Cimeio Therapeutics and University of Pennsylvania Collaborate on CD45 CAR T Cell Therapy for Blood and Bone Marrow Cancers

Cimeio Therapeutics, a key player in the field of innovative therapeutics, has made a significant announcement regarding a preclinical research collaboration with the University of Pennsylvania. 

This collaboration, spearheaded by Saar Gill, M.D., Ph.D., an esteemed associate professor of medicine and a researcher at the University’s Center for Cellular Immunotherapies, aims to delve into the realm of universal immunotherapy. 

The objective is to create a potential treatment modality for various types of blood and bone marrow cancers. The collaboration capitalizes on the unique strengths of both entities, leveraging Cimeio Therapeutics’ proprietary epitope-editing and CD45-targeting technologies in tandem with Penn Medicine’s epitope-editing and CAR T cell technology. 

The ultimate goal is to design a revolutionary CD45-targeting CAR T cell therapy coupled with epitope-edited hematopoietic stem cells (HSCs). CD45, being prominently present on the surface of a wide array of blood cells, is a pivotal receptor that holds promise for the development of a universal CAR T cell therapy tailored for blood cancers. 

Recent breakthroughs in epitope editing have shown promise in effectively editing CD45, a receptor ubiquitously expressed on the surface of both healthy HSCs and numerous blood and bone marrow cancers. 

This collaboration builds upon the research and findings that have demonstrated the potential to shield healthy HSCs while making malignant cells susceptible to a CD45-targeting therapy, presenting a promising avenue for drug development. In addition to this groundbreaking research, Cimeio Therapeutics is advancing its efforts in the field by also working on the development of a CD45-directed antibody-drug conjugate. 

The company has a strategic vision to develop this therapy utilizing CD45 epitope shielded cells, not only for blood cancers but also for autoimmune diseases and various other indications.

GE Healthcare and Optellum Collborate to Advance Lung Cancer Diagnosis with Artificial Intelligence

GE Healthcare and Optellum have announced that they have signed a letter of intent to collaborate to advance precision diagnosis and treatment of lung cancer.

Optellum’s Virtual Nodule Clinic identifies and scores the probability of malignancy in a lung nodule, which is key to determining whether biopsy is necessary, and accelerating diagnosis. It is the only FDA-cleared AI-assisted diagnosis software for early-stage lung cancer, and has been shown to improve the sensitivity and specificity of malignancy assessments of indeterminate nodules — enabling pulmonologists and radiologists to make optimal clinical decisions.

The clinician’s AI-assisted diagnosis of malignancy may enable patients whose nodules are not malignant to avoid unnecessary and aggressive procedures such as biopsy and surgical resection, while expediting the diagnostic process, and enabling the right treatment to start earlier. This has the potential to provide patients with personalized diagnosis and treatment plans, enabling lung cancer patients to be treated at the earliest possible stage when survival rates are the highest.

GE plans to collaborate with Optellum’s sales team on the distribution of the Virtual Nodule Clinic and work with Optellum to integrate the platform with AI solutions powered by GE Healthcare’s Edison platform. In addition the companies intend to bring results from Optellum’s Lung Cancer Prediction AI into the existing workflow of various GE Healthcare technological pathways, including CT and PACS.

Veracyte's Immunoscore Colon Cancer Test Included in ESMO Clinical Practice Guidelines Adapted for Pan-Asia

 Veracyte. (Nasdaq: VCYT) have announced that their Immunoscore Colon Cancer test has been included in the Pan-Asian adapted ESMO Clinical Practice Guidelines for the diagnosis, treatment and follow-up of patients with localized colon cancer. The new guidelines appear online in Annals of Oncology and will be highlighted at the ESMO Asia Virtual Oncology Week 2021 meeting, being held November 17-23, 2021

Veracyte acquired the Immunoscore Colon Cancer test through its acquisition of HalioDx in August 2021. The test measures patient immune response at the tumor site and is used to inform chemotherapy decision-making for patients with Stage II and III colon cancer.

The Immunoscore Colon Cancer test was included in the 2020 ESMO Clinical Practice Guidelines for Diagnosis, Treatment, and Follow-up of Colon Cancer. The new Pan-Asian guidelines take into account ethnic differences associated with the treatment of localized colon cancer in Asian patients. They comprise the consensus opinions reached by 14 experts representing the oncological societies of Japan, China, India, Korea, Malaysia, Singapore and Taiwan.

The 2020 ESMO guidelines and the new Pan-Asian adapted version both emphasize that tumor recurrence risk-assessment and expected benefit from chemotherapy are key to the evaluation of adjuvant therapy options. In this context, the Immunoscore Colon Cancer test is recommended for its ability to refine the prognosis of stage II and stage III colon cancer patients, in conjunction with standard cancer staging known as TNM (Tumor, Node, Metastasis).

Dr. Reddy’s Laboratories and Citius Pharmaceuticals enter into agreement for denileukin diftitox

 Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY) have announced that they have entered into a definitive agreement with Citius Pharmaceuticals pursuant to which they sold all of their rights to E7777 (an engineered IL-2-diphtheria toxin fusion protein) and certain related assets.

Under the terms of agreement, Dr. Reddy’s will receive $40 million upfront upon the closing of the transaction, followed by approval milestone payment of up to $40 million related to the CTCL (cutaneous T-cell lymphoma) indication approval and up to $70 million for additional indication approvals. Further, Dr. Reddy’s will receive certain sales-based milestones and tiered earn-out payments.

Recall, in Mar 2016, Dr. Reddy’s had acquired the exclusive global rights (excluding Japan and Asia) to the investigational anti-cancer agent E7777 from Eisai Co. Ltd.

Click here to know more about the clinical trials of denileukin diftitox.

Roche launches new test for diagnosis and monitoring of Thyroid Cancer

Roche has announced the global launch (except US) of Elecsys Calcitonin, a new laboratory test for the diagnosis and lifelong monitoring of medullary thyroid cancer patients after thyroid surgery. This test is based on Calcitonin, a specific tumour marker that can help diagnose medullary thyroid carcinoma early, as elevated concentrations of calcitonin in the blood are associated with the onset of this type of cancer.

 

Designed for use on Roche’s cobas modular analyser platform, Elecsys Calcitonin offers healthcare professionals an integrated solution for accurate diagnosis and reliable patient monitoring, significantly improving medical decision-making and treatment planning.

Click here for more info

 

FDA announces changes in drug center’s oncology office

The US Food and Drug Administration announced organizational changes within the office responsible for reviewing all drug and biologic applications for cancer therapies. The Center for Drug Evaluation and Research’s (CDER) Office of Oncology Drug Products has been reorganized and renamed the Office of Hematology and Oncology Products (OHOP).

“Under the new office structure, the agency anticipates greater clarity and more transparent interactions with companies about the requirements to bring cancer treatments to market,” said CDER director Janet Woodcock, M.D. “We don’t expect these changes to slow down pending applications, in fact, we expect to see greater efficiencies that will better support our work to get cancer treatments to patients.”

Richard Pazdur, M.D., who joined the FDA in 1999 and became director of the office in 2005, will continue to serve as the office director. Dr. Pazdur will also continue to head the agency-wide oncology program that coordinates oncology activities within the FDA as well as with external stakeholders. This program will remain in OHOP.

“As the practice of oncology and the treatments being developed for these diseases have become more complex, we’ve recognized the need and importance of taking a more disease-specific review approach to these therapies,” said Dr. Pazdur. “Reorganizing the office in this manner also aligns FDA with the organizational structure of leading cancer treatment centers, academic programs and the National Cancer Institute.”

The previous structure contained three divisions: Division of Hematology Products (DHP), Division of Drug Oncology Products (DDOP), and Division of Biologic Oncology Products (DBOP).

The new structure contains four divisions: Division of Hematology Products (DHP), Division of Oncology Products 1 (DOP1), Division of Oncology Products 2 (DOP2), and Division of Hematology Oncology Toxicology (DHOT).

