On March 9, 2022 Savara Inc. (Nasdaq: SVRA), a clinical stage biopharmaceutical company focused on rare respiratory diseases, reported that its management team will present at Oppenheimer’s 32nd Annual Healthcare Conference on March 16, 2022 at 3:20 pm ET (Press release, Savara, MAR 9, 2022, View Source [SID1234609810]). A live webcast of the presentation will be available on Savara’s website at www.savarapharma.com/investors/events-presentations/ and will be archived for 90 days.

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On March 9, 2022 Mustang Bio, Inc. ("Mustang") (NASDAQ: MBIO), a clinical-stage biopharmaceutical company focused on translating today’s medical breakthroughs in cell and gene therapies into potential cures for hematologic cancers, solid tumors and rare genetic diseases, reported that an abstract reporting on Phase 1 trials being conducted at the University of Alabama at Birmingham (UAB) and City of Hope of Mustang Bio’s exclusively licensed oncolytic viral and CAR T-cell therapies for the treatment of patients with glioblastoma (GBM), has been selected as a late-breaking poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place April 8 – 13, 2022, in New Orleans, Louisiana (Press release, Mustang Bio, MAR 9, 2022, View Source [SID1234609809]). The abstract will also be published in the online Proceedings of the AACR (Free AACR Whitepaper).

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Manuel Litchman, M.D., President and Chief Executive Officer of Mustang, said, "We look forward to the upcoming data to be presented by City of Hope’s Dr. Christine Brown at the AACR (Free AACR Whitepaper) Annual Meeting about the potential of our MB-108 oncolytic virus to enhance the efficacy of our MB-101 CAR T cell therapy for GBM. Each program is actively enrolling patients in respective investigator-sponsored UAB and City of Hope Phase 1 trials, and we believe that the clinical data from those trials, together with results from the in vivo combination studies currently underway at City of Hope, will support the first ever industry-sponsored trial of an oncolytic virus with a CAR T for the treatment of cancer patients. Mustang will refer to the combination therapy as MB-109, and we anticipate filing an Investigational New Drug application for MB-109 later this year."

Details of the presentation are as follows:

Title: Oncolytic viral reshaping of the tumor microenvironment to promote CAR T cell therapy for glioblastoma
Abstract Number: CT541
Session Title: Phase I Trials in Progress 2
Session Date and Time: Wednesday, April 13, 2022 from 9 a.m. – 12 p.m. CT
Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 35
Poster Board Number: 19
Presenter: Christine Brown, Ph.D., Deputy Director, T Cell Therapeutics Research Laboratory, Professor, Departments of Hematology & Hematopoietic Cell Transplantation and Immuno-Oncology and The Heritage Provider Network Professor in Immunotherapy at City of Hope, one of the largest cancer research and treatment organizations in the United States

For more information, please visit the AACR (Free AACR Whitepaper) Annual Meeting website.

About MB‐101 (IL13Rα2‐targeted CAR T cells)
MB-101 is an IL13Rα2-targeted CAR T cell therapy developed by Dr. Brown and her City of Hope colleagues for the treatment of GBM. It is the first CAR T cell therapy to demonstrate durable complete responses in GBM based on a 54-patient Phase 1 trial conducted by City of Hope (NCT02208362), with Dr. Behnam Badie, Professor and Chief, Division of Neurosurgery, as the Principal Investigator. IL-13Rα2 is a GBM restricted receptor expressed abundantly on over 75% of GBM patients. Mustang is developing MB‐101 as an optimized CAR T product incorporating enhancements in CAR design and T cell engineering to improve antitumor potency and T cell persistence. MB‐101 includes a second‐generation hinge optimized CAR containing mutations in the IgG4 linker to reduce off‐target Fc interactions, the 4-1BB (CD137) co‐stimulatory signaling domain for improved persistence of CAR T cells and the extracellular domain of CD19 as a selection/safety marker. To further improve persistence, central memory T cells are enriched and genetically engineered using a manufacturing process that limits ex vivo expansion to reduce T cell exhaustion and maintain a memory T cell phenotype. Ongoing MB-101 malignant glioma clinical trials under City of Hope’s IND include a study in patients with leptomeningeal disease (NCT04661384) and a combination study with checkpoint inhibitors (NCT04003649).

