1stOncology™: Cancer Intelligence Service – Page 3813 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

NMPA and FDA Approved the First-in-Human Clinical Trial Applications to Evaluate LBL-034, An Anti-GPRC5D/CD3 Bispecific Antibody Developed by Leads Biolabs, in Relapsed/Refractory Multiple Myeloma

On July 31, 2023 Nanjing Leads Biolabs Co., Ltd. (hereinafter referred to as "Leads Biolabs" or "Company") reported that the National Medical Products Administration (NMPA) and the U.S. Food and Drug Administration (FDA) have approved its first-in-human Investigational New Drug (IND) applications for LBL-034, an anti-GPRC5D/CD3 bispecific antibody invented by Leads Biolabs with global intellectual property rights, for the treatment of relapsed/refractory multiple myeloma (Press release, Nanjing Leads Biolabs, JUL 31, 2023, View Source [SID1234633557]). Currently, no GPRC5D-targeting antibody has been approved for marketing.

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

Schedule Your 30 min Free Demo!

This is a first-in-human, single-arm, multicenter, open-label, dose-escalation and expansion clinical study, and plans to enroll patients with relapsed/refractory multiple myeloma who have failed prior therapies including but not limited to at least one proteasome inhibitor (PI), one immunomodulator (IMiD) as well as other standard treatments. This study aims to evaluate the safety and tolerability of LBL-034, determine the recommended Phase II dose and assess its efficacy in patients with multiple myeloma.

"Despite recent progress and continuous advancements in multiple myeloma, the time between recurrences has been steadily decreasing, particularly as the number of treatment lines increases. This ultimately leads to emergence of relapsed or refractory multiple myeloma, reaffirming its status as an incurable malignant tumor that poses a serious threat to human life. In light of this challenging reality, the urgent need for more effective and innovative treatment options has never been more evident." said Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, "LBL-034 adopts a unique molecular design, which enables the drug to specifically bind to GPRC5D-expressing tumor cells with high affinity, and reduces the risk of non-specific activation of T-cells, thereby enhancing anti-tumor efficacy and reducing potential risk of immunotoxicity. LBL-034 demonstrated robust anti-tumor activities and good safety profile in pre-clinical studies. We adhere to our tradition of innovation and aim to deliver an important, novel and effective treatment option for patients with poor prognosis of relapsed/refractory multiple myeloma."

About GPRC5D:

G Protein-Coupled Receptor Class C Group 5 Member D (GPRC5D) is a C-type 7-channel transmembrane receptor protein. GPRC5D is low expressed in normal human tissues but specifically overexpressed in multiple myeloma. The intensity of GPRC5D expression is an independent prognostic factor in multiple myeloma, and its overexpression is significantly associated with reduced overall survival. Therefore, GPRC5D may be an important potential target for the treatment of plasma cell diseases such as multiple myeloma.

About multiple myeloma:

Multiple myeloma is a malignant plasma cell disease caused by abnormal proliferation of clonal plasma cells, accounting for 10-15% of hematologic malignancies and about 1.4% of all malignancies. It is the second most common hematological malignancy in adults after non-Hodgkin’s lymphoma and mostly occurs in the elderly. According to the data released by the World Health Organization (WHO), the number of new cases and deaths of multiple myeloma worldwide in 2020 were 176,000 and 117,000 respectively, and the number of new cases and deaths of multiple myeloma in China were 21,000 and 16,000 respectively. Currently, multiple myeloma is still an incurable malignant tumor, and the five-year survival rate of patients is approximately 24.8% in China, 33.3% in Japan, and 46.7% in the United States. In recent years, with the successful development of proteasome inhibitors (PIs), immunomodulatory drugs (IMiDs), selective nuclear output inhibitors, CD38-targeted antibodies, bispecific antibodies, and CAR-T cell therapies, the tumor response rate and survival prognosis have been significantly improved. However, multiple myeloma remains an unmet clinical need for more effective treatments.

