On April 10, 2025 Omeros Corporation (Nasdaq: OMER) reported the establishment of the Omeros Oncology Clinical Steering Committee to advance Omeros’ OncotoX biologics program focused on acute myeloid leukemia (AML) (Press release, Omeros, APR 10, 2025, View Source [SID1234651874]). AML is the most fatal form of leukemia and accounts for approximately 80 percent of acute leukemias in adults and one-third of all cancers affecting the blood/bone marrow, representing a high unmet need. Omeros’ OncotoX program for AML consists of proprietary targeted, engineered molecules (about half the size of an antibody) that deliver a toxic payload within the cancer cells, thereby killing them.

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Members of the Omeros Oncology Clinical Steering Committee include:

Naval Daver, M.D., Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center (Chair of the Omeros Oncology Clinical Steering Committee)
Aref Al-Kali, M.D., Chair of the Acute Myeloid Group and Research Chair of the Acute Leukemia and Myeloid Neoplasms Disease Group at Mayo Clinic
Jessica K. Altman, M.D., Professor of Medicine in the Division of Hematology and Oncology and Director of the Leukemia Program of Robert H. Lurie Comprehensive Cancer Center at Northwestern University
Jayastu Senapati, M.B.B.S., M.D., D.M., Assistant Professor in the Department of Leukemia at MD Anderson Cancer Center
Mithun Shah, M.D., Ph.D., Assistant Professor of Medicine and Oncology, and Consultant in the Division of Hematology at Mayo Clinic
Anthony S. Stein, M.D., Co-director of the Gehr Family Center for Leukemia Research within the Hematologic Malignancies and Stem Cell Transplantation Institute at City of Hope
Eytan M. Stein, M.D., Chief of the Leukemia Service and Director of the Program for Drug Development in Leukemia in the Division of Hematologic Malignancies at Memorial Sloan Kettering Cancer Center
Roland B. Walter, M.D., Ph.D., M.S., Professor in the Translational Science and Therapeutics Division and José Carreras/E. Donnall Thomas Endowed Chair for Cancer Research at the Fred Hutchinson Cancer Center
The steering committee will, among other activities, assist Omeros with development of the OncotoX-AML program, clinical trial design and interactions with institutional review boards and will participate in OncotoX-AML clinical trials.

"AML is a devastating disease, and these patients have difficulty tolerating the side effects of chemotherapeutic agents and current antibody-drug conjugates, which generally have a narrow therapeutic index," stated Naval Daver, M.D., Professor and Director of the Leukemia Research Alliance Program in the Department of Leukemia at MD Anderson Cancer Center and Chair of the Omeros Oncology Clinical Steering Committee. "The OncotoX platform is designed to kill only dividing cancer cells while sparing normal cells. In animal models using cell lines derived from AML patients, the OncotoX-AML molecule has shown superior efficacy to current standard of care in AML treatment, and its potential utility extends broadly beyond AML to other types of leukemia. Together with my esteemed physician-scientist colleagues on the steering committee, I look forward to advancing the Omeros therapeutic for AML and bringing this novel treatment to patients as quickly as possible."

Across extensive in vivo and ex vivo studies, the OncotoX-AML therapeutic has shown to be highly effective even at very low doses, providing a significant survival benefit over currently approved combination therapy (venetoclax and azacytidine). These studies, conducted with human cell lines in well-established animal models and considered predictive of clinical response, have targeted AML tumors with mutational backgrounds commonly found in nearly 90 percent of AML patients (TP53, NPM1, KMT2a, and FLT3) indicating that the OncotoX-AML therapeutic could be "mutation-agnostic," a currently large unmet need for oncologists and their patients. In studies using primary AML derived from patients, the OncotoX molecule preferentially and efficiently kills AML blasts (abnormal myeloid cells). OncotoX-AML also targets leukemia stem cells (LSC), which are often refractory to chemotherapy and represent another major challenge in the treatment of AML. The OncotoX-AML therapeutic is designed specifically to kill both AML blasts and LSCs that can lead to relapse. Preliminary in vivo tolerability studies demonstrate that the OncotoX therapeutic is well tolerated at doses substantially greater than one order of magnitude above efficacious doses without causing neutropenia or meaningful changes in blood chemistry values.

