On September 5, 2024 Akeso, Inc. (9926.HK) reported that it will showcase promising results from 13 clinical studies on its internally developed PD-1/CTLA-4 bispecific antibody cadonilimab, PD-1/VEGF bispecific antibody ivonescimab, next-generation CD47 monoclonal antibody ligufalimab, and commercially available PD-1 monoclonal antibody penpulimab at the ESMO (Free ESMO Whitepaper) Congress 2024 from September 13th to 17th (CEST) (Press release, Akeso Biopharma, SEP 5, 2024, View Source [SID1234646383]). These studies span advanced colorectal cancer, triple-negative breast cancer, head and neck squamous cell carcinoma, hepatocellular carcinoma, nasopharyngeal carcinoma, gynecological malignancies, gastric cancer, esophageal squamous cell carcinoma, and biliary tract malignancies.

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Notably, ivonescimab’s clinical results in combination with ligufalimab will be presented for the first time. Data on ivonescimab ± ligufalimab plus chemotherapy for mCRC and ivonescimab combined with chemotherapy for TNBC will be featured in the Mini Oral Session. Additionally, the Phase III study of anlotinib combined with penpulimab versus sorafenib for HCC will be presented as a late-breaking abstract in the Proffered Paper Session. Stay tuned for additional updates!

Details of the Presentations:

Colorectal Cancer
Abstract Title: The efficacy and safety of ivonescimab with or without ligufalimab in combination with FOLFOXIRI as first-line (1L) treatment for metastatic colorectal cancer (mCRC)

Key Study Findings:
For first-line treatment of MSS-type mCRC, previous immunotherapies have shown limited benefits. Ivonescimab has achieved meaningfully significant ORR, DCR, and PFS (although data is immature) in these mCRC patients. When combined with ligufalimab (CD47), the clinical outcome improved further, surpassing current standard treatments. These findings highlight the promising potential of ivonescimab, both alone and in combination with ligufalimab, for treating MSS-type mCRC.

Session Type: Mini Oral Session
Number: 514MO
Presentation Presentation Time: Saturday, 14 September 15:50-15:55 (CEST)
Speaker: Yanhong Deng, Sun Yat-sen University Sixth Affiliated Hospital
Triple-Negative Breast Cancer
Abstract Title: The safety and efficacy of ivonescimab in combination with chemotherapy as first-line (1L) treatment for triple-negative breast cancer (TNBC)

Key Study Findings:
Most patients were PD-L1 negative (53.3%). The proportion of patients who had previously received taxane-based neoadjuvant therapy (60%) was higher than in similar targeted drug studies. Ivonescimab demonstrated robust ORR and DCR. PFS results were meaningfully significant, even in patients with limited follow-up time and immature data. The safety profile of ivonescimab aligns with results from prior studies.

Session Type: Mini Oral Session
Number: 347MO
Presentation Time: Monday, 16 September 08:30-08:35 (CEST)
Speaker: Xiaojia Wang, Zhejiang Provincial Cancer Hospital
Head And Neck Squamous Cell Carcinoma
Abstract Title: Evaluation of the safety and efficacy of ivonescimab in combination with ligufalimab as first-line treatment for PD-L1 positive recurrent/metastasis head and neck squamous cell carcinoma (R/M HNSCC)

Key Study Findings:
PD-1 is the standard first-line treatment for CPS≥1 R/M HNSCC but has limited efficacy. Preliminary data from this study suggest that ivonescimab improves ORR and PFS for patients needing rapid tumor shrinkage. Ivonescimab combined with ligufalimab (CD47) further extends both ORR and PFS. Ivonescimab, both as monotherapy and in combination with ligufalimab, has yielded preliminary results that significantly outperform currently approved PD-1 treatments. A Phase III head-to-head trial against Keytruda is scheduled to initiate patient enrollment in the fourth quarter of 2024.

