On December 12, 2024 ALX Oncology Holdings Inc. ("ALX Oncology" or "the Company") (Nasdaq: ALXO), a clinical-stage biotechnology company advancing therapies that boost the immune system to treat cancer and extend patients’ lives, reported that the company will host a virtual event on Tuesday, December 17, at 5:00 AM PST / 8:00 AM EST to discuss the first data from a Phase 1b/2 clinical trial evaluating the company’s investigational CD47-blocker evorpacept in combination with Jazz Pharmaceuticals’ zanidatamab in heavily pretreated patients with metastatic breast cancer (Press release, ALX Oncology, DEC 12, 2024, View Source [SID1234649067]). The data were featured today in a spotlight poster presentation at the 2024 San Antonio Breast Cancer Symposium (SABCS). The poster is now available on the ALX Oncology site under Publications.

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During the virtual company event, Alberto J. Montero, MD, MBA, Clinical Director, Breast Cancer Medical Oncology Program, Diana Hyland Endowed Chair for Breast Cancer, and Professor of Medicine at University Hospitals Seidman Cancer Center, Case Western Reserve University, and the study’s principal investigator, will provide an overview of the data presented at SABCS 2024 and participate in a fireside chat with Alan Sandler, MD, ALX Oncology’s Chief Medical Officer. Jason Lettmann, Chief Executive Officer at ALX Oncology, will provide opening and closing remarks, highlighting progress and upcoming milestones for the company’s evorpacept clinical program.

The event will be webcast live and can be accessed by visiting the Investors section of ALX Oncology’s website at www.alxoncology.com and selecting Events under News and Events. To participate in the live event, please register using this link: View Source An archived webcast will be available following the event.

On December 12, 2024 Alessa Therapeutics, Inc., a clinical-stage drug development company pioneering an innovative and proprietary localized drug delivery technology for the early interception of cancer and other diseases, reported the closing of a $15M seed financing led by Mission BioCapital joined by Johnson & Johnson (through its corporate venture capital organization, Johnson & Johnson Innovation – JJDC, Inc. (JJDC)., and a representative of JJDC will join the Board of Directors at Alessa Therapeutics Inc (Press release, Alessa Therapeutics, DEC 12, 2024, View Source [SID1234649066]).

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"We are appreciative of the support provided by this syndicate of leading life science industry investors," said Pamela Munster, M.D., Founder & Chief Executive Officer of Alessa. "Alessa is well positioned to advance our pipeline and leverage our platform of tissue-targeted drug delivery for the treatment of prostate cancer and other solid organ diseases. This funding enables us to pursue our mission and bring new medicines to patients who desperately need more effective treatments."

Alessa will use the funds to advance development of its lead program, Enolen, a novel enzalutamide-eluting seed implant for the treatment of localized prostate cancer. Alessa recently announced the start of a first-in-human trial with Enolen in collaboration with the NCI, and the company anticipates initial data to read out next year. Alessa’s Enolen program builds on the company’s successful proof of concept for the approach with Biolen, which were presented at the 39th Annual EAU Congress (EAU24, April 2024) in Paris, France and at the AUA Annual Meeting (May 2024) in San Antonio, TX.

Prostate cancer is the most common cancer among men in the United States. According to the American Cancer Society, an estimated 299,010 men will be diagnosed with prostate cancer in 2024 in the United States alone. Patients with low-risk prostate cancer face difficult treatment decisions today between potentially invasive surgical and ablative procedures or active surveillance. While many efficacious therapeutics have been developed for regional and metastatic disease, to date, they have failed to move forward to patients with localized low-risk disease given their adverse-event profiles. Alessa’s proprietary localized drug-delivering implants are designed for sustained release of an anti-androgen selectively to the prostate thus limiting systemic side effects despite providing therapeutic concentrations in the prostate.

On December 12, 2024 NEC Bio Therapeutics reported 24-week promising interim results from an ongoing Phase 1 basket clinical trial of an orally administered cancer vaccine, NECVAX-NEO1, used in combination with checkpoint inhibitors (CPI) for treating patients with solid tumors (Press release, NEC, DEC 12, 2024, View Source [SID1234649050]). The findings are being presented in a poster at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress in Geneva, Switzerland from December 11 to 13, 2024.

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NECVAX-NEO1 is a personalized bacteria-based oral DNA therapeutic vaccine, developed using AI prediction of the most immunogenic patient-specific neoepitopes. This vaccine is designed to activate the patient’s immune system, prompting a T-cell response that can precisely target and eliminate tumor cells based on the individual’s unique neoantigens.

