Kuraray Publishes the Kuraray Report 2022

On June 23, 2022 Kuraray Co., Ltd. (Head Office: Chiyoda-ku, Tokyo; President: Hitoshi Kawahara; hereinafter "Kuraray") reported that it has published the Kuraray Report 2022, an integrated report (A4 size, 58 pages, full color) (Press release, Kuraray, JUN 23, 2022, View Source [SID1234616231]).

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The aim of the Kuraray Report is to help shareholders, investors, and all other stakeholders better understand the value that the Kuraray Group creates over the medium to long term by providing a comprehensive overview of financial and non-financial information, including environmental, social and governance data.
Going forward, the Kuraray Group will continue to hold constructive dialogues with its stakeholders while also enhancing the content of the report.

Front cover of the Kuraray Report 2022
Cover of the Kuraray Report 2022
Overview of the Kuraray Report 2022
This year’s report focuses on the initiatives under the medium-term management plan "PASSION 2026," which started in fiscal 2022. The "PASSION 2026" is a medium-term management plan to realize the long-term vision "Kuraray Vision 2026," which was revised for Kuraray’s 100th anniversary, and our newly articulated sustainability long-term vision. In "PASSION 2026", the Kuraray Group has identified "Our Challenges," three areas that must be addressed in order to achieve sustainable growth, and these are introduced along with messages from top management. Under "Our Challenges," Sustainability as an Opportunity (Sustainability medium-term plan), we adopt the 3P model, which is defined by the three Ps of Planet, Product, and People. In this report, we explain each measure being taken in concrete terms to clearly convey the Kuraray Group’s approach and efforts toward sustained development.
To read this report, please click on the following link:

View Source
Sustainability Section of Kuraray’s Corporate Website
The sustainability section of Kuraray’s corporate website features detailed sustainability-related information about initiatives, activities and their results for fiscal 2021 not fully covered in the report. The site uses responsive web design, making it easy to view on smartphones and tablets.
In addition, the sustainability section reports are created in line with the GRI Standards, international guidelines for sustainability reports.

Entry into a Material Definitive Agreement

On June 23, 2022, Replimune Group, Inc. (the "Company") reported that entered into a Sales Agreement (the "Sales Agreement") with SVB Securities LLC (the "Agent"), pursuant to which the Company may sell, from time to time, at its option, up to an aggregate of $100,000,000 of shares of the Company’s common stock, $0.001 par value per share (the "Shares"), through the Agent, as the Company’s sales agent (Filing, 8-K, Replimune, JUN 23, 2022, View Source [SID1234616230]).

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Any Shares to be offered and sold under the Sales Agreement will be issued and sold (i) by methods deemed to be an "at the market offering" as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or if authorized by the Company, in negotiated transactions or block trades and (ii) pursuant to, and only upon the effectiveness of, a registration statement on Form S-3 filed by the Company with the Securities and Exchange Commission on June 23, 2022 for an offering of up to $400,000,000 of various securities, including shares of the Company’s common stock, preferred stock, debt securities, warrants and/or units for sale to the public in one or more public offerings.

Subject to the terms of the Sales Agreement, the Agent will use reasonable efforts to sell the Shares from time to time, based upon the Company’s instructions (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company cannot provide any assurances that it will issue any Shares pursuant to the Sales Agreement. The Company will pay the Agent a commission of up to 3.0% of the gross proceeds from the sale of the Shares, if any. The Company has also agreed to provide the Agent with customary indemnification rights.

Pursuant to the Sales Agreement, the parties mutually agreed to terminate that certain sales agreement, dated August 11, 2020, by and between the Company and the Agent (as amended, the "2020 Sales Agreement") with respect to the Company’s previous at-the-market offering program (the "2020 ATM Program").

This Current Report on Form 8-K shall not constitute an offer to sell or the solicitation of an offer to buy the Shares nor shall there be any sale of the Shares in any state in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state.

