ARG1

Pictured: Stack of coins with trading graph/iStock, KanawatTH Following a recent rebranding and executive team overhaul, Spyre Therapeutics announced Thursday it scored $180 million in private financing from existing and new investors. Thursday’s deal has Spyre selling six million shares of common stock for $15 a share and 150,000 shares of its Series B preferred stock at $600 a pop. The biotech will use the proceeds, in addition to the $205 million in cash it had on hand as of September 30, 2023, to fund its programs. The cash runway is expected to last into the second half of 2026. Spyre, previously branded as Aeglea BioTherapeutics, has had a tough run. Initially focused on rare diseases, the FDA turned down Aeglea’s candidate for arginase 1 deficiency in June 2022, asking for more efficacy data to support its BLA. What followed was a 25% cut to its workforce and the departure of its CEO in August 2022. The headcount was whittled down two more times as part of sweeping reorganization efforts to a staff of 10. In June 2023, Aeglea made a big jump and acquired Spyre Therapeutics in a stock-trade deal, adding its pipeline of antibody therapeutics for inflammatory bowel disease to the portfolio. In November 2023, the combined company rebranded to take the Spyre name, bringing in a new CEO, expanding the leadership team and adding to its board of directors. Spyre’s lead candidates, SPY001 and SPY002 are best-in-class hopefuls already in IND-enabling studies. The monoclonal antibody therapeutics target a4b7 and TL1A, respectively, and are anticipated to be in the clinic next year. SPY001 is the same class of drug as Takeda’s Entyvio, which is approved to treat Crohn’s disease and ulcerative colitis. Last year, global sales came in at over $6.4 billion. This week has been a busy one for biopharma capital raises. Amgen-backed Seismic Therapeutics nabbed $121 million for its two lead programs—a pan-immunoglobulin G protease sculpting enzyme candidate and a PD-1 agonist. Odyssey Therapeutics took in $101 million in Series C financing to advance its portfolio of immunology and oncology therapeutics. A fresh infusion of $90 million will help radiopharmaceutical company ArtBio take its prostate cancer program into the clinic. Kate Goodwin is a freelance life science writer based in Des Moines, Iowa. She can be reached at kate.goodwin@biospace.com and on LinkedIn.

– New data from PERIO-03 clinical trial indicates PEDD™ method resulted in modulation of the tumor microenvironment by enabling performance of a TLR9 agonist in pancreatic tumors – DENVER & SAN DIEGO--(BUSINESS WIRE)-- TriSalus Life Sciences® Inc., (Nasdaq: TLSI), an oncology company integrating its novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors, today announced initial positive safety and feasibility data from a Phase 1 trial at the Society of Immunotherapy for Cancer (SITC) 2023 Annual Meeting. TriSalus is studying an investigational class C toll-like receptor-9 (TLR9) agonist, SD-101, delivered intravascularly using the Company’s proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method of administration in three Phase 1 trials (periotrial.com). In PERIO-03, SD-101 is delivered via PEDD with the TriSalus Infusion System® using a retrograde venous approach, leveraging established interventional radiology access techniques. The TriSalus Infusion System has an expandable SmartValve® and can interface with standard invasive blood pressure transducers for continuous pressure monitoring during infusion of a therapeutic. During infusion, the device blocks retrograde flow and modulates pressure in the vessel, resulting in the perfusion of the venous and capillary network isolated by the device. Early safety and feasibility data from the PERIO-03 locally advanced pancreatic adenocarcinoma trial revealed that in three patients who received SD-101 via retrograde venous infusion PEDD at the lowest dose level (0.5 mg), there were no serious grade 3/4 adverse events related to treatment. This is a first-in-human experience for use of PEDD and retrograde venous infusion for delivery of an immunologic agent into pancreatic tumors. Immune signals pointed to a decrease in myeloid derived suppressor cells (MDSC) activity in the treated pancreatic tumors, with declines in MDSC associated genes, including arginase-1, nitric oxide synthetase-2, and S100A9 (n=3). Signals associated with T cell activation were also noted in pancreatic tumor biopsy specimens. “There is a critical need for novel treatments and approaches in locally advanced pancreatic cancer. The PERIO-03 trial is a highly innovative and multidisciplinary approach of delivery of a novel immunotherapy into the pancreas through pancreatic retrograde venous infusion,” stated Michael S. Lee, M.D., associate professor of Gastrointestinal (GI) Medical Oncology at The University of Texas MD Anderson Cancer Center. “The treatments have been well tolerated and the translational studies show intriguing changes in immune markers. We are excited to continue enrolling patients in this study.” “These data offer additional validation of our innovative immunotherapy approach for pancreatic tumors. SD-101 was selected based on its mechanism of action, which has the potential to reverse immunosuppression in the pancreas through depletion of MDSC in concert with broad stimulation of immune cells in the