Omeros is initiating IND-enabling work for its OncotoX-AML therapeutic. Clinical efficacy in AML, considered one of the most aggressive leukemias, is thought to bode well for a therapeutic agent’s broad applicability across leukemias. In addition to OncotoX-AML, Omeros’ portfolio of oncology platforms include signaling and antigen-driven immunomodulators, immune memory-enhancing immunostimulators, and an adoptive T-cell technology that, unlike other cell therapy approaches, does not require cellular engineering.

"We are very pleased to be working with all the members of our oncology steering committee," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "Each is an internationally recognized leader in the fields of leukemia and AML and has been integrally involved in the development of new treatments for their patients. Their willingness to invest time and effort in our OncotoX-AML program is a strong endorsement of our molecule’s potential and, with their help, we look forward to assessing this next-generation therapeutic in AML patients."

In the U.S. alone, AML is diagnosed in over 20,000 patients annually and is responsible each year for more than 11,000 deaths. In 2030, the global AML therapeutic market size is projected to be over $6 billion with the leukemia therapeutic market forecast at $29 billion.

On April 10, 2025 Biocon Biologics Ltd (BBL), a subsidiary of Biocon Ltd (BSE code: 532523, NSE: BIOCON), reported that the U.S. Food and Drug Administration (U.S. FDA) has approved Jobevne (bevacizumab-nwgd), a biosimilar Bevacizumab for intravenous use (Press release, Biocon, APR 10, 2025, View Source [SID1234651875]). JOBEVNE, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab). JOBEVNE is a vascular endothelial growth factor (VEGF) inhibitor that binds with VEGF and blocks the interaction with its receptors to prevent angiogenesis – combating cancer by restricting blood supply to the tumor.

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The approval of JOBEVNE expands Biocon Biologics’ biosimilar oncology portfolio in the United States, which also includes OGIVRI (Trastuzumab-dkst) and FULPHILA (Pegfilgrastim-jmdb). The Company also markets Bevacizumab in Europe (approved February 2021) and Canada (approved November 2021) under the name ABEVMY.

The U.S. FDA has approved Jobevne (bevacizumab-nwgd) from Biocon Biologics to treat several different types of cancer.

Shreehas Tambe, CEO & Managing Director, Biocon Biologics Ltd., said: "The U.S. FDA approval of JOBEVNE (bevacizumab-nwgd) is a significant milestone—our seventh biosimilar approved in the U.S. and a strong addition to our robust oncology portfolio. It underscores the depth of our scientific expertise and commitment to expanding access to high-quality, affordable biologics. We look forward to working with all stakeholders to bring more treatment options to patients."

In the U.S., sales of bevacizumab were approximately $2.0 billion in 2023.**

Biocon Biologics is a leading global player in biosimilars and insulin production and has achieved many "firsts" in the industry including the first to receive approval of a trastuzumab in the United States, OGIVRI (Trastuzumab-dkst), as well as FULPHILA (Pegfilgrastim-jmdb) and the first U.S. approval of an interchangeable biosimilar for SEMGLEE (insulin glargine). Serving over 5 million patients annually, Biocon Biologics has a comprehensive portfolio of in-market and in-development biosimilar products across multiple therapies, including seven approved biosimilars in the United States and six in Canada, with a robust development pipeline of 20 biosimilar assets, including insulins and monoclonal antibodies spanning multiple therapy areas.

About JOBEVNE:

The approval for JOBEVNE (bevacizumab-nwgd) was based on a comprehensive package of comparative pharmacokinetic, safety, efficacy, nonclinical, structural, analytical and functional data, which confirmed that JOBEVNE is highly similar to Avastin (bevacizumab).

The data demonstrated that there were no clinically meaningful differences between JOBEVNE and Avastin in terms of pharmacokinetics, safety, efficacy, and immunogenicity.

