On October 7, 2024 BerGenBio ASA (OSE: BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical needs, reported preliminary safety data from the Phase 1b portion of the BGBC016 study in first-line (1L) Non-Small Cell Lung Cancer (NSCLC) patients (Press release, BerGenBio, OCT 7, 2024, View Source [SID1234647074]).

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The Phase 1b part of the study evaluated three escalating doses of BerGenBio’s selective AXL inhibitor bemcentinib in combination with standard chemo-immunotherapy (CIT), doublet chemotherapy and pembrolizumab, Keytruda, for the 1L treatment of advanced/metastatic NSCLC patients. The primary endpoint was the assessment of the safety profile of the combination in NSCLC patients regardless of their STK11 mutational status.

Key conclusions include:

All three selected doses demonstrated that the triplet combination is well tolerated with no new safety signals identified, supporting the further clinical development of bemcentinib and CIT in 1L NSCLC patients.
No dose-related impact on electrocardiographic changes (QTc), a known class effect of tyrosine kinase inhibitors, was reported for bemcentinib during the observation period.
Pharmacokinetic analyses confirmed adequate plasma exposure of bemcentinib, achieving levels consistent with that previously observed in responders in BerGenBio’s BGBC008 study of bemcentinib and pembrolizumab in second-line NSCLC patients.

Martin Olin, Chief Executive Officer of BerGenBio, commented: "The data show that bemcentinib has a manageable safety profile and gives us increased confidence in continuing the BGBC016 clinical trial. The global trial is currently enrolling patients in Phase 2a targeting patients with a mutation in the STK11 gene, and we look forward to sharing the first preliminary data as they mature."

On October 7, 2024 Monopar Therapeutics Inc. (Nasdaq: MNPR), a clinical-stage radiopharma company focused on developing innovative treatments for cancer patients, reported that the Phase 1a clinical trial for its novel therapeutic radiopharmaceutical MNPR-101-Lu (MNPR-101 conjugated to lutetium-177) is now active and recruiting patients with advanced cancers (Press release, Monopar Therapeutics, OCT 7, 2024, View Source [SID1234647059]).

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The Phase 1a trial is an open-label dose-escalation study of MNPR-101-Lu in patients with solid tumors. The first clinical trial site activated for the study is the Melbourne Theranostic Innovation Centre (MTIC) in Australia. To help identify those patients most likely to benefit from MNPR-101-Lu, the trial will only be open to those participating in the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial.

MNPR-101 is Monopar’s proprietary antibody that targets the urokinase plasminogen activator receptor (uPAR), which is expressed in numerous tumor types including pancreatic, breast, colorectal, ovarian, and bladder. By selectively targeting uPAR, Monopar aims to deliver a radiopharma therapy that kills cancer cells while minimizing damage to healthy tissue. Both clinical (link) and preclinical (link) data to date have demonstrated highly specific and durable tumor uptake of MNPR-101-Zr (MNPR-101 conjugated to zirconium-89).

"We are very encouraged by the recently released human clinical data and preclinical efficacy results (link), and are thrilled to be launching this therapeutic trial months ahead of our originally planned schedule," said Chandler Robinson, MD, Monopar’s Chief Executive Officer.

"We believe this may be the world’s first uPAR-targeted therapeutic radiopharma clinical trial," commented Andrew Cittadine, Monopar’s Chief Operating Officer. "Our goal is to light up the tumors with MNPR-101-Zr and then treat them with MNPR-101-Lu."

Further information about the MNPR-101-Lu trial is available at www.ClinicalTrials.gov under study identifier NCT06617169. Details about the ongoing MNPR-101-Zr Phase 1 imaging and dosimetry clinical trial are available at www.ClinicalTrials.gov under study identifier NCT06337084.

On October 7, 2024 Scholar Rock Holding Corporation (Nasdaq: SRRK), a late-stage biopharmaceutical company focused on advancing innovative treatments for spinal muscular atrophy (SMA), cardiometabolic disorders, and other serious diseases where protein growth factors play a fundamental role, reported that it has commenced an underwritten public offering for $275 million of shares of its common stock and, in lieu of common stock to investors who so choose, pre-funded warrants to purchase shares of its common stock (Press release, Scholar Rock, OCT 7, 2024, View Source [SID1234647075]). All of the shares and pre-funded warrants are being offered by Scholar Rock. In addition, Scholar Rock intends to grant the underwriters a 30-day option to purchase additional shares of its common stock in an amount up to 15% of the securities offered in the public offering. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Scholar Rock intends to use the net proceeds from the offering to support commercialization of apitegromab, to advance its ongoing and future clinical programs, to further develop its technology platform to continue to advance its clinical and preclinical pipeline, and for working capital and other general corporate purposes.

