On December 4, 2022 Qilu Pharmaceutical, one of the leading vertically integrated pharmaceutical companies in China that develops, manufactures, and distributes both finished formulations and Active Pharmaceutical Ingredients, reported that the results of the phase II study evaluating QL1604 plus chemotherapy as first-line treatment for patients with recurrent or metastatic (R/M) cervical cancer were released on 4 December 2022 in oral presentation (Proffered Paper, 179O) at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia Congress 2022 (Press release, Qilu Pharmaceutical, DEC 4, 2022, View Source [SID1234624756]).

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Cervical cancer is the fourth most frequently diagnosed cancer and the fourth leading cause of cancer death in women worldwide. Patients with R/M cervical cancer have a poor prognosis and the 5-year survival rate is less than 20%. Although immune checkpoint inhibitors (ICIs) have shown clinical activity in R/M cervical cancer as second-line treatment, the studies on ICIs given in the first-line setting are limited.

QL1604 is a highly selective, humanized monoclonal antibody that binds to PD-1. This is a phase II, open-label, single-arm study of QL1604 plus chemotherapy in patients with R/M cervical cancer (NCT04864782). Eligible patients received QL1604 200 mg plus chemotherapy (paclitaxel and cisplatin/carboplatin) once every 3 weeks (Q3W) for up to 6 cycles, and then QL1604 200 mg Q3W for maintenance therapy until disease progression or other discontinuation events.

As of the data cutoff, 46 patients with R/M cervical cancer and naïve to systemic treatment were enrolled at 12 sites in China. Twenty (43.5%) patients previously underwent surgery and 40 (87%) patients previously received radiotherapy. Thirty-nine (84.8%) patients had recurrent disease and 7 (15.2%) patients had stage IV disease.

The median follow-up time was 12.91 months. A total of 8 (17.4%) patients achieved complete response and 19 (41.3%) patients achieved partial response, resulting in an objective response rate of 58.7% (27/46). The disease control rate was 84.8% (39/46). The median duration of response was 9.6 months (95% CI: 5.5, NE). The median progression-free survival was 8.1 months (95% CI: 5.7, 14.0). The overall survival was not reached.

QL1604 plus chemotherapy demonstrated a manageable safety profile, which was consistent with that reported for chemotherapy or anti-PD-1 therapy. The most common treatment-related adverse event was white blood cell count decreased.

Ms. Xiaoyan Kang, Head of Qilu Pharmaceutical clinical research center, stated, "We are pleased to release the latest study results of QL1604 plus chemotherapy as first-line treatment for patients with advanced cervical cancer. QL1604 plus chemotherapy showed promising antitumor activity and manageable safety profile as first-line treatment for women with R/M cervical cancer. Further investigations in this setting are ongoing.

On December 3, 2022 Philogen reported its attendance at the Antibody Engineering & Therapeutics 2022.
Prof. Dario Neri, CEO and CSO of Philogen, is giving a lecture entitled "Small Molecule-drug Conjugates (SMDCs) and Antibody-drug Conjugates (ADCs): A Comparative Evaluation (Press release, Philogen, DEC 3, 2022, View Source [SID1234624754]).

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Please follow the link below for more information
Antibody Engineering & Therapeutics 2022

On December 2, 2022 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates," or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported that they will present a poster on interim clinical results for the MT-5111 program at the San Antonio Breast Cancer Symposium (SABCS) which will take place December 6 – December 10, 2022 at the Henry B. Gonzalez Convention Center in San Antonio, TX. Molecular Templates will also participate in one-on-one meetings at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting which will take place December 10 – December 13, 2022 at the Ernest N. Morial Convention Center in New Orleans, LA. In-person and virtual meetings may be scheduled directly with Molecular Templates (Press release, Molecular Templates, DEC 2, 2022, View Source [SID1234624758]).