The foregoing description of the Sales Agreement does not purport to be complete and is qualified in its entirety by reference to the full text of the Sales Agreement, which is attached hereto as Exhibit 1.1 and is incorporated by reference herein.

Interim Results for the Six Months Ended 31 March 2022

On June 23, 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 its unaudited financial results for the six months ended 31 March 2022 (Press release, Redx Pharma, JUN 23, 2022, View Source [SID1234616229]).

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Lisa Anson, Chief Executive Officer, Redx Pharma, said: "We have made strong progress across all aspects of our pipeline. Importantly, we have moved our lead oncology asset, RXC004, into Phase 2 clinical studies; reported encouraging Phase 1 clinical results for our lead fibrosis asset, RXC007; and nominated our next development candidate, RXC008. We expect RXC008, a GI targeted ROCK inhibitor with the potential to be a first-in-class treatment for fibrostenotic Crohn’s disease, to be ready to enter the clinic by the end of 2023. Together with the recent acceptance of the IND submission for the pan-RAF inhibitor, JZP815, by our partner, Jazz Pharmaceuticals, Redx has demonstrated strong progress across all aspects of our pipeline-a testament to the world class abilities of our drug discovery team."

"In addition to our strong pipeline progress, we were particularly pleased, post-period, to have completed a £34.3 million (gross) placing of our shares. These proceeds will fund our development plans through the end of 2023. We were delighted to receive strong support from all our existing investors as well as welcoming a new specialist healthcare investor, Invus."

Operational Highlights
· Significant clinical progress on lead oncology asset, RXC004, an oral, potent, selective, small molecule Porcupine inhibitor: o In November 2021, initiated PORCUPINE, a Phase 2 trial in genetically selected MSS metastatic colorectal cancer, with US Investigational New Drug (IND) now open; o In January 2022, initiated PORCUPINE2, a second Phase 2 trial in genetically selected pancreatic cancer and unselected biliary cancer.
· On 10 March 2022, Redx presented encouraging Phase 1 safety data for RXC007, an oral selective Rho Associated Protein Kinase 2 (ROCK2) inhibitor with potential for development in multiple fibrotic conditions: o Data showed an excellent safety and pharmacokinetic profile in both the Single Ascending Dose (SAD) and multiple dose cohorts. 23/06/2022, 10:43 View Source View Source 2/25
· On 30 March 2022 nominated RXC008, a Gastrointestinal (GI) targeted Rho Associated Coiled-Coil Containing Protein Kinase (ROCK) inhibitor, as the Company’s next clinical development candidate: o RXC008 is a potential first-in-class treatment for fibrostenotic Crohn’s disease, which has shown strong anti-fibrotic effects in preclinical models. · Progressed the discovery portfolio with the announcement on 27 January 2022 of the Company’s Discoidin Domain Receptor (DDR) inhibitor fibrosis programme: o Developed potent proprietary DDR inhibitors with drug-like characteristics that are now in the lead optimisation phase.
· Advanced preclinical and clinical collaborations with world-leading institutions to enhance the Company’s research capabilities: o Entered a strategic partnership with Caris Life Sciences in December 2021 to accelerate Phase 2 study recruitment in the US for the RXC004 PORCUPINE clinical trial; o Post-period, in April 2022, expanded our collaboration with the Garvan Institute of Medical Research to investigate novel therapeutic targets in cancer-associated fibrosis.
· Significantly progressed our partnered programmes with AstraZeneca and Jazz Pharmaceuticals, resulting in milestones totalling $19 million during the period: o On 9 December 2021, a $10 million (£7.4 million) milestone was triggered from Jazz Pharmaceuticals for the progress in the oncology research collaboration focused on two cancer targets on the MAPK pathway. Post period, one target under this oncology research collaboration with Jazz Pharmaceuticals is confirmed to continue to progress towards an IND application, whilst a second target has been discontinued due to pipeline prioritisation by Jazz given the evolving competitive landscape; o On 23 December 2021, a $9 million (£6.6 million) milestone was triggered from AstraZeneca as RXC006 entered Phase 1 clinical trials; o Post period, on 15 June 2022, Redx announced a milestone of $5 million from Jazz Pharmaceuticals triggered by the US Food and Drug Administration (FDA) clearance of the IND for pan-RAF inhibitor programme, JZP815, which will represent the fifth clinical programme from Redx’s discovery engine to enter the clinic. · Further strengthened the Board of Directors and management team: o Board appointments of Dr Jane Griffiths as Chair from 1 December 2021 and Dr Rob Scott as Non-Executive Director on 27 January 2022; o Established a Science Committee of the Board on 8 March 2022 to oversee Redx’s progress in achieving its scientific and clinical goals; o Appointed Claire Solk on 17 January 2022 to the newly created position of General Counsel.

