On November 8, 2021 xCures reported the release of xDECIDE, the latest in the company’s suite of tools to empower oncologists and their teams to identify the most suitable, personalized treatment options for advanced cancer patients more efficiently (Press release, xCures, NOV 8, 2021, View Source [SID1234594826]). Through xDECIDE, providers may add patients and review their cases via a consolidated platform, saving them time while ensuring and supporting robust consideration of potential treatment options.

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Whether working in a community setting or in larger institutions, oncologists typically struggle to keep up with their caseloads. Individual case review and treatment options research are time-consuming tasks, and no corners can be cut. xDECIDE’s goal is to save oncologists and their staff members a significant amount of that time by leveraging xCures’ core technology to expedite case preparation and research, including record collection, standardization, structuring, and expert interpretation of the records. The result is that when patients arrive for a visit (and/or return for future visits), both provider and patient are assured by the mutual understanding of the patient’s case history. Also reassuring is the fact that expert research has been conducted and presented for discussion and that all possible options have been evaluated.

xCures’ insights are generated for registered patients by two deliverables: a Cancer Journey and a Treatment Options Report. The patient’s Cancer Journey is a visual overview of their case history, assembled from source medical records compiled seamlessly from all institutions where the patient has received prior care. The Treatment Options Report provides a rank-ordered set of treatments for consideration, with supporting medical rationales and information regarding therapy access. The options themselves are chosen from a library of potential therapies, including those that go beyond standard of care and guidelines-based management, and even beyond clinical trial matching. The most promising treatments are identified and presented, even when non-traditional methods are needed to access those treatments (e.g., compassionate use program enrollment for an experimental treatment, or; patient assistance for access to a drug or drug combination outside of its primary indication).

Cancer Journeys and Treatment Options Reports are available to patients and their providers at no cost — patients participate with their data, and providers receive obligation-free information for any registered patient who has identified them as their treating oncologist. Both patients and linked providers receive access to xCures’ reports simultaneously, allowing for guided review and discussion.

A patient’s Treatment Options Report is generated through a combination of xCures’ technology, overseen by an expert team of Ph.D. scientists. It takes into account patient features, a broad set of patient outcomes data, expert recommendations, and insights from virtual tumor boards, public data sources, and an active learning network. Through xDECIDE, providers also have an opportunity to contribute to the refinement of xCures’ technology by making treatment decisions that feedback into xCures’ ever-growing knowledge base.

Providers who have collaborated with xCures via their xACCESS platform (e.g., expanded/managed access program) will see the xDECIDE toolset as an adjunct feature in their portal. As of today’s general availability of xDECIDE, all providers and staff users may also create new accounts via the following link: View Source To access these same resources as a patient, please register here: View Source

On November 8, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated therapeutic and companion diagnostic strategy for treating patients with cancer, reported financial results for the third quarter ended September 30, 2021 and summarized recent business progress (Press release, Celcuity, NOV 8, 2021, View Source [SID1234595207]).

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"We made great progress advancing our gedatolisib program this past quarter. We initiated preparation for a Phase 3 clinical trial evaluating gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced or metastatic breast cancer that we expect to activate in the first half of 2022," said Brian Sullivan, CEO and co-founder of Celcuity. "Site identification and feasibility activities are underway. We are excited to have the opportunity to present updated results from our Phase 1b clinical trial in patients with ER+/HER2- advanced breast cancer at the San Antonio Breast Cancer Symposium in December. Finally, we are pleased to have entered into another clinical trial collaboration to evaluate CELsignia selected patients with advanced breast cancer. The collaboration with University of Rochester Wilmot Cancer Center and Puma represents an important opportunity to identify a potential new treatment for patients with breast cancer that has metastasized to the brain."

Third Quarter 2021 Business Highlights and Other Recent Developments

Completed transfer of regulatory, clinical trial, and safety reporting responsibilities for gedatolisib from Pfizer to Celcuity ahead of schedule.