In the phase 1 study, 5 patients with melanoma, renal cell cancer, or head and neck cancer, who have been on CPI treatment for at least three months, were treated with NECVAX-NEO1. The safety run-in phase showed no treatment-related toxicities, allowing a dose increase. An ELISPOT response was induced by 68% of neoepitopes, with 40% of patients showing significant neoantigen-specific signals. After a 24-week treatment period, 80% of patients had a stable disease status, indicating a high disease control rate.

On the results of the clinical study, Dr. Heinz Lubenau, CEO of NEC Bio Therapeutics, commented, "We are very excited about our first proof-of-concept data showing signs of promising immunogenicity and associated biomarker changes in patients. This is very encouraging, especially in light of new clinical trials currently ongoing at various locations in early and late-stage cancer patients. We are looking forward to generating more data for NECVAX-NEO1 as an additional treatment option for patients with difficult to treat cancer in the future."

Motoo Nishihara, Corporate Executive Vice President and CTO of NEC Corporation, further commented, "We are certainly excited to present the progress of the NECVAX-NEO1 trial demonstrating safety and signs of immunogenicity. NECVAX-NEO1 is the first cancer vaccine asset to be clinically developed at NEC. This development ties in with the larger NEC mission of providing healthcare solutions globally using the state of art technologies developed in-house."

Details of the poster are below:

Poster title: Oral DNA vaccination targeting personalised neoantigens in immune checkpoint inhibitor treated solid tumor patients – Interim results.

Authors: Domas Vaitiekus, E. Juozaityte, L. Puzauskienė, S. Tulyte, L. Gatijatullin, M. Platten, I. Poschke, I.Hulsmeyer, A. Kuhn, A. Aranguren, H. Lubenau, H. Fontenelle, B. Simovski, Y. Yamashita, C.Chaput, A. Meiser, V. Urbonas

Poster Number: 160P

Date: 12 December 2024

The poster may also be found here: Link to PDFNEC Bio website. Trial details can also be viewed at: new windowNCT05354323

NECVAX-NEO1 is currently under evaluation at additional clinical trial sites in Lithuania, Germany, and Spain. These sites are actively recruiting patients and are open for enrollment.

On December 11, 2024 EsoBiotec SA, a biotechnology company empowering cells in vivo to fight cancer, reported the launch of an Investigator-Initiated Clinical Trial (IIT) in China of ESO-T01, an immune shielded lentiviral vector that reprograms T lymphocytes in vivo into highly effective BCMA CAR-T cells, for the treatment of multiple myeloma (Press release, EsoBiotec, DEC 11, 2024, View Source [SID1234651163]).

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"ESO-T01 is the first in vivo BCMA CAR-T candidate to reach the clinical stage, which is a testament to our ENaBL platform technology that reprograms immune cells inside the body to fight cancer," said EsoBiotec CEO Jean-Pierre Latere, Ph.D. "There are different types of treatments available for patients with multiple myeloma, including ex vivo CAR-T options, but many are associated with debilitating side effects and patient access remains limited by manufacturing capacity, logistical complexity, and high costs. We are keen to explore the safety and efficacy of ESO-T01 in this study, and we believe the results could allow expansion to other indications including autoimmune diseases."

EsoBiotec Chief Scientific Officer Philippe Parone, Ph.D., commented, "ESO-T01 leverages our third-generation immune-shielded lentiviral vector platform, ENaBL, designed to reprogram T cells into potent BCMA CAR-T cells directly within patients. This innovative approach delivers high specificity and efficient transduction in vivo due to the unique design features of our ENaBL technology. When this technology is combined with a robust, scalable, and reproducible manufacturing process, ESO-T01 represents an opportunity to provide patients with a cost-effective, off-the-shelf therapy, redefining access to advanced therapies."

The proof-of-concept, first-in-human IIT is underway and initial clinical data are expected to be presented in the second half of 2025. In preclinical studies, a single injection of ESO-T01 demonstrated potent anti-tumor activity against cancer cells in humanized mice. These studies showed highly effective in vivo transduction, with the BCMA CAR transgene specifically expressed in T cells. This led to the generation of a large population of circulating BCMA CAR-T cells, which persisted throughout the study, highlighting their long-term durability and efficacy.

