On September 4, 2024 HEPTA Medical ("HEPTA"), a private medical device company dedicated to providing an efficient, safe, and minimally-invasive thermal ablation therapy for early-stage lung cancer, reported it has successfully raised €5.7M in the first close of its Series A funding round (Press release, Hepta Medical, SEP 4, 2024, View Source [SID1234646362]). The investment was led by BPI France with the participation of M&L Healthcare and Clery IG.

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This financing round will enable HEPTA to initiate the US regulatory approval process for the first version of its microwave ablation platform and to commence its clinical trials. Lung cancer is the leading cause of cancer-related deaths worldwide. As lung cancer screening programs are being implemented, the management of early-stage lung cancer patients has become an increasingly urgent concern for healthcare organizations. HEPTA aims to address this need by offering a controlled, incision-less technology, that provides a minimally invasive approach to treat patients quickly, safely, and efficiently.

"We are grateful for our new investors, and excited to bring microwave ablation therapy to new heights. In August, we obtained our first proprietary patent, completing our three patent families under license. We have multiple upcoming milestones, including the release of early preclinical trial results conducted in collaboration with world-renowned centers, which we’ll publish at the CIRSE conference in September," says Dr. Thomas Bancel, CEO of HEPTA Medical.

The chairman of the board of directors, Gérard Hascoët, a Sofinnova Venture Partner, will be joined by Philippe Boucheron and Jocelyn Kum as representatives for BPI France and M&L Healthcare, respectively.

"We are thrilled to be part of HEPTA Medical’s journey as they push the boundaries of innovation in minimally invasive lung cancer treatment. This investment aligns with our commitment to support groundbreaking medical technologies that have the potential to significantly improve patient outcomes. HEPTA’s unique approach to thermal ablation therapy, combined with their dedicated team and cutting-edge technology, positions them at the forefront of transforming lung cancer care. We are confident that HEPTA Medical will achieve significant milestones in the near future and are excited to support their continued growth and success," comments Philippe Boucheron, Deputy Chief of Life Sciences Investments at BPI France.

HEPTA Medical was founded in 2019 by Sofinnova medtech acceleration team, MD Start. HEPTA develops a flexible microwave ablation probe compatible with any lung navigation system. It is equipped with a proprietary patented tissue temperature sensor that enables monitoring of the growth of the ablation zone in-situ and in real-time during endobronchial ablation procedures. The device also incorporates predictive software, powered by artificial intelligence, which combines procedural CT images and temperature measurements to display the ablation zone in real-time to the clinician during the procedure.

On September 4, 2024 Sensei Biotherapeutics, Inc. (Nasdaq: SNSE), a clinical stage immuno-oncology company focused on the discovery and development of next-generation therapeutics for cancer patients, reported that Company management will present at the following conferences in September 2024 (Press release, Sensei Biotherapeutics, SEP 4, 2024, View Source [SID1234646347]):

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H.C. Wainwright 26th Annual Global Investment Conference
Corporate Presentation
Monday, September 9, 2024, at 7:00 a.m. ET.
Virtual and New York, NY

2024 Cantor Fitzgerald Global Healthcare Conference
Fireside Chat
Wednesday, September 18, 2024, at 2:30 p.m. ET.
New York, NY

Webcasts of both presentations will be available on the Investors section of the Sensei website. Replays will be on the website for approximately 90 days following the events.

On September 4, 2024 MaaT Pharma (EURONEXT: MAAT – the "Company"), a clinical-stage biotechnology company and a leader in the development of Microbiome Ecosystem Therapies (MET) dedicated to enhancing survival of patients with cancer, reported that it will present two posters at the Society of Hematologic Oncology Annual Meeting taking place September 4-7, 2024, in Houston, Texas, USA (Press release, MaaT Pharma, SEP 4, 2024, View Source [SID1234646363]). In addition, MaaT Pharma announced that Company management will participate in three investor conferences in September. Details are as follows:

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Society of Hematologic Oncology Annual Meeting – Presentation

Presentation Title – Poster MaaT013: Pooled Fecal Allogenic Microbiotherapy for Refractory Gastrointestinal Acute Graft-Versus-Host Disease: Results from Early Access Program in Europe – Poster Number: CT-198
Presentation Title – Poster MaaT033: A Multicentre, Randomized, Double-Blinded, Phase 2b Study Evaluating The Efficacy And Safety Of Maat033, an Oral, Pooled Microbiome Ecosystem Therapy In Patients Undergoing Allogenic Hematopoietic Cell Transplantation to Improve Overall Survival: the PHOEBUS Study – Poster Number: CT-200
Session Date & Time: Wednesday, September 4, 2024, 6:15-7:30 PM CDT (7:15-8:30 PM EST)
Location: George R. Brown Convention Center, Houston, Texas, United States
Data included in both posters have been already presented at the 50th Annual Meeting of the European Society for Blood and Marrow Transplantation (EBMT) in April 2024. The posters will be available on the Posters section of the MaaT Pharma website following the Congress.

Investor conferences

H.C. Wainwright 26th Annual Global Investment Conference – Presentation

Date: September 9-11, 2024
Location: New York, NY United States
The presentation will be available on-demand through the H.C. Wainwright conference portal, starting Monday, September 9, 2024.
Lyon Pole Bourse Forum – Participation

Date: September 24, 2024
Location: Lyon, France
KBC Securities’ Life Sciences Conference – Participation

Date: September 26, 2024
Location: Brussels, Belgium

On September 4, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that Chairman and Chief Executive Officer Vlad Vitoc, M.D. will present at the H.C. Wainwright & Co. 26th Annual Global Investment Conference taking place September 9–11, 2024, in New York City (Press release, MAIA Biotechnology, SEP 4, 2024, View Source [SID1234646364]).

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Dr. Vitoc’s presentation will reveal the latest clinical data from MAIA’s Phase 2 THIO-101 clinical trial of lead candidate THIO sequenced with the immune checkpoint inhibitor cemiplimab (Libtayo) in patients with advanced non-small cell lung cancer (NSCLC) who failed 2 or more standard-of-care therapy regimens.

Conference details:

MAIA live presentation:

Tuesday, September 10, 2024, at 08:00 am ET*

Live webcast:

Join here.

Conference location:

Lotte New York Palace, New York City

Conference registration:

Available on the conference website.

1-on-1 meetings:

Requests available upon registration.

Presentation slides:

ir.maiabiotech.com under Company Info: Presentations

*Please note that the presentation date and time are subject to change. Participants should refer to H.C. Wainwright’s final program agenda for up-to-date information.

THIO is a small molecule telomere-targeting anticancer agent that acts by producing direct telomeric DNA damage and inducing cancer-specific immune responses. THIO-101’s treatment results to date have demonstrated exceptional efficacy in NSCLC, the most prevalent tumor type by mortality. Long-term efficacy results are expected before year-end. THIO-101 is expected to be the first completed clinical study of a telomere-targeting agent in the field of cancer drug discovery and treatment.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by Regeneron’s cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On September 4, 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 new data from a case study of a patient with relapsed multiple myeloma treated in a clinical trial of P-BCMA-101, the Company’s original investigational T stem cell memory (TSCM)-rich BCMA targeting autologous CAR-T cell therapy (Press release, Poseida Therapeutics, SEP 4, 2024, View Source [SID1234646349]). The data were presented in an oral session at the Society of Hematologic Oncology (SOHO) Twelfth Annual Meeting in Houston.

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"This case study demonstrates the remarkable potential of T stem cell memory-based therapies, providing a strong anti-myeloma response with a long-term remission and notably CAR-T cell persistence," said Thomas G. Martin, M.D., Clinical Professor of Medicine, Adult Leukemia and Bone Marrow Transplantation Program and Director of Hematology, Blood and Marrow Transplantation and Cellular Therapy at UCSF, and co-leader of the Cancer Immunology & Immunotherapy Program at the UCSF Helen Diller Family Comprehensive Cancer Center. "Most notably, we believe this is the first time that a T-cell engager has been seen to reactivate a CAR-T therapy, and the evidence suggests that this reactivation drove a second wave of CAR-T cell proliferation that led to another complete response three years after the initial successful CAR-T treatment. This patient is now off all anti-myeloma treatments and living in remission for more than nine months following 1 week of TCE therapy, a truly amazing outcome."

