On February 6, 2025 Tubulis reported the appointment of Matthew Norkunas, MD, MBA, as Chief Financial Officer (CFO) and President of Tubulis Inc., further strengthening its management team at a pivotal stage of growth. Dr. Norkunas’ proven track record of achieving financial and corporate goals for rapidly evolving biotechs will be instrumental in advancing Tubulis’ strategic objectives (Press release, Tubulis, FEB 6, 2025, View Source [SID1234650093]). His unique background as a physician-turned-business executive will support the company’s position as a leader and innovator in ADC drug development. Based in Tubulis’ U.S. Cambridge office, Dr. Norkunas’ appointment also expands the company’s U.S. presence.

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"Tubulis has built a strong financial position to advance its portfolio of ADC drug candidates and Matt’s impressive expertise in finance, business operations and capital markets, combined with his deep understanding of value creation in the biotech sector, makes him an outstanding addition to our team," said Dominik Schumacher, PhD, CEO and Co-founder of Tubulis. "As we focus on the next stage of corporate and pipeline development, his strategic insights and financial acumen will be critical in positioning Tubulis for long-term success."

"Tubulis is rapidly emerging as a front-runner in the ADC space, with a differentiated approach and cutting-edge technologies designed to overcome long-standing challenges in the field," said Matthew Norkunas, MD, MBA, CFO of Tubulis. "I am genuinely excited to join the company and look forward to working with the entire Tubulis team to further accelerate its innovative pipeline, which has the potential to make a profound difference in patients’ lives."

Dr. Norkunas brings extensive experience in financial leadership within the life sciences industry, having served as CFO at publicly listed and private biotech companies. Most recently, he was CFO at Generation Bio (Nasdaq: GBIO), where he oversaw financial operations and strategy for over four years. Before that, he served as CFO and Head of Corporate & Business Development at SomaLogic, driving key corporate growth initiatives. His career also includes experience in healthcare investment and operational roles, providing a broad perspective on biotech financial strategy. In addition to his position at Tubulis, Matthew Norkunas currently serves as a Board Member at oncology-focused cell and gene therapy company Obsidian Therapeutics. He is a trained anesthesiologist with an MD from the University of Maryland School of Medicine and an MBA from the Columbia Business School.

On February 6, 2025 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery platform, reported the pricing of a firm commitment, underwritten public offering of 11,523,810 shares of its common stock at a price to the public of $1.05 per share (Press release, Renovorx, FEB 6, 2025, View Source [SID1234650092]). All shares in the offering are being sold by RenovoRx.

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The gross proceeds from the offering are expected to be approximately $12.1 million before deducting underwriting discounts and commissions and offering expenses. The offering is expected to close on February 10, 2025, subject to satisfaction of customary closing conditions.

RenovoRx intends to use the net proceeds received from the offering for working capital and general corporate purposes, including continued progression of its Phase III TIGeR-PaC study and the continued development and execution of commercial sales and marketing activities for RenovoCath as a standalone device.

Titan Partners Group, a division of American Capital Partners, is acting as the sole bookrunner for the offering.

The shares of common stock will be issued pursuant to a shelf registration statement on Form S-3 (File No. 333-268302) previously filed with the Securities and Exchange Commission (the "SEC") on November 10, 2022, which became effective on November 21, 2022. The offering is being made only by means of a prospectus supplement and the accompanying base prospectus. A final prospectus supplement 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 final prospectus supplement and the accompanying base prospectus relating to the offering, when available, may be obtained by contacting Titan Partners Group LLC, a division of American Capital Partners, LLC, 4 World Trade Center, 29th Floor, New York, NY 10007, by phone at (929) 833-1246 or by email at prospectus@titanpartnersgrp.com.

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

On February 6, 2025 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators within the Caris Precision Oncology Alliance (Caris POA) will collectively present three studies at the 2025 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers (ASCO GU) Symposium, February 13-15, in San Francisco (Press release, Caris Life Sciences, FEB 6, 2025, View Source [SID1234650091]). The findings demonstrate the continued and expanded capabilities of Caris’ comprehensive database to enable novel insights into cancer that could have profound effects on a patient’s diagnosis, prognosis, care plan and response to treatment.