INDICATIONS AND USAGE:

JOBEVNE is a vascular endothelial growth factor inhibitor indicated for the treatment of:

Metastatic colorectal cancer, in combination with intravenous fluorouracil-based chemotherapy for first-or second-line treatment.*
Metastatic colorectal cancer, in combination with fluoropyrimidine-irinotecan-or fluoropyrimidine-oxaliplatin-based chemotherapy for second-line treatment in patients who have progressed on a first-line bevacizumab product-containing regimen.*
Unresectable, locally advanced, recurrent or metastatic non-squamous non-small cell lung cancer, in combination with carboplatin and paclitaxel for first-line treatment.
Recurrent glioblastoma in adults.
Metastatic renal cell carcinoma in combination with interferon alfa.
Persistent, recurrent, or metastatic advanced cervical cancer, in combination with paclitaxel and cisplatin, or paclitaxel and topotecan.
Epithelial ovarian, fallopian tube, or primary peritoneal cancer:
in combination with carboplatin and paclitaxel, followed by JOBEVNE as a single agent, for stage III or IV disease following initial surgical resection
in combination with paclitaxel, pegylated liposomal doxorubicin, or topotecan for platinum-resistant recurrent disease who received no more than 2 prior chemotherapy regimens
in combination with carboplatin and paclitaxel or carboplatin and gemcitabine, followed by JOBEVNE as a single agent, for platinum-sensitive recurrent disease
* Limitations of Use: JOBEVNE is not indicated for adjuvant treatment of colon cancer.

WARNINGS AND PRECAUTIONS:

Gastrointestinal Perforations and Fistula: Discontinue for gastrointestinal perforations, tracheoesophageal fistula, Grade 4 fistula, or fistula formation involving any organ
Surgery and Wound Healing Complications: In patients who experience wound healing complications during JOBEVNE treatment, withhold JOBEVNE until adequate wound healing. Withhold for at least 28 days prior to elective surgery. Do not administer JOBEVNE for at least 28 days following a major surgery, and until adequate wound healing. The safety of resumption of bevacizumab products after resolution of wound healing complication has not been established. Discontinue for wound healing complications of necrotizing fasciitis.
Hemorrhage: Severe or fatal hemorrhages have occurred. Do not administer for recent hemoptysis. Discontinue for Grade 3-4 hemorrhage.
Arterial Thromboembolic Events (ATE): Discontinue for severe ATE.
Venous Thromboembolic Events (VTE): Discontinue for Grade 4 VTE.
Hypertension: Monitor blood pressure and treat hypertension. Withhold until medically controlled; resume once controlled. Discontinue for hypertensive crisis or hypertensive encephalopathy.
Posterior Reversible Encephalopathy Syndrome (PRES): Discontinue.
Renal Injury and Proteinuria: Monitor urine protein. Discontinue for nephrotic syndrome. Withhold until less than 2 grams of protein in urine.
Infusion-Related Reactions: Decrease rate for infusion-related reactions. Discontinue for severe infusion-related reactions and administer medical therapy.
Embryo-Fetal Toxicity: May cause fetal harm. Advise females of potential risk to fetus and need for use of effective contraception.
Ovarian Failure: Advise females of the potential risk.
Congestive Heart Failure (CHF): Discontinue JOBEVNE in patients who develop CHF.
Please refer to full Prescribing Information for Jobevne (bevacizumab-nwgd) for more information. To report SUSPECTED ADVERSE REACTIONS, contact Biocon Biologics at 1-833-986-1468 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

JOBEVNE is a trademark of Biosimilars Newco Limited, a Biocon Biologics Company.
OGIVRI, FULPHILA, SEMGLEE and ABEVMY are registered trademarks of Biosimilars Newco Limited, a Biocon Biologics Company.
BIOCON BIOLOGICS and the Biocon Biologics Logo are registered trademarks of Biocon Biologics Limited.
All other trademarks are the property of their respective owners.
**Sales projections are based on Biocon Biologics’ analysis of IQVIA 2023 data.

On April 9, 2025 TC BioPharm (Holdings) PLC ("TC BioPharm" or the "Company") (OTC: TCBPY) a clinical-stage biotechnology company developing platform allogeneic gamma-delta T cell therapies for cancer and other indications, reported receipt of a patent, granted from the European Patent Office (EPO), for targeting microbial, oncological, and viral indications using modified gamma delta T cells (Press release, TC Biopharm, APR 9, 2025, View Source [SID1234651859]).

