On June 7, 2021 Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext:IPN; ADR:IPSEY) reported detailed results from the phase 3 COSMIC-311 pivotal trial of cabozantinib (CABOMETYX) in patients with previously treated radioactive iodine-refractory differentiated thyroid cancer (DTC) (Press release, Exelixis, JUN 7, 2021, View Source [SID1234583659]). Results from the trial, which met the co-primary endpoint of significant improvement in progression-free survival (PFS) assessed by blinded independent radiology committee (BIRC), are in press to be published in The Lancet Oncology and have been submitted to the U.S. Food and Drug Administration (FDA). The data are being presented during the Oral Abstract Session: Head and Neck Cancer at 11:45 a.m. PT on Monday, June 7 at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (abstract #6001).

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"Following disease progression on anti-VEGFR therapy, patients with radioactive iodine-refractory differentiated thyroid cancer currently have no standard of care available to them, making the positive results of the COSMIC-311 trial an important clinical advance for this community in need of additional treatment options," said Marcia S. Brose, M.D., Ph.D., Full Professor of Otorhinolaryngology: Head and Neck Surgery and Director of the Center for Rare Cancers and Personalized Therapy at the Abramson Cancer Center of the University of Pennsylvania, and principal investigator of COSMIC-311. "The significant improvement in progression-free survival and favorable trend for overall survival suggest cabozantinib could be an important new option for these patients."

Results from COSMIC-311 served as the basis for the supplemental New Drug Application that Exelixis has submitted to the FDA, seeking an expanded indication for CABOMETYX for patients 12 and older with DTC that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

As previously announced, at a planned interim analysis, cabozantinib demonstrated a significant reduction in the risk of disease progression or death of 78% versus placebo (hazard ratio [HR]: 0.22; 96% confidence interval [CI]: 0.13-0.36; P<0.0001) in the intent-to-treat (ITT) population. At a median follow-up of 6.2 months, median PFS was not reached (96% CI: 5.7 months – not estimable) in patients treated with cabozantinib and was 1.9 months (96% CI: 1.8-3.6 months) for placebo. The data presented at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting demonstrate that HRs for PFS consistently favored cabozantinib over placebo for prespecified subgroups, including age ≤65 vs. >65; prior treatment with lenvatinib (yes vs. no), and number of prior vascular endothelial growth factor receptor (VEGFR)-targeting therapies (1 vs. 2).

The results for the co-primary endpoint of objective response rate in the first 100 randomized patients after six months favored cabozantinib at 15% versus 0% for placebo, although this difference was not statistically significant (P=0.028). In the ITT population, a reduction in target lesion size was found in 76% of patients receiving cabozantinib versus 29% of patients receiving placebo; median overall survival was not reached in either treatment arm but favored cabozantinib (HR: 0.54; 95% CI: 0.27-1.11).

The safety profile was consistent with that previously observed for cabozantinib and adverse events (AEs) were managed with dose modifications. The discontinuation rate due to treatment-emergent AEs was 5% for cabozantinib versus 0% for placebo. The most common (≥5%) all-causality grade 3 or 4 AEs with cabozantinib were palmar-plantar erythrodysesthesia (10%), hypertension (9%), fatigue (8%), diarrhea (7%) and hypocalcemia (7%). There were no treatment-related deaths per investigator.

In February 2021, the U.S. FDA granted Breakthrough Therapy Designation to cabozantinib as a potential treatment for patients with DTC that has progressed following prior therapy and who are radioactive iodine-refractory (if radioactive iodine is appropriate).

"We’re excited to offer a more detailed picture of results from the COSMIC-311 trial following the previous announcements that the trial met its co-primary endpoint of PFS, and that we received Breakthrough Therapy Designation for cabozantinib earlier this year," said Gisela Schwab, M.D., President, Product Development and Medical Affairs and Chief Medical Officer, Exelixis. "The submission of our regulatory application for CABOMETYX to the FDA is an important step toward our goal of addressing an urgent treatment need for this patient community as soon as possible."

