On October 15, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that the Company’s abstract highlighting its U.S. phase 1 dose escalation trial data from its CD47 program, lemzoparlimab (also known as TJC4) in relapsed or refractory malignancy, will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s 35th Anniversary Annual Meeting & Pre-Conference Programs (SITC 2020), taking place online November 9 – 14, 2020 (Press release, I-Mab Biopharma, OCT 15, 2020, View Source [SID1234568537]). The data to be presented will include clinical safety, pharmacokinetics (PK) & pharmacodynamics (PD), receptor occupancy (RO), and preliminary evidence of efficacy of lemzoparlimab as a monotherapy.

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Lemzoparlimab is a highly differentiated anti-CD47 monoclonal antibody originally discovered and developed by I-Mab that has been designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity, a critical attribute in differentiating lemzoparlimab from other antibodies of the same class currently in clinical development. Initial results from I-Mab’s phase 1 study in U.S. described above have demonstrated the unique differentiation in drug safety and pharmacokinetics profile in cancer patients.

Details of the poster are as follows:

Title

A first-in-patient study of lemzoparlimab, a differentiated anti-CD47 antibody,
in subjects with relapsed/refractory malignancy: initial monotherapy results

Abstract #

385

Presenting Author

Jordan Berlin, MD, Vanderbilt University

The abstract is available at View Source

About CD47 and Lemzoparlimab

CD47 is a cell surface protein over-expressed in a wide variety of cancers and can act to protect tumors by delivering a "don’t eat me" signal to otherwise tumor-engulfing macrophages. CD47 antibody blocks this signal and enables macrophages to attack tumor cells, making it a potentially promising cancer drug. However, development of CD47 antibody as a cancer therapy is hampered by its hematologic side effects, such as severe anemia, caused by natural binding of CD47 antibody to red blood cells. In a scientific breakthrough, scientists at I-Mab have discovered a unique CD47 antibody, lemzoparlimab, that works efficiently to target tumor cells while exerting a minimal untoward effect on red blood cells to avoid severe anemia.

Lemzoparlimab’s hematologic safety advantage and superb anti-tumor activities have been demonstrated previously in a series of robust pre-clinical studies. The results of phase 1 clinical trial have provided further clinical validation of this differentiation in patients with cancer. I-Mab continues to advance a combination study of lemzoparlimab with Keytruda for solid tumor and with Rituxan for lymphoma in the U.S., in addition to an on-going clinical trial in patients with AML/MDS in China.

In September 2020, I-Mab and AbbVie entered into a global strategic partnership to develop and commercialize lemzoparlimab, including to design and conduct further clinical trials to evaluate lemzoparlimab in multiple cancers globally and in China. The collaboration is subject to certain pre-closing conditions.

On October 15, 2020 The National Comprehensive Cancer Network (NCCN) Oncology Research Program (ORP) reported plans to evaluate neratinib, a type of tyrosine kinase inhibitor (TKI) that works as a dual inhibitor of the epidermal growth factor receptor 1 (EGFR) and human epidermal growth factor receptor 2 (HER2) (Press release, NCCN, OCT 15, 2020, View Source [SID1234568536]). The research funding is supported by a $2-million grant from Puma Biotechnology, Inc.

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Projects may include pre-clinical, translational and clinical trials. They will focus on treatment of:

Pediatric tumors(including neurofibromatosis Type 2 and progressive Vestibular Schwannoma)
Early-stage and metastatic breast cancer, including those with HER2+ brain metastases
Other HER2-amplified tumors
EGFR-mutated glioblastoma multiforme.
Specific research areas will be determined by a group of cancer research experts from NCCN Member Institutions who form a Request for Proposals (RFP) Development Team.

"We look forward to advancing knowledge of the role this dual HER breast cancer drug may have in improving outcomes for various cancer presentations," said Wui-Jin Koh, MD, Chief Medical Officer, NCCN. "The projects we oversee will provide important information on this emerging mechanism for personalized cancer care."

"We thank the National Comprehensive Cancer Network for their inclusion of neratinib for further evaluation," said Alan H. Auerbach, Chief Executive Officer and President of Puma Biotechnology. "We are proud to support NCCN’s research projects to better understand the full potential of neratinib across a variety of indications. Our goal is to use these insights to expand the potential indications, as well as to identify patients who may benefit from neratinib."

The first phase of this project will involve the creation of an RFP, which will open in early 2021. The awarded projects will be announced following review of submitted proposals.

The NCCN ORP fosters innovation and knowledge discovery that improves the lives of people with cancer and supports preclinical, translational, and clinical research and quality improvement projects in oncology at NCCN Member Institutions. In an effort to improve collaboration in cancer research, the NCCN ORP also maintains a shared resources website and an informed consent database. For more information, visit NCCN.org/orp.