About MB-108 (C134 oncolytic virus)
Developed by Dr. Kevin Cassady, Professor of Pediatrics at Nationwide Children’s Hospital, and his colleagues for the treatment of malignant brain cancers, MB-108 (C134 oncolytic virus) is a second-generation attenuated herpes simplex virus type 1 (HSV-1) oncolytic virus that has improved replication in tumors in murine models, but with the same toxicity profile as its first-generation predecessors. MB-108 can replicate in tumor cells, but not in normal cells, which kills the infected tumor cells and causes the tumor cell to act as a factory to produce new virus. MB-108 can also induce pro-inflammatory signals and chemotaxis, thereby improving CAR T infiltration into the tumor mass. In February 2019, Mustang Bio entered into a licensing agreement with Nationwide Children’s Hospital for worldwide development rights to C134 oncolytic virus, including but not limited to developing MB-108 for the treatment of GBM, and a Phase 1 clinical trial is currently ongoing at the University of Alabama at Birmingham in patients with recurrent disease (NCT03657576), with Dr. James Markert, Professor and Chair, Department of Neurosurgery, as the Principal Investigator.

About MB-109 (MB-101 (IL-13Rα2) + MB-108 oncolytic virus)
MB-109 is a treatment that combines MB-101 (IL13Rα2‐targeted CAR T cells) CAR T cell therapy with MB-108 (C134 oncolytic virus). The combination is designed to leverage MB-108 to make cold tumors "hot," as described above, and thereby improve the efficacy of MB-101 CAR T cell therapy. MB-108 oncolytic virus is first injected to infect tumor cells which, in turn, leads to inflammation of the tumor microenvironment and cytokine production. MB-101 CAR T cells are injected into and around the hot tumor to better allow MB-101 to infiltrate into, undergo activation and kill the tumor. Mustang intends to file a Phase 1 Investigational New Drug application for MB-109 in the second half of 2022.

On March 9, 2022 Sapience Therapeutics, Inc., a clinical-stage biotechnology company focused on the discovery and development of small protein therapeutics to address difficult-to-treat cancers, reported that two abstracts have been accepted for presentation during the late-breaking research sessions at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting taking place April 8-13, 2022 in New Orleans, LA (Press release, Sapience Therapeutics, MAR 9, 2022, View Source [SID1234609808]).

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Details of the poster presentations are as follows:

Abstract Number: 8125
Title: Characterizing the PK/PD relationship of C/EBPβ antagonist peptide ST101 in a mouse orthotopic breast cancer model
Session Title: Late-Breaking Research: Experimental and Molecular Therapeutics 2
Session Date and Time: 4/13/2022 9:00:00 AM
Location: New Orleans Convention Center, Poster Section 16

Abstract Number: 8148
Title: β-catenin antagonist peptide, ST316, attenuates Wnt-dependent oncogenic activity
Session Title: Late-Breaking Research: Molecular/Cellular Biology and Genetics 1
Session Date and Time: 4/11/2022 9:00:00 AM
Location: New Orleans Convention Center, Poster Section 16

Abstracts and full session details can be accessed through the AACR (Free AACR Whitepaper) meeting planner: AACR (Free AACR Whitepaper) Annual Meeting 2022 | April 8-13, 2022 | New Orleans

About ST101
ST101, a first-in-class antagonist of C/EBPβ, is currently being evaluated in the Phase 2 portion of an ongoing Phase 1-2 clinical study in patients with advanced unresectable and metastatic solid tumors (NCT04478279). This is an open-label, two-part, Phase 1-2 dose-finding study designed to determine the safety, tolerability, PK, PD, and proof-of-concept efficacy of ST101 in patients with advanced solid tumors. The study consists of two phases: a Phase 1 dose escalation/regimen exploration phase and a Phase 2 expansion phase. In the ongoing dose escalation study, ST101 has demonstrated clinical proof-of-concept with a RECIST 1.1-confirmed partial response (PR) in a patient with cutaneous melanoma and evidence of long-lasting stable disease in several additional patients. In the ongoing Phase 2 dose expansion part of the study, Sapience has initiated dosing in patients with GBM and metastatic cutaneous melanoma, and will soon commence dosing in patients with refractory, locally advanced or metastatic hormone-receptor-positive breast cancer and castrate-resistant prostate cancer. ST101 has been granted Fast Track designation for recurrent GBM and advanced cutaneous melanoma in patients who have disease progression on or after anti-PD-1/anti-PD-L1 therapy, as well as Orphan designation from the U.S. Food and Drug Administration and the European Commission for the treatment of glioma.

About ST316
ST316, a first-in-class β-catenin antagonist, is currently being evaluated in IND-enabling studies. β-catenin is a critical member of the canonical Wnt signaling pathway, a well-known development stage pathway that has been considered an "undruggable" cancer target, as small molecules have proven ineffective or toxic. Wnt/β-catenin signaling drives cancer initiation and contributes to tumor growth, angiogenesis and metastasis. ST316 exerts its activity through disruption of the BCL9/β-Catenin interaction to suppress transcription of Wnt target genes regulating proliferation, migration, invasion, and the metastatic potential of tumor cells.

