On October 18, 2021 ViewRay, Inc. (Nasdaq: VRAY) reported that the company will host a Virtual Clinical Data Event for Investors and Analysts on Thursday, October 28, 2021. The event will begin at 8:30 am ET / 5:30 am PT (Press release, ViewRay, OCT 18, 2021, View Source [SID1234591476]).

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The Virtual Clinical Data Event will be hosted by the ViewRay leadership team and will feature the clinical work of Dr. Michael Chuong MD, FACRO, Medical & Clinical Research Director, Dept of Radiation Oncology, Miami Cancer Institute, GI Service Lead, Department of Radiation Oncology, Miami Cancer Institute, Associate Professor, Vice Chair of Research and Education, Florida International University, and Dr. Himanshu Nagar, MD, radiation oncologist Assistant Professor, Weill Cornell Medicine, New York-Presbyterian.

Guests must register to participate in the event on the company’s website beginning on October 21, 2021. A replay of the event will be available on the company’s website following the event.

On October 18, 2021 Isofol Medical AB (publ), (Nasdaq First North Premier Growth Market: ISOFOL), ("Isofol" or the "Company"), reported that the prospectus prepared by the Company in connection with the listing on Nasdaq Stockholm has been approved and registered by the Swedish Financial Supervisory Authority (Finansinspektionen) (Press release, Isofol Medical, OCT 18, 2021, View Source [SID1234591501]). The prospectus contains updated financial information, due to regulatory requirements, attributable to the Company’s equity and liabilities as well as net indebtedness as of July 31, 2021. The prospectus is available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

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Prospectus and new financial information
On October 15, 2021 Isofol announced that Nasdaq Stockholm’s listing committee made the assessment that Isofol fulfills the applicable listing requirements and will approve an application for admission to trading of the Company’s shares on Nasdaq Stockholm, provided that certain customary conditions are fulfilled, including approval and registration of a prospectus by the Swedish Financial Supervisory Authority. The prospectus that has been prepared in connection with the listing was approved and registered today by the Swedish Financial Supervisory Authority and is now available on Isofol’s website, www.isofolmedical.com and on the Swedish Financial Supervisory Authority’s website, www.fi.se.

The prospectus contains previously unpublished financial information attributable to Isofol’s equity and liabilities and net indebtedness as of July 31, 2021. The financial information, which is also outlined below, is presented due to regulatory requirements, according to which financial information regarding the capital structure must not be older than 90 days at the time of the prospectus’ publication. Note that only interest-bearing liabilities are reported in the tables below. The information has not been reviewed by the Company’s auditor.

Equity and liabilities as of July 31, 2021
KSEK Unaudited
Total current liabilities 1 613
For which guarantees have been issued –
Against other security –
Without secutity 1 613
Total long-term liabilities 687
Guaranteed –
With security –
Without guarantee/security 687
Equity 413 972
Share capital 4 945
Other contributed capital 1 217 607
Retained earnings -809 581
Total 416 272
Net indebtedness as of July 31, 2021
KSEK Unaudited
(A) Cash and cash equivalents 483 906
(B) Other cash and cash equivalents –
(C) Other financial fixed assets –
(D) Liquidity (A) + (B) + (C) 483 906
(E) Current financial liabilities (including debt instruments, but excluding the current portion of long-term financial liabilities) 1 613
(F) Current portion of long-term financial liabilities –
(G) Current financial indebtedness (E + F) 1 613
(H) Net current financial indebtedness (G – D) -482 293
(I) Long-term financial liabilities (excluding current portion and debt instruments) 687
(J) Debt instruments –
(K) Long-term accounts payable and other liabilities –
(L) Long-term financial debt (I + J + K) 687
(M) Total financial indebtedness (H + L) -481 606
Additional information about the listing
The first day of trading on Nasdaq Stockholm’s Main Market is planned to take place on Thursday, October 21, 2021 and the final day of trading on Nasdaq First North Premier Growth Market is expected to be Wednesday, October 20, 2021.

The Company’s shares will be traded with unchanged ticker ISOFOL and ISIN-code (SE0009581051). No new shares will be issued in connection with the shares being admitted to trading on Nasdaq Stockholm and the Company’s shareholders do not need to take any action in connection with the listing.

Advisors
Isofol has engaged Advokatfirman Vinge KB as legal advisor and Carnegie Investment Bank AB (publ) as financial advisor in connection with the listing on Nasdaq Stockholm.

The information was submitted for publication, through the agency of the contact person set out above, at 13:00 CEST on October 18, 2021.

