This phase II trial tests how well personalized reduction of chemotherapy (nivolumab, doxorubicin, vinblastine and dacarbazine) based on circulating tumor deoxyribonucleic acid (ctDNA) evaluation works for treating patients with Hodgkin lymphoma that may have spread from where it first started to nearby tissue, lymph nodes, or distant parts of the body (advanced). Chemotherapy drugs, such as nivolumab, doxorubicin, vinblastine and dacarbazine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Many types of tumors tend to lose cells or release different types of cellular products including their DNA, which is referred to as ctDNA, into the bloodstream before changes can be seen on scans. Health care providers can measure the level of ctDNA in blood or other bodily fluids and, based on the result, assign patients to a reduced number of chemotherapy treatments or the standard number of chemotherapy treatments. Using ctDNA to assign a personalized reduction of chemotherapy may be effective in treating patients with advanced Hodgkin lymphoma.

Start Date01 Jun 2025

Sponsor / Collaborator

University of Washington

CTRI/2024/07/069820

/ Not yet recruitingPhase 4

A Multicenter, Single-arm, Open-label, Phase 4 Study to Evaluate the Safety and Efficacy of Brentuximab Vedotin plus Doxorubicin, Vinblastine and Dacarbazine in Indian Patients with Untreated Stage 3/4 Classical Hodgkin Lymphoma - NIL

Start Date30 Jul 2024

Sponsor / Collaborator

Baxalta US, Inc.

NCT06528496

/ RecruitingPhase 2IIT

N10: Reduced Therapy for High-Risk Neuroblastoma

The purpose of this study is to find out whether N10 chemotherapy is a safe and effective treatment for children with high-risk neuroblastoma.

Start Date22 Jul 2024

Sponsor / Collaborator

Memorial Sloan Kettering Cancer Center

100 Clinical Results associated with Vinblastine Sulfate

100 Translational Medicine associated with Vinblastine Sulfate

100 Patents (Medical) associated with Vinblastine Sulfate

10,471

Literatures (Medical) associated with Vinblastine Sulfate

01 Feb 2025·Current Computer-Aided Drug Design

Computer-aided Drug Discovery Approaches in the Identification of Anticancer Drugs from Natural Products: A Review

Review

Author: Manisha, Jessica ; Solomon, Viswas Raja ; Lazar, Lal Prasanth Mercy ; Priya, Muthiah Gnana Ruba ; Rathore, Seema Singh

:Natural plant sources are essential in the development of several anticancer drugs, such as vincristine, vinblastine, vinorelbine, docetaxel, paclitaxel, camptothecin, etoposide, and teniposide. However, various chemotherapies fail due to adverse reactions, drug resistance, and target specificity. Researchers are now focusing on developing drugs that use natural compounds to overcome these issues. These drugs can affect multiple targets, have reduced adverse effects, and are effective against several cancer types. Developing a new drug is a highly complex, expensive, and time-consuming process. Traditional drug discovery methods take up to 15 years for a new medicine to enter the market and cost more than one billion USD. However, recent Computer Aided Drug Discovery (CADD) advancements have changed this situation. This paper aims to comprehensively describe the different CADD approaches in identifying anticancer drugs from natural products. Data from various sources, including Science Direct, Elsevier, NCBI, and Web of Science, are used in this review. In-silico techniques and optimization algorithms can provide versatile solutions in drug discovery ventures. The structure-based drug design technique is widely used to understand chemical constituents' molecular-level interactions and identify hit leads. This review will discuss the concept of CADD, in-silico tools, virtual screening in drug discovery, and the concept of natural products as anticancer therapies. Representative examples of molecules identified will also be provided.

01 Feb 2025·Genetics in Medicine

A germline PDGFRB splice site variant associated with infantile myofibromatosis and resistance to imatinib

Article

Author: Minard-Colin, Véronique ; Boulouadnine, Boutaina ; Smetsers, Stephanie ; Masliah-Planchon, Julien ; Demoulin, Jean-Baptiste ; Bies, Joshua ; Leducq, Camille ; de Lange, Iris ; Kordes, Uwe Richard ; Brichard, Bénédicte ; Filser, Mathilde ; Losole, Taylor ; de Krijger, Ronald ; Mensenkamp, Arjen ; Orbach, Daniel ; Kouwenberg, Dorus

