On September 5, 2024 Genetic Leap, an AI-native techbio company innovating at the cutting edge of Artificial Intelligence and RNA genetic medicine, reported a research collaboration with Eli Lilly and Company to develop genetic medicine therapeutics (Press release, Genetic Leap, SEP 5, 2024, View Source [SID1234654445]).

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The collaboration builds on a successful pilot between the two companies and will leverage Genetic Leap’s RNA-targeted AI platform to generate oligonucleotide drugs against targets selected by Lilly in high priority therapeutic areas. The central role of RNA in orchestrating essential biological processes holds significant potential to address critical diseases that traditional drugs have not been able to target effectively. Historically, drugging RNA has presented tremendous challenges. Genetic Leap’s proprietary AI platform is revolutionizing the approach to drugging RNA.

"We are thrilled to collaborate with Lilly and deeply share their strong commitment to developing RNA medicines," said Dr. Bertrand Adanve, CEO and founder of Genetic Leap. "Our primary goal in building the Genetic Leap AI platform is to accelerate the development of life-saving medicines for patients, and this collaboration with Lilly’s talented and savvy R&D team takes us significantly closer to that goal."

Under the terms of the agreement, Genetic Leap will receive from Lilly up to $409 million in upfront, development, clinical, regulatory, and commercial milestone payments, in addition to tiered royalties.

On September 5, 2024 Asgard Therapeutics, a privately held biotech company pioneering in vivo direct cell reprogramming for cancer immunotherapy, reported the publication of key proof-of-concept data supporting its lead program, AT-108, in the high-impact, peer-reviewed journal, Science (Press release, Asgard Therapeutics, SEP 5, 2024, View Source [SID1234646366]). Novel data shows that AT-108 reprograms tumor cells, directly within the immunosuppressed tumor microenvironment, into an immunogenic cell fate, which mounts strong anti-tumor, antigen-specific responses and durable tumor shrinkage even upon metastatic rechallenge.

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The study, co-led by Asgard Therapeutics and the Pereira Lab at Lund University, demonstrated efficient dendritic cell reprogramming in mouse models resistant to checkpoint blockade treatment and patient-derived tumor samples. The data provides preclinical proof-of-concept for an off-the-shelf, yet tumor-specific, first-in-class cancer immunotherapy, paving the way for first-in-human trials of AT-108. Reprogramming tumor cells so that they are converted into antigen-presenting dendritic cells "elicits systemic and long-term antitumor immunity," stated the authors of the study. The study entitled, In vivo dendritic cell reprogramming for cancer immunotherapy, also shows the systematic selection of an optimal delivery system for expression of key reprogramming factors in the tumor, which led to the nomination of Asgard’s lead program.

Publication of the study follows Asgard’s €30 million Series A financing to advance its cell reprogramming platform, as the Company continues to make significant progress in preparing AT-108 for clinical development. Asgard recently commenced activities to establish CMC process for scale-up manufacturing of GMP-grade AT-108 for Phase I/II trials.

Cristiana Pires, Co-founder and Chief Executive Officer of Asgard Therapeutics, said: "This study demonstrates that Asgard’s platform converts tumor cells into dendritic cells within living organisms – and not just in vitro. This publication in such a high-impact journal as Science demonstrates the enormous potential of our cell reprogramming approach and the quality of our scientific methodology. Together with ongoing work to establish manufacturing process for lead program, AT-108, we are focused on completing IND-enabling studies, including pharmacokinetic and GLP toxicology studies, in advance of our near-term objective of filing a clinical trial application for testing of AT-108 in patients."

Co-Lead author Fábio Rosa, PhD, Co-founder and Head of Research of Asgard Therapeutics, commented: "We are very pleased with the publication of this joint effort with Filipe Pereira and his team at Lund University, as it represents a significant milestone for the company ahead of clinical development. The new findings support the selection of a replication-deficient adenoviral vector for AT-108, demonstrating its proof-of-concept and prompting the start of advanced preclinical development. We were very excited to see that AT-108 induces complete tumor regressions and protects mice from tumor re-challenge – even in the metastatic setting."

The reprogramming of tumor cells to cDC1-like cells restores tumor antigen presentation and remodels the tumor microenvironment, reducing exhausted and regulatory populations, and promoting infiltration and activation of cytotoxic T cells. Importantly, in vivo dendritic cell reprogramming induces complete responses as a monotherapy and synergizes with immune checkpoint blockade in aggressive immune-deserted tumor models. The finding of an abscopal effect on distant non-treated tumors highlights that benefits extend beyond the primary tumor.

