On April 12, 2023 Byondis B.V., an independent, clinical-stage Dutch biopharmaceutical company creating precision medicines, reported that Molecular Cancer Therapeutics (an American Association for Cancer Research (AACR) (Free AACR Whitepaper) journal) has published encouraging preclinical data on its investigational, next generation antibody-drug conjugate (ADC) BYON3521 (Press release, Byondis, APR 12, 2023, View Source [SID1234630018]).

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The article, "Preclinical profile of BYON3521 predicts an effective and safe c-MET-antibody-drug conjugate," suggests that BYON3521 has an encouraging safety/efficacy window with potential for clinical benefit in patients. A First-in-Human dose escalation study is currently ongoing to determine the maximum tolerated dose and recommended dose for expansion (NCT05323045). The study is enrolling patients in leading oncology centers in Belgium, Italy, the Netherlands and the United Kingdom.

The data from in vitro and in vivo studies showed that BYON3521 potently and selectively kills tumor cells expressing c-MET, even at low c-MET-expressing levels. In addition, the nonclinical safety evaluation showed that BYON3521 is well tolerated, predicting a substantial clinical therapeutic window.

"The c-MET/HGF pathway is one of the most dysregulated pathways in human solid tumors and is generally associated with a poor prognosis," said Byondis Chief Scientific Officer Wim Dokter, Ph.D. "Being able to use that pathway to deliver clinical benefit to patients will therefore be extra rewarding."

c-MET (also called tyrosine-protein kinase MET [Mesenchymal Epithelial Transition] factor or HGFR [Hepatocyte Growth Factor Receptor]) is a receptor expressed on the surface of epithelial cells of many different organs. Binding of the growth factor HGF to c-MET leads to normal cell division, growth and differentiation, important in the generation of new tissue, e.g., during the development of a fetus, or during growth or wound repair.

But in many tumor cells, c-MET activation is dysregulated: too much c-MET is expressed, c-MET is mutated or c-MET is active even without the binding of HGF. c-MET is overexpressed in a variety of solid tumors, such as renal cell cancer, uveal (ocular) melanoma, non-small cell lung cancer and head and neck squamous cell cancer.

BYON3521, a Next Generation Antibody-Drug Conjugate

BYON3521 is comprised of the humanized IgG1 c-MET-targeting monoclonal antibody, SYD2884, and a cleavable linker-drug called valine-citrulline-seco-DUocarmycin-hydroxyBenzamide-Azaindole (vc-seco-DUBA or SYD980). The antibody part of BYON3521 binds to c-MET on the surface of the cancer cell and the ADC is internalized. After proteolytic cleavage of the linker in the lysosome, the inactivated cytotoxin is activated, binds to the DNA and DNA damage is induced, eventually resulting in tumor cell death. BYON3521 is considered a form of targeted chemotherapy.

Byondis’ Distinctive, Proprietary Linker-Drug and Site-Specific Conjugation Technology

BYON3521 incorporates Byondis’ distinctive, proprietary duocarmazine linker-drug (LD) technology ByonZine and its site-specific conjugation technology ByonShieLD. The characteristic design of the selectively cleavable linker connecting the antibody to the duocarmycin drug leads to high stability in circulation and induces efficient release of the cytotoxin in the tumor. Uptake of the activated payload by neighboring tumor cells with lower or no c-MET expression may improve the efficacy potential through the so-called bystander effect.

On April 12, 2023 Geneos Therapeutics, a clinical stage biotherapeutics company focused on the development of personalized therapeutic cancer vaccines (PTCV), reported that it has secured $5 million in its Series A3 round (Press release, Geneos Therapeutics, APR 12, 2023, View Source [SID1234630017]). This financing adds 3B Future Health Fund (3B FHF) to Geneos’ investor syndicate. Further, Dr. Roberto DePonti, managing director and general partner of 3B FHF, joins Geneos as a board observer, adding decades of pharmaceutical drug development experience to the company.

