On October 30, 2024 SynOx Therapeutics Limited ("SynOx"), a late clinical-stage biopharmaceutical company developing a novel treatment for CSF-1 related and macrophage-driven disorders, reported that it has raised additional funding in a final close of its Series B financing (Press release, SynOx Therapeutics, OCT 30, 2024, View Source [SID1234647546]). The Series B extension was led by new investor Gilde Healthcare and brings the total capital raised by SynOx in the round to $92 million including earlier investments from Forbion, HealthCap and Bioqube Ventures. Proceeds from the financing are supporting a registrational Phase 3 clinical trial of emactuzumab, a potentially best-in-class CSF-1 receptor (CSF-1R) inhibiting monoclonal antibody for the treatment of Tenosynovial Giant Cell Tumour (TGCT).

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In conjunction with the closing of the Series B extension, SynOx reported that the first patients have been dosed in its Phase 3 registrational study of emactuzumab. The study, named TANGENT, is a global, multi-centre, randomized, double-blind, placebo-controlled Phase 3 trial designed to evaluate the efficacy and safety of emactuzumab in patients with TGCT. The study’s primary outcome measure is overall response rate (ORR). Investigators will also assess several secondary outcomes including functional and quality of life measurements, impact on tumour volume, and duration of response. Investigators expect to enrol approximately 130 patients in the trial. Additional study details can be found on ClinicalTrials.gov (Identifier: NCT05417789).

TGCT is a rare, non-malignant but aggressively growing tumour of the synovium, primarily located in knee, hip, and ankle joints and caused by excessive production of CSF-1. It is a chronically debilitating disease for patients causing loss of function of the affected joints, pain, stiffness and limited range of motion. Emactuzumab specifically inhibits CSF-1R and earlier clinical work in TGCT1 showed it to be a highly effective, next-generation therapy with a short treatment cycle, rapid onset of action and long duration of response.

"We are pleased to add Gilde Healthcare to our impressive investor syndicate and are appreciative for their support of our team and our vision for the potential of emactuzumab to address the unmet needs, and improve the quality of life, of TGCT patients around the world," said Ray Barlow, Ph.D., Chief Executive Officer of SynOx. "The dosing of patients in the TANGENT trial marks an important milestone for SynOx and is a testament to the dedication and hard work of our team. We look forward to efficiently conducting this study and continuing to pursue our goal of advancing emactuzumab toward market for TGCT patients in desperate need of new treatment options."

As part of the Series B extension, Arthur Franken, general partner at Gilde Healthcare, will join the SynOx Board of Directors. Mr. Franken brings more than two decades of venture and growth capital investment expertise, including several public listings and trade sales.

"We are pleased to join SynOx as an investor and help support the late-stage development of emactuzumab, which we believe has a best-in-class profile as a CSF-1R targeted antibody. Importantly, we also believe that the SynOx team is well positioned to successfully complete clinical development of emactuzumab and deliver this important treatment option to TGCT patients," said Mr. Franken.

On October 30, 2024 SynOx Therapeutics Limited ("SynOx" or the "Company"), the late-stage clinical biopharmaceutical company developing emactuzumab for the treatment of Tenosynovial Giant Cell Tumour (TGCT) and other diseases, reported it has entered into a $35m loan facility with Hercules Capital, Inc. (NYSE:HTGC) ("Hercules") (Press release, SynOx Therapeutics, OCT 30, 2024, View Source [SID1234647545]).

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The transaction strengthens the Company’s balance sheet as it executes TANGENT, a registrational Phase 3 study of emactuzumab, SynOx’s potentially best-in-class CSF-1(R) inhibiting monoclonal antibody (mAb) for the treatment of TGCT.

This loan facility provides SynOx with flexibility to fund additional clinical work in TGCT to augment TANGENT, activities to support the successful registration and commercialisation of emactuzumab in TGCT, and potentially to explore the use of emactuzumab in other CSF-1 driven and macrophage-mediated diseases.

The term loan facility provides up to $35m, in total, in four tranches. The initial tranche was drawn on signing, with subsequent tranches available over the medium term and upon achievement of certain clinical milestones.

Ray Barlow, Chief Executive Officer of SynOx Therapeutics, said: "This funding will provide SynOx with additional capital to fulfil its mission of establishing emactuzumab as a best-in-class drug, to address significant unmet medical needs and greatly improve the quality of life for as many patients as possible. We are grateful for the support from Hercules, which together with the $75m we raised recently in our Series B round, puts SynOx on a strong financial footing."

R. Bryan Jadot, Senior Managing Director and Group Head – Life Sciences, Hercules, said: "We have been impressed by the quality of data SynOx has already generated on emactuzumab, which demonstrate it to be highly differentiated from other CSF-1 inhibiting drugs in development. Emactuzumab is showing great promise in treating TGCT, and we believe it has the potential to treat other related conditions as well."

