Leiomyosarcoma

FIBROSARC (NCT04650984) is a Phase III trial evaluating Onfekafusp alfa (L19TNF, also known as Fibromun) plus doxorubicin versus doxorubicin alone as front-line therapy for patients with advanced or metastatic Soft Tissue Sarcoma An Independent Data and Safety Monitoring Board reviewed safety and efficacy data of the pre-planned interim analysis and recommended continuing the study as planned by the protocol L19TNF is also currently studied in pivotal trials for the treatment of newly diagnosed and recurrent Glioblastoma, for which very encouraging data have recently been published SIENA, Italy, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Philogen S.p.A. (BIT:PHIL) is pleased to announce that the Phase III FIBROSARC trial (NCT04650984) will continue as planned by the protocol. The decision was made by an Independent Data and Safety Monitoring Board (DSMB) following the review of efficacy and safety data in the pre-planned interim analysis. FIBROSARC is a Phase III 1:1 randomized trial (NCT04650984) which studies L19TNF in combination with doxorubicin (Experimental Arm) versus doxorubicin alone (Control Arm) in 118 patients as first-line therapy for advanced or metastatic Soft Tissue Sarcoma (STS). The primary objective of the study is Progression Free Survival (PFS), with an estimated 45% reduction in the risk of progression in the Experimental Arm (Hazard Ratio 0.55). The pre-planned interim analysis was carried out at 50% of the expected events (i.e., one event corresponds to a disease progression or death) necessary for the primary outcome. The 46 events required to trigger the interim analysis were reached on 9th November 2023, and at the time of this Press Release the study has enrolled 97 out of 118 patients across 24 clinical centers in Germany, Italy, France, Poland, and Spain. The enrolment of 118 patients is expected to be completed in 2024. Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented: "We are very pleased with the recommendation of the DSMB to continue the study as planned by the protocol. The Phase III FIBROSARC trial was designed to demonstrate a significant clinical benefit of L19TNF plus doxorubicin compared to doxorubicin alone. If the final analysis is successful, the study is expected to provide an innovative treatment option for patients with advanced or metastatic STS, for whom no new paradigm-shifting therapies have been available in the last decades.” Alfredo Covelli, MD, Chief Medical Officer of Philogen, commented: "Advanced or metastatic STS are aggressive tumors still treated with chemotherapy-based regimens that were approved in the 1970s. Most innovative therapies, such as immune checkpoint inhibitors, failed to provide a significant benefit to this patient population. We are excited to record the outcome of the interim analysis of FIBROSARC and look forward to seeing the final analysis.” L19TNF is also being evaluated in (i) a Phase IIb randomized trial in first-line metastatic Leiomyosarcoma in the United States (NCT03420014), (ii) a Phase II randomized trial in pre-treated advanced or metastatic Soft Tissue Sarcoma in Europe (NCT04733183), (iii) a Phase II randomized trial in Glioblastoma at first progression in Europe (NCT04573192), and (iv) a Phase I/II/IIb trial in newly diagnosed Glioblastoma in Europe (NCT04443010). Philogen is currently launching a new Phase II study in Glioblastoma at first or later progression in the United States, based on the very encouraging preliminary data observed in the European study. These results have already been published in the journal Science Translational Medicine in 2023 (Look at al. Sci. Trans. Med. 2023, 15:eadf2281). For more information about Onfekafusp alfa (also known as Fibromun), FIBROSARC Phase III study (NCT04650984), Soft Tissue Sarcoma, and Philogen, please visit https://www.philogen.com/investors/press-releases/. FOR MORE INFORMATION: Philogen - Investor Relations IR@philogen.com - Emanuele Puca | Investor Relations

FDA provides "Study May Proceed" letter for open-label, randomized phase 3 protocol in soft tissue sarcoma, and plans to initiate phase 3 study in first half of 2024 SHELTON, Conn., Jan. 3, 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 intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, today announced a business update reflecting progress in its phase 3 sarcoma clinical program. IND Submission for Phase 3 In the fourth quarter of 2023, the Company submitted a new Investigational New Drug ("IND") to the Food and Drug Administration ("FDA"). The submission included the phase 3 protocol for a superiority trial of the Company's lead product INT230-6 used as monotherapy compared to the standard of care drugs in 2nd and 3rd line treatment for certain soft tissue sarcoma subtypes. The FDA provided the Company a "Study May Proceed" letter for phase 3 within the 30 day period following the IND submission. The study is an open-label, randomized phase 3 trial expected to enroll 333 patients. For every three patients enrolled, two will receive INT230-6 and one will receive standard of care drug(s) chosen by the investigators depending on the type of sarcoma. The Company is working with its contracted vendors to initiate the phase 3 trial in the first half of 2024. Manufacturing In the fourth quarter of 2023, the Company successfully developed the phase 3 quality analytical methods for measurement of the key INT230-6 components, validated those methods and manufactured a clinical batch of the drug product that met specifications. During the fourth quarter, the Company requested and was granted a meeting that was held with the FDA to review the INT230-6 chemical manufacturing and controls ("CMC") for INT230-6. The CMC discussion focused on the tasks necessary to initiate the phase 3 study and future product registration as part of a potential New Drug Application (NDA). During the meeting, the Company and FDA agreed upon a plan for the CMC set of activities for the active pharmaceutical ingredients and the drug product (INT230-6) necessary for the NDA. "The FDA's 'Study May Proceed' letter is another important milestone towards achieving our mission to develop