EXUMA Biotech to Present Preclinical Data from its Subcutaneous CAR-TaNK and In Vivo CAR Cell and Gene Therapy Programs at the American Association for Cancer Research Annual Meeting

On March 15, 2022 EXUMA Biotech, Corp., a clinical-stage biotechnology company discovering and developing cell and gene therapies for liquid and solid tumors, announced that preclinical data from its novel, subcutaneous CAR-TaNK therapy for hematological tumors, and in vivo engineered CAR gene therapy program (GCAR), will be presented in two posters at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2022, taking place April 8-13, in New Orleans, LA (Press release, EXUMA Biotechnology, MAR 15, 2022, View Source [SID1234610120]).

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EXUMA is currently conducting IND-enabling studies of the first products on its CAR-TaNK cell therapy platform, targeting CD19 and CD22. CAR-TaNKs are potent cancer killers with T and NK features, which preclinically have been observed to reproducibly and robustly expand in vivo in lymphoreplete animal models following the generation of synthetic lymph nodes post subcutaneous injection. Based on the absence of a lymphodepleting preparatory regimen, and favorable preclinical CAR-TaNK blood cytokine profile, EXUMA plans to pursue development of its CD19 and CD22 cell therapies for use in the community oncology setting.

Additionally, EXUMA presented robust B cell aplasia results obtained by directly injecting a CD3-targeting lentiviral vector (GCAR) into two different lymphoreplete humanized animal models. Further pre-clinical studies are ongoing to characterize the pharmacokinetic and pharmacodynamic effects of EXUMA’s GCAR gene therapy.

"We are excited to share data for the first time from our in vivo GCAR platform, as we continue our work to bring this program into the clinic. We will also be presenting important biological and mechanistic findings from our subcutaneous rPOC CAR-TaNK program, which is currently undergoing IND enabling studies. CAR-TaNK therapy holds great promise as a cancer treatment modality. EXUMA’s goal is to make engineered cell and gene therapies more scalable, affordable, and accessible to patients across the globe," said Sid Kerkar, M.D., VP of R&D.

Abstract Title ("rPOC"): "Generation of tertiary lymphoid structures and CD3 + CD8+ CD56+ NKG2D+ CAR-TaNK cells following subcutaneous injection of CD3- directed lentiviral-loaded PBMCs"
Session: Adoptive Cell Therapy 1
Abstract Number: 5673
Presentation Date & Time: Sunday, April 10th, 1:30 pm-5:00 pm
Presenter: Dr. Sid P. Kerkar, M.D.
Location: Poster Section 36

Abstract Title ("GCAR") : "In vivo delivery of a novel CD3-targeted lentiviral vector generates CD19 CAR-T cells in two different humanized mouse models and results in complete B cell depletion"
Session: Gene and Vector-Based Therapy
Abstract Number: 6345
Presentation Date & Time: Tuesday, April 12th, 1:30 pm-5:00 pm
Presenter: Frederic Vigant, Ph.D.
Location: Poster Section 24

About rPOC SC CAR-TaNK platform

EXUMA’s next-generation "rPOC" platform is being developed for subcutaneous administration without the need for lymphodepleting chemotherapy or long-term immunosuppression. The unique CAR-TaNK cell type producing less CRS-associated cytokines, combined with the lack of lymphodepleting chemotherapy, may result in fewer side effects and hospitalizations thereby potentially allowing for administration in a community oncology setting.

About GCAR in vivo gene therapy platform

"GCAR" is a novel in vivo CAR gene therapy platform that holds the potential to directly deliver CAR constructs specifically into CD3+ cells, while simultaneously providing an activation signal to enable efficient gene integration in vivo without the need to modify cells ex vivo and without the need for lymphodepleting chemotherapy. This platform has the potential to address many of the challenges of existing cell therapy including manufacturing cost and complexity, time, scalability, and safety.

Biomea Fusion to Present at Oppenheimer’s 32nd Annual Virtual Healthcare Conference

On March 15, 2022 Biomea Fusion, Inc. (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel irreversible covalent small molecules to treat and improve the lives of patients with genetically defined cancers and metabolic diseases, reported that it is scheduled to participate in a fireside chat at the Oppenheimer 32nd Annual Virtual Healthcare Conference on Wednesday, March 16, 2022 at 7:00am Pacific Time (Press release, Biomea Fusion, MAR 15, 2022, View Source [SID1234610119]). Thomas Butler, Biomea’s CEO and Chairman of the Board, will participate in the fireside chat.

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An audio webcast for this conference will be available on the Company’s website at www.biomeafusion.com in the Investor Relations section.

PDS Biotech Announces Achievement of an Enrollment Objective in National Cancer Institute-Led Phase 2 Clinical Trial of PDS0101-Based Combination in Advanced HPV-Associated Cancers

On March 15, 2022 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing molecularly-targeted cancer therapies and infectious disease vaccines based on the Company’s proprietary Versamune and Infectimune T-cell activating technologies, reported that the National Cancer Institute (NCI) has achieved the intended enrollment objective of 30 patients in the checkpoint inhibitor (CPI) refractory arm of the NCI-Led Phase 2 clinical trial (NCT04287868) evaluating PDS0101 (Versamune+HPV16mix) in combination with two investigational immune-modulating agents in advanced HPV-associated cancers (Press release, PDS Biotechnology, MAR 15, 2022, View Source [SID1234610118]). Currently, the study has enrolled 45 patients and will continue to enroll both CPI refractory and CPI naïve patients until the total enrollment of 56 is achieved.

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The trial is evaluating the novel triple combination in two groups of patients. Firstly, in second line treatment of recurrent or metastatic HPV-positive cancers including anal, cervical, head and neck, penile, vaginal and vulvar cancers in patients who have not been treated with CPIs (CPI naïve) and have failed at least one standard of care therapy. Secondly, in third-line treatment of the above-listed recurrent or metastatic HPV-positive cancers in patients who have failed at least two standard of care therapies including CPI treatment (CPI refractory).

The NCI, part of the National Institutes of Health, presented highly promising preliminary efficacy and safety data from the trial at the June 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Conference. The NCI plans to present an update in the near future. It was reported earlier this year that median survival of these patients now exceeds 12 months.

"We are pleased the NCI has achieved this important milestone as CPI refractory patients with various HPV-associated cancers have very few effective treatment options and the study data have shown the potential to extend the lives of these patients," commented Dr. Lauren V. Wood, Chief Medical Officer of PDS Biotech. "All of us at PDS Biotech would like to thank the NCI for all of their efforts in the achievement of this enrollment objective."

For patients interested in enrolling in this clinical study, please call NCI’s toll-free number 1-800-4-Cancer (1-800-422-6237) (TTY: 1-800-332-8615), email [email protected], and/or visit the website: View Source

Mersana Therapeutics to Present an Analysis from the Expansion Cohort of the Phase 1 Trial of Upifitamab Rilsodotin at the Society of Gynecologic Oncology (SGO) Annual Meeting on Women’s Cancer

On March 15, 2022 Mersana Therapeutics, Inc. (NASDAQ:MRSN), a clinical-stage biopharmaceutical company focused on discovering and developing a pipeline of antibody-drug conjugates (ADCs) targeting cancers in areas of high unmet medical need, reported that it will present an analysis based on the June 10th, 2021 data cut from the expansion cohort of the Company’s Phase 1 trial of upifitamab rilsodotin (UpRi) at the upcoming Society of Gynecologic Oncology Annual Meeting on Women’s Cancer being held from March 18-21, 2022 in Phoenix, Arizona (Press release, Mersana Therapeutics, MAR 15, 2022, View Source [SID1234610117]).

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UpRi is a Dolaflexin ADC targeting NaPi2b and is being studied in UPLIFT, a single-arm registrational trial in patients with platinum-resistant ovarian cancer, as well as in UPGRADE, a Phase 1/2 umbrella trial evaluating UpRi in combinations starting with carboplatin. The Company plans to initiate UP-NEXT, a Phase 3 trial of UpRi monotherapy maintenance in platinum-sensitive recurrent ovarian cancer with a design informed by FDA and CHMP feedback, in the second quarter of 2022.

"The upcoming presentation at SGO will include analysis from the nearly 100 patients with ovarian cancer treated in the expansion cohort of our UpRi Phase 1 trial based on the June 10th, 2021 data cut which supported the decision to select 36 mg/m2 as the recommended Phase 2 dose for UPLIFT. The data highlight UpRi’s robust clinical activity and differentiated safety profile which further support the design of the ongoing UPLIFT registrational trial in platinum-resistant ovarian cancer," said Anna Protopapas, President and Chief Executive Officer of Mersana Therapeutics.

Details of the presentation and posters are as follows:

Oral Plenary Session Title: Updated Results from the Phase 1 Expansion Study of Upifitamab Rilsodotin (UpRi; XMT-1536), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) in Ovarian Cancer
Abstract #: 76
Date/Time: Saturday, March 19, 2022 at 11:46 am MST
Oral Presenter: Debra L. Richardson, MD

Poster Title: Optimizing the Dose of Upifitamab Rilsodotin (UpRi; XMT-1536), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC): Updated Analysis of a Phase 1b Expansion Study in Ovarian Cancer
Abstract #: 319
Poster Lead Author: Bradley J. Monk, MD

Poster Title: UPGRADE: Phase 1 Combination Trial of the NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) Upifitamab Rilsodotin (UpRi; XMT-1536) in ​Patients With Ovarian Cancer
Abstract #: 588
Poster Lead Author: Nehal Lakhani, MD, PhD

Poster Title: UPLIFT (ENGOT-ov67/GOG-3048): A Pivotal Cohort of Upifitamab Rilsodotin (XMT-1536; UpRi), a NaPi2b-directed Dolaflexin Antibody Drug Conjugate (ADC) in Platinum-Resistant Ovarian Cancer
Abstract #: 585
Poster Lead Author: Debra L. Richardson, MD

Additional information can be found on the SGO website.

VBI Vaccines to Participate in the 32nd Annual Oppenheimer Healthcare Conference

On March 15, 2022 VBI Vaccines Inc. (Nasdaq: VBIV) (VBI), a biopharmaceutical company driven by immunology in the pursuit of powerful prevention and treatment of disease, reported that Jeff Baxter, VBI’s President and CEO, will participate in an analyst-led fireside chat at the 32nd Annual Oppenheimer Healthcare Conference on Wednesday, March 16, 2022 (Press release, VBI Vaccines, MAR 15, 2022, View Source [SID1234610116]).

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Presentation Details

Event: 32nd Annual Oppenheimer Healthcare Conference
Date: Wednesday, March 16, 2022
Time: 10:00-10:30 AM ET
Webcast Link: View Source
A live webcast of the presentation will also be available on the Investors page of VBI’s website at: View Source A replay of the webcast will be archived on the Company’s website following the presentation.