On November 20, 2024 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), a clinical-stage precision oncology company developing highly differentiated oral targeted agents to treat hematologic malignancies, reported initiation of the TUSCANY study, tuspetinib (TUS) in combination therapy with azacitidine (AZA) and venetoclax (VEN) as a frontline triplet combination therapy for patients newly diagnosed with acute myeloid leukemia, or AML (Press release, Aptose Biosciences, NOV 20, 2024, View Source [SID1234648513]). The trial is being conducted at multiple U.S. clinical sites.

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Tuspetinib is being developed for frontline AML therapy as part of the TUS+VEN+AZA triplet for newly diagnosed AML patients ineligible to receive intensive chemotherapy. Tuspetinib, a convenient once daily oral agent that potently targets SYK, FLT3, mutated KIT, JAK1/2, and RSK2 kinases, avoids many typical toxicity concerns observed with other agents and has the potential to treat the larger AML populations, not just narrow subpopulations. In the recently conducted Phase 1/2 APTIVATE trial in a very ill and heavily pre-treated relapsed or refractory (R/R) AML population, tuspetinib as a single agent (TUS) and in combination with venetoclax (TUS+VEN) safely achieved broad activity across various difficult-to-treat AML subpopulations. This included patients with prior-VEN, prior-FLT3 inhibitor (FLT3i) and prior-hematopoietic stem cell transplantation (HSCT) therapies, those with highly adverse genetics – including mutations in TP53 and RAS genes, and those with mutated or unmutated (wildtype) FLT3 genes.

"Initiation of the trial is a key milestone for Aptose. AML treatment has rapidly shifted to combination therapies, and we are pleased to include tuspetinib as part of TUS+VEN+AZA triplet combination therapy in patients with newly-diagnosed AML – representing a new patient population for TUS," said William G. Rice, Chairman, President and Chief Executive Officer. "We thank our investigators for their enthusiasm and our clinical team for activating the TUSCANY triplet study. As one of our investigators noted, if TUS brings added efficacy to frontline treatment of a broad array of AML patients without the added toxicities that are plaguing some other agents, we may have a game changer in TUS."

TUSCANY: TUS+VEN+AZA Triplet Phase 1/2 Study
The triplet Phase 1/2 study is designed to test various doses and schedules of TUS in combination with standard of care dosing of azacitidine and venetoclax. TUS will be administered in 28-day cycles, beginning with 40mg, with dose escalations planned after safety review of each dose level. A planned 12 sites in the US will enroll in the TUSCANY trial with anticipated enrollment of 18-24 patients by mid-late 2025.

On November 20, 2024 Alloy Therapeutics Inc. ( "Alloy"), a biotechnology ecosystem company dedicated to democratizing access to cutting edge drug discovery technologies reported a strategic collaboration and license agreement with Takeda Pharmaceutical Company Limited (TSE:4502/NYSE:TAK "Takeda") to develop Takeda’s proprietary induced pluripotent stem cell (iPSC) derived CAR-T cell platform (iCAR-T) and iPSC-derived CAR-NK platform (iCAR-NK) (Press release, Alloy Therapeutics, NOV 20, 2024, View Source [SID1234648512]). Alloy will focus on accelerating the development of key therapies to overcome solid and hematological malignancies.

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iCAR-T technology was developed as part of the T-CiRA joint research program between Takeda and the Center for iPS Research and Application (CiRA) at Kyoto University. The core technology to differentiate iPSC into immune cells originates from CiRA’s Shin Kaneko’s laboratory. iCAR-T has potential to develop ‘off-the-shelf’ cell therapies, offering the potential for best-in-class performance with enhanced potency, and significantly lower manufacturing costs compared to autologous cell therapy.

"iCAR-T is one of our flagship projects graduating from T-CiRA, our decade-long joint research program between Takeda and CiRA. This agreement between Takeda and Alloy aims to advance iCAR-T from discovery to clinical development," said Yasushi Kajii, Head of R&D Japan Region at Takeda. "We are impressed with Alloy’s corporate culture of valuing platform technologies, flexibility in collaboration, patient-centric mindset, and company creation abilities, all of which were key elements to our decision to work with Alloy. We look forward to seeing iCAR-T and iCAR-NK blossom as the technology advances to its next phase."