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45th Annual San Antonio Breast Cancer Symposium (SABCS)

Format: Poster presentation
Title/Poster Number: A phase 1 study of the novel immunotoxin MT-5111 in patients with HER2+ tumors: interim results, Poster Number OT2-11-01
Time/Date: 5:00 – 6:15 PM CST, Wednesday December 7, 2022
Location: Hall 1, Henry B. Gonzalez Convention Center, San Antonio, TX and accessible via corporate website
64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting

Format: One-on-one meetings
Dates: December 10, 2022 – December 13, 2022
Location: Ernest N. Morial Convention Center, New Orleans, LA and Virtual

On December 1, 2022, Advaxis, Inc. (the "Company") reported that it has entered into a Subscription and Investment Representation Agreement (the "Subscription Agreement") with Kenneth A. Berlin, its President and Chief Executive Officer, who is an accredited investor (the "Purchaser"), pursuant to which the Company agreed to issue and sell ten (10) shares of the Company’s Series E Preferred Stock, par value $0.001 per share (the "Preferred Stock"), to the Purchaser for $1,000 per share in cash (Filing, 8-K, Advaxis, DEC 2, 2022, sec.gov/ix?doc=/Archives/edgar/data/1100397/000149315222034327/form8-k.htm [SID1234624752]). The sale closed on December 1, 2022. Additional information regarding the rights, preferences, privileges and restrictions applicable to the Preferred Stock is set forth under Item 5.03 of this Current Report on Form 8-K and is incorporated herein by reference.

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The Subscription Agreement contains customary representations and warranties and certain indemnification rights and obligations of the parties.

The foregoing summary of the Subscription Agreement does not purport to be complete and is subject to, and qualified in its entirety by, such document, which is filed as Exhibit 10.1 to this Current Report on Form 8-K and is incorporated herein by reference.

On December 2, 2022 BostonGene Corporation reported that two abstracts were selected for presentation at the 64th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, BostonGene, DEC 2, 2022, View Source [SID1234624751]). The event will be held from December 10 – 13, 2022, at the Ernest N. Morial Convention Center in New Orleans, Louisiana. BostonGene will exhibit in booth #2214.

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"As part of our commitment to improving patient outcomes, we remain focused on further developing our innovative analytical tools to understand the composition and activity of the tumor and its microenvironment," said Nathan Fowler, MD, Chief Medical Officer at BostonGene. "We look forward to presenting robust data at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition demonstrating the critical need for molecular and immune profiling and analytics to advance precision medicine for cancer patients."

Details of the presentations are below:

Title: Integrated Genomic and Transcriptomic Analysis Provides Molecular Characterization of Distinct Clonal Evolution Pathways during Follicular Lymphoma Transformation
Abstract Number: 2973
Session: 627. Aggressive Lymphomas: Clinical and Epidemiological: Poster II
Time and Location: Sunday, December 11 | 6:00 PM-8:00 PM, Hall D
Presenter: Kevin Ferguson, MD, Western Diagnostic Services Laboratory

Research conducted by Pacific Central Coast Health Centers at Dignity Health, Mission Hope Medical Oncology, Western Diagnostic Services Laboratory and BostonGene.

This presentation demonstrates the utility of integrated genomic and transcriptomic methods in elucidating clonal evolution during transformation of real-world cases of patients with follicular lymphoma, potentially leading to earlier identification of high-risk FL subsets and the improvement of personalized treatment options.

Title: Correlative Biomarkers for CART19 Response in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma
Abstract Number: 4159
Session: Session: 621. Lymphomas: Translational—Molecular and Genetic: Poster III
Time and Location: Monday, December 12 | 6:00 PM-8:00 PM, Hall D
Presenter: Connie Lee Batlevi, MD, PhD, Memorial Sloan Kettering Cancer Center

Research conducted by Memorial Sloan Kettering Cancer Center and BostonGene.

In this study, whole-exome sequencing (WES) and RNA sequencing (RNA-seq) were used to identify potential biomarkers of response to CART19 cellular therapy in patients with DLBCL, underscoring the role of integrative molecular analysis to improve personalized treatment recommendations.

In addition to the poster presentations, the abstracts have been published online in the November supplemental issue of "Blood."

For more information, please visit the 64th ASH (Free ASH Whitepaper) Annual Meeting and Exposition website at View Source