On March 9, 2022 Cyclacel Pharmaceuticals, Inc. (NASDAQ: CYCC, NASDAQ: CYCCP; "Cyclacel" or the "Company"), a biopharmaceutical company developing innovative medicines based on cancer cell biology, reported that management will be presenting at the virtual 32nd Annual Oppenheimer Healthcare Conference and participating in the Targeted Oncology Panel as part of the Conference (Press release, Cyclacel, MAR 9, 2022, View Source [SID1234609807]).

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Conference details can be found below:

Panel: Targeted Oncology 2.0 – Moving Beyond TKIs
Date: March 14th, 2022
Time: 10:00am ET
Format: Fireside Chat (Registration Link)

Company Presentation
Date: March 17th, 2022
Time: 12:40pm – 1:10pm ET
Format: Fireside Chat (Registration Link)
A replay will be available following the presentation for 90 days

On March 9, 2022 Transgene a biotech company that designs and develops virus-based immunotherapeutics against cancer, and BioInvent International AB ("BioInvent") (Nasdaq Stockholm: BINV), a biotech company focused on the discovery and development of novel and first-in-class immune-modulatory antibodies for cancer immunotherapy, reported that an abstract reporting preclinical studies of BT-001, a novel oncolytic virus, has been selected for a poster presentation at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022 (Press release, Transgene, MAR 9, 2022, View Source [SID1234609806]). The conference will be held in person in New Orleans, LA, April 8-13, 2022.

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The poster will highlight that BT-001, a co-developed clinical stage product, based on Transgene’s patented oncolytic vector and encoding BioInvent’s proprietary anti-CTLA-4 antibody, has the potential to provide greater therapeutic benefit than systemically administered anti-CTLA-4 antibodies.

The preclinical data to be presented demonstrate that vectorized anti-CTLA-4 antibodies delivered intratumorally (i.t.) can improve safety by reducing their systemic exposure. Efficacy may also be improved, with evidence from the immunocompetent murine model showing that vectorized anti-CTLA-4 antibodies have anti-tumoral activity even against ‘cold tumors’ that are resistant to systemically-delivered checkpoint inhibitors.

Furthermore, the precise targeting of the antibody to a unique functional epitope of CTLA-4 provides a higher level of regulatory T cell (Treg) depletion than currently available immune checkpoint blockade (ICB) therapies.

The studies also provide several key insights into likely mechanisms underlying the efficacy of BT-001. Vectorized anti-CTLA-4:

· triggered both Fcγ-receptor-dependent Treg depletion and antigen cross-presentation – mechanisms known to trigger and promote long-lasting, systemic, CD8+ T cell antitumor immunity;
· showed broad antitumor activity, including activity against murine ‘cold tumor’ models which are resistant to systemic checkpoint inhibitors;
· showed additive or synergistic anti-tumor activity when combined with anti-PD-1.

The details of the poster presentation are as follows:

Abstract Title: Comprehensive preclinical studies of BT-001: an oncolytic vaccinia virus armed with Treg-depleting @CTLA4 and GM-CSF.

Authors: Jean-Baptiste Marchand, Monika Semmrich, Christelle Remy, Matilda Rehn, Laetitia Fend, Petra Holmkvist, Nathalie Silvestre, Carolin Svensson, Patricia Kleinpeter, Jules Deforges, Fred Junghus, Linda Mårtensson, Johann Foloppe, Ingrid Teige, Björn Frendéus, Éric Quéméneur.

Session Category: Immunology

Session Title: Vaccines: Oncolytic and Prophylactic

Session Date and Time: Tuesday Apr 12, 2022, 1:30 PM – 5:00 PM

Location: New Orleans Convention Center, Exhibit Halls D-H, Poster Section 40

Poster Board Number: 17

Abstract Number: 3567

The abstract can be accessed on the AACR (Free AACR Whitepaper) annual meeting website: View Source

About BT-001

BT-001 is an oncolytic virus generated using Transgene’s Invir.IO platform and its patented large-capacity VVcopTK-RR- oncolytic virus, which has been engineered to encode both a Treg-depleting human recombinant anti-CTLA-4 antibody generated by BioInvent’s proprietary n-CoDeR/F.I.R.S.T platforms, and the human GM-CSF cytokine. By selectively targeting the tumor microenvironment, BT-001 is expected to elicit a much stronger and more effective antitumoral response. As a consequence, by reducing systemic exposure, the safety and tolerability profile of the anti-CTLA-4 antibody will be greatly improved.

BT-001 is currently in a Phase I/IIa clinical study (NCT04725331) and recruitment is progressing steadily. The trial assesses BT-001 as a single agent and in combination with the PD-1 checkpoint inhibitor pembrolizumab against solid tumors. Initial Phase I data are expected in the first half of 2022.

BT-001 is being co-developed as part of a 50/50 collaboration on oncolytic viruses between Transgene and BioInvent. To know more on BT-001, watch our video here.