PURPOSEInfantile myofibromatosis is characterized by the development of myofibroblastic tumors in young children. In most cases, the disease is caused by somatic gain-of-function variants in platelet-derived growth factor (PDGF) receptor beta (PDGFRB). Here, we reported a novel germline intronic PDGFRB variant, c.2905-8G>A, in 6 unrelated infants with multifocal myofibromatosis and their relatives.METHODSWe performed constitutional and tumor DNA and RNA sequencing to identify novel variants, which were subsequently characterized in cellular assays.RESULTSAll patients had multiple skin nodules, 4 had bone lesions, and 2 had aggressive disease with bowel obstruction. The c.2905-8G>A substitution creates an alternative acceptor splice site in intron 21, inserting 2 codons in the PDGFRB transcript. Functional studies revealed that the splice change induced a partial loss of function, contrasting with previously described variants. In 4 tumor samples, we identified a second somatic hit at position Asp850 in PDGFRB exon 18, triggering constitutive receptor activation and resistance to imatinib. In addition to vinblastine and methotrexate, 2 patients received imatinib without objective response. One of them switched to dasatinib with concomitant improvement.CONCLUSIONThis splice-site PDGFRB variant favors the development of myofibroma, featuring an acquired oncogenic variant in the same gene and resistance to targeted therapy.

16 Jan 2025·Blood

Brentuximab vedotin, nivolumab, doxorubicin, and dacarbazine for advanced-stage classical Hodgkin lymphoma

Article

Author: Melear, Jason ; Gandhi, Mitul D. ; Renshaw, John ; Patel, Ameet ; Burke, John M. ; Fanale, Michelle A. ; Metheny, Leland ; Guo, Wenchuan ; Feldman, Tatyana A. ; Yimer, Habte ; Chintapatla, Rangaswamy ; Ho, Linda ; Yasenchak, Christopher A. ; Gonzales, Paul ; Linhares, Yuliya ; Ramchandren, Rod ; Lee, Hun Ju ; Islas-Ohlmayer, Miguel ; Dean, Asad ; Flinn, Ian W. ; Peterson, Matthew ; Raval, Mihir ; Friedman, Judah ; Rana, Vishal

AbstractTreatment options for stage I/II bulky and advanced-stage disease have recently extensively changed. For decades in North America, ABVD (doxorubicin hydrochloride [Adriamycin], bleomycin sulfate, vinblastine sulfate, and dacarbazine) has been a frontline standard-of-care option for patients with advanced classical Hodgkin lymphoma (cHL). Recent data on combining brentuximab vedotin, doxorubicin, vinblastine, and dacarbazine demonstrated improved overall survival compared with ABVD but increased adverse events (AEs). We hypothesized that replacing vinblastine with nivolumab (brentuximab vedotin and nivolumab [AN] + doxorubicin and dacarbazine [AD]; AN+AD) may improve efficacy and safety. This phase 2, open-label multipart, multicenter study enrolled patients with treatment-naive stage II bulky or III/IV cHL. Patients received ≤6 cycles of AN+AD; granulocyte-colony stimulating factor (G-CSF) prophylaxis was optional, per institutional guidelines. At the time of planned analysis (N = 57), complete response (CR) and objective response rates were 88% (95% confidence interval [CI], 76.3-94.9) and 93% (95% CI, 83.0-98.1), respectively. With a median follow-up of 24.2 months (95% CI, 23.4-26.9), the 2-year progression-free survival rate was 88% (95% CI, 75.7-94.6); 88% (95% CI, 75.7-94.6) had a response lasting >2 years. Most common grade ≥3 treatment-related AEs were alanine aminotransferase increased (11%) and neutropenia (9%); 44% had treatment-related peripheral sensory neuropathy (grade 1/2, 40%; grade 3, 4%). No febrile neutropenia occurred; 49% received G-CSF prophylaxis. AN+AD led to a high CR rate and favorable safety profile. Further evaluation of programmed death receptor 1 inhibitor and CD30 antibody–drug conjugate combination regimens in frontline advanced-stage cHL is warranted. This trial was registered at www.clinicaltrials.gov as #NCT03646123 and www.clinicaltrialsregister.eu as #EudraCT 2020-004027-17.

News (Medical) associated with Vinblastine Sulfate

10 Jan 2025

·www.prnewswire.com

Intensity Therapeutics Provides Business Update Highlighting Key Achievements with Lead Drug Candidate INT230-6

