On May 25, 2022 Exscientia plc (Nasdaq: EXAI) (Press release, Exscientia, MAY 25, 2022, View Source [SID1234615050])

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Recent advancements in the Company’s pipeline, collaborations, and operations, as well as financial results for the first quarter 2022, are summarised below. In addition, Exscientia will host a conference call Thursday, May 26 at 1:30 p.m. BST / 8:30 a.m. ET to provide an overview of the Company’s precision medicine platform.

"We started 2022 by commencing a groundbreaking collaboration with Sanofi to develop a pipeline of AI-designed medicines utilising the breadth of our end-to-end platform of AI-driven capabilities from target prioritisation, to drug engineering and patient selection. At this year’s American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, we highlighted our advancements in this area, including how AI-enabled drug design can help create drug candidates for challenging targets in oncology. In addition, we showed how a deep learning approach to phenomics can be integrated with single cell sequencing to potentially identify patient signatures and biomarkers in early discovery to stratify which treatment is likely to work best for each patient. With these advancements in our precision medicine platform, we are able to leverage AI to design and discover a new generation of medicines," said Andrew Hopkins, DPhil., Exscientia’s founder and Chief Executive Officer. "We are well-capitalised and are continuing to build an organisation with a balanced business model. This will enable us to continue advancing new medicine programmes, focusing on those areas where our platform and expertise provides the highest probability of success."

Recent Highlights

Recent progress demonstrates the Company’s patient tissue-derived translational capabilities, including identifying novel targets, evaluating modulation of complex tumour microenvironments, and enabling patient selection through biomarkers

– Exscientia researchers presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting in April:

Enriching for adenosine antagonist patient responses through deep learning: in this study, researchers modelled and functionally evaluated patient gene signatures to map the association of anti-cancer immune activity with the inhibition of adenosine signalling by EXS-21546, Exscientia’s clinical stage A2a antagonist. These data suggest stratification of gene signatures could be used in future clinical studies to identify patients that may best respond to A2aR targeted therapies.
AI-driven discovery and profiling of GTAEXS-617, a selective and highly potent inhibitor of CDK7: preclinical data highlighting potential benefits of Exscientia’s AI-driven design to overcome identified issues with CDK7 inhibitors, including toxicity and selectivity. In addition, the precision medicine platform identified patient subsegments that can inform biomarker strategies.
Deep learning supported high content analysis of primary patient samples identifies ALK inhibition as a novel mechanism of action in a subset of ovarian cancers: research highlighting the potential of Exscientia’s precision medicine platform to identify novel targets and targetable pathways using human disease-relevant patient tissue models, which could have the potential to improve patient outcomes by uncovering clinical relevance at the target discovery stage.
– Together with the University of Oxford, the Company launched Xcellomics, a programme that invites academic researchers to collaborate to advance novel phenotypic biology research with the potential to be developed into meaningful new therapies.

Continued to identify and validate new targets, as well as progress and prioritise broad pipeline

– Partnered programmes

Extended collaboration with Bristol Myers Squibb (BMS) to generate additional data including the use of precision medicine capabilities for key targets under the collaboration; $5 million in cash inflows in first quarter 2022 to be recognised as revenue throughout 2022
Target identification and validation ongoing in Sanofi collaboration, signed in January 2022, leveraging precision medicine platform and Centaur Biologist
– Co-owned programmes

GTAEXS-617 CTA submission expected by year-end 2022, progress in generating data in additional tumour types to inform planned Phase I clinical trial in cancer patients
CTA and IND-enabling studies are ongoing, including pre-clinical studies to explore potential dosing regimens for planned clinical trials
– Wholly and majority owned programmes

EXS-21546 top-line data for Phase 1 healthy volunteer study on track for the first half of 2022
Anticipate commencing Phase 1b/2 study in patients with high adenosine signature cancers in the second half of 2022
Strong balance sheet and anticipated cash flows position Company for execution

– $6.4 million cash flow from collaborations in first quarter 2022, ending the quarter with $719.8 million in cash and cash equivalents

– First quarter 2022 net cash outflows from operations of approximately $10.4 million

– $100 million upfront payment from Sanofi collaboration signed in January 2022 was received in April, and will be reflected in cash inflows for the second quarter 2022

Further expanded Exscientia’s leadership team

– Michael Krams, M.D., was appointed as Chief Quantitative Medicine Officer, and will lead the clinical development strategy for Exscientia’s portfolio of investigational medicines

Investor Call and Webcast Information

Exscientia will host a conference call on Thursday, May 26 at 1:30 p.m. BST / 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.

