On June 28, 2021 Agilent Technologies Inc. (NYSE: A) reported the publication of a study carried out in partnership with Resolution Bioscience (a part of Agilent) and Dana-Farber Cancer Institute (Press release, Agilent, JUN 28, 2021, View Source [SID1234584420]). The paper was published in the New England Journal of Medicine (NEJM) on June 24 and is titled "Acquired Resistance to KRAS G12C Inhibition in Cancer." It demonstrates the clinical utility of liquid biopsy techniques to detect resistance to targeted therapies, including inhibitors of KRAS, one of the most commonly mutated oncogenes in cancer.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

KRAS G12C inhibitors, such as adagrasib, have shown promising efficacy in clinical trials, however, mechanisms of acquired resistance are not yet fully understood. Leveraging cell-free DNA (cfDNA) analysis, this study was conducted to investigate mutations that arise that may confer resistance to patients treated with KRAS inhibitors, including adagrasib and to better understand the process of acquired resistance and to identify new strategies to combat acquired resistance.

The results of the study showed KRAS G12C cancers have diverse genomic and histologic mechanisms, including point mutations, copy number changes, and fusions, that appear to impart resistance to KRAS G12C inhibitors. Developing therapeutic strategies to delay and overcome drug resistance will be an essential component in improving therapeutic outcomes in cancer patients.

"While results from these early clinical trials are encouraging, the cancer usually becomes resistant to these drugs," said Dana-Farber’s Mark Awad, MD, Ph.D., the co-first author of the paper with Shengwu Liu, Ph.D., also of Dana-Farber. "The mechanisms of resistance – the genomic and other changes that occur that allow the cancer to begin growing again – are largely unknown. This study sought to identify them."

"Given the high prevalence of KRAS driven cancers and resulting unmet medical need, elucidating the genetic underpinnings of acquired resistance to KRAS inhibitors at the time of progression is critical," Mark Li, CEO of Resolution Bioscience, said. "Importantly, in this study, more than three times as many patients were able to be genotyped by cfDNA compared to tissue alone at the time of progression. Furthermore, this study highlights the importance for cfDNA assays to accurately detect all major types of genetic aberrations, including gene fusions and copy number variations."

Agilent’s Resolution Bioscience team has partnered with Mirati Therapeutics Inc. (NASDAQ: MRTX) to use the Resolution ctDx FIRST assay as a companion diagnostic (CDx) in support of adagrasib for identifying patients with non-small cell lung cancer patients that harbor a KRAS G12C mutation. Liquid biopsy biomarker testing of patients in the adagrasib registrational clinical trial is being performed in Resolution’s clinical lab based in Kirkland, Washington.

On June 28, 2021, Oncotelic Therapeutics, Inc., formerly Mateon Therapeutics, Inc. (the "Company"), reported that it entered into a Securities Purchase Agreement (the "SPA") with Geneva Roth Remark Holdings, Inc. ("Geneva"), pursuant to which the Company issued to Geneva a Convertible Promissory Note (the "Geneva Note") in the amount of $103,750, on the same terms and subject to the same conditions as set forth in the Securities Purchase Agreement and Convertible Promissory Note as disclosed by the Company in its Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 1, 2021 (Filing, 8-K, Mateon Therapeutics, JUN 28, 2021, View Source [SID1234584573]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

For a description of the terms and conditions of the SPA and Geneva Note, see the Company’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on June 1, 2021, for which the form of the SPA and Geneva Note were attached as Exhibit 10.1 and Exhibit 10.2, respectively.

Extension of Maturity Date for J.H. Darbie Financing Notes & Issuance of Oncotelic Warrants

As previously disclosed in the Current Report on Form 8-K, filed with the Securities and Exchange Commission ("SEC") on July 23, 2020, and subsequently in the Current Report on Form 8-K filed with the SEC on March 26, 2021, the Company entered into subscription agreements with certain accredited investors (the "Investors"), whereby the Company issued and sold a total of 100 units ("Units"), with each Unit consisting of (i) 25,000 shares of the common stock, par value $0.01 per share ("Edgepoint Common Stock"), of EdgePoint AI, Inc., a Delaware Corporation ("EdgePoint"), a division of the Company, for a price of $1.00 per share of Edgepoint Common Stock; (ii) one convertible promissory note issued by the Company (the "Note"), convertible into up to 25,000 shares of EdgePoint Common Stock at a conversion price of $1.00 per share, or up to 138,889 shares of the Company’s common stock, par value $0.01 per share ("Common Stock"), at a conversion price of $0.18 per share; and (iii) 100,000 warrants, consisting of (a) 50,000 warrants to purchase an equivalent number of shares of EdgePoint Common Stock at $1.00 per share, and (b) 50,000 warrants to purchase an equivalent number of shares of Company Common Stock at $0.20 per share ("Oncotelic Warrant")(collectively, the "JH Darbie Financing").