About arfolitixorin
Arfolitixorin is Isofol’s proprietary drug candidate being developed to increase the efficacy of standard of care chemotherapy for advanced colorectal cancer. The drug candidate is currently being studied in a global Phase III study, AGENT. As the key active metabolite of the widely used folate-based drugs, arfolitixorin can potentially benefit more patients with advanced colorectal cancer, as it does not require complicated metabolic activation to become effective.

On October 18, 2021 Sirnaomics, Inc., a biopharmaceutical company engaged in the discovery and development of RNAi therapeutics against cancer and fibrotic diseases, reported that Professor Brian Berman, M.D., Ph.D., Professor Emeritus, Dermatology and Dermatologic Surgery, University of Miami will be giving a talk on the clinical study result of the Company’s lead drug candidate, STP705, at the 2021 Fall Clinical Dermatology Conference, as the principal investigator (Press release, Sirnaomics, OCT 18, 2021, View Source [SID1234591459]). The Company will also exhibit a poster at the conference highlighting results from a Phase IIa clinical trial of STP705 for the treatment of cutaneous squamous cell carcinoma in situ (nonmelanoma skin cancer). The hybrid conference is taking place in person at the Wynn Las Vegas hotel in Las Vegas, NV, USA from October 21-24, 2021.

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Talk: New and Future Innovations in Dermatologic Care
Title: Advances in Therapeutic Technology: STP705 siRNA for in situ Squamous Cell Carcinoma
Presenter: Brian Berman, M.D., Ph.D., Professor Emeritus, Dermatology and Dermatologic Surgery, University of Miami; Co-Director Center for Clinical and Cosmetic Research, Aventura, FL, USA
Overview: Clinical trial results showing STP705, used to target TGF-β1 and COX-2 siRNAs for the treatment of nonmelanoma skin cancer, has demonstrated rates of histological clearance that rival surgical excision combined with improved cosmetic appearance.
Date and Time: October 21, 2021, from 10:20 AM to 10:55 AM PT
Location: Wynn Las Vegas,Cristal 2, 4, 6
Poster:

Title: Open Label, Phase I/II, Dose Escalation Study to Evaluate Safety and Efficacy of Intralesional Injection of a TGF-β1/COX-2 dual targeting small interfering (si)RNA therapeutic, in Adult Patients with Cutaneous Squamous Cell Carcinoma in situ (isSCC)
Date and Time: October 21, 2021, from 7:00 AM to 4:30 PM PT; October 22, 2021, from 7:00 AM to 12:30 PM PT
Location: Wynn Las Vegas,Cristal 1, 3, 5

On October 18, 2021 I-Mab (the "Company") (Nasdaq: IMAB), a clinical-stage biopharmaceutical company committed to the discovery, development, and commercialization of novel biologics, reported that the Center for Drug Evaluation (CDE) of the China National Medical Products Administration (NMPA) has approved the IND submission for the initiation of phase 2 clinical trial of efineptakin alfa (also known as TJ107/GX-I7/NT-I7) in combination with PD-1 antibody in patients with advanced solid tumors, including triple-negative breast cancer (TNBC) as well as head and neck cancers (Press release, I-Mab Biopharma, OCT 18, 2021, View Source [SID1234591477]).

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Efineptakin alfa is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7) developed as a T lymphocyte-booster for cancer-related immunotherapy. Efineptakin alfa is expected to show therapeutic effect as a combination therapy with immune checkpoint inhibitors due to its inherent properties to increase T-cells that are critical for tumor suppression. Treatment with efineptakin alfa has distinct advantages over other cytokines such as human IL-2 that have a narrow therapeutic window and cause serious adverse effects.

Efineptakin alfa has been tested as monotherapy and in combination with checkpoint inhibitors to treat advanced solid tumors in the U.S., South Korea and China. According to the data from the NIT-110 dose-escalation study presented at ASCO (Free ASCO Whitepaper) 2021, the combination of efineptakin alfa and pembrolizumab is safe and well-tolerated in patients with advanced solid tumors. It significantly increased T cell numbers in both the tumor microenviroment and the peripheral blood. At the SITC (Free SITC Whitepaper) 2020, data from the phase 1b/2 Keynote-899 study (NCT03752723) have shown that simultaneuous treatment of efineptakin alfa at 1200μg/kg with pembrolizumab (Keytruda) induced 27.8% ORR in patients with metastatic TNBC. In addition, interim results from the phase 1 trial (NCT03687957) in high-grade gliomas unresponsive to chemoradiotherapy showed a 1.3 – 4.1 fold increase in the absolute lymphocyte count (ALC) with a one-year survival rate of 83.3%.[1] Further, a China phase 1b trial (NCT04001075) in patients with advanced solid tumors will soon complete to facilitate further development of efineptakin alfa.

