On December 9, 2021 Alloy Therapeutics, a biotechnology ecosystem company, reported it has acquired deepCDR Biologics, a Basel, Switzerland-based developer of deep learning technology for antibody discovery and optimization (Press release, Alloy Therapeutics, DEC 9, 2021, View Source [SID1234596652]). The team and technology stack will form new bioinformatics and machine learning (ML) capabilities for Alloy and will be fully integrated into Alloy Discovery Services complementary workflow and processes. Alloy will expand the Basel deepCDR site as a permanent Alloy research facility and will hire additional computational scientists and developers as it grows with the Alloy network.

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The deepCDR engine combines deep sequencing and deep learning methods with a proprietary mammalian display process to select from a wide range of antibodies and rapidly identify candidates with the highest possible affinity and developability profiles. The company was a spinoff of ETH Zurich and Department of Biosystems Science and Engineering and was founded by Sai Reddy, an Associate Professor of Systems and Synthetic Immunology at ETH Zurich and an expert in immunogenomics and machine learning-guided protein engineering.

"Uniting deepCDR and Alloy reflects our conviction in the power of network effects and scientific collaboration—together our companies’ capabilities are amplified to better serve the global scientific community in its pursuit of finding the best medicines for patients," said Alloy Therapeutics CEO and Founder Errik Anderson. "Our network of partners will be able to work with deepCDR’s machine learning engine in a way that otherwise would have been cost prohibitive or inaccessible. The ongoing technology improvements will enhance the output of Alloy platforms and Alloy Discovery Services for the benefit of all of our drug discovery partners."

DeepCDR’s technology will strengthen Alloy Discovery Services capabilities with patent-pending machine learning-powered antibody repertoire screening, in silico library screening, and mammalian display. DeepCDR thoughtfully integrates wet lab antibody screening and characterization with the computational tools to enable a powerful learning loop generating real world results. The deepCDR team will form Alloy’s new Basel, Switzerland operations and comprises expertise in antibody engineering and optimization, bioinformatics, and in silico library screening.

"We are thrilled to join Alloy on its mission of empowering scientific entrepreneurs and democratizing foundational drug discovery capabilities," said deepCDR founder Sai Reddy. "The data sets and infrastructure within Alloy unlock powerful new opportunities for the deepCDR technology and team that will in turn enable us to help drug discovery teams more effectively and efficiently find the best antibody candidates. We envision a future where Alloy will be a leader in unifying real-world patient, genomic, and protein sequence data to empower integrated AI and ML drug discovery and engineering."

On December 9, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer reported that it will host today a financial community call to discuss recent findings from the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center investigating the treatment of CD30-positive lymphoma patients with its innate cell engager (ICE) AFM13, pre-complexed with cord blood-derived natural killer (cbNK) cells (AFM13-104) (Press release, Affimed, DEC 9, 2021, View Source [SID1234596651]).

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A treatment cycle consists of lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed two days later by a single infusion of cytokine-preactivated and expanded cbNK cells that are pre-complexed with AFM13, followed by three weekly infusions of AFM13 (200 mg) monotherapy. Responses are assessed on day 28 by FDG-PET and patients can receive up to two cycles. Three patients were treated with 1×106, three patients with 1×107 and 13 patients with 1×108 AFM13-pre-complexed cbNK cells per kg body weight.

Response Assessment

A total of 19 patients with CD30-positive relapsed or refractory Hodgkin and non-Hodgkin lymphomas (17 and 2 patients, respectively) have been treated to date across three dose cohorts. According to investigator assessment, 17 of 19 patients had achieved an objective response (ORR 89.5%) to the treatment, with seven complete responses (CR 36.8%) and ten partial responses (PR 52.6%).

In patients treated at the RP2D level of 1×108 cbNK cells per kg, 12 of 13 had classical Hodgkin lymphoma and 1 patient had CD30-positive NHL. In this cohort, 100% of patients responded after the first cycle of treatment with five CRs (38.5%) and seven PRs (61.5%). All patients treated at the RP2D have now received a second cycle of therapy. Response evaluation after cycle 2 will be reported at a future scientific conference.

Initial Durability of Response Observations

Nine patients treated in the dose escalation phase of the study had follow-up at 6 months. Of note, the three patients treated at the RP2D remain in remission at 6 months after start of treatment, two without additional treatment and one on anti-PD-1 antibody maintenance.

In the four responders out of six treated at the two lower dose levels, one patient, who started treatment in September 2020, remains in remission after consolidation autologous stem cell transplant, and three relapsed at 3.4, 4.8 and 6.3 months after start of therapy.

Safety

Five reported cases of transient infusion related reactions were reported after the monotherapy infusions of AFM13. Of note, there were no instances of serious adverse events such as cytokine release syndrome, immune cell-associated neurotoxicity syndrome or graft-versus-host disease.

Conference Call/Webcast Information

The event today will include a review of Affimed’s approach to activating the innate immune system in the fight against cancer, preclinical data supporting the combination of Affimed’s ICE molecules with adoptive NK cell transfer, a review of the treatment challenges and clinical opportunities for CD30+ lymphomas, and review of the interim data from AFM13-104 by the study’s principal investigator, Yago L. Nieto, M.D., Ph.D., professor of Stem Cell Transplantation and Cellular Therapy at of The University of Texas MD Anderson Cancer Center.

Affimed will host a conference call and webcast today, December 9th, 2021, at 8:30 a.m. EST. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 3065475 approximately 15 minutes prior to the call.

A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source or View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

About the Phase 1-2 Study

The University of Texas MD Anderson Cancer Center is studying AFM13 in an investigator-initiated phase 1-2 trial in combination with cord blood-derived allogeneic NK cells in patients with recurrent or refractory CD30-positive lymphomas. The first phase of this study involves dose escalation of pre-complexed NK cells, with patients receiving lymphodepleting chemotherapy followed by 1×106 NK cells/kg in Cohort 1; 1×107 NK cells/kg in Cohort 2; and 1×108 NK cells/kg in Cohort 3. The trial is designed to explore safety and to determine the recommended phase 2 dose and evaluate its activity. The recommended phase 2 dose was determined as 1×108 NK cells/kg. In each cohort, the dose of the pre-complexed NK cells with AFM13 is followed by weekly doses of 200 mg AFM13 monotherapy for three weeks, with each patient evaluated for dose-limiting toxicities and responses on day 28. MD Anderson has an institutional financial conflict of interest with Affimed related to this research and has therefore implemented an Institutional Conflict of Interest Management and Monitoring Plan. Additional information about the study can be found at www.clinicaltrials.gov (NCT04074746).

About AFM13

AFM13 is a first-in-class innate cell engager (ICE) that uniquely activates the innate immune system to destroy CD30-positive hematologic tumors. AFM13 induces specific and selective killing of CD30-positive tumor cells, leveraging the power of the innate immune system by engaging and activating natural killer (NK) cells and macrophages. AFM13 is Affimed’s most advanced ICE clinical program and is currently being evaluated as a monotherapy in a registration-directed trial in patients with relapsed/refractory peripheral T-cell lymphoma or transformed mycosis fungoides (REDIRECT). The study is actively recruiting. Additional details can be found at www.clinicaltrials.gov (NCT04101331).

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.