On June 29, 2021, the Company and the Investors agreed to extend the maturity date of the Notes from June 30, 2021, to March 31, 2022. Additionally, the Company will issue to the Investors an aggregate of 20.0 million additional Oncotelic Warrants, and 2.0 million additional Oncotelic Warrants to J.H. Darbie & Co., Inc., as placement agent. Each Investor will be entitled to receive 200,000 additional Oncotelic Warrants for each Unit purchased. For a description of the JH Darbie Financing and the Units sold thereunder, see the Company’s Current Report on Form 8-K, filed with the Securities and Exchange Commission on July 23, 2020.

On June 28, 2021 Exelixis, Inc. (NASDAQ: EXEL) and Ipsen (Euronext: IPN; ADR: IPSEY) reported that COSMIC-312, the ongoing phase 3 pivotal trial evaluating cabozantinib (CABOMETYX) in combination with atezolizumab versus sorafenib in patients with previously untreated advanced hepatocellular carcinoma (HCC), met one of the primary endpoints, demonstrating significant improvement in progression-free survival (PFS) at the planned primary analysis (Press release, Exelixis, JUN 28, 2021, View Source [SID1234584389]). A prespecified interim analysis for the second primary endpoint of overall survival (OS), conducted at the same time as the primary analysis for PFS, showed a trend favoring the combination of cabozantinib and atezolizumab but did not reach statistical significance. Based on the preliminary OS data, Exelixis anticipates that the probability of reaching statistical significance at the time of the final analysis is low. The trial will continue as planned to the final analysis of OS; results are anticipated in early 2022.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

In the analysis of the primary endpoint of PFS in the PFS intent-to-treat population, cabozantinib in combination with atezolizumab significantly reduced the risk of disease progression or death by 37% compared with sorafenib (hazard ratio: 0.63; 99% confidence interval: 0.44-0.91; P=0.0012). Safety for the combination appeared to be consistent with the known safety profiles of the individual medicines, and no new safety signals were identified. Exelixis plans to discuss the trial results and next steps for a potential regulatory filing with the U.S. Food and Drug Administration (FDA).

"While we are encouraged by the data supporting the potential for the combination of cabozantinib and atezolizumab to reduce the risk of disease progression or death, we are disappointed by the interim result of lack of significant improvement on overall survival versus the comparator arm," said Michael M. Morrissey, Ph.D., Exelixis’ President and Chief Executive Officer. "As these data continue to mature, we are working to understand the potential impact of various contributing factors on the results, including patient demographics, subsequent anti-cancer therapy and the impact of COVID-19 on the trial. We anticipate presenting the results at a future medical conference."

About COSMIC-312

COSMIC-312 is a global, multicenter, randomized, controlled phase 3 pivotal trial that aimed to enroll approximately 840 patients at up to 200 sites globally. Patients were randomized approximately 2:1:1 to one of three arms: cabozantinib (40 mg) in combination with atezolizumab, sorafenib, or cabozantinib (60 mg). Exelixis is sponsoring COSMIC-312, and Ipsen is co-funding the trial. Genentech, a member of the Roche Group, is providing atezolizumab for use in this trial. More information about COSMIC-312 is available at ClinicalTrials.gov.

About HCC

More than 900,000 new cases of liver cancer, 90% of which are HCC, are diagnosed worldwide each year.1,2 HCC is a leading cause of cancer-related death, expected to cause 1 million global deaths annually by 2030.3 In the U.S., HCC is the fastest-rising cause of cancer-related death.4 Median survival for patients with symptomatic advanced HCC who are treated with systemic therapies is just 1 to 1.5 years.2

About CABOMETYX (cabozantinib)

