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Crinetics Pharmaceuticals Announces Proposed Public Offering of Common Stock

On October 8, 2024 Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX), a clinical-stage pharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for endocrine diseases and endocrine-related tumors, reported that it intends to offer and sell, subject to market and other conditions, $400.0 million of shares of its common stock in a proposed underwritten public offering (Press release, Crinetics Pharmaceuticals, OCT 8, 2024, View Source [SID1234647083]). In addition, Crinetics intends to grant the underwriters a 30-day option to purchase up to an additional $60.0 million of shares of common stock. All of the shares to be sold in the proposed offering are to be sold by Crinetics. 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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Crinetics intends to use the net proceeds from the proposed offering, together with its existing cash, cash equivalents and investment securities, to fund research and development of its clinical-stage product candidates, other research programs, pre-commercialization activities and other general corporate purposes, which may include, among other things, capital expenditures or working capital. Crinetics may also use a portion of the remaining net proceeds, together with its existing cash, cash equivalents and investment securities, to in-license, acquire, or invest in complementary businesses, technologies, products or assets; however, it has no current commitments or obligations to do so.

Leerink Partners and Morgan Stanley are acting as joint bookrunning managers for the proposed offering.

The securities described above are being offered by Crinetics pursuant to a shelf registration statement that became automatically effective upon its filing with the Securities and Exchange Commission (SEC). The proposed offering may be made only by means of a prospectus supplement and accompanying prospectus. A preliminary prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Leerink Partners LLC, Attention: Syndicate Department, 53 State Street, 40th Floor, Boston, MA 02109, by telephone at (800) 808-7525, ext. 6105, or by email at [email protected]; or Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014, by email at [email protected]. Electronic copies of the preliminary prospectus supplement and accompanying prospectus will also be available on the website of the SEC at www.sec.gov.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

BPGbio and University of Oxford Enter into Strategic Collaboration Focused on Breakthrough E2-based Protein Degradation Research in Oncology and CNS Diseases

On October 7, 2024 BPGbio, Inc., a leading biology-first, AI-powered, clinical stage biopharma focused on mitochondrial biology and protein homeostasis, and the University of Oxford’s Centre for Medicines Discovery, reported a five-year research collaboration focused on advancing novel protein degradation technologies, particularly in oncology and central nervous system (CNS) diseases, with the goal of unlocking new therapeutic pathways for conditions with limited treatment options (Press release, BPGbio, OCT 7, 2024, View Source [SID1234647077]). The organizations will work in phases, starting with the validation of BPGbio’s novel E2 TPD technology, and expanding into future study of the degradable target space, to identify novel targets and generate high quality publications.

This collaboration builds on BPGbio’s first-in-class E2-based protein degradation program, which features a proprietary library of more than 1,000 Ro3 fragments discovered by BPGbio that are potential ligands and seed compounds to a variety of E2 targets. The collaboration will also utilize BPGbio’s proprietary ternary structures, its computational toolkit for E2 ligand design, and assays for rapidly attaining selectivity and specificity.

The partnership will leverage the Centre for Medicines Discovery’s expertise in translational research, including their groundbreaking efforts in neurological diseases such as Parkinson’s Disease. The team will utilize BPGbio’s proprietary NAi Interrogative Biology Platform, which integrates patient biology with AI-driven analysis, to accelerate biomarker discovery and therapeutics development.

"This collaboration represents a powerful alliance of biology-first science and cutting-edge translational research," said Niven R. Narain, Ph.D., President and CEO of BPGbio. "By harnessing our NAi Interrogative Biology Platform alongside the University of Oxford’s expertise, we aim to push the boundaries of protein degradation science and deliver transformative therapies for diseases like cancer and CNS disorders, where unmet medical needs remain significant."

"By partnering with BPGbio, we’re combining our world-class translational research expertise with their pioneering approach to protein degradation," said Prof. Paul Brennan, Ph.D., FRSC, Director of the Centre for Medicines Discovery at University of Oxford. "This collaboration has the potential to unlock new therapeutic strategies for diseases that have long resisted treatment, including challenging cancers and CNS disorders. We are excited to explore novel targets and bring forward breakthrough therapies that could make a profound difference for patients."

Equillium Announces Abstract Accepted for Poster Presentation at the Society for Immunotherapy of Cancer

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.

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.

Scholar Rock Announces Proposed Public Offering of Common Stock and Pre-Funded Warrants

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.

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].

BerGenBio Announces Safety Data from Dose Escalation Phase 1b in First Line NSCLC Patients

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]).

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."