On January 24, 2024 CG Oncology, Inc. (Nasdaq: CGON), a late-stage clinical biopharmaceutical company focused on developing and commercializing a potential backbone bladder-sparing therapeutic for patients afflicted with bladder cancer, reported the pricing of its upsized initial public offering of 20,000,000 shares of its common stock at an initial public offering price of $19.00 per share (Press release, CG Oncology, JAN 24, 2024, View Source [SID1234639462]). All of the shares are being offered by CG Oncology. The gross proceeds from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be $380.0 million. CG Oncology’s common stock is expected to begin trading on the Nasdaq Global Select Market on January 25, 2024 under the ticker symbol "CGON." The offering is expected to close on January 29, 2024, subject to the satisfaction of customary closing conditions. In addition, CG Oncology has granted the underwriters a 30-day option to purchase up to an additional 3,000,000 shares of common stock at the initial public offering price, less underwriting discounts and commissions.

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Morgan Stanley, Goldman Sachs & Co. LLC and Cantor are acting as joint book-running managers for the offering. LifeSci Capital is acting as co-manager for the offering.

Registration statements relating to the offering have been filed with the Securities and Exchange Commission and became effective on January 24, 2024. The offering is being made only by means of a prospectus. When available, copies of the final prospectus may be obtained from Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, NY 10014, or by email at [email protected]; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, NY 10022, 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 offer or 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 January 24, 2024 Onward Therapeutics SA (Onward Therapeutics), a global biotechnology company focused on developing innovative immunotherapies for cancer treatment, reported that the phase 1 clinical trial of OT-A201 (Study No. A20101), a first-in-class bispecific antibody targeting two immune checkpoints is in progress (Press release, Onward Therapeutics, JAN 24, 2024, View Source [SID1234639461]).

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The study aims to evaluate the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary anti-tumoral activity of OT-A201. The study is a European multicenter and open-label study that will be conducted in two parts. The first part is a dose escalation stage of OT-A201 as single agent in patients with selected relapsed/refractory hematological malignancies or advanced/metastatic solid tumors. The second part is an expansion stage that will further evaluate the safety and preliminary anti-tumoral activity of OT-A201 as monotherapy or in combination in defined hematological malignancies and solid tumors at the dose(s) selected from the first part.

Onward Therapeutics licensed the exclusive worldwide rights of development, manufacture, and commercialization of OT-A201 from Biomunex Pharmaceuticals (Biomunex), a biopharmaceutical company discovering and developing bi- and multi-specific antibodies, in February 2021. Onward Therapeutics and Biomunex will co-develop this bispecific antibody until the completion of the phase 1 study in one of the indications. Dosing of the first patient has triggered an undisclosed amount of milestone payment to Biomunex.

"With the drug development expertise and successful track records of the Onward Therapeutics team, we have moved forward from the cell line development, scale up, 1,000-liter manufacture, preclinical pharmacology and toxicology studies, as well as clinical development and regulatory application of OT-A201 rapidly and efficiently. We are enthusiastic to test OT-A201 for the first time in patients. The study marks an important milestone of Onward Therapeutics in transitioning into a clinical stage company. It also represents a step forward in advancing innovative projects based on our ‘buy-to-build’ business model", said Dr. C. Grace Yeh, Chairman and CEO.

"Despite the recent advances in cancer immunotherapy, there is still a significant unmet need for new treatment options to improve clinical outcome. OT-A201 offers an effective strategy to overcome tumor resistance and to provide better anti-tumor effects. This bispecific antibody has shown excellent in vitro and in vivo activity and safety, opening up the possibility of a favorable therapeutic window. We are looking forward to providing clinically meaningful information from this study to bring a differentiated approach in difficult-to-treat cancer patients", said Dr. Alain Herrera, Chief Medical Officer.