"The results from the COSMIC-311 phase 3 trial have been highly anticipated, with the current survival time for people living with this uncommon form of differentiated thyroid cancer at just three to five years from the time metastatic lesions are detected," said Howard Mayer, M.D., Executive Vice President and Head of Research and Development, Ipsen. "We’re delighted to share these data at ASCO (Free ASCO Whitepaper) together with Exelixis, highlighting our continued commitment to exploring the potential of cabozantinib across a range of hard-to-treat cancers. We look forward to working with regulatory authorities in our territories with the aim of bringing a meaningful new treatment option to a patient population in critical need."

About COSMIC-311
COSMIC-311 is a global, multicenter, randomized, double-blind, placebo-controlled phase 3 pivotal trial that aimed to enroll approximately 300 patients at 150 sites globally. Patients were randomized in a 2:1 ratio to receive either cabozantinib 60 mg or placebo once daily. The co-primary endpoints are PFS and ORR, both assessed by BIRC. Patients randomized to placebo were eligible to cross over to open label cabozantinib upon BIRC-confirmed disease progression. Exelixis is sponsoring COSMIC-311, and Ipsen is co-funding the trial. More information about this trial is available at ClinicalTrials.gov.

About Differentiated Thyroid Cancer
Approximately 44,000 new cases of thyroid cancer will be diagnosed in the U.S. in 2021.1 Nearly three out of four of these cases will be in women, and the disease is more commonly diagnosed at a younger age compared to most other adult cancers.2 While cancerous thyroid tumors include differentiated, medullary and anaplastic forms, differentiated thyroid tumors make up about 90 percent of cases.2 These include papillary, follicular and Hürthle cell cancer.2 Differentiated thyroid cancer is typically treated with surgery followed by ablation of the remaining thyroid tissue with radioiodine, but approximately 5% to 15% of cases are resistant to radioiodine treatment. 2,3 For these patients, life expectancy is only three to five years from the time metastatic lesions are detected.4,5,6

About CABOMETYX (cabozantinib)
In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced RCC; for the treatment of patients with HCC who have been previously treated with sorafenib; and for patients with advanced RCC as a first-line treatment in combination with nivolumab. CABOMETYX tablets have also received regulatory approvals in the European Union and additional countries and regions worldwide. In 2016, Exelixis granted Ipsen exclusive rights for the commercialization and further clinical development of cabozantinib outside of the United States and Japan. In 2017, Exelixis granted exclusive rights to Takeda Pharmaceutical Company Limited for the commercialization and further clinical development of cabozantinib for all future indications in Japan. Exelixis holds the exclusive rights to develop and commercialize cabozantinib in the United States.

CABOMETYX is not indicated for the treatment of differentiated thyroid cancer.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Hemorrhage: Severe and fatal hemorrhages occurred with CABOMETYX. The incidence of Grade 3 to 5 hemorrhagic events was 5% in CABOMETYX patients in RCC and HCC studies. Discontinue CABOMETYX for Grade 3 or 4 hemorrhage. Do not administer CABOMETYX to patients who have a recent history of hemorrhage, including hemoptysis, hematemesis, or melena.

Perforations and Fistulas: Fistulas, including fatal cases, occurred in 1% of CABOMETYX patients. Gastrointestinal (GI) perforations, including fatal cases, occurred in 1% of CABOMETYX patients. Monitor patients for signs and symptoms of fistulas and perforations, including abscess and sepsis. Discontinue CABOMETYX in patients who experience a Grade 4 fistula or a GI perforation.

Thrombotic Events: CABOMETYX increased the risk of thrombotic events. Venous thromboembolism occurred in 7% (including 4% pulmonary embolism) and arterial thromboembolism in 2% of CABOMETYX patients. Fatal thrombotic events occurred in CABOMETYX patients. Discontinue CABOMETYX in patients who develop an acute myocardial infarction or serious arterial or venous thromboembolic events that require medical intervention.