In the U.S., CABOMETYX tablets are approved for the treatment of patients with advanced renal cell carcinoma (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. Outside of the U.S., CABOMETYX is approved in 58 countries, including in the European Union, the U.K., Norway, Iceland, Australia, New Zealand, Switzerland, South Korea, Canada, Brazil, Taiwan, Hong Kong, Singapore, Macau, Jordan, Lebanon, Russian Federation, Ukraine, Turkey, United Arab Emirates, Saudi Arabia, Serbia, Israel, Mexico, Chile, Peru, Panama, Guatemala, Dominican Republic, Ecuador, Thailand and Malaysia for the treatment of advanced RCC in adults who have received prior VEGF-targeted therapy; in the European Union, the U.K., Norway, Iceland, Canada, Australia, Brazil, Taiwan, Hong Kong, Singapore, Lebanon, Jordan, Russian Federation, Ukraine, Turkey, United Arab Emirates, Saudi Arabia, Israel, Mexico, Chile, Peru, Panama, Guatemala, Dominican Republic, Ecuador, Thailand and Malaysia for previously untreated intermediate- or poor-risk advanced RCC; and in the European Union, the U.K., Norway, Iceland, Canada, Australia, New Zealand, Switzerland, Saudi Arabia, Serbia, Israel, Taiwan, Hong Kong, South Korea, Singapore, Jordan, Russian Federation, Ukraine, Turkey, Lebanon, United Arab Emirates, Peru, Panama, Guatemala, Chile, Dominican Republic, Ecuador, Thailand and Malaysia for HCC in adults who have previously been treated with sorafenib. In the European Union, CABOMETYX is also approved in combination with nivolumab as first line treatment for patients living with advanced RCC. 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 as a treatment for previously untreated advanced HCC.

U.S. 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.

EUROPEAN UNION IMPORTANT SAFETY INFORMATION

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

On June 28, 2021 Sensei Biotherapeutics, an immunotherapy company focused on the discovery and development of next generation therapeutics for cancer, reported that it is reprioritizing its pipeline programs to focus on its product candidates, including its multi-antigenic next generation ImmunoPhage candidate, now referred to as SNS-401-NG, and its monoclonal antibody SNS-VISTA (V-set Immunoglobulin Domain Suppressor of T cell Activation) candidate (Press release, Sensei Biotherapeutics, JUN 28, 2021, View Source [SID1234584405]). With this reallocation of resources, Sensei expects its cash and cash equivalents will be sufficient to fund its operations into the first half of 2024.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Sensei’s approach to drug development is deeply rooted in targeting key mechanisms of checkpoint resistance to induce a robust, focused and coordinated immune response to cancer. We believe our next generation, multi-antigenic ImmunoPhage product candidates have the potential to drive robust antigen-specific T cell responses that will translate into clinical benefit," said John Celebi, president and chief executive officer of Sensei Biotherapeutics. "Given the totality of data generated to-date from the Phase 1/2 combination trial of first-generation SNS-301, we believe we have captured important insights into the power of our ImmunoPhage platform that will further advance development of our pipeline product candidates. Through SNS-301, we have gained important information on key product attributes that we believe contribute to the safety and immunogenicity of our ImmunoPhage platform as well as how to manufacture and scale our product candidates. Specifically, we have learned that the use of gpD fusion as an antigen display technology is suboptimal for use in an active cancer vaccine. We believe the incorporation of new antigen attachment technologies will ensure optimal immunogenicity. We are excited by our next generation programs, and we look forward to further advancing our two ongoing programs SNS-401-NG and SNS-VISTA into the clinic and completing discovery work for our VSIG4 antibody program."

"I would like to express my gratitude to all of the patients and their families, investigators and collaborators who participated in the SNS-301 study," said, Marie-Louise Fjaellskog, M.D., Ph.D. chief medical officer of Sensei Biotherapeutics. "Our data-driven decision-making process is at the forefront of our work, and we are well positioned and capitalized to further progress our next-generation pipeline programs, SNS-401-NG and SNS-VISTA, by utilizing our two unique drug discovery approaches – our ImmunoPhage platform and our monoclonal antibody and nanobody platform. We look forward to initiating IND-enabling studies for SNS-VISTA by the end of 2021 and for SNS-401-NG in second half of 2022."

SNS-301 was developed as a first-generation, bio-engineered, inactivated bacteriophage virus expressing a fragment of the tumor-associated antigen, human aspartate β-hydroxylase (ASPH), as a fusion protein to the bacteriophage lambda capsid decoration protein, gpD, for patients with locally advanced unresectable or metastatic squamous cell head and neck cancer (SCCHN). To date, 25 patients were enrolled in the Phase 1/2 clinical study and received at least one dose of SNS-301 in combination with pembrolizumab; one patient had a deep and durable partial response (PR) and 8 patients had stable diseases. While encouraged by the safety profile of the SNS-301 single antigen approach, based upon the recent analysis of antigen specific T-cell activation which did not show a significant increase in ASPH-specific T cells, including the one patient who experienced a long-standing and deep PR, and an updated analysis of clinical data, Sensei has decided to reprioritize its pipeline and refocus resources. Sensei anticipates sharing full SNS-301 clinical data and the results of specific B and T cell response data at a future scientific conference.

