RayzeBio, Inc. Announces Closing of Upsized $358 Million Initial Public Offering and Full Exercise of Underwriters’ Option to Purchase Additional Shares

On September 19, 2023 RayzeBio, Inc. (Nasdaq: RYZB), a targeted radiopharmaceutical company developing an innovative pipeline against validated solid tumor targets, reported the closing of its previously announced upsized $358 million initial public offering (IPO) of 19,869,240 shares of common stock, including the full exercise of the underwriters’ option to purchase up to 2,591,640 additional shares from RayzeBio, at a price to the public of $18.00 per share (Press release, RayzeBio, SEP 19, 2023, View Source [SID1234635263]). RayzeBio sold 18,706,240 shares of common stock and the selling stockholder named in the prospectus sold 1,163,000 shares of common stock. RayzeBio did not receive any proceeds from the sale of shares by the selling stockholder. The aggregate gross proceeds to RayzeBio from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by RayzeBio, were approximately $336.7 million. The shares began trading on The Nasdaq Global Market on September 15, 2023 under the symbol "RYZB."

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J.P. Morgan, Jefferies, Evercore ISI and Truist Securities acted as joint book-running managers for the offering.

Registration statements relating to these securities have been filed with the U.S. Securities and Exchange Commission (SEC) and became effective on September 14, 2023. A copy of the registration statements can be accessed through the SEC’s website at www.sec.gov. This offering was made only by means of a prospectus forming part of the registration statements relating to these securities. A copy of the final prospectus relating to this offering may be obtained from: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by email at [email protected]; Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, NY 10055, by telephone at (888) 474-0200, or by email at [email protected]; and Truist Securities, Inc., Attention: Prospectus Department, 3333 Peachtree Road NE, 9th floor, Atlanta, GA 30326, or by telephone at (800) 685-4786, or by email at [email protected].

This press release shall not constitute an offer to sell, or a solicitation of an offer to buy these securities, 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 the registration or qualification under the securities laws of any such state or jurisdiction.

EpimAb Biotherapeutics to Present Initial First-in-human Data of EMB-02 at the 2023 ESMO Conference

On September 19, 2023 EpimAb Biotherapeutics, a clinical stage biotechnology company specializing in the development of bispecific antibodies, reported that the company will present the first-in-human results for EMB-02 as a poster display at the 2023 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress on October 23 (local time) (Press release, EpimAb Biotherapeutics, SEP 19, 2023, View Source [SID1234635261]). This poster will feature initial safety, efficacy, and pharmacokinetic/ pharmacodynamic (PK/PD) data from the EMB-02 Phase I dose escalation study in advanced solid tumors (NCT04618393). The presentation details are as follows:

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Title: Preliminary Phase I Results from a First-in-Human Study of EMB-02, a PD-1xLAG-3 Bispecific Antibody, in Patients (pts) with Advanced Solid Tumors

Presentation number: 1028P

EMB-02 is a bispecific antibody based on EpimAb’s proprietary FIT-Ig (Fabs-In-Tandem Immunoglobulin) technology, which generates bispecific molecules with superior properties. The EMB-02 bispecific antibody targets two checkpoint proteins, PD-1 and LAG-3, and restores effector T cell function through robust inhibition and degradation of the target proteins in the tumor microenvironment. In addition, it has shown strong anti-tumor efficacy in in vivo tumor models resistant to standard anti-PD-1 monotherapies.

Dr. Chengbin Wu, Founder and CEO of EpimAb commented, "The ESMO (Free ESMO Whitepaper) Congress is one of the premier global oncology conferences and we look forward to sharing the detailed EMB-02 data with key stakeholders, including clinicians, researchers, patient advocates, and other health industry representatives, at this event."

Pillar Biosciences Launches oncoReveal™ Core LBx, an NGS Kit to Enable Localized Liquid Biopsy Testing

On September 19, 2023 Pillar Biosciences, Inc., the leader in Decision Medicine, reported the global launch of oncoReveal Core LBx, a research-use-only (RUO) next-generation sequencing (NGS) kit designed to enable laboratories with a solution for liquid biopsy-based pan-cancer tumor profiling (Press release, Pillar Biosciences, SEP 19, 2023, View Source [SID1234635260]). The oncoReveal Core LBx is the latest addition to Pillar Biosciences’ portfolio of cancer profiling assays designed to enable localized testing and reduce time to treatment initiation.

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The oncoReveal Core LBx panel interrogates 104 clinically relevant genes in one multiplex reaction and has a fully automatable workflow that can be performed by any clinical laboratory, with a sample-to-report time in less than three days. With oncoReveal Core LBx, a laboratory will be able to batch >20 clinical samples on a single Illumina NextSeq run, enabling both the economic value and scale of sequencing needed to properly interrogate circulating cell-free tumor DNA (cfDNA) at extremely high levels of sensitivity and specificity.

"We are excited to launch oncoReveal Core LBx, specifically designed to meet the emerging needs of local laboratories looking for scalable and efficient NGS-based liquid biopsy testing solutions," said Randy Pritchard, CEO of Pillar Biosciences. "Currently, both clinicians and their patients are dependent on large national commercial reference labs to perform liquid biopsy testing, which is both expensive and delays treatment decisions. By enabling local and regional laboratory customers with in-house NGS capabilities for liquid biopsy, Pillar Biosciences can help ensure cancer patients are receiving the quality clinical testing they deserve in a more timely and cost-effective manner, leading to improved treatment decisions and clinical outcomes."

oncoReveal Core LBx analyzes cfDNA present in plasma for genetic alterations in cancer, including assessment of MSI, eliminating the need for an invasive biopsy or tumor tissue. With mutation detection performance as low as 0.1%, oncoReveal Core LBx provides highly accurate genetic profiles and clinically actionable information. oncoReveal Core LBx is powered by PiVAT, an automated secondary bioinformatics software that supports the identification of somatic mutations from cell-free DNA with high sensitivity and specificity. Pillar Biosciences’ proprietary PiVAT technology is fully compatible with third-party clinical reporting solutions.