Hypertension and Hypertensive Crisis: CABOMETYX can cause hypertension, including hypertensive crisis. Hypertension was reported in 36% (17% Grade 3 and <1% Grade 4) of CABOMETYX patients. Do not initiate CABOMETYX in patients with uncontrolled hypertension. Monitor blood pressure regularly during CABOMETYX treatment. Withhold CABOMETYX for hypertension that is not adequately controlled with medical management; when controlled, resume at a reduced dose. Discontinue CABOMETYX for severe hypertension that cannot be controlled with anti-hypertensive therapy or for hypertensive crisis.

Diarrhea: Diarrhea occurred in 63% of CABOMETYX patients. Grade 3 diarrhea occurred in 11% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 diarrhea, Grade 3 diarrhea that cannot be managed with standard antidiarrheal treatments, or Grade 4 diarrhea.

Palmar-Plantar Erythrodysesthesia (PPE): PPE occurred in 44% of CABOMETYX patients. Grade 3 PPE occurred in 13% of CABOMETYX patients. Withhold CABOMETYX until improvement to Grade 1 and resume at a reduced dose for intolerable Grade 2 PPE or Grade 3 PPE.

Hepatotoxicity: CABOMETYX in combination with nivolumab can cause hepatic toxicity with higher frequencies of Grades 3 and 4 ALT and AST elevations compared to CABOMETYX alone.

Monitor liver enzymes before initiation of and periodically throughout treatment. Consider more frequent monitoring of liver enzymes than when the drugs are administered as single agents. For elevated liver enzymes, interrupt CABOMETYX and nivolumab and consider administering corticosteroids.

With the combination of CABOMETYX and nivolumab, Grades 3 and 4 increased ALT or AST were seen in 11% of patients. ALT or AST >3 times ULN (Grade ≥2) was reported in 83 patients, of whom 23 (28%) received systemic corticosteroids; ALT or AST resolved to Grades 0-1 in 74 (89%). Among the 44 patients with Grade ≥2 increased ALT or AST who were rechallenged with either CABOMETYX (n=9) or nivolumab (n=11) as a single agent or with both (n=24), recurrence of Grade ≥2 increased ALT or AST was observed in 2 patients receiving CABOMETYX, 2 patients receiving nivolumab, and 7 patients receiving both CABOMETYX and nivolumab.

Adrenal Insufficiency: CABOMETYX in combination with nivolumab can cause primary or secondary adrenal insufficiency. For Grade 2 or higher adrenal insufficiency, initiate symptomatic treatment, including hormone replacement as clinically indicated. Withhold CABOMETYX and/or nivolumab depending on severity.

Adrenal insufficiency occurred in 4.7% (15/320) of patients with RCC who received CABOMETYX with nivolumab, including Grade 3 (2.2%), and Grade 2 (1.9%) adverse reactions. Adrenal insufficiency led to permanent discontinuation of CABOMETYX and nivolumab in 0.9% and withholding of CABOMETYX and nivolumab in 2.8% of patients with RCC.

Approximately 80% (12/15) of patients with adrenal insufficiency received hormone replacement therapy, including systemic corticosteroids. Adrenal insufficiency resolved in 27% (n=4) of the 15 patients. Of the 9 patients in whom CABOMETYX with nivolumab was withheld for adrenal insufficiency, 6 reinstated treatment after symptom improvement; of these, all (n=6) received hormone replacement therapy and 2 had recurrence of adrenal insufficiency.

Proteinuria: Proteinuria was observed in 7% of CABOMETYX patients. Monitor urine protein regularly during CABOMETYX treatment. Discontinue CABOMETYX in patients who develop nephrotic syndrome.