Latere added, "EsoBiotec has been operating in stealth mode and has raised €22M in a challenging funding environment thanks to the support of very committed investors including Thuja Capital, UCB Ventures, Invivo Partners, Wallonie Entreprendre (WE), SambrInvest and Investsud. We have now entered the clinic and are well positioned to bring groundbreaking cancer treatments to patients globally leveraging our differentiated science, experienced team and established collaborations."

About ESO-T01

ESO-T01 is a third-generation replication-deficient self-inactivating lentiviral vector expressing a BCMA-targeted CAR construct under a T cell-specific synthetic promoter. It is immune shielded and resistant to phagocytosis. ESO-T01 is an "off-the-shelf" single dose treatment, directly administered systemically without the need for lymphodepletion.

About ENaBL Platform

EsoBiotec’s Engineered NanoBody Lentiviral (ENaBL) platform vectors are designed to specifically reprogram T cells and have demonstrated a high level of CAR T potency in animal studies. In large scale clinical manufacturing, the company has preserved vector specificity with high physical titer and high purity. EsoBiotec’s lead product candidate, ESO-T01, leverages the ENaBL platform to validate this novel technological approach using a clinically proven antigen.

On December 11, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported its impressive survival and clinical benefit data in MBC patients, including those with CNS metastases, treated with the Bria-IMT plus CPI regimen (Press release, BriaCell Therapeutics, DEC 11, 2024, View Source [SID1234649127]). The data is featured in BriaCell’s "Spotlight" poster presentation session, at the 2024 San Antonio Breast Cancer Symposium (SABCS ) held at Henry B. Gonzalez Convention Center, San Antonio, TX.

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"Metastatic breast cancer remains an essentially incurable disease, with a significant unmet medical need in patients who are relapsed/refractory to recently approved therapies such as CPIs and antibody-drug conjugates (ADCs)," stated Dr. William V. Williams, BriaCell’s President & CEO. "We are very pleased with the Bria-IMT combination regimen’s tolerability profile, and most importantly its outstanding clinical activity in heavily pre-treated patients who failed other therapeutic options."

"In addition to our striking survival data in MBC patients, we are excited by potential biomarkers for early identification of patients who would benefit from treatment with the Bria-IMT combination regimen," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "We expect to replicate Phase 2’s impressive survival and clinical benefit data in our ongoing pivotal Phase 3 study."

"While CNS metastatic disease has historically had a very poor prognosis, our clinical data to date, shows solid survival and clinical benefit in patients with CNS metastasis," stated Sailaja Kamaraju, MD, Assistant Professor of Medicine at the Medical College of Wisconsin, Division of Hematology and Oncology. "We are optimistic that the Bria-IMT combination regimen, with its unique targeted mechanism of action, may be able to produce meaningful clinical and survival benefits in other cancer patients with CNS metastases who have lost hope with little to no other therapeutic options."

The data presented is from the fully enrolled BriaCell Phase 2 combination study of Bria-IMT plus CPI.

An aggregate of 54 MBC patients were enrolled in the study – all treated with the Bria-IMT combination regimen {11 patients received KEYTRUDA (pembrolizumab), and 43 patients received Incyte’s retifanlimab with one patient cross over from the KEYTRUDA study to retifanlimab}. Data is available on all 54 of these heavily pre-treated metastatic breast cancer patients (average number of prior treatments = 6). Of these 54 patients, 37 were treated with the formulation currently under investigation in BriaCell’s ongoing pivotal Phase 3 study in metastatic breast cancer (listed on ClinicalTrials.gov as NCT06072612 ). Final median overall survival calculation for the patients in the Phase 2 portion of the study is pending, as most of these patients remain alive over 1 year following their start on the study. No Bria-IMT related discontinuations have been reported to date.

The details about the Spotlight presentation and other poster sessions are as follows:

Abstract Number: SESS-1071 (Spotlight Poster)
Title: Overall survival results of Bria-IMT allogenic whole cell-based cancer vaccine
Time: Wednesday, December 11, 2024 7:00 AM – 8:30 AM CST
Presentation ID: PS3-06