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"We are proud to present innovative research for prostate cancer and urothelial carcinoma at the upcoming ASCO (Free ASCO Whitepaper) GU meeting," said James Hamrick, MD, MPH, Chairman of the Caris Precision Oncology Alliance. "Through our comprehensive molecular profiling, powerful database and in-depth collaboration with Caris POA members, we are pushing the boundaries of precision medicine and helping improve outcomes for cancer patients."

Caris will present three posters at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers Symposium:

Evaluating molecular alteration profiles to distinguish intraductal carcinoma of the prostate
Poster Session A | Poster Board L3 | Abstract 407
February 13; 11:25 a.m. – 12:45 p.m. PST

Downregulation of E-selectin and contributions to immune restraining in prostate cancer
Poster Session A | Poster Board G30 | Abstract 257
February 13; 11:25 a.m. – 12:45 p.m. PST

Real-world analysis of 2IR immune response score in urothelial carcinoma (UC)
Poster Session B | Poster Board D36 | Abstract 739
February 14; 11:30 a.m. – 12:45 p.m. PST
Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth (#32). The full abstracts will be available on the Caris website beginning on February 13.

The Caris POA includes 96 cancer centers, academic institutions, research consortia and healthcare systems, including 47 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research to improve clinical outcomes for cancer patients.

On February 6, 2025 Shanghai Henlius Biotech, Inc. (2696.HK) reported it has entered into a license agreement with Dr. Reddy’s Laboratories SA, wholly-owned subsidiary of Dr. Reddy’s Laboratories Ltd., (BSE: 500124 | NSE: DRREDDY| NYSE: RDY | NSEIFSC: DRREDDY, along with its subsidiaries hereafter referred to as "Dr. Reddy’s") for the company’s independently developed investigational daratumumab biosimilar HLX15, a recombinant anti-CD38 fully human monoclonal antibody injection (Press release, Shanghai Henlius Biotech, FEB 6, 2025, View Source [SID1234650090]). Dr. Reddy’s will gain exclusive rights to commercialize both subcutaneous and intravenous formulation of HLX15 in a total of 43 countries and regions, comprising 42 European countries and regions and the United States (U.S.).

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Under the terms of the agreement, Henlius will be responsible for development, manufacturing and commercial supply, and may receive up to a total of $131.6 million, including a $33 million upfront payment and additional milestone payments. In addition, Henlius is eligible to receive royalties on annual net sales of the product. Dr. Reddy’s is a global pharmaceutical company, operating in over 75 countries across the globe. Through a partnership with Dr. Reddy’s, Henlius aims to boost the growth and reach of its products in the European and U.S. markets, providing local patients with enhanced treatment options.

"This collaboration with Dr. Reddy’s on HLX15 is a significant step in our response to global health needs and improving access to advanced biologics," said Dr. Jason Zhu, Executive Director and Chief Executive Officer of Henlius. "Dr. Reddy’s has a long-standing dedication to oncology, driven by the purpose that ‘Good Health Can’t Wait’, and is committed to timely access to affordable and high-quality medicines, which complement Henlius’ focus on addressing unmet medical needs in research and development. We are confident that this partnership will enhance the global market competitiveness of both organizations in oncology treatment, ultimately allowing us to reach and support more patients around the world."

"We are pleased to join hands with Dr. Reddy’s, signifying a pivotal moment in Henlius’ journey to expand our global partner network," said Ping Cao, Chief Business Development Officer and SVP of Henlius, "Henlius’ robust product development capabilities in biosimilars, along with its advanced manufacturing and quality systems that meet global standards, paired with Dr. Reddy’s vast experience and resources in the global commercialization of biosimilars, positions this collaboration to effectively harness the strengths of both organizations. Together, we aim to deliver more high-quality and affordable treatment options to the U.S. and European markets."

