On May 12, 2022 Knight Therapeutics Inc. (TSX: GUD) ("Knight"), a pan-American (ex-USA) specialty pharmaceutical company, and Helsinn Healthcare SA ("Helsinn"), a fully integrated, global biopharma company with a diversified pipeline of innovative oncology assets and strong track record of commercial execution, reported that Knight, through one of its wholly-owned subsidiaries, and Helsinn have entered into an exclusive license, distribution and supply agreement for AKYNZEO oral/IV (netupitant/palonosetron / fosnetupitant/palonosetron) in Canada, Brazil, Argentina, Uruguay and Paraguay, and ALOXI oral/IV (palonosetron) in Canada (the "Products") (Press release, Knight Therapeutics, MAY 12, 2022, View Source;Distribution–and-Supply-Agreement-for-Akynzeo174–and-Aloxi174–5-12-2022 [SID1234614406]). According to IQVIA, sales of AKYNZEO in Canada and Brazil were approximately $7 million in 2021.

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Under the terms of the agreement, Knight shall have the exclusive right to distribute, promote, market and sell the Products in the licensed territories. Knight will begin commercial activities following a transition period from Helsinn’s current licensees.

"We are very excited to enter into this agreement with Helsinn for AKYNZEO in Canada, Brazil and other selected Latin American countries, and ALOXI in Canada," said Samira Sakhia, President and CEO of Knight. "These products are highly synergistic with our oncology portfolio and commercial footprint, and we look forward to widening access to these therapies in our target markets. AKYNZEO and ALOXI are leading, guideline-recommended1,2,3 antiemetics that help to prevent one of the most common side effects of chemotherapy."

"AKYNZEO and ALOXI form a key part of Helsinn’s commercial engine of supportive cancer care products," said Giorgio Calderari, Helsinn CEO. "Knight has a unique footprint with strong capabilities across Canada and Latin America, and we look forward to collaborating with them as they work to ensure patients in these geographies have access to these important medicines."

The financial terms of the transaction were not disclosed.

About Akynzeo

AKYNZEO is the first and only 5-HT3 and NK1 receptor antagonist fixed combination approved for the prevention of chemotherapy-induced acute and delayed nausea and vomiting. A single dose of AKYNZEO given with dexamethasone has been shown to prevent chemotherapy-induced nausea and vomiting for up to 5 days. AKYNZEO oral is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cancer chemotherapy and the prevention of acute nausea and vomiting associated with moderately emetogenic cancer therapy that is uncontrolled by a 5-HT3 receptor antagonist alone in adults. AKYNZEO oral is also approved and marketed in Argentina and Brazil for the prevention of acute and delayed nausea and vomiting associated with highly emetogenic cisplatin-based cancer chemotherapy and prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy in adults.

About Aloxi

ALOXI is a second generation 5-HT3 receptor antagonist with high receptor binding affinity and a duration of action up to 5 days after chemotherapy administration4,5. ALOXI solution for injection is approved and marketed in Canada for the prevention of acute and delayed nausea and vomiting associated with moderately emetogenic cancer chemotherapy and highly emetogenic cancer chemotherapy, including high dose cisplatin in adults. In Canada, the product is also indicated in pediatric patients aged 2 to 17 years for the prevention of acute nausea and vomiting associated with moderately and highly emetogenic cancer chemotherapy. ALOXI oral is approved in Canada for use in adults for the prevention of acute nausea and vomiting associated with moderately emetogenic cancer chemotherapy.

References
1 Roila F. et al. Ann Oncol. 2016 Sep;27(suppl 5):v119-v133. MASCC/ESMO Antiemetic Guideline 2016 V.1.4 last update July 2019. Available at: View Source;
2 Hesketh J. et al. J Clin Oncol. 2020 Aug 20;38(24):2782-2797. doi: 10.1200/JCO.20.01296. Epub 2020 Jul 13;
3 NCCN: National Comprehensive Cancer Network; NCCN Clinical Practice Guidelines in Oncology; Version 2.2022. Available at: www.nccn.org
4 Rojas C, Slusher BS. Eur J Pharmacol 2012;684(1-3):1-7; 6;
5 Navari RM and Aapro M. N Engl J Med 2016;374:1356-67.