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The Company intends to proceed with the patent process in specific European countries, in alignment with the existing commercial strategy.

"The expanding patent portfolio secures our future development of high-value assets," said Bryan Kobel, CEO of TC BioPharm. "The potential for off-target recognition of healthy tissues limits the application of modified cell therapies. By refining the targeting of these modified cells, we can apply high-impact therapies to a broad spectrum of indications while mitigating the toxicity risks associated with modified cell therapies."

On April 9, 2025 Diakonos Oncology, a clinical-stage biotechnology company developing innovative immunotherapies for difficult-to-treat cancers, reported the successful presentation of an abstract at the 2025 American Academy of Neurology (AAN) Annual Meeting, which took place April 5-9, 2025, in San Diego, California (Press release, Diakonos Oncology, APR 9, 2025, View Source [SID1234651860]). The abstract presentation, titled "Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma", featured promising data from an open-label Phase I trial evaluating the safety, immunogenicity, and early efficacy signals of DOC1021.

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"We were honored to present our latest research at the American Academy of Neurology Annual Meeting," said Jay Hartenbach, President and Chief Operating Officer of Diakonos Oncology. "Glioblastoma remains one of the most aggressive and challenging cancers to treat, and we are committed to advancing novel immunotherapy approaches that have the potential to make a meaningful impact for patients. The results of this Phase I analysis are highly encouraging and reinforce the potential of DOC1021 as a novel immunotherapy for glioblastoma."

Abstract Presentation Details:

Title: Phase I Analysis of DOC1021, a Cell-Based Vaccination Platform for Adjuvant Therapy of Glioblastoma
Authors: Zhu J-J, Esquenazi-Levy Y, Hsu S, Zvavanjanja RC, Vu M, Schumann EH, Trivedi A, Liu W, Namekar M, Hofferek CJ, Ernste K, Mossop C, Clay CM, Amin S, Ravi V, Kemnade JO, Aguilar LK, Turtz A, Tandon N, Konduri V, Georges JF, Decker WK
Session: S29 – Neuro-oncology
Date and Time: Tuesday, April 8, from 4:06-4:18 p.m. PT
Location: San Diego Convention Center, 25C
Key Highlights:

DOC1021 vaccines were administered to 16 newly diagnosed glioblastoma patients, with 94% (15/16) being MGMT unmethylated.
No adverse events greater than Grade 2 attributable to the investigational regimen and no dose-limiting toxicities (DLTs) were observed.
CD4+ (13/13) and CD8+ (11/13) central memory T-cell compartments expanded post-vaccination (p<0.002 and p<0.05, respectively), indicating robust immune activation.
CD8+CD127+ memory precursor effector cells (MPECs) expanded in 12/13 patients (p<0.001), suggesting enhanced immune memory potential.
Spatial transcriptomics analysis of three patients showed intense CD25+ foci overlapping effector memory T-cell and migratory microglial markers post-vaccination.
One-year overall survival (OS) rate in the 15/16 unmethylated cohort was 88%, compared to 53% in an age-matched control cohort (p<0.002), highlighting a potential survival benefit.
"In the Phase I trial, the dendritic vaccine injections at the lymph nodes were well tolerated, with no significant side effects observed in any participants," said Dr. Jay-Jiguang Zhu, Principal Investigator of the study and Professor and Director of Neuro-oncology at UTHealth Houston. "We are looking forward to assessing this dendritic cell-based vaccine therapy in the upcoming Phase II trial."

About DOC1021

DOC1021 is an autologous dendritic cell vaccine (DCV) that initiates a complete cytotoxic TH1 immune response against a patient’s cancer through the company’s proprietary double loading technology. The vaccines are made with a patient’s dendritic cells combined with mRNA and proteins prepared from freshly obtained patients’ tumor specimens.

This unique approach unlocks a synergistic tumor killing TH1 response driven by dual protein and RNA antigen sourcing, and it allows targeting of the complete cancer antigen pool. Moreover, the approach does not require any molecular modification of the patient’s immune cells for manufacturing, and does not require preconditioning of bone marrow or high dose IL-2 for administration.

