On July 1, 2021 QIAGEN (NYSE:QGEN; Frankfurt Prime Standard:QIA) reported a global strategic alliance with Japan’s Sysmex Corporation (Tokyo Stock Exchange, First Section [Ticker Code: 6869]) for the development and commercialization of cancer companion diagnostics, which will leverage both QIAGEN’s leadership in this field and Sysmex’s Plasma-Safe-SeqS technology for next generation sequencing (NGS) (Press release, Sysmex, JUL 1, 2021, View Source [SID1234584531]).

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The alliance aims to foster collaborations with pharmaceutical companies for the development of drug treatments for cancer and promote early clinical adoption of ultra-sensitive liquid biopsy companion diagnostics. QIAGEN and Sysmex have a longstanding partnership, which, for example, provides the ipsogen JAK2 blood-cancer test in Japan. Cancer companion-diagnostics products will be launched by QIAGEN and Sysmex in various regions of the world.

Genetic analysis of tumors makes it possible to identify the genes responsible for the development and spread of a tumor and to target treatment accordingly. But the traditional analysis of solid tumors is constrained by their heterogeneity – varying concentrations of cancer cells, for example – and by sample availability. Liquid biopsy addresses these challenges and, in combination with sensitive NGS, allows the evaluation of patients at different points of their cancer treatment. It enables doctors to spot new anomalies and adjust treatments to make them more precise, and to develop novel targeted therapies.

"Combining QIAGEN’s global reach with Sysmex’s NGS capabilities is an important milestone in advancing the use of NGS technologies in clinical decision-making and is a testament to our shared vision of using this powerful technology to improve outcomes for patients worldwide," said Jean-Pascal Viola, Senior Vice President, Head of the Molecular Diagnostics Business Area and Corporate Business Development at QIAGEN. "This alliance will add strong NGS capabilities to our regulatory and clinical expertise and commercialization, and help our partners in the pharmaceuticals industry by expanding our strong position and product offering in companion diagnostics. We look forward to this alliance creating significant benefits for our pharma partners – and ultimately for treating patients."

"The alliance with QIAGEN promises Sysmex a great application for Sysmex’s Plasma-Safe-SeqS technology, which can detect gene mutations of cancer in blood with ultra-high sensitivity. We believe that QIAGEN is the best for Sysmex to expand this globally," said Hiroshi Kanda, Member of the Managing Board and Senior Executive Officer, Head of Corporate Business Development at Sysmex.

QIAGEN is a pioneer in precision medicine. It is the global leader in collaborating with pharmaceuticals and biotechnology companies to co-develop companion diagnostics that detect genetic abnormalities and guide clinical decision-making. QIAGEN has an unmatched breadth and depth of technologies – from NGS to polymerase chain reaction (PCR) – for companion-diagnostics development. QIAGEN’s portfolio includes ten PCR-based companion-diagnostics products that are approved by the FDA. They include therascreen EGFR for non-small cell lung cancer, therascreen KRAS for colorectal cancer and NSCL (including the G12C mutation), therascreen FGFR for urothelial cancer, therascreen PIK3CA for breast cancer based on tissue or plasma samples, and the therascreen BRAF kit for colorectal cancer.

QIAGEN has master collaboration agreements with more than 25 companies to develop and commercialize companion diagnostics for drugs in development – a pipeline of potential products to advance precision medicine and benefit patients. QIAGEN has partnered with Illumina to broaden the use of NGS-based companion and other in-vitro diagnostics (IVD) kits in patient management.

On July 1, 2021 Sirnaomics Ltd., a leading biopharmaceutical company in discovery and development of RNAi therapeutics, reported that it has sealed $105 million in a Series E financing (Press release, Sirnaomics, JUL 1, 2021, View Sourcesirnaomics-secures-105-million-series-e-financing/" target="_blank" title="View Sourcesirnaomics-secures-105-million-series-e-financing/" rel="nofollow">View Source [SID1234584548]). This round of funding was led by Rotating Boulder Fund, an investor that has been supporting the company since its Series B round, with participation from existing investors and a well-recognized syndicate of new investors.

