On September 5, 2024 Celularity Inc. (Nasdaq: CELU) ("Celularity"), a regenerative and cellular medicine company developing placental-derived allogeneic cell therapies and advanced biomaterial products, reported that Robert J. Hariri, M.D., Ph.D., Chairman, CEO and founder, will present at H.C. Wainwright’s 26th Annual Global Investment Conference being held at the Lotte New York Palace Hotel in New York City on September 9-11, 2024 (Press release, Celularity, SEP 5, 2024, https://celularity.com/celularity-to-present-at-h-c-wainwrights-26th-annual-global-investment-conference/ [SID1234646368]).

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H.C. Wainwright 26th Annual Global Investment Conference
Date: Monday, September 9, 2024
Time: 12:30 p.m. ET
Location: Lotte New York Palace Hotel, New York
Speaker: Robert J. Hariri, M.D., Ph.D., Founder, Chairman & CEO

Celularity will also participate in one-on-one investor meetings at the conference. To obtain more information on the conference, or schedule an investor meeting with Dr. Hariri, please contact your H.C. Wainwright representative or KCSA Strategic Communications at [email protected].

A replay of this presentation will be available on the Company’s website at View Source for at least 90 days following the date of the presentation.

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 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 Agios Pharmaceuticals, Inc. (Nasdaq: AGIO), a leader in cellular metabolism and PK activation pioneering therapies for rare diseases, reported that the company is scheduled to present at the 2024 Cantor Global Healthcare Conference on Wednesday, September 18, 2024, at 10:20 a.m. ET (Press release, Agios Pharmaceuticals, SEP 5, 2024, View Source [SID1234646365]).

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A live webcast of the presentation can be accessed under "Events & Presentations" in the Investors section of the company’s website at www.agios.com. A replay of the webcast will be archived on the company’s website for at least two weeks following the presentation.

On September 4, 2024 – EpimAb Biotherapeutics, Inc. ("EpimAb" or "EpimAb Biotherapeutics") a clinical stage biopharmaceutical company specializing in the discovery and development of multi-specific antibodies for diseases with high unmet need, and Vignette Bio, Inc. ("Vignette" or "Vignette Bio") a clinical stage company incubated by Foresite Labs and backed by Foresite Capital, Qiming Venture Partners USA, Samsara BioCapital, and Mirae Asset Capital Life Science, announced today that EpimAb and Vignette have entered into a license agreement for EpimAb’s BCMA-targeting T-cell engager (TCE) EMB-06 (Press release, EpimAb Biotherapeutics, SEP 4, 2024, View Source [SID1234648258]).

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Under this agreement, EpimAb will grant Vignette the exclusive rights to develop and commercialize EMB-06 outside of Greater China (mainland China, Hong Kong, Macau and Taiwan), while EpimAb shall retain the rights to EMB-06 in Greater China. EpimAb will receive total upfront considerations of $60 million in cash and equity of Vignette, and will be eligible to receive up to $575 million development, regulatory and commercial milestones, plus royalties on net sales.

"EpimAb is excited to enter into this partnership with Vignette on EMB-06, which is well positioned to realize the potential of EMB-06," said Dr. Chengbin Wu, CEO and founder of EpimAb. "EMB-06 is the first candidate developed with our proprietary T-cell engager platform and has shown promising clinical activity when evaluated in patients with multiple myeloma. We look forward to evaluating the potential of EMB-06 in autoimmune diseases."

"Emerging clinical data using B-cell depletion in autoimmune diseases has shown compelling results," said Michael Rome, managing director at Foresite Capital and lead investor of Vignette. "EMB-06 is a promising clinical asset and we look forward to building a leading company focused on T-cell engagers for autoimmune diseases."

EMB-06 is the first TCE developed within EpimAb’s T-cell engager platform, which combines EpimAb’s proprietary FIT-Ig bispecific platform and CD3 binder panel, and EpimAb’s in-house discovery and antibody engineering expertise. This allows EpimAb to quickly generate and screen a suite of engagers in the discovery stage for diseases of interest, and advance TCE candidates that could provide the optimal efficacy and safety profile into the pre-IND and clinical stages.