On May 13, 2024 Aldevron, a leading global manufacturer of DNA, RNA, and proteins used in cell and gene therapies and vaccine development, reported it has entered a strategic partnership with Acuitas Therapeutics, Inc., a private biotechnology company specializing in the development of delivery systems for nucleic acid therapeutics based on lipid nanoparticles (LNPs) (Press release, Aldevron, MAY 13, 2024, View Source [SID1234643176]). This partnership will allow Aldevron to expand its capabilities in mRNA LNP encapsulation by incorporating Acuitas’ proprietary LNP encapsulation platform, increasing Aldevron’s services and capabilities as an mRNA sequence-to-vial custom manufacturer.

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In May of 2023, Aldevron announced the expansion of its mRNA production capabilities to include Cytiva’s mRNA LNP encapsulation and aseptic fill-finish platform. This new strategic partnership with Acuitas Therapeutics, working with its encapsulation platform, equips Aldevron with a diverse range of mRNA LNP technologies, significantly enhancing its mRNA end-to-end drug product service capabilities. The partnership will enable Aldevron to support Acuitas’ LNP formulations and licensees.

"This collaboration with Acuitas is an exciting addition to our existing mRNA sequence-to-vial services and will enable Acuitas partners to leverage Aldevron’s extensive mRNA manufacturing experience and comprehensive end-to-end capabilities," said Mark Wetzel, Vice President mRNA CDMO at Aldevron. "We look forward to our continued partnership that is poised to enhance the landscape of mRNA-based therapies, bringing faster timelines and hope, to patients worldwide."

"We have long known of Aldevron’s reputation and broad experience in the manufacturing of nucleic acids and their commitment to quality," said Chris Barbosa, Vice President of Technology Development at Acuitas Therapeutics, Inc. "We are pleased to work with Aldevron to provide Acuitas partners with an integrated path to clinical drug products using Acuitas’ lipid nanoparticle manufacturing processes." He added, "We look forward to Aldevron’s contribution to working with us to support our global partners in bringing new mRNA-based therapies to patients as quickly and efficiently as possible."

"The Acuitas technology, combined with Aldevron’s extensive experience providing cutting-edge solutions for advancing therapies and rigorous quality processes, provides an exceptional advantage," continued Wetzel. "With our two decades of experience in mRNA technologies, Aldevron has developed a seamless workflow from mRNA sequence-to-vial, and this partnership provides clients LNP platform flexibility for the appropriate development stage for their program."

On May 13, 2024 Leads Biolab reported that the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting will be held in Chicago from May 31 to June 4, 2024 (Press release, Nanjing Leads Biolabs, MAY 13, 2024, View Source [SID1234643175]). As the largest and most academically prestigious international oncology conference in the world, the ASCO (Free ASCO Whitepaper) Annual Meeting gathers the latest and most cutting-edge research findings in the field of oncology. Leads Biolabs will present the exciting clinical data on its four innovative clinical programs at the ASCO (Free ASCO Whitepaper) meeting. These presentations will include one oral presentation, two posters, and one online publication, showcasing advancements in various cancer indications such as nasopharyngeal cancer (NPC), extrapulmonary neuroendocrine carcinoma (EP-NEC), hepatocellular carcinoma (HCC), and renal cell carcinoma (RCC).

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Oral Presentation：A novel and uniquely designed bispecific antibody (LBL-024) against PD-L1 and 4-1BB in patients with advanced malignant tumors and neuroendocrine carcinoma: A report of safety and robust efficacy of LBL-024 monotherapy in phase Ⅰ/Ⅱ first in human, open-label, multicenter, dose escalation/expansion Study
Date and Time：2024.06.02 4:30 PM-6:00 PM CDT
Abstract Number：4010

LBL-024, a bispecific antibody composed of an anti-Programmed Cell Death Ligand-1 (PD-L1) and an anti-4-1BB (CD137) antibody. LBL-024 blocks the immunosuppressive pathway of tumor cells by targeting PD-L1 and effectively localizes 4-1BB co-stimulation to the tumor microenvironment, to improve the anti-tumor immune response.

LBL-024 received IND approvals from FDA and NMPA on July 30, 2021 and September 9, 2021 respectively to conduct phase Ⅰ/Ⅱ clinical research. Subsequently, the therapy has achieved outstanding results. On April 30, 2024, it received approval from China’s Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) to conduct a single-arm pivotal study for registration and market authorization. According to the results in the oral presentation, LBL-024 demonstrated good safety profile and very promising antitumor effects in patients with advanced malignant tumors, particularly extrapulmonary neuroendocrine carcinomas (EP-NEC) patients who failed at least one line of chemotherapy. Notably, the efficacy observed in EP-NEC surpassed historic reports with immunotherapy and chemotherapy. The extremely robust efficacy and good safety profiles support the advancement to a pivotal study to accelerate the development of LBL-024 in EP-NEC, a deadly disease of high unmet medical need.