Under the agreement, Alloy gains co-exclusive rights to commercialize iCAR-T and iCAR-NK products for oncology indications. Alloy will leverage synergies across its unique business model to further advance the iCAR-T/NK platform while enabling broader access to the technology for biotech and pharma partners to develop therapies for cancers including solid tumors. Future clinical validation and platform enhancements will further strengthen the platform.

"We are honored and excited to be chosen by Takeda to collaborate in fulfilling the promise of iPSC," said Errik Anderson, Founder, Chairman & CEO of Alloy. "This is another instance of how Alloy’s flexible approach allows us to enable the global scientific community with cutting edge technologies designed for rapid, successful drug development. We believe a robust engagement with the ecosystem will play a critical role in unlocking the vast potential of iPSC and enabling the next generation of cancer therapeutics."

To support these efforts, Alloy is establishing a Japanese subsidiary at Shonan Health Innovation Park in Kanagawa Prefecture, to be led by Victor Stone (Yoshihide Ishii) as the Head of Alloy Cell Therapies and Alloy Therapeutics Japan.

On November 20, 2024 The business combination of two AI-powered drug discovery and development companies, Recursion (Nasdaq: RXRX) and Exscientia has been completed, with Exscientia becoming a wholly owned subsidiary of Recursion creating a vertically-integrated and technology-enabled drug discovery platform. Exscientia ADSs (Nasdaq: EXAI) ceased trading and will be delisted from Nasdaq (Press release, Recursion Pharmaceuticals, NOV 20, 2024, View Source [SID1234648509]).

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"I believe the combination of the incredible teams and platforms at Exscientia and Recursion position us as the leader of the AI-enabled drug discovery and development space," said Chris Gibson, Ph.D., Co-Founder and CEO of Recursion. "With more than 10 clinical and preclinical programs in the internal pipeline, more than 10 partnered programs and over $450M in upfront and realized milestone payments received from partners to date out of more than $20B possible, we are advancing a flywheel of discovery and creating value in our pipeline through technology."

"The combination of our platforms and people make us the company to beat," said David Hallett, Ph.D., former CSO and Interim CEO of Exscientia and newly appointed Chief Scientific Officer at Recursion. "With our combined strength of real-world proprietary data and the models we’ve created – hypothesizing, testing and learning in a continuous loop – we’re redefining the space by shrinking timelines and costs, identifying and optimizing lead candidates faster than traditional methods."

The Company is pleased to share updates on the combined entity’s pipeline, partnerships, and platform below:

Pipeline

The combined pipeline represents more than 10 clinical and preclinical programs. In addition there are approximately 10 advanced discovery programs in the current pipeline.

Updated guidance is bulleted below as well as a snapshot of our pipeline:

REC-617 (CDK7 inhibitor; Advanced Solid Tumors): Initial Phase 1 monotherapy safety and PK/PD data expected at the AACR (Free AACR Whitepaper) Special Conference on December 9th 2024, and a webinar to follow on December 10th 2024.
REV102 (ENPP1 inhibitor; Hypophosphatasia): Development candidate nomination expected in Q4 2024
REC-4881 (MEK1/2 inhibitor, Familial Adenomatous Polyposis): Phase 1b/2 safety and early efficacy data expected in H1 2025
REC-2282 (pan-HDAC inhibitor; Neurofibromatosis Type 2): PFS6 futility analysis expected by H1 2025
REC-3565 (MALT1 inhibitor, B-Cell Malignancies): Phase 1 first patient dosed (FPD) expected in Q1 2025
REC-4539 (LSD1 inhibitor, Small-Cell Lung Cancer): Phase 1 first patient dosed (FPD) expected in H1 2025
REC-994 (Superoxide scavenger, Cerebral Cavernous Malformation): Further data to be shared at an upcoming medical conference / publication / webinar in H1 2025; regulatory update expected by H2 2025
REC-394 (C. difficile Toxin B selective inhibitor, C. difficile): Phase 2 update expected in Q1 2026
REC-1245 (RBM39 degrader; Solid Tumors and Lymphoma): Phase 1 dose-escalation data update expected in H1 2026
REC-4209 (undisclosed target; Idiopathic Pulmonary Fibrosis): IND-enabling studies are ongoing
REC-4881 in APC/AXIN1 indications have been deprioritized as part of a disciplined strategic prioritization of the portfolio. Study status will be updated on clinicaltrials.gov
Recursion’s Pipeline of Programs

Partnerships

The combined company’s therapeutic partnerships represent more than 10 partnered programs in areas such as oncology and immunology. The combined company has received approximately $450M in upfront and milestone payments from partnerships to date. Through these partnerships, we have the potential to receive more than approximately $20B in additional milestone payments before royalties.

Recursion’s Partnership

Platform

With chemical design and synthesis methods from Exscientia and over 60 petabytes of proprietary data generated in house or licensed from partners like Helix and Tempus, the combined entity will strengthen the Recursion OS to be a first-in-class and best-in-class drug discovery and development platform.

Recursion Model2

The platform will continue to drive iterative loops of hypotheses and active learning all the way from research to development, with the goal of eventually creating virtual cells that will allow the company to execute clinical trials at scale.

Company, Board, and Leadership Updates

The combined company will have approximately 800 employees with the headquarters remaining in Salt Lake City, and primary offices in Toronto, Montreal, Milpitas, New York, the Oxford area, and London.

Individual board and executive leadership changes of Recursion, effective as of November 20, 2024, are summarized below:

Franziska Michor, a former member of the Board of Directors of Exscientia, was appointed as a Class II Director of the Board of Directors of Recursion, with her initial term to extend until the 2026 Annual Meeting of Stockholders of Recursion.
Ben Taylor, former Chief Financial and Strategy Officer of Exscientia, was appointed as the Chief Financial Officer of the Company and President of Recursion UK.
Dave Hallett, former Interim Chief Executive Officer of Exscientia, was appointed as Chief Scientific Officer of the Company.
Kristen Rushton, Chief Business Operations Officer of the Company, was promoted to Chief Operating Officer of the Company.
Matthew Kinn, Senior Vice President, Business Development and Corporate Initiatives of the Company was promoted to serve as Chief Business Officer of the Company.
Lina Nilsson, Senior Vice President, Emerging Technologies of the Company, was promoted to serve on the executive team as Senior Vice President, Head of Platform of the Company.
Michael Secora, Tina Marriott, and Laura Schaevitz will transition from their executive roles into advisor roles for the combined company. All three have provided many years of dedicated service to the Company and we wish to express our heartfelt gratitude for each of them. Recursion would not be where it is today without their dedication and efforts.
Update Call Information

Recursion will host an update call today at 7:30 a.m. ET / 5:30 a.m. MT / 12:30 p.m. GMT. The Company will broadcast the live stream from Recursion’s X (formerly Twitter), LinkedIn and YouTube accounts, and on Exscientia’s LinkedIn account. Questions can be submitted via this link ahead of time or during the livestream.

On November 19, 2024 Lantern Pharma Inc. (NASDAQ: LTRN), an artificial intelligence (AI) company developing targeted cancer therapies using its proprietary RADR AI platform, reported that the first patient has been dosed – as part of the expansion cohort – in Japan for its Phase 2 HARMONIC clinical trial evaluating LP-300 in never-smoker patients with non-small cell lung cancer (NSCLC) who have progressed after receiving treatment with tyrosine kinase inhibitors (TKIs) (Press release, Lantern Pharma, NOV 19, 2024, View Source [SID1234648508]).

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The dosing of the first patient in Japan marks a significant expansion of the HARMONIC trial into Asia, where there is a notably higher prevalence of never-smoker NSCLC patients compared to Western populations. The trial is being conducted at five sites across Japan, including the National Cancer Center Japan under the leadership of Dr. Yasushi Goto, a renowned physician-researcher focused on lung cancer.

"The initiation of patient dosing in Japan is a significant milestone for the HARMONIC trial and our mission to develop LP-300 as a potential new treatment option for never-smoker NSCLC patients," said Panna Sharma, President and CEO of Lantern Pharma. "Japan and other Asian countries have a significantly higher proportion of never-smokers among NSCLC patients, with estimates suggesting that 33-40% of new lung cancer cases in Japan occur in never-smokers. This expansion allows us to accelerate enrollment while addressing a critical unmet need in a region where this disease has a particularly high impact."

Dr. Reggie Ewesuedo, VP of Clinical Development at Lantern Pharma commented, "This marks the achievement of a significant milestone for the Harmonic Trial. It is the beginning of an anticipated acceleration in enrollment following activation of sites in Japan as well as active screening of patients across sites in Taiwan. We are encouraged by the high level of interest from our clinical partners in Asia in this unique trial aimed at improving survival among never-smokers with lung cancer after relapsing from tyrosine kinase inhibitor-based treatment regimens."