Session Type: Poster Session
Number: 876P
Presentation Time: Saturday, 14 September 2024 (CEST)
Abstract Title: Neoadjuvant and Adjuvant AK104 in patients with recurrent, resectable squamous cell carcinoma of the head and neck: A phase II study

Session Type: Poster Session
Number: 866P
Presentation Time: Saturday, 14 September 2024 (CEST)
Hepatocellular Carcinoma
Abstract Title: Primary results from the phase III ALTN-AK105-III-02 study: Anlotinib plus penpulimab versus sorafenib as first-line (1L) therapy for advanced hepatocellular carcinoma (aHCC)

Session Type: Proffered Paper Session
Number: LBA40
Presentation Time: Friday,13 September 16:55-17:05 (CEST)
Gynecological Oncology
Abstract Title: A phase II study of cadonilimab plus chemotherapy in persistent recurrent/ metastatic cervical cancer patients who failed previous immuno/chemotherapy

Session Type: Poster Session
Number: 732P
Presentation Time: Saturday, 14 September 2024 (CEST)
Abstract Title: Real-world efficacy and safety of cadonilimab in recurrent or metastatic cervical cancer: a multicenter retrospective analysis in China

Session Type: Poster Session
Number: 727P
Presentation Time: Saturday, 14 September 2024 (CEST)
Abstract Title: Cadonilimab with neoadjuvant chemotherapy in advanced ovarian cancer patients : an open, prospective, single arm, phase II trial

Session Type: Poster Session
Number: 760P
Presentation Time: Saturday, 14 September 2024(CEST)
Nasopharyngeal Carcinoma
Abstract Title: Combination of cadonilimab (anti-PD-1 and CTLA-4 bispecific antibody) with chemotherapy in anti-PD-1 resistant recurrent or metastatic nasopharyngeal carcinoma: an open-label, single-arm, phase II clinical trial

Session Type: Poster Session
Number: 893P
Presentation Time: Saturday, 14 September 2024(CEST)
Biliary Tract Cancer
Abstract Title: Cadonilimab in combined with gemcitabine and cisplatin in advanced biliary tract cancer (BicureX): A Phase II, single-arm clinical trial

Session Type: Poster Session
Number: 52P
Presentation Time: Monday, 16 September 2024 (CEST)
Gastric Cancer
Abstract Title: Chemotherapy combined with cadonilimab (AK104) as neoadjuvant treatment for locally advanced gastric/gastroesophageal junction cancer: A prospective, single-arm, phase II clinical trial

Session Type: Poster Session
Number: 1455P
Presentation Time: Monday, 16 September 2024(CEST)
Abstract Title: Neoadjuvant SOX combined with cadonilimab (AK104) for PD-L1 negative upper GC/GEJC patients

Session Type: Poster Session
Number: 1473TiP
Presentation Time: Monday, 16 September 2024 (CEST)
Esophageal Squamous Cell Carcinoma
Abstract Title: Efficacy and safety of cadonilimab combined albumin-paclitaxel, cisplatin and fluorouracil (APF) in neoadjuvant therapy for resectable locally advanced esophageal squamous cell carcinoma (LAESCC): results from the CAPITAL trial

Session Type: Poster Session
Number: 1446P
Presentation Time: Monday, 16 September 2024 (CEST)

On September 5, 2024 Hansa Biopharma reported that Søren Tulstrup will participate in a Fireside chat hosted by Douglas Tsao, Managing Director and Senior Financial Analyst at H.C. Wainwright on Wednesday, September 11 at 8:00 AM EST (Press release, Hansa Biopharma, SEP 5, 2024, https://www.prnewswire.com/news-releases/hansa-biopharma-to-participate-in-hc-wainwright-26th-annual-global-investment-conference-302239226.html [SID1234646382]). Mr. Tsao’s research focuses on biopharmaceuticals and specialty pharmaceuticals. The company will cover Hansa’s clinical stage programs, recent performance and upcoming milestones.

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Hansa management will be available for meetings at the conference. If you are interested in meeting with the management team, please contact Hansa Biopharma at [email protected].

On September 5, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer and rare diseases, reported that new clinical data from an ongoing Phase 1 study of P-BCMA-ALLO1 in patients with relapsed/refractory multiple myeloma will be presented in an oral session at the 21st International Myeloma Society (IMS) Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024 (Press release, Poseida Therapeutics, SEP 5, 2024, View Source [SID1234646381]). The Company is developing P-BCMA-ALLO1, an investigational off-the-shelf allogeneic CAR-T cell therapy enriched for stem cell memory T cells (TSCM), in partnership with Roche for the treatment of relapsed/refractory multiple myeloma.

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"Despite therapeutic advances, multiple myeloma remains an incurable hematologic cancer and relapses are common with BCMA-targeting immunotherapies, such as bispecific T-cell engagers and autologous CAR-T therapies. As a result, patient-focused, off-the-shelf therapies are needed that can provide clinical benefit to patients with relapsed or refractory disease," said Syed Rizvi, M.D., Chief Medical Officer of Poseida Therapeutics. "We look forward to presenting the latest data from our ongoing Phase 1 study of P-BCMA-ALLO1 and its potential as an ‘off-the-shelf’ therapy for patients at IMS. We are also pleased to announce the initiation of the Phase 1b portion of the study, which will allow us to further explore the promise of this program."

