On December 9, 2021 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that a milestone payment from Jazz Pharmaceuticals (NASDAQ: JAZZ) has been triggered as a result of entering the second year of the oncology research collaboration with the Company (Press release, Redx Pharma, DEC 9, 2021, View Source [SID1234596649]).

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The milestone payment of $10 million arises in accordance with the terms of the research collaboration agreement announced on 9 September 2020. Under the agreement to discover and develop drug candidates for two cancer targets in the Ras/Raf/MAP kinase (MAPK) pathway, Redx is responsible for research and preclinical development activities up to Investigational New Drug (IND) submission. In addition to the $20 million in payments that have now been realised, Redx may receive up to a further $200 million from Jazz in development, regulatory and commercial milestone payments for each programme. The next milestone is payable upon successful IND submission and all subsequent milestones are contingent on successful completion of the relevant stages of development. In addition, Redx is eligible for tiered royalties in mid-single digit percentages, based on any future net sales.

Lisa Anson, Chief Executive Officer of Redx, commented: "We are extremely pleased to extend our productive oncology research collaboration with Jazz into its second year. This is based on advancing our programmes in this key signalling pathway and reflects Redx’s core strength in discovering highly targeted potential drug candidates. We look forward to further progress in partnership with Jazz."

Redx continues to execute on its strategy, progressing its lead oncology and fibrosis programmes. These include the oral Porcupine inhibitor, RXC004, targeting Wnt-ligand driven tumours, which has recently entered a Phase 2 trial in genetically selected patients with microsatellite stable metastatic colorectal cancer (MSS mCRC) and the oral selective ROCK2 inhibitor, RXC007, being developed for idiopathic pulmonary fibrosis, where first in human studies commenced in June 2021.

On December 9, 2021 QIAGEN (NYSE: QGEN; Frankfurt Prime Standard: QIA) and Denovo Biopharma LLC reported a collaboration to develop a blood-based companion diagnostic (CDx) test to identify patients expressing Denovo Genomic Marker 1 (DGM1TM) who are likely to respond to Denovo’s investigational cancer drug DB102TM for treatment of diffuse large B-cell lymphoma (DLBCL), one of the most common lymphoid cancers (Press release, Qiagen, DEC 9, 2021, View Source [SID1234596648]).

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Under the agreement, QIAGEN will develop a diagnostic assay that can detect the Denovo Genomic Marker 1 (DGM1TM) in DLBCL patients, a biomarker discovered by Denovo that predicts the responsiveness to DB102. Also known as enzastaurin, Denovo’s drug is a first-in-class investigational small molecule inhibitor of PKC-beta, a protein whose presence has been compellingly linked to DLBCL cases.

"We are proud to be at the cutting edge of precision medicine, a quantum leap from traditional one-drug-fits all medicine," said Jonathan Arnold, Vice President, Head of Oncology and Precision Diagnostics at QIAGEN. "Our molecular testing expertise will help Denovo to develop the use of the DGM1 marker with the DB102 drug for patients with DLBCL."

QIAGEN will develop a real-time qualitative PCR companion diagnostic for the QIAGEN Rotor-Gene Q MDx instrument and apply for premarket approval (PMA) with the US-based Food and Drug Administration (FDA). The goal is to get the PMA for the test contemporaneously with Denovo receiving new drug application (NDA) approval for its DB102. The drug and the DGM1 marker are currently in a phase III trial, called ENGINE, on newly diagnosed, high-risk DLBCL patients.

"As our ENGINE trial nears completion, we are pleased to be working with QIAGEN on commercial development of our DB102 program to enable patients and physicians to potentially benefit from DB102 treatment," said Xiao-Xiong Lu, Denovo’s Chief Technology Officer. "As a pioneer in precision medicine QIAGEN brings extensive experience in companion diagnostics, including ten FDA-approved tests."