First Quarter 2022 Financial Results

For the convenience of the reader, the Company has translated pound sterling amounts to U.S. dollars at the rate of £1.000 to $1.3152, which was the noon buying rate of the Federal Reserve Bank of New York on March 31, 2022.

Revenue: Revenue for the first quarter 2022, was $9.2 million, an increase of $2.2 million compared to the first quarter 2021, primarily due to additional revenues derived from an extension of the Company’s first collaboration with BMS in March 2022 to generate additional data including leveraging translational research capabilities for key targets under the collaboration, as well as revenue from additional targets in the second BMS collaboration.

R&D and cost of drug discovery: Due to various collaboration structures, expenditure incurred in relation to research and development activities may be recognised within one of several financial statement captions. The tables below show how these expenses are separated across the accounting categories.

General and administrative expenses: G&A expenses for the three months ended March 31, 2022, were $10.3 million, or 21% of total operating expenses. For the first quarter 2022, G&A expenses increased by $6.0 million compared to the first quarter 2021, primarily associated with an increase in personnel costs.

Cash inflows: For the first quarter 2022, Exscientia received $6.4 million in cash inflows from its collaborations as compared to $0.2 million during the first quarter 2021.

Cash and cash equivalents: Cash and cash equivalents as of March 31, 2022, were $719.8 million as compared to $739.4 million as of December 31, 2021.

SELECTED CONSOLIDATED STATEMENT OF OPERATIONS, CONSTANT CURRENCY CONVERSION (unaudited)

On May 25, 2022 ImmunoGen, Inc. (Nasdaq: IMGN), a leader in the expanding field of antibody-drug conjugates (ADCs) for the treatment of cancer, reported that the following presentations by Company management at upcoming investor conferences will be webcast (Press release, ImmunoGen, MAY 25, 2022, View Source [SID1234615049]):

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William Blair 42nd Annual Growth Stock Conference
June 8 at 11:20am CT / 12:20pm ET
Jefferies Healthcare Conference
June 9 at 9:30am ET
A webcast of each presentation will be accessible through the "Investors and Media" section of the Company’s website, www.immunogen.com. Following the live webcast, a replay will be available at the same location.

On May 25, 2022 Castle Biosciences, Inc. (Nasdaq: CSTL), a company improving health through innovative tests that guide patient care, reported that an abstract demonstrating the ability of the Company’s DecisionDx-Melanoma test to risk-stratify patients with cutaneous melanoma according to their survival likelihood will be available online during the upcoming 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, being held virtually and in Chicago, June 3-7, 2022 (Press release, Castle Biosciences, MAY 25, 2022, View Source [SID1234615048]).

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Details are as follows:

Abstract Title: "Validation of the 31-gene expression profile test to stratify melanoma-specific survival in an unselected, prospectively tested cohort of patients with stage IIB-III cutaneous melanoma"
Abstract number: e21538
About DecisionDx-Melanoma

DecisionDx-Melanoma is a gene expression profile test that uses an individual patient’s tumor biology to predict individual risk of cutaneous melanoma (CM) metastasis or recurrence, as well as the risk of sentinel lymph node positivity, independent of traditional staging factors, and has been studied in more than 6,300 patient samples. Using tissue from the primary melanoma, the test measures the expression of 31 genes. Additionally, Castle has an ongoing collaboration with the National Cancer Institute (NCI) to link DecisionDx-Melanoma testing data with data from the Surveillance, Epidemiology and End Results (SEER) Program’s registries on CM cases. This collaboration has resulted in Castle’s analysis of 5,226 samples (clinically tested through December 31, 2018) in a study to evaluate melanoma-specific survival and overall survival; in this study, patients tested with DecisionDx-Melanoma had better survival rates than untested patients, and the data suggested that DecisionDx-Melanoma can accurately risk-stratify for disease progression to aid in risk-aligned treatment plans for improved patient outcomes and survival. The test has been validated in four archival risk of recurrence studies of 901 patients and six prospective risk of recurrence studies including more than 1,600 patients. Additionally, impact on patient management plans for one of every two patients tested has been shown in five multi-center/single-center studies including more than 800 patients. The consistent performance and accuracy demonstrated in these studies provides confidence in disease management plans that incorporate DecisionDx-Melanoma test results. To predict risk of recurrence and likelihood of sentinel lymph node positivity, the Company utilizes its proprietary algorithms, i31-ROR and i31-SLNB, to produce an Integrated Test Result. Through March 31, 2022, DecisionDx-Melanoma has been ordered 97,288 times for patients with cutaneous melanoma.