The US FDA, Health Canada, European Medicines Authority, and the Australian Therapeutic Goods Administration authorized the Company's global, randomized Phase 3 study (INVINCIBLE-3) in Metastatic Soft Tissue Sarcoma Twenty-three sites are currently contracted in the INVINCIBLE 3 study, and several sites have treated patients Seven Swiss sites are activated in the Phase 2 (INVINCIBLE-4) study for early-stage, operable Triple Negative Breast Cancer ("TNBC"), and several patients have been treated SHELTON, Conn., Jan. 10, 2025 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or the "Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announces a business update highlighting key achievements with its lead drug candidate INT230-6. Business Development Discussions with multiple companies regarding potential strategic collaborations and licenses in various territories for INT230-6 initiated in 2024. While term sheets may be negotiated, there is no assurance that any ongoing discussions, negotiations, or due diligence processes will result in definitive agreements, partnerships, collaborations, or relationships. Sarcoma INVINCIBLE-3 In July 2024, the Company initiated and dosed its first patient in a Phase 3 open-label, randomized study (the "INVINCIBLE-3 Study") testing INT230-6 as a monotherapy compared to the standard of care ("SOC") drugs in second-and third-line treatment for certain soft tissue sarcoma subtypes. This study has been authorized by the US FDA, Health Canada, the European Medicines Authority, and Australia's Therapeutics Goods Administration. The trial is enrolling and being conducted in eight countries: the US, Australia, Canada, France, Germany, Italy, Poland, and Spain. Up to 62 sarcoma-focused hospitals and other centers are expected to participate from these countries. In November 2024, the Company presented INT230-6 Phase 1/2 data in a late-breaking session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS). These data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone. INVINCIBLE-3 continues recruiting with an expected enrollment of 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma. Breast Cancer INVINCIBLE-2 and INVINCIBLE-4 In October 2024, the Company, in collaboration with the Swiss Group for Clinical Cancer Research SAKK ("SAKK") in the INVINCIBLE-4 Study, a Phase 2 trial to treat patients with localized triple-negative breast cancer ("TNBC"), announced that the first patient has been dosed in the study. In December 2024, Phase 2 data in presurgical breast cancer from the completed INVINCIBLE-2 study along with an overview of the ongoing INVINCIBLE-4 (SAKK 66/22), was presented at the 2024 San Antonio Breast Cancer Symposium (SABCS). The Company's completed INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including TNBC, showed the following: Tumor-killing properties at levels greater than 95% in some patients on a single intratumoral dose with systemic immune activation. Tumors larger than 2 cm showed significant necrosis in 74% of subjects at the time of surgery. Gene expression analysis showed a significant difference between baseline biopsies and surgical specimens. Pathway analysis identified genes associated with TCR signaling, B-cell and T-cell activation, with increasing effects in post-treatment samples (SABCS 2023 #PS16-03). The study demonstrated pathologic and immune priming effects of intratumoral cytotoxicity in traditional immune quiescent breast cancers, with a treatment that showed favorable safety and was well tolerated. INT230-6 patients had increases in CD4 T cells and NK cells within the tumor and associated changes in the diversity of T cell repertoire. The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with tumors greater than two centimeters having early-stage, operable Triple Negative Breast Cancer ("TNBC"). These patients undergo standard-of-care neoadjuvant immunochemotherapy ("SOC") treatment, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522 regimen). The primary endpoint is pathological complete response ("pCR") in the primary tumor and affected lymph nodes. Patients will be randomized one to one to receive a regimen of two doses of INT230-6 followed by SOC, or SOC alone. The study is expected to enroll 54 patients in up to 16 centers in Switzerland and France. "The data from our prior studies and trial design has allowed INT230-6 to be authorized by the leading regulatory agencies globally to move into late-stage clinical trials. INT230-6 is being tested in metastatic and pre-surgical cancers, which highlights the broad potential for our new cancer treatment," said Lewis H. Bender, President and CEO of Intensity Therapeutics, "There are many risks and hurdles in drug development and advancing programs into phase 3 trials is an important achievement and a testament that reflects the expertise and dedication of our team. We are excited that contracts exist with nearly two dozen top sarcoma-centric hospitals in our Phase 3 study and nine sites in our Phase 2 presurgical breast cancer trial with seven activated. Several sites are enrolling and continue to recruit patients for both studies. Given the potential benefit of our new drug, we are working to establish partnerships that expedite product development and ultimate market access in the US and abroad." About Soft Tissue Sarcoma Soft tissue sarcoma is a broad term for cancers that start in soft tissues (muscle, tendons, fat, lymph and blood vessels, and nerves). These cancers can develop anywhere in the body but are found mainly in the arms, legs, chest, and abdomen. There are many types of sarcomas; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS), and liposarcoma. According to SEER estimates, approximately 14,500 patients have metastatic liposarcoma, leiomyosarcoma, and undifferentiated pleomorphic disease at any one time in the US. When sarcoma is metastatic, the prognosis is poor, even with systemic chemotherapy. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Triple Negative Breast Cancer in the Presurgical Setting Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates lower in the larger-sized tumors. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the primary endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Phase 2ImmunotherapyPhase 3Clinical ResultASCO

12 Dec 2024

·ir.intensitytherapeutics.com

Intensity Therapeutics, Inc. and The Swiss Group for Clinical Cancer Research SAKK Present Phase 2 Data in Presurgical Breast Cancer from the completed INVINCIBLE-2 Study, and an Overview of the Ongoing Randomized, Presurgical Triple Negative Breast