On May 12, 2022 Orca Bio, a clinical-stage biotechnology company developing purified, high-precision cell therapies for the treatment of cancer, genetic blood disorders and autoimmune diseases, reported that new clinical data on its lead investigational high-precision cell therapy, Orca-T, will be shared in an oral presentation at the hybrid European Hematology Association (EHA) (Free EHA Whitepaper) Congress from June 9-17, 2022, in Vienna, Austria (Press release, Orca Bio, MAY 12, 2022, View Source [SID1234614424]).

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Oral Session: Clinical Studies in Transplantation

Title: Orca-T, an Engineered Allograft, Results in High GVHD-Free and Relapse-Free Survival Following Myeloablative Conditioning for Hematological Malignancies
Abstract Number: S237
Date and Time: Sunday, June 12, at 11:30–12:45 CEST / 5:30AM–6:45AM EDT
Location: Hall Stolz 1-2

The presentation will highlight results from the single-center Phase 2 and multi-center Phase 1b trials of Orca-T in patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) and myelodysplastic syndromes (MDS). Data included in the abstract will be updated at the time of presentation.

The oral session will take place in Vienna and will be livestreamed on the EHA (Free EHA Whitepaper) Congress platform.

About Orca-T

Orca-T is an investigational, high-precision allogeneic cell therapy derived from the stem and immune cells from either related or unrelated HLA-matched donors. Orca-T is intended to safely replace a patient’s compromised blood and immune system with that from a healthy donor. Orca-T is currently being evaluated in a Phase 3 clinical trial for the treatment of multiple hematologic malignancies and has received Regenerative Medicine Advanced Therapy (RMAT) designation from the U.S. Food and Drug Administration.

On May 12, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported its financial results for the first quarter of 2022 and provided a business update (Press release, Xenetic Biosciences, MAY 12, 2022, View Source [SID1234614471]).

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"Our strategic focus throughout the first quarter was working towards the completion of our exclusive license agreement with CLS Therapeutics ("CLS") to develop its interventional DNase based oncology platform. This platform was extremely attractive to us as we realized that adding the licensed programs could expand and enhance our oncology pipeline, provide an accelerated path to the clinic, create the potential for value-driving clinical and regulatory milestones, and position us as an emerging clinical-stage company," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Our team, along with advisors and preeminent key opinion leaders in this space, will make it a priority to advance the systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers, as quickly and efficiently as possible."

DNase Oncology Platform: Targeting Neutrophil Extracellular Traps ("NETs") to improve cancer therapies with a focus on advancing systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers.

The Company’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The exclusive license to CLS’ intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies. In addition, the licenses cover "DNase-armored" CAR T therapies in which novel CAR T products are engineered to secrete DNases into the tumor microenvironment to potentially improve T-cell infiltration, activity and persistence.

The licensed DNase platform is designed to target NETs, which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

A substantial amount of scientific literature has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies such as checkpoint inhibitors and cell therapies). In published reports, elevated levels of NETs have been a biomarker associated with poor prognosis in patients with a variety of cancers.

In addition, resistance to existing therapeutic agents can involve the release of immunosuppressive signaling factors from NETs, or physical barriers created by NETs which can impede the infiltration, activity, and survival of cytotoxic T cells in the tumor microenvironment.

Published pre-clinical models have demonstrated the effectiveness of systemically administered DNase, alone or in combination with other agents, for the elimination of NETs and prevention of tumor growth and metastasis.

Adoptive transfer of CAR T cells has emerged as one of the most promising advances in cancer immunotherapy. Engineered CAR T cells, designed to recognize cancer-associated antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden. CAR T therapies have exhibited remarkable clinical success against hematological malignancies but thus far have failed to demonstrate success in the context of solid tumors. Recent approaches to CAR T design include "armored" CAR-T cells, so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s extracellular matrix, including NETs. The Company plans to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications.

Program Highlights:

In April 2022, executed exclusive license and sublicense agreements with CLS Therapeutics to develop its interventional DNase based oncology platform, which is aimed at improving outcomes of existing treatments, including immunotherapies.
Advancing toward first-in-human study with IND filing targeted for the end of 2023.
Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma.
DNase armored CAR T program focused on demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications.
XCART Platform Technology: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells.

