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 [email protected].

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).

On February 6, 2025 Allarity Therapeutics, Inc. ("Allarity" or the "Company") (NASDAQ: ALLR), a Phase 2 clinical-stage pharmaceutical company dedicated to developing stenoparib—a differentiated dual PARP/Wnt pathway inhibitor—as a personalized cancer treatment using its proprietary, drug-specific patient selection technology—the Drug Response Predictor (DRP)—reported plans for the next step in advancing the clinical development of stenoparib toward FDA approval in advanced ovarian cancer (Press release, Allarity Therapeutics, FEB 6, 2025, View Source [SID1234650088]). With this new phase 2 protocol, Allarity will capitalize and expand on the ongoing phase 2 clinical trial data to optimize the dose of stenoparib and to refine the DRP patient selection criteria in order to maximize the clinical benefit from stenoparib.

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An in-depth review of Allarity’s maturing clinical data, in collaboration with leading clinical investigators, prompted Allarity to design this new Phase 2 protocol to enable a more aggressive push of stenoparib toward regulatory approval. The protocol will enable new enrollment expressly focusing on patients with advanced, recurrent, platinum-resistant disease, a group that has shown durable clinical benefit from stenoparib in the current phase 2 trial and who have only limited treatment options following standard chemotherapy. In addition to expanding and deepening the clinical data set necessary for regulatory approval, this trial is also designed to enhance the understanding of stenoparib’s unique therapeutic mechanism of action. Of particular interest will be the impact of stenoparib treatment on the Wnt pathway, a key cellular pathway repeatedly shown to be involved in advanced ovarian cancers as well as many other advanced cancer types, most notably colon cancers. A richer understanding of stenoparib’s potential for controlling the Wnt pathway—a key aspect of the newly designed trial—could further distinguish stenoparib as a unique investigational cancer treatment.

The protocol will also further refine Allarity’s understanding of the stenoparib-DRP for identifying patients most likely to benefit from stenoparib treatment. As part of the trial, a DRP score will be assessed for all enrolled patients to generate the deeper, more robust data set necessary to refine the DRP cut-off that would ring-fence patients most likely to benefit from stenoparib. These data will be fundamental for supporting any regulatory approval for the stenoparib-DRP as a companion diagnostic (CDx) specific to stenoparib.

The Company has previously announced long-lasting clinical benefit for advanced, recurrent ovarian cancer patients, with some of these patients continuing on therapy for more than 14 months. Based upon these encouraging clinical benefit data, Allarity intends to pursue an advantaged regulatory path toward approval to further enable stenoparib’s clinical development.

Patient enrollment is expected to begin in the first half of 2025, subject to final protocol review by regulatory authorities. Recruitment will commence at leading U.S. trial sites, with the potential inclusion of additional sites in the U.K. as warranted.

"Until now, patients receiving stenoparib have had diverse and often extensive treatment histories, with many being very heavily pretreated. Based on data we have gathered to date from our clinical trials, and through in-depth analysis and consultation with leading gynecologic oncologists, we have developed a new clinical trial protocol focused on a well-defined, commercially significant patient population in desperate need of newer, safer treatment options beyond more chemotherapy, which comes with well-documented side effects," said Thomas Jensen, CEO of Allarity Therapeutics. "We are therefore pleased to have submitted this trial design and are eager to begin patient enrollment as soon as we receive the final green light from the regulatory authorities, including the FDA."

About Stenoparib
Stenoparib is an orally available, small-molecule dual-targeted inhibitor of PARP1/2 and tankyrase 1/2. At present, tankyrases are attracting significant attention as emerging therapeutic targets for cancer, principally due to their role in regulating the Wnt signaling pathway. Aberrant Wnt/β-catenin signaling has been implicated in the development and progression of numerous cancers. By inhibiting PARP and blocking Wnt pathway activation, stenoparib’s unique therapeutic action shows potential as a promising therapeutic for many cancer types, including ovarian cancer. Allarity has secured exclusive global rights for the development and commercialization of stenoparib, which was originally developed by Eisai Co. Ltd. and was formerly known under the names E7449 and 2X-121.

About the Drug Response Predictor – DRP Companion Diagnostic
Allarity uses its drug-specific DRP to select those patients who, by the gene expression signature of their cancer, are found to have a high likelihood of benefiting from a specific drug. By screening patients before treatment, and only treating those patients with a sufficiently high, drug-specific DRP score, the therapeutic benefit rate may be significantly increased. The DRP method builds on the comparison of sensitive vs. resistant human cancer cell lines, including transcriptomic information from cell lines, combined with clinical tumor biology filters and prior clinical trial outcomes. DRP is based on messenger RNA expression profiles from patient biopsies. The DRP platform has shown an ability to provide a statistically significant prediction of the clinical outcome from drug treatment in cancer patients in dozens of clinical studies (both retrospective and prospective). The DRP platform, which may be useful in all cancer types and is patented for more than 70 anti-cancer drugs, has been extensively published in the peer-reviewed literature.