On October 15, 2020 OS Therapies, a clinical-stage biopharmaceutical company focused on discovering and developing innovative therapies to treat and cure Osteosarcoma (OS) and other deadly cancers in children and adults, reported that they have initiated their sponsorship of the FDA Investigational New Drug (IND) application for OST-HER2 a live, attenuated Listeria monocytogenes vector, expressing a tLLO-chimeric HER2 fusion protein (Press release, OS Therapies, OCT 15, 2020, View Source;phase-iib-trial-in-osteosarcoma-in-early-2021-301152798.html [SID1234568535]). This sets the pathway for initiation of the first clinical trial in Osteosarcoma patients in partnership with the Children’s Oncology Group (COG) – AOST-2121: An Open-Label Phase 2 Study of Maintenance Therapy with OST-HER2 (OST31-164) After Resection of Recurrent Osteosarcoma – in early 2021.

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A veterinary formulation of OST-HER2 had previously received accelerated approval from the USDA for Osteosarcoma in canines, and Phase I and III trials conducted in canines have had positive clinical benefit with manageable safety. The AOST-2121 clinical trial sponsored by OS Therapies and in coordination with COG will be the first trial in Adolescents and Young Adults (AYA) with Osteosarcoma, a deadly and debilitating bone cancer.

"OST-HER2 holds the promise of stimulating the patient’s immune system to seek out and combat hidden micro-metastases that can cause the osteosarcoma to recur," said Dr. Robert Petit, Chief Medical & Scientific Officer for OS Therapies. "In the Canine version of osteosarcoma, this form of treatment significantly delayed or prevented further osteosarcoma metastases and improved overall survival by three-fold. This clinical trial of OST-HER2 is an essential step towards bringing this potential clinical benefit to the children and young adults who are battling osteosarcoma."

On October 15, 2020 Global health service company Cigna Corporation (NYSE:CI) reported that it will release its third quarter 2020 financial results on Thursday, November 5, 2020 and will host a conference call on the same day (Press release, Cigna , OCT 15, 2020, View Source [SID1234568534]).

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Third quarter 2020 financial results will be released no later than 6:30 a.m. Eastern Time (ET). Management will review these results on a conference call beginning at 8:30 a.m. ET that same morning. The call-in numbers for the conference call are as follows:

It is strongly suggested you dial in to the conference call by 8:15 a.m. ET on November 5. A replay of the call will be available from 12:30 p.m. ET on Thursday, November 5 until 11:59 p.m. ET on Thursday, November 19, 2020. Additionally, the conference call will be available on a live Internet webcast at www.cigna.com under the About Cigna, Investor Relations section. Please note that this feature will be in listen-only mode.

A copy of the company’s news release and financial supplement will be available online at www.cigna.com under the About Cigna, Investor Relations section, no later than 6:30 a.m. ET on November 5.

On October 15, 2020 Savran Technologies Inc., a Massachusetts based biotech company with a mission to revolutionize non-invasive diagnostics via isolation of ultra-rare cells from blood, reported the completion of an important Phase 2 multi-center clinical trial conducted at 20 sites across the country utilizing its unique detection platform (Press release, Savran Technologies, OCT 15, 2020, View Source [SID1234568533]).

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The trial involved about 200 patients with early stage triple negative breast cancer who received chemotherapy and underwent surgery. An important goal of the study was to assess the utility of circulating markers (namely ctDNA and CTCs) in predicting whether the disease would relapse. The study, which is the largest of its kind to date, involved using circulating biomarkers with triple negative breast cancer who had residual disease. Results demonstrated that circulating markers were more successful in predicting relapse than other, more commonly used clinical markers such as tumor size, lymph node status, grade and stage. The study also showed that if a patient is negative for circulating markers, the chances of relapse are low. Augmenting a ctDNA analysis with Savran Technologies’ CTC analysis platform improved the sensitivity of predicting relapse to 90%.

"We are happy to see our technology help manage this agressive cancer," said Dr. Cagri Savran, the Founder and CEO of Savran Technologies Inc. "We expect our platform to be useful in a wide variety of conditions. Whole cells are precious biomarkers. They can be counted like in this clinical trial. They can be cultured to test drugs. They offer access to an intact genome which allows whole genome sequencing without a background. They can also complement other markers like ctDNA because we have seen instances where a patient was negative for ctDNA but positive for CTCs."

The application of Savran Technologies’s platform offers a unique benefit as seen in this landmark study in the field of cancer but also presents a meaningful opportunity in the prenatal field. "We are looking forward to exploring business development opportunities with innovative companies in these two fields of use who are interested in a technology platform offering a real competitive advantage" said Savran.