On May 24, 2023 Excyte Biopharma reported its YK012 (CD3), a bispecific antibody drug, was used for the treatment of recurrent/refractory B-cell non Hodgkin’s lymphoma × CD19) Phase I clinical study completed the first drug administration in Phase I ward of Chinese Academy of Medical Sciences Cancer Hospital (Press release, Excyte Biopharma, MAY 24, 2023, View Source;lang=en [SID1234646276]).

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At 9:40 am on the same day, YK012 injection slowly flowed into the subject’s body through a micro injection pump and infusion pipeline. After 24 hours of administration, the subject had no adverse reactions and was in stable condition. In order to ensure the safety of the subjects and collect safety data of this product, the research team is closely monitoring the treatment response of the subjects and will promptly share information with all parties involved in the project.

Under the full promotion of the project team of the company, contract research organization Beijing New Leading Medicine and the Cancer Hospital of the Chinese Academy of Medical Sciences worked together to complete the first drug administration 17 days after the project kick-off meeting, highlighting the "speed of Yikesite". Yike Si Te is making every effort to rapidly advance the clinical progress of YK012, complete the product launch as soon as possible, and enable more patients to use the new drug as soon as possible, solve their pain, and improve their quality of life.

YK012 developed by Yikesite has a similar mechanism of action to Amgen’s Beretol, but it is significantly superior to Beretol in terms of molecular structure, half-life, production level and toxicity. Preclinical studies have shown that YK012 may have better clinical efficacy and safety, and is expected to provide better treatment options for refractory and recurrent ALL and NHL. In addition, through clinical trial exploration, it is possible to expand YK012 to more indications.

Yikesite (Beijing) Pharmaceutical Technology Development Co., Ltd. was jointly founded by Dr. Yuan Qing’an and Mr. Meng Qingwu, who came back from a famous American pharmaceutical company. The company makes full use of the founder’s years of experience, technical advantages and team strength to develop innovative bispecific antibody drugs for blood cancer, multiple myeloma, triple negative breast cancer and liver cancer. These projects have the characteristics of long-term, low toxicity, and high-yield technological innovation, and are positioned as the best or first of their kind. I believe that with the progress of the product pipeline, the company will have more dual antibody varieties entering the clinical stage, providing better treatment methods for patients.

On May 24, 2023 Cyteph, a spin-out biotechnology company from QIMR Berghofer Medical Research Institute, reported a $1.5m grant via the CUREator incubator (Press release, Cyteph, MAY 24, 2023, View Source [SID1234638281]).

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This grant signals an official launch milestone for the Company, supporting its imminent plan to conduct a phase 1 clinical trial for its lead candidate CYT-101 in recurrent glioblastoma multiforme (GBM) patients. Under the guidance of QIMR Berghofer’s Professor Rajiv Khanna, the goal is to develop allogeneic or ‘off-the-shelf’ T cell therapies and a dual-targeting CAR T platform to rapidly advance the treatment of solid tumours.

CYT-101 is an allogeneic cytomegalovirus (CMV)-specific T cell therapy developed by Professor Khanna’s team. The novel immunotherapy uses the immune system and the power of virus-specific T cells to recognise and attack cancer cells. CMV-specific T cells are particularly effective at targeting and destroying virus-infected and malignant cells because they are primed in the body as killer T cells which rapidly migrate and penetrate deep into diseased tissues.

The program has been de-risked through two previous clinical trials using autologous CMVspecific T cell therapy in GBM patients, where it was found to be safe with preliminary efficacy signals. Autologous treatments use the patient’s own immune cells which are harvested, manipulated, then injected back into the patient; a process which is costly, can take many weeks, and the immune cells can be dysfunctional. Allogeneic treatments, often termed ‘offthe-shelf’, use donor cells from healthy volunteers. Pivoting to allogeneic treatment offers many potential benefits over autologous, including a more robust and consistent product with longer duration and treatment without delay, which is crucial for treating fast-growing tumours such as GBM.