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Proceeds from the financing will be used to fund the continued development of Sirnaomics’ novel RNAi therapeutics for treating diverse human disorders, which include cancers, viral infections, fibrosis, and metabolic diseases. Sirnaomics will also further advance its delivery technology platforms and strengthen its large-scale manufacturing capacity to support the company’s fast-growing product pipeline at different clinical stages (See: View Source).

Sirnaomics’ product candidates, STP705 and STP707, are dual targeting siRNA therapeutics against TGF-β1 and COX-2 for either local or systemic administration to treat various types of cancers and fibrotic diseases. Based on successful clinical and preclinical studies, a future clinical focus will be targeted towards immune oncological evaluation, with combination design of the novel RNAi drug candidate and immune checkpoint inhibitors, such as PD-1/PD-L1 monoclonal antibodies. With further expansion of the company’s systemic RNAi drug delivery platforms, encompassing siRNA-chemodrug conjugates and proprietary GalNAc-siRNA conjugates, Sirnaomics is poised to address multiple therapeutic areas.

"We are pleased to close the Series E round of financing with oversubscription from a very diversified and strong investor base," commented Patrick Lu, Ph.D., Founder, President and Chief Executive Officer. "This is another powerful validation that the RNAi therapeutics, fuelled by innovative delivery platforms, ground-breaking CMC technologies, and fast expansion of multiple clinical programs with positive results, are attracting significant interests from the investment community. We appreciate strong trust and persistent support from our existing investors, and we are very excited with this addition of a well-regarded syndicate of investors for the Series E financing. This combination of existing and new investors will not only strengthen our financial foundation, but also bring tremendous experience and expertise to Sirnaomics as it enters the next phase of growth."

On June 1, 2021 Taiho Pharmaceutical Co., Ltd. reported the launch of Taiho Smile Support, a program to support organizations and individuals working to solve social issues in the field of oncology, Taiho Pharmaceutical’s main business area (Press release, Taiho, JUL 1, 2021, View Source [SID1234584533]). Under the program, Taiho Pharmaceutical will solicit project proposals on the theme of "Addressing Issues in the Field of Oncology" via its website from July 1 to September 30, 2021.

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Taiho Smile Support is an initiative to support organizations and individuals seeking to solve various social issues in the field of oncology that cannot be solved by drugs alone. Taiho Pharmaceutical will be calling for organizations and individuals who plan to use crowdfunding to raise funds to address these social issues. Selected organizations and individuals will conduct a crowdfunding campaign and, if they reach their funding target,1 they will receive matching funds equal to the target they have raised from Taiho Pharmaceutical in the form of a donation.

If the crowdfunding target is achieved
For example, suppose the cost for an entire project is 1 million yen. If the project is selected, then the crowdfunding target will be set at 500,000 yen (50% of the necessary cost). If the organizer succeeds in raising the funding target, Taiho Pharmaceutical will then provide matching funds of 500,000 yen (the other 50%) to support the project.

Through this program, Taiho Pharmaceutical aims to support the dreams of organizations and individuals who are working to address challenges in the field of oncology. In partnership with these organizations, individuals, and all of the people who support them via crowdfunding, Taiho Pharmaceutical seeks to create a world where the precious moments of everyday life keep flowing for cancer patients and their families, "Today and Every Day."

1 The crowdfunding target is to be 50% of all funds needed to realize the project. If the target is met, Taiho Pharmaceutical will provide the remaining 50%. Thus, the success of the crowdfunding campaign will determine whether or not Taiho Pharmaceutical will provide support.

Round One of Taiho Smile Support
Theme
A project that will use crowdfunding to take on the challenge of solving various issues (physical, mental, social, or economic) surrounding cancer, under the theme of "Addressing Issues in the Field of Oncology."
(Examples: Activities to support cancer patients and their families; activities to raise awareness of cancer and spread education about cancer; or activities to convey the importance of early detection of cancer. The activities can take place in Japan, another country, or be international.)
Plans for events sponsored or co-sponsored by a government, medical institutions, or medical professionals are not eligible.

