On November 8, 2022 Adaptimmune Therapeutics plc (NASDAQ: ADAP), a leader in cell therapy to treat cancer, reported that updated clinical data from its MAGE-A4 franchise (Press release, Adaptimmune, NOV 8, 2022, View Source [SID1234623452]). Clinical data continue to support the potential of Adaptimmune’s engineered T-cell therapies for people with cancer across multiple solid tumor indications . The company will provide further details on a call to be held today, November 8, 2022, at 8:00 a.m. EST (1:00 p.m. GMT) during which management will be available for Q&A.

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"The data in the SURPASS trial continue to demonstrate the potential of our next-generation cell therapy targeting MAGE-A4 in a broad range of difficult-to-treat, late-stage solid tumors," said Elliot Norry, Adaptimmune’s Chief Medical Officer. "We are initiating a Phase 2 trial, SURPASS-3, for people with ovarian cancer in collaboration with The GOG Foundation, Inc. I am pleased to announce that we recently received FDA RMAT Designation for ADP-A2M4CD8 for the treatment of patients with platinum resistant ovarian cancer. We also plan to gather data in urothelial and head & neck cancers with two additional cohorts that will focus on earlier lines of treatment. Finally, we will evaluate further development opportunities in the ongoing signal finding Phase 1 SURPASS trial in both monotherapy as well as in combination with the checkpoint inhibitor nivolumab."

New positive data reported in the Phase 1 SURPASS trial

Since data were reported at ESMO (Free ESMO Whitepaper) in September, there have been additional clinical responses including a new complete response in urothelial cancer and one new response in ovarian cancer
The objective response rate (ORR) has increased to 52% in heavily pre-treated patients with late -stage ovarian, urothelial, and head & neck cancers after a single dose of ADP-A2M4CD8 (ORR of 44% reported at ESMO (Free ESMO Whitepaper))
The overall ORR has increased to 37% (ORR of 33% reported at ESMO (Free ESMO Whitepaper))
Increased ORR in ovarian cancer to 43% (ORR of 36% reported at ESMO (Free ESMO Whitepaper))
Increased ORR in urothelial cancer to 57% (ORR of 43% reported at ESMO (Free ESMO Whitepaper))
There have been no new responses reported in head & neck cancer since the last update of 3 out of 4 patients responding as presented at ESMO (Free ESMO Whitepaper)
Durability continues to increase in this ongoing trial and is now at a median of ~20 weeks; previously reported as ~12 weeks at ESMO (Free ESMO Whitepaper)
Development plans for the SURPASS family of trials

The Phase 1 signal finding SURPASS trial is ongoing in both a monotherapy and a combination cohort evaluating ADP-A2M4CD8 with nivolumab (a checkpoint inhibitor)
Adaptimmune is working with The GOG Foundation, Inc and has initiated a Phase 2 trial (SURPASS-3) evaluating ADP-A2M4CD8 in both monotherapy and in combination with nivolumab in platinum-resistant ovarian cancer
The Company recently received FDA RMAT Designation for ADP-A2M4CD8 for the treatment of patients with platinum resistant ovarian cancer
The Company plans to pursue two new cohorts in the SURPASS Phase 1 trial with ADP–A2M4CD8
In combination with a checkpoint inhibitor in a second-line setting for advanced urothelial cancer
In combination with a checkpoint inhibitor in the first-line setting for advanced head & neck cancer
Conference Call Information

The Company will host a live teleconference and webcast to provide additional details at 8:00 a.m. EST (1:00 p.m. GMT) today, November 8, 2022. A live webcast of the conference call and replay can be accessed at View Source Call in information is as follows: (800)- 319-4610 (US or Canada) or +1 (416)- 915-3239 (International and additional options available HERE).

On November 8, 2022 Reata Pharmaceuticals, Inc. (Nasdaq: RETA) ("Reata," the "Company," "our," "us," or "we"), a clinical-stage biopharmaceutical company, reported financial results for the third quarter of 2022 and provided an update on the Company’s business operations and clinical development programs (Press release, Reata Pharmaceuticals, NOV 8, 2022, View Source [SID1234623451]).

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Recent Company Highlights

Omaveloxolone in Patients with Friedreich’s Ataxia

In May 2022, the U.S. Food and Drug Administration ("FDA") accepted our New Drug Application ("NDA") for filing and granted Priority Review for omaveloxolone for patients with Friedreich’s ataxia. We completed a Mid-Cycle Communication Meeting with the FDA and submitted additional data and analyses to the FDA after the meeting. The FDA determined that these submissions were a major amendment to our NDA and extended the Prescription Drug User Fee Act ("PDUFA") date by three months to provide time for a full review of the new data and analyses. The PDUFA date is now February 28, 2023.