a new, safer, and more effective way to treat cancer patients especially in the difficult to treat types such as sarcoma. A head-to-head comparison of INT230-6 as monotherapy locally delivered in metastatic sarcoma against the active, systemically-delivered standard-of-care drugs may be a first-of-its kind clinical trial," said Lewis H. Bender, President and Chief Executive Officer of Intensity. "Current standard-of-care drugs used for sarcoma after progression of the first line therapies require extensive safety monitoring. The standard of care drugs cause severe toxicities and provide median overall survival of only between 12 and 15 months depending on the drug and sarcoma subtype used. New and more effective ways to treat these patients are desperately needed." In November of 2023 at the annual Connective Tissue Oncology meeting held in Dublin, Christian Frederick Meyer, M.D., Ph.D., M.S., an Assistant Professor of Oncology at the Sidney Kimmel Cancer Center at Johns Hopkins University and an investigator for Intensity's Phase 1/2 clinical trial of INT230-6, presented that when compared to a synthetic control1, INT230-6 alone extended survival in refractory soft tissue sarcoma subjects by approximately 14.9 months. Dosing higher amounts of INT230-6 relative to a patient's presenting total tumor burden showed a potential further increase in survival when compared to the synthetic control. Median survival of the synthetic control for subjects failing a median of 3 lines of prior therapy was about 6.8 months. Median overall survival of INT230-6 monotherapy (n=15) was 21.5 months. The INT230-6 Disease Control Rate2 was 93% in subjects who received at least one dose of INT230-6 as monotherapy. Data on INT230-6 generated in metastatic patients indicated that INT230-6 has a favorable safety profile and is well tolerated with the majority of treatment-emergent adverse events (TEAEs) being grade 1 or 2 primarily localized pain, fatigue, and nausea. In September of 2023 the Company announced that the US FDA's Office of Orphan Products Development granted orphan-drug designation for the treatment of soft tissue sarcoma (STS) to the three active moieties comprising INT230-6, cisplatin, vinblastine sulfate, and the diffusion enhancer SHAO-FA (8-((2-hydroxybenzoyl) amino) octanoate). 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 mostly in the arms, legs, chest, and abdomen. There are many types of sarcoma; however, the four most common are bone sarcoma (referred to as osteosarcoma), leiomyosarcoma, undifferentiated pleomorphic sarcoma (UPS) and liposarcoma. When sarcoma is metastatic prognosis is poor, even with chemotherapy. Each year, 12,000 people in the U.S. and 1,150 in Canada are diagnosed with soft tissue sarcomas. About 3,000 patients have bone sarcomas . 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 composed 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 i.e. direct killing of the tumor by INT230-6, the dying tumor releases a bolus of neoantigens specific to the patient's malignancy, leading to engagement of the immune system and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression that so often occurs with systemically delivered chemotherapy. About Intensity Therapeutics Intensity Therapeutics is a late-stage clinical biotechnology company that applies novel engineered chemistry to turn "cold" tumors "hot" by enabling its aqueous cytotoxic-containing drug product, INT230-6, to mix and saturate the dense, high-fat pressurized environment of the tumor. 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 truly novel approach to cancer cell death that holds the potential to shift the treatment paradigm and turn many deadly cancers into chronic diseases. For more information about the Company, including publications, papers and posters about its novel approach to cancer therapeutics, visit . INT230-6 has completed enrollment of over 200 patients in two phase 2 and phase 1 dose escalation clinical trials (NCT03058289 and NCT04781725) with various advanced solid tumors; IT-01 in metastatic disease, and IT-02 (the INVINCIBLE study) in presurgical breast cancer. The Company partnered with Merck Sharpe & Dohme (Merck) to evaluate the combination of INT230-6, Intensity's lead product candidate, and KEYTRUDA® (pembrolizumab), Merck's anti-PD-1 (programmed death receptor-1) therapy, in patients with advanced malignancies. The Company also partnered with Bristol-Myers Squibb to evaluate the combination of INT230-6 with Bristol-Myers Squibb's anti-CTLA-4 antibody, ipilimumab, in patients with advanced cancers. The Company also executed agreements with the Ottawa Hospital Research Institute (OHRI) and the Ontario Institute of Cancer Research (OICR) to study INT230-6 in the INVINCIBLE study, a randomized controlled neoadjuvant phase 2 study in women with early-stage breast cancer. 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 expected future plans, development activities, projected milestones, business activities or results. We have based these forward-looking statements on our 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 we make. These risks and uncertainties, many of which are beyond our control, include: the risk that the anticipated milestones may be delayed or not occur or be changed, as well as 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: Argot Partners Jonathan Nugent [email protected] 205-566-3026 Media Contact: Argot Partners David Rosen [email protected] 212-600-1902 1 A synthetic control is a construction of a weighted combination of reported data to which the treatment group is compared. This comparison is used to estimate what would have happened to the treatment group if it had not received the treatment. The synthetic control developed to predict survival of the enrolled IT-01 sarcoma population was based on the presenting biomarker data and used the Royal Marsden Hospital Index method for survival prediction. 2 The disease control rate measures the percentage of patients with advanced or metastatic cancer who have achieved had stable disease, partial response or complete response while on a therapy. SOURCE Intensity Therapeutics Inc.