Osteonecrosis of the Jaw (ONJ): ONJ occurred in <1% of CABOMETYX patients. ONJ can manifest as jaw pain, osteomyelitis, osteitis, bone erosion, tooth or periodontal infection, toothache, gingival ulceration or erosion, persistent jaw pain, or slow healing of the mouth or jaw after dental surgery. Perform an oral examination prior to CABOMETYX initiation and periodically during treatment. Advise patients regarding good oral hygiene practices. Withhold CABOMETYX for at least 3 weeks prior to scheduled dental surgery or invasive dental procedures, if possible. Withhold CABOMETYX for development of ONJ until complete resolution.

Impaired Wound Healing: Wound complications occurred with CABOMETYX. Withhold CABOMETYX for at least 3 weeks prior to elective surgery. Do not administer CABOMETYX for at least 2 weeks after major surgery and until adequate wound healing is observed. The safety of resumption of CABOMETYX after resolution of wound healing complications has not been established.

Reversible Posterior Leukoencephalopathy Syndrome (RPLS): RPLS, a syndrome of subcortical vasogenic edema diagnosed by characteristic findings on MRI, can occur with CABOMETYX. Evaluate for RPLS in patients presenting with seizures, headache, visual disturbances, confusion, or altered mental function. Discontinue CABOMETYX in patients who develop RPLS.

Embryo-Fetal Toxicity: CABOMETYX can cause fetal harm. Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Verify the pregnancy status of females of reproductive potential prior to initiating CABOMETYX and advise them to use effective contraception during treatment and for 4 months after the last dose.

ADVERSE REACTIONS

The most common (≥20%) adverse reactions are:

CABOMETYX as a single agent: diarrhea, fatigue, decreased appetite, PPE, nausea, hypertension, vomiting, weight decreased, constipation, and dysphonia.

CABOMETYX in combination with nivolumab: diarrhea, fatigue, hepatotoxicity, PPE, stomatitis, rash, hypertension, hypothyroidism, musculoskeletal pain, decreased appetite, nausea, dysgeusia, abdominal pain, cough, and upper respiratory tract infection.

DRUG INTERACTIONS

Strong CYP3A4 Inhibitors: If coadministration with strong CYP3A4 inhibitors cannot be avoided, reduce the CABOMETYX dosage. Avoid grapefruit or grapefruit juice.

Strong CYP3A4 Inducers: If coadministration with strong CYP3A4 inducers cannot be avoided, increase the CABOMETYX dosage. Avoid St. John’s wort.

USE IN SPECIFIC POPULATIONS

Lactation: Advise women not to breastfeed during CABOMETYX treatment and for 4 months after the final dose.

Hepatic Impairment: In patients with moderate hepatic impairment, reduce the CABOMETYX dosage. Avoid CABOMETYX in patients with severe hepatic impairment.

Please see accompanying full Prescribing Information View Source

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.

For detailed recommendations on the use of CABOMETYX in the European Union, please see the Summary of Product Characteristics.

On June 7, 2021 Osel Inc., a company developing live biotherapeutic products (LBPs) for diseases linked to the disruption of the human microbiome, reported that City of Hope, a world-renowned independent cancer and diabetes research and treatment center, presented data from a Phase 1b trial showing that an LBP, CBM588 (Clostridium butyricum MIYAIRI 588 strain), plus nivolumab/ipilimumab improved overall response rate (ORR) and progression-free survival (PFS) compared to nivolumab/ipilimumab alone in patients with metastatic renal cell carcinoma (RCC) (Press release, Osel, JUN 7, 2021, View Source [SID1234583675]).

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Osel licensed the rights for the pharmaceutical use of CBM588 in the United States, Canada and Europe from Miyarisan Pharmaceutical Co., Ltd., and has a clinical trial agreement for the CBM588 study with City of Hope.

The data were presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting by City of Hope’s Luis Meza, a postdoctoral fellow, and Sumanta K. Pal, M.D., clinical professor, Department of Medical Oncology & Therapeutics Research. The presentation titled First results of a randomized phase IB study comparing nivolumab/ipilimumab with or without CBM588 in patients with metastatic renal cell carcinoma (Abstract #4513) is part of the session titled Genitourinary Cancer – Kidney and Bladder.