QIMR Berghofer Distinguished Scientist, Co-Director of Queensland Immunology Research Centre and Cyteph Founder, Professor Rajiv Khanna, commented: "Securing this grant is an important commercial milestone for Cyteph and a vital step in progressing the development of its lead technology, which has been nurtured at QIMR Berghofer for 15 years. For our medical research team, one of the most rewarding parts of the job is guiding work from the lab, closer to the patient, and I am optimistic about how CYT-101 may improve the lives of people suffering from GBM."

Cyteph Chief Executive Officer, Dr Melissa Knight, shared her enthusiasm: "We are thrilled to receive the CUREator funding and are right now welcoming further engagement with the investor community to progress our broader pipeline into the clinic. We are resolutely focused on our near-term goal to test and prove the merits of this Australian technology and to address pressing, unmet needs in the treatment of cancer."

In addition to CYT-101, Cyteph plans to utilise the unique properties of allogenic CMV-specific T cells as a dual targeting, CAR T delivery platform ‘Cyt-ATTAC’ (Cytomegalovirus – Allogeneic Tumor TArgeting Car t) to treat solid tumours. The first CAR T asset in pre-clinical development using the platform, CYT-AT1, targets EphA3 positive solid tumours such as GBM, colorectal, prostate and lung cancer. Capital raise efforts are underway to support this promising pipeline of medical research.

On May 24, 2023 Philogen S.p.A. (BIT:PHIL), a clinical-stage biotech company focused on the development of innovative medicines based on tumor-targeting antibody and small molecule ligands, reported the publication of the latest results of Fibromun (L19TNF, Onfekafusp alfa) in combination with lomustine (an alkylating agent) for the treatment of glioblastoma in Science Translational Medicine describing how the combination treatment cured orthotopic glioma-bearing mice and mediated durable objective responses and major tumor shrinkage in patients with recurrent glioblastoma (Press release, Philogen, MAY 24, 2023, https://www.philogen.com/2023/05/26/philogen-publishes-new-data-on-a-fibromun-based-treatment-combination-in-science-translational-medicine-in-collaboration-with-the-university-hospital-zurich/ [SID1234632147]). The paper can be accessed at the following link.

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The study demonstrated that the combination Fibromun and lomustine was highly synergistic and relied on an intact immune system. A thorough investigation of the treatment’s mechanism of action showed that it could transform tumors from being "invisible" to the immune system ("cold") into being easily recognized and attacked ("hot"). This transformation was proven by several indicators: the activation of the tumor endothelium, enhanced tumor DNA damage signaling pathways, treatment-associated tumor necrosis, increased immunogenicity of cancer cells and elevation of immune cell infiltration within the neoplastic mass.

Prof. Michael Weller and Dr. Tobias Weiss of University Hospital Zürich, commented: "We are excited to release this follow-up work based on the Science Translational Medicine paper published together with Philogen back in 2020. The preclinical anti-tumor activity of the combination of Fibromun with lomustine chemotherapy is very promising and the emerging clinical results of the ongoing Phase I/II trial NCT04573192 provide hope for better therapeutic opportunities for patients affected by this serious disease. We now look forward to exploring this promising approach in the Phase II randomized part which is currently starting."

Prof. Dario Neri, co-founder, CEO and CSO of Philogen, commented: "These latest findings show the promising potential of Fibromun for the treatment of glioblastoma, one of the biggest unmet medical needs. While the Phase II randomized part of the GLIOSTAR clinical trial is about to start, the preliminary evidence collected in the Phase I part demonstrates encouraging, durable objective responses in an indication where responses are very rare. We are committed to advancing our research and development efforts, with the ultimate goal of delivering this innovative treatment to patients in need." * * *

About L19TNF (also known as Fibromun)

L19TNF is a fully-human immunomodulatory product consisting of the L19 antibody and tumor necrosis factor (TNF), a strong proinflammatory cytokine. The L19 antibody is specific to the EDB domain of fibronectin and mediates selective localization of TNF to the site of disease while sparing healthy organs. The product is currently investigated in multiple clinical trials for the treatment of soft tissue sarcoma and glioblastoma, both in Europe and in the United States.

