On November 15, 2022 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in oncogene amplified cancers, reported that its Chief Executive Officer, Zachary Hornby, will participate in a presentation and fireside chat at upcoming investor conferences (Press release, Boundless Bio, NOV 15, 2022, View Source [SID1234624113]):

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Piper Sandler 34th Annual Healthcare Conference

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On November 15, 2022 Exscientia plc (Nasdaq: EXAI) reported that Recent developments in the Company’s pipeline, collaborations, and operations, as well as financial results for the third quarter 2022, are summarised below (Press release, Exscientia, NOV 15, 2022, View Source [SID1234624112]). Exscientia will host a conference call today, November 15, at 1:30 p.m. GMT / 8:30 a.m. ET.

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"At Exscientia, we are working towards the goal of leading the transformation of our industry’s approach to how drugs are created and how we can then specifically match these treatments to patients. Our capabilities in drug design and precision medicine have distinguished us as a pioneer in the field of AI-based drug discovery," commented Professor Andrew Hopkins, D.Phil., Exscientia’s founder and Chief Executive Officer. "Receiving the Prix Galien award in recognition of our integration of AI-driven precision medicine into drug discovery and development is a testament to our innovation. The concept of improving patient selection through our platform is a key tenet of our new strategic collaboration with The University of Texas MD Anderson Cancer Center, where we will combine our AI-driven drug discovery technology with the institution’s deep clinical expertise in oncology to develop treatments for patients. We believe that this partnership, in addition to our recent expansion into biologics, further positions us as leaders in the field as we continue to advance our pipeline and enhance our end-to-end platform."

Recent Highlights

Internal pipeline

Exscientia announced novel patient stratification methods and biomarker data supporting development of GTAEXS-617 (‘617) at the 34th EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) (ENA) Annual Symposium
CTA submission expected by year-end 2022
Anticipate Phase 1/2 study to begin in the first half of 2023 in multiple solid tumour indications, including ovarian cancer
The Company remains on track to initiate "IGNITE-AI," a Phase 1b/2 study of its A2A programme EXS-21546 (‘546) by year-end 2022
Planned clinical study to look at combination therapies, including checkpoint inhibitors
New results outlining a predictive biomarker for patient selection, identified using Exscientia’s precision medicine platform, will be shared on today’s call
Additional data on patient selection modelling to be presented at a medical meeting by year-end 2022
Partnered programmes

Yesterday, Exscientia and MD Anderson, a premier cancer research and treatment centre in the United States, announced a strategic collaboration to develop small-molecule therapies in oncology
The agreement aligns MD Anderson’s drug development expertise with Exscientia’s AI-based patient-first precision medicine and drug discovery platforms
Additional target advanced in Sanofi collaboration for oncology
Continued progress in Bristol Myers Squibb (BMS) collaboration with all programmes from the 2021 expansion currently in the design phase
Expansion into new modality with biologics AI design

Exscientia announced the expansion of its platform for fast and accurate generative AI design of novel antibodies
Produced accurate protein modelling up to 35,000 times faster than Alphafold2
Approach of virtually modelling antibodies enables an evaluation of far more possibilities than laboratory screening, which Exscientia believes will help find the right antibody for a specific target
Exscientia’s deep learning virtual screening methodology for antibodies is now over three times more accurate than the published state-of-the-art
Sequencing paired human antibody data to create better AI models for antibody design
An additional 8,000 square foot laboratory facility in Oxford Science Park will automate the production of proprietary data for each antibody, measuring essential qualities including affinity, immunogenicity, aggregation and stability
The Company’s precision medicine platform is uniquely positioned for the characterisation of biologics in the oncology space with proven preclinical data from development of monoclonal and bi-specific immunotherapies
Next-generation sequencing (NGS) integrated into precision medicine platform