"We are very pleased with results generated from this clinical study," said Thomas Parks, Ph.D., Head of Development at Osel. "There is considerable interest in microbiome modulation to enhance immune checkpoint inhibitor efficacy that is more consistent and scalable than fecal transplants. These data are an encouraging indicator of potential patient benefit in an initial indication of metastatic RCC."

CBM588 is a spore forming anaerobe that produces short chain fatty acids, mainly butyric acid, which is a well-known energy source of intestinal epithelium. The bacterial strain exerts several beneficial effects through multiple modes of action, including inhibition of pathogenic microorganisms, immunomodulatory activities and restorative effects on intestinal dysbiosis.

"Adjunctive treatment with CBM588 is associated with improvements in response rate and PFS in patients treated in combination with standard of care versus standard of care alone – there is also a compelling trend favoring overall survival early on," Pal said. "These results warrant further investigation in a larger multi-center trial."

CBM588 is manufactured and marketed in Japan by Miyarisan Pharmaceutical as a prescription product known as Clostridium butyricum MIYAIRI 588 strain for the treatment of gastrointestinal (GI) indications. It has an excellent safety profile in all age groups and immunocompromised patients, as confirmed by post-marketing surveillance.

"Microbiome analysis showed a statistically significant increase in Bifidobacteria in CBM588 treated clinical responders compared to CBM588 treated non-clinical responders or standard of care patients," said Motomichi Takahashi, Ph.D., Executive Senior Director, Miyarisan Pharmaceutical. "These preliminary data support the GI microbiome being successfully modulated as a mechanism of clinical efficacy."

On June 7, 2021 Morphogenesis, Inc., a clinical-stage biotechnology company, reported that it has obtained funding to develop a new therapeutic drug to treat cervical cancer (Press release, Morphogenesis, JUN 7, 2021, View Source [SID1234583692]). Globally, more than half a million women are diagnosed and over 300,000 die from cervical cancer each year due to lack of access to lifesaving care. Cancer treatment regimens in low-resource settings require a fundamental transformation to overcome this horrific toll.

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A multi-discipline team that includes scientists from Morphogenesis, Medisca, a pharmaceutical compounding company specializing in customized medication, and Moffitt Cancer Center is developing an innovative therapy that would expand care to patients with limited access to lifesaving treatments. A Small Business Innovation Research (SBIR) proposal entitled, "A low-cost topical immunotherapy formulation suitable for treating cervical cancer in low- and middle-income countries and low-resource settings in the U.S.", received excellent scores following a competitive review process, and was awarded $400,000 from the National Cancer Institute (NCI) at the National Institutes of Health (NIH). The proposed work will reformulate Morphogenesis’s immunomodulatory cancer drug, IFx-Hu2.0, to a preparation that is applicable to treat women in locations with limited healthcare infrastructure.

IFx-Hu2.0 functions by recruiting the enormous power of the immune system towards the destruction of tumor cells. IFx-Hu2.0 treatment delivers a bacterial gene to a patient’s tumor that leads to the expression of an antigenic bacterial protein on the surface of those tumor cells. The bacterial antigen primes and educates the immune system to destroy tumor cells without harming healthy tissues.

IFx-Hu2.0 is a liquid drug preparation that is delivered by intratumoral injection. To facilitate cancer treatment in limited-resource settings, the team will formulate IFx-Hu2.0 to a non-toxic, affordable, commercially viable immunotherapy that can be stored and shipped at room temperature and self-administered. The goal is for this product to enable treatment in a variety of settings without the need for surgery, specialized training, or facilities.

"We are extremely excited about the global implications of our technology," said Pat Lawman, PhD, CEO of Morphogenesis, Inc. "While some of the other immune-oncology products being tested have tremendous promise, they will be prohibitively expensive and logistically unfeasible for treating patients in low resource settings. This project is near and dear to my heart since it embodies the culture of Morphogenesis, which is to create products that are accessible to those who would otherwise be without hope."

Shari Pilon-Thomas, Ph.D., Associate Member of Moffitt’s Department of Immunology, will direct studies designed to measure the efficacy of the reformulated drug in pre-clinical models. "This grant strengthens the ongoing collaboration between Moffitt and Morphogenesis. Results from this study will raise the potential for this incredible product to reach cervical cancer patients that are most in need of novel therapies," said Dr. Pilon-Thomas.

"The immuno-oncology products that we are developing will be instrumental in our company’s mission to end needless suffering. The lack of side-effects from our treatment means that there will be no added expense for supportive care needed with other therapies to treat chemotoxic or immunotoxic reactions," added Morphogenesis’ President, Michael Lawman, FRSB, Ph.D.

About Morphogenesis, Inc.: Morphogenesis is a clinical-stage pharmaceutical company based in Tampa, Florida developing novel "off-the-shelf" personalized immunotherapies for the treatment of cancer. Their IFx-based treatments induce personalized, tumor agnostic, multivalent, systemic, and sustained immune responses and have the potential to treat a broad range of cancers through enhanced tumor recognition, immune activation, and epitope spreading. IFx-based drugs have an established safety profile in multiple animal models. The IFx-Hu2.0 drug has just completed a Phase 1 clinical trial (safety) for Stage III/IV unresectable cutaneous melanomas and is currently in an expanded Phase 1 trial that includes cutaneous squamous cell carcinoma (cSCC) and Merkel cell carcinoma.

The Company’s patented immunotherapy is based on a single bacterial gene that when expressed on the surface of a patient’s tumor cells, educates the immune system to target the patient’s unique set of tumor antigens (neoantigens) without the toxic side effects that are common to most other cancer treatment regimens. Morphogenesis continues to innovate and reach major milestones towards its goal of bringing their gene therapy to treat a wide range of human cancer patients. Last year, Morphogenesis augmented its portfolio with three US patent awards and made multiple applications for worldwide patent protection. These patents are an important component of Morphogenesis’s exclusive intellectual property portfolio that includes some 55 issued patents and patent applications.

On June 7, 2021 Thermo Fisher Scientific, the world leader in serving science, and Newomics, a commercial-stage biotechnology company, reported that they are collaborating to develop a novel native liquid chromatography-mass spectrometry (LC−MS) platform to support various LC−MS applications (Press release, Lifescience Newswire, JUN 7, 2021, View Source [SID1234583793]). This agreement utilizes Newomics’ experience in creating innovative and integrative platforms and solutions for precision medicine and Thermo Fisher’s cutting-edge LC-MS systems to improve the throughput and robustness of microflow LC-MS in proteomics and biopharmaceutical applications.

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The agreement will bring together Thermo Fisher’s new-generation LC-MS systems, providing high-performance, innovative technology, and the Newomics Microflow-nanospray Electrospray Ionization (MnESI) source, to achieve high-sensitivity and high-throughput LC-MS analysis of bioorganic complexes, while maintaining their native state. The platform can tolerate a wide range of LC flow rates and high salt concentrations, which are critical for accommodating different native LC methods. The MnESI-MS platform provides a highly sensitive and reproducible analysis of nanospray applications, such as targeted peptide quantitation, and intact native and denatured protein analysis.

"Native MS is a powerful technique for studying the structure of intact proteins, large protein complexes, and protein-protein, protein-ligand interactions; however, the analysis of large native protein complexes and their mixtures in a high-throughput manner is challenging," said Andreas Huhmer, senior director of omics marketing, Thermo Fisher Scientific. "Our workflow with Newomics provides a hands-free approach to improve throughput for native MS analysis of large bioorganic complexes, providing the sensitivity of nanospray and the ability to maintain the native state of protein complexes during the MS analysis."