Enrollment is ongoing and seven sites in Switzerland have been activated SHELTON, Conn. and BERN, Switzerland, Dec. 12, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. ("Intensity" or "the Company") (Nasdaq: INTS), a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumorally injected cancer therapies intended to kill tumors directly and increase immune system recognition of cancers, and The Swiss Group for Clinical Cancer Research SAKK ("SAKK"), a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965, announced that Andreas Mueller, M.D., Past-President of the Project Group Breast Cancer of SAKK and Head of the Breast Center at Kantonsspital Winterthur, Switzerland and a supporting coordinating investigator for the study presented in an evening poster session on December 11 the final data from Intensity's INVINCIBLE-2 Study (NCT04781725), and an overview / update of the INVINCIBLE-4 Study (NCT06358573) at the San Antonio Breast Cancer Symposium being held December 10-13, at the Henry B. Gonzalez Convention Center in San Antonio, Texas. The INVINCIBLE-4 Study is a randomized open-label, multicenter study to determine the clinical activity, safety, and tolerability of INT230-6 in patients with early-stage, operable Triple Negative Breast Cancer ("TNBC") who undergo standard of care neoadjuvant immunochemotherapy ("SOC") treatment and SOC alone. The primary endpoint is pathological complete response ("pCR") in the primary tumor and affected lymph nodes. Patients will be randomized one to one to receive a regimen of either two doses of INT230-6 followed by SOC, which consists of pembrolizumab, anthracyclines, carboplatin, cyclophosphamide, and paclitaxel (i.e. the Keynote-522 regimen), or the SOC alone. The study is recruiting and expected to enroll 54 patients. "Women with aggressive forms of breast cancer, such as TNBC, are often counseled to undergo pre-surgical (neoadjuvant) systemic therapy in advance to reduce the risk of the disease returning. Having a pathological complete response, meaning the absence of live cancer at the time of surgery, has been shown to result in a lower risk of recurrence. When the tumor diameters are bigger than two centimeters, recurrence is more likely, so that neoadjuvant treatment is warranted" said Dr. Mueller. "If the immunological cancer cell death caused by INT230-6 and the ignition of an anti-cancer immune response without increased toxicity shows a meaningful increase in pCR, it would be a major advance for the neoadjuvant treatment of breast cancer and potentially other cancers. Further, if the results of this study are highly favorable, perhaps the cardiotoxic anthracycline drugs could be reduced or eliminated in future studies." The Company's completed INVINCIBLE-2 Study, where INT230-6 was given alone in multiple tumor types including TNBC, showed several benefits: Tumor-killing properties at levels greater than 95% in some patients on a single intratumoral dose with systemic immune activation. Results in tumors larger than 2 cm showed significant necrosis in 74% of subjects at the time of surgery. Gene expression analysis showed a significant difference between baseline biopsies and surgical specimens. Pathway analysis identified genes associated with TCR signaling, B-cell and T-cell activation, with increasing effects in post-treatment samples (SABCS 2023 #PS16-03). The study demonstrated pathologic and immune priming effects of intratumoral cytotoxicity in traditional immune quiescent breast cancers, with a treatment that showed favorable safety and was well tolerated. INT230-6 patients had significant differential gene expression present and identified genes were associated with T cell activation, lymphocyte activation and inflammatory response. INT230-6 patients had increases in CD4 T cells and NK cells within the tumor, and associated changes in the diversity of T cell repertoire. About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the primary endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit www.intensitytherapeutics.com. About Triple Negative Breast Cancer in the Presurgical Setting Approximately 11-17% of breast cancers test negative for estrogen receptors (ER), progesterone receptors (PR), and overexpression of human epidermal growth factor receptor 2 (HER2) protein, qualifying them as triple negative. TNBC is considered to be more aggressive and has a poorer prognosis than other types of breast cancer, because there are fewer available targeted medicines. Most patients with local TNBC typically receive immune/chemotherapy before surgery. Since the publication of Keynote-522, standard neoadjuvant treatment for TNBC includes systemic chemotherapy (anthracyclines, cyclophosphamide, paclitaxel, carboplatin) and the anti-PD-1 monoclonal antibody pembrolizumab. pCR rates are 65%, with rates generally lower in the larger-sized tumors. The toxicity of the Keynote-522 regimen is high, with 80% of patients experiencing grade 3 or higher treatment-related AEs, including treatment-related adverse events that lead to death in 0.5% of patients. About SAKK The Swiss Group for Clinical Cancer Research (SAKK) is a decentralized academic research institute that has been conducting clinical trials of cancer treatments in all major Swiss hospitals since 1965. It federates a large network of research groups with a Competence Center in Bern in charge of coordinating the clinical operations. It also works with selected cooperative groups abroad, particularly on rare forms of cancer. SAKK's aim is to advance existing cancer treatments, investigate the efficacy and tolerability of new treatments (radiotherapy, medicines and surgery), and set new standards in treatment. 22 Swiss hospitals are full members of SAKK. Research activity is funded by federal subsidies provided by the State Secretariat for Education, Research and Innovation (SERI) and financial support from other partner organizations such as the Swiss Cancer League and the Swiss Cancer Research Foundation. Further information can be found at https://www.sakk.ch/en. Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at www.sec.gov. Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik Justin@coreir.com CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR pr@coreir.com View original content to download multimedia:https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-and-the-swiss-group-for-clinical-cancer-research-sakk-present-phase-2-data-in-presurgical-breast-cancer-from-the-completed-invincible-2-study-and-an-overview-of-the-ongoing-randomized-presurgical-tri-302328744.html SOURCE Intensity Therapeutics Inc.