Alongside the Pereira Lab from where the technology spun-out, Asgard collaborated with additional researchers at Lund University, Inge Marie Svane and Özcan Met from CCIT-DK, Denmark, and Irina Agarkova and team from InSphero, Switzerland to complete the study. The Company’s research has received support from Eurostars-2 Joint Program with co-funding from the European Union’s Horizon 2020 research and innovation program, Sweden’s Innovation Agency, E!115376 REPRINT Grant 2021-03371, and the Strategic innovation programs, Swelife.

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 BioNTech SE (Nasdaq: BNTX, "BioNTech" or "the Company") reported that it will present clinical trial data for selected assets from its multi-platform oncology pipeline at the European Society for Molecular Oncology ("ESMO") Congress 2024 in Barcelona, Spain from September 13-17, 2024 (Press release, BioNTech, SEP 5, 2024, View Source [SID1234646367]). The oral and poster presentations will feature programs across BioNTech’s clinical pipeline, including mRNA-based cancer vaccines, next-generation immunomodulators and targeted therapy approaches.

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"We believe that the future of cancer treatment will be driven by the combination of modalities, including immunomodulators, targeted and mRNA-based therapies," said Prof. Özlem Türeci, M.D., Co-Founder and Chief Medical Officer at BioNTech. "At this year’s ESMO (Free ESMO Whitepaper), we will present data from three clinical trials with BNT327/PM8002, one of the key backbones for our combination treatment strategy. This bispecific antibody will be an element in multiple novel combination treatment approaches that may open up new synergistic mechanisms of action. Our mRNA platforms are another important component of our combination strategy. At ESMO (Free ESMO Whitepaper), we will present clinical data that further support the proof of concept of our mRNA-based FixVac approach, which targets non-mutated tumor-associated antigens, showing early clinical activity across various indications."

Highlights of BioNTech’s clinical stage programs to be presented at ESMO (Free ESMO Whitepaper) Congress 2024:

Updates on several Phase 2 and Phase 1/2 clinical trials evaluating BNT327/PM8002 in various indications as monotherapy and in combination with chemotherapy will be presented. BNT327/PM8002 is an investigational bispecific antibody combining PD-L1 checkpoint inhibition with VEGF-A neutralization for vascular normalization and immunostimulation in the microenvironment of the tumor. Two oral presentations and one poster will provide clinical data updates for cohorts with advanced non-small cell lung cancer ("NSCLC"), locally advanced/metastatic triple-negative breast cancer ("TNBC") and advanced renal cell carcinoma. BNT327/PM8002 is being developed in collaboration with Biotheus Inc. ("Biotheus").
Preliminary data from an ongoing clinical Phase 2 trial (NCT04534205) evaluating BNT113 in combination with PD-1 blockade and data from an investigator-initiated Phase 1/2 clinical trial (NCT03418480) evaluating BNT113 as monotherapy in HPV16-driven cancers will be presented. The data show immunogenicity and antitumor activity in heavily pre-treated patients in several HPV16-positive indications, including head and neck cancer, and a manageable safety profile. BNT113 is an investigational lipoplex-formulated uridine mRNA immunotherapy encoding E6 and E7 antigens of HPV16.
Preliminary data of the randomized Phase 2 clinical trial (NCT05446298) with BNT316/ONC-392 (gotistobart), an investigational anti-CTLA-4 antibody, in combination with pembrolizumab in patients with platinum-resistant recurrent ovarian cancer ("PROC") will be presented in a late-breaking session. BNT316/ONC-392 is being developed in collaboration with OncoC4, Inc. ("OncoC4").
Follow-up data of activity and immune responses from the ongoing first-in-human Phase 1 clinical trial (NCT04503278) with BNT211 in patients with relapsed/refractory CLDN6+ solid tumors will be presented. BNT211 combines autologous CAR-T cells directed against the oncofetal antigen Claudin-6 ("CLDN6") and an CLDN6-encoding CAR-T cell amplifying mRNA vaccine ("CARVac"). The data update shows signs of antitumor activity across all indications and an increased persistence of cancer-specific CAR-T cells when combined with CARVac, for example in patients with testicular and ovarian cancers. The safety profile is consistent with the previously published data of CAR-T therapies.
BioNTech has established a diversified clinical oncology pipeline including mRNA-based therapeutic cancer vaccines, targeted therapies comprising cell therapies and ADCs, and novel immunomodulators in unmet medical need solid tumor indications. These investigational treatments are currently being evaluated in more than 32 clinical trials, including eight programs in advanced Phase 2 trials and two assets in pivotal Phase 3 trials globally. BioNTech is advancing the Company’s key programs into late-stage development with the aim of having ten or more potentially registrational trials in its oncology pipeline by the end of 2024.