On July 1, 2021 Affimed N.V. (Nasdaq: AFMD), a clinical-stage immuno-oncology company committed to giving patients back their innate ability to fight cancer, reported financial results for the quarter ended March 31, 2021, and provided an update on clinical and corporate progress (Press release, Affimed, JUL 1, 2021, View Source [SID1234584549]).

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"As we continue to build momentum with our clinical programs, we see growing interest in the important work that we are doing in the emerging field of innate immuno-oncology. We published clinical data for AFM13 that is supporting our three-pronged development strategy of our ICE as monotherapy, in combination with NK cells and in combination with a checkpoint inhibitor," said Dr. Adi Hoess, CEO of Affimed. "Over the next several months, we have a number of value-creating events on AFM13, AFM24, where we expect to initiate several clinical studies, and AFM28, and are allocating capital across our portfolio to develop multiple opportunities for shareholder value creation."

Clinical Stage Program Updates
AFM13 (CD30/CD16A)

Affimed is continuing to recruit patients in the REDIRECT study (AFM13-202) after reporting positive results from the preplanned interim futility analysis in March 2021; the trial combined the high- and low-CD30 expressing cohorts into one. Affimed expects to complete enrollment in the study in the first half of 2022. REDIRECT is a phase 2, registration-directed study of AFM13 as monotherapy in patients with relapsed or refractory CD30-positive peripheral T-cell lymphoma (PTCL).
Affimed reported all three dose escalation cohorts in the investigator sponsored trial (IST) at The University of Texas MD Anderson Cancer Center of AFM13 precomplexed with natural killer (NK) cells (AFM13-104) are now fully enrolled. The study is evaluating increasing doses of cord-blood derived NK cells pre-complexed with AFM13 followed by three weekly infusions of AFM13 monotherapy in patients with recurrent or refractory CD30-positive lymphomas.
Preclinical data published in Clinical Cancer Research support the therapeutic potential of AFM13, demonstrating that AFM13 in combination with NK cells improved tumor recognition and enhanced tumor cell killing in vitro and in vivo compared to NK cells alone. This data supported the Investigational New Drug (IND) application for the ongoing phase 1 clinical study of AFM13 pre-complexed with NK cells.
AFM24 (EGFR/CD16A)

AFM24-101, the phase 1/2a clinical trial of AFM24, the EGFR/CD16A targeted ICE for patients with EGFR-expressing solid tumors, completed dose cohort 5 (320 mg) and patients are currently being enrolled and treated in dose cohort 6 (480 mg). Affimed expects to determine the recommended phase 2 dose and initiate dose expansion cohorts in the second half of 2021.
The phase 1/2a combination study of AFM24 with NKGen Biotech’s autologous NK cell therapy, SNK01, a first-in-human proof of concept trial with EGFR-expressing solid tumors is on track to start in the second half of 2021.
The phase 1/2a combination study of AFM24 with the PD-L1 checkpoint inhibitor atezolizumab (Tecentriq) with EGFR-expressing solid tumors is on track to start in the second half of 2021.
Preclinical and Partnered Programs
Affimed expects to disclose the target of its preclinical asset AFM28 and publish initial preclinical data in the second half of 2021. The company remains on track to file an IND application for AFM28 in the first half of 2022.
Genentech has completed the dose escalation portion of the phase 1 study of RO7297089 (anti-BCMA/CD16A). No dose limiting toxicities were observed during the study. However, due to broader portfolio considerations, Genentech decided to stop the phase 1 study of RO7297089. The decision does not impact the development of other targets pursuant to the collaboration agreement with Genentech.
First Quarter 2021 Financial Highlights
As of March 31, 2021, cash and cash equivalents totaled €240.7 million compared to €146.9 million on December 31, 2020. Based on its current operating plan and assumptions, Affimed anticipates that its cash and cash equivalents will support operations into the second half of 2023.
Net cash used in operating activities for the quarter ended March 31, 2021, was €16.0 million compared to €16.5 million for the quarter ended March 31, 2020.
Total revenue for the quarter ended March 31, 2021, was €11.7 million compared with €5.1 million for the quarter ended March 31, 2020. Revenue predominately relates to the Genentech and Roivant collaborations.
Research and development expenses for the quarter ended March 31, 2021, remained flat at €11.4 million compared to the quarter ended March 31, 2020.
General and administrative expenses increased 27.3% from €3.5 million in the quarter ended March 31, 2020, to €4.5 million in the quarter ended March 31, 2021. The increase relates largely to higher personnel expenses, higher premiums for our Directors and Officers liability insurance and higher legal and consulting expenses.
Net finance income for the quarter ended March 31, 2021, increased by 242% from €1.6 million in the quarter ended March 31, 2020, to €5.5 million. This increase is largely due to foreign exchange gains related to assets denominated in U.S. dollars as a result of the strengthening of the U.S. dollar against the Euro during the quarter.
Net income for the quarter ended March 31, 2021, was €1.4 million, or €0.01 per common share compared with a net loss of €8.3 million, or loss €0.11 per common share, for the quarter ended March 31, 2020.
The weighted number of common shares outstanding for the quarter ended March 31, 2021, was 116.2 million.
Additional information regarding these results will be included in the notes to the consolidated financial statements as of March 31, 2021, of Affimed’s filings with the U.S. Securities and Exchange Commission (SEC).