Dr. Daojing Wang, founder and CEO of Newomics, said, "Newomics is very excited to be launching our second co-marketing agreement with Thermo Fisher Scientific. When coupled with Thermo Fisher’s industry-leading mass spectrometers, Newomics’ new MnESI source offers an unmatched balance of sensitivity, robustness and reproducibility for small-volume, high-throughput analysis of biomolecules, such as therapeutic antibodies and RNAs for drug discovery and clinical research. The plug-and-play MnESI source works by rapidly delivering small amounts of samples to the award-winning Newomics M3 multinozzle emitters. The M3 emitter was the focus of Newomics’ first co-marketing agreement with Thermo Fisher in 2019, and once again, we’ll be working closely with their team to fulfill customer needs and address any challenges in mass spectrometry workflows."

To find out more about Thermo Fisher Scientific’s next-generation LC-MS systems, please browse our complete portfolio here.

Thermo Fisher Scientific will showcase its newest products, software solutions and collaborations in a company-hosted virtual event, "Innovation Summit: Shaping the Future of LC-MS in Life Science Together," from June 8-10, 2021. Register here to learn more.

On June 7, 2021 Kineta, Inc., a clinical stage biotechnology company focused on the development of novel immunotherapies in oncology,reported that Thierry Guillaudeux, Ph.D., SVP Immuno-oncology at Kineta, will participate in the virtual symposium "VISTA: A New Immune Checkpoint in Cancer, Autoimmunity and Beyond," taking place on June 18, 2021 (Press release, Kineta, JUN 7, 2021, View Source;utm_medium=rss&utm_campaign=kineta-to-participate-in-vista-a-new-immune-checkpoint-in-cancer-autoimmunity-and-beyond-virtual-symposium [SID1234583660]).

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The symposium will focus on the emerging checkpoint molecule VISTA, its function, the role it plays in several disease areas and current development programs. The event will be hosted by Randolph Noelle, Ph.D., Professor of Microbiology and Immunology, Department of Microbiology and Immunology, Norris Cotton Cancer Center, Geisel School of Medicine at Dartmouth; and Padmanee Sharma, M.D., Ph.D., Professor, Department of Genitourinary Medical Oncology, Division of Cancer Medicine, University of Texas, MD Anderson Cancer Center.

Presentation Details:
Dr. Guillaudeux will participate on the following panels during the Symposium:

Session Title: Discovery of Anti-VISTA Antibodies
Date/Time: June 18, 2021 from 9:50 AM to 10:35 AM Eastern Time

Session Title: VISTA Advances into Clinical Development
Date/Time: June 18, 2021 from 12:20 PM to 1:05 AM Eastern Time

To access the panel discussion please register as an attendee here: https://bit.ly/3hBzIUj

"I am pleased to participate in this exciting event", said Thierry Guillaudeux of Kineta. "VISTA is an important target that I believe has a central role in converting cold, hard-to-treat tumors into hot tumors that are more susceptible to treatment. This myeloid checkpoint has the potential to improve cancer management for patients in a variety of solid tumors,"

Kineta is developing KVA12.1, a novel anti-VISTA antibody in preclinical evaluation for the treatment of solid tumors. VISTA is a key driver of the immunosuppressive tumor microenvironment (TME) and is overexpressed on myeloid-derived suppressor cells (MDSC) and regulatory T cells (Tregs). It is a critical myeloid cell immune-checkpoint, and VISTA blockade can reprogram suppressive myeloid cells and reactivate antitumor immune function. Blocking VISTA activates an immune cell cascade that increases T cell effector functions to drive an efficient anti-tumor response. Preclinical studies have demonstrated single agent anti-VISTA activity but also demonstrate that targeting VISTA in combination with PD-1, PD-L1 or CTLA-4 can significantly improve the efficacy of those checkpoint inhibitors.