ImmPACT Bio Doses First Patient in Phase 1/2 Trial Evaluating IMPT-314, a Bispecific CD19/CD20 CAR T-cell Therapy for the Treatment of Aggressive B-cell Lymphoma

On September 19, 2023 ImmPACT Bio USA, Inc. ("ImmPACT Bio"), a clinical-stage company developing transformative logic-gate-based chimeric antigen receptor (CAR) T-cell therapies for treating cancer and autoimmune diseases reported that the first patient has been dosed in the Phase 1/2 trial evaluating IMPT-314, a bispecific CD19/CD20 CAR T-cell therapy for the treatment of relapsed or refractory (R/R) aggressive B-cell lymphoma (Press release, ImmPACT-Bio, SEP 19, 2023, View Source [SID1234635259]).

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"We are pleased to have treated the first patient with IMPT-314 and build on the clinical evidence from the ongoing investigator-led study of this dual-targeted CD19/CD20 CAR T-cell therapy. We believe IMPT-314 may improve tolerability and durability of responses in patients with B-cell lymphomas and therefore has best-in-class potential," said Jonathan Benjamin, M.D., Ph.D., chief medical officer of ImmPACT Bio. "Safety and efficacy data from this Phase 1/2 study will determine the recommended Phase 2 dose for IMPT-314 and inform on potential cohort expansion opportunities. We expect to present Phase 1 safety and initial efficacy data from patients with relapsed or refractory aggressive B-cell lymphoma in the first half of 2024."

Sarah Larson, M.D. principal investigator and associate clinical professor of medicine, David Geffen School of Medicine at University of California, Los Angeles added, "While CD19 CAR T-cell therapies have transformed the lymphoma treatment landscape, durability has been limited by treatment resistance due to selective pressure against the target antigen and subsequent loss of expression. We designed this therapy to target both CD19 and CD20 to help restrict antigen escape and ultimately prolong treatment response. We look forward to delineating the differentiated therapeutic potential of this bispecific approach through data from ImmPACT Bio’s Phase 1/2 trial of IMPT-314."

ImmPACT Bio’s Phase 1/2 is a multi-center, open-label clinical trial that will evaluate the safety and efficacy of IMPT-314 in participants with R/R aggressive B-cell lymphoma. The dose-finding Phase 1 portion of the study will include both CAR T-experienced and CAR T-naïve patients.

IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for the treatment of R/R aggressive B-cell lymphoma.

About B-cell Lymphoma
B-cell lymphomas are a type of blood cancer affecting B cells of the immune system that often relapse and require multiple lines of therapy. In the U.S., approximately 85% of the non-Hodgkin lymphomas (NHL) are a type of B-cell lymphoma, including diffuse large B-cell lymphoma (DLBCL), follicular lymphoma, chronic lymphocytic leukemia (CLL), small lymphocytic lymphoma (SLL), and mantle cell lymphoma (MCL). Despite various approved therapies available, including CD19-targeted CAR T-cell therapies, there remains a significant unmet need for safe and highly efficacious therapies for B-cell lymphomas.

About IMPT-314
IMPT-314 is a CD19/CD20-targeting chimeric antigen receptor (CAR) T-cell therapy that utilizes a potent bispecific CAR and a 4-1BB costimulatory domain. It is the same CAR construct as ImmPACT Bio’s IMPT-514, which is under development for systemic lupus erythematosus and lupus nephritis. IMPT-314 and IMPT-514 are based on work by Yvonne Chen, Ph.D., associate professor, and Sarah Larson, M.D., associate clinical professor, both of the University of California, Los Angeles (UCLA). Initial Phase 1 data from a UCLA investigator-led study evaluating the bispecific CAR construct underlying IMPT-314 demonstrated a 91% (10/11) overall response rate, 73% (8/11) complete response rate, 18.2-month median progression free survival, and a well-tolerated safety profile with no cytokine release syndrome above Grade 1 and no neurotoxicity in patients with relapsed or refractory (R/R) non-Hodgkin lymphoma. IMPT-314 is currently being evaluated in the ongoing Phase 1/2, multi-center, open-label trial in participants with R/R aggressive B-cell lymphoma. IMPT-314 has received Fast Track Designation from the U.S. Food and Drug Administration for the treatment of R/R aggressive B-cell lymphoma.

Corbus Pharmaceuticals to Present Pre-Clinical Data Characterizing its CRB-701 Nectin-4 ADC at the at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics

On September 19, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported the pre-clinical data on its CRB-701 Nectin-4 anti-drug-conjugate (ADC) will be presented at the 2023 AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper), to be held in Boston, MA October 11-15, 2023 (Press release, Corbus Pharmaceuticals, SEP 19, 2023, View Source [SID1234635258]).

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Poster Details

Title:

Development of CRB-701 (SYS6002): A novel site-specific, Nectin-4 targeting ADC

Authors:

Zhaopeng Sun, Mo Dan, Lu Lv, Can Yuan, Congcong Niu, Yang Zhang, Mingyue Shen,
Xixin Hu, Xiwu Hui, Andrew Kolodziej and Rachael Brake

Abstract Number:

C121

Date/Time:

Saturday, October 14 from 12:30-4 P.M.