Phase 2ImmunotherapyClinical ResultPhase 3

18 Nov 2024

·www.prnewswire.com

Intensity Therapeutics Presents INT230-6 Phase 1/2 Data in Sarcoma and an Overview of its Ongoing Global Randomized Phase 3 Sarcoma Trial ("INVINCIBLE-3 Study") in a Late-Breaking Session at the 2024 Annual Connective Tissue Oncology Society Meeting (CTOS)

Phase 1/2 data showed a median overall survival ("mOS") of 21.3 months versus a synthetic control of 6.7 months, an increase in T-cell activation, and favorable safety profile for patients receiving INT230-6 alone INVINCIBLE-3 Study is recruiting and expected to enroll 333 patients with leiomyosarcoma, liposarcoma and undeferential pleomorphic sarcoma; authorizations for the INVINCIBLE-3 Study have been received in the U.S., Canada, Europe and Australia SHELTON, Conn., Nov. 18, 2024 /PRNewswire/ -- Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or "the Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University's Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company's Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company's ongoing INVINCIBLE-3 Study design (NCT06263231). Dr. Meyer shared the information during an oral podium presentation in a late-breaking session at the 2024 Connective Tissue Oncology Society ("CTOS") on November 16, 2024, at 9 AM PST. The abstract's lead author was Albiruni Razak, MB BCh, BM BCh, Clinician Investigator, Princess Margaret Cancer Centre at the University Hospital Network in Toronto, Ontario, Canada. Both Drs. Razak and Meyer, enrolled patients in the Phase 1/2 clinical trial. This year's annual CTOS conference was held in San Diego from November 13 to 16, 2024 at the Grand Hyatt. "The data in the Phase 1/2 study has shown that INT230-6 causes cell death leading to tumor necrosis, improved cancer recognition by immune cells, and an ignition of a systemic anti-cancer immune response that results in T-cells entering the tumor microenvironment and has shown a favorable safety profile in soft tissue sarcomas," said Dr. Razak. "Systemically delivered chemotherapies have severe side effects, including cardiotoxicity, and most sarcoma subtypes have only a minimal response to immunotherapies. In addition, most sarcoma patients remain on current therapies for only a few months prior to progression, death or excessive toxicity. Demonstrating statistically significant improvement in median overall survival for the INT230-6 treatment arm compared to the standard of care arm in the INVINCIBLE-3 Study would be a major step forward in treating patients with these deadly soft tissue sarcomas." Phase 1/2 Study (Sarcoma Subset Data: 15 Patients): Demographics: Median (min, max) lines for prior drug therapies: 3 (1.00, 7.00) Mean (SD) age: 62.8 (8.1) years and ranged from 41.9 to 76.1 years ECOG performance status at screening was 0, 1 and 2 for 2 (13.3%), 12 (80.0%), and 1 (6.7%) subjects respectively The sarcoma diagnoses of the Phase 2 patients included liposarcoma, pleomorphic sarcoma, leiomyosarcoma, chondrosarcoma, osteosarcoma (chondroid syringoma), myofibroblastic, osteosarcoma, Kaposi sarcoma and chordoma Efficacy: The mOS in the mixed sarcoma population: 21.3 months for INT230-6 The mOS had not been reached with 21.4 months of median follow-up for patients who received a cumulative INT230-6 dose volume that was greater than 40% of their total tumor burden INT230-6 extended overall survival in refractory sarcoma subjects by nearly 15 months as monotherapy when compared to a synthetic control group based on the Royal Marsden Hospital scoring method Sarcoma population's overall disease control rate (DCR): 93.3% (95% CI: 68.1, 99.8) at 2 months Median duration of response (DOR): 4.0 months (95% CI: 1.7, NA) and 11.3 months (95% CI: 2.8, NA) for subjects who received a cumulative dose of ≥ 40% of the total incoming total tumor burden INT230-6 demonstrated an increase in T-cells within the tumors 27% of patients had uninjected tumors shrink (abscopal effects), though tumors less than 1 cm were uninjected, untracked and unreported by investigators, so the true abscopal percentage is unknown; further radiomics work is on-going Safety INT230-6 demonstrated a favorable safety profile and was well-tolerated 3 subjects (20%) had one or more drug regimen-related Grade ≥ 3 Treatment Emergent Adverse Events (TEAE); all were grade 3 (there were no grade 4 or 5 TEAEs) INVINCIBLE-3 Study Overview The INVINCIBLE-3 Study is designed to evaluate INT230-6 administered intratumorally by an interventional radiologist or an equivalently trained physician using image guidance compared to systemically dosed standard of care ("SOC") chemotherapy. The study endpoints are overall survival and safety, along with an exploratory quality of life (QoL) assessment using the EORTC-30 survey. This is a global randomized Phase 3 study comparing the efficacy and safety of INT230-6 intratumoral (IT) injection with any of three standard of care therapies (pazopanib, trabectedin, or eribulin) in approximately 333 adult participants with locally recurrent, inoperable, or metastatic soft tissue sarcoma ("STS") patients who had disease progression prior to study enrollment following standard therapies, which must have included an anthracycline-based regimen unless contraindicated. Participants may also have received a maximum of one additional regimen. Randomization will occur after screening and eligibility confirmation. As this is a survival study, there is no crossover allowed between SOC and INT230-6. Disease progression will be determined by the World Health Organization (WHO) criteria. Participants will be prospectively stratified into 1 of 3 histologically defined STS strata: leiomyosarcoma liposarcoma (dedifferentiated, myxoid, round cell and pleomorphic) undifferentiated pleomorphic sarcoma The comparator agents used are all U.S., Europe, Canadian and Australian-approved agents for sarcomas: pazopanib tablets, trabectedin, and eribulin mesylate. Authorizations for the INVINCIBLE-3 Study have been obtained from the U.S. FDA, Health Canada, the European Medicines Agency, and Australia's Therapeutic Goods