On November 1, 2023 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that company management will participate in the following conferences and invited investors to participate by webcast (Press release, Exact Sciences, NOV 1, 2023, View Source [SID1234636634]).

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Stifel Healthcare Conference, New York
Fireside chat on Tuesday, November 14, 2023 at 10:20 a.m. ET

Jefferies London Healthcare Conference, London
Fireside chat on Wednesday, November 15, 2023 at 9:30 a.m. ET

Piper Sandler 35th Annual Healthcare Conference, New York
Fireside chat on Tuesday, November 28, 2023 at 2:00 p.m. ET

Evercore ISI HealthCONx Conference, Miami
Fireside chat on Wednesday, November 29, 2023 at 12:30 p.m. ET

The webcasts can be accessed in the investor relations section of Exact Sciences’ website at www.exactsciences.com.

On November 1, 2023 Exact Sciences Corp. (Nasdaq: EXAS), a leading provider of cancer screening and diagnostic tests, reported that the company generated revenue of $628.3 million for the third quarter ended September 30, 2023, compared to $523.1 million for the same period of 2022 (Press release, Exact Sciences, NOV 1, 2023, View Source [SID1234636633]).

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"Exact Sciences’ third-quarter results reflect our unwavering dedication to improving cancer care on a global scale," said Kevin Conroy, chairman and CEO. "Our team delivered answers to more patients than ever before, giving us confidence to raise our full-year revenue and adjusted EBITDA guidance. To achieve our mission to eradicate cancer, we’ll continue to focus on making our current and future tests the top choice for patients and healthcare professionals globally."

Third -quarter 2023 financial results

For the three-month period ended September 30, 2023, as compared to the same period of 2022 (where applicable):

Total revenue was $628.3 million, an increase of 20 percent
Core revenue was $624.8 million, an increase of 23 percent
Screening revenue was $472.0 million, an increase of 31 percent
Precision Oncology revenue was $156.3 million, an increase of 3 percent, or 5 percent on a core revenue basis
Other operating income (loss) was $72.0 million, which includes a gain related to the sale of the Oncotype DX Genomic Prostate Score Test
Gross margin including amortization of acquired intangible assets was 70 percent, and non-GAAP gross margin excluding amortization of acquired intangible assets was 73 percent
Net income was $0.8 million, or $0.00 per basic and diluted share, compared to a net loss of $148.8 million, or $(0.84) per basic and diluted share
EBITDA was $61.2 million and adjusted EBITDA was $56.3 million
Cash provided by operating activities was $24.4 million and free cash flow was $(0.8) million, including a one-time payment of $32.5 million for a previously disclosed and reserved legal matter
Cash, cash equivalents, and marketable securities were $734.4 million at the end of the quarter
Screening primarily includes laboratory service revenue from Cologuard tests and PreventionGenetics. Precision Oncology includes laboratory service revenue from global Oncotype DX and therapy selection tests.

2023 outlook

The company anticipates revenue of $2.476-$2.486 billion during 2023, assuming:

Screening revenue of $1.848-$1.853 billion,
Precision Oncology revenue of $622-$627 million, and
COVID-19 testing revenue of $6 million.
Revenue guidance has been raised from the previously expected range of $2.441-$2.466 billion, which assumed:

Screening revenue of $1.820-$1.835 billion,
Precision Oncology revenue of $615-$625 million, and
COVID-19 testing revenue of $6 million.
Third -quarter 2023 conference call & webcast
Company management will host a conference call and webcast on Wednesday, November 1, 2023, at 5 p.m. ET to discuss third-quarter 2023 results. The webcast will be available at exactsciences.com. Domestic callers should dial 888-330-2384 and international callers should dial +1-240-789-2701. The access code for both domestic and international callers is 4437608.

An archive of the webcast will be available at exactsciences.com. A replay of the conference call will be available by calling 800-770-2030 domestically or +1-647-362-9199 internationally. The access code for the replay of the call is 4437608. The webcast, conference call, and replay are open to all interested parties.

On November 1, 2023 Enterome, a clinical-stage company developing first-in-class immunomodulatory drugs for solid and liquid malignancies and inflammatory diseases based on its unique Mimicry platform, reported the presentation of immune-monitoring data from the ongoing trials of EO2401 in adrenal tumors and recurrent glioblastoma at the 38th Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting taking place from November 1-5, 2023, in San Diego, California, and virtually (Press release, Enterome, NOV 1, 2023, View Source [SID1234636632]).

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EO2401 is Enterome’s first-in-class off-the-shelf OncoMimics peptide-based immunotherapy. It is designed to activate pre-existing effector memory T cells initially reacting against bacterial (non self) peptides and strongly cross-reacting against selected Tumor Associated Antigens (TAAs) IL13Ra2, BIRC5, and FOXM1, which are upregulated in adrenal tumors and in glioblastoma, thereby triggering a target-dependent cytotoxic response.

The poster details are as follows:

Poster Details – Abstract #630

Title: "EO2401, a new peptide immunotherapy against cancer, in combination with nivolumab, induces a strong and durable immune response in patients from the EOADR1-19/SPENCER Study"
Authors: Lucie Aubergeon, et al.
Link to abstract can be accessed here
Poster Details – Abstract #1423

Title: "Novel immunotherapy based on commensal-derived peptides to drive an effective CD8+ T cell response against selected Tumor-Associated Antigens (TAAs)"
Authors: Alice Talpin, et al.
Link to abstract can be accessed here
In addition, research collaborator from Tübingen University, Germany, presents immune response data from the ongoing Phase 1/2 ROSALIE study of EO2401 in combination with nivolumab in recurrent glioblastoma.

Poster Details – Abstract #638

Title: "Characterisation of the immune response to EO2401, a new immunotherapy approach against cancer, plus nivolumab in recurrent glioblastoma: The EOGBM1-18/ROSALIE study"
Authors: Ana Maia, et al.
Link to abstract can be accessed here
All abstracts will subsequently be published as a supplement in the Journal for ImmunoTherapy of Cancer (JITC), Dec. 2023.

About SPENCER

SPENCER (EOADR1-19) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab) for the treatment of patients with locally advanced or metastatic adrenocortical carcinoma, or malignant pheochromocytoma/paraganglioma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in sites in Europe and the US.

For more information on the Phase 1/2 trial of EO2401 in adrenal tumors, please refer to ClinicalTrials.gov Identifier: NCT04187404

About ROSALIE

ROSALIE (EOGBM1-18) is a multicenter, open-label, first-in-human, Phase 1/2 study of EO2401 in combination with an immune checkpoint inhibitor (nivolumab, Opdivo) +/- bevacizumab for the treatment of patients with first progression/recurrence of glioblastoma. The study aims to assess the safety, tolerability, immunogenicity, and preliminary efficacy of the combination in 100 patients enrolled at 10 clinical sites in Europe and the US.

For more information on the Phase 1/2 trial of EO2401 in recurrent glioblastoma, please refer to ClinicalTrials.gov Identifier: NCT04116658

About OncoMimics

OncoMimics immunotherapies are designed to activate pre-existing effector memory T cells that target bacterial (non-self) peptides, which are strongly cross-reactive against selected Tumor-Associated Antigens (TAAs), or B cell markers expressed on tumoral cells, resulting in a rapid, targeted cytotoxic response against cancer.

On November 1, 2023 CytomX Therapeutics, Inc. (Nasdaq: CTMX), a leader in the field of conditionally activated, localized biologics, reported that management will participate in the following investor conferences in November (Press release, CytomX Therapeutics, NOV 1, 2023, View Source [SID1234636631]).

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BMO Biopharma Spotlight Series: Oncology Day
Date: Wednesday, November 8, 2023
Fireside Chat: 1:30 p.m. ET
Location: Virtual

Jefferies London Healthcare Conference
Date: Thursday, November 16, 2023
Fireside Chat: 2:00 p.m. GMT
Location: London, UK

Piper Sandler Healthcare Conference
Date: Wednesday, November 29, 2023
Fireside Chat: 11:30 a.m. ET
Location: New York, NY

Live webcasts of the Jefferies London and Piper Sandler Healthcare Conference fireside chats will be available on the Events and Presentations page of CytomX’s website at www.cytomx.com. In addition, management will be available for one-on-one meetings with investors who are registered to attend the conferences.

On November 1, 2023 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported the publication of preclinical data that demonstrated the potential of ITK inhibition as a novel approach to treat T cell-mediated inflammatory and immune diseases (Press release, Corvus Pharmaceuticals, NOV 1, 2023, View Source [SID1234636630]). Corvus’ ITK inhibitors include soquelitinib (formerly known as CPI-818), which was used in the preclinical studies and is currently in clinical trials for oncology indications, and several next-generation molecules that are being optimized for use in a variety of inflammatory and immune disease indications.

