple myeloma commonly becomes refractory to available treatments.[4]

About B-cell maturation antigen (BCMA)
The normal function of BCMA is to promote plasma cell survival by transduction of signals from two known ligands, BAFF (B-cell activating factor) and APRIL (a proliferation-inducing ligand). This pathway has been shown to be important for myeloma cell growth and survival. BCMA expression is limited to B-cells at later stages of development. BCMA is expressed at varying levels in myeloma patients and BCMA membrane expression is universally detected in myeloma cell lines.[2]

About belantamab mafodotin (GSK2857916)
Belantamab mafodotin is an investigational antibody-drug conjugate comprising a humanised anti-B-cell maturation antigen (BCMA) monoclonal antibody conjugated to the cytotoxic agent auristatin F via non-cleavable linker. The drug linker technology is licensed from Seattle Genetics; monoclonal antibody is produced using POTELLIGENT Technology licensed from BioWa.

Belantamab mafodotin is not currently approved for use anywhere in the world.

Trial Name

GSK ID/NCT ID

Status

Design

DREAMM-1

117159/ NCT02064387

Completed

A Phase I Open-label Study to Investigate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity and Clinical Activity of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma and Other Advanced Hematologic Malignancies Expressing BCMA

DREAMM-2

205678/ NCT03525678

Active, not recruiting

A Phase II Study to Investigate the Efficacy and Safety of Two Doses of Belantamab Mafodotin (GSK2857916) in Subjects with Relapsed/Refractory Multiple Myeloma Who are Refractory to a Proteasome Inhibitor and an Immunomodulatory Agent and Have Failed Prior Treatment with an Anti-CD38 Antibody

DREAMM-3

207495/ NCT04162210

Recruiting

A Phase III Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) Compared to Pomalidomide plus low-dose Dexamethasone (Pom/Dex) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-4

205207/ NCT03848845

Recruiting

A Phase I/II Single Arm Open-Label Study to Explore Safety and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pembrolizumab in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-5

208887/

NCT04126200

Recruiting

A Phase I/II, Randomized, Open-label Platform Study of Belantamab Mafodotin (GSK2857916) with Innovative Combination Anti-Cancer Treatments in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-6

207497/ NCT03544281

Recruiting

A Phase I/II Randomized Study to Evaluate Safety, Tolerability and Clinical Activity of Belantamab Mafodotin (GSK2857916) Administered in Combination with Lenalidomide plus Dexamethasone (Arm A), or in Combination with Bortezomib plus Dexamethasone (Arm B) in Subjects with Relapsed/Refractory Multiple Myeloma

DREAMM-7

207503/

NCT04246047

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Dexamethasone versus Daratumumab, Bortezomib, and Dexamethasone in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-8

207499

Planned

A Phase III, Multicentre, Open-Label, Randomized Study to Evaluate the Efficacy and Safety of Belantamab Mafodotin (GSK2857916) in Combination with Pomalidomide plus Low-Dose Dexamethasone (BPd) versus Pomalidomide plus Bortezomib and Low-Dose Dexamethasone (PVd) in Participants with Relapsed/Refractory Multiple Myeloma

DREAMM-9

209664/ NCT04091126

Recruiting

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Bortezomib plus Lenalidomide and Low-Dose Dexamethasone (VRd) vs. VRd in Participants with Newly Diagnosed Multiple Myeloma who are Ineligible for Transplant

DREAMM-10

207500

Planned

A Phase III Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with a Novel Agent versus SoC

ISS/GSK Co-Sponsored Study

209418/ NCT03715478

Recruiting

A Phase I/II Dose-escalation and Dose-expansion Study of Belantamab Mafodotin (GSK2857916) Administered in Combination with Pomalidomide plus Low-dose Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma Who Have Received Two or More Prior Lines of Therapy That Must Have Included Lenalidomide and a Proteasome Inhibitor

On June 4, 2020 Jounce Therapeutics, Inc. (NASDAQ: JNCE), a clinical-stage company focused on the discovery and development of novel cancer immunotherapies and predictive biomarkers, reported that it has regained the worldwide rights to JTX-8064 from Bristol Myers Squibb (Press release, Jounce Therapeutics, JUN 4, 2020, View Source [SID1234560826]). JTX-8064 is a highly-selective, potential first-in-class antibody that targets the Leukocyte Immunoglobulin Like Receptor B2 (LILRB2) on macrophages, and was licensed to Celgene in July 2019. As part of its Celgene integration process, Bristol Myers Squibb is streamlining its pipeline and addressing areas of overlap. As a result, Bristol Myers Squibb notified Jounce that the JTX-8064 License Agreement is being terminated.

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"We are thrilled to regain the rights to JTX-8064 and we view this as a significant opportunity for Jounce. Though we highly valued our longstanding partnership with Celgene, now a Bristol Myers Squibb company, having an additional wholly-owned program enables us to further our mission to discover new immunotherapies from a variety of important immune cell types, and develop them for patients who are not well served by today’s therapies," said Richard Murray, Ph.D., chief executive officer and president of Jounce Therapeutics. "The discovery and development of JTX-8064 showcases the strength of our Translational Science Platform in target identification, and our ability to move programs towards the clinic in a rapid manner. In particular, we believe that LILRB2 may function as an immune checkpoint for macrophages and based on our body of existing preclinical data, JTX-8064 has the potential to re-program tumor-associated macrophages within the tumor microenvironment and enhance anti-tumor immunity. We are eager to advance this program into the clinic and will make every effort to do this expeditiously.