Administration. Sites will be opened in 8 countries and the study is presently recruiting participants in the U.S., Canada, and Europe. "The safety and efficacy data of our lead drug candidate, INT230-6, generated for sarcomas was quite encouraging. Many insights were gained from the over 200 patients treated before initiating the INVINCIBLE-3 study and applied to the ongoing study. Our approach uses sophisticated interventional radiology technologies to guide needles into tumors to inject our novel cytotoxic drug, which is highly absorbed by tumors, and showed a potential meaningful impact on lengthening metastatic sarcoma patient lives, reducing toxicities and improving quality of life compared to current treatments in our first clinical trial," said Lewis H. Bender, Intensity's President and Chief Executive Officer. "Our unique chemistry enables water-based products to diffuse throughout tumors and into cancer cells, causing immunologic cell death." About INT230-6 INT230-6, Intensity's lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity's proprietary DfuseRx℠ technology platform. The drug is comprised of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a penetration enhancer molecule (SHAO) that helps disperse potent cytotoxic drugs throughout tumors for diffusion into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy. About Intensity Therapeutics Intensity is a late-stage clinical biotechnology company whose novel engineered chemistry enables aqueous cytotoxic-containing drug formulations to mix and saturate a tumor's dense, high-fat, pressurized environment following direct intratumoral injection. As a result of the saturation, Intensity's clinical trials have demonstrated the ability of INT230-6 to kill tumors and elicit an adaptive immune response within days of injection, representing a new approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases even for malignancies that do not respond to conventional immunotherapy. Intensity has completed two clinical studies and enrolled over 200 patients using INT230-6: a Phase 1/2 dose escalation study in metastatic cancers including sarcomas (NCT03058289), and a Phase 2 randomized control clinical trial in locally advanced breast cancer (the "INVINCIBLE-2 Study") (NCT04781725) in women without undergoing chemotherapy prior to their surgery. The Company initiated a Phase 3 trial in soft tissue sarcoma (the "INVINCIBLE-3 Study") (NCT06263231), testing INT230-6 as second or third-line monotherapy compared to the standard of care ("SOC") with overall survival as an endpoint. Intensity also initiated a Phase 2 study in collaboration with The Swiss Group for Clinical Cancer Research, SAKK (the "INVINCIBLE-4 Study") (NCT06358573) as part of a Phase 2/3 program evaluating INT230-6 followed by the SOC immunochemotherapy and the SOC alone for patients with presurgical triple-negative breast cancer. Pathological complete response ("pCR") is the endpoint. For more information about Intensity, including publications, papers, and posters about its novel approach to cancer therapeutics, visit . Forward-Looking Statements Certain statements in this press release may constitute "forward-looking statements" within the meaning of the United States Private Securities Litigation Reform Act of 1995, as amended to date. These statements include, but are not limited to, statements relating to the Company's expected future plans, cash runway, development activities, projected milestones, business activities or results. When or if used in this communication, the words "may," "could," "should," "anticipate," "believe," "estimate," "expect," "intend," "plan," "predict" and similar expressions and their variants, as they relate to the Company or its management, may identify forward-looking statements. The forward-looking statements contained in this press release are based on management's current expectations and projections about future events. Nevertheless, actual results or events could differ materially from the plans, intentions, and expectations disclosed in, or implied by, the forward-looking statements. These risks and uncertainties, many of which are beyond our control, include: the initiation, timing, progress and results of future preclinical studies and clinical trials and research and development programs; the need to raise additional funding before the Company can expect to generate any revenues from product sales; plans to develop and commercialize product candidates; the timing or likelihood of regulatory filings and approvals; the ability of the Company's research to generate and advance additional product candidates; the implementation of the Company's business model, strategic plans for the Company's business, product candidates and technology; commercialization, marketing and manufacturing capabilities and strategy; the rate and degree of market acceptance and clinical utility of the Company's system; the Company's competitive position; the Company's intellectual property position; developments and projections relating to the Company's competitors and its industry; the Company's ability to maintain and establish collaborations or obtain additional funding; expectations related to the use of cash and cash equivalents and investments; estimates regarding expenses, future revenue, capital requirements and needs for additional financing; and other risks described in the section entitled "Risk Factors" in the Company's SEC filings, which can be obtained on the SEC website at . Readers are cautioned not to place undue reliance on the forward-looking statements, which speak only as of the date on which they are made and reflect management's current estimates, projections, expectations and beliefs. The Company does not plan to update any such forward-looking statements and expressly disclaims any duty to update the information contained in this press release except as required by law. Investor Relations Contact: Justin Kulik [email protected] CORE IR (516) 222-2560 Media Contact: Jules Abraham CORE IR [email protected] SOURCE Intensity Therapeutics Inc. WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