Polaris Group (The Company, TWSE:6550) announced that its board approved to increase the acquisition of Genovior Biotech's shares to 100%. Additionally, Dr. Steve Hsu, Chairman of Genovior Biotech Corporation, has been appointed as the CEO of Polaris Group. This significant decision not only allows Polaris Group to expand the product pipeline beyond its novel cancer metabolism therapy but also marks its entry into the highly promising realm of peptide drugs, such as the widely recognized Semaglutide-related products. These two highly prospective product lines will serve as the dual engines propelling Polaris Group's future growth. The newly appointed CEO, Dr. Steve Hsu, holds a Ph.D. in Chemical Engineering from the Massachusetts Institute of Technology (MIT) and has over 30 years of professional experience in the pharmaceutical industry. He is among the outstanding experts in organic chemistry synthesis. Notably, his expertise extends to peptide drugs with over thirty amino acids, achieving exceptionally high yields through synthesis or semi-synthesis approach. Under his leadership, Genovior Biotech has successfully developed the widely sought-after drug "Semaglutide" for diabetes and weight management. Polaris intends to commence large-scale production based on this achievement, with anticipated mass product shipments starting in the latter half of the upcoming year. Market evaluations suggest a sustained high demand for this drug in the coming years, potentially resulting in significant revenue for Polaris Group. Regarding novel anti-cancer drugs, Polaris submitted a Biologics License Application (BLA) Rolling Submission for ADI-PEG 20 in malignant pleural mesothelioma to the U.S. FDA in November of this year. Currently preparing for commercialization, the company is actively engaging in negotiations with global and regional commercialization partners. In addition, Polaris has three Phase III clinical trials underway for glioblastoma (GBM), leiomyosarcoma (LMS), and hepatocellular carcinoma (HCC). Expectations are high for obtaining approvals for multiple cancer indications in the future, promising considerable revenue from either licensing deals or sales. Polaris Group acquired Genovior Biotech's shares for over 2 billion NT dollars (approximately USD 70 millions), gaining not only access to the peptide product line but also a formidable group of workforce in Taiwan. Dr. Hsu leads a team of over 160 professionals and oversees facilities in both Zhunan Science Park and Southern Taiwan Science Park. Notably, the E. coli production line closely resembles that of Polaris Group' Vacaville facility. With the upcoming launch of Polaris's anti-cancer drugs, expanding production capacity in Taiwan can be swiftly accomplished. Consequently, Genovior Biotech fills critical gaps for Polaris Group, providing not just high-quality manufacturing capabilities but also a substantial entry into the market for peptide products. The integration of resources between the two entities is poised to significantly enhance the company's competitiveness, fostering expectations for further elevation in company value. Polaris Group is a biopharmaceutical company dedicated to pioneering advanced therapies, primarily focusing on metabolic related diseases. Our lead drug candidate, Pegargiminase (ADI-PEG 20), is presently advancing through the BLA-enabling stage and clinical development. Pegargiminase is designed to disrupt cancer cell metabolism, providing a novel approach to treating a wide range of cancers heavily influenced by metabolic pathways. Our mission is to revolutionize the treatment of complex diseases like cancer by concentrating on their metabolic foundations, ultimately striving to enhance patient outcomes globally. Genovior Biotech Corporation is a leading Contract Development and Manufacturing Organization (CDMO) in Asia. Operating from state-of-the-art facilities located in Hsinchu and Tainan, Taiwan, Genovior holds prestigious PIC/S GMP certification, distinguishing itself in the production of commercial Active Pharmaceutical Ingredients (APIs) and injectables. Renowned as a reliable partner, Genovior specializes in the comprehensive development, formulation, and manufacturing of biologics, adhering to stringent GMP regulations. With a steadfast commitment to safeguarding intellectual property and ensuring client satisfaction, Genovior offers a broad spectrum of expertise in peptide and protein biologics, injectable formulations, and versatile manufacturing capacities, catering to preclinical, clinical, and commercial requirements. The content above comes from the network. if any infringement, please contact us to modify.