"These patient clinical data demonstrate the power of TSCM CAR-T cells, which are a core element of all our investigational next-generation, off-the-shelf allogeneic CAR-T cell therapies," said Syed Rizvi, M.D., Chief Medical Officer of Poseida Therapeutics. "P-BCMA-101 demonstrated durable persistence due to the high TSCM content in the final product. This long-term persistence and engraftment led to activation by the TCE several years after initial CAR-T therapy. The high TSCM content and durable persistence is a unique feature of all autologous and allogeneic Poseida CAR-T."

Background Information and Oral Presentation Highlights
Patients with relapsed/refractory multiple myeloma who receive BCMA-directed CAR-T therapy can achieve deep and durable remissions, but most patients relapse. Detection of CAR-positive cells wanes rapidly over the first six months, and significant re-expansion of CAR-T cells has not been demonstrated previously in the clinical setting.

In this case study, a 57-year-old female patient with relapsed multiple myeloma received P-BCMA-101, an investigational TSCM-rich autologous CAR-T therapy. TSCM cells are a subset of T cells that have unique properties: They are long-lived, multi-potent and self-replicating and can engraft and create differentiated cells.

Two months after receiving treatment, the patient achieved a partial response that deepened into a stringent complete response and remained in remission for nearly 2 years (22.5 months). More than three years after receiving P-BCMA-101, she relapsed and was treated with one cycle of talquetamab, a T-cell engaging bispecific antibody that targets CD3 and GPRC5D. Upon receiving talquetamab, the patient developed a brisk lymphocytosis. Evaluation of peripheral blood revealed high levels of P-BCMA-101 CAR-T cells. Thorough molecular analysis revealed that the lymphocytosis was benign and reactive. The patient achieved complete remission with slow resolution of lymphocytosis. The patient continues to be in sCR and off all therapy more than nine months after receiving the last and only full dose of the T-cell engaging therapy.

Poseida’s lead investigational allogeneic CAR-T program, P-BCMA-ALLO1, is currently being evaluated in patients with relapsed/refractory multiple myeloma. The Company will report new clinical data at the International Myeloma Society 21st Annual Meeting, which is being held in Rio de Janeiro from September 25-28, 2024. Additional P-BCMA-ALLO1 clinical updates are planned for the second half of 2024, subject to coordination with Roche, which has a strategic collaboration with Poseida covering multiple investigational allogeneic CAR-T therapies targeting blood cancers, including P-BCMA-ALLO1.

In November 2022, Poseida made the strategic decision to transition its cell therapy focus from an autologous to an allogeneic approach. The Company believes the future of cell therapy and its ability to offer new treatment options lies in an allogeneic approach in which T cells are derived from healthy donors rather than from the patients themselves. Poseida has applied learnings from its autologous programs to support the development of its allogeneic pipeline.

About P-BCMA-ALLO1
P-BCMA-ALLO1 is an investigational allogeneic CAR-T therapy licensed to Roche that targets B-cell maturation antigen (BCMA) for the treatment of patients with relapsed/refractory multiple myeloma. This allogeneic program includes a VH-based binder that targets BCMA. Phase 1 clinical data presented at ASH (Free ASH Whitepaper) 2023 supports the Company’s belief that TSCM-rich allogeneic CAR-Ts have the potential to offer an effective, safe and reliable treatment addressing unmet needs in multiple myeloma. The U.S. Food and Drug Administration granted Orphan Drug Designation to P-BCMA-ALLO1 for the treatment of multiple myeloma. Additional information about the Phase 1 study is available at www.clinicaltrials.gov (NCT04960579).