Poster：Anti-LAG-3 antibody LBL-007 in combination with anti-PD-1 antibody Tislelizumab with or without chemotherapy, in patients with advanced nasopharyngeal cancer and other malignant tumors A phase Ⅰb/Ⅱ dose escalation/expansion Study
Date and Time：2024.06.02 9:00 AM-12:00 PM CDT
Abstract Number：6033

LBL-007 is a fully humanized monoclonal antibody against Lymphocyte Activation Gene-3 (LAG-3). By specifically binding to human LAG-3, it relieves the inhibitory effect of LAG-3 on T cells, restores the immune function, and inhibits tumor growth.

Dual inhibition of programmed cell death receptor-1 (PD-1) and LAG-3 is expected to synergistically increase immune response against tumor growth while chemotherapy can enhance the efficacy of immunotherapy through various mechanisms. This phase Ⅰb/Ⅱ study indicates that the combination of LBL-007 and tislelizumab is well-tolerated in patients with advanced malignant tumors.

Poster：Anti-PD-1/TGF-βRII Bispecific Antibody Fusion Protein LBL-015 in patients with advanced malignant tumors：A phase Ⅰ, first-in-human, open-label, multicenter, dose-escalation Study
Date and Time：2024.06.01 9:00 AM-12:00 PM CDT
Abstract Number：2592

LBL-015 is a bifunctional antibody fusion protein targeting PD-1 and Transforming Growth Factor Beta Receptor 2 (TGF-βR2). LBL-015 blocks both PD-1/PD-L1 and TGF-β/TGF-βR2 signaling pathways to reverse immunosuppression and boost immune responses. In addition, LBL-015 can boost immune cell response and inhibit tumor metastasis by blocking TGF-β in the tumor microenvironment. In a Phase 1 clinical study, LBL-015 has demonstrated a good safety profile and encouraging preliminary efficacy signals in patients with advanced solid tumors.

Online Publication：Anti-TNFR2 monoclonal antibody LBL-019 in patients with advanced malignant tumors: A phase Ⅰ, first-in-human, open-label, multicenter, dose escalation Study
Date and Time：2024.05.23 5:00 PM EDT
Abstract Number：e14580

LBL-019 is a humanized IgG1 monoclonal antibody against Tumor Necrosis Factor Receptor 2 (TNFR2). LBL-019 binds specifically to TNFR2 with high affinity and co-stimulates TNFR2 in an Fc crosslinking-dependent manner. This leads to the activation of NF-κB signaling, T cell activation and expansion, thereby promoting antitumor immunity. The data from the Phase 1 study indicate that LBL-019 is well tolerable and has demonstrated preliminary efficacy in patients with advanced malignant tumors.

Dr. Charles Cai, Chief Medical Officer of Leads Biolabs, said "Leads Biolabs will be presenting four clinical projects at 2024 ASCO (Free ASCO Whitepaper). Among them, the efficacy of LBL-024 is significantly higher than the historic reports with immunotherapy and chemotherapy, providing tremendous support for the approval and accelerated development of our pivotal study. The encouraging efficacy and safety profile of LBL-007 is impressive, which is conducive to advancing the pivotal study of LBL-007 in combination with tislelizumab, gemcitabine and cisplatin for NPC. We have adopted a differentiated, innovative, and efficient clinical development strategy, aiming to bring more effective therapies to market sooner. This is a manifestation of Leads Biolabs’ unwavering commitment to addressing patient needs and delivering clinical value, aligning with the company’s mission of ‘care for life’."

On May 13, 2024 Aktis Oncology, a biotechnology company discovering and developing novel targeted alpha radiopharmaceuticals to treat a broad range of solid tumors, reported an oral presentation at the Oligonucleotide & Peptide Therapeutics (TIDES USA) Conference 2024, being held May 14-17, 2024, in Boston, Mass. and virtually (Press release, Aktis Oncology, MAY 13, 2024, View Source;peptide-therapeutics-tides-usa-conference-2024-302143244.html [SID1234643174]). Presentation details can be found below and additional general conference information can be found on the TIDES website here.

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Presentation Details

Presenter:

Paul Feldman, Ph.D., Chief Scientific Officer, Aktis Oncology

Title:

"Pioneering Aktis Oncology’s Miniprotein Radioconjugates"

Session:

Peptide Discovery to CMC

Location:

Hynes Convention Center, Boston, Mass.

Date:

Friday, May 17, 2024

Time:

11:15 a.m. ET

On May 13, 2024 Mabwell (688062.SH), an innovation-driven biopharmaceutical company with entire industry chain, reported the progress of the clinical study of its novel Nectin-4-targeting ADC (R&D code: 9MW2821) for triple-negative breast cancer (Press release, Mabwell Biotech, MAY 13, 2024, View Source [SID1234643173]).

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Based on 9MW2821’s current ongoing monotherapy clinical data, in 20 subjects with locally advanced or metastatic triple-negative breast cancer treated with the 1.25 mg/kg dose and evaluable for tumor assessment, the objective response rate (ORR) and disease control rate (DCR) were 50% and 80%, respectively, with one patient achieved CR and had been in complete response (CR) for 20 months and is currently sustained to be CR. Investigational new drug application of 9MW2821 in combination with immune checkpoint inhibitor for the treatment of triple-negative breast cancer has been accepted by the China National Medical Products Administration (NMPA).

9MW2821 is currently undergoing clinical studies across multiple indications. Phase III monotherapy study of locally advanced/metastatic urothelial carcinoma on patients previously treated with platinum-based chemotherapy and PD-(L)1 inhibitor has formally initiated; A Phase I/II study evaluating first-line combination therapy options with a PD-1 inhibitor has also begun. The first patient enrollment for the two studies were both completed. For cervical cancer and esophageal cancer, Mabwell is actively seeking for Phase III clinical trial approval, and additionally conducting scientific assessments of front-line combination regimens, with clinical trial application expected to be submitted soon. 9MW2821 has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer, respectively.

About 9MW2821

9MW2821 is the first site-specific conjugated novel Nectin-4-targeting ADC developed by Mabwell using ADC platform and automated high-throughput hybridoma antibody molecular discovery platform, and is the first drug candidate to enter clinical study among the Nectin-4-targeting ADCs developed by Chinese companies, and the first therapeutic drug candidate targeting Nectin-4 in the world to reveal clinical efficacy data of cervical cancer, esophageal cancer and breast cancer. 9MW2821 has been granted Fast Track Designation (FTD) and Orphan Drug Designation (ODD) by the U.S. Food and Drug Administration for the treatment of advanced, recurrent, or metastatic esophageal squamous cell carcinoma and esophageal cancer in Feb. 2024 and May 2024, respectively.

9MW2821 achieves site-specific modification of antibody through proprietary conjugate technology linkers and optimized ADC conjugation process. After injection, 9MW2821 can specifically bind to Nectin-4 on the cell membrane surface, be internalized and release cytotoxic drug, and induce the apoptosis of tumor cells.

On May 13, 2024DURECT Corporation (Nasdaq: DRRX) reported financial results for the three months ended March 31, 2024 and provided a business update (Press release, DURECT, MAY 13, 2024, View Source [SID1234643168]).

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"We are pleased that the feedback from the U.S. Food and Drug Administration (FDA) supports the advancement of larsucosterol into a single pivotal Phase 3 clinical trial which, if successful, may serve as the basis for a New Drug Application (NDA) in alcohol-associated hepatitis (AH)," stated James E. Brown, D.V.M., President and CEO of DURECT. "We are in the process of designing the registrational Phase 3 trial incorporating the FDA’s comments and insights gained from our Phase 2b AHFIRM trial. In addition, we are excited about the upcoming presentation at the European Association for the Study of the Liver (EASL) Congress 2024, which will be the first presentation of the AHFIRM data at a medical conference. We expect to provide additional details on our planned Phase 3 protocol and present new analyses from AHFIRM later in the year."

Business Update:

•
During a Type C meeting with the FDA, DURECT received feedback on the recommendations for a Phase 3 clinical trial for larsucosterol in AH that could support a potential NDA filing. DURECT is in the process of designing its planned Phase 3 clinical trial based on the FDA feedback and the results from its completed Phase 2b AHFIRM clinical trial.
•
DURECT announced the acceptance of a late-breaking oral presentation at the European Association for the Study of the Liver (EASL) Congress 2024 to take place June 5-8, 2024 in Milan, Italy. The presentation will feature data from the Company’s Phase 2b AHFIRM trial, which evaluated the safety and efficacy of larsucosterol as a treatment for patients with severe AH.

Financial Highlights for Q1 2024:

•
Total revenues were $1.8 million and net loss was $7.6 million for the three months ended March 31, 2024 compared to total revenues of $2.1 million and net loss of $12.0 million for the three months ended March 31, 2023.
•
Cash, cash equivalents and investments were $21.6 million at March 31, 2024, compared to $29.8 million at December 31, 2023. Debt at March 31, 2024 was $14.6 million, compared to $16.7 million at December 31, 2023.

Earnings Conference Call

We will host a conference call and webcast today at 4:30 p.m. Eastern Time/1:30 p.m. Pacific Time to discuss the first quarter 2024 results and provide a corporate update:

Monday, May 13 @ 4:30 p.m. Eastern Time / 1:30 p.m. Pacific Time

Toll Free: 1-877-407-0790

International: 1-201-689-8560

Conference ID: 13746111