About LBL-034:

LBL-034 is a humanized IgG1 subtype asymmetric bispecific antibody targeting both GPRC5D and CD3 and Leads Biolabs fully owns the worldwide intellectual property rights. LBL-034 induces T-cell-mediated killing of myeloma cells by redirecting CD3+ T-cells to myeloma cells expressing GPRC5D.

LBL-034 has the potential to be a transformative best-in-class GPRC5D-targeted immunotherapy for multiple myeloma. Clinical studies are planned to evaluate the safety and efficacy of LBL-034 in patients with relapsed/refractory multiple myeloma.

Akeso Inc. Published 2023 Interim Results Positive Profit Alert

On July 31, 2023 Akeso Inc. ("Akeso", the "Company"; 9926.HK), a commercial-stage biopharmaceutical company focused on developing and commercializing first-in-class and best-in-class innovative medicines globally, reported that it is expected that the Company will record a profit of not less than RMB2.3 billion for the six months ended June 30, 2023 (Press release, Akeso Biopharma, JUL 31, 2023, View Source [SID1234633556]). This is the first time for the Company to achieve half-year profits.

The turnaround from loss to profit during the Reporting Period was mainly attributable to:

In respect of Ivonescimab (AK112, PD-1/VEGF) independently developed by the Company, the Company has entered into the collaborative and licensing agreement with Summit Therapeutics (details of which are set out in the announcement of the Company dated December 6, 2022). The Company has received the total upfront payment equivalent to US$500 million in full during the first quarter of 2023 (details of which are set out in the announcements of the Company dated January 26, 2023 and March 6, 2023). Part of such upfront payment was recognized as licensing fee income which significantly contributed to the revenue of the Company for the Reporting Period, and amounted to approximately RMB2.9 billion. The revenue recognition of the remaining portion of the upfront payment will be recognized as revenue in batches going forward.

In respect of the Company’s innovative product 开坦尼 (cadonilimab, PD-1/CTLA-4), since its launch in June 2022, it has recorded significant increase of the patients as well as product sales, which reflects the excellent clinical value of cadonilimab. In addition, 安尼可(penpulimab, PD-1) also continued to contribute to the growth in the Company’s product sales revenue during the Reporting Period.

The Company has continued to optimise its cost management capabilities in a scientific and efficient way and has achieved better results in cost control while accelerating innovative products development and pipelines advancement.

Corbus Pharmaceuticals to Present at the BTIG Virtual Biotechnology Conference

On July 31, 2023 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), a precision oncology company, reported that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will participate in a fireside chat and one-on-one investor meetings at the BTIG Virtual Biotechnology Conference, to be held August 7-8, 2023 (Press release, Corbus Pharmaceuticals, JUL 31, 2023, View Source [SID1234633555]).

BTIG Virtual Biotechnology Conference
Format: Fireside chat and one-on-one investor meetings
Fireside Chat Date: Tuesday, August 8, 2023
Fireside Chat Time: 9:00 a.m. ET

To register for the conference, contact your BTIG sales representative.

Oncolytics Biotech® Announces US$15 Million Bought Deal Offering of Units

On July 31, 2023 Oncolytics Biotech Inc. ("Oncolytics" or the "Company") (NASDAQ: ONCY) (TSX: ONC) reported that it has entered into an agreement with Leede Jones Gable Inc. as underwriter and bookrunner (the "Underwriter"), pursuant to which the Underwriter has agreed to purchase, on a bought-deal basis, 6,667,000 units (the "Equity Units") for gross proceeds to the Company of US$15,000,750 (the "Offering") at a price of US$2.25 per Equity Unit (Press release, Oncolytics Biotech, JUL 31, 2023, View Source [SID1234633554]).

Each Equity Unit will consist of one common share of the Company (a "Common Share") and one Common Share purchase warrant (each whole purchase warrant, a "Warrant"). Each Warrant will entitle the holder thereof to purchase one Common Share at an exercise price of US$2.81 (the "Exercise Price") at any time up to 60 months following the Closing (as defined below).

