On May 18, 2022 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology, reported its participation at Preclinical Immuno-oncology Online 2022 (Press release, Kineta, MAY 18, 2022, View Source;utm_medium=rss&utm_campaign=kineta-presenting-in-multiple-sessions-at-the-preclinical-immuno-oncology-online-2022 [SID1234614802]). Thierry Guillaudeux, PhD, EVP Research and Development at Kineta, will make a presentation on "Human Knock-In Mice For Selecting Next Generation Immune Checkpoint Inhibitors" and participate in a panel discussion on "The Future of In Vivo Models" at the virtual symposium to be held on May 18, 2022.

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As part of his presentation, Dr Guillaudeux will discuss key technology and advantages of Kineta’s proprietary PiiONEER platform. The company’s immuno-oncology platform was designed for the discovery and development of first or best-in-class immunotherapies that address the major challenges with cancer resistance to current therapies. Kineta has developed novel, innate immuno-oncology antibody therapeutics targeting VISTA and CD27.

"I am thrilled to participate in this symposium and discuss Kineta’s immuno-oncology focused PiiONEER platform", said Dr. Guillaudeux. "Kineta’s specialized in vivo preclinical models are used to characterize a therapeutic antibody’s anti-cancer efficacy, pharmacokinetics, receptor occupancy and biomarkers and are key development technologies in our innovative platform"

Kineta has developed monoclonal antibody programs targeting VISTA and CD27 through the PiiONEER platform. KVA12.1 is a potential best-in-class VISTA blocking immunotherapy. It is a fully human engineered IgG1 monoclonal antibody that was designed to bind to VISTA through a unique epitope. In preclinical models, KVA12.1 demonstrates strong single agent efficacy in cold tumors and complementary efficacy when dosed in combination with other checkpoint inhibitors (CPI’s). It is well-tolerated with no change IL6 and TNFα levels responsible for cytokine release syndrome (CRS) in preclinical toxicology studies. KVA12.1 is being developed as an intravenous infusion for patients with advanced solid tumors. Kineta plans to initiate Phase 1 clinical studies in Q4 2022. Kineta is also developing an anti-CD27 agonist monoclonal antibody for patients with solid and hematologic tumors. Kineta is in the final stage of lead selection and plans to nominate a clinical candidate in Q2 2022.

Preclinical Immuno-oncology Online 2022 is a virtual conference that assembles a wide range of senior leaders from leading healthcare, biotech, pharma and research institutions. The conference delves into the challenges and opportunities in innovative approaches to preclinical drug development with a goal to achieve translational success.

On May 18, 2022 Fortress Biotech, Inc. (NASDAQ: FBIO) ("Fortress"), an innovative biopharmaceutical company focused on efficiently acquiring, developing and commercializing or monetizing promising therapeutic products and product candidates, reported that Lindsay A. Rosenwald, M.D., Chairman, President and Chief Executive Officer, will participate in two investor conferences in May 2022 (Press release, Fortress Biotech, MAY 18, 2022, View Source [SID1234614818]).

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Details of the events are as follows:

H.C. Wainwright Global Investment Conference: The company will present on Tuesday, May 24, 2022, at 9:30 a.m. ET and will participate in one-on-one meetings during the conference. A webcast of the presentation will be available on the Events page under the News & Media section of Fortress’ website: www.fortressbiotech.com for approximately 30 days following the meeting.
B. Riley Securities 22nd Annual Institutional Investor Conference: The company will participate in a fireside chat on Thursday, May 26, 2022, at 10:10 a.m. PT and will participate in one-on-one meetings during the conference.

On May 18, 2022 Cytovia Therapeutics, LLC ("Cytovia Therapeutics"), a global biotechnology company focused on harnessing the power of natural killer (NK) cells to fight cancer through multispecific antibodies and stem cell engineering, reported that it will be presenting at the the Annual European Hematology Association (EHA) (Free EHA Whitepaper)’s (EHA) (Free EHA Whitepaper) 2022 Hybrid Congress, taking place June 9 – 12, 2022 at the Messe Wien Exhibition and Congress Center in Vienna, Austria, and online (Press release, Cytovia Therapeutics, MAY 18, 2022, View Source [SID1234614834]).