tumor microenvironment,” said Steven C. Katz, M.D., FACS, Chief Medical Officer at TriSalus. “TriSalus delivery systems, which use the PEDD method, are designed to overcome mechanical barriers to immunotherapy success, which may be underappreciated factors in limiting performance of TLR agonists in liver and pancreas tumors. Pancreatic tumors in particular contain very dense stromal tissue, which may accentuate the mechanical barriers to effective drug delivery in these patients.” Overall, the data emerging from PERIO-03 trials indicate immunologic changes are occurring within the pancreas, with a favorable safety profile. Additionally, pre-clinical data presented by TriSalus at SITC indicates that SD-101 administered via PEDD can enable both intravenously and subcutaneously administered checkpoint inhibitors. TriSalus will also present data from its PERIO-01 trial for uveal melanoma liver metastases at a SITC late breaker session on Saturday, November 4 at 11:25 am PT. All TriSalus presentations from SITC are available here following their respective sessions. About Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials The Pressure-Enabled Regional Immuno-Oncology (PERIO) clinical trials are studying an investigational class C toll-like receptor-9 agonist, SD-101, delivered intravascularly by TriSalus’ TriNav® Infusion System (TriNav) using the Company’s proprietary Pressure-Enabled Drug Delivery™ (PEDD™) method of administration in three Phase 1 trials. The PERIO-01 Phase 1 clinical study for uveal melanoma with liver metastases (UMLM), is studying SD-101 delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors. The PERIO-02 Phase 1b clinical study for hepatocellular carcinoma and intrahepatic cholangiocarcinoma, is studying SD-101 delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors. The PERIO-03 Phase 1 clinical study for locally advanced pancreatic adenocarcinoma, is studying SD-101 delivered via PEDD with TriNav in combination with intravenous checkpoint inhibitors. About TriSalus Life Sciences TriSalus Life Sciences® is an oncology company integrating novel delivery technology with immunotherapy to transform treatment for patients with liver and pancreatic tumors. The Company’s platform includes devices that utilize a proprietary drug delivery technology and a clinical stage investigational immunotherapy. The Company’s two FDA-cleared devices use its proprietary Pressure-Enabled Drug Delivery™ (PEDD™) approach to deliver a range of therapeutics: the TriNav® Infusion System for hepatic arterial infusion of liver tumors and the Pancreatic Retrograde Venous Infusion System for pancreatic tumors. PEDD is a novel delivery approach designed to address the anatomic limitations of arterial infusion for the pancreas. The PEDD approach modulates pressure and flow in a manner that delivers more therapeutic to the tumor and is designed to reduce undesired delivery to normal tissue, bringing the potential to improve patient outcomes. SD-101, the Company’s investigational immunotherapeutic candidate, is designed to improve patient outcomes by treating the immunosuppressive environment created by many tumors and that can make current immunotherapies ineffective in the liver and pancreas. Patient data generated during Pressure-Enabled Regional Immuno-Oncology™ (PERIO) clinical trials support the hypothesis that SD-101 delivered via PEDD may have favorable immune effects within the liver and systemically. The target for SD-101, TLR9, is expressed across cancer types and the mechanical barriers addressed by PEDD are commonly present as well. SD-101 delivered by PEDD will be studied across several indications to address immune dysfunction and overcome drug delivery barriers in the liver and pancreas. In partnership with leading cancer centers across the country – and by leveraging deep immuno-oncology expertise and inventive technology development – TriSalus is committed to advancing innovation that improves outcomes for patients. Learn more at trisaluslifesci.com and follow us on Twitter and LinkedIn. For Patients To learn more about the clinical trial treatment protocol and enrollment, visit or and search NCT04935229, NCT05220722, and NCT05607953. Forward Looking Statements Statements made in this press release regarding matters that are not historical facts are “forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward‐looking statements. Such statements include, but are not limited to, statements regarding the benefits and potential benefits of the Company’s PEDD drug delivery technology and SD-101 investigational immunotherapy. Risks that could cause actual results to differ from those expressed in these forward‐looking statements include risks associated with clinical development and regulatory approval of drug delivery and pharmaceutical product candidates, including that future clinical results may not be consistent with patient data generated during the Company’s PERIO clinical trials, and other risks described in the Company’s filings with the Securities and Exchange Commission under the heading “Risk Factors.” All forward‐looking statements contained in this press release speak only as of the date on which they were made and are based on management’s assumptions and estimates as of such date. The Company undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made except as required by law.