About OT-A201

OT-A201 is a first-in-class humanized bispecific antibody targeting two immune checkpoints. With the potential synergistic anti-cancer effects, it is being evaluated as a new treatment for advanced hematological malignancies and solid tumors. In preclinical studies, OT-A201 has demonstrated excellent specificity, safety and displayed significant anti-tumoral activities at different doses with the potential for a wider therapeutic window as compared to its parental antibodies. Based on the proprietary structure generated from the BiXAb technology of Biomunex, OT-A201 possesses a functional Fc domain in contributing to ADCC activity against tumor cells. It has demonstrated good pairing, low aggregation, high stability, and good manufacturability.

On January 24, 2024 Chengdu-based WestGene reported a significant impact at the 3rd mRNA-Based Therapeutics Summit in Berlin, Germany (Press release, WestGene Biopharma, JAN 24, 2024, View Source [SID1234639460]). Renowned for her pivotal role in mRNA research, Dr. Xiangrong Song, co-founder and CEO of WestGene, presented the latest advances in the company’s oncology sector, with a special focus on mRNA-based cancer vaccines.

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The Summit, held January 23-25, is a key event in the field of mRNA drug development, attracting over 200 specialists from various parts of the world. This year’s discussions highlighted the versatility of mRNA technology in addressing novel diseases and emphasized the importance of global collaboration in drug development and access. Insights from influential bodies such as WHO, CEPI, and EMA, as well as industry giants such as Pfizer, Sanofi, Moderna, Merck, BioNTech and CureVac, focused on the application of AI and ML in mRNA research, overcoming regulatory complexities, and advances in therapeutic development and manufacturing.

In her keynote, Dr. Song discussed updates and interim data on mRNA-based cancer vaccines targeting EBV-associated cancers and HBV positive liver cancer. She discussed WestGene’s breakthroughs in the treatment of specific cancers such as nasopharyngeal carcinoma, NKT lymphoma, HBV-related hepatocellular carcinoma and colorectal cancer, highlighting the safety and efficacy established by the IIT clinical trial data. This speech underscored the transformative impact of WestGene’s mRNA therapy in the field of oncology.

The EBV-associated cancer vaccine, a prominent project in WestGene’s portfolio of over 20 mRNA initiatives, has overcome significant hurdles such as tumor vaccine efficacy and immunogenicity. Its rapid production and cost-effectiveness, coupled with its high efficacy and low toxicity, significantly improve patient accessibility, and provide a more viable treatment option for a broader patient base. This innovation was especially recognized at the 2022 National Disruptive Technology Innovation Competition, where WestGene triumphed as the only winner in the mRNA category among 2,800 entries, cementing its status as a pioneer in the biotech industry in China.

Founded by two visionary scientists, Dr. Wei Yuquan and Dr. Xiangrong Song, WestGene Biotech is dedicated to pioneering the field of mRNA therapeutics. Focusing on the development of avant-garde mRNA therapeutics, the company aims to consolidate its position in the global biopharmaceutical market, backed by its robust technological infrastructure and exclusive intellectual property rights.

2023 marked a year of monumental progress for WestGene, with the acquisition of a U.S. patent for its innovative LNP delivery technology and government approval for a key project in AI-driven mRNA drug design for cancer vaccine development and protein replacement. This project, along with its extensive pipeline, positions WestGene at the forefront of biopharmaceutical innovation and research.

On January 24, 2024 Sirnaomics Ltd. (the "Company", Stock Code: 2257, together with its subsidiaries, the "Group" or "Sirnaomics"), a leading biopharmaceutical company engaging in discovery and development of advanced RNAi therapeutics, reported that the Company published a research article with NAR Cancer (Press release, Sirnaomics, JAN 24, 2024, View Source [SID1234639459]). The article reveals a novel mechanism of action of lead RNAi cancer drug candidate, STP707, a polypeptide nanoparticle (PNP) formulation comprised of two active siRNA (small interfering RNA) inhibitors targeting TGF-β1 and COX-2 for intravenous treatment of solid tumors. The publication provides support to the company’s ongoing clinical studies and a strong rationale for combination treatment with immune-checkpoint inhibitors.

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The published study, ‘Codelivery of TGFβ and Cox2 siRNA inhibits HCC by promoting T-cell penetration into the tumor and improves response to Immune Checkpoint Inhibitors’ demonstrates how PNP delivered the siRNA to multiple cell types besides hepatocytes in the liver. It also demonstrates that STP707 can simultaneously deliver the siRNAs targeting TGF-β1 and COX-2 to tumor cells. Systemic administration of the PNP packaged with dual-targeted siRNAs (2mg/kg) in mice bearing orthotopic hepatocellular carcinoma (HCC) tumors induced tumor growth inhibition to an undetectable level. A combination study with a lower dosage of the siRNAs (1mg/kg) and PD-L1 mAbs revealed an additive effect on tumor growth inhibition and an increase in penetration of CD4+ and CD8+ T-cells into the tumor microenvironment. These study results provide a scientific rationale for further exploration using STP707 for the treatment of HCC and potentially other solid tumors.

"By publishing Sirnaomics’ pioneering efforts in cancer RNAi therapeutics with the leading peer-reviewed journal in the field of nucleic acid therapeutics, it demonstrates strong scientific rationale for developing STP707," said Dr. Patrick Lu, Founder, Chairman of the Board, Executive Director, President and Chief Executive Officer of Sirnaomics. "The newly described mechanism of action of dual-targets TGF-β1 and COX-2 siRNAs for enhancing antitumor immunogenicity provides further scientific foundation for recent successes from our Phase I clinical study for STP707, as a single drug and, potentially, in combination with immune check point inhibitors."

The corresponding author of the publication, Dr. David Evans, Executive Director and Head of Discovery of Sirnaomics, commented, "The discovery from this study illustrates for the first time that silencing both TGF-β1 and COX-2 simultaneously in the tumor microenvironment may enhance antitumor activity through recruitment of activated CD4+ and CD8+ T-cells. Tumor inhibition is further augmented when an immune checkpoint inhibitor is added to STP707."

On January 24, 2024 Biosion USA, Inc. (Biosion), a global clinical-stage R&D biotechnology company, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for BSI-082, a novel anti-SIRPα monoclonal antibody (mAb) candidate (Press release, Biosion, JAN 24, 2024, View Source [SID1234639458]).

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"The FDA clearance of our investigational new drug application for BSI-082 marks a pivotal milestone for Biosion and our mission to discover and develop antibody-based therapeutics for the treatment of patients worldwide," said Mingjiu Chen, Ph.D., Founder and Chief Executive Officer of Biosion, Inc.. "BSI-082 was discovered by Biosion’s H³ antibody discovery platform that has delivered seven clinical candidates in our global innovative pipeline. This IND approval once again validates the unique advantages and potential of our antibody technology platform."

"We are pleased that the FDA has cleared our IND for BSI-082 clinical development. Our novel anti-SIRPa mAb provides many therapeutic opportunities for patients- it has the potential to be combined with a broad array of anti-tumor agents such as mAbs with ADCC/ADCP activity, immune oncology therapies and Antibody Drug Conjugates (ADCs) to enhance both hematologic and solid tumor killing" said Hugh M. Davis, Ph.D., Chief Business & Development Officer, and President of Biosion USA, Inc.. "We are very excited about BSI-082’s broad applicability and patient population and are looking forward to showing its potential in upcoming clinical development" continued Dr. Davis.

About BSI-082

BSI-082 is a best-in-class highly differentiated fully human anti-SIRPα antagonistic monoclonal antibody. It shows strong binding activity to huSIRPα variants V1/V2/V8, thus can cover over 90% of human populations. BSI-082 specifically binds to SIRPα and SIRPβ but not to SIRPγ, and blocks the interaction of SIRPα to CD47, the "don’t eat me" signal expressed on a wide variety of tumors. Blocking SIRPα enables tumor associated macrophages and dendritic cells to resume their phagocytoxic activity against tumor cells while avoiding the broad toxicity issue that many CD47-targeting therapies encountered. BSI-082 demonstrated potent in vivo anti-tumor efficacy when combined with mAbs against tumor-associated antigens in multiple animal models.