On July 11, 2022 Cue Biopharma, Inc. (Nasdaq: CUE), a clinical-stage biopharmaceutical company developing a novel class of injectable biologics to selectively engage and modulate tumor-specific T cells directly within the patient’s body, reported that it will take part in a fireside chat at the Guggenheim I&I Spotlight Series – Treg-based Therapies being held July 12–13, 2022 (Press release, Cue Biopharma, JUL 11, 2022, View Source [SID1234616588]).

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A live and archived webcast of the presentation will be available on the Events page in the Investors and Media section of the Company’s website at www.cuebiopharma.com.

On July 11, 2022 Median Technologies (ALMDT:PA) (Paris:ALMDT) reported its business indicators for the first half of 2022 (Press release, MEDIAN Technologies, JUL 11, 2022, View Source [SID1234616589]).

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Steady growth of revenue

Following record revenues in Q1 2022 of €5.7 million, Median Technologies continued its strong growth with Q2 2022 revenues of €7.0 million, which is a 43% increase versus Q2 2021 (€4.9 million). First half revenue stood at €12.7 million on June 30, 2022, up 25% versus the same period year ago (€10.1 million). Revenues are generated entirely from the iCRO1 business, which provides services for image management in oncology trials to the biopharmaceutical industry worldwide.

The order backlog totaled €60 million on June 30, 2022, up 14.3% relative to June 30, 2021 (€52.5 million). Median has overcome operational challenges caused by the lockdown in Shanghai region, especially with regards to handling tenders, which translated in a limited and temporary decrease of €2.2 million of the order backlog versus March 30th, 2022. The growth of our business in China remains solid.

On June 30, 2022, cash and cash equivalents amounted to €28.2 million. The temporary closure of official administrative services in Shanghai delayed the invoicing process and the collection of customer receivables. The group estimates current delayed payments at €2.5 million. Since the end of the Shanghai lockdown, relations between Median Technologies and official administrative services are gradually recovering their normal course and the company expects the payment delays to be caught up during Q3 2022.

"The growth momentum of our business continued during the second quarter of 2022, with record quarterly revenues, up 43% versus the same period year ago. Our affiliate in China overcame the challenge of the lockdown in Shanghai region and expectations for the year remain unchanged", indicated Fredrik Brag, CEO and founder of Median Technologies.

Median confirms its objective to obtain marketing approval in Q4 2023 for its Software as Medical Device iBiopsy LCS CADe/CADx

In March 2022, the company announced outstanding performances for the combined malignant/benign detection and characterization capabilities of its iBiopsy LCS CADe/CADx2 software as medical device based on Artificial Intelligence and Machine Learning technologies (press release of March 22). The excellent performance of iBiopsy LCS CADe/CADx in terms of sensitivity and specificity could open new perspectives for the early diagnosis of lung cancer and the implementation of massive screening programs for this cancer, which is currently the most deadly in the world. Moreover, these results come at a time when the pharmaceutical industry is heavily investing to position new drug candidates on early stages of the disease.

Simultaneously, Median Technologies has initiated discussions with the FDA in preparation for the launch of the iBiopsy LCS CADe/CADx pivotal study at the end of 2022: following the FDA’s response to its 513(g) filing, Median will proceed with a 510k submission to file for marketing approval with the FDA for its iBiopsy LCS CADe/CADx software as medical device. Median Technologies also initiated a Q-submission process on May 2, with the aim of obtaining the FDA’s opinion on several elements including the pivotal trial protocols and potential predicates. This process will continue through the third quarter of 2022.

The significant advancements of the second quarter, allow Median to confirm its objective of obtaining marketing authorization on the US market in Q4 2023 for its Software as Medical Device iBiopsy LCS CADe/CADx.

New synergies between the iCRO and iBiopsy activities

During ASCO (Free ASCO Whitepaper) annual conference, Median Technologies announced the creation of Imaging Lab, a new and highly differentiated iCRO entity focused on leveraging AI, data mining and radiomics technologies to exploit imaging data for oncology clinical trials. This creation expands the portfolio of services provided by the company to the biopharmaceutical industry and materializes the convergence between the iCRO division activities and those of iBiopsy.