QIAGEN is the global leader in collaborations with pharmaceutical and biotechnology companies to co-develop companion diagnostics, which detect clinically relevant genetic abnormalities to provide insights that guide clinical decision-making in diseases such as cancer. The company has an unmatched depth and breadth of technologies from next-generation sequencing (NGS) to polymerase chain reaction (PCR) for companion diagnostic development. Its ten PCR-based CDx tests with FDA approval include therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer, therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples and the therascreen BRAF kit for colorectal cancer.

Currently, QIAGEN is working under master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostic tests for their drug candidates – a deep pipeline of potential future products to advance Precision Medicine for the benefit of patients.

On December 9, 2021 Innate Pharma SA (Euronext Paris:IPH; Nasdaq:IPHA) ("Innate" or the "Company") reported that data from the Phase 2 expansion cohort (‘cohort 3’), exploring the triplet combination of monalizumab, cetuximab and durvalumab in the first-line treatment of patients with recurrent or metastatic head and neck squamous cell cancer (R/M HNSCC), will be presented virtually today at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress 2021 (Press release, Innate Pharma, DEC 9, 2021, View Source [SID1234596647]).

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Monalizumab, Innate’s lead partnered asset, is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor-infiltrating cytotoxic CD8+ T cells and NK cells.

"These data show anti-tumor activity in the first study to evaluate this chemo-free triplet combination in first-line recurrent or metastatic head and neck cancer," said Joyson Karakunnel, M.D., MSc, FACP, Chief Medical Officer of Innate Pharma. "We believe that the combination of monalizumab with the other two antibodies has the potential to become a new treatment option for patients. We look forward to collaborating with AstraZeneca on next steps of this program."

Key Data Highlights

After a median follow-up of 16.3 months, preliminary data suggest anti-tumor activity in the triplet of monalizumab, cetuximab and durvalumab in first-line treatment of R/M HNSCC.

As of August 1, 2021, 40 patients were enrolled. Thirteen patients had a confirmed response with a 32.5% overall response rate (95% confidence interval (CI): 20-48), including three complete responses. Seven out of 13 responders were still on treatment. Median duration of response was not yet reached (95% CI: 7.1-not available). The survival rate at 12 months was 58.6% (95% CI: 45-77) and the median overall survival was 15 months (95% CI: 11.4 – not available).

In addition, Innate performed an exploratory subgroup analyses (n=40) according to Combined Positive Score (CPS), which is a PD-L1 scoring method that helps predict response to anti-PD-(L)1 therapy. In this analysis, CPS>1 (n = 25), the subset that had the greatest number of patients, showed a 40% overall response rate (95% CI: 23-59) and median overall survival of 17.3 months (95% CI: 14.7-NA). There were 5 patients with CPS<1, and CPS was unavailable for 10 patients.

The safety of this chemotherapy free regimen was acceptable with a low rate of discontinuation.

Presentation Details

The oral presentation (#123MO) entitled, "Monalizumab, cetuximab and durvalumab in first-line treatment of recurrent or metastatic squamous cell carcinoma of the head and neck (R/M SCCHN): a phase 2 trial," will be presented from 12:15-12:20 pm CET today.
About Monalizumab:

Monalizumab is a potentially first-in-class immune checkpoint inhibitor targeting NKG2A receptors expressed on tumor infiltrating cytotoxic CD8+ T cells and NK cells.

NKG2A is an inhibitory checkpoint receptor for HLA-E. By expressing HLA-E, cancer cells can protect themselves from killing by NKG2A+ immune cells. HLA-E is frequently overexpressed in the cancer cells of many solid tumors and hematological malignancies. Monalizumab may reestablish a broad anti-tumor response mediated by NK and T cells, and may enhance the cytotoxic potential of other therapeutic antibodies.

AstraZeneca obtained full oncology rights to monalizumab in October 2018 through a co-development and commercialization agreement initiated in 2015. The ongoing development for monalizumab is focused on investigating monalizumab in various combination strategies in different malignancies.

