On September 19, 2023 A recently published paper in the International Journal of Radiation Oncology – Biology – Physics (Red Journal) reported encouraging results from a multicenter clinical study conducted with Humanetics Corporation’s (Humanetics) novel radioprotective drug, BIO 300, in patients with non-small cell lung cancer (NSCLC) (Press release, Humanetics, SEP 19, 2023, View Source [SID1234635264]). Radiation therapy is a vital component of cancer treatment, delivering targeted doses of radiation to tumor sites to eliminate cancer cells. However, the challenge lies in minimizing the damage from radiation to surrounding healthy tissues, which can lead to debilitating side effects and limit treatment options. Humanetics aims to address this critical issue with BIO 300, which can safeguard normal tissues during radiotherapy without protecting the tumor, thereby enhancing patient outcomes and quality of life.

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Twenty-one patients were enrolled in the phase 1b/2a study evaluating the safety and clinical utility of BIO 300 as a radioprotector of normal tissues in patients with NSCLC (NCT02567799). The study was a nonrandomized, open-label, single-arm, ascending dose study in NSCLC patients prescribed concurrent radiotherapy and chemotherapy. Patients self-administered BIO 300 orally once daily starting before initiating radiotherapy and continued for the entire 6-7 week course of concurrent chemoradiotherapy. The primary endpoint was acute dose-limiting toxicities attributable to BIO 300. Secondary outcomes included pharmacokinetics, pharmacodynamics, overall toxicity profile, quality of life, local response rate, and survival.

The study found that BIO 300 was safe and well tolerated, and no dose-limiting toxicities were reported. Patient-reported quality of life and body weight were stable throughout the study period. The tumor response rate was 65%, with a complete response rate of 20%. BIO 300 did not alter the pharmacokinetics of standard chemotherapy. Serum TGFβ1, a pro-inflammatory/pro-fibrotic cytokine implicated in pulmonary fibrosis and radiation pneumonitis, was reduced in a dose-dependent manner across cohorts. In addition, patients receiving BIO 300 had a lower rate of hematological, pulmonary, and gastrointestinal toxicities compared to previous clinical studies with the same chemoradiotherapy regimen in the absence of BIO 300.

The pharmacodynamic results, combined with the tumor response and low toxicity rates, support further investigation of BIO 300 as an effective radioprotective drug in patients with NSCLC.

Ronald J. Zenk, CEO at Humanetics, expressed his enthusiasm regarding the clinical trial results, stating, "Showing that BIO 300 is safe and may protect normal lung tissues in NSCLC patients without compromising concurrent chemoradiotherapy has the potential to reform current cancer treatment. By reducing the risk of debilitating side effects, BIO 300 has the potential to improve quality of life for cancer patients undergoing radiation therapy."

BIO 300 is also under advanced development as a radiation medical countermeasure for the military and first responders, and BIO 300 is in a phase 2b trial evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

On September 19, 2023 A recently published paper in the International Journal of Radiation Oncology – Biology – Physics (Red Journal) reported encouraging results from a multicenter clinical study conducted with Humanetics Corporation’s (Humanetics) novel radioprotective drug, BIO 300, in patients with non-small cell lung cancer (NSCLC) (Press release, Humanetics, SEP 19, 2023, View Source [SID1234635264]). Radiation therapy is a vital component of cancer treatment, delivering targeted doses of radiation to tumor sites to eliminate cancer cells. However, the challenge lies in minimizing the damage from radiation to surrounding healthy tissues, which can lead to debilitating side effects and limit treatment options. Humanetics aims to address this critical issue with BIO 300, which can safeguard normal tissues during radiotherapy without protecting the tumor, thereby enhancing patient outcomes and quality of life.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Twenty-one patients were enrolled in the phase 1b/2a study evaluating the safety and clinical utility of BIO 300 as a radioprotector of normal tissues in patients with NSCLC (NCT02567799). The study was a nonrandomized, open-label, single-arm, ascending dose study in NSCLC patients prescribed concurrent radiotherapy and chemotherapy. Patients self-administered BIO 300 orally once daily starting before initiating radiotherapy and continued for the entire 6-7 week course of concurrent chemoradiotherapy. The primary endpoint was acute dose-limiting toxicities attributable to BIO 300. Secondary outcomes included pharmacokinetics, pharmacodynamics, overall toxicity profile, quality of life, local response rate, and survival.

The study found that BIO 300 was safe and well tolerated, and no dose-limiting toxicities were reported. Patient-reported quality of life and body weight were stable throughout the study period. The tumor response rate was 65%, with a complete response rate of 20%. BIO 300 did not alter the pharmacokinetics of standard chemotherapy. Serum TGFβ1, a pro-inflammatory/pro-fibrotic cytokine implicated in pulmonary fibrosis and radiation pneumonitis, was reduced in a dose-dependent manner across cohorts. In addition, patients receiving BIO 300 had a lower rate of hematological, pulmonary, and gastrointestinal toxicities compared to previous clinical studies with the same chemoradiotherapy regimen in the absence of BIO 300.

The pharmacodynamic results, combined with the tumor response and low toxicity rates, support further investigation of BIO 300 as an effective radioprotective drug in patients with NSCLC.

Ronald J. Zenk, CEO at Humanetics, expressed his enthusiasm regarding the clinical trial results, stating, "Showing that BIO 300 is safe and may protect normal lung tissues in NSCLC patients without compromising concurrent chemoradiotherapy has the potential to reform current cancer treatment. By reducing the risk of debilitating side effects, BIO 300 has the potential to improve quality of life for cancer patients undergoing radiation therapy."

BIO 300 is also under advanced development as a radiation medical countermeasure for the military and first responders, and BIO 300 is in a phase 2b trial evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

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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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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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.

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."

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.