Clinical ResultPhase 2Phase 3ImmunotherapyASCO

100 Deals associated with Vinblastine Sulfate

External Link

KEGG	Wiki	ATC	Drug Bank
D01068	Vinblastine Sulfate	L01CA01	DB00570

R&D Status

Approved

10 top approved records.

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Indication	Country/Location	Organization	Date
Pheochromocytoma	JP	Nippon Kayaku Co., Ltd.	26 Mar 2013
Astrocytoma	JP	Nippon Kayaku Co., Ltd.	14 Feb 2005
Glioma	JP	Nippon Kayaku Co., Ltd.	14 Feb 2005
Multiple Myeloma	JP	Nippon Kayaku Co., Ltd.	14 Feb 2005
Ovarian Cancer	JP	Nippon Kayaku Co., Ltd.	14 Dec 2004
Recurrent Malignant Extragonadal Germ Cell Tumor	JP	Nippon Kayaku Co., Ltd.	14 Dec 2004
Testicular Neoplasms	JP	Nippon Kayaku Co., Ltd.	14 Dec 2004
Transitional Cell Carcinoma	JP	Nippon Kayaku Co., Ltd.	30 Jan 2004
Choriocarcinoma	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Embryonal Carcinoma	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Hemangiosarcoma	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Neuroblastoma	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Rhabdomyosarcoma	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Sarcoma	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Trophoblastic Neoplasms	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Wilms Tumor	JP	Nippon Kayaku Co., Ltd.	02 Aug 2001
Hodgkin's Lymphoma	-	Eli Lilly & Co.	02 Mar 1961
Lymphoma	-	Eli Lilly & Co.	02 Mar 1961

Developing

10 top R&D records.

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Indication	Highest Phase	Country/Location	Organization	Date
Hodgkin's Lymphoma	Phase 2	DE	Eli Lilly & Co.	01 Mar 2004