Exscientia’s newly established NGS capabilities enable state-of-the-art bulk and single-cell sequencing technologies, which can now be used across all Exscientia programmes, regardless of phase
The scalable sequencing platform allows time-efficient in-house genomic and transcriptomic profiling of all cancer patient tissue samples as well as the characterisation of the intratumoural heterogeneity, the tumour microenvironment and anti-tumour drug compound response at single-cell resolution
Exscientia recognition and leadership expansion

Awarded the Prix Galien USA 2022 Digital Health Solution for Exscientia’s AI-driven precision medicine platform. The Prix Galien recognises excellence in scientific innovation that improves the state of human health
Exscientia was pleased to welcome Caroline Rowland to the Company’s executive team as Chief People Officer in September. Caroline brings a wealth of deep tech experience in building culture and developing high performing teams
Investor call and webcast information

Exscientia will host a conference call today, November 15 at 1:30 p.m. GMT / 8:30 a.m. ET. A webcast of the live call can be accessed by visiting the "Investors and Media" section of the Company’s website at investors.exscientia.ai. Alternatively, the live conference call can be accessed by dialling +1 (888) 330 3292 (U.S.), +44 203 433 3846 (U.K.), +1 (646) 960 0857 (International) and entering the conference ID: 8333895. A replay will be available for 90 days under "Events and Presentations" in the "Investors and Media" section of the Exscientia website.

Third quarter and first nine months 2022 financial results

Exscientia consolidates and reports its financials in pounds sterling. For the convenience of the reader, the Company has translated pounds sterling amounts to U.S. dollars at the rate of £1.000 to $1.1134, which was the noon buying rate of the Federal Reserve Bank of New York on September 30, 2022.

Revenue: Recognised revenue for the three and nine months ended September 30, 2022, was $7.0 million and $22.7 million, respectively, compared to $19.6 million and $25.9 million for the three and nine months ended September 30, 2021.

Research and development expenses: R&D expenses for the three and nine months ended September 30, 2022, were $40.9 million and $103.8 million, respectively, as compared to $14.4 million and $28.2 million for the three and nine months ended September 30, 2021. The increase in research and development expenses was in part due to the growth of Exscientia’s internal and co-owned portfolio, in addition to increased headcount and other costs associated with the Company’s continued technology investments. Share-based compensation accounted for $8.1 million for the quarter ended September 30, 2022, as compared to $2.4 million for the same period ended September 30, 2021.

General and administrative expenses: G&A expenses for the three and nine months ended September 30, 2022, were $11.5 million, or 18.3% of total operating expenses, and $33.6, or 20.5% of total operating expenses respectively. For the third quarter 2022, G&A expenses increased by $1.9 million compared to the third quarter 2021, primarily associated with an increase in personnel costs. Share-based compensation accounted for $3.2 million for the quarter ended September 30, 2022, as compared to $1.4 million for the same period ended September 30, 2021.

Cash inflows: For the first nine months of 2022, Exscientia received $117.3 million in cash inflows from its collaborations as compared to $67.5 million during the first nine months of 2021.

Net operating cash flow and cash balance: For the first nine months ending September 30, 2022, net operating cash outflows were $15.0 million, in comparison to net operating cash inflows of $8.3 million in the nine months of 2021. Cash, cash equivalents and bank deposits as of September 30, 2022, were $624.7 million as compared to $625.9 million as of December 31, 2021.

Includes constant currency mark-to-market foreign exchange impact of negative 9% based on the strength of the USD during the quarter
During the quarter, Exscientia recognised realised foreign exchange gains of $8.3 million
The Company holds its deposits in both GBP and USD intended to match expected operational cash needs in order to limit the impact of exchange rate fluctuations
SELECTED CONSOLIDATED STATEMENT OF OPERATIONS, CONSTANT CURRENCY CONVERSION (unaudited)
($ millions, except per share data, at the rate of £1.000 to $1.1134)

