CAR T cells headline HER2 cell therapy pipeline

On June 23, 2022 Triumvira Immunologics reported At least 17 cell therapy programs are targeting solid tumor-selective HER2, 10 of which are CAR T cells. Companies are also expressing HER2 CARs on other cell types such as NK cells, myeloid cells, and macrophages (Press release, Triumvira Immunologics, JUN 23, 2022, View Source [SID1234616492]).

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CAR T cell therapies have been highly effective against hematological malignancies, but solid tumors have been more challenging. Overcoming the major obstacles, including a lack of highly tumor-selective solid tumor targets, was a major theme at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) annual meeting in April.

Entry into a Material Definitive Agreement

On June 23, 2022, DiaMedica USA Inc. (the "Tenant"), a Delaware corporation and wholly owned subsidiary of DiaMedica Therapeutics Inc., a corporation existing under the laws of British Columbia, Canada (the "Company"), entered into an office lease (the "Lease") with Medica Services Company, LLC, a Delaware limited liability company (the "Landlord"), whereby the Tenant agreed to lease approximately 6,175 square feet at 301 Carlson Parkway, Suite 210, Minnetonka, Minnesota, USA 55305 (the "Premises") (Filing, 8-K, DiaMedica, JUN 23, 2022, View Source [SID1234616393]). The Lease has an initial term of five years and five months, commencing on September 1, 2022, and the Tenant has the option to extend the Lease for an additional five years. The Company intends to relocate its principal executive offices, together with its research and development operations, to the Premises on September 1, 2022 following the expiration of the Tenant’s current lease in August 2022.

Under the Lease, the Tenant has agreed to pay rent, after an initial five-month abatement period, in an initial amount equal to approximately $9,000 per month, plus its pro rata share of operating expenses and real estate taxes. The Lease contains customary representations, warranties, covenants, indemnification provisions, default provisions, and other provisions.

As an inducement to the Landlord to enter into the Lease with the Tenant, on June 22, 2022, the Company entered into a lease guaranty agreement (the "Lease Guarantee Agreement") pursuant to which the Company agreed to fulfill and perform or cause the Tenant to fulfill and perform all of the terms and every payment, covenant and condition which the Tenant is required to make or perform under the Lease. The Lease Guarantee Agreement terminates once full payment of all sums due under the Lease and full performance of all terms, covenants and conditions therein have been kept, observed or performed by the Tenant.

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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.