On June 2, 2022 Boehringer Ingelheim and the Agency for Science, Technology and Research (A*STAR) reported a global licensing agreement under which Boehringer Ingelheim will obtain exclusive worldwide rights to research, develop and commercialize products based on a panel of innovative, tumor-specific antibodies from A*STAR (Press release, Boehringer Ingelheim, JUN 2, 2022, View Source [SID1234615457]). Boehringer Ingelheim aims to use these antibodies to direct therapeutic effector mechanisms such as antibody-drug conjugates (ADCs) and T-cell engagers exclusively to tumor cells, and to that end develop a range of highly targeted cancer treatments.

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"Boehringer Ingelheim believes that these promising antibodies in-licensed from A*STAR will help us advance potent therapeutic candidates against key molecular cancer targets," says Clive R. Wood, Senior Corporate Vice President and Global Head of Discovery Research at Boehringer Ingelheim and continues: "We look forward to developing these assets for a broad range of cancers with the goal to deliver breakthrough opportunities for patients."

Boehringer Ingelheim is pioneering a range of versatile therapeutic platforms in order to develop innovative medicines that target the tumor directly (tumor cell-directed therapies) or that enable the immune system to target the tumor (immune cell-targeted therapies). One tumor cell-directed modality is antibody drug conjugates, which allows for delivery of toxins directly into tumor cells. Another is T-cell engagers facilitating direct contact between T-cells and tumor cells, leading to T-cell-mediated killing of the tumor. Both technologies are directed towards markers on the surface of cancer cells, also known as antigens, in order to attack tumor cells but spare healthy tissues.

The innovative antibodies from A*STAR can potentially enable the development of safer, more efficacious therapies as they selectively bind to antigens that are highly expressed on tumor cells but are absent on normal healthy tissues.

Under the terms of the agreement, Boehringer Ingelheim will be responsible for further research, preclinical and clinical development as well as commercialization of targeted cancer therapies using the antibodies from A*STAR. A*STAR may receive payments totalling >100 million EUR in upfront and success-based development and commercialization milestones.

The technology used to identify the unique A*STAR antibodies resulted from a multi-institutional collaboration in Singapore. A*STAR’s Genome Institute of Singapore (GIS) and Institute of Bioengineering & Bioimaging (IBB) generated antibodies which exclusively target antigens that were initially identified from gastric cancer cells. Experimental Drug Development Centre (EDDC), Singapore’s national platform for drug discovery and development hosted by A*STAR, then optimized the antibodies and confirmed their applicability to a range of other solid cancers. EDDC also demonstrated the utility of these antibodies in directing different therapeutic modalities selectively to cancer cells.

Professor Damian O’Connell, Chief Executive Officer of EDDC, says, "As Singapore’s national drug discovery and development platform, EDDC is proud to translate great science in Singapore into valuable assets that can enable the precise treatment of cancer. We believe that Boehringer Ingelheim, with its broad expertise and technologies, is the right partner to maximize the potential of these antibodies for the development of safer, more targeted therapies for cancer patients."

Professor Tan Sze Wee, Assistant Chief Executive (Enterprise) of A*STAR, says, "These antibodies were developed in Singapore through close collaboration across multiple institutions. There was also strong support by the Singapore Gastric Cancer Consortium. The agreement is testament to the best-in-class research taking place in Singapore. Cancer is a devastating disease, and we hope the fruits of our research can improve patient outcomes."

On June 2, 2022 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported the acceptance of seven key oncology research abstracts authored in collaboration with Illumina at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting taking place June 3 – June 7 in Chicago (Press release, Illumina, JUN 2, 2022, View Source [SID1234615474]). In addition, Illumina will host a related event, "Unlocking Precision Medicine: The Transformational Impact of Comprehensive Genomic Profiling," featuring Chief Medical Officer, Phil Febbo, MD; Kevin Keegan, Vice President and General Manager, Oncology; and a panel of leading oncologists from select community and academic programs.

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Illumina announced the acceptance of seven key oncology research abstracts authored in collaboration with Illumina for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place June 3 – June 7 in Chicago.
Illumina announced the acceptance of seven key oncology research abstracts authored in collaboration with Illumina for publication at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, taking place June 3 – June 7 in Chicago.
"At Illumina, we are seeing increased adoption of comprehensive genomic profiling in both in-house pathology labs and centralized labs to inform and enhance patient care," said Keegan. "Through our involvement in this year’s ASCO (Free ASCO Whitepaper), we look forward to learning more about and exploring the comprehensive genomic profiling experiences of leading oncology researchers to help inform this important work moving forward."

Illumina’s mission in oncology is to save lives by enabling personalized cancer care through genomics. This includes increasing enablement for pathology labs to perform comprehensive genomic profiling for cancer tumors.

Comprehensive genomic profiling is a next-generation sequencing (NGS) approach that uses a single test to assess hundreds of genes including relevant cancer biomarkers, as established in medical guidelines and clinical trials, for solid tumor therapy guidance. CGP is being increasingly adopted by pathologists and oncologists to enhance their abilities to identify actionable biomarkers, which can lead to better matches between patients and precision therapies and clinical trials. Studies show that patients who receive a genomic match to biomarker-driven targeted therapies or immunotherapies experience improved clinical outcomes.

"For a physician, the priority is finding the best course of therapy for the patient as quickly as possible," said Dr. Febbo. "With a rapidly growing catalogue of targeted drugs and immunotherapies for many cancer types we are increasingly able to prescribe more and more personalized treatments. In addition, pan cancer markers identify an important group of patients that benefit from targeted therapy regardless of their tumor’s tissue of origin."

Abstracts accepted at ASCO (Free ASCO Whitepaper)
Collaborations across the oncology field are vital to increasing clinical utility evidence for comprehensive genomic profiling (CGP). Illumina is proud to present the following results of joint studies at ASCO (Free ASCO Whitepaper):

Identification of Clinically Actionable Biomarkers via Routine CGP Across a Large Community Health System, is an abstract summarizing data from a joint study between Illumina and Providence Health System. The results show the improvement in identification of clinically actionable biomarkers via routine CGP versus conventional testing methods (clinical actionability: 45% CGP vs. 19% small panel, p<0.001 and clinical trial eligibility: 49% CGP vs. 23% small panel, p<0.001). This highlights that adoption of CGP over conventional testing across a large community health network enables better patient access to highly effective cancer therapies.

Pathogenic fusion detection in solid malignancies utilizing RNA-DNA based CGP testing is a poster presentation, also a result of the collaboration between Illumina and Providence Health System. The results show that the 523-gene, combined DNA and RNA assay used at Providence Health System identified actionable fusion targets across tumor types in 7% (N=216) of patients. Of the patients with pathogenic fusions, 29% were actionable to a targeted therapy, and 31% eligible for 1 of 3 basket clinical trials. Conventional testing methods, namely FISH and DNA-only targeted panels, have technical limitations that prevent the detection of all relevant fusion partners. This potentially leads to false negatives, which would leave these patients without eligibility to highly effective therapies in absence of a combined DNA- and RNA-based CGP assay.

Blood-based CGP analysis is an emerging area of growth and interest as a complement to tissue-based tumor profiling or other alternatives when tissue is unavailable. In a poster session at ASCO (Free ASCO Whitepaper), The National Cancer Institute will present data generated in collaboration with Illumina. The abstract is entitled Blood-based detection of actionable alterations from NCI-MATCH patients with no tissue results. As part of The Molecular Analysis for Therapy Choice (NCI-MATCH) study, it evaluated the blood-based detection of actionable alterations from NCI-MATCH patients with no tissue results. Pathologists observed variants in the blood samples consistent with what was reported in tumor tissue samples from the larger NCI-MATCH study cohort. Using liquid biopsy provided valuable mutation information for these patients and could have resulted in up to an additional 75 patients being eligible for treatment selection based on their mutation profile.

In addition to these, the following abstracts, authored in collaboration with Illumina, will be published.

Effective biomarker testing rates in a large U.S. oncology practice – Abstract presents data from real-world clinical utility study of CGP testing with Florida Cancer Specialists & Research Institute.

Assessing homologous recombination deficiency (HRD) in ovarian cancer – Optimizing concordance of the regulatory-approved companion diagnostic and a next-generation sequencing (NGS) assay kit – Study data resulting from collaboration with Institute of Pathology, Technical University of Munich, Merck, AstraZeneca and Myriad Genetics.

Prototype precision oncology learning ecosystem: Norwegian precision cancer medicine implementation initiative – Data resulting from national CGP trial in Norway – IMPRESS (Improving public cancer care by implementing precision medicine in Norway).

Actionability of comprehensive genomic profiling (CGP) compared to single-gene and small panels in patients with advanced/metastatic non-small cell lung cancer (aNSCLC): A real-world study – Illumina in partnership with Syapse are presenting an abstract from a study assessing advanced Non-Small Cell Lung Cancer (aNSCLC) patients.

Recently announced CGP collaborations
Illumina continues to expand its broad portfolio of oncology partnerships with industry leaders, aimed at advancing cancer diagnostics and precision medicine. Most recently, in collaboration with Bayer, Illumina launched the first companion diagnostic claim for the TruSightTM Oncology Comprehensive (EU) test enabling targeted therapy with Bayer’s VITRAKVI (larotrectinib) for patients with NTRK fusion cancer. Also recently announced was a collaboration with Allegheny Health Network to evaluate the impact of in-house comprehensive genomic profiling (CGP) to enhance patient care.