"Efineptakin alfa is the first rhIL-7 for cancer treatment and underscores I-Mab’s commitment to innovation. Oriented by patients’ needs, we look forward to initiating this important trial to accelerate the clinical development and deliver a potentially transformative solution to patients," said Dr. Joan Shen, CEO of I-Mab.

Efineptakin alfa is also being studied in another phase 2 clinical trial (NCT04600817) to evaluate its efficacy and safety in lymphopenic patients with newly diagnosed glioblastoma multiforme (GBM) who have been treated with standard concurrent chemoradiotherapy. The study is currently advancing rapidly with the first patient dosed in February 2021.

[1] Data can be viewed in NeoImmuneTech’s poster presentation at 2021 ASCO (Free ASCO Whitepaper) Annual Meeting at the following link: View Source;fname=AX_7356756659.pdf&orifname=nit_ir%20presentation_asco2021_e.pdf

About Efineptakin alfa

Efineptakin alfa, also known as TJ107/GX-I7/NT-I7, is the world’s first and only long-acting recombinant human interleukin-7 (rhIL-7), known to boost T lymphocytes by increasing their number and functions. It emerged from Genexine’s proprietary hyFc platform for the discovering of long-acting biologics. I-Mab has acquired exclusive rights from Genexine to develop and commercialize efineptakin alfa in Greater China. Efineptakin alfa may have utility in cancer treatment-related lymphopenia (low blood lymphocyte levels), a common condition that occurs in cancer patients who have received chemotherapy or radiation therapy, for which there is no approved treatment. Efineptakin alfa has also been shown to synergize with a PD-1 antibody in various tumor animal models potentially through increased T-lymphocyte activation and proliferation.

On October 18, 2021 Clarity Pharmaceuticals (ASX: CU6) ("Clarity" or the "Company"), an Australian-based clinical stage radiopharmaceutical company developing next-generation products to address the growing need in oncology, reported that the C-BOBCAT study led by Prof Louise Emmett has closed for recruitment at St Vincent’s Hospital, Sydney (Press release, Clarity Pharmaceuticals, OCT 18, 2021, View Source [SID1234591502]).

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C-BOBCAT is a pilot trial assessment of the diagnostic value of 64Cu SAR-Bombesin PET/CT imaging for staging of ER/PR + HER2- breast cancer patients with metastatic disease in comparison with conventional imaging (CT, bone scan and 18F FDG PET/CT). SAR-Bombesin has been used to image 7 patients with ER/PR positive metastatic breast cancer under the C-BOBCAT trial and a number of patients via the Therapeutic Goods Administration (TGA) Special Access Scheme (SAS) in both breast and prostate cancer patients.

Clarity’s Executive Chairman, Dr Alan Taylor, commented, "We are very pleased with the imaging and safety data acquired during the trial and under the TGA SAS and have made a decision to close the trial early to enable the human clinical data to be used for regulatory submissions, including the upcoming Investigational New Drug (IND) Application filings with the US Food and Drug Administration (FDA) for SAR-Bombesin. As per our recent announcement, Evergreen Theragnostics, Inc. will be one of the US manufacturing groups to supply the Targeted Copper Theranostics for the US-based SAR-Bombesin clinical trial. We anticipate this trial to commence in 2022."

Prof Louise Emmett, Principal Investigator in the C-BOBCAT trial at St Vincent’s Hospital Sydney, commented, "Our collaboration with Clarity on the C-BOBCAT trial has been a very exciting one as the diagnostic program with 64Cu SAR-Bombesin generated evidence of the utility and superiority compared to conventional imaging in some patient subgroups (e.g. 99mTc bone scan, 18F FDG). In addition to these benefits for some breast cancer patients, we also found SAR-Bombesin advantageous for prostate cancer patients who are prostate specific membrane antigen (PSMA) negative, thus validating the product’s pan-cancer application. I look forward to finalising and publishing the results from the C-BOBCAT trial and wish Clarity every success in progressing this asset through clinical development."

Dr Taylor said: "SAR-Bombesin is a promising asset that can be developed for a number of cancer indications. The high uptake and strong product retention visualised by PET imaging of patients at 1, 3 and 24 hours after product administration suggest significant potential for therapy applications with 67Cu SAR-Bombesin. We are excited to further advance its clinical development with a strong focus on regulatory approvals in the US and leverage the results generated in collaboration with some of the leading Australian scientific organisations and hospitals to reach our ultimate goal of improving treatment outcomes for children and adults with cancer."