On December 9, 2021 HiberCell, a clinical-stage biotechnology company developing therapeutics to address therapeutic resistance, cancer relapse and metastasis, reported that it will deliver a virtual presentation on the clinical applications of our odetiglucan (Imprime PGG) therapy for patients with metastatic and late-stage cancer at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Virtual Congress 2021, December 8-11, 2021 (Press release, HiberCell, DEC 9, 2021, View Source;utm_medium=rss&utm_campaign=hibercell-to-present-clinical-applications-of-odetiglucan-and-the-role-of-beta-glucan-in-cancer-treatment-at-esmo-immuno-oncology-virtual-congress-2021 [SID1234596646]).

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This 20-minute presentation will focus on the broad applicability of odetigulcan in combination with different therapeutic agents and across multiple cancers.

Title: Beta-glucan in cancer treatment
Presenter: Nandita Bose, Ph.D., Senior Vice President of Clinical and Translational Medicine, HiberCell
Session: Trained Immunity Educational Session
Time/Date: Saturday, December 11, 2021: 10:00 – 10:20 am CT
Odetiglucan is a Dectin-1, pattern recognition receptor agonist that is currently in a phase 2 clinical trial in combination with pembrolizumab, an anti-programmed death receptor-1 (PD-1) used in cancer immunotherapy, for the treatment of metastatic, hormone-refractory breast cancer patients. The World Health Organization assigned "odetiglucan" as the International Nonproprietary Name (INN) for Imprime PGG as of November 2021.

For more information about HiberCell’s clinical trials, visit the website at www.HiberCell.com.

On December 8, 2021 Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery, development and commercialization of targeted drugs for the treatment of cancer, reported a poster presentation featuring data from the company’s ongoing Phase 2 CLOVER-1 study of iopofosine I-131 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition being held virtually December 11-14, 2021 (Press release, Cellectar Biosciences, DEC 8, 2021, View Source [SID1234597073]).

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The poster will highlight data from eleven multiple myeloma patients who were at least triple class refractory (immunomodulatory agent, proteasome inhibitor and monoclonal antibody) that were treated with iopofosine I-131 in the company’s Phase 2 CLOVER-1 study, with data current as of the end of May 2021.

Details for the poster presentation are as follows:

Title: CLR 131 (Iopofosine I-131) Treatment in Triple Class Refractory and Beyond Multiple Myeloma Patients: Preliminary Efficacy and Safety Results from the Phase 2 CLOVER-1 Trial
Session/Title: 653/Myeloma and Plasma Cell Dyscrasias: Clinical-Prospective Therapeutic Trials: Poster I
Abstract: 1652
Authors: Sikander Ailawadhi; Patrick Stiff; Emad Ibrahim; Damian J. Green; Brea Lipe; Elizabeth H. Cull; Natalie S. Callander; John Friend; Jarrod Longcor, and Kate Oliver
Date/Time: Saturday, December 11, 2021 at 5:30 pm – 7:30 pm

A copy of the poster will be available after the presentation on the News and Events section of the company’s website.

About iopofosine (also known as CLR 131)

Iopofosine is a small-molecule Phospholipid Drug Conjugate designed to provide targeted delivery of iodine-131 (radioisotope) directly to cancer cells, while limiting exposure to healthy cells. We believe this profile differentiates iopofosine from many traditional on-market treatments. Iopofosine is currently being evaluated in the CLOVER-WaM Phase 2 pivotal study in patients with relapsed/refractory (r/r) Waldenstrom’s macroglobulinemia (WM), a Phase 2b study in r/r multiple myeloma (MM) patients and the CLOVER-2 Phase 1 study for a variety of pediatric cancers. The U.S. Food and Drug Administration granted iopofosine Fast Track Designation for WM patients having received two or more prior treatment regimens, as well as r/r MM and r/r diffuse large B-cell lymphoma (DLBCL). Orphan Drug Designations (ODDs) have been granted for WM, MM, neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. Iopofosine was also granted Rare Pediatric Disease Designation (RPDD) for the treatment of neuroblastoma, rhabdomyosarcoma, Ewing’s sarcoma and osteosarcoma. The European Commission granted an ODDs for r/r MM and WM.