Clinical Result

Indication

Phase

Evaluation

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT03331341 (4429, CTgov)	Phase 1/2	Classical Hodgkin's Lymphoma	50	Laboratory Biomarker Analysis+Dacarbazine+Doxorubicin Hydrochloride+pembrolizumab+Vinblastine	uymqndjdpi(xyqeolgumv) = uesgdbuorw bxttcqejwa (ldumobfnkr, qxdtitqzgn - axzpzaeavs) View more	-	09 Jan 2025
NCT03907488 (S1826, Pubmed) Manual	Phase 3	Classical Hodgkin's Lymphoma	994	Brentuximab vedotin with doxorubicin, vinblastine, and dacarbazine (BV+AVD)	(zncmmqbudf) = gayupdvuxb jbbvagisdq (ildiamthic, 79 - 86)	Positive	17 Oct 2024
				Nivolumab with doxorubicin, vinblastine, and dacarbazine (N+AVD)	(zrfkbcvwij) = yjgdluffya rknbplhqvd (ochgfjpumq ) View more
NCT05008224 (KEYNOTE-C11, CTgov)	Phase 2	Classical Hodgkin's Lymphoma	146	Dacarbazine+Etoposide+CYCLOPHOSPHAMIDE+Prednisone+Doxorubicin+pembrolizumab+Vinblastine+Procarbazine+Bleomycin+Vincristine	kvxjxymwgs(ftcrlzdbqe) = ggdirozuma npouveflrt (oopsdnexik, mqbkhvywdo - hswzvuiiny) View more	-	16 Oct 2024
NCT01712490 (ECHELON-1, ASCO2024) Manual	Phase 3	Classical Hodgkin's Lymphoma First line	-	A+AVDbrentuximab vedotindoxorubicinvinblastinedacarbazine	(idafybdjfm) = lhpiuxowhh azmigqjiei (cluodfjhpq, 91.1 - 95.2) View more	Positive	24 May 2024
				ABVDdoxorubicinbleomycinvinblastinedacarbazine	(idafybdjfm) = ictitiwatq azmigqjiei (cluodfjhpq, 85.8 - 91.1) View more
NCT03517137 (EORTC-1537-COBRA, EHA2024) Manual	Phase 2	Hodgkin's Lymphoma First line	145	A-AVD (Brentuximab vedotin + doxorubicin +vinblastine + dacarbazine) or BrECADD ( Brentuximab vedotine + etoposide + cyclophosphamide + doxorubicin + dacarbazine + dexamethasone)	(fybmahuiaj) = vrgjqyadvm hifjiabnre (ujbfnjjgxu, 85.7 - 92.4) View more	Positive	14 May 2024
				Brentuximab vedotBrentuximab vedotinnblastine, dacarvinblastineVD)dacarbazine	(fybmahuiaj) = isvcvzzmya hifjiabnre (ujbfnjjgxu )
NCT03912818 (CTgov)	Phase 2	Bladder Mixed Adenocarcinoma \| Urothelial Carcinoma of the Urinary Bladder \| Bladder Squamous Cell Carcinoma	7	Cystectomy+doxorubicin+cisplatin+Vinblastine+Durvalumab+methotrexate (Cohort I (Durvalumab, DD MVAC))	rmdogvvtbd(vkzeztjcir) = jysyxvoswj ipeisggoca (hgsjauyeyn, frmyafwsub - osxvdliwbn) View more	-	11 Sep 2023
				Cystectomy+Carboplatin+Gemcitabine+Durvalumab (Cohort III (Durvalumab, Carbo-gem))	rmdogvvtbd(vkzeztjcir) = ckwdzsuxjd ipeisggoca (hgsjauyeyn, mhhztewvts - scwcmqmsrb) View more
NCT01712490 (ECHELON-1, FDA) Manual	Phase 3	Classical Hodgkin's Lymphoma	1,334	ADCETRIS+doxorubicin+vinblastine+dacarbazine	(utqrxjrgmv) = ghkukgfwte ufubhoxuwk (vmwhxwqkyj ) View more	Positive	14 Jun 2023
				doxorubicin+bleomycin+vinblastine+dacarbazine	(utqrxjrgmv) = wydpddsvbn ufubhoxuwk (vmwhxwqkyj ) View more
NCT01712490 (Pubmed \| Lancet Haematol) Manual	Phase 3	Classical Hodgkin's Lymphoma First line	1,334	brentuximab vedotin + doxorubicin + vinblastine + dacarbazine	(bggmcmpdmg) = jbjmpjmbti ikzosguvuc (zdooalfzhi, 79.0 - 85.0) View more	Positive	01 Jun 2023
				doxorubicin + bleomycin + vinblastine + dacarbazine	(bggmcmpdmg) = anfouqysgi ikzosguvuc (zdooalfzhi, 71.7 - 78.5) View more
NCT01771107 (AMC 085, CTgov)	Phase 1/2	Classical Hodgkin's Lymphoma \| HIV Infections	41	Pharmacological Study+Dacarbazine+Doxorubicin Hydrochloride+Vinblastine+Brentuximab Vedotin	hlcyhfeiuj(nkghzxloud) = vljmmtdgga hqndmosajo (oyfcbzhswv, sbxspgtntg - geasdvxgbc)	-	03 Mar 2023
NCT02979522 (ASCO2022) Manual	Phase 1/2	Classical Hodgkin's Lymphoma First line	59	doxorubicin+vinblastine+dacarbazine+brentuximab vedotin	(lwzsszzqst) = ysqbtpyvwx ehivlimtfv (jzigfgifsl ) View more	Positive	02 Jun 2022

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