On November 15, 2022 ElevateBio, LLC (ElevateBio), a technology-driven company focused on powering transformative cell and gene therapies, and Affini-T Therapeutics, a biotechnology company unlocking the power of T cells against oncogenic driver mutations, reported a partnership to advance Affini-T’s engineered TCR-T therapies focused on KRAS (Kirsten rat sarcoma viral oncogene homolog), one of the most prevalent oncogenic driver mutations in solid tumor cancers (Press release, ElevateBio, NOV 15, 2022, View Source [SID1234624111]). Affini-T will leverage ElevateBio BaseCamp’s LentiPeakTM lentiviral vector technology platform and cell therapy production capabilities to advance its investigational oncogenic driver programs into clinical development. ElevateBio BaseCamp is a purpose-built viral vector and cell therapy center of excellence with end-to-end process development and current Good Manufacturing Practice (cGMP) manufacturing capabilities for research, clinical and commercial cell and gene therapies, and regenerative medicines.

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"Affini-T is pioneering novel T cell therapy approaches to treat solid tumor cancers by striking at the core of tumor biology, which entails leveraging the most advanced tools and techniques in cell engineering," said Kim Nguyen, Ph.D., Chief Technical Officer, Affini-T Therapeutics. "Deep expertise in autologous cellular therapies manufacturing and analytics combined with its scalable platform for suspension-based lentiviral production, make ElevateBio an ideal partner as we progress our oncogenic driver programs into the clinic and work to deliver transformative therapies to patients and their families."

"We are pleased that our LentiPeak platform and cell therapy expertise can enable innovative developers like Affini-T to further accelerate their pipeline and look forward to working together so that we can bring forth these important therapies for difficult to treat solid tumors," said David Hallal, Chairman and Chief Executive Officer of ElevateBio. "At ElevateBio, we’ve combined multiple next-generation technology platforms with industry-leading expertise to transform the current cell and gene therapy development paradigm and provide our partners with a strategic advantage in the development of their therapies, and ultimately improve the speed of novel therapies to patients."

Affini-T’s proprietary platform is designed to select and engineer the right immune cells to orchestrate a durable and coordinated immune response within the immunosuppressive tumor microenvironment. The company is pioneering engineered T cell therapies with cutting-edge synthetic biology and gene editing enhancements to target oncogenic driver mutations at the core of tumor biology. Its engineered cell therapies are designed to overcome the immunosuppressive tumor microenvironment, enhancing T cell function to increase durability, build persistent responses, and augment tumor infiltration. Affini-T’s investigational cell therapies have the potential to offer new treatment options for patients affected by cancer with mutant variants of KRAS, which account for up to 30% of all cancers and are particularly frequent in cancers with high mortality rates, including lung cancer, colorectal cancer, and pancreatic cancer.

On November 15, 2022 Casma Therapeutics, Inc., a biotechnology company engaging the autophagy system to provide innovative new medicines, reported the closing of a Series C financing round of $46.0 million (Press release, Casma Therapeutics, NOV 15, 2022, View Source [SID1234624110]). New investors participating in the round include Amgen Ventures, LLC, Astellas Venture Management, Eisai Co., Ltd., Euclidean Capital, Mirae Asset, and Ono Venture Investment. Current investors Eventide Asset Management, LLC, Schroders Capital, The Column Group, Third Rock Ventures, and other funds also participated in the financing. Dr. Hiromichi Kimura, Investment Director of Astellas Ventures, has joined the board of directors. Dr. Tomotaka Okino of Ono Venture Investment and Amgen Ventures have joined as board observers.

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Casma will use proceeds to advance its lead program for MYD88 mutant lymphoma through preclinical and into IND enabling studies.

"The closing of this financing has strengthened our resources to continue advancing our drug pipeline focused on autophagy-based degradation," said Keith Dionne, Ph.D., Chief Executive Officer of Casma Therapeutics, Inc. "We are thrilled to welcome several top-tier investors who recognize the potential of our biological platforms and therapeutic assets targeting well-known high-value and traditionally undruggable targets."