License Agreement
In July 2019, Jounce and Celgene, which is now a Bristol Myers Squibb company, announced an exclusive License Agreement for the worldwide rights to JTX-8064. Under the terms of the agreement, Jounce received a $50.0 million non-refundable license fee from Celgene. Effective, June 3, 2020, the License Agreement is terminated. Beyond transition costs and efforts, neither Bristol Myers Squibb or Jounce have any further financial or service obligations to one another. All Jounce intellectual property rights pertaining to JTX-8064 and licensed to Celgene have been reacquired by Jounce.

About JTX-8064
JTX-8064 is an anti-LILRB2 antibody and is the first tumor-associated macrophage candidate to emerge from Jounce’s Translational Science Platform. Preclinical data presented at the 2019 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting supports the development of JTX-8064 as a novel immunotherapy to reprogram immune-suppressive macrophages and enhance anti-tumor immunity.

On June 4, 2020 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates, reported that it has submitted requests to Polish regulatory authorities for approval to open two additional clinical sites for its Phase 1/2 clinical study of Annamycin for the treatment of acute myeloid leukemia ("AML") (Press release, Moleculin, JUN 4, 2020, View Source [SID1234560825]).

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Moleculin Biotech, Inc. is a clinical stage pharmaceutical company focused on the development of a broad portfolio of oncology drug candidates for the treatment of highly resistant tumors. (PRNewsfoto/Moleculin Biotech, Inc.)

"We are pleased to report that the Annamycin trial in AML continues forward despite the disruptions from the COVID-19 pandemic," commented Walter Klemp, Chairman and CEO of Moleculin. "Two additional hospitals in Poland, one in Szczecin and one in Kielce, have been moving quickly to participate in this trial. Assuming these requests are granted in a timely manner, we expect both sites to begin recruiting in the third quarter."

Moleculin currently has 5 clinical sites for the Annamycin AML clinical trial operating in Europe. The addition of sites in Szczecin and Kielce would bring this total to 7.

On June 4, 2020 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported it has successfully concluded a meeting with the Scientific Advice Working Party (SAWP) of the European Medicines Agency (EMA) regarding Phase III development of its drug candidate Namodenoson in the treatment of hepatocellular carcinoma (HCC), the most common form of liver cancer (Press release, Can-Fite BioPharma, JUN 4, 2020, View Source [SID1234560824]).

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Namodenoson is Can-Fite’s adenosine A3 receptor (A3AR) agonist which has recently been shown to prolong median overall survival (OS) in a selected patient population with HCC in a Phase II clinical trial. Can-Fite sought scientific advice from the EMA to complement previous input from the U.S. Food and Drug Administration (FDA) in its recent End-of-Phase II meeting regarding plans for a Phase III registration trial of Namodenoson in patients with HCC and Child Pugh Class B7 (CPB7) cirrhosis. Having completed its meeting with the SAWP, Can-Fite now has sufficient regulatory input to conduct a registration trial in accordance with the requirements of both the U.S. and the European Union.

The planned trial, a randomized, double blind, placebo controlled trial, will enroll approximately 450 patients with HCC and underlying CPB7 cirrhosis at multiple centers worldwide. Patients will be randomized to oral treatment with either Namodenoson 25 mg or matching placebo given twice daily. The primary efficacy endpoint of the trial is overall survival (OS), based on the favorable OS response seen in the Phase II trial in patients with HCC and CPB7 cirrhosis. Other oncology trial efficacy outcomes, such as tumor radiographic response rates and median progression-free survival, as well as standard safety parameters, will be assessed.

"We appreciate the EMA’s advice which, combined with the input we received last October from the U.S. FDA along with recommendations from our academic key opinion leaders, gives us excellent guidance for conducting a successful Phase III clinical and registration program," stated Can-Fite CEO Dr. Pnina Fishman.

According to the American Cancer Society, liver cancer accounts for more than 700,000 deaths globally each year. HCC is commonly aggressive with poor survival rates. As new drugs that effectively and safely treat HCC are developed and approved, the market for HCC treatments is estimated by Delveinsight to reach $3.8 billion by 2027 for the G8 countries.

About Namodenoson

Namodenoson is a small orally bioavailable drug that binds with high affinity and selectivity to the A3 adenosine receptor (A3AR). Namodenoson is being evaluated as a second line treatment for hepatocellular carcinoma, with a recently completed Phase II trial and planned Phase III trial in this indication. The drug recently concluded a Phase II trial which successfully achieved efficacy and safety endpoints in the treatment for non-alcoholic fatty liver disease (NAFLD) and non-alcoholic steatohepatitis (NASH). A3AR is highly expressed in diseased cells whereas low expression is found in normal cells. This differential effect accounts for the excellent safety profile of the drug.