Financial Highlights

· Cash balance at 31 March 2022 of £31.6 million (31 March 2021 £39.9 million) which includes $19 million in milestone payments received from partnered programmes during the period;
· Successful placing of £34.3 million (gross) completed post-period in June 2022, which received strong support from existing investors and included a new specialist healthcare investor, Invus, which funds the Company’s operations through calendar year 2023, including important Phase 2 proof of concept data readouts for RXC004 and RXC007;
· Post period, on 15 June 2022, Redx also triggered a further milestone payment of $5 million from Jazz; · Increasing investment, reflecting the strong progress in our pipeline, led to increased research and development expenses of £12.9 million (H1 2021: £10.5 million);
· Loss for the period of £9.8 million (H1 2021 £12.7 million). 23/06/2022, 10:43 View Source View Source 3/25 The person responsible for the release of this announcement on behalf of the Company is Andrew Booth, Company Secretary.

SCG Cell Therapy Presents Clinical Proof-of-Concept Data at International Liver Congress (ILC) 2022 Annual Meeting

On June 23, 2022 Singapore-based SCG Cell Therapy Pte Ltd ("SCG") reported interim data from an investigator-initiated clinical trial of SCG101, which included data evaluating single dose SCG101 in patients with advanced hepatitis B (HBV) related hepatocellular carcinoma (HCC) (Press release, SCG Cell Therapy, JUN 23, 2022, View Source [SID1234616224]). The data showed significant antiviral activity and tumour control in two of three patients. This set of data was presented at the International Liver Congress (ILC) 2022 Annual Meeting in London on 23 June.

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In the three HLA-A*02:01-positive patients with advanced HBV-related HCC who had received at least two prior cancer therapies, the tumour growth was controlled in two out of three patients with lesion shrinkage observed. In addition, there is rapid and significant serum HBsAg reduction observed in both subjects from a baseline of 1,004.3 IU/mL and 521.6IU/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.

"These data showed encouraging antiviral activity and tumour control by a unique T cell receptor (TCR) therapeutic targeting hepatitis B surface antigen (HBsAg) which provides the first clinical proof-of-concept," said Prof. Dr Ulrike Protzer, Director of the Institute of Virology at Helmholtz Munich and Technical University of Munich and Scientific Founder of SCG. "These early results support the continued development of SCG101 for patients with HBV-associated hepatocellular carcinoma where we see a high unmet medical need."

The safety profile of SCG101 was consistent with the side effects expected in T cell therapy. There was no neurotoxicity observed and also no treatment-related AE or SAE (Adverse Event or Serious Adverse Event) which led to treatment discontinuation. Treatment-related cytokine release syndrome (CRS) with fever and bloating were observed in all three patients. Transient ALT and AST increase, without bilirubin elevation or clinical symptoms, was observed but expected due to SCG101 mechanisms of target cells clearance.

"The results of SCG101 show for the first time that an HBsAg directed TCR T cell therapy can provide dual benefit of antiviral and tumour control to patients with HBV-related HCC," said Shunda Du, MD, hepatologist, Peking Union Medical College and principal investigator for the trial. "Chronic HBV infection accounts for more than half of all patients with liver cancer worldwide. The development of HBV-directed TCR therapeutic prompts us to reconsider hepatitis B as a factor in diagnosis and treatment planning for patients with liver cancer."