Two unique features of the reorganization include the creation of DOP1 and DOP2, the agency’s primary review divisions for cancer solid tumor therapies, and the creation of DHOT, which will review nonclinical information.

DOP1 and DOP2 will have disease-specific therapeutic areas of responsibility regardless of whether the product is a drug or biologic. DHOT is a newly created division that will be dedicated to reviewing nonclinical pharmacology and toxicology aspects of cancer therapies. DHP will continue reviewing hematology therapies, including those for benign disorders and malignancies. The division directors for each division are listed below.

New OHOP Structure and Division Therapeutic Areas

DOP1	DOP2	DHP	DHOT
Division Director Robert Justice, M.D., M.S.	Division Director Patricia Keegan, M.D.	Division Director Ann Farrell, M.D.	Division Director John Leighton, Ph.D.
Breast, Gynecologic, Genitourinary, Supportive care (non-hematologic)	Gastrointestinal, Lung/Head & Neck, Neuro-oncology/Rare cancers/Pediatric Solid Tumor, Melanoma/Sarcoma	Benign hematology, Hematologic malignancies, Hematology support, Pediatric Hematology	Nonclinical Review Division for Hematology/Oncology products

OHOP at-a-glance

• 130: total employees in OHOP
• 55: number of medical oncologists in OHOP
• 39: number of pharmacists, nurses and non-clinical Ph.D.s in OHOP
• 19: Number of medical oncologists, nurses and pharmacists still treating patients
• 24: OHOP staff published in 2010
• 10: number of new drug indications approved in 2010
• 7: number of new molecular entities approved to date in 2011

FDA approves Adcetris to treat two types of lymphoma

The U.S. Food and Drug Administration has approved Adcetris (brentuximab vedotin) to treat Hodgkin lymphoma (HL) and a rare lymphoma known as systemic anaplastic large cell lymphoma (ALCL).

Lymphomas are cancers of the lymphatic system. Adcetris is an antibody-drug conjugate that combines an antibody and drug, allowing the antibody to direct the drug to a target on lymphoma cells known as CD30.

Adcetris is to be used in patients with HL whose disease has progressed after autologous stem cell transplant or after two prior chemotherapy treatments for those who cannot receive a transplant. Autologous stem cell transplant is a procedure using a patient’s own bone marrow that is designed to repair damaged bone marrow after the use of high chemotherapy doses. Adcetris may also be used in patients with ALCL whose disease has progressed after one prior chemotherapy treatment.

Adcetris is the first new FDA-approved treatment for HL since 1977 and the first specifically indicated to treat ALCL.

For more information, please visit: Adcetris

Avastin may no longer be used for the treatment of breast cancer

The U.S. Food and Drug Administration has recommended to removing the breast cancer indication from the label for Avastin (bevacizumab) because the drug has not been shown to be safe and effective for that use.

This recommendation has come after reviewing the results of four clinical studies of Avastin in women with breast cancer and determining that the data indicate that the drug does not prolong overall survival in breast cancer patients or provide a sufficient benefit in slowing disease progression to outweigh the significant risk to patients. These risks include severe high blood pressure; bleeding and hemorrhage; the development of perforations (or “holes”) in the body, including in the nose, stomach, and intestines; and heart attack or heart failure.

In July 2010, after reviewing all available data an independent advisory committee, composed primarily of oncologists, voted 12-1 to remove the breast cancer indication from Avastin’s label.

The drug is also approved for the treatment of colon, kidney, brain, and lung cancers. The recommendation that came today does not affect the use of Avastin for other indications.

Genentech, the manufacturer of Avastin has not agreed to remove the breast cancer indication voluntarily, so the FDA has issued a Notice of Opportunity for a Hearing, which permits Genentech to request a public hearing if it wishes to contest the agency’s determination.

Additional studies of Avastin in patients with metastatic breast cancer could be conducted by Genentech to identify a population of patients in which the drug’s benefits exceed the risks