We recently completed a Late-Cycle Meeting with the FDA. The purpose of the Late-Cycle Meeting is for the FDA to discuss any substantive issues identified, and the Division’s objectives for the remainder of the review. The meeting does not address the final regulatory decision for the NDA. While we have not received formal minutes from the FDA, in the preliminary agenda for, and during, the Late-Cycle Meeting, the FDA stated that they continue to review the analyses and data included in the recent NDA submissions. The FDA made no request for additional data or analyses but stated that additional data may be requested as reviews are ongoing. The FDA confirmed that no information requests were outstanding. The FDA reiterated that they do not currently plan to hold an advisory committee meeting.

The FDA stated that no issues related to risk management have been identified to date. During the meeting, the FDA indicated that post-marketing requirements and label review are ongoing. With respect to post-marketing requirements and commitments, FDA stated that if omaveloxolone is approved, they anticipate requiring a drug-drug interaction trial with CYP3A4 modulators, a thorough QT trial, and an evaluation of pregnancy outcomes. FDA stated that other post-marketing requirements and commitments may be considered depending on the findings of the review. With respect to label review, during the meeting we noted that the original proposed label language did not reflect the data and analyses included in the amendments to the NDA and that we have updated it in connection with the planned filing of our Marketing Authorization Application ("MAA") in Europe later this year. We committed to submit the updated proposed label language to the NDA. The FDA indicated that post-marketing requirements and label comments will be communicated in early in 2023.

We have advanced our commercial launch preparations in the United States and are building the infrastructure necessary to support the commercialization of omaveloxolone for the treatment of Friedreich’s ataxia, if and when we receive regulatory approval. We have designed our patient access programs and our product distribution network. The payer field team has been hired and deployed. Hiring of the sales leadership team is underway and we intend to onboard our sales organization and reimbursement specialists in the first quarter of 2023, pending regulatory advancement.

We plan to submit an MAA to the European Medicines Agency ("EMA") for omaveloxolone this year.

Third Quarter Financial Highlights

Cash and Cash Equivalents

On September 30, 2022, we had cash and cash equivalents and marketable securities of $435.9 million, as compared to $590.3 million of cash and cash equivalents on December 31, 2021.

GAAP and Non-GAAP Research and Development ("R&D") Expenses

R&D expenses according to generally accepted accounting principles in the U.S. ("GAAP") were $43.5 million for the third quarter of 2022, as compared to $39.4 million for the same period of the year prior.

Non-GAAP R&D expenses were $36.8 million for the third quarter of 2022, as compared to $34.0 million, for the same period of the year prior.1

GAAP and Non-GAAP General and Administrative ("G&A") Expenses

GAAP G&A expenses were $27.3 million for the third quarter of 2022, as compared to $25.7 million, for the same period of the year prior.

Non-GAAP G&A expenses were $19.5 million for the third quarter of 2022, as compared to $17.5 million for the same period of the year prior.1

GAAP and Non-GAAP Net Loss

The GAAP net loss for the third quarter of 2022, was $79.0 million, or $2.16 per share, on both a basic and diluted basis, as compared to a GAAP net loss of $71.8 million, or $1.97 per share, on both a basic and diluted basis, for the same period of the year prior.

The non-GAAP net loss for the third quarter of 2022, was $53.9 million, or $1.47 per share on both a basic and diluted basis, as compared to a non-GAAP net loss of $46.2 million, or $1.27 per share, on both a basic and diluted basis, for the same period of the year prior.1

[1]See "Non-GAAP Financial Measures" below for a description of non-GAAP financial measures and a reconciliation between GAAP and non-GAAP R&D expenses, GAAP and non-GAAP G&A expenses, and GAAP and non-GAAP net loss, respectively, appearing later in the press release.

Cash Guidance

The Company reaffirms that its existing cash and cash equivalents and marketable debt securities will be sufficient to enable it to fund operations through the end of 2024.

Non-GAAP Financial Measures

This press release contains non-GAAP financial measures, including non-GAAP R&D expenses, non-GAAP G&A expenses, non-GAAP operating expenses, non-GAAP net loss and non-GAAP net loss per common share – basic and diluted. These measures are not in accordance with, or an alternative to, GAAP, and may be different from non-GAAP financial measures used by other companies.

The Company defines non-GAAP R&D expenses as GAAP R&D expenses, excluding stock-based compensation expense; non-GAAP G&A expenses as GAAP G&A expenses, excluding stock-based compensation expense; non-GAAP operating expenses as GAAP operating expenses, excluding stock-based compensation expense; non-GAAP net loss as GAAP net loss, excluding stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties; and non-GAAP net loss per common share – basic and diluted as GAAP net loss per common share – basic and diluted, excluding stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties. The Company has excluded the impact of stock-based compensation expense, which may fluctuate from period to period based on factors including the variability associated with performance-based grants of stock options and restricted stock units and changes in the Company’s stock price, which impact the fair value of these awards. The Company has excluded the impact of accreted non-cash interest expense from liability related to sale of future royalties as it may be calculated differently from, and therefore may not be comparable to, peer companies who also provide non-GAAP disclosures. The Company has excluded the impact of stock-based compensation expense and non-cash interest expense from liability related to sale of future royalties because the Company believes its impact makes it difficult to compare its results to prior periods and anticipated future periods.

Because management believes certain items, such as stock-based compensation expense and non-cash interest expense from liability related to sales of future royalties, can distort the trends associated with the Company’s ongoing performance, the following measures are often provided, excluding special items, and utilized by the Company’s management, analysts, and investors to enhance consistency and comparability of year-over-year results, as well as to industry trends, and to provide a basis for evaluating operating results in future periods: non-GAAP net loss; non-GAAP net loss per common share – basic and diluted; non-GAAP R&D expenses; non-GAAP G&A expenses; and non-GAAP operating expenses.

The Company believes the presentation of these non-GAAP financial measures provides useful information to management and investors regarding the Company’s financial condition and results of operations. When GAAP financial measures are viewed in conjunction with these non-GAAP financial measures, investors are provided with a more meaningful understanding of the Company’s ongoing operating performance and are better able to compare the Company’s performance between periods. In addition, these non-GAAP financial measures are among those indicators the Company uses as a basis for evaluating performance, allocating resources, and planning and forecasting future periods. These non-GAAP financial measures are not intended to be considered in isolation or as a substitute for GAAP financial measures. A reconciliation between these non-GAAP measures and the most directly comparable GAAP measures is provided later in this press release.

Conference Call Information

Reata’s management will host a conference call on November 8, 2022, at 8:30 am ET. The conference call will be accessible by dialing (844) 200-6205 (toll-free domestic) or (929) 526-1599 (international) using access code 756839. The webcast link is View Source

Third quarter 2022 financial results to be discussed during the call will be available on the Company’s website shortly before the call at View Source and will be available for 12 months after the call. The audio recording and webcast of the conference call will be accessible for at least 90 days after the event at View Source.

On November 8, 2022 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported financial results for the third quarter ended September 30, 2022 (Press release, Zymeworks, NOV 8, 2022, View Source [SID1234623447]).

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"Treatment of HER2-positive (HER2+) hormone-receptor positive (HR+) metastatic breast cancer (mBC) with the novel combination of zanidatamab, palbociclib, and fulvestrant."

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"We have had a transformative quarter beginning with the presentation of results from our Phase 1 trial of zanidatamab zovodotin, the presentation of our early R&D day and culminating in our announcement of the zanidatamab licensing agreement with Jazz," said Kenneth Galbraith, Chair & CEO of Zymeworks. "All of these events are important steps in our path forward over the coming years. With a zanidatamab partnership executed, our cash runway expected to be extended, and a growing portfolio of exciting preclinical product candidates, we are well situated to continue advancing the development of novel biotherapeutics and further progress towards our goal of addressing difficult to treat cancers with traditionally poor patient prognoses."