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The abstract was released on May 12, 2022. The e-poster presentation will be published on the virtual congress platform on Friday, June 10.

Details of Cytovia’s poster presentation:
Title: NOVEL MULTIFUNCTIONAL TETRAVALENT CD38 NKP46 FLEX-NK ENGAGERS ACTIVELY TARGET AND KILL MULTIPLE MYELOMA CELLS
Session Title: Poster session
Session date and time: Friday, June 10, 2022 – 16:30 – 17:45 CEST
Final Abstract Code: P842
Presenting Author: Jean Christophe Bories
Summary: CYT-338 is a tetravalent IgG1-like multifunctional NK cell engager antibody with a novel FLEX-linker that simultaneously binds CD38-expressing cells and NK cells via the activation receptor NKp46. The in vitro and in vivo activity of CYT-338 was studied in myeloma models. CYT-338 showed specific dose-dependent binding to CD38 expressing MM cells with ~ 2-fold higher mean fluorescence intensity than daratumumab. Epitope mapping studies suggest binding of CYT-338 to a CD38 epitope distinct from daratumumab. CYT-338 showed greater dose dependent NK cell redirected cytolysis, degranulation, and cytokine production against MM1S cells compared to daratumumab. CYT-338 combined with peripheral blood NK cells inhibited tumor growth in a MM1S-NSG mouse model. CYT-338 showed minimal immune subset depletion, NK cell fratricide, and cytokine release compared to daratumumab in human PBMCs in-vitro. These results suggest that the CYT-338 engager has a favorable NK cell engager profile for targeting CD38-expressing multiple myeloma distinct from daratumumab.

On May 18, 2022 LabCorp reported that Finding treatment options for skin cancer may become easier with the launch of a new test by Labcorp (NYSE: LH), a leading global life sciences company (Press release, LabCorp, MAY 18, 2022, View Source [SID1234614803]). The new test measures Lymphocyte-activation gene 3 (LAG-3) expression levels by immunohistochemistry (IHC) in tumor tissue. LAG-3 is an immune-oncology target with demonstrable clinical benefit in patients with melanoma. The test is available for use in both clinical trials and for the care and treatment of patients.

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"Our goal is to provide diagnostic solutions that can help guide the clinical application of new cancer treatments, improving the lives of those living with cancer," Prasanth Reddy, M.D., MPH, senior vice president and oncology head at Labcorp. "The LAG-3 IHC assay provides physicians with actionable information to evaluate the best treatment options, including newly approved treatments and clinical trials, for their patients."

The LAG-3 IHC assay was developed by Labcorp Drug Development for use in a clinical trial studying dual checkpoint inhibitors that included a LAG-3 immunotherapy. As is published in the Journal of Clinical Pathology, this assay will enable the analysis of LAG-3 status in the tumor and the correlation between expression status and response to LAG-3 immunotherapy. This assay is also being used in other ongoing clinical trials evaluating clinical response to LAG-3-directed cancer treatments.

According to the National Cancer Institute, skin cancer is the most common form of cancer in the United States. While melanoma is one of the rarer types, it poses a greater risk of spreading to other parts of the body. One of the first signs of melanoma is a change to the appearance of an existing mole. Anyone noticing a new mole or changes to existing moles should speak to health care provider. A tissue biopsy is the only way to diagnose melanoma and can be performed in most health care settings.

The development of the LAG-3 IHC assay coupled with its availability for clinical use, demonstrates Labcorp’s unique leading capabilities in diagnostic testing and comprehensive drug development services. By delivering targeted biomarker solutions to power better decisions by clinicians, Labcorp is helping to improve patient outcomes.

On May 18, 2022 Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, reported that it has received the first "Therapeutic Accelerator Award" from the Pancreatic Cancer Network (PanCAN) (Press release, Verastem, MAY 18, 2022, View Source [SID1234614819]). The Award will support a Phase 1b/2 clinical trial of the Company’s lead investigational candidates, RAF/MEK Clamp, VS-6766, with FAK inhibitor, defactinib, to evaluate whether a more complete blockade of KRAS signaling, which is mutated in more than 95% of pancreatic cancer tumors, will improve outcomes for patients with front-line metastatic pancreatic cancer.