"Casma’s autophagy-based degradation platform, PHLYT, is unique and impressive," commented Dr. Kimura. "Along with a rich pipeline of autophagy degraders, the company has also established a highly qualified team with extensive scientific experience in drug development. We expect that this round of funding will accelerate development of Casma’s pipeline assets, especially its degrader for MYD88 mutant tumors."

On November 15, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported new data showing how the Company’s DecisionDx-SCC test can provide objective, independent and significant risk-stratification for cutaneous squamous cell carcinoma (cSCC) tumors with uncertainty in differentiation status (Press release, Castle Biosciences, NOV 15, 2022, View Source [SID1234624109]). The data were shared in an oral presentation given at the American Society of Dermatopathology (ASDP) 59th Annual Meeting by Sarah Estrada, M.D., dermatopathologist with Affiliated Dermatology in Scottsdale, Arizona.

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Overall, these data demonstrate how DecisionDx-SCC can significantly stratify the risk of metastasis in high-risk cSCC patients with an ambiguous tumor differentiation status. Additionally, the study suggests that incorporating the test’s results into clinical cSCC risk assessments could improve risk-stratification and enhance current patient management decisions to improve patient outcomes.

Subjective pathology variability in the histologic grading of cSCC tumors is an important clinical issue, particularly when comparing moderately differentiated tumors. Poor differentiation has been shown to be an independent risk factor associated with poor patient outcomes.1–3 However, there is a lack of consistency in differentiation assessment4 which can adversely impact the value of differentiation as a prognostic factor. In fact, the two most widely used cSCC staging systems, American Joint Committee on Cancer Staging Manual Eighth Edition (AJCC8) and Brigham and Women’s Hospital (BWH), vary on their inclusion of poor differentiation as a risk factor for staging; BWH includes it, while AJCC8 does not.

"A single clinicopathologic risk factor, including a cSCC tumor’s differentiation status, can affect staging and thereby escalate or deescalate patient treatment plans," commented Estrada. "Objective risk-stratification that is independent of clinicopathologic factors and staging, as provided by DecisionDx-SCC test results, can identify high-risk cSCC lesions and provide clarity in challenging staging situations."

The presentation, titled "Incorporating the 40-GEP test for poorly differentiated cutaneous squamous cell carcinoma (cSCC) tumors mitigates risk assessment uncertainty from histologic grading," describes the results of a study involving a cohort of 420 high-risk cSCC patients divided into either moderately or poorly differentiated statuses, based on their pathology report and review by an independent dermatopathologist.

A sub-cohort of 171 tumors with differentiation uncertainty was then staged using BWH criteria. The differentiation status of the tumors in this "differentiation uncertainty cohort" was then manually changed so that poorly differentiated was changed to moderately differentiated and vice versa, and changes to BWH staging were analyzed.

The study data showed that:

For 40% of patients in the sub-cohort, the BWH stage changed based upon the alteration of differentiation status, which could impact treatment decisions.
DecisionDx-SCC independently and significantly stratified the sub-cohort according to metastatic risk; patients with a low-risk (Class 1) result had a statistically significant higher three-year metastasis free survival than both moderate-risk (Class 2A) and high-risk (Class 2B) patients (90.1% vs. 78.6% and 62.5%, respectively; p=0.02).
About DecisionDx-SCC

DecisionDx-SCC is a 40-gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous squamous cell carcinoma metastasis for patients with one or more risk factors. The test result, in which patients are stratified into a Class 1 (low), 2A (moderate) or 2B (high) risk category, predicts individual metastatic risk to inform risk-appropriate management.

Peer-reviewed publications have demonstrated that DecisionDx-SCC is an independent predictor of metastatic risk and that integrating DecisionDx-SCC with current prognostic methods can add positive predictive value to clinician decisions regarding staging and management.