On May 25, 2022 Agendia, Inc., a commercial-stage company focused on improving outcomes for breast cancer patients worldwide by providing physicians and patients with next-generation diagnostic and information solutions to inform optimized treatment decision-making, reported 10,000 patients have been successfully enrolled in the FLEX Registry (Press release, Agendia, MAY 25, 2022, View Source [SID1234615047]). Agendia’s unique FLEX Registry is a real-world, large-scale, prospective, observational breast cancer study (NCT03053193) intended to enable the discovery of novel genomic profiles to improve precision in the management of breast cancer.

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The FLEX Registry’s groundbreaking approach to cancer research is accelerating impactful data generation with its patient-centric design and national network of participating sites, allowing its investigator-initiated sub-studies to produce critical results that drive science forward. Six posters based on data from FLEX will be presented at ASCO (Free ASCO Whitepaper) 2022, one of which will be a poster discussion session.

"When we developed the idea for FLEX, we knew it was essential for breast cancer care but did not immediately expect this high level of engagement of the medical community in this real-world data trial," said Bastiaan van der Baan, Chief Clinical and Business Development Officer at Agendia. "Because we blazed this trail, we are ahead in data collection and already producing actionable insights. We are so proud of the FLEX Registry, which allows not only for the gathering of whole transcriptomic data from valuable tumor samples, but also expands the power of genomic insights to physicians practicing in their communities. We look forward to further partnering with physicians to continue this valuable work, and believe FLEX will advance cancer care for the better."

Since its launch in April 2017, FLEX has enrolled patients at greater than 90 global study sites, including ten National Cancer Institute-designated comprehensive cancer centers. Participating sites also include community hospitals to ensure inclusion of diverse populations, especially those which are often underrepresented in traditional clinical trials. Additionally, the FLEX collaborative platform allows participating investigators the opportunity to author their own sub-study protocols, as approved by the FLEX Scientific Review Committee. To date, 38 investigator-initiated sub-studies have been approved, resulting in 30 published abstracts at major oncology conferences, including those to be shared at ASCO (Free ASCO Whitepaper) 2022.

"The massive dataset provided by the FLEX Registry has the potential to be one of the most impactful and representative prospective breast cancer studies in recent history," said Cynthia X Ma, MD, PhD, oncologist and FLEX national principal investigator at Washington University School of Medicine in St. Louis. "Not only will the data from FLEX be valuable to clinicians like myself, but to the millions of women with breast cancer seeking clarity, guidance, and evidence-based research throughout their journey. The broad and inclusive nature of FLEX translates into findings beyond data collection, allowing for several ongoing sub-studies to be conducted to uncover new, meaningful insights to inform personalized, precise breast cancer treatment plans."

The FLEX Registry has yielded potentially practice-changing data across a wide variety of questions researchers seek to answer about breast cancer. These include:

Insights from multiple sub-studies which showed clinical and molecular differences between tumors of African American and Caucasian patients with HR+ breast cancer;
An age-related sub-study of ER+ breast cancers from women over 50 compared to those 50 and younger showed there is no substantial difference in gene expression, suggesting any observed differences in response to therapy are determined more by genomic features than by age; and
A molecular subtype sub-study showed the gene expression patterns of high-risk ER+, BluePrint Basal breast cancers are much more like IHC triple negative breast cancers than other ER+ cancers.
"It is truly remarkable how rapidly the FLEX Registry was able to enroll 10,000 breast cancer patients especially in light of the COVID-19 pandemic, signifying the uptick in clinical momentum to better understand the real-world impact of genomic differences among women with breast cancer," said Joyce O’Shaughnessy, MD, Director, Breast Cancer Research, Baylor University Medical Center, Texas Oncology and the US Oncology Research Network in Dallas, TX. "Under a shared vision to improve patient outcomes via personalized treatment planning, Agendia, in partnership with clinicians and researchers, is leading the charge to capture robust and valuable data that has the potential to change the breast cancer treatment paradigm for women of all backgrounds and genomic subtypes."

Open to both women and men diagnosed with stage I, II, or III cancer, including all clinical subtypes, the dataset aims to be a true representation of the entire patient population. By capturing data from patients of all ethnicities, ages, genders, and health statuses, the FLEX database provides valuable opportunities to accelerate real-world breast cancer research and has the ability to enroll less prevalent patient populations on a larger scale. This enrollment strategy enables further investigation and the potential to provide targets for treatment optimization for those patients. FLEX is currently recruiting patients for sub-studies, including one prospective study that aims to assess treatment response differences of ER+ Basal-Type tumors, in comparison to Luminal tumors, to DNA-damaging neoadjuvant chemotherapy regimens.