Erez Israeli, Chief Executive Officer of Dr. Reddy’s, said: "We are pleased to collaborate with Henlius to make this daratumumab biosimilar available to patients in the U.S., and Europe. Over the years, we have created a portfolio of biosimilar products that are being marketed in several emerging markets. This latest collaboration with Henlius further progresses our regulated markets journey in biosimilars. Additionally, oncology has been a top focus therapy area for us. We look forward to leveraging our strong commercial capabilities in these markets to ensure patients receive access to best-in-class therapies and affordable treatment options."

About HLX15

HLX15 is a fully human anti-CD38 IgG1κ monoclonal antibody independently developed by Henlius, and is a biosimilar candidate to Darzalex & Darzalex Faspro* which are indicated for the treatment of multiple myeloma. In accordance with the biosimilar guidelines of NMPA, EMA, and USFDA, HLX15 is being developed following the principles of stepwise development. HLX15 and reference daratumumab are considered comparable based on analytical similarity assessment and pre-clinical studies. In June 2024, the Phase 1 clinical study (NCT05679258) of HLX15 was successfully completed, meeting its primary endpoint. The findings indicate that HLX15 had similar pharmacokinetic characteristics, as well as comparable safety and immunogenicity profiles to the US-, EU-, and CN-sourced daratumumab. Comparative efficacy studies are currently underway.

*Darzalex & Darzalex Faspro are registered trademarks of Johnson & Johnson.

On February 6, 2025 TransCode Therapeutics, Inc. (NASDAQ: RNAZ), the RNA oncology company committed to more effectively treating cancer using RNA therapeutics, reported that Cohort 3 of its Phase 1 clinical trial enrolled three patients and all have been dosed with TTX-MC138, its lead candidate (Press release, TransCode Therapeutics, FEB 6, 2025, View Source [SID1234650089]). The Safety Review Committee monitoring the clinical trial unanimously approved opening of the third cohort based on its review of Cohort 1 and 2 safety and pharmacokinetic (PK) data and is monitoring Cohort 3 as preliminary data becomes available. The dose administered to patients in the third cohort is approximately double the dose administered in the second cohort.

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Several patients in the first and second cohort remain on study for continued treatment, receiving additional doses of TTX-MC138 over cycles of approximately 28 days each. No significant safety or dose limiting toxicities have been reported in any of the trial’s nine patients. Analyses of PK data and pharmacodynamic (PD) activity from Cohorts 1 and 2 is ongoing. To date, the analyses suggest that TTX-MC138 demonstrates a PK/PD profile consistent with preclinical results and results from TransCode’s previous Phase 0 clinical trial. Specifically, results from Cohort 1 confirmed the Phase 0 observation that TTX-MC138 shows evidence of pharmacodynamic activity in the presence of high baseline expression of miR-10b, reaching a 66% inhibition at 24 hours after infusion, similar to that seen in the Phase 0 trial. Additionally, TTX-MC138 activity increased with the escalated dose administered in Cohort 2 and was consistent at subsequent administrations suggesting a favorable pharmacokinetic profile.

About TTX-MC138

TTX-MC138 is a first-in-class therapeutic candidate designed to inhibit microRNA-10b, or miR-10b, a microRNA widely believed to be critical to the emergence and progression of many metastatic cancers. TransCode’s 2023 Phase 0 clinical trial produced evidence of delivery of a radiolabeled version of TTX-MC138 to metastatic lesions and pharmacodynamic activity, even at a microdose of the drug candidate, suggesting a broad therapeutic window for TTX-MC138.

About the Trial

TransCode’s Phase 1 clinical trial is a multicenter, open-label, dose-escalation and dose-expansion study designed to generate critical data to support evaluation of the safety and tolerability of TTX-MC138 in patients with a variety of metastatic solid cancers. While not an endpoint, the trial may provide early evidence of clinical activity of TTX-MC138. The trial comprises an initial dose-escalation stage followed by a dose-expansion stage. The primary objective of the dose-escalation stage is to evaluate the safety and tolerability of escalating dose levels of TTX-MC138. In the dose-expansion stage, the safety, tolerability and anti-tumor activity of TTX-MC138 will be further evaluated in certain tumor types selected based on preliminary results from the dose-escalation phase.

Further information is available at www.clinicaltrials.gov NCT Identifier: (NCT06260774).