TGCT is a type of tumour that affects the soft tissue lining of joints and tendons. It is a highly debilitating disease that often impacts large, important joints such as the knee, hip and ankle. It seriously impacts quality of life by causing significant pain and stiffness in affected joints and limiting range of motion. While most patients receive surgical intervention, more than 50% of patients with diffuse disease experience tumour recurrence within three years of surgery [1].

Emactuzumab, a novel next-generation CSF-1R mAb with a potentially best-in-class profile, has demonstrated substantial clinical activity in earlier clinical work in TGCT [2], with an objective response rate (ORR) of 71%, rapid and robust tumour reduction, a long duration of effect, significant improvements in functional ability, good tolerability and a manageable safety profile. The Phase 3 TANGENT trial will assess its safety and efficacy in patients with localized and diffuse TGCT.

On October 30, 2024 Replimune Group, Inc. (NASDAQ: REPL), a clinical stage biotechnology company pioneering the development of novel oncolytic immunotherapies, reported that a late-breaking abstract featuring the IGNYTE clinical trial primary analysis has been selected for oral presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2024) being held November 6-10, 2024, in Houston, Texas (Press release, Replimune, OCT 30, 2024, View Source [SID1234647544]). Data from the ARTACUS clinical trial of RP1 monotherapy in solid organ transplant patients with advanced cutaneous malignancies will also be shared in an encore poster presentation.

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Presentation Details

Title: Primary analysis of the registration-intended cohort of patients with anti-PD1 failed melanoma from the IGNYTE trial of RP1 plus nivolumab, including clinical subgroup and initial biomarker data
Abstract Number: 1504
Presentation Session Title: Session 204 – Clinical Late-Breaking Abstract Session
Date and Time: Saturday, November 9, 2024, 11:45 am – 12:45 pm CST
Presenter: Michael K. Wong, MD, PhD, University of Texas MD Anderson Cancer Center

Title: Safety and efficacy results from an open-label phase 1b/2 study of RP1 oncolytic immunotherapy in solid organ transplant recipients with advanced cutaneous malignancies (ARTACUS)
Abstract Number: 693
Date and Time: Friday, November 8, 2024
Presenter: Diwakar Davar, MD, UPMC Hillman Cancer Center

On October 30, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR) ("Monopar Therapeutics" or the "Company"), a clinical-stage biotechnology company focused on developing innovative treatments for patients with unmet medical needs, reported the closing of its previously announced best efforts public offering of shares of its common stock at a public offering price of $16.25 per share, for aggregate gross proceeds of approximately $19.2 million, before deducting the placement agent’s fees and other offering expenses payable by the Company (Press release, Monopar Therapeutics, OCT 30, 2024, View Source [SID1234647543]).

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Janus Henderson Investors, RA Capital Management, L.P. and other notable growth and life science investors participated in the offering.

Rodman & Renshaw LLC acted as the exclusive placement agent for the offering.

Monopar Therapeutics intends to use the net proceeds from the offering for general corporate purposes, which may include research and development expenditures, clinical trial expenditures, manufacture and supply of product and working capital.

The securities were offered and sold pursuant to a "shelf" registration statement on Form S-3 (File No. 333-268935), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on December 21, 2022, and declared effective on January 4, 2023. A final prospectus supplement and accompanying prospectus describing the terms of the offering has been filed with the SEC and is available on its website at www.sec.gov. Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained by contacting Rodman & Renshaw LLC at 600 Lexington Avenue, 32nd Floor, New York, NY 10022, by email at [email protected], or by telephone at (212) 540-4414.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of the securities described herein, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. The offering was made only by means of the prospectus supplement and accompanying prospectus forming a part of the effective registration statement.

On October 30, 2024 Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, reported it will host a conference call and audio webcast at 8:00 a.m. ET on Thursday, October 31, 2024 to provide a favorable study design update on the Company’s pivotal Phase 3 SENTRY study in JAKi naive myelofibrosis (Press release, Karyopharm, OCT 30, 2024, View Source,-2024 [SID1234647542]).

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The call will feature leading myelofibrosis key opinion leaders Dr. Raajit Rampal, Director of the Center for Hematologic Malignancies and Director of the Myeloproliferative Neoplasms Program at Memorial Sloan Kettering Cancer Center and Dr. John Mascarenhas, principal investigator of the Phase 3 SENTRY trial, Professor of Medicine at the Icahn School of Medicine at Mount Sinai and Director of the Center of Excellence for Blood Cancers and Myeloid Disorders.

To access the conference call, please dial (800) 836-8184 (local) or (646) 357-8785 (international) at least 10 minutes prior to the start time and ask to be joined into the Karyopharm Therapeutics call. A live audio webcast of the call, along with accompanying slides, will be available under "Events & Presentations" in the Investor section of the Company’s website, View Source An archived webcast will be available on the Company’s website approximately two hours after the event.