The Company has granted the Underwriter an option (the "Over-Allotment Option"), exercisable in part or in whole at the Underwriter’s sole discretion, at any time beginning on the Closing until 30 days following the Closing, to purchase up to that number of additional Equity Units, Common Shares or Warrants, or any combination thereof, as is equal to 15% of the aggregate number of Equity Units sold in the Offering to cover over-allotments, if any.

The Equity Units will be offered by way of a prospectus supplement to the Company’s short form base shelf prospectus to be filed in all provinces of Canada except Quebec pursuant to National Instrument 44-101 – Short Form Prospectus Distributions and National Instrument 44-102 – Shelf Distributions.

The Company intends to use the net proceeds from the Offering to continue its pelareorep clinical programs in metastatic breast cancer and pancreatic cancer and general corporate and working capital purposes.

The closing of the Offering is expected to occur on or about August 4, 2023 (the "Closing") and is subject to the Company receiving all necessary regulatory approvals, including the approval of the Exchange.

The securities referred to in this news release have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and may not be offered or sold within the United States or to, or for the account or benefit of, U.S. persons absent U.S. registration or an applicable exemption from the U.S. registration requirements. This press release does not constitute an offer for sale of securities, nor a solicitation for offers to buy any securities in the United States, nor in any other jurisdiction in which such offer, solicitation or sale would be unlawful. Any public offering of securities in the United States must be made by means of a prospectus containing detailed information about the company and management, as well as financial statements.

ITM and POINT Biopharma Expand Global Supply Agreement for n.c.a. Lutetium-177

On July 31, 2023 ITM Isotope Technologies Munich SE (ITM), a leading radiopharmaceutical biotech company and POINT Biopharma Global Inc. (NASDAQ: PNT) ("POINT"), a company accelerating the discovery, development, and global access to life-changing radiopharmaceuticals, reported the expansion of their global supply agreements signed in 2020 (Press release, ITM Isotopen Technologien Munchen, JUL 31, 2023, View Source [SID1234633553]). The expanded agreement broadens the supply of ITM’s non-carrier-added lutetium-177 (n.c.a. 177Lu) to POINT to enable its usage in the clinical and potential future commercial development of the 177Lu-based molecules in POINT’s development pipeline. Financial details of the agreement were not disclosed.

"Since POINT launched in late 2019, ITM has been a key partner to us as we have worked to establish a commercially scalable, reliable and redundant n.c.a. lutetium-177 supply chain," said Joe McCann, Ph.D., CEO of POINT Biopharma. "In building on this established trust and ITM’s position as the world’s leading manufacturer of n.c.a. lutetium-177, we value the ability to utilize ITM’s highly pure radioisotope across our growing pipeline of next-generation radioligands for precision oncology."

Steffen Schuster, CEO of ITM added, "It is our objective to make Targeted Radionuclide Therapy as broadly available as possible, not only by advancing our own pipeline, but also by supporting the whole industry with a stable and scalable isotope supply. We look forward to enriching our long-term collaboration with POINT by supplying our versatile n.c.a. lutetium-177 for the development and commercialization of various novel molecules."

ITM holds a U.S. Drug Master File (DMF) with the Food and Drug Administration (FDA) for n.c.a. 177Lu and has marketing authorization in the EU (brand name EndolucinBeta).

‍

About Targeted Radionuclide Therapy

Targeted Radionuclide Therapy is an emerging class of cancer therapeutics, which seeks to deliver radiation directly to the tumor while minimizing radiation exposure to normal tissue. Targeted radiopharmaceuticals are created by linking a therapeutic radioisotope to a targeting molecule (e.g., peptide, antibody, small molecule) that can precisely recognize tumor cells and bind to tumor-specific characteristics, such as receptors on the tumor cell surface. As a result, the radioisotope accumulates at the tumor site and decays, releasing a small amount of ionizing radiation, with the goal of destroying tumor tissue. The precise localization enables targeted treatment with potentially minimal impact to healthy surrounding tissue.