"There is growing engagement and awareness around CGP and we will work with our partners to continue expanding the evidence to help broaden reimbursement and drive awareness across provider communities for this testing," said Dr. Febbo. "We are fully committed to improving outcomes by enabling personalized cancer care through genomics."

On June 2, 2022 Pieris Pharmaceuticals, Inc. (NASDAQ:PIRS), a clinical-stage biotechnology company advancing novel biotherapeutics through its proprietary Anticalin technology platform for respiratory diseases, cancer and other indications, reported that management is scheduled to present at the Jefferies Healthcare Conference on Wednesday, June 8, 2022 at 8:00 AM EDT (Press release, Pieris Pharmaceuticals, JUN 2, 2022, View Source [SID1234615408]). A webcast of the company’s presentation will be available at this link.

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On June 2, 2022 NuCana plc (NASDAQ: NCNA) reported that financial results for the first quarter ended March 31, 2022 and provided an update on its broad clinical program with its transformative ProTide therapeutics (Press release, Nucana BioPharmaceuticals, JUN 2, 2022, View Source [SID1234615424]).

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As of March 31, 2022, NuCana had cash and cash equivalents of £52.6 million compared to £60.3 million as of December 31, 2021. NuCana continues to advance its various clinical programs and reported a net loss of £8.4 million for the quarter ended March 31, 2022, as compared to a net loss of £9.8 million for the quarter ended March 31, 2021. Basic and diluted loss per share was £0.16 for the quarter ended March 31, 2022, as compared to £0.19 per share for quarter ended March 31, 2021.

"We are excited about the optimized development plan we recently announced for NUC-3373 in colorectal cancer and have initiated the randomized Phase 2 study, NuTide:323, in second-line patients", said Hugh S. Griffith, NuCana’s Founder and Chief Executive Officer. "We are also pleased to have initiated the NuTide:303 Phase 1b/2 study of NUC-3373 in combination with other agents, including PD-1 inhibitors, for the treatment of patients with solid tumors. In addition, we have enrolled the first patients into the Phase 2 part of the NuTide:701 study of NUC-7738. We look forward to providing numerous data updates throughout 2022 for both NUC-3373 and NUC-7738."

Mr. Griffith continued: "Positive data that we have previously announced for NUC-3373 and NUC-7738 have demonstrated our ProTides’ potential to provide cancer patients with more efficacious and safer treatment options. These data continue to demonstrate our ProTides’ encouraging anti-cancer activity and favorable safety profiles and pharmacokinetic properties."

Mr. Griffith concluded: "We have an anticipated cash runway which we expect will extend into 2025 and through many key milestones for both NUC-3373 and NUC-7738. We look forward to progressing towards our goal of significantly improving treatment options for patients with cancer."

Anticipated 2022 Milestones

NUC-3373 (a ProTide transformation of 5-FU)

In 2022, NuCana expects to:

Commence enrollment in the randomized, controlled Phase 2 (NuTide:323) study of NUC-3373 in combination with other agents for the second-line treatment of patients with colorectal cancer;
Commence enrollment in the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents, including PD-1 inhibitors, in patients with solid tumors to identify additional indications for development;
Expand the Phase 1b/2 (NuTide:302) study of NUC-3373 in second-line colorectal cancer patients, and evaluate NUC-3373-based regimens in combination with bevacizumab;
Announce data from the Phase 1b/2 (NuTide:302) study of NUC-3373 combined with leucovorin, irinotecan and bevacizumab in patients with colorectal cancer; and
Announce data from the Phase 1b/2 (NuTide:303) modular study of NUC-3373 in combination with other agents in patients with solid tumors to identify additional indications for development.
NUC-7738 (a ProTide transformation of 3’-deoxyadenosine)

In 2022, NuCana expects to:

Announce data from the Phase 1 part of the NuTide:701 study of NUC-7738 in patients with solid tumors; and
Announce data from the Phase 2 part of the NuTide:701 study of NUC-7738 in patients with solid tumors.

On June 2, 2022 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported that it will participate in a "Fireside Chat" presentation at the Jefferies Healthcare Conference, to take place June 8-10, 2022, in New York, NY (Press release, Ayala Pharmaceuticals, JUN 2, 2022, View Source [SID1234615442]). The company will also be available for one-on-one meetings with institutional investors at the conference.

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Details on the presentation can be found below:

A webcast of the presentation will be available on the "Events and Presentations" section of the Ayala Pharmaceuticals website.