"We’re extremely proud of this landmark achievement that brings us closer to meeting our 30,000-patient goal for total enrollment in the FLEX Registry," said William Audeh, MD, Chief Medical Officer at Agendia. "At Agendia, our main goal with FLEX is to utilize the extensive genomic information present within each breast cancer to better understand the differences between breast cancer subgroups, in both clinically-defined subtypes and diverse patient populations. The genome-level insights we obtain are connected to clinical data and help us understand differences in response to therapy and outcomes. In designing FLEX’s wide inclusion criteria, we’re enabling researchers to access critical genomic data in a pooled database from many centers — data that otherwise would have been challenging to gather via recruitment in standard clinical trials. This approach furthers our collective understanding of tumor biology, providing more specific insights to support treatment planning decisions for women with breast cancer."

After more than five years of collecting data, the FLEX Registry approaches a critical new phase of research in which Agendia will be able to generate outcomes-based analyses, develop interventional sub-studies, and extend the potential utility of liquid biopsy testing. With its centralized database, the FLEX Registry could be positioned to yield full transcriptome data to determine gene expression characteristics of tumors on a large scale, translating and qualifying these observations into clinically meaningful takeaways to help advise women with breast cancer throughout treatment planning.

On May 25, 2022 InnoCare Pharma (HKEX: 09969) reported that it has received approval to conduct a single-arm, open-label, multicenter phase II clinical trial evaluating the safety and efficacy of tafasitamab in combination with lenalidomide by China’s National Medical Products Administration (NMPA) for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplantation (ASCT) (Press release, InnoCare Pharma, MAY 25, 2022, View Source [SID1234615046]).

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Tafasitamab is a humanized Fc-modified cytolytic CD19 targeting monoclonal antibody, which is conditionally approved by both the U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL who are not eligible for ASCT. Tafasitimab is not approved by the NMPA for any indication.

Dr. Jasmine Cui, Co-founder, Chairwoman and CEO of InnoCare, said, "We will make every effort to accelerate the clinical development of tafasitamab in combination with lenalidomide to help address the unmet needs of DLBCL patients in China."

Tafasitamab (Monjuvi) is co-commercialized by Incyte and MorphoSys in the United States and by Incyte under the brand name Minjuvi in the EU. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

DLBCL is the most common type of non-Hodgkin lymphoma (NHL), and its incidence accounts for 31% to 34% of NHL globallyi. In China, DLBCL accounts for 45.8% of all NHLsi.

About Tafasitamab

Tafasitamab is a humanized monoclonal antibody targeting CD19.

In 2010, MorphoSys licensed exclusive worldwide rights to develop and commercialize tafasitamab from Xencor, Inc.

Tafasitamab incorporates an XmAb engineered Fc domain, which mediates B-cell lysis through apoptosis and immune effector mechanism including Antibody-Dependent Cell-Mediated Cytotoxicity (ADCC) and Antibody-Dependent Cellular Phagocytosis (ADCP).

In the United States, Monjuvi (tafasitamab-cxix) is approved by the U.S. Food and Drug Administration in combination with lenalidomide for the treatment of adult patients with relapsed or refractory DLBCL not otherwise specified, including DLBCL arising from low grade lymphoma, and who are not eligible for ASCT. This indication is approved under accelerated approval based on overall response rate. Full approval for this indication may be contingent upon results in a confirmatory trial(s).

In Europe, Minjuvi (tafasitamab) received conditional approval, in combination with lenalidomide, followed by Minjuvi monotherapy, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who are not eligible for autologous stem cell transplant (ASCT).

Tafasitamab is being clinically investigated as a therapeutic option in B-cell malignancies in several ongoing combination trials.

Tafasitamab is not approved for use in China except for in the Boao Lecheng International Medical Tourism Pilot Zone through an early access program.

Minjuvi and Monjuvi are registered trademarks of MorphoSys AG. Tafasitamab is co-marketed by Incyte and MorphoSys under the brand name Monjuvi in the U.S. and marketed by Incyte under the brand name Minjuvi in the EU. As part of its agreement with MorphoSys, Incyte received exclusive commercialization rights for tafasitamab outside the United States, and in August 2021, Incyte entered into a collaboration and license agreement with InnoCare for the development and exclusive commercialization of tafasitamab in hematology and oncology in Greater China.

XmAb is a registered trademark of Xencor, Inc.