About glioblastoma

Glioblastoma is the most common and most aggressive primary brain tumor. It affects approximately 5 out of 100’000 people every year (Source: Orphanet). Newly diagnosed patients are typically treated with surgery, radiation and temozolomide (chemotherapy), which result in a median Overall Survival (mOS) in the range of 15 months. Virtually all patients progress and may subsequently receive another systemic or local second-line therapy. The mOS of patients at first progression ranges between 4.7 and 9.8 months in previous clinical trials.

About clinical trial NCT04573192

The Phase I/II clinical trial NCT04573192, which investigates the combination of L19TNF and lomustine for the treatment of patients suffering from glioblastoma at first progression after standard of care radiotherapy and chemotherapy. The Phase I part of the trial with escalating dose levels of L19TNF and lomustine is followed by a randomized Phase II part to investigate the efficacy of the combination treatment compared to standard of care lomustine as monotherapy with overall survival as primary endpoint. The first cohort of the phase I part of the study, comprising 6 patients, is presented in this publication.

On May 24, 2023 OSE reported completion of patient enrollment in the Phase 2 clinical trial TEDOPaM sponsored and conducted by the GERCOR Group and evaluating Tedopi in advanced or metastatic pancreatic ductal adenocarcinoma (Press release, OSE Immunotherapeutics, MAY 24, 2023, View Source [SID1234632027]).

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This randomized, non-comparative Phase 2 trial is designed to evaluate Tedopi plus FOLFIRI* chemotherapy versus FOLFIRI as maintenance treatment in patients (HLA-A2 genotype) with advanced or metastatic pancreatic ductal adenocarcinoma (PDAC) with no progression after 8 cycles of FOLFIRINOX induction chemotherapy**. The primary endpoint of the trial is the one-year overall survival (OS) rate (Fleming- futility analysis; null hypothesis ≤25%; alternative hypothesis ≥ 50%), and the key secondary endpoint is the progression-free survival [TEDOPaM GERCOR D17-01 PRODIGE 63 study: Maintenance With OSE2101 Plus FOLFIRI, or FOLFIRI After FOLFIRINOX-based Induction Therapy in Locally Advanced or Metastatic Pancreatic Ductal Adenocarcinoma NCT03806309].

Prof. Cindy Neuzillet, MD PhD (Curie cancer research Institute, Paris), Principal Investigator of the TEDOPaM study, comments: "Completing enrollment of this Phase 2 trial represents a major milestone in evaluating an innovative activating immunotherapy-based maintenance strategy for patients with pancreatic cancer. Tumor-associated antigens selected for Tedopi are found overexpressed in pancreatic tumor, thus giving a rationale for testing this cancer vaccine in a very hard to treat patient population. We now look forward to advancing on the patients’ follow-up period and to reporting the research main findings, including survival and predictive biomarkers. We are very grateful to the patients involved and their families, and to the clinical investigators and centers for their trust and participation in this important development program."

Nicolas Poirier, Chief Executive Officer of OSE Immunotherapeutics, concludes: "We are very pleased with the progress of the TEDOPaM clinical study and are now expecting the final results in Q3 next year as additional source of clinical value of Tedopi beyond non-small lung cancer, further to the first encouraging interim results shared at the 2022 ASCO (Free ASCO Whitepaper) meeting. We warmly thank the GERCOR academic group, sponsor of the trial, and the PRODIGE Intergroup, for this important milestone in Tedopi’s development program in pancreatic cancer. This step brings us closer to delivering potential evidence to assess the use of Tedopi as a potentially maintenance treatment in an aggressive disease with a generally poor prognosis, demanding for novel therapeutic approaches and representing significant unmet medical need."

The interim results from the TEDOPaM Phase 2 trial presented at the 2022 ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) meeting referred to the first 29 randomized HLA-A2 positive patients with no progression after 8 cycles of FOLFIRINOX: 9 patients included in standard arm A (FOLFIRI) with a 1-year OS rate of 44% and one partial response (11%); 10 patients in experimental arm B (Tedopi monotherapy) with a similar 1-year OS rate of 40% and one partial response (10%); and 10 patients in experimental arm C (nivolumab + Tedopi) with a 1-year OS rate of 30% and no partial response.