IMS Oral Presentation

Talk Title: OA – 04: A Phase 1 Study of P-BCMA-ALLO1, a Non-viral, Allogeneic BCMA Directed CAR-T in Relapsed/Refractory Multiple Myeloma (RRMM)
Presenting Author: Bhagirathbhai R. Dholaria, MBBS, Assistant Professor of Medicine, Department of Medicine, Division of Hematology and Oncology, Vanderbilt University Medical Center
Session: Abstract Session 7
Presentation Date/Time: Friday, September 27, 2024, at 5:42 PM-5:54 PM local time (4:42 PM ET / 1:42 PM PT)
Room: 101 A1-A2
Company-Hosted IMS Webcast and Conference Call Information:
Poseida will host a webcast and conference call on Saturday, September 28, 2024, at 1 PM ET / 10 AM PT. The conference call can be accessed by dialing 800-225-9448 or 203-518-9708 (International) with the conference ID PSTX0928. A live webcast may be accessed using the link here, or by visiting the Events and Presentations section of the Poseida website at investors.poseida.com. After the live webcast, the event will remain archived on the Poseida site for approximately 90 days.

P-BCMA-ALLO1 Phase 1b Clinical Trial
The Company also announced the initiation of a Phase 1b portion of the ongoing Phase 1 clinical trial of P-BCMA-ALLO1 in patients with multiple myeloma. As a result of achieving this milestone, Poseida will receive a $20 million payment from Roche. Poseida and Roche partnered together on the P-BCMA-ALLO1 Phase 1b trial design, which incorporates process improvements and feedback from recently completed advisory board meetings with leading clinicians. Poseida will continue to have responsibility for the expanded Phase 1/1b trial, which will be funded by Roche.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an allogeneic CAR-T product candidate licensed to Roche targeting B-cell maturation antigen (BCMA) for the treatment of relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA and clinical data presented at ASH (Free ASH Whitepaper) in December 2023 support the Company’s belief that T stem cell (TSCM)-rich allogeneic CAR-Ts have the potential to offer effective, safe, and reliable treatment addressing unmet needs in multiple myeloma. Additional information about the Phase 1 study is available at www.clinicaltrials.gov using identifier: NCT04960579.

On September 5, 2024 Medigene AG (Medigene or the "Company", FSE: MDG1, Prime Standard), an oncology platform company focused on the research and development of T cell receptor (TCR)-guided therapies for the treatment of cancer, reported that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for its lead program MDG1015 for the treatment of advanced gastric cancer, ovarian cancer, myxoid/round cell liposarcoma and synovial sarcoma in the phase 1 clinical trial (EPITOME1015-I) (Press release, MediGene, SEP 5, 2024, View Source [SID1234646380]).

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EPITOME1015-I consists of a dose escalation followed by an expansion segment and aims to assess safety, feasibility and preliminary efficacy of MDG1015 in multiple solid tumor indications.

"We are very excited to reach this milestone with our lead program MDG1015 which reinforces our ambition to become a leading company with a range of different TCR-guided therapies for patients suffering from multiple advanced solid tumor types," said Selwyn Ho, CEO of Medigene AG. "In preclinical studies, MDG1015 has shown strongly enhanced and persistent T cell-driven anti-tumor activity and the ability to mitigate the effects of PD-L1, one of the major immunosuppressive signals present in the tumor microenvironment of solid cancers which hinder the effectiveness of TCR-T therapies. This very first FDA clearance of an IND Application for a Medigene TCR-T therapy represents a pivotal achievement, and we look forward to commencing our MDG1015 phase 1 study EPITOME1015-I targeting multiple solid tumors, subject to additional financing."

MDG1015 is a first-in-class, third generation T cell receptor engineered T cell (TCR-T) therapy targeting the cancer-testis antigen New York esophageal squamous cell carcinoma 1 / L Antigen Family Member-1a (NY-ESO-1/LAGE-1a) with a natural and optimal affinity 3S (specific, sensitive and safe) TCR and human leukocyte antigen (HLA)-A*02. The TCR-T cells are further armored and enhanced by the addition of the proprietary PD1-41BB costimulatory switch protein (CSP) technology and has demonstrated significantly enhanced anti-tumor activities against tumor cells expressing varying levels of PD-L1, one of the most immunosuppressive signals emanating from the solid tumor microenvironment. Importantly, compared to first generation TCR-T therapies, MDG1015 will be manufactured with a short, 6-day cell expansion period, leading to younger, fitter cells, with the potential for a markedly reduced number of cells required during dosing and a shorter vein-to-vein time for patients of approximately 20 days. This has also resulted in a drug product with an almost pure CD8+ population and with a very high proportion of cells with stemness-like qualities (~95%) that could lead to improved durability of response, greater efficacy and reduced adverse events.