The expansion into Japan and Taiwan follows encouraging preliminary results from the U.S. trial’s initial safety lead-in cohort, which demonstrated an 86% clinical benefit rate and 43% objective response rate among the first seven patients. The HARMONIC trial is evaluating LP-300 in combination with carboplatin and pemetrexed in never-smoker NSCLC patients who have recurrent NSCLC and have stopped responding to tyrosine kinase inhibitor (TKI) based therapies.

ABOUT THE HARMONIC TRIAL

The HARMONIC trial is a multicenter, open-label, randomized Phase 2 trial designed to evaluate the efficacy and safety of LP-300 in combination with standard-of-care chemotherapy (pemetrexed/carboplatin) versus chemotherapy alone. The trial is expected to enroll approximately 90 patients across sites in the United States and Asia. The primary endpoints are progression-free survival (PFS) and overall survival (OS).

On November 19, 2024 Illumina, Inc. (NASDAQ: ILMN), a global leader in DNA sequencing and array-based technologies, reported that it will release TruSight Oncology 500 v2 (TSO 500 v2), a new version of its flagship cancer research assay to enable comprehensive genomic profiling (CGP) (Press release, Illumina, NOV 19, 2024, View Source [SID1234648507]). The assay is currently under development, with global release planned for mid-2025. Detailed plans for the product will be shared November 21 in a spotlight presentation at the annual meeting of the Association of Molecular Pathology (AMP) in Vancouver, British Columbia.

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TSO 500 v2 assesses hundreds of genes across all variant classes, and immuno-oncology biomarkers, in a single assay from one sample, to facilitate therapy selection research.

Key features of TSO 500 v2 include:

Faster turnaround time and reduced hands-on time
Sensitive variant calling and improved coverage of difficult genomic regions
Gold-standard Myriad Genomic Instability Score (GIS) to determine homologous recombination deficiency (HRD) status, included for all samples
New kit configurations with 50% less packaging, 70% fewer tubes, and improved usability
Automation methods available with flexible batch sizes
Integrated and automated data analysis, from sequencer to insights supported with DRAGEN secondary analysis and Illumina Connected Insights, or Velsera’s Clinical Genomics Workspace (CGW)
Broad platform compatibility
At AMP, several abstracts accepted for poster presentations will demonstrate preliminary analytical performance data and automation compatibility of TSO 500 v2. The studies support the assay’s applications for clinical research in identifying rare genetic biomarkers and fusion biomarkers.

TSO 500 v2 early access customer response

Wei Song, MD, PhD, director of Clinical Genomics and Molecular Pathology at the University of California, San Diego, is an early access customer testing TSO 500 v2.

"We are excited to assess the new features of the TruSight Oncology 500 v2 tissue assay, such as the faster workflow, improved coverage, and lower DNA/RNA input levels," he said. "Such improvements are highly relevant to clinical research laboratories and can positively affect time to results, quality of results, and the processing of challenging tissue samples."

TruSight Oncology portfolio enables clinical research and in-vitro diagnostic CGP solutions

Illumina’s oncology portfolio has evolved over time to fit customers’ diverse needs for versatility and scalability. The TSO portfolio encompasses research-use-only (TSO 500 products) and in-vitro diagnostic (TSO Comprehensive) solutions across a range of low-, mid-, and high-throughput instrumentation. Illumina also announced today that TSO Comprehensive kits are now available to ship. In August, the company announced FDA approval of its TSO Comprehensive test and its first two companion diagnostic indications.

"In listening to our broad range of customers, we understand there are different needs for biomarker profiling, and Illumina has successfully introduced a continuum of solutions to address varying levels of need," said Traci Pawlowski, vice president of Clinical Solutions at Illumina.

CGP is a critical tool for identifying actionable alterations, including rare mutations, which enables precision medicine in accordance with professional guidelines. At AMP, several customer-led poster presentations will provide further evidence for the clinical utility of CGP and demonstrate its versatility in hospital and community oncology care settings.

Illumina will cohost a workshop with Bayer, featuring a panel discussion of key opinion leaders on the challenges and practice gaps in precision medicine implementation, and the coordination of a multidisciplinary team to ensure optimal biomarker detection and targeted therapy utilization