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Proceeds Will Fund Expansion of Phase 1b/2a GT-30 Program
GT-30 is evaluating safety, immunogenicity, and efficacy of PTCV (GNOS-PV02 plus plasmid-encoded IL-12) administered in combination with the immune checkpoint inhibitor pembrolizumab, in patients with unresectable or metastatic hepatocellular carcinoma (HCC) who progress on, or are intolerant to, first line tyrosine kinase inhibitors (sorafenib or lenvatinib). The company previously reported data from the first 24 patients enrolled showing strong tumor reductions including three complete responses (complete disappearance of tumor), and four patients with a partial response. Based on these encouraging results, the study enrollment was expanded to 36 patients. Geneos plans to report the efficacy and durability of response data from the full cohort of 36 patients in 2023.

"We are excited to contribute to the development of Geneos’ advanced approach to treat, patients with HCC as well as multiple additional types of cancer in the future," stated Riccardo Braglia, general partner of 3B Future Health Fund II. "We are encouraged by the very promising results in the current clinical trial and look forward to working closely with the talented Geneos team."

"We are delighted to welcome Roberto and 3B FHF into our investor syndicate. We look forward to working with 3B FHF and their strong worldwide pharmaceutical development expertise and broad network in advancing our novel personalized therapeutic cancer vaccines," stated Niranjan Sardesai, PhD., president and chief executive officer of Geneos Therapeutics.

On April 12, 2023 Navrogen, Inc., a biopharmaceutical company specialized in developing therapies for cancer and immune-related disorders, reported that it will be presenting new preclinical data on its NAV-001 antibody-drug conjugate (ADC) and NAV-003 bispecific programs at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Conference in Orlando, Florida on April 17 and 18 (Press release, Navrogen, APR 12, 2023, View Source [SID1234630016]).

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NAV-001 and NAV-003 both target mesothelin, a cell surface protein over-expressed on various malignancies, including breast, colon, lung and mesothelioma cancers. Certain ADCs and therapeutic antibodies targeting mesothelin are negatively affected by Humoral Immuno-Oncology (HIO) factors that are produced in the tumor microenvironment. These HIO factors are able to directly bind to affected antibody-based agents and suppress their immune-effector activities as well as suppress target cell internalization, thereby lowering their therapeutic efficacy. To overcome this mechanism of suppression, Navrogen has employed its proprietary HIO factor screening and block-removed immunoglobulin technology (BRITE) platforms to engineer HIO refractory mesothelin-targeting agents. NAV-001 and NAV-003 both have the BRITE feature integrated to avoid suppression by HIO factors, while NAV-001 contains a novel highly toxic payload, and NAV-003 is configured to have an optimized anti-CD3/anti-MSLN bispecific format to elicit robust CD3-redirected T-cell mediated cytotoxicity. These drug candidates have demonstrated significant in vivo efficacy across a wide array of mesothelin-positive cancer models.

"We look forward to sharing scientific data around our programs and technology platforms with the AACR (Free AACR Whitepaper) community", said Dr. Luigi Grasso, Navrogen’s Chief Scientific Officer. "Based on the efficacy and preliminary safety data, we are advancing our NAV-001 and NAV-003 programs forward for clinical testing in HIO suppressed cancers identified by diagnostic screens of various cancer types".

On April 12, 2023 Reaction Biology ("Reaction" or the "Company"), an industry- leading provider of drug discovery and development services, reported that eleven abstracts highlighting data from the Company’s expanding suite of research offerings will be presented at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2023, held April 14-19, 2023, in Orlando, Florida (Press release, REACTION BIOLOGY, APR 12, 2023, View Source [SID1234630015]).

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"The immuno-oncology landscape has undergone profound and encouraging progress in recent years and there is a growing demand for large molecule services in the search for new treatment options for patients with difficult-to-treat cancers," said Haiching Ma, Ph.D., Chief Scientific Officer of Reaction Biology. "At AACR (Free AACR Whitepaper) 2023, we look forward to showcasing data from our expansive suite of in vitro assays and in vivo tumor models that can provide our customers with solutions to help accelerate the identification and validation of important new drug candidates."

New data will be presented on the Company’s innovative assay technologies, preclinical profiling models and proprietary screening platforms. The full range of data presented at AACR (Free AACR Whitepaper) include:

Humanized MOLM-13 AML model as a versatile tool to study immune-activating agents (Sunday, April 16, 2023, 1:30 – 5:00 PM; Poster Section 2, Poster Board Number: 1, Permanent Abstract Number: 33)

Exploiting macrophage differentiation and plasticity as an immunomodulating strategy (Sunday, April 16, 2023, 1:30 – 5:00 PM; Poster Section 23, Poster Board Number: 11, Permanent Abstract Number: 671)

Characterization of the selective inhibitory effect of KRas inhibitors in different cellular assay formats (Sunday, April 16, 2023, 1:30 – 5:00 PM; Poster Section 19, Poster Board Number: 16, Permanent Abstract Number: 549)

Application of NanoBRET target engagement cellular assay for development of inhibitors against protein kinases, RAS, and epigenetic proteins in cancer therapy (Monday, April 17, 2023, 1:30 – 5:00 PM; Poster Section 17, Poster Board Number: 18, Permanent Abstract Number: 2764)

Assay toolkit for the discovery of new RAS pathway inhibitors (Monday, April 17, 2023, 1:30 – 5:00 PM; Poster Section 11, Poster Board Number: 8, Permanent Abstract Number: 2624)

Immunophenotyping of responses to immunotherapy in syngeneic tumor models using multiplex immunofluorescence compared to multiparametric flow cytometry (Tuesday, April 18, 2023, 9:00 AM – 12:30 PM; Poster Section 25, Poster Board Number: 10, Permanent Abstract Number: 4148)

Use of luciferase-labeled target cells to explore immune cell killing in high throughput format in 2D and 3D co-cultures (Tuesday, April 18, 2023, 9:00 AM – 12:30 PM; Poster Section 40, Poster Board Number: 5, Permanent Abstract Number: 4419)

Humanized PD-1 knock-in mice as a model system for combination therapies with human specific PD-1 therapeutics (Tuesday, April 18, 2023, 12:30 – 5:00 PM; Poster Section 25, Poster Board Number: 7, Permanent Abstract Number: 5194)

Introduction of a platform for preclinical profiling of drug conjugates: a case study with sacituzumab govitecan (Tuesday, April 18, 2023, 1:30 – 5:00 PM; Poster Section 14, Poster Board Number: 6, Permanent Abstract Number: 4895)

Cell-based assay to support development and characterization of new drugs in immuno-oncology (Wednesday, April 19, 2023, 9:00 AM – 12:30 PM; Poster Section 38, Poster Board Number: 22, Permanent Abstract Number: 6650)
Identification of CDK15 activating cyclins by a recombinant co-expression approach (Wednesday, April 19, 2023, 9:00 AM – 12:30 PM; Poster Section 9, Poster Board Number: 9, Permanent Abstract Number: 5980)

"Over the past year, we have made significant investments in talent, infrastructure and resources to expand our preclinical oncology and immuno-oncology drug discovery and development services," said John H. Johnson, Chief Executive Officer of Reaction Biology. "We maintain one of the broadest collections of syngeneic tumor models, and largest target panels and assays for kinase, Kras and epigenetics, in addition to well-characterized tumor cell lines and highly qualified technicians using our state-of-the-art laboratories. Our efforts to deliver high integrity data with passionate customer service to help biopharmaceutical companies discover and develop innovative medicines more effectively underscores why we continue to be a preferred global partner of choice."

Copies of the poster presentations will be available at Reaction Biology’s booth (#1527) during exhibit hall hours from April 14 – 19.

On April 12, 2023 ViewRay, Inc. (NASDAQ: VRAY) reported it will hold a conference call to discuss results on Thursday, April 13, 2023, at 8:00 AM ET (Press release, ViewRay, APR 12, 2023, View Source [SID1234630014]). The dial-in number for domestic callers is (888) 886-7786. The confirmation number is 56031524. A live webcast of the conference call will be available on the investor relations page of ViewRay’s corporate website at View Source

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After the live webcast, a replay will remain available online on the investor relations page of ViewRay’s website under "Events and Webinars".