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"The goal of the Therapeutic Accelerator Award is ultimately to develop new drugs for patients with metastatic pancreatic cancer faster and more efficiently than standard clinical trials," said Julie Fleshman, president and CEO of PanCAN. "We are delighted that Verastem, with rigorous scientific and clinical evidence for addressing this critical pathway, will be the inaugural awardee for this grant. We are looking forward to partnering with them to determine whether their investigational treatment combination will be beneficial to patients."

"We are honored to have been selected for this important award that will expand our development program for VS-6766 and defactinib to evaluate the combination in patients with metastatic pancreatic cancer," said Louis Denis, Chief Medical Officer at Verastem Oncology. "We look forward to a strong collaboration with PanCAN and applaud its commitment to bring patients, academia and industry together to advance the science and accelerate development of much needed novel treatment options for patients."

PanCAN created the Therapeutic Accelerator Award as part of its innovative approach to pancreatic cancer research. This includes grants for scientists across the country as well as large-scale research initiatives such as PanCAN’s Precision PromiseSM Clinical Trial, which seeks to accelerate the approval of new treatment options for pancreatic cancer patients and PanCAN’s Early Detection Initiative, with a goal of developing a strategy to diagnose pancreatic cancer early when surgery is still possible.

Verastem Oncology was selected to receive the 2022 PanCAN Therapeutic Accelerator Award of $3.8M through a rigorous, competitive process involving scientific, business and programmatic review from leading experts in the field.

KRAS is mutated in more than 95% of pancreatic cancers and Verastem Oncology’s RAF/MEK clamp VS-6766 blocks tumorigenic signaling downstream of mutant KRAS. Verastem’s selective FAK inhibitor, defactinib, is included in the trial as FAK has been identified preclinically and clinically as a potential resistance mechanism to RAF and MEK inhibition. FAK inhibition has been shown to reduce stromal density in pancreatic cancer both preclinically and clinically which may enhance anti-tumor immunity and efficacy of the standard gemcitabine/nab-paclitaxel regimen.

About the Pancreatic Cancer Action Network

The Pancreatic Cancer Action Network (PanCAN) leads the way in accelerating critical progress for pancreatic cancer patients. PanCAN takes bold action by funding life-saving research, providing personalized patient services and creating a community of supporters and volunteers who will stop at nothing to create a world in which all pancreatic cancer patients will thrive.

About VS-6766

VS-6766 (formerly known as CH5126766 and RO5126766) is a RAF/MEK clamp that induces inactive complexes of MEK with ARAF, BRAF and CRAF potentially creating a more complete and durable anti-tumor response through maximal RAS pathway inhibition. VS-6766 is currently in late-stage development.

In contrast to other MEK inhibitors, VS-6766 blocks both MEK kinase activity and the ability of RAF to phosphorylate MEK. This unique mechanism allows VS-6766 to block MEK signaling without the compensatory activation of MEK that appears to limit the efficacy of other inhibitors. The U.S. Food and Drug Administration granted Breakthrough Therapy designation for the combination of Verastem Oncology’s investigational RAF/MEK inhibitor VS-6766, with defactinib, its FAK inhibitor, for the treatment of all patients with recurrent low-grade serous ovarian cancer (LGSOC) regardless of KRAS status after one or more prior lines of therapy, including platinum-based chemotherapy.

Verastem Oncology is conducting Phase 2 registration-directed trials of VS-6766 alone and with defactinib in patients with recurrent LGSOC and in patients with recurrent KRAS G12V-mutant NSCLC as part of its RAMP (Raf And Mek Program) clinical trials, RAMP 201 and RAMP 202, respectively. Verastem Oncology has also established clinical collaborations with Amgen and Mirati to evaluate LUMAKRAS (sotorasib) and adagrasib in combination with VS-6766 in KRAS G12C-mutant NSCLC as part of the RAMP 203 and RAMP 204 trials, respectively.