On April 4, 2022 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported a partnership with Epic, the nation’s most widely used comprehensive health record, to integrate the company’s broad portfolio of cancer tests with Epic (Press release, Guardant Health, APR 4, 2022, View Source [SID1234612025]). This integration will make it easier for health systems, community healthcare providers and retail health clinics to make Guardant Health blood tests part of routine clinical care by providing direct ordering access and results delivery.

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"This partnership will allow us to provide a best-in-class customer experience for healthcare providers to easily order Guardant Health tests and access results quickly, giving them more time to focus on their patients," said Helmy Eltoukhy, Guardant Health co-CEO. "We are committed to providing the highest quality service to healthcare professionals, and the integration of our tests with Epic, which will include Guardant SHIELD, our blood test to screen for early signs of colorectal cancer, will help to increase the scale and adoption of our offerings in both community practices and large health systems."

Clinicians will be able to order Guardant Health tests electronically within Epic once the integration is complete in the third quarter of this year. In addition to Guardant SHIELD, clinicians will be able to order current flagship tests such as Guardant360 CDx and Guardant360 Response to help physicians inform treatment decisions for patients with advanced cancer, and Guardant Reveal to detect residual and recurrent disease in patients with early-stage cancer. This integration will ensure healthcare providers have easy access to test results and health information in one single, secure place so that they can quickly make informed treatment decisions for their patients.

"Our shared commitment to healthcare innovation makes this partnership a natural fit that will benefit clinicians and patients alike," said Alan Hutchison, vice president of population health at Epic. "Guardant Health’s integration with Epic will provide an easier and more efficient workflow for clinicians to order cancer tests and access real-time results, giving providers the information they need to make the best care decision for their patients."

On April 4, 2022 INmune Bio, Inc. (NASDAQ: INMB) ("INMB" or "the Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that key findings from the NK Cells in Solid Tumors workshop (Press release, INmune Bio, APR 4, 2022, View Source [SID1234611501]). Dr. Mark Lowdell, INmune Bio’s Chief Scientific Officer (CSO), led the workshop on the role of NK cells in treatment of solid tumors during the Innate Killer Summit in San Diego (March 30 -April 1, 2022).

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The conference is widely viewed as one of the most important in translational NK cell immunotherapy.

Two consistent themes of this year’s conference were the importance of memory-like NK cells and the poor in-vivo survival of adoptively transferred allogeneic NK cells, with or without genetic modification. Strategies to improve NK cell "fitness" and improve NK cell metabolism were at the forefront. NK cell dysfunction and poor survival in the recipient and, in particular the TME may be due to damaged mitochondria – considered the "powerplants" of the cell that are essential for survival. Dr. Lowdell observed that INKmune, unlike IL15 and other NK-activating cytokines, simultaneously upregulates all mitochondrial survival proteins and more than 40 nutrient receptors on the NK cell. These unique changes may help INKmune-primed NK cells survive and thrive in the hypoxic immunosuppressive TME. Data from patients treated with INKmune have shown tumor killing memory-like NK cells present in peripheral blood and bone marrow for at least 15 weeks after INKmune therapy and provoked a lot of discussion about whether INKmune can be used in combination with adoptive NK therapies to sustain the memory-like phenotype and increase survival.

"For NK cells to become relevant in the treatment of solid tumors, several problems must be solved," said Dr. Lowdell, CSO of INmune Bio. "At the workshop, we presented how INKmune, INmune Bio’s NK cell therapeutic, may solve these problems as demonstrated by published and unpublished pre-clinical and clinical data from the INKmune Phase I trial in high-risk MDS."

Dr. Lowdell’s presentation underscored the purpose of NK cell immunotherapy for solid tumors is to kill cancer cells in the tumor microenvironment (TME). He outlined three goals for NK cell immunotherapy in treatment of solid tumors, including increasing the ability of NK cells to infiltrate the tumor; improving the ability of NK cells to survive the hostile environment of the TME; and facilitating the killing of NK resistant cancer cells. Based on available evidence, INKmune-treated NK cells appear to solve two of the three problems – survival and killing NK resistant cancers.

"A common therapeutic strategy is giving ex vivo-activated NK cells from peripheral blood which are conditioned to normal oxygen levels. Hoping that these cells track to the tumor and aren’t inhibited by the hypoxic, immunosuppressive TME does not align with our understanding of tumor biology in patients," Dr. Lowdell posited during his talk. "Activation of tumor-resident NK cells in vivo is likely to be important for patient treatment and tumor-activated NK cells seem to be better than cytokine-primed NK cells in surviving the hostile hypoxic and immunosuppressive environment of the TME. As far as we know, INKmune is the only agent which can give the pleiotropic NK activating signals that improve NK function in the hostile immunosuppressive and hypoxic environment of the TME."

Dr. Lowdell also discussed therapeutic persistence, the period of time there are adequate numbers of functional tumor killing NK cells in the circulation, most probably a key metric of therapeutic efficiency. Up-regulated mitochondrial survival and nutrient receptor proteins should contribute to therapeutic persistence by polarizing INKmune-primed NK cells to long-term survival. He presented data showing that cytokine-primed NK cells do not upregulate mitochondrial survival proteins or nutrient proteins, which may make cytokine-primed NK cells more prone to death in-vivo.

"I came away from this meeting even more convinced that INKmune can have a major impact in current and future NK immunotherapies in hematological and solid tumors and with a list of potential new collaborators for our future trials", said Dr Lowdell.

Slides from Dr. Lowdell’s presentation can be reviewed by clicking here.

On April 4, 2022 The American Association for Cancer Research (AACR) (Free AACR Whitepaper) reported that it will host its Annual Meeting April 8-13, 2022. Light Chain Bioscience is very pleased to have Xavier Chauchet attend in-person (Presentation, Light Chain Bioscience, APR 4, 2022, View Source [SID1234611437]).

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Xavier will be presenting two posters #3225 and #3283 describing differentiating CD47xPD-L1 bispecific #antibody approaches, NI-2601 & NI-2901.

"NI-2601, an Fc-active CD47xPD-L1 bispecific antibody that selectively targets CD47 on PD-L1-positive tumors" (#3283) will be exposed and presented on April 12 between 1:30-5:00 p.m.

↠ Read 1st poster – Poster section 32 : Will be available on website from April 9th.

"NI-2901, a CD47xPD-L1 bispecific antibody for dual immune checkpoint blockade with fine-tuned affinity to reduce erythrocyte binding and improve biodistribution" (#3225) will be exposed and presented on April 12 between 1:30-5:00 p.m.

:↠ Read 2nd poster – Poster section 32 :Will be available on website from April 9th.

Ernest N. Morial Convention Center New Orleans, Louisiana

900 Convention Center Blvd, New Orleans, LA 70130, United States

On April 4, 2022 Kyowa Kirin Co., Ltd. ("Kyowa Kirin", TSE:4151, President and CEO: Masashi Miyamoto) reported that the result from a phase 1 study of automated injection device ("the device") of G-Lasta [KRN125, generic name: pegfilgrastim (genetical recombination), long-acting Granulocyte Colony-Stimulating Factor (G-CSF)*1 preparation] was published in Cancer Science (Press release, Kyowa Hakko Kirin, APR 4, 2022, View Source [SID1234611432]).

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＝Article information=
"Evaluation of a novel medical device for pegfilgrastim administration"
Tomoyuki Aruga et al., Cancer Science, 2022;00:1–8., Article DOI: 10.1111/CAS.15335

This publication is based on the data from a multicenter study in patients with breast cancer undergoing neoadjuvant or adjuvant chemotherapy on outpatient basis to evaluate the safety of pegfilgrastim administration via the device.

G-Lasta is a long-acting G-CSF preparation, which has been licensed from Amgen K-A, Inc. to Kyowa Kirin. It has been marketed in Japan since 2014 to decrease the incidence of febrile neutropenia*2 in patients receiving cancer chemotherapy. In the case that the risk of developing febrile neutropenia is high, patients need to visit a medical institution again for administration of G-Lasta at least one day after administration of chemotherapy.

This device administers pegfilgrastim about 27 hours after being attached to the patient’s abdomen through a timer-controlled dosing function. The study period consisted of four cycles of neoadjuvant or adjuvant chemotherapy with docetaxel plus cyclophosphamide. Pegfilgrastim was administered subcutaneously via the device one time for each cycle of chemotherapy. The study enrolled 35 patients and no serious adverse events or febrile neutropenia occurred. All administrations of the product were successfully completed at all injection procedures and no safety concerns associated with the device function arose.

Yoshifumi Torii, Ph.D., Executive Officer, Vice President, Head of R&D Division of Kyowa Kirin commented. "We are very pleased to publish the successful results of our phase 1 study assessing safety of the automated injection device. We will continue to push forward with the belief that this novel device provides additional value in meeting the unmet medical needs for patients who receive cancer chemotherapy."

With applying it to patients on the same day of chemotherapy, an outpatient revisit required for administration of G-Lasta on the following day can be omitted. With the device, it is expected that burden on both patients and healthcare providers can be reduced. Based on the data from the clinical study, New Drug Application (NDA) was submitted to Ministry of Health, Labour and Welfare (MHLW) in August 2021 in Japan by Kyowa Kirin and has been under review*3.

The Kyowa Kirin Group companies strive to contribute to the health and well-being of people around the world by creating new value through the pursuit of advances in life sciences and technologies.

*1: About Granulocyte Colony-Stimulating Factor (G-CSF) G-CSF is a protein produced by gene recombination technology. G-CSF selectively stimulates production of neutrophils and also enhances the neutrophil function. Based on this mechanism, G-CSF accelerates recovery from chemotherapy-induced neutropenia and reduces various risks associated with neutropenia.

*2: About febrile neutropenia Myelosuppressive chemotherapy causes low neutrophil count, i.e. neutropenia, which can raise risk of infections. Neutropenia with fever, known as febrile neutropenia, can be a sign of a serious infection and patients’ needs to be given appropriate treatments.

*3: About the NDA submission in August 2021

For more information, please visit the website below. View Source

On April 4, 2022 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported that management will be presenting a corporate overview at the 21st Annual Needham Virtual Healthcare Conference being held April 11 – 14, 2022 (Press release, CorMedix, APR 4, 2022, View Source [SID1234611431]).

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21st Annual Needham Virtual Healthcare Conference
Date: Tuesday, April 12, 2022
Time: 11:00am EDT
Webcast Link