To complement the IND approval, a Clinical Trial Application (CTA) submission for MDG1015 to the European Medicines Agency (EMA) is on track for the fourth quarter of 2024. Pending additional financing, the Company plans to initiate the phase 1 clinical trial EPITOME‑1015-I, which consists of a dose escalation followed by an expansion segment, by the end of 2024. Based on this timeline, the Company expects to be able to present early data from the dose escalation phase towards the end of 2025.

On September 5, 2024 Vor Bio (Nasdaq: VOR), a clinical-stage cell and genome engineering company, reported new clinical data from its ongoing Phase 1/2 VBP101 study of patients with relapsed/refractory AML receiving trem-cel followed by MylotargTM (Press release, Vor BioPharma, SEP 5, 2024, View Source [SID1234646379]). The data demonstrated reliable engraftment, shielding from Mylotarg on-target toxicity, a broadened Mylotarg therapeutic window, and early evidence of patient benefit.

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"We are encouraged by this data and the potential benefit that trem-cel in combination with Mylotarg may offer to patients in a disease that has extremely poor outcomes even after transplant," said Dr. Eyal Attar, Vor Bio’s Chief Medical Officer. "With this data, we plan to explore a registrational trial while we continue to pursue other synergistic opportunities for Vor Bio’s platform such as VCAR33ALLO and VADC45."

The data released today included 18 patients treated with trem-cel of which ten had received Mylotarg as of the data cut-off date of July 19, 2024. The data demonstrated:

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Reliable engraftment, with 100% of patients achieving primary neutrophil engraftment (median 9 days) and robust platelet recovery (median 16.5 days). High CD33 editing efficiency (median 89%, range 71-94%) and full myeloid chimerism at Day 28.

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Shielding of the blood system, with maintained neutrophil and platelet counts across multiple Mylotarg doses of 0.5, 1, and 2 mg/m2.

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Broadened therapeutic index for Mylotarg with drug exposure represented by AUC which is related to efficacy, consistent with labeled Mylotarg doses, and with maximal concentrations, measured by Cmax and related to veno-occlusive disease, well below known toxic range.

•
Early evidence suggesting patient benefit as measured by relapse-free survival when compared to published high-risk AML comparators1.

"All the hope I had in the safety of this approach has been supported by the data from this trial thus far," said Guenther Koehne, MD, PhD, an investigator on the VBP101 study and Deputy Director and Chief of Blood & Marrow Transplant and Hematologic Oncology at Miami Cancer Institute of Baptist Health South Florida, "I look forward to treating my next patients at high risk of relapse on this trial as their outcomes are otherwise limited with standard transplants."

Vor Bio plans to approach the U.S. Food & Drug Administration to discuss a pivotal trial design for trem-cel + Mylotarg by around year end.

Continued progress with VCAR33ALLO

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VCAR33ALLO represents another potentially significant synergistic treatment option after trem-cel.

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The VBP301 study continues enrolling patients with initial focus on relapsed/refractory AML post-transplant.

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Vor Bio is encouraged by in vivo CAR-T expansion data from three patients treated to date, all at the lowest dose of 1 x 106 CAR+ cells/kg.

Vor Bio announced today, a new preclinical asset, VADC45, which has a number of potential opportunities in oncology, gene therapy, and autoimmune disorders.

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VADC45 is an ADC that targets the CD45 protein. CD45 is a well-validated target for a wide variety of blood cancers with clinical proof of concept. The linker-payload used in VADC45 is also clinically validated.

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VADC45 has the potential to treat a number of diseases, including treatment of hematologic malignancies, as a targeted conditioning agent for gene therapies such as for sickle cell disease, holistic immune reset for autoimmune disorders, and for Vor Bio’s approach of combining this asset with epitope modification of CD45 to shield healthy stem cells.

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Vor Bio already has robust preclinical data for VADC45 and is progressing IND-enabling studies to enable future Phase 1 studies.