On March 22, 2022 Tollys, a biopharmaceutical company developing TL-532, the first anti-cancer immunotherapy based on a new generation of synthetic toll-like receptor 3 (TLR3) specific agonist, reported that it will release the latest preclinical developments of TL-532 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Tollys, MAR 22, 2022, View Source [SID1234610532]).

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The preclinical data included in the poster identified TL-532 as the spearhead of a new rationally designed TLR3-agonist family. In monotherapy, it demonstrated substantial tolerance and promising anti-cancer and auto-vaccinal activity, which included unrelated cancers. TL-532 also demonstrated its remarkable ability to overcome Immune Checkpoint Inhibitor (ICI) tumorresistance, thus increasing the clinical landscape for ICI combination treatment.

Further key highlights from the poster, titled ‘The specific TLR3-agonist TL-532 induces lifelong anti-tumor auto-vaccination, cross-immunity against unrelated cancers and reverses resistance to immune checkpoint inhibitors’:

 In vivo activity of TL-532 led to substantial tumor growth inhibition (88%) and delay (370%), translating into 35% Complete Response (CR) rate and 5.3-fold median survival benefit
 Interestingly, among these CRs, 62% (13/21) showed life-long tumor auto-vaccination after three consecutive rechallenges at 3, 10 and 30 months
 Remarkably, 54% (6/11) of the mice autovaccinated against bladder cancer also demonstrated cross-immunity against an unrelated and poorly immunogenic, syngeneic osteosarcoma cancer cell model (LM8)
 TL-532 treatment appeared to decrease the expression of the immune checkpoint PD-L1 on tumor cells ex-vivo and in cDCs in vivo and demonstrated a remarkable ability to reverse the anti-PD-L1 tumor-resistance when combined with the ICI leading to doubling of CR rate
 Ex vivo and in vivo, the tumor cell death by apoptosis induced by TL-532 was associated with a tumor microenvironment switch, evidenced by increases in antitumor biomarker secretion (IFN-α, IFN-λ1, IFN-γ, CCL5, CXCL9, CXCL10, CX3CL10), decreases in protumor biomarkers CCL22 and sFAS, and was associated in vivo with the recruitment and activation of conventional Dendritic Cells (cDCs) and Cytotoxic T-Lymphocytes (CTLs) at the tumor site.

Abstract title: ‘The specific TLR3-agonist TL-532 induces life-long anti-tumor autovaccination, cross-immunity against unrelated cancers and reverses resistance to immune checkpoint inhibitors’ Authors: Marc Bonnin, Saïd Ourfali, Mathilde Boucard-Jourdin, Clémence Perret, Chloé Renoux, Nelly Vey, Marc Colombel, Bettina Werlé, Sylvain Thierry. Tollys SAS, Lyon, France, Hospices Civils de Lyon, Université Claude Bernard Lyon 1, Lyon, France
Session category: Immunology Session title: Inflammation, Immunity and Cancer
Session date and Time: Tuesday Apr 11, 2022, 1:30 PM-5:00 PM
Location: New Orleans Convention Center, Exhibition Halls D-H, Poster Section 39
Poster board number: 2
Abstract number: 2085

The complete abstract can be accessed on the AACR (Free AACR Whitepaper) annual meeting website.

About TL-532
TL-532 is the first synthetic specific TLR3 agonist with a proprietary defined doublestranded RNA sequence. As such, TL-532 has the potential to be the best-in-class and firstto-market TLR3 agonist. TL-532 was shown to have a triple mechanism of action inducing 1) death by apoptosis selective to cancer cells-not in normal cells-, leading to the in-situ release of tumor specific antigens, 2) activation of the myeloid dendritic cells of the immune system to mount a specific T-cell response against the tumor antigens and 3) a switch of the tumor microenvironment by producing cytokines and chemokines which are unfavorable to tumor development. The result is the immunogenic cell death of tumor cells, accompanied by an auto-vaccination preventing the recurrence of cancer

On March 21, 2022 OSE Immunotherapeutics SA (ISIN: FR0012127173; Mnemo: OSE) reported that the United States Patent and Trademark Office (USPTO) has issued a first notice of allowance for a patent application covering OSE-279, an anti-PD1 monoclonal antibody, and its use in cancer treatment (Press release, OSE Immunotherapeutics, MAR 21, 2022, View Source [SID1234612853]). This patent will strengthen the global intellectual property of OSE-279 and will provide the product protection until 2039.

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OSE-279 is a humanized anti-PD1 monoclonal antibody blocking PD-L1 and PD-L2, the ligands of PD1 overexpressed by tumor cells. PD-L1 and PD-L2 are used by tumor cells to escape the immune system. Upregulation of PD-L1 and PD-L2 on tumor cells and other cell types of the tumor microenvironment is a proposed mechanism of tumor immune escape.

OSE-279 is the key anti-PD-1 backbone of BiCKI-IL-7*, an innovative bifunctional therapy combining anti-PD1 and the cytokine IL-7 and targeting PD1 to sustain exhausted T cell function and to disarm Treg suppressive activity.

Dominique Costantini, Chief Executive Officer of OSE Immunotherapeutics, comments: "We are very pleased with this first notice of allowance for a patent covering OSE-279 in a major territory that simultaneously reinforces the product’s intellectual property and its position in our portfolio as an immunotherapy that has the potential to transform the current anti-PD1 standard of care for hard-to-treat cancers. We look forward advancing our anti-PD1 backbone development with the Phase 1 clinical trial planned to start in 2022."