Program Highlights:

Advancing preclinical efforts through ongoing research and development collaborations including with The Scripps Research Institute and other institutions in the U.S. covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $0.4 million were received in the three months ended March 31, 2022, representing an approximate 103.4% increase over the same period in 2021 as Takeda’s sublicensee continued its worldwide launch of the product.
Summary of Financial Results for First Quarter 2022

Net loss for the quarter ended March 31, 2022 was approximately $1.6 million. Research & development expenses for the three months ended March 31, 2022 increased by approximately $0.5 million, or 74.9%, to approximately $1.1 million from approximately $0.6 million in the comparable quarter in 2021. The increase was primarily due to the Company’s increase in spending related to XCART U.S. pre-clinical development efforts. General and administrative expenses for the three months ended March 31, 2022 decreased by approximately $23,000, or 2.5%, to approximately $0.9 million from approximately $0.9 million in the comparable quarter in 2021. The decrease was primarily due to lower consulting costs offset by an increase in legal costs related to the CLS transaction during the three months ended March 31, 2022 compared to the same period in 2021.

The Company ended the quarter with approximately $16.2 million of cash.

On May 12, 2022 Sysmex Corporation (HQ: Kobe, Japan; Chairman and CEO: Hisashi Ietsugu) reported certain differences between its financial forecast on November 10, 2021, for the fiscal year ended March 31, 2022 (April 1, 2021, to March 31, 2022) (Press release, Sysmex, MAY 12, 2022, View Source [SID1234614269]). Furthermore, at a meeting of the Managing Board on May 12, 2022, Sysmex resolved to award dividends from surplus as described below, with a record date of March 31, 2022. We intend to propose this payment of dividends from surplus at the General Meeting of Shareholders scheduled for June 24, 2022.

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1. Change from Financial Forecasts
(1) Consolidated Financial Results for Fiscal Year from April 1, 2021, to March 31, 2022
(2) Reason Consolidated net sales were higher than previously expected, owing to favorable sales in the EMEA region and lower yen exchange rates than we had assumed earlier. On the profit front, operating profit, profit before tax and profit attributable to owners of the parent outpaced our previous expectations due to higher-than-expected consolidated net sales and a decline in selling, general and administrative expenses, owing to sales activities being constrained due to COVID-19. A change in the accounting treatment of cloud computing contracts during the fiscal year under review has been applied retroactively to the previous fiscal year’s figures, which are provided for reference. For details, please see the "Summary of Consolidated Financial Results for the Fiscal Year Ended March 31, 2022," disclosed today (May 12, 2022).

2. Dividend from Surplus
(1) Dividend
(2) Reason In terms of returns to shareholders, we intend to provide a stable dividend on a continuous basis and aim for a consolidated payout ratio of 30% under our basic policy of sharing the successes of our operations in line with business performance.

In accordance with this policy, we have set the ordinary year-end dividend for the fiscal year ended March 31, 2022, at ¥39 per share. Accordingly, annual total dividends will be ¥76 and the consolidated payout ratio will be 36.0%.

On May 12, 2022 Cogent Biosciences, Inc. (Nasdaq: COGT), a biotechnology company focused on developing precision therapies for genetically defined diseases, reported a poster presentation at the European Hematology Association (EHA) (Free EHA Whitepaper) Congress being held June 9-12, 2022 (Press release, Cogent Biosciences, MAY 12, 2022, View Source [SID1234614320]). The poster will review initial clinical data from the Company’s ongoing Phase 2 APEX trial with bezuclastinib. The abstract is available on the EHA (Free EHA Whitepaper) website at www.ehaweb.org and the poster will be published on the EHA (Free EHA Whitepaper) Congress platform on June 10, 2022.

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Presentation Title: A Phase 2 Study of Bezuclastinib (CGT9486), a Novel, Highly Selective, Potent KIT D816V inhibitor, in Adults with Advanced Systemic Mastocytosis (Apex): Methods, Baseline Data, and Early Insights
Session Type: Poster Session
Session Date and Time: Friday, June 10, 2022 – 16:30 – 17:45 CEST (10:30am-11:45am ET)
Abstract Number: P1049