On July 11, 2022 RefleXion Medical, a therapeutic oncology company pioneering the use of biology-guided radiotherapy (BgRT)* for all stages of cancer, reported that researchers will present new data from 14 medical physics investigations validating the efficacy and feasibility of the RefleXion X1 radiotherapy platform with and without BgRT at the 2022 American Association of Physicists in Medicine (AAPM) Annual Meeting in Washington, D.C., July 10-14 (Press release, RefleXion Medical, JUL 11, 2022, View Source [SID1234616590]).

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Two of the 14 abstracts are oral presentations, one of which was selected as "Best in Physics," a distinction granted to only 15 abstracts by the AAPM. The company is showcasing the X1 radiotherapy platform and future BgRT capabilities in booth #5093.

RefleXion is also hosting an industry lunch symposium during the AAPM annual meeting at 12:45 pm EDT today. Titled "Preparing for Biology-guided Radiotherapy in the Clinic," the symposium features a presentation on BgRT and advantages for eliminating challenges with motion management by Murat Surucu, Ph.D., as well as a presentation on BgRT commissioning and workflow by Nataliya Kovalchuk, Ph.D., based on their facility’s experience participating in RefleXion’s Investigational Device Exemption (IDE) clinical study.

"We are extremely encouraged by the growing body of scientific evidence validating the RefleXion X1 platform, the future potential of BgRT, and its impact on workflow and treatment planning," said Sean Shirvani, M.D., chief medical officer of RefleXion. "To have 14 medical physics investigations presented at AAPM, including an oral presentation that earned the distinction ‘Best in Physics,’ further underscores our commitment to achieving and surpassing industry standards of quality radiotherapy treatments for patients."

The following two oral presentations and two poster presentations highlight some of the new research being shared regarding the use of BgRT for treatment planning for various anatomic sites, time savings, and simplification in workflow:

Oral Presentations:

"Investigation of computation time and storage savings using Generative Adversarial Network (GAN) source models for dose simulation of a binary MLC Lina," presented by Bin Han, Ph.D., Sunday, July 10 from 4:00 pm – 5:00 pm EDT. This study investigated the feasibility of Generative Adversarial Network (GAN) in modeling the RefleXion X1 Linac by replacing each collimated beam with a GAN generator for Monte Carlo simulation.
"Evaluation of 89Zr immune-PET for Biology Guided Radiation Therapy," selected "Best in Physics," and presented by Guillem Pratx, Ph.D., Thursday, July 14, from 7:30 am – 8:30 am EDT. This study investigated whether a long-lived PET isotope tagged with antibody (immune-PET) could simplify the BgRT workflow by reducing the multiple tracer injections while improving tumor-specific uptake and guidance.
Poster Presentations:

"One-year quality assurance experience of the first RefleXion system," presented by Murat Surucu, Ph.D., Tuesday, July 12, from 1:15 pm – 1:45 pm EDT. This study reports on the daily, monthly, and annual quality assurance (QA) measurement results of the first clinical BgRT capable machine following the AAPM TG-148 protocol.
"Biology Guided Radiotherapy (BgRT) treatment planning feasibility study for head-and-neck, abdomen, and pelvis," presented by Nataliya Kovalchuk, Ph.D., Tuesday, July 12 from 3:45 pm – 4:15 pm EDT. The purpose of this study was to evaluate the feasibility of BgRT treatment planning for various treatment sites in five cancer patients.

On July 11, 2022 Redx (AIM: REDX), the clinical-stage biotechnology company focused on discovering and developing novel, small molecule, highly targeted therapeutics for the treatment of cancer and fibrotic disease, reported that it will be presenting at the Proactive One2One Virtual Investor Forum on Thursday 14 July 2022 (Press release, Redx Pharma, JUL 11, 2022, View Source [SID1234616574]). The webinar event will begin at 18:00 BST and investors can register to attend here: View Source There will also be the opportunity for investors to ask questions during the event.