* Presentation at the 2022 American Society for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (April 8 – 13): "Anti-PD1/IL7v immunocytokine promotes durable T-cell responses and overcomes anti-PD1 resistance"
Session ED015 – Immunocytokines: Strategies for Drug Delivery and Tissue Targeting
April 9, 2022, 2:30 PM – 2:50 PM

ABOUT OSE Immunotherapeutics
OSE Immunotherapeutics is an integrated biotechnology company focused on developing and partnering therapies to control the immune system for immuno-oncology and autoimmune diseases. Its balanced first-in-class clinical and preclinical portfolio has a diversified risk profile:

Immuno-Oncology first-in-class products

Tedopi (innovative combination of neoepitopes): the company’s most advanced product; positive results for Phase 3 trial (Atalante 1) in Non-Small Cell Lung Cancer patients in secondary resistance after checkpoint inhibitor failure.
Other ongoing combination trials sponsored by cooperative clinical research groups in oncology:
Phase 2 in pancreatic cancer (TEDOPaM), sponsor GERCOR.
Phase 2 in ovary cancer, in combination with pembrolizumab (TEDOVA), sponsor ARCAGY-GINECO.
Phase 2 in non-small cell lung cancer in combination with nivolumab, sponsor Italian foundation FoRT.
BI 765063 (OSE-172, anti-SIRPα mAb on CD47/SIRPα pathway): developed in partnership with Boehringer Ingelheim in advanced solid tumors; positive Phase 1 dose escalation results of BI 765063 in monotherapy and in combination with ezabenlimab (PD-1 antagonist); ongoing expansion Phase 1.
OSE-279, anti-PD1 – advanced preclinical stage.
BiCKI: bispecific fusion protein platform built on the key backbone component of anti-PD1 combined with a new immunotherapy target (for example: BiCKI-IL7, preclinical stage) to increase anti-tumor efficacy.
Immunity & Inflammation first-in-class products

OSE-127/S95011 (humanized monoclonal antibody antagonist of IL-7 receptor): developed in partnership with Servier; positive Phase 1 results; ongoing Phase 2 in ulcerative colitis (sponsor OSE) and ongoing Phase 2a in Sjögren’s syndrome (sponsor Servier).
FR104 (anti-CD28 monoclonal antibody): licensing partnership agreement with Veloxis Pharmaceuticals, Inc. in transplantation; ongoing Phase 1/2 in renal transplant (sponsored by the Nantes University Hospital); US IND obtained by Veloxis Pharmaceuticals, Inc. for a clinical trial; Phase 2 planned in an autoimmune disease indication.
OSE-230 (ChemR23 agonist mAb): preclinical stage therapeutic agent with the potential to resolve chronic inflammation by driving affected tissues to tissue integrity.
CoVepiT: a prophylactic second-generation vaccine activating cytotoxic T lymphocytes against COVID-19, developed using optimized epitopes from SARS-CoV2 viral proteins, epitopes non impacted by multi-variants. Shows good tolerance and very good level of T cell immune response. In clinical testing, a long-term memory response was confirmed at 6 months.

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On March 21, 2022 Oasmia Pharmaceutical AB, an oncology-focused specialty pharmaceutical company, and Lonza, a global development and manufacturing partner to the pharma, biotech and nutrition industries, reported that the companies have signed a large-scale manufacturing agreement for the main drug intermediate in the supply of clinical material for its investigational drug candidate, Cantrixil (Press release, Vivesto, MAR 21, 2022, View Source [SID1234611841]).

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Cantrixil, an intraperitoneally administered drug in development for the treatment of late-stage ovarian cancer, was licensed by Oasmia from the Australian pharmaceutical company Kazia in 2021, having successfully completed a Phase I trial. Ovarian cancer is one of the most aggressive cancers and is difficult to treat in advanced stages. The Phase I study of Cantrixil demonstrated the potential for it to provide prolonged survival in advanced ovarian cancer by inducing ovarian cancer stem cells’ death and sensitizing cancer cells to standard chemotherapy. Oasmia is now preparing for the initiation of a Phase II trial of Cantrixil in advanced ovarian cancer.

Under the terms of the agreement, Lonza will provide kilogram-scale synthesis, purification, and stability testing of Cantrixil, and deliver cGMP batches of drug substance for clinical supply. Oasmia will leverage Lonza’s extensive experience and expertise in manufacturing highly-potent API (HPAPI). The drug substance will be manufactured at Lonza’s recently expanded production facility at Nansha, China. The manufacturing is expected to begin later in March 2022.

Kai Wilkinson, Chief Technical Officer at Oasmia, commented: "We are excited to have partnered with Lonza, a global leader in drug manufacturing. The manufacture of Cantrixil is planned to be performed in three steps and this agreement is the first and most crucial step in us securing the clinical drug supply for its development."

Christian Dowdeswell, VP and Global Head, Commercial Development – Small Molecules, Lonza, added: "Our team has extensive experience with supporting the development and manufacture of challenging molecules. We are looking forward to collaborating with Oasmia to advance this promising drug candidate in the clinic."

On March 21, 2022 Pulse Biosciences, Inc. (Nasdaq: PLSE), a novel bioelectric medicine company commercializing the CellFX System powered by Nano-Pulse Stimulation (NPS) technology, reported it will report financial results for the fourth quarter and full year of 2021 after market close on Thursday, March 31, 2022 (Press release, Pulse Biosciences, MAR 21, 2022, View Source [SID1234610604]). Company management will host a corresponding conference call beginning at 1:30pm Pacific Time.

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Investors interested in listening to the conference call may do so by dialing 1-877-705-6003 for domestic callers or 1-201-493-6725 for international callers. A live and recorded webcast of the event will be available at View Source

On March 21, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that members of its senior management team will participate in a fireside chat at the Stifel 2022 Virtual CNS Days on Monday March 28, 2022 at 12:30 PM ET (Press release, Prothena, MAR 21, 2022, View Source [SID1234610603]).

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A live webcast of the fireside chat can be accessed through the investor relations section of the Company’s website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.