J.P. Morgan Securities LLC, Jefferies LLC and Piper Sandler & Co. are acting as joint book-running managers for the offering. BMO Capital Markets Corp., Wedbush Securities Inc. and Raymond James & Associates, Inc. are acting as co-managers for the offering.

An automatically effective shelf registration statement on Form S-3 relating to the offering of the securities described above was filed with the Securities and Exchange Commission (SEC) on October 7, 2024. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, by contacting: J.P. Morgan Securities LLC, c/o: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by email at [email protected] and [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, by telephone at 877-821-7388, or by email at [email protected]; or Piper Sandler & Co., 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, Attention: Prospectus Department, by telephone at 800-747-3924, or by email at [email protected].

On October 7, 2024 Mural Oncology plc (Nasdaq: MURA), a clinical-stage immuno-oncology company developing novel, investigational engineered cytokine therapies designed to address areas of unmet need for patients with a variety of cancers, reported three upcoming poster presentations at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) taking place November 6-10, 2024 in Houston (Press release, Mural Oncology, OCT 7, 2024, View Source [SID1234647060]).

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The company will present tumor microenvironment pharmacodynamic data from the phase 1/2 ARTISTRY-3 study, an evaluation of less frequent dosing of nemvaleukin, Mural’s engineered interleukin-2 (IL-2). Additionally, Mural will share data from its two preclinical research programs in IL-18 and IL-12, including new preclinical efficacy data for IL-18. The details are as follows.

Title: Tumor microenvironment pharmacodynamic effect of nemvaleukin less frequent intravenous dosing in multiple solid tumors: results from the phase 1/2 ARTISTRY-3 study
Abstract Number: 217
Presentation Date: Friday, Nov. 8

Title: Preclinical efficacy and immune activity of half-life extended IL-18 fusion proteins resistant to IL-18BP suppression
Abstract Number: 1340
Presentation Date: Saturday, Nov. 9

Title: Modulation of IL-12p70 exposure and activity following sequential administration of tumor targeted self-assembling split IL-12 subunits
Abstract Number: 1300
Presentation Date: Saturday, Nov. 9

On October 7, 2024 Equillium Inc. (Nasdaq: EQ), a clinical-stage biotechnology company leveraging a deep understanding of immunobiology to develop novel therapeutics to treat severe autoimmune and inflammatory disorders, reported that an abstract was accepted for poster presentation at the 39th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (Press release, Equillium, OCT 7, 2024, View Source [SID1234647076]). The conference will take place at the George R. Brown Convention Center in Houston, Texas from November 6 to 10, 2024.

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Title: Interleukin (IL)-15 and IL-21 synergistically enhance NK and CD8+ T cell responses
Presenting Author: Phoi Tiet, Senior Research Associate, Equillium, Inc.
Abstract Number: 908
Location: Exhibit Halls A & B
Date: Saturday, November 9, 2024

The abstract highlights that cytokines are a focus of anti-cancer therapeutic development due to their central role in regulating anti-tumoral immune responses, and that data demonstrates that IL-15 and IL-21 synergistically augment NK and CD8 T cells activities, which further enhanced their proliferation and cytolytic function. With the ability to rescue T cell dysfunction, this cytokine combination could be a promising treatment approach to stimulating anti-tumor immune responses.

About Multi-Cytokine Platform and Multi-Cytokine Inhibitors EQ101 & EQ302

Our proprietary multi-cytokine platform generates rationally designed composite peptides that selectively block key cytokines at the shared receptor level targeting pathogenic cytokine redundancies and synergies while preserving non-pathogenic signaling. This approach is expected to avoid the broad immuno-suppression and off-target safety liabilities that may be associated with other therapeutic classes, such as Janus kinase inhibitors. Many immune-mediated diseases are driven by the same combination of dysregulated cytokines, and we believe identifying the key cytokines for these diseases will allow us to target and develop customized treatment strategies for multiple autoimmune and inflammatory diseases.

Current platform assets include EQ101, a clinical stage, first-in-class, selective, tri-specific inhibitor of IL-2, IL-9, and IL-15 for intravenous and subcutaneous delivery and EQ302, a preclinical stage, first-in-class, selective, bi-specific inhibitor of IL-15 and IL-21 for oral delivery.