Updated data from Celcuity’s ongoing Phase 1b clinical trial for patients with ER+/HER2- advanced breast cancer will be presented at the San Antonio Breast Cancer Symposium during a Spotlight Poster Discussion Session on December 10, 2021. Rachel M. Layman, MD, an oncologist at the University of Texas MD Anderson Cancer Center who was a principal investigator for the clinical trial, will be the presenting author.

Celcuity entered into a clinical trial collaboration agreement with the University of Rochester Wilmot Cancer Center and Puma Biotechnology in October 2021. This single arm Phase 2 trial will evaluate the efficacy and safety of Puma’s pan-HER inhibitor, NERLYNX (neratinib), and capecitabine, a chemotherapy, in patients selected with Celcuity’s CELsignia HER2 Activity Test who have metastatic HER2-negative breast cancer that has progressed on prior treatments. Based on estimates of patient enrollment rates, Celcuity expects to obtain interim results 12 to 15 months after initiation of the trial followed by the final results 12 to 15 months later. Enrollment is planned to begin by mid-2022.

Enrollment in the FACT-1 and FACT-2 trials that are evaluating CELsignia selected patients who have early-stage ER+/HER2- breast cancer was negatively impacted by COVID-19 related delays during the third quarter. Hospitalizations of patients with COVID-19 increased dramatically during this period which led hospitals to reduce clinical trial related activities. Interim results are now expected to be available in the second half of 2022.

Third Quarter 2021 Financial Results

Unless otherwise stated, all comparisons are for the third quarter ended September 30, 2021, compared to the third quarter ended September 30, 2020. The following discussion should be read in conjunction with our unaudited condensed consolidated financial statements and related notes on Form 10-Q for the third quarter ended September 30, 2021.

Total operating expenses were $5.6 million for the third quarter of 2021, compared to $2.5 million for the third quarter of 2020.

Research and development (R&D) expenses were $5.0 million for the third quarter of 2021, compared to $2.0 million for the third quarter of 2020. The increase in R&D expenses during the third quarter of 2021 compared to the prior year primarily resulted from costs associated with the development of gedatolisib. Employee related expenses, including consulting fees, accounted for $1.1 million of the increase. The remaining increase of $1.9 million in expenses is related to clinical trials, patent legal fees, and costs associated with the transfer of the gedatolisib-related activities from Pfizer to Celcuity.

General and administrative (G&A) expenses were $0.6 million for the third quarter of 2021, compared to $0.5 million for the third quarter of 2020. The increase in the third quarter of 2021 arose primarily from non-cash stock-based compensation.

Net loss for the third quarter of 2021 was $6.0 million, or $0.41 loss per share, compared to a net loss of $2.5 million for the third quarter of 2020, or $0.24 loss per share. The Non-GAAP adjusted net loss for the third quarter of 2021 was $5.1 million compared to a non-GAAP adjusted net loss of $2.0 million for the third quarter of 2020. Non-GAAP adjusted net loss excludes stock-based compensation expense, issuance of common stock and non-cash interest. Because these items have no impact on Celcuity’s cash position, management believes non-GAAP adjusted net loss better enables Celcuity to focus on cash used in operations. For a reconciliation of financial measures calculated in accordance with generally accepted accounting principles (GAAP) in the United States to non-GAAP financial measures, please see the financial tables at the end of this press release.

Net cash used in operating activities for the third quarter of 2021 was $4.0 million, compared to $1.6 million for the third quarter of 2020.

At September 30, 2021, Celcuity had cash and cash equivalents of $90.4 million, compared to cash and cash equivalents of $11.6 million at December 31, 2020.

Anticipated Milestones

Celcuity expects to achieve the following potential milestones over the next twelve months:

Obtain formal feedback from the FDA on the design of its proposed Phase 3 clinical trial by early 2022.

Initiate a Phase 3 clinical trial to evaluate gedatolisib in combination with Ibrance and Faslodex in patients with ER+/HER2- advanced breast cancer in the first half of 2022, subject to the FDA feedback.

Provide an update on lifecycle development priorities for gedatolisib in the first half of 2022.

Obtain interim results from the FACT-1 and FACT-2 trials in the second half of 2022.