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"Our research on soquelitinib and selective ITK inhibition is uncovering valuable new information about immune function and the role of ITK in different diseases," said James Rosenbaum, M.D., senior vice president of research at Corvus. "The activity of soquelitinib in various inflammatory and immune disease models highlights the essential role of ITK in multiple T cell functions. Our publication demonstrates that soquelitinib can impact disease-associated cytokines by targeting the cellular sources, specifically Th2 and Th17 cells, which produce cytokines like IL-4, IL-5, IL-13 and IL-17. We believe that blocking the source of cytokine production upstream offers advantages over existing therapies that individually target specific cytokines."

Professor Yannick Allanore, M.D., Ph.D., Professor of Rheumatology, Université Paris Cité, Institut Cochin, Paris, France, and a co-author of the publication, said, "Pulmonary fibrosis and systemic sclerosis are often fatal diseases for which current therapy is inadequate. Soquelitinib utilizes a novel mechanism and was effective in our model related to systemic sclerosis which is based on Fra2 gene overexpression, a model designed to represent human lung disease manifestations. Based on these data, we are eager to evaluate soquelitinib in a clinical trial for fibrotic diseases."

The publication, entitled "Soquelitinib, A Selective Inhibitor of Interleukin- 2- Inducible T Cell Kinase (ITK), is Active in Several Murine Models of T Cell-Mediated Inflammatory Disease," highlights data demonstrating that soquelitinib was active in six different models of T cell-mediated inflammatory and immune disease, including acute and chronic asthma, pulmonary fibrosis, systemic sclerosis (scleroderma), psoriasis, and acute graft versus host disease. The data also describe soquelitinib’s unique mechanism of action, providing rationale for the development of ITK inhibition in a range of additional Th2 and Th17 mediated diseases, including asthma, psoriasis, atopic dermatitis, chronic obstructive pulmonary disease (COPD), systemic sclerosis, lupus and other diseases. The published research was a result of collaborations between scientists at Corvus and researchers at both Memorial Sloan Kettering Cancer Center in New York and The National Institute of Health and Medical Research (INSERM) in France. The publication is now available online as a preprint at bioRxiv.org and on the Publications and Presentations page of the Corvus website.

"We are making significant progress with soquelitinib and believe that Corvus is firmly positioned as a leader in the scientific and clinical development of ITK inhibition as a platform opportunity across cancer, inflammation and immune disease," said Richard A. Miller, M.D., co-founder, president, and CEO of Corvus. "Our primary focus is treating T cell lymphomas and cancer and we are actively preparing for a registrational Phase 3 trial of soquelitinib for peripheral T cell lymphoma. With this new publication, we further demonstrate the wide range of opportunities for ITK inhibition across specific indications with ongoing patient needs for new therapies. In addition, we have a robust pipeline of next generation ITK inhibitors and a portfolio of intellectual property that we believe provide attractive partnering opportunities for companies focused on various inflammatory and immune diseases."

Key results from the preclinical studies described in the publication demonstrated that soquelitinib had the following observed effects in models of inflammatory disease:

Acute and chronic asthma models:
Significant reductions in Th2 cytokines IL-4, IL-5 and IL-13 in both models, along with reductions in a validated disease activity score
Reduction in IL-6 signifying amelioration of inflammation
Systemic sclerosis (Fra2 gene overexpression) model:
Improvement in clinical score and preservation of body weight
Improvement in lung histology, reduction of fibrosis and improvement in pulmonary vascular hypertension
Reduction of GATA3-expressing T cells, indicative of effect on Th2 cells
Reduction of ROR gammaT cells (RORγT), indicative of effects on Th17 cells
Pulmonary fibrosis (bleomycin-induced) model:
More consistent reduction of pulmonary fibrosis compared to an FDA-approved medication (nintedanib)
Similar reduction in GATA3 as the systemic sclerosis model results
Reduction in MMP2 and TGF beta, two messenger RNAs associated with fibrosis
Psoriasis (imiquimod (IMQ)-induced) model:
Improvement in epidermal thickness, erosion and inflammation
In vitro studies demonstrated a reduction in the expression of RORγT protein, a master transcription factor that is responsible for developing Th17 cells, and a corresponding dose-dependent reduction in IL-17 cytokine production
Graft versus host disease (GVHD) model:
Improvement in survival rates and corresponding decrease in clinical GVHD score
No impact on engraftment or graft-versus-tumor effect