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:

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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.
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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:

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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.
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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

On May 13, 2024 Verrica Pharmaceuticals Inc. ("Verrica") (Nasdaq: VRCA), a dermatology therapeutics company developing medications for skin diseases requiring medical interventions, reported financial results for the first quarter ended March 31, 2024 (Press release, Verrica Pharmaceuticals, MAY 13, 2024, View Source [SID1234643163]).

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"The first quarter of 2024 marked a period of significant accomplishments across our business, as we continued to expand utilization of YCANTH, received a permanent J-Code from CMS, and secured new chemical entity status from the FDA for YCANTH," said Ted White, Verrica’s President and Chief Executive Officer. "I am also pleased to report that we have seen a meaningful uptick in prescription growth and onboarding of buy and bill accounts following the listing of the permanent J-Code for YCANTH, which went into effect on April 1.

"Looking ahead, this quarter we expect to announce Phase 2 results from our lead pipeline candidate, VP-315, which is being evaluated for the treatment of basal cell carcinoma. As a potential first-in-class oncolytic peptide, VP-315 is designed to have a direct killing activity of the cancer cells, and also to stimulate the immune system to recognize, infiltrate, and attack the cancer. We expect to share data from the Phase 2 study later this quarter, and we are excited about VP-315’s potential to provide an important treatment alternative for the thousands of patients who are diagnosed each year with BCC."

Conference Call and Webcast Information

The Company will host a conference call today, Monday, May 13, 2024, at 8:30 AM, Eastern Time, to discuss its first quarter 2024 financial results and provide a business update. To participate in the conference call, please utilize the following information:

Domestic Dial-In Number: Toll-Free: 1-877-407-4018

International Dial-In Number: 1-201-689-8471

Conference ID: 13746100

Call me:

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View Source;passcode=13741589&h=true&info=company-email&r=true&B=6

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Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me link for instant telephone access to the event.

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Call me link will be made active 15 minutes prior to scheduled start time.

The call will also be broadcast live over the Web and can be accessed on Verrica Pharmaceuticals’ website: www.verrica.com or directly at View Source;tp_key=caf7d1fe6b

The conference call will also be available for replay for one month on the Company’s website in the Events Calendar of the Investors section.

Business Highlights and Recent Developments

YCANTH (VP-102)

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On March 26, 2024, the Company announced that YCANTH received New Chemical Entity ("NCE") Status and a listing in the Orange Book from the U.S. Food and Drug Administration ("FDA"), providing a minimum five years of regulatory exclusivity. The Company’s U.S. patents and pending patent applications related to YCANTH are projected to expire between 2034 and 2041, excluding any patent term adjustment or patent term extension.

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On January 29, 2024, the Company announced that the Centers for Medicare & Medicaid Services (CMS) issued a permanent J-Code (J7354) for YCANTH. Under the Healthcare Common Procedure Coding System (HCPCS) process, the J-Code for YCANTH will become fully published April 1, 2024. The Company believes that securing a permanent J-Code will accelerate utilization of YCANTH among the U.S. Medicaid and Medicare patient populations and will streamline billing and the reimbursement process.

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On January 4, 2024, the Company announced that it received the minutes from the Company’s recent Type C meeting with the FDA, which was held on November 6, 2023, to discuss the Phase 3 clinical development plan for YCANTH for the treatment of common warts. Verrica believes that the Type C meeting satisfied its objective of gaining the FDA’s advice and agreement on the overall design of a pivotal Phase 3 study of YCANTH that would support an efficacy supplement for the proposed indication of common warts.

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On January 3, 2024, the Company announced that it expanded its distribution network by entering into an agreement with Walgreen Co. to distribute YCANTH through its specialty pharmacy.

VP-315

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On January 5, 2024, the Company announced that the last patient had been dosed in Part 2 of its ongoing Phase 2 trial of VP-315, a potential first-in-class oncolytic peptide, for the treatment of basal cell carcinoma. The Phase 2 trial is a two-part, open-label, multicenter, dose-escalation, proof-of-concept study with a safety run-in designed to assess the safety, pharmacokinetics, and efficacy of VP-315 when administered intratumorally to adults with biopsy-proven basal cell carcinoma. The study is expected to enroll approximately 80 adult subjects with a histological diagnosis of basal cell carcinoma in at least one eligible target lesion. For additional information about this clinical trial, please visit clinicaltrials.gov, identifier NCT05188729.

First Quarter 2024 Financial Results

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Verrica recognized product revenue of $3.2 million in the first quarter of 2024. As commercial sales of YCANTH began in the third quarter of 2023, Verrica did not recognize any product revenue prior to that point.

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Verrica recognized collaboration revenues of $0.6 million for the three months ended March 31, 2024 related to the Collaboration and License Agreement with Torii Pharmaceutical Co., Ltd ("Torii") for supplies and development activity with Torii.

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Selling, general and administrative expenses were $16.3 million in the first quarter of 2024, compared to $4.3 million for the same period in 2023. The increase of $12.0 million was primarily due to higher expenses related to commercial activities for YCANTH, including increased compensation, recruiting fees, benefits and travel due to ramp-up of sales force of $6.2 million, increased marketing and sponsorship costs of $2.3 million, other commercial activity of $1.9 million, and increased legal costs of $0.6 million.

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Research and development expenses were $4.9 million in the first quarter of 2024, compared to $2.7 million for the same period in 2023. The increase of $2.2 million was primarily related to increased clinical costs for VP-315 of $1.5 million and increased headcount related costs of $0.6 million.

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Costs of product revenue were $0.5 million for the quarter ended March 31, 2024 including product costs of $0.2 million and obsolete inventory write-off of $0.3 million. Product costs were $0.1 million lower as some materials were expensed as research and development costs prior to FDA approval.

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Costs of collaboration revenue were $0.6 million for the quarter ended March 31, 2024, compared to $0.1 million for the quarter ended March 31, 2023. These costs of collaboration revenue consisted of payments for manufacturing supply to support development and testing services pursuant to the Torii Clinical Supply Agreement.

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Interest income was $0.6 million for the three months ended March 31, 2024, compared to $0.5 million for the same period in 2023. The increase of $0.1 million was primarily due to higher interest rates.

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Interest expense of $2.3 million for the three months ended March 31, 2024 consisted of interest expense related to the OrbiMed Credit Agreement that commenced in July 2023.

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For the quarter ended March 31, 2024, net loss was $20.3 million, or $0.44 per share, compared to a net loss of $6.6 million, or $0.15 per share, for the same period in 2023.

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For the quarter ended March 31, 2024, non-GAAP net loss was $17.8 million, or $0.38 per share, compared to a non-GAAP net loss of $5.5 million, or $0.13 per share, for the same period in 2023.

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As of March 31, 2024, Verrica had cash and cash equivalents of $48.9 million. Verrica believes that its existing cash and cash equivalents as of March 31, 2024 will be sufficient to support planned operations into the first quarter of 2025.