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".

On April 12, 2023 Pacira BioSciences, Inc. (NASDAQ: PCRX) reported that it will participate in an analyst-led fireside chat at the 22nd Annual Needham Virtual Healthcare Conference at 10:15 AM ET on Wednesday, April 19, 2023 (Press release, Pacira Pharmaceuticals, APR 12, 2023, View Source [SID1234630013]). Live audio of the virtual event can be accessed by visiting the "Events" page of the company’s website at investor.pacira.com. A replay of the webcast will also be available for two weeks following the event.

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On April 12, 2023 Fusion Pharmaceuticals Inc. (Nasdaq: FUSN), a clinical-stage oncology company focused on developing next-generation radiopharmaceuticals as precision medicines, reported the clearance of investigational new drug (IND) applications for [225Ac]-FPI-2068 (FPI-2068) and corresponding imaging analogue [111In]-FPI-2107 (FPI-2107) to the U.S. Food and Drug Administration (FDA) (Press release, Fusion Pharmaceuticals, APR 12, 2023, View Source,-a-Jointly-Developed-Novel-Targeted-Alpha-Therapy [SID1234630012]). Fusion is jointly developing FPI-2068 with AstraZeneca (LSE/STO/Nasdaq: AZN) under the companies’ multi-asset collaboration agreement.

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FPI-2068 is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are both validated targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma.

"The IND filing for FPI-2068 is an important milestone for Fusion as we advance this novel TAT, created by combining our radiopharmaceutical expertise, actinium supply and manufacturing infrastructure with AstraZeneca’s bispecific antibody which preferentially binds to cancer cells that express both EGFR and cMET," said Fusion Pharmaceuticals Chief Executive Officer John Valliant, Ph.D. "FPI-2068, which we believe will be the first TAT for two validated targets to enter the clinic, was designed to provide enhanced tumor specificity resulting from the co-expression of the two targets when compared to individual monoclonal antibodies against each of these targets. We are excited about the innovative work with AstraZeneca as we advance this and other programs under our broad collaboration agreement."

Fusion’s radiopharmaceuticals are a type of precision medicine whereby the cancer-targeted vector (e.g., the bispecific antibody) can be used to screen patients for expression of a tumor biomarker when combined with a corresponding imaging isotope (e.g., indium-111), and subsequently used for therapy when combined with the alpha-emitting radionuclide, actinium-225. Using imaging to identify patients who show uptake of the drug in tumors increases the likelihood of response to therapy. Fusion plans to provide additional guidance on timelines for the FPI-2068 program following initial experience with patient screening in order to better predict the cadence of patient enrollment.

FPI-2068 will be the first program to enter clinical development under the Company’s previously announced collaboration agreement with AstraZeneca, which includes joint discovery, development and the option to co-commercialize novel TATs leveraging Fusion’s proprietary Fast-Clear linker technology platform with antibodies from AstraZeneca’s oncology portfolio, as well as exploration of potential combination strategies involving existing assets in their respective portfolios. Fusion will be operationally responsible for the Phase 1 study, while AstraZeneca will be responsible for subsequent clinical development. The companies will share costs equally through clinical development.

About FPI-2068

[225Ac]-FPI-2068 (FPI-2068) is a targeted alpha therapy (TAT) designed to deliver actinium-225 to various solid tumors that express EGFR and cMET. EGFR and cMET are validated cancer targets that are co-expressed in multiple tumor types, including head and neck squamous cell carcinoma, non-small cell lung cancer, colorectal cancer, and pancreatic ductal adenocarcinoma. FPI-2068 will be evaluated in a Phase 1 study.