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Lisa Anson, Chief Executive Officer of Redx, will be presenting an overview of the Company following the recent successful fundraise of £34.3m and strong progress reported at the time of the Company’s Interim Financial Results in June. This included the acceptance of the Investigational New Drug (IND) submission for JZP815, a pan-RAF inhibitor from the Company’s partnership with Jazz Pharmaceuticals. JZP815 is the fifth molecule from the Redx Discovery Engine to enter the clinical stage of development, highlighting the strength of Redx’s worldclass medicinal chemistry expertise and drug discovery capabilities. The presentation will also include updates on the clinical programmes for Redx

On July 11, 2022 Singapore-based SCG Cell Therapy Pte Ltd ("SCG") reported that U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for SCG101, an investigational T-cell receptor (TCR) T cell therapy for patients with hepatitis B virus (HBV) related liver cancer (Press release, SCG Cell Therapy, JUL 11, 2022, View Source [SID1234616592]). This clearance initiates the advancement of SCG101 Phase 1/2 clinical trials globally.

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This announcement follows SCG’s previous IND approvals from China National Medical Products Administration (NMPA) in March 2022 and Singapore Health Sciences Authority (HSA) in May 2022. This further establishes SCG101 as the first TCR-T cell therapy product approved for clinical trial across the U.S, China and Singapore.

"Clearance of the IND for SCG’s leading cell therapy product SCG101 across the United States and Asia is an important milestone for the company," said Frank Wang, Chief Executive Officer of SCG Cell Therapy. "We are eager to start international multicenter clinical trial that utilizes our TCR-T technologies to offer innovative treatment option for patients."

SCG101 is an autologous TCR T cell therapy that can recognize HBV-derived T cell epitope presented on the cell surface by specific major histocompatibility complex (MHC) class I molecules. With the specific HLA typing, SCG101 can redirect T cells specifically against the HBV antigen not only to target and eliminate HBsAg-positive HCC cells but also to eradicate HBV cccDNA (covalently closed circular DNA).

"Our previous preclinical and clinical studies demonstrated that SCG101 has dual antiviral and antitumor activities, which is a profoundly important and exciting clinical proof-of-concept for SCG in cancer drug development," stated Ke Zhang, PhD, Chief Scientific Officer of SCG Cell Therapy. "We believe tumour microenvironment is a major barrier to successful cell therapy in solid tumours. Redirecting T cells specifically against HBsAg-positive HCC cells as well as HBV-infected cells could potentially induce immunological cascades altering the tumour microenvironment and offer a path forward to better outcomes for patients."

In June 2022, SCG Cell Therapy presented interim data from an investigator-initiated clinical trial of SCG101 at the International Liver Congress (ILC) 2022, the 57th EASL Annual Meeting. The trial evaluated single-dose SCG101 in patients with advanced HBV-related hepatocellular carcinoma (HCC) who had received at least two prior cancer therapies. The data showed significant antiviral activity and tumour control. Two out of three patients observed lesion shrinkage as well as rapid and significant serum HBsAg reduction from a baseline of 1,004.3 IU/mL and 521.6 IU/ML to 23.8 IU/mL and 9.1 IU/mL in just 28 days from SCG101 treatment and further reduced to 14.0 IU/m and 0.3 IU/mL within 60 days from treatment.

About SCG101

SCG101, an autologous T-cell receptor (TCR) T cell therapy, is an investigational cell therapy product that targets specific epitopes of hepatitis B surface antigen (HBsAg). SCG101 incorporates SCG’s proprietary technology, which allows for redirecting and engineering endogenous T cells using virus-specific TCRs with high sensitivity and avidity selectively against dysfunctional infected and tumour cells. Preclinical studies of SCG101 demonstrated tumour inhibition and HBV cccDNA eradication. In 2022, SCG101 was granted clinical trial approvals by the U.S Food and Drug Administration (FDA), China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for the potential treatment of HBV-related HCC. The Phase 1/2 clinical trial evaluating SCG101 is underway.

About Liver Cancer

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated that more than 905,000 new cases of liver cancer and more than 830,100 deaths from the disease globally in 2020, making it one of the leading causes of cancer deaths around the world [1]. Chronic hepatitis B virus (HBV) infection accounts for at least 50% of cases of HCC worldwide [2]. HCC is typically diagnosed at an advanced stage and is associated with a poor prognosis. The five-year survival rate of less than 15%.