In addition to the lead GBM study, a clinical trial of another Diakonos dendritic cell vaccine is ongoing for the treatment of pancreatic cancer. Diakonos has received Fast Track designations from the FDA for both the GBM and pancreatic cancer programs. The company has also received Orphan Drug Designation for the GBM program.

On April 9, 2025 Infinitopes Ltd reported that the UK Medicines and Healthcare products Regulatory Agency (MHRA) has granted Clinical Trial Application (CTA) approval for the first-in-human Phase I/IIa clinical trial of ITOP1, the company’s lead ‘off-the-shelf’ cancer vaccine (Press release, Infinitopes, APR 9, 2025, View Source [SID1234651861]). ITOP1 is a precision cancer vaccine, designed to safely and accurately target tumour antigens, leveraging the company’s vector delivery system, aiming to drive strong and durable T-cell protection for patients with surgically resectable oesophageal adenocarcinoma (OAC).

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The vaccine is designed to stimulate a robust immune response, including activation of CD8+ cytotoxic T cells, to eliminate residual cancer cells expressing the target antigens, reducing the risk of disease recurrence. Tumour antigen targets for ITOP1, Infinitopes’ lead asset from its Precision Immunomics platform, are derived using the company’s bespoke AI/ML-driven immunopeptidomics approach and demonstrate high tumour-specificity and inter-patient conservation with potential clinical applicability across multiple cancer types.

The VISTA* study is a phase I/IIa double-blind, randomised, placebo-controlled trial to assess the safety, tolerability and anti-tumour activity of ITOP1 in reducing OAC recurrence rates. 60 patients will receive ITOP1 in a prime/boost regimen, in combination with the best standard of care, i.e., a priming dose following neoadjuvant and a boost dose before adjuvant FLOT (fluorouracil, leucovorin, oxaliplatin, and docetaxel) chemotherapy. Infinitopes’ VISTA trial will be one of the first in the world to administer a cancer vaccine in the neoadjuvant setting while the primary tumour remains in situ, unlocking the potential for enhanced protection from epitope spreading.

The multicentre VISTA study will be conducted at specialist cancer centres in the UK under the leadership of Prof Mark Middleton, a world-renowned Chief Investigator. The VISTA* study is set to commence in Q2 2025. For further details, visit the UK Clinical Trials Registry for Integrated Research Application System (IRAS) project 1008088.

Prof Mark Middleton, Chief Investigator, Head of Oncology & Co-director, CRUK Oxford Centre, University of Oxford, and Scientific Advisory Board Member for Infinitopes, said: "Half of us will suffer cancer in our lifetimes, so we need better, affordable treatments for the disease. ITOP1 is an exciting new immunotherapy with the potential to make a difference across a wide range of cancers, bringing hope to many patients. This first trial in oesophageal cancer will evaluate ITOP1’s precision targeting, which enables anti-tumour immunity through epitope spreading to tackle residual cancer cells and prevent recurrence. We are particularly excited that, by working with the MHRA, we can test ITOP1 where we believe it will achieve the best protection, in potentially curable disease."

Dr Jonathan Kwok, Chief Executive Officer & Co-Founder at Infinitopes, commented: "We are delighted that we have advanced our lead vaccine candidate, ITOP1, from university research to a groundbreaking clinical programme in just over three years. This marks a major performance milestone for the company, bringing Infinitopes an important step closer to offering lifesaving solutions for patients with oesophageal and other aggressive cancers. This achievement is a testament to the power of our team, across immunopeptidomics, computational biology/AI/ML, immunology, oncology, advanced trial design, and our collaborations with Cancer Research UK and leading centres around the world."

Infinitopes recently strengthened its scientific and clinical team with the appointments of exceptional industry leaders, Dan Menichella and Jo Brewer, PhD, supporting the company’s ambition to advance ITOP1 through clinical development to prolong survival and improve the quality of life for patients.

Dan Menichella, Non-Executive Director at Infinitopes, noted: "Infinitopes’ Precision Immunomics approach has the potential to revolutionise cancer treatment as we know it today. I am very excited for the start of our VISTA study, to validate our ITOP1 vaccine and the fundamental enabling technologies."

*VISTA (Vaccination with ITOP1 in resectable oesophageal adenocarcinoma, to evaluate Safety, Tolerability & Anti-tumour activity)