Next-Generation Pipeline Highlights and Upcoming Milestones

Sensei is focused on progressing novel product candidates generated from both its ImmunoPhage platform and Phortress Library, coupled with its human monoclonal antibody and nanobody platform. Sensei’s Phortress Library of immunophages, derived from antigens found across multiple patient populations and tumor types, enables a personalized, yet off-the-shelf therapeutic option to patients.

SNS-401-NG is a first-in-class, multi-antigenic personalized ImmunoPhage candidate being developed in collaboration with the University of Washington. Sensei has designed SNS-401-NG as a personalized product candidate composed of premanufactured Immunophage from Sensei’s Phortress library on an improved and proprietary bacteriophage construct. Sensei intends to initiate IND-enabling studies for this product candidate in the second half of 2022. The first clinical application is directed to the treatment of Merkel Cell Carcinoma (MCC), an aggressive form of skin cancer commonly driven by the Merkel Cell Polyoma Virus. If clinical proof of concept is achieved, Sensei plans to evaluate a broader basket study in patients with head and neck cancer, lung cancer, melanoma, and triple negative breast cancer based on the prevalence of Phortress antigens.
VISTA (V-domain Ig suppressor of T cell activation) is an immune checkpoint that inhibits anti-tumor immune responses. VISTA is implicated in PD-1/PD-L1 resistance and therapeutic intervention. VISTA has the potential to be effective as a monotherapy and synergistic with PD-1/PD-L1 inhibition. Sensei has generated potent pH-dependent parental antibodies that block the interaction of VISTA with its receptor, PSGL1, expected to result in a favorable pharmacokinetic (PK) profile and selective activity in the acidic tumor microenvironment – a critical feature of this product candidate, and an important differentiator to other compounds in development targeting VISTA. Sensei plans to present preclinical data from the SNS-VISTA program at a scientific conference in 2021 and to initiate IND-enabling studies by the end of 2021.
VSIG4 (V-Set And Immunoglobulin Domain Containing 4) is a potent inhibitor of T cell activity, often overexpressed on macrophages within the tumor microenvironment. Sensei believes that a tumor-selective blocking monoclonal antibody will have potent anti-tumor immune effects. Sensei is extending its approach to developing antibodies with enhanced tumor selective activity to other candidate immune checkpoint targets, and anticipates selecting a product candidate from this program in 2023.
Conference Call and Webcast Information

Sensei will host a live conference and webcast today, June 28, 2021, at 4:30 p.m. ET, to discuss these company updates. To access the conference call, please dial 833-362-0204 (domestic) or 914-987-7673 (international) and refer to conference ID number 7464477. The live webcast can be accessed under the "Events & Presentations" section of Sensei’s website at www.senseibio.com. The webcast will be archived and made available for replay on Sensei’s website approximately two hours after the call and will be available for 30 days.

On June 28, 2021 Biocept (Nasdaq: BIOC), a leading provider of molecular diagnostic assays, products and services, reported that it will be added to the Russell Microcap Index after the U.S. market opens today, June 28, 2021 (Press release, Biocept, JUN 28, 2021, View Source [SID1234584421]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are pleased that Biocept will now be included in the Russell Microcap Index, which is a broadly used performance benchmark for smaller growth stocks in the U.S.," said Michael Nall, President and CEO of Biocept. "This is an exceptionally exciting time with the full commercial launch underway of our novel, proprietary CNSide assay that provides physicians with a significantly improved tool to diagnose and manage patients with tumors that have metastasized to the central nervous system. We believe the addition to the Russell Microcap Index will further raise awareness of Biocept within the global investment community."

Membership in the Russell Microcap Index, which remains in place for one year, means automatic inclusion in the appropriate growth and value style indexes. FTSE Russell, a leading global index provider, determines membership for its Russell indexes primarily by objective, market-capitalization rankings and style attributes.

Russell indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $10.6 trillion in assets are benchmarked against Russell’s U.S. indexes. For more information on the Russell Microcap Index and the Russell indexes reconstitution, go to the "Russell Reconstitution" section on the FTSE Russell website.