Bria-IMT regimen’s impressive OS and tolerability in MBC patients

Median overall survival (OS) to date of 13.4 months for Phase 2 patients treated with the Phase 3 formulation (15.6 months for those treated since 2022 with the Phase 3 formulation) double that of comparable patients in the literature (Cortes J, et al. Annals of Oncology 2018; Kazmi S, et al. Breast Cancer Res Treat. 2020; O’Shaughnessy J et al. Breast Cancer Res Treat. 2022; Tripathy D, et al. JAMA Oncol. 2022; Bardia A, et al. J Clin Oncol. 2024)
Final Phase 2 OS calculation is pending as many patients remain alive well over 1 year after starting the study
Median overall survival (OS) for patients who received the Phase 3 formulation in the Phase 2 portion of the study who also developed an immune response to the vaccine as measured by delayed-type hypersensitivity (DTH) not yet reached with >1 year follow-up
13.7 months median OS in MBC patients with central nervous system (CNS)/intracranial tumors treated with the Bria-IMT regimen with or without a CPI
Objective response rates (ORR) and clinical benefit rates (CBR) were observed across all MBC patient subsets, but positive clinical outcomes were more prominent in HER2+ and HR+/HER2- patient subsets
Bria-IMT regimen was well-tolerated and produced clinical benefit in heavily pretreated MBC patients
Patients who developed a DTH response had lower neutrophil to lymphocyte ratio (NLR), suggesting improved clinical benefit in these patients
Delayed-type hypersensitivity (DTH) response, and circulating tumor cells (CTC) levels were significantly different between patients who responded vs those who did not respond to the Bria-IMT combination regimen
In conclusion, clinical findings to date support the potential safety and efficacy of Bria-IMT, along with its potential use in CNS metastases, as well as the possible use of biomarkers to predict clinical outcomes in BriaCell’s ongoing pivotal Phase 3 study in MBC.

Abstract Number: SESS-1431
Title: Identification of antigenic determinants in SV-BR-1 derived cellular breast cancer vaccines
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-06-02

Summary:
BriaCell successfully identified immunogenic (i.e. immune system activating) peptides in patients treated with Bria-IMT, a cell-based cancer vaccine, and showed Bria-IMT’s ability to produce a targeted immune response against tumor antigens.

Key immunogenic peptides detected included those with post-translational modifications (PTMs), such as citrullination and cysteinylation, an important type of neoantigen that may be shared across many patients with cancer
Highlighted the advantage of cell-based cancer vaccines over RNA and peptide-based vaccines including their ability to present a broad and diverse repertoire of antigens (i.e. both conventional and unconventional types)
Cell-based cancer vaccines also display unknown, patient-specific neoantigens that are hard to reproduce with RNA or peptide vaccines
Diverse antigen presentation produces a robust, polyclonal immune response, engaging both CD8+ and CD4+ T cells against multiple tumor target
In conclusion, scientific data presented suggests that the unique mechanism of cell-based cancer vaccines may reduce cancer cells’ immune escape and may potentially lead to strong and long-lasting clinical outcomes in cancer patients.

Abstract Number: SESS-2217
Title: PD-L1 upregulation in circulating tumor associated cells predicts for clinical outcomes in a phase I/II clinical trial using SV-BR-1-GM vaccine with the checkpoint inhibitor retifanlimab in metastatic breast cancer patients, an interim analysis
Time: Wednesday, December 11, 2024 12:00 – 2:00 PM CST
Presentation ID: P1-01-17

Summary:
Interim analysis after at least one year of Bria-IMT plus CPI regimen shows the following:

Significantly lowered levels of circulating tumor cells (CTCs) and cancer associated macrophage-like cells (CAMLs) in 40% of heavily pre-treated MBC patients
Lower CTCs/CAMLs levels were significantly correlated with better survival outcomes (i.e. better PFS and trended for better OS)
Bria-IMT appeared to increase PD-L1 levels in 15 patients which correlated with better clinical responses to combination treatment with the anti-PD-1 check point inhibitor retifanlimab
In conclusion, clinical data support the combination regimen in our ongoing pivotal Phase 3 study and suggests CTCs and CAMLs and PD-L1 levels may be relevant indicators of clinical outcome in MBC patients treated with Bria-IMT plus CPI.

Abstract Number: SESS-1068
Abstract Title: ASTRO-VAC CNS: Bria-IMT in the management of tumor agnostic metastatic CNS lesions
Time: Wednesday, December 11, 2024 5:30 – 7:00 PM CST
Presentation ID: P2-10-24

Results: The poster provides the details of a planned Phase 2 study design expanding the use of Bria-IMT + CPI to tumor agnostic cancer patients (i.e. kidney cancer, brain cancer, etc.) with central nervous system (CNS) metastasis.

To view the posters, please visit View Source