The full abstracts are available on the ESMO (Free ESMO Whitepaper) Congress website. Click here for further information on BioNTech’s pipeline assets.

Full presentation details:

Late-breaking presentation
Asset: BNT316/ONC-392 (gotistobart)
Session title: Mini oral session 1: Gynaecological cancers (ID 166)
Room: Burgos Auditorium – Hall 5
Presentation title: "A randomized, Phase 2, dose optimization of gotistobart, a pH-sensitive anti-CTLA-4, in combination with standard dose pembrolizumab in platinum-resistant recurrent ovarian cancer: safety, efficacy and dose optimization (PRESERVE-004/GOG-3081)"
Presentation number: LBA32
Date: Sunday, September 15, 2024
Lecture time: 09:10 AM – 09:15 AM CEST

Mini oral presentations
Asset: BNT113
Session title: Mini oral session: Investigational immunotherapy
Room: Granada Auditorium – Hall 6
Presentation title: "HARE-40: A phase I/II trial of therapeutic HPV vaccine (BNT113) in patients with HPV16 driven carcinoma"
Presentation number: 999MO
Date: Monday, September 16, 2024
Lecture time: 11:15 AM – 11:20 AM CEST

Asset: BNT211
Session title: Proffered paper session 2: Developmental therapeutics
Room: Salamanca Auditorium – Hall 5
Presentation title: "Updated results from BNT211-01 (NCT04503278), an ongoing, first-in-human, Phase 1 study evaluating safety and efficacy of CLDN6 CAR T cells and a CLDN6-encoding mRNA vaccine in patients with relapsed/refractory CLDN6+ solid tumors"
Presentation number: 611O
Date: Sunday, September 15, 2024
Lecture time: 03:45 PM – 03:55 PM CEST

Asset: BNT327/PM8002
Session title: Mini oral session: NSCLC metastatic
Room: Santander Auditorium – Hall 5
Presentation title: "A Phase II Safety and Efficacy Study of PM8002/BNT327 in Combination with Chemotherapy in Patients with EGFR-mutated Non-Small Cell Lung Cancer (NSCLC)"
Presentation number: 1255MO
Date: Saturday, September 14, 2024
Lecture time: 10:20 AM – 10:25 AM CEST

Asset: BNT327/PM8002
Session title: Mini oral session 2: Breast cancer, metastatic
Room: Barcelona Auditorium – Hall 2
Presentation title: "A Phase Ib/II Study to Assess the Safety and Efficacy of PM8002/BNT327 in Combination with Nab-Paclitaxel for First Line Treatment of Locally Advanced or Metastatic Triple-Negative Breast Cancer"
Presentation number: 348MO
Date: Monday, September 16, 2024
Lecture time: 08:35 AM – 08:40 AM CEST

Posters
Asset: BNT113
Poster title: " Exploratory efficacy and translational results from the safety run in of AHEAD-MERIT, a phase II trial of first line pembrolizumab plus the fixed-antigen cancer vaccine BNT113 in advanced HPV16+ HNSCC "
Room: Hall 6
Poster number: 877P
Date: Saturday, September 14, 2024

Asset: BNT314/GEN1059
Poster title: "Phase 1/2 dose escalation/expansion trial to evaluate safety and preliminary efficacy of DuoBody-EpCAMx4-1BB (BNT314/GEN1059) alone or in combination with an immune checkpoint inhibitor in patients with malignant solid tumors"
Room: Hall 6
Poster number: 1072TiP
Date: Saturday, September 14, 2024

Asset: BNT323/DB-1303
Poster title: "DYNASTY-Breast02: A Phase 3 trial of BNT323/DB-1303 vs Investigator’s Choice Chemotherapy in HER2-low, Hormone Receptor Positive, Metastatic Breast Cancer"
Room: Hall 6
Poster number: 436TiP
Abstract number: 7363
Date: Monday, September 16, 2024

Asset: BNT327/PM8002
Poster title: "A Phase Ib/IIa Trial to Evaluate the Safety and Efficacy of PM8002/ BNT327, a Bispecific Antibody Targeting PD-L1 and VEGF-A, as a Monotherapy in Patients with advanced renal cell carcinoma"
Room: Hall 6
Poster number: 1692P
Date: Sunday, September 15, 2024

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)