NEW YORK, Nov. 01, 2023 (GLOBE NEWSWIRE) -- IO Biotech (Nasdaq: IOBT), a clinical-stage biopharmaceutical company developing novel, immune modulating cancer vaccines based on its T-win® technology platform, today announced three poster presentations at the Society for Immunotherapy of Cancer’s 38th Annual Meeting (SITC) being held in San Diego, California from November 1-5, 2023. “The data presented provide clear evidence that our immune modulating vaccines, developed based on our T-win technology platform, impact several immune escape mechanisms as elegantly exemplified in abstract #1468,” said Mai-Britt Zocca, PhD, President and Chief Executive Officer of IO Biotech. “The data in this poster demonstrate enhanced in vivo anti-tumor effect when IDO and PD-L1 vaccines are co-administered in these models, further supporting the clinical observations regarding our lead investigational therapeutic vaccine candidate, IO102-IO103, which targets IDO and PD-L1. Data from clinical trials of IO102-IO103 administered with a PD-1 inhibitor demonstrated enhanced anti-tumor activity in multiple tumor types, including metastatic melanoma, non-small cell lung cancer and squamous cell cancer of the head and neck.” Dr. Zocca continued, “Additionally, the arginase-1 data presented in abstract #1335 further demonstrate the potential of our T-Win® technology platform to generate additional vaccine candidates. Our T-Win technology vaccine candidates are designed to kill both tumor cells and immune suppressive cells in the TME, by stimulating activation of T cells against a particular target, such as arginase-1. Arginase-1 is expressed by multiple difficult-to-treat tumor types including colorectal and ovarian cancers.” Abstract Number 1468: Peptide vaccination against PD-L1 reduces tumor growth in preclinical models through stimulation of PD-L1-targeting T cells in the tumor microenvironment Presenter: Marion Chapellier, PhD, Senior Scientist, IO Biotech Date and time: Saturday, November 4, 2023; poster session 11:55 am – 1:25 pm and poster reception 7:00 – 8.30 pm PDT Abstract Number 1335: Arginase-1 vaccine promotes T cell immunity against arginase 1+ cells, controls tumor growth via immune modulation of tumor microenvironment Presenter: Marco Carretta, PhD, Senior Scientist, IO Biotech Date and time: Friday, November 3, 2023; poster session lunch 12:00 – 1.30 pm and poster reception 5:10 – 6:40 pm PDT Abstract Number 1029: T Cell Receptor Diversity Analysis of in vitro-Expanded T cells Against IDO1 and PD-L1-Derived Peptides Presenter: Preeyam Patel, PhD, Senior Scientist, IO Biotech Date and time: Friday, November 3, 2023; poster session lunch 12:00 – 1.30 pm and poster reception 5:10 – 6:40 pm PDT The posters will be available on the “Posters & Publications” page of the IO Biotech website as of Friday, November 3, 2023, 9:00 am PDT. About IO102-IO103 IO102-IO103 is an investigational immune modulating therapeutic cancer vaccine designed to target the immunosuppressive mechanisms mediated by the proteins indoleamine 2,3-dioxygenase (IDO) and programmed death-ligand 1 (PD-L1). The company is currently conducting a pivotal Phase 3 trial (IOB-013/KN-D18; NCT05155254) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced melanoma patients, a Phase 2 basket trial (IOB-022/KN-D38; NCT05077709) evaluating IO102-IO103 in combination with pembrolizumab in first-line advanced non-small cell lung cancer and head and neck cancer (SCCHN), and a Phase 2 basket trial (IOB-032/PN-E40; NCT05280314) evaluating IO102-IO103 plus pembrolizumab as a perioperative treatment in solid tumors including melanoma and SCCHN. The clinical trials are sponsored by IO Biotech and conducted in collaboration with Merck and Merck is supplying pembrolizumab. IO Biotech maintains global commercial rights to IO102-IO103. KEYTRUDA® is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. About IO Biotech IO Biotech is a clinical-stage biopharmaceutical company developing novel, immune-modulating therapeutic cancer vaccines based on its T-win® vaccine platform. The T-win platform is a novel approach to cancer vaccines designed to activate T cells to target the immunosuppressive cells in the tumor microenvironment. IO Biotech is advancing its lead cancer vaccine candidate, IO102-IO103, in clinical trials, and additional pipeline candidates through preclinical development. Based on positive Phase 1/2 first line advanced melanoma data, IO102-IO103 has been granted a breakthrough therapy designation for the treatment of unresectable / metastatic melanoma by the US Food and Drug Administration. IO Biotech is headquartered in Copenhagen, Denmark and has US headquarters in New York, New York. For further information, please visit Forward-Looking Statement This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements, including regarding the timing of the interim analysis of our Phase 3 trial, current or future clinical trials, their progress, enrollment or results, or the company’s financial position or cash runway, are based on IO Biotech’s current assumptions and expectations of future events and trends, which affect or may affect its business, strategy, operations or financial performance, and actual results and other events may differ materially from those expressed or implied in such statements due to numerous risks and uncertainties. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified. Because forward-looking statements are inherently subject to risks and uncertainties, you should not rely on these forward-looking statements as predictions of future events. These forward-looking statements speak only as of the date hereof and should not be unduly relied upon. Except to the extent required by law, IO Biotech undertakes no obligation to update these statements, whether as a result of any new information, future developments or otherwise. Company Contact: Maryann Cimino, Director of Investor Relations IO Biotech, Inc. 617-710-7305 mci@iobiotech.com