"We’re proud to collaborate with our partnered hospitals to deliver the world’s first clinical proof of concept for TCR T cell therapy targeting HBV, which we believe validates the strength of our platform and opens doors for us to explore further breakthrough discoveries for the treatment of other cancers and diseases with high unmet need," said Dr Ke Zhang, Chief Scientific Officer of SCG.

SCG101 was granted clinical trial approvals by China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) in May 2022. It is the first TCR-T cell therapy product approved by the NMPA for the treatment of HCC and the first multi-country clinical trial approval across China and Singapore in the field of cell therapy.

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 China National Medical Products Administration (NMPA) and Singapore Health Science Authority (HSA) for the potential treatment of HBV-related HCC. The Phase 1/2 study evaluating SCG101 is underway.

About Liver Cancer

Hepatocellular carcinoma (HCC) is the most common type of liver cancer. It is estimated 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%.

CAPS Medical Enrolls Patients from Sheba Medical Center in First Ever Study for Treatment of Bladder Cancer Using Selective Endoscopic Cancer Treatment Technology

On June 23, 2022 CAPS Medical, developer of a highly selective and minimally invasive non-thermal plasma (NTAP) device for cancer treatment, reported the enrollment of the first patients in a multi-center study to assess the safety and technical performance of their NTAP system in the treatment of Non Muscle Invasive Bladder Cancer (NMIBC) (Press release, CAPS Medical, JUN 23, 2022, View Source [SID1234616223]). The cancer patients in the study have been treated at Sheba Medical Center’s Urology Department. This is the first ever worldwide study for minimally invasive treatment of Bladder Cancer using Non Thermal Plasma.

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Non-Muscle Invasive Bladder Cancer (NMIBC) impacts 500,000 people in the U.S. alone with over 80,000 new cases added annually. NMIBC is characterized by a high recurrence rate of up to 80%, which means that in the majority of cases NMIBC is not cured. It is treated and retreated –using a Transurethral Resection of Bladder Tumor (TURBT) procedure, which can cause scarring and damage to the bladder. This is followed by a series of intravesical instillations, which cause life-altering side effects. "We hope that CAPS Medical’s NTAP solution will help reduce the cancer recurrence rate by replacing the existing TURBT procedure while also avoiding the typical side effects, damage to the bladder and complications associated with the treatment options available today," said Prof. Zohar Dotan, Chairman of the Department of Urology and the principal investigator of the trial at the Sheba Medical Center. Sheba has been ranked by Newsweek magazine, for the fourth consecutive year, as one of the 10 top hospitals in the world

Non-thermal Atmospheric Plasmas are streams of low ionized gas at room temperature. Their efficacy in selectively destroying cancer cells while preserving surrounding healthy tissue and their ability to trigger an immunological effect and encourage the body to heal itself are well-known and have been demonstrated. To date, however, the high energy required for existing non-thermal plasma applications necessitated the use of large-sized devices. This made using non-thermal plasma to treat cancerous tumors in minimally invasive procedures unfeasible.

Overcoming these limitations, CAPS Medical is a pioneer in creating a device for NTAP delivery through a working channel of standard minimally invasive tools, making it possible to avoid surgery. "This multi-center study should demonstrate how NTAP could be painlessly and safely used to treat tumors inside the body, while preserving healthy tissue. CAPS Medical intends to continue working to improve patients’ lives through the use of this revolutionary technology which can be tailored to a variety of additional cancer types," said Ilan Uchitel, CEO and Co-Founder of CAPS Medical.

"With its NTAP system, CAPS Medical is overcoming a real barrier within the cancer treatment ecosystem. The NTAP procedure selectively targets cancer cells with greater precision-which should lead to fewer side effects than many current treatment options. We look forward to seeing the company progress through its clinical trials," said Harel Gadot, Executive Chairman of CAPS Medical and Company Group Chairman of MEDX Ventures Group.