Third Quarter 2022 Business Highlights and Recent Developments

Announced Exclusive Licensing Agreement for Zanidatamab with Jazz Pharmaceuticals
The exclusive licensing agreement to develop and commercialize zanidatamab globally, excluding existing Asia-Pacific territories already licensed to BeiGene Ltd., represents an exciting step in delivering this important therapy to patients globally. Under the terms of the agreement, Jazz will receive an exclusive license to develop and commercialize zanidatamab in the United States, Europe, Japan and all other territories except for those Asia/Pacific territories that Zymeworks previously licensed to BeiGene. Zymeworks is eligible to receive a $50 million upfront payment, following receipt of the clearance relating to the United States Hart-Scott Rodino Antitrust Improvements Act of 1976, and should Jazz decide to continue the collaboration following readout of the top-line clinical data from HERIZON-BTC-01, a second, one-time payment of $325 million. Zymeworks is also eligible to receive up to $525 million upon the achievement of certain regulatory milestones and up to $862.5 million in potential commercial milestone payments, for total potential payments of up to $1.76 billion. Pending approval, Zymeworks is eligible to receive tiered royalties between 10% and 20% on Jazz’s net sales. The transaction is expected to close before the end of 2022.
Zanidatamab Zovodotin (ZW49) Results from Preliminary Phase 1 Trial Presented in Oral Presentation at the ESMO (Free ESMO Whitepaper) Congress
Zymeworks presented encouraging preliminary results in this first-in-human trial evaluating zanidatamab zovodotin in HER2-expressing cancers as a monotherapy. Zanidatamab zovodotin exhibited a confirmed objective response rate of 31% at the 2.5 mg/kg Q3W dose (dose escalation plus expansion) across multiple tumor types in a heavily pretreated patient population and also displayed a differentiated tolerability profile with the majority of adverse events being grade 1 or 2 with no signals of interstitial lung disease, no significant neuropathy, and no significant neutropenia. The Company continues to consider multiple potential paths of development in indications such as non-small cell lung cancer, metastatic breast cancer, and other HER2-expressing pan-tumor indications as a monotherapy or in combination with standards of care, including PD-1 inhibitors. Enrollment in our weekly dosing cohort is complete, and we expect to determine a recommended Phase 2 dose over the next few months.
Completed Plan to Become a Delaware Domiciled Corporation
The corporate redomicile was an important step in helping facilitate our key strategic priorities, as laid out in January, and continues the consistent efforts towards increasing long-term stockholder value. The redomicile was overwhelmingly approved by Zymeworks securityholders at a Special Meeting held on October 7, 2022, and the Delaware Common Stock began trading on the New York Stock Exchange under the symbol "ZYME" on October 13, 2022.
Continued Progress in Zanidatamab Clinical Studies
Zanidatamab continued to advance in clinical studies across multiple HER2-expressing cancers with an acceptance for publication this year of a manuscript detailing results from our Phase 1 dose-escalation and expansion study of zanidatamab as monotherapy in patients with locally advanced and/or metastatic HER2-expressing or amplified cancers. Further, Zymeworks will present results in a spotlight poster discussion at the San Antonio Breast Cancer Symposium on Friday, December 9 at 7:00 am Central Time (CT) in a poster titled, "Treatment of HER2-positive (HER2+) hormone-receptor positive (HR+) metastatic breast cancer (mBC) with the novel combination of zanidatamab, palbociclib, and fulvestrant."
Early Research & Development Program Update

Zymeworks presented an update on its preclinical programs at an Early R&D day in New York City on October 20, 2022. At this event, we highlighted the progress in development of our novel pipeline assets and next-generation technology platforms and outlined the programs supporting our goal of filing five new investigational new drug (IND) applications in the next 5 years.

"It is an exciting time to be a part of a team at the forefront of antibody engineering and design," said Paul Moore, Ph.D., Chief Scientific Officer at Zymeworks. "With the presentation of our new pipeline assets, as well as the vision behind where we see our future growth in multispecific antibody therapeutics and antibody-drug conjugate development, we have an exciting future ahead. We look forward to reporting further progress as we develop and expand our product pipeline in the years ahead to pursue our goal of filing 5 new IND applications in the next 5 years."

Updates on the Company’s antibody drug conjugate programs, included:

Topoisomerase 1 inhibitor (TOPO1i) payload technology development
ZW191: a Folate Receptor-alpha targeted topoisomerase-1 ADC with IND expected in 2024
ZW251: a Glypican-3 targeted topoisomerase-1 ADC
ZW220: a NaPi2b targeted topoisomerase-1 ADC
Review of progress in multispecific antibody therapeutics development, including:

ZW171: a Mesothelin x CD3 targeted 2+1 format bispecific t cell engaging antibody with IND expected in 2024
Tri-specific T-cell Engagers incorporating co-stimulation (TriTCE-costim)
Tri-specific T-cell Engagers incorporating checkpoint inhibition (TriTCE-CPI)
Financial Results for the Quarter Ended September 30, 2022

Zymeworks’ revenue relates primarily to non-recurring upfront fees, expansion payments or milestone payments from collaboration and license agreements, which can vary in timing and amount from period to period, as well as payments for research and development support. Revenue for the three months ended September 30, 2022 was $2.6 million compared to $4.4 million for the same period of 2021. Revenue for 2022 included $2.6 million for research support and other payments from our partners. Revenue for the same period in 2021 included milestone revenue of $4.0 million from Janssen and $0.4 million in research support and other payments from our partners.

Research and development expense decreased by $12.8 million in the three months ended September 30, 2022 compared to the same period in 2021. Research and development expense in 2022 included non-cash stock-based compensation expense of $2.2 million, comprised of a $2.2 million expense from equity classified awards and a nominal amount of expense related to the non-cash, mark-to-market revaluation of certain historical liability classified awards. Excluding stock-based compensation expense and restructuring recovery of $0.1 million, research and development expense decreased on a Non-GAAP basis by $10.3 million in 2022 compared to 2021. The decrease related primarily to lower employee compensation expense as a result of a decrease in headcount due to the Company’s restructuring program, a decrease in manufacturing and clinical expenses for zanidatamab, as well as a decrease in licensing expenses related to preclinical activities.

"With the anticipated proceeds from our exclusive licensing agreement with Jazz, our significantly improved financial position allows Zymeworks to properly fund and advance exciting opportunities in our product pipeline," said Chris Astle, Ph.D., SVP and Chief Financial Officer. "With our cash runway potentially extended through at least 2026, and potentially beyond, we can focus on strategically advancing our preclinical and early clinical pipeline assets, and will look to maintain our strong balance sheet through proper expense management and continued pursuit of additional partnership and collaboration opportunities and asset monetizations."

We expect research and development expenditures to fluctuate over time in line with the advancement, expansion and completion of the clinical development of our product candidates, as well as our ongoing preclinical research activities.

Excluding the impact of stock-based compensation and restructuring recovery of $0.8 million, general and administrative expense decreased on a Non-GAAP basis by $0.1 million during three months ended September 30, 2022 compared to same period in 2021. This decrease was primarily due to a decrease in salaries and benefits expense as a result of decrease in headcount due to the Company’s restructuring program, partially offset by an increase in professional fees, depreciation and other expenses in 2022.

Net loss for the three months ended September 30, 2022 was $47.8 million compared to $60.6 million for the same period of 2021, representing a 21% decrease.

As of September 30, 2022, Zymeworks had $166.2 million in cash resources consisting of cash, cash equivalents and short-term investments. We continue to pursue additional partnerships and collaborations across our product portfolio in order to advance and broaden our early clinical and preclinical candidate pipeline.

On November 8, 2022 Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for cancer, reported financial results and operational highlights for the third quarter ended September 30, 2022 (Press release, Adicet Bio, NOV 8, 2022, View Source [SID1234623446]).

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"We have continued to make very encouraging clinical progress in 2022, reporting promising safety and efficacy data for our lead candidate ADI-001 for the potential treatment of relapsed or refractory B-cell non-Hodgkin’s lymphoma," said Chen Schor, President and Chief Executive Officer at Adicet Bio. "We’re currently enrolling patients in dose level 4 and expect to initiate a potentially pivotal program with the recommended Phase 2 dose for ADI-001 in the first half of 2023. We look forward to providing additional clinical data on ADI-001 at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December as well as promising preclinical data on our emerging pipeline programs at the upcoming Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s Annual Meeting and our upcoming R&D event."

Third Quarter 2022 and Recent Operational Highlights:

Preclinical Data for Four New Pipeline Programs at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 37th Annual Meeting. Preclinical data from four new pipeline programs will be presented at the SITC (Free SITC Whitepaper) 37th Annual Meeting on November 10-11, 2022.
Company to Host R&D Webcast Event to Outline Pipeline Updates. Adicet is hosting an R&D webcast event on Thursday, November 10, 2022, at 9:00 a.m. ET to provide additional preclinical data from its newly disclosed pipeline and upcoming milestones.
Updated Data from Ongoing Phase 1 Study of ADI-001 at the 2022 American Society of Hematology (ASH) (Free ASH Whitepaper) 64th Annual Meeting. In November, Adicet announced that as of the July 15, 2022 data-cut date for the ASH (Free ASH Whitepaper) abstract, ADI-001 demonstrated a 78% overall response rate (ORR) and complete response rate (CR) (7/9) and sustained durability in adults with relapsed or refractory B-cell non-Hodgkin’s lymphoma (NHL). For the four patients who had prior autologous CD19 CAR T therapies, the ORR and CR rate was 100% (4/4). ADI-001 continued to demonstrate a favorable safety and tolerability profile. Based on data collected on ADI-001, Adicet expects to establish the recommended Phase 2 dose for ADI-001 in the second half of 2022.

In December 2022, the Company plans to provide data from a more recent data-cut date from the ongoing Phase 1 study of ADI-001 in adults with relapsed or refractory B-cell NHL during the upcoming 2022 ASH (Free ASH Whitepaper) Annual Meeting. The Company will host an ADI-001 webcast on Sunday, December 11, 2022, at 8:00 a.m. CT / 9:00 a.m. ET to discuss data from the ongoing study.
Establishing In-House Manufacturing Capacity in Redwood City Facility. Adicet’s new in-house manufacturing capabilities in the Redwood City facility, which is designed to enable manufacturing for early clinical development of its pipeline candidates, is expected to be operational in the fourth quarter of 2022.
Financial Results for Third Quarter 2022:

Research and Development (R&D) Expenses: R&D expenses were $16.6 million for the three months ended September 30, 2022, compared to $11.9 million during the same period in 2021. The $4.6 million increase is primarily driven by a $3.2 million increase in payroll and personnel expenses resulting from an increase in overall headcount and a $1.2 million increase in contract manufacturing organizations and other externally conducted research and development expense. Payroll and personnel expenses for the three months ended September 30, 2022 includes $1.7 million of non-cash stock-based compensation expense compared to $0.8 million during the same period in 2021.
General and Administrative (G&A) Expenses: G&A expenses were $6.4 million for the three months ended September 30, 2022, compared to $5.2 million during the same period in 2021. The $1.2 million increase is primarily driven by an increase of $1.3 million of payroll and personnel expenses. Payroll and personnel expenses for the three months ended September 30, 2022 includes $2.4 million of non-cash stock-based compensation expense compared to $1.7 million during the same period in 2021.
Net Loss: Net loss for the three months ended September 30, 2022 was $22.0 million, or a net loss of $0.53 per basic and diluted share, including non-cash stock-based compensation expense of $4.2 million, as compared to a net loss of $14.0 million during the same period in 2021, or a net loss of $0.44 per basic and diluted share, including non-cash stock-based compensation expense of $2.5 million.
Cash Position: Cash and cash equivalents were $282.7 million as of September 30, 2022, compared to $277.5 million as of December 31, 2021. The Company expects that current cash and cash equivalents as of September 30, 2022, will be sufficient to fund its operating expenses into the first half of 2025.

On November 8, 2022 SimBioSys, the precision medicine company behind TumorScope, the 4D tumor modeling platform for treatment planning, reported it has been awarded a $2M Phase II Small Business Innovation Research (SBIR) contract from the National Cancer Institute (NCI), part of the National Institutes of Health (Press release, SimBioSys, NOV 8, 2022, View Source [SID1234623445]).

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Heterogeneity among cancers and differences within individual tumors continue to challenge the efforts to develop effective therapies and design clinical trials. Therefore, SimBioSys’ goal with PhenoScope is to provide a cutting-edge extension of their TumorScope platform to capture tumor heterogeneity and develop the next generation of multi-modal biomarkers to support cancer research in academia and biopharma.

"It’s an exciting time in cancer research due to the explosion of cancer phenotyping datasets, yet the computational complexity of analyzing and connecting such data across scales is hindering progress," said Dr. Joseph Peterson, CTO of SimBioSys. "PhenoScope builds on our strong 4D tumor modeling fundamentals to further support our collaborators and researchers at earlier stages of the cancer care industry."

PhenoScope integrates data from multiple biological scales including genomic, cellular/pathway, microscopic tissue environment, and organ scales with clinical outcomes data. This multi-scale interconnection will enable study of diverse biological characteristics that affect tumor phenotype, from mutations and response to drugs and spatial heterogeneity.

The technology combines state-of-the-art machine learning, dimensionality reduction techniques, novel spatio-temporal simulation algorithms, and supports numerous public data repositories. Platform users will have new means of assessing factors contributing to a cancer’s phenotypical behavior, thereby allowing elucidation of new pharmacodynamic, prognostic, predictive, and surrogate biomarkers.

"It’s fascinating how PhenoScope connects complex cancer datasets and allows the visualization of such data in a 4D manner," said Tricia Carrigan, SVP of precision medicine at SimBioSys. "We now have a tool that enables us to determine drug dosing and biomarker relationships more precisely before ever dosing a patient, which will play an important role in drug development."

The company successfully completed a Phase I contract in 2021 centered around the development of the prototype cloud- and web-based version of PhenoScope. During the Phase II contract, SimBioSys will expand access to PhenoScope and novel datasets to a broader user base.