Webcast and Conference Call Information

The Celcuity management team will host a webcast/conference call at 4:30 p.m. ET today to discuss the third quarter financial results and provide a corporate update. To participate in the teleconference, domestic callers should dial (877) 407-0784 and international callers should dial (201) 689-8560. A live webcast presentation can also be accessed using this weblink: https://78449.themediaframe.com/dataconf/productusers/vvdb/mediaframe/46959/indexl.html. A replay of the webcast will be available on the Celcuity website following the live event.

On November 8, 2021 ATP, a leader in life sciences venture capital, reported the launch of Marengo Therapeutics, Inc. to develop novel antibodies that target V T cell receptor (TCR) variants, selectively boosting anti-tumor T cells and promoting longterm protection against cancer. $80 million in launch financing from ATP will help advance Marengo’s proprietary Selective T Cell Activation Repertoire (STAR) platform and progress the company’s lead candidate into the clinic in 2022 (Press release, Marengo Therapeutics, NOV 8, 2021, View Source [SID1234594707]).

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Marengo is based in Cambridge, Massachusetts, and led by Chief Executive Officer Zhen Su, M.D., MBA, who joined from Merck KGaA, where he was Senior Vice President and Head of Global Oncology following a successful tenure as Chief Medical Officer for EMD Serono. During his time at Merck KGaA, Dr. Su was instrumental in delivering multiple drug approvals and double-digit growth of the oncology business in addition to building a robust pipeline of assets and establishing key partnerships in the immuno-oncology field.

"Existing immuno-oncology therapies have transformed cancer care, yet they are often unable to overcome dysfunctional T cell responses that develop in patients with cancer and that result in less than a third of patients achieving a durable response," Dr. Su said. "Marengo’s deep understanding of T cell biology and TCR signaling has driven our discovery of a new mode of T cell activation that promises to more effectively attack tumors and provide long-term protection against cancer. We believe this discovery represents a remarkable departure in the field of immuno-oncology, and our team is working to translate it into a great leap forward for patients."

From its proprietary antibody library targeting diverse germline-encoded TCR Vβ variants, Marengo can deploy therapeutic antibodies to prime the activation of clonally diverse T cells within both CD8+ and CD4+ effector pools that drive both near-term effector responses to tumors and long-term tumor immunity-promoting memory T cell responses. The activation of T 2 cells using this approach also comes with reduced pro-inflammatory cytokine release that may translate into a better safety and tolerability profile.

"ATP created Marengo Therapeutics to realize the potential of an exciting scientific discovery we have been incubating for several years," said Seth Harrison, M.D., founder and Managing Partner at ATP. "Priming specific T cells to fight cancer could pave the way to an entirely new class of much-needed effective and durable immunotherapies. We have been and continue to be incredibly energized by the promise of Marengo’s science, and I have great confidence that Zhen and the Marengo leadership team, with their experience and expertise, will deliver on our ambitions to transform cancer care for patients."

Lead Program
Marengo’s first-in-class lead candidate, STAR0602, is an antibody fusion molecule that binds and activates a specific Vβ TCR variant T cell subset while also delivering additional signals to the same T cell (known as cis-targeting) to further re-program the T cell to enhance anti-tumor activity. STAR0602 is expected to enter the clinic in late 2022 for the treatment of advanced and metastatic solid tumor cancers. Marengo is developing a broad pipeline of additional STAR programs that engage other immune cell types.

"Marengo’s STAR platform is highly flexible; it can turbo-charge cancer patients’ T cells, but with an inherent selectivity and flexibility that enables the engineering of more robust adaptive immune responses to tumors," said Andrew Bayliffe, Ph.D., Chief Scientific Officer of Marengo and Venture Partner at ATP.

Raj Chopra, FRCP, FRCPath, FRSB, Ph.D., Chief Medical Officer of Marengo and Head of Oncology and Venture Partner at ATP, added: "The platform has far-reaching applications, with the potential to ’tune’ a patient’s T cell responses on a personalized basis and in a way that could be integrated into different therapeutic regimens to treat a wide variety of advanced cancers."