Tedopi as maintenance monotherapy showed a favorable safety profile and encouraging time to strategy failure warranting further evaluation. Nivolumab + Tedopi was associated with poorer outcomes leading to the closing of this arm. Following an Independent Data Monitoring Committee (IDMC) recommendation, the study continued with an amended protocol comparing a maintenance treatment Tedopi in combination with FOLFIRI versus FOLFIRI chemotherapy after treatment with FOLFIRINOX. A total of 107 patients were enrolled in this second part.

* FOLFIRI: A combination chemotherapy with folinic acid, fluorouracil and irinotecan
**FOLFIRINOX: A combination chemotherapy with folinic acid, fluorouracil, irinotecan and oxaliplatin

PDAC is the most common type of pancreatic cancer with approximately 60,000 patients diagnosed in the U.S. each year and nearly 500,000 new cases per year globally1,2. Due to lack of initial symptoms at early stage and high invasive potential, PDAC diagnosis is made at an advanced stage in 80% of cases, when patients already have metastases (50%) or locoregional extension (30%) precluding surgical treatment3, 4, 5. Advanced PDAC remains a challenging, non-curable disease6,7. Currently, fewer than half of patients diagnosed with metastatic PDAC and treated with FOLFIRINOX8 survive longer than one year and overall, pancreatic cancer has the lowest 5-year OS rate of all cancer types globally and in the U.S, not exceeding 10%1,2. The global pancreatic cancer treatment market size was estimated at USD 2.527 billion in 2022 and is projected to reach USD 6.859 billion by 2030.

On May 24, 2023 A recently published paper in Translational Lung Cancer Research reported encouraging results from nonclinical studies conducted with Humanetics Corporation’s (Humanetics) novel radioprotective drug, BIO 300 (Press release, Humanetics, MAY 24, 2023, View Source [SID1234632026]). The studies evaluated the therapeutic utility of BIO 300 when lung cancer undergoes treatment by radiation therapy. The positive results showcased that BIO 300 can protect normal tissues from collateral damage associated with radiotherapy without protecting the lung tumor, while potentially sensitizing the tumors to radiotherapy.

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"We are delighted with the outcome of these nonclinical studies. Showing that BIO 300 can protect normal tissues during radiotherapy has the potential to revolutionize cancer treatment by reducing the risk of debilitating side effects."

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These studies, which were conducted by researchers at Henry Ford Health in Detroit, Michigan, assessed the impact of daily, oral administration of BIO 300 in a model of human lung cancer exposed to thoracic or abdominal radiotherapy. The studies compared the effect of radiotherapy, with and without BIO 300 dosing, on normal tissue and tumors.

The researchers concluded that BIO 300 was radioprotective of normal lung tissue without compromising the efficacy of radiotherapy on lung tumors. The drug appeared to sensitize lung tumors to radiotherapy, suggesting a role in enhancing the therapeutic efficacy of radiotherapy. Importantly, BIO 300 was well-tolerated with no toxic effects following continuous daily oral dosing for up to 20 weeks. Taken together, this work highlights the therapeutic utility of BIO 300 and supports clinical investigation in patients with lung cancer.

Radiation therapy is a vital component of cancer treatment, often delivering highly targeted doses of radiation to tumor sites to eliminate cancer cells. However, the challenge lies in minimizing the damage to surrounding healthy tissues, which can lead to adverse side effects and limit treatment options. Humanetics aims to address this critical issue with BIO 300 which can safeguard normal tissues during radiotherapy, thereby enhancing patient outcomes and their quality of life.

Ronald J. Zenk, CEO at Humanetics, expressed his enthusiasm regarding the study results, stating, "We are delighted with the outcome of these nonclinical studies. Showing that BIO 300 can protect normal tissues during radiotherapy has the potential to revolutionize cancer treatment by reducing the risk of debilitating side effects."

BIO 300 is in clinical development for oncology applications to protect cancer patients from unintentional side effects caused by radiation therapy. Humanetics has completed a phase 1b/2a clinical trial in lung cancer patients (NCT02567799). In addition, a phase 2b trial is currently in progress evaluating the clinical utility of BIO 300 to protect lung tissues against the long-term effects of COVID-19 (NCT04482595).

The views expressed herein are those of Humanetics Corporation and may not reflect the official policy or position of Henry Ford Health.