Note on International Financial Reporting Standards (IFRS)
Affimed prepares and reports consolidated financial statements and financial information in accordance with IFRS as issued by the International Accounting Standards Board. None of the financial statements were prepared in accordance with Generally Accepted Accounting Principles in the United States. Affimed maintains its books and records in Euro.

Conference Call and Webcast Information
Affimed will host a conference call and webcast today, July 1, 2021, at 8:30 a.m. EDT to discuss first quarter 2021 financial results and recent corporate developments. The conference call will be available via phone and webcast. To access the call, please dial +1 (409) 220-9054 for U.S. callers, or +44 (0) 8000 323836 for international callers, and reference passcode 4485380 approximately 15 minutes prior to the call. A live audio webcast of the conference call will be available in the "Webcasts" section on the "Investors" page of the Affimed website at View Source A replay of the webcast will be accessible at the same link for 30 days following the call.

On July 1, 2021 XNK Therapeutics AB ("XNK") reported that the first patient has been included in a Phase II clinical study to treat patients with Multiple myeloma using XNK’s leading autologous natural killer (NK) cell-based candidate drug in combination with Sanofi’s anti-CD38 antibody Sarclisa (Isatuximab).

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"Having the first patient included in this clinical study is a key step in XNK’s development", said Johan Liwing, CEO of XNK Therapeutics. "While our leading drug candidate is now entering into Phase II, we are in parallel dedicated to progressing our clinical development plan into other indications building on a Phase I/II first-in-human study".

The present investigator-initiated, open, randomized, controlled, Phase II study ISA-HC-NK (EudraCT: 2020-000994-26) compares XNK’s leading candidate drug combined with Sanofi’s anti-CD38 antibody Isatuximab with Isatuximab alone as a consolidation treatment following autologous stem cell transplantation in patients with newly diagnosed Multiple myeloma. The clinical study takes place at the Karolinska University Hospital at its Huddinge site, and encompasses at total of 60 patients with 30 patients in each treatment arm.

"Combining NK cells that mediate antibody dependent cellular cytotoxicity (ADCC) with targeted antibodies is an appealing concept. The idea envisaged is a synergetic effect with possible reduced toxicity, helping the Multiple myeloma patients maintaining a disease-free stage. This study is unique as it is the first investigator-initiated study randomizing patients to an NK cell-based therapy", said Hareth Nahi, Associate Professor at Karolinska Institutet and Principal Investigator for the study.

XNK Therapeutics and Sanofi are both collaborative industrial partners within NextGenNK, a recently established Competence Center for the development of next-generation NK cell-based cancer immunotherapies coordinated by Karolinska Institutet and supported by Sweden’s Innovation Agency (Vinnova).