On November 8, 2021 Gossamer Bio, Inc. (Nasdaq: GOSS), a clinical-stage biopharmaceutical company focused on discovering, acquiring, developing and commercializing therapeutics in the disease areas of immunology, inflammation and oncology, reported its financial results for the third quarter of 2021 and provided a corporate update (Press release, Gossamer Bio, NOV 8, 2021, View Source [SID1234594723]).

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Clinical-Stage Product Candidate Updates

Seralutinib (GB002): Inhaled PDGFR, CSF1R and C-KIT Inhibitor for Pulmonary Arterial Hypertension (PAH)

Enrollment is ongoing in the TORREY Study, a Phase 2 clinical trial in patients with PAH whose disease has progressed despite standard-of-care therapy. The primary endpoint is change in pulmonary vascular resistance (PVR) from baseline at week 24.
Due to COVID-19 related trial and site delays, topline data from the TORREY study are now expected in the second half of 2022, subject to developments in the ongoing COVID-19 pandemic.
Phase 2 TORREY Study protocol summary manuscript published in Pulmonary Circulation on October 22nd.
GB004: Oral, Gut-Targeted HIF-1α Stabilizer for Inflammatory Bowel Disease (IBD)

Enrollment has been completed in the ongoing SHIFT-UC Study, a Phase 2 clinical trial in patients with active ulcerative colitis (UC) despite treatment with 5-ASAs. The primary endpoint is proportion of patients with clinical remission at week 12.
12-week topline data from the SHIFT-UC study are expected in the second quarter of 2022.
36-week topline data from the treat-through portion of the SHIFT-UC study are expected in the fourth quarter of 2022.
GB5121: Oral, Covalent, CNS-Penetrant BTK Inhibitor for Primary CNS Lymphoma (PCNSL)

First subject dosed in first-in-human Phase 1 clinical trial in healthy volunteers.
Gossamer expects to initiate a Phase 1b/2 clinical trial of GB5121 in PCSNL patients in the first half of 2022.
GB7208: Oral, Covalent, CNS-Penetrant BTK Inhibitor for Multiple Sclerosis

Gossamer expects to initiate a first-in-human Phase 1 clinical trial of GB7208 in healthy volunteers in the second half of 2022.
Financial Results for the Quarter Ended September 30, 2021

Cash, Cash Equivalents and Marketable Securities: Cash, cash equivalents and marketable securities as of September 30, 2021, were $366.0 million. The Company expects the combination of current cash, cash equivalents and marketable securities, and access to its debt facility will be sufficient to fund its operating and capital expenditures into the second half of 2023.
Research and Development (R&D) Expenses: For the quarter ended September 30, 2021, R&D expenses were $43.2 million, compared to R&D expenses of $41.8 million for the same period in 2020.
General and Administrative (G&A) Expenses: For the quarter ended September 30, 2021, G&A expenses were $12.5 million, compared to $11.4 million for the same period in 2020.
Net Loss: Net loss for the quarter ended September 30, 2021, was $60.2 million, or $0.80 per share, compared to a net loss of $57.8 million, or $0.80 per share, for the same period in 2020.
Conference Call and Webcast

Gossamer’s management team will host a conference call and live audio webcast at 4:15 p.m. ET today, Monday, November 8, to discuss its third quarter 2021 financial results and provide a corporate update.

The live audio webcast may be accessed through the "Events / Presentations" page in the "Investors" section of the Company’s website at www.gossamerbio.com. Alternatively, the conference call may be accessed through the following:

On November 8, 2021 Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq: SNDX), a clinical stage biopharmaceutical company developing an innovative pipeline of cancer therapies, reported that it will release its third quarter 2021 financial results on Monday, November 15, after the close of the U.S. financial markets (Press release, Syndax, NOV 8, 2021, View Source [SID1234594739]).

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In connection with the earnings release, Syndax’s management team will host a conference call and live audio webcast at 4:30 p.m. ET on Monday, November 15, to discuss the Company’s financial results and provide a general business update.

The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company’s website at www.syndax.com. Alternatively, the conference call may be accessed through the following: