On June 29, 2023 Atossa Therapeutics, Inc. (Nasdaq: ATOS), a clinical stage biopharmaceutical company developing innovative medicines in areas of significant unmet medical need in oncology with a focus on breast cancer, and Quantum Leap Healthcare Collaborative ("Quantum Leap") reported that six patients have been dosed with Atossa’s proprietary Selective Estrogen Receptor Modulator (SERM), (Z)-endoxifen, in the ongoing Phase 2 I-SPY 2 clinical trial. (Z)-endoxifen is being evaluated as a neoadjuvant treatment for patients with newly diagnosed estrogen receptor-positive (ER+) invasive breast cancer whose tumors are predicted to be sensitive to endocrine therapy but for whom chemotherapy is expected to provide little or no benefit (Press release, Atossa Therapeutics, JUN 29, 2023, View Source [SID1234632987]).

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The I-SPY 2 TRIAL is a collaborative effort among academic investigators from major cancer research centers across the United States, Quantum Leap Healthcare Collaborative, the U.S. Food and Drug Administration, and the Foundation for the National Institutes of Health (FNIH) Cancer Biomarkers Consortium. The (Z)-endoxifen treatment arm, which is expected to enroll approximately 20 patients, is part of the I-SPY 2 Endocrine Optimization Pilot Protocol (EOP). Patients will receive 10 mg of (Z)-endoxifen daily for up to 24 weeks prior to surgery. Currently, there are 41 I-SPY 2 sites, all of which have the EOP program open.

"Reaching 30% enrollment in the I-SPY 2 study is another important milestone in our ambitious (Z)-endoxifen development program," said Dr. Steven Quay, Atossa’s President and Chief Executive Officer. "These patients have substantial risk for recurrence and need novel treatments options that are more tolerable and more efficacious than currently approved drugs. (Z)-endoxifen has the potential to slow the progression of ER-positive breast cancer in the neoadjuvant setting, making surgery more effective and reducing the risk of recurrence. We look forward to seeing data from this trial, which along with data from our Phase 2 EVANGELINE trial, will inform conversations with the FDA and our planned Phase 3 protocol."

"With the ISPY 2.2 TRIAL, we have focused on optimizing treatments for the fast-growing breast cancers; that focus has allowed us to make great progress. But one of the biggest challenges in breast cancer is the hormone positive breast cancers that are slow growing. They can recur for up to 15 years or more, and we urgently need to find predictors of response so that we can prevent late recurrence. And we know that women suffer from the side effects of years of extended endocrine therapy, especially when they have larger tumors. So, we have a great need to find more effective and more tolerable agents so that women with live longer and better. The goal of the endocrine optimization pilot is to test these new and exciting hormone directed therapies like endoxifen," said Dr. Laura Esserman of the University of California San Francisco, founder and leader of the I-SPY TRIAL.

About Premenopausal Patients with ER+ / HER2- Breast Cancer
Breast cancer is the most frequently diagnosed cancer in premenopausal women worldwide and accounts for almost half of the cancers that occur in women aged 15-49. An overwhelming majority (75%) of premenopausal breast cancer falls under luminal A (ER+/HER2-) or B (ER+/HER2+) subtypes. Ovarian function suppression, when combined with either tamoxifen or an aromatase inhibitor, is the standard of care for the endocrine management of stage 2 and 3 premenopausal ER+/HER2- breast cancer. The I SPY Endocrine Optimization Pilot (EOP) specifically targets women of all ages with molecularly low risk stage 2 and 3 breast cancer.

About (Z)-Endoxifen
(Z)-endoxifen is the most active metabolite of the FDA approved Selective Estrogen Receptor Modulator (SERM), tamoxifen. Studies by others have demonstrated that the therapeutic effects of tamoxifen are driven in a concentration-dependent manner by (Z)-endoxifen. In addition to its potent anti-estrogen effects, (Z)-endoxifen at higher concentrations has been shown to target PKCβ1, a known oncogenic protein.

Atossa is developing a proprietary oral formulation of (Z)-endoxifen that does not require liver metabolism to achieve therapeutic concentrations and is encapsulated to bypass the stomach as acidic conditions in the stomach convert a greater proportion of (Z)-endoxifen to the inactive (E)-endoxifen. Atossa’s (Z)-endoxifen has been shown to be well tolerated in Phase 1 studies and in a small Phase 2 study of women with breast cancer. The Company is currently studying (Z)-endoxifen in three Phase 2 studies: one in healthy women with measurable breast density and two other studies including the EVANGELINE study in women with ER+/HER2- breast cancer. Atossa’s (Z)-endoxifen is protected by three issued U.S. patents and numerous pending patent applications.

On June 29, 2023 Devyser reported the launch of two new products, Devyser LynchFAP and Devyser BRCA PALB2 (Press release, Devyser Diagnostics, JUN 29, 2023, View Source [SID1234632986]). These kits offer efficient, targeted, and confident analysis of genes associated with increased cancer risk, such as those involved in Lynch syndrome, and in breast and ovarian cancers.

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New comprehensive solution for Lynch syndrome testing

Devyser LynchFAP provides a comprehensive solution to analyze PMS2 and 9 other genes associated with hereditary colorectal cancer syndromes. Devyser LynchFAP is designed to overcome one of the greatest challenges for Lynch syndrome genetic testing – the localization of genetic variants to PMS2 and its pseudogene PMS2CL. Devyser LynchFAP is the first commercial library prep kit to allow this specific analysis of the PMS2 gene.

With a simple next-generation sequencing (NGS) workflow, this test and dedicated software enable our users to disentangle complex genetics with an intuitive and easy-to-use solution. Devyser is proud to add Devyser LynchFAP to its expanding oncology offering.

The importance of hereditary cancer testing

Colorectal cancer is the third most common cancer worldwide. 10-20% of cases are due to hereditary cancer syndromes such as Lynch syndrome. Having a hereditary cancer syndrome significantly increases an individual’s risk of developing colorectal cancer, among multiple other cancer types. It is estimated that 1 in 300 individuals carry mutations in DNA mismatch repair genes, such as those associated with Lynch syndrome. The challenge is that many people, up to 95% in certain regions, do not know that they carry these mutations.

Targeting the information that matters most

Devyser BRCA PALB2 provides a targeted solution with the simplest commercially available workflow for crucial genetic information related to breast and ovarian cancer. This kit allows for the sequencing of genetic variants in BRCA1, BRCA2, and PALB2, the three most significant genes increasing breast cancer risk. The simplified workflow of Devyser BRCA PALB2 enables fast laboratory implementation and streamlines two applications in one solution – the analysis of genetic variants in DNA from human blood and tumor tissue.

"We are delighted to introduce Devyser LynchFAP and Devyser BRCA PALB2 to the market," says Fredrik Alpsten, CEO of Devyser. "These genetic testing solutions represent a significant advancement in our hereditary cancer offering. By understanding mutations associated with increased cancer risks, our ambition is to enable more personalized care and preventive measures, ultimately saving lives."

Devyser is committed to advancing genetic testing technologies to improve patient outcomes and contribute to the field of personalized medicine. With the launch of Devyser LynchFAP and Devyser BRCA PALB2, the company is taking a significant step towards achieving its mission of enabling early detection and targeted interventions for individuals at risk of hereditary cancer syndromes.

For more information about Devyser’s innovative genetic testing solutions, please visit www.devyser.com or contact [email protected].

On June 29, 2023 Jacobio Pharma (1167.HK), a clinical-stage oncology company drugging the undruggable targets, reported clinical results of its novel KRAS G12C inhibitor glecirasib monotherapy and in combination therapy with cetuximab to treat KRAS G12C mutant advanced CRC (colorectal cancer) in Second JCA- AACR (Free AACR Whitepaper) Precision Medicine International Conference (Press release, Jacobio Pharmaceuticals, JUN 29, 2023, View Source [SID1234632985]).

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In the monotherapy study, overall response rate (ORR) is 33.3% (11/33), disease control rate (DCR) is 90.9% (30/33), mPFS (median progression-free survival) is 6.9 months.

In a trial of glecirasib with cetuximab, ORR is 62.8% (27/43), DCR is 93% (40/43). mPFS has not reached before the data cutoff date on May 23, 2023.

The majority TRAEs (treatment related adverse event) are grades 1-2.

Colorectal cancer is the second most common cancer in China, with about 550,000 new cases per year, of which about 3% of colorectal cancer patients have KRAS G12C mutation. Patients with KRAS G12C mutation are insensitive to existing standard chemotherapies and targeted therapies, have rapid disease progression, short survival, and they have high unmet clinical treatment needs. Glecirasib has potential to bring effective and less toxic treatment option for patients.

About Glecirasib

Glecirasib is Jacobio’s novel KRAS G12C inhibitor. Jacobio has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors harbouring KRAS G12C mutation, including a pivotal clinical trial int NSCLC in China; a monotherapy study for STK11 co-mutated NSCLC in the front-line setting; combination therapy trials with SHP2 inhibitor JAB-3312, anti-PD-1 antibody and Cetuximab.

On June 29, 2023 Merus N.V. (Nasdaq: MRUS), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics) for cancer, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation (BTD) for zenocutuzumab (Zeno) for the treatment of patients with advanced unresectable or metastatic NRG1 fusion (NRG1+) pancreatic cancer following progression with prior systemic therapy or who have no satisfactory alternative treatment options (Press release, Merus, JUN 29, 2023, View Source [SID1234632984]). This designation for Zeno follows a Fast Track Designation for the treatment of patients with metastatic solid tumors harboring NRG1 gene fusions (NRG1+ cancer) that have progressed on standard of care therapy on January 7, 2021 and Orphan Drug Designation for the treatment of patients with pancreatic cancer on July 27, 2020.

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BTD is supported by data from the ongoing phase 1/2 eNRGy trial and Early Access Program (EAP) which are assessing the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer (Phase 1/2: NCT02912949, EAP: NCT04100694). Data from the eNRGy trial and EAP were featured as oral presentations during the 2021 and 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meetings (Abstract #3003, #105 respectively). As of June 1, 2023, more than 175 patients with NRG1+ cancer have been treated with Zeno monotherapy.

BTD is intended to expedite the development and review of a medicine to treat a serious or life-threatening condition, where preliminary clinical evidence indicates that the drug may demonstrate substantial improvement on clinically significant endpoints over available therapies. BTD allows for more intensive FDA guidance on an efficient drug development program, an organizational commitment involving senior managers, and experienced review staff, as appropriate, in a collaborative, cross-disciplinary review, and eligibility for rolling review and priority review. With this BTD, Merus plans to engage in these discussions with the FDA in an expedited manner, and then provide a further update on the path and timeline to a potential Biologics License Application (BLA) submission.

Merus believes that obtaining a commercialization partnership agreement will be an essential step in bringing Zeno to patients with NRG1+ cancer, if approved.

"We believe the compelling clinical data for Zeno in NRG1+ cancer, and Breakthrough Therapy Designation, provide the opportunity to further engage with the FDA to expedite the review of a potential BLA submission," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Additionally, our intention to partner Zeno is a reflection of our strategy to carefully balance value creation with capital allocation requirements across our portfolio."

Merus plans to provide a clinical update on Zeno in NRG1+ cancer at a major medical conference in 2023.

Further, Merus is evaluating Zeno in combination with androgen deprivation therapy (enzalutamide or abiraterone) in castration resistant prostate cancer (CRPC), irrespective of NRG1+ status. Merus plans to provide initial clinical data on Zeno in CRPC in the second half of 2023. Merus is also evaluating Zeno in combination with afatinib in patients with NRG1+ NSCLC.

About the eNRGy Clinical Trial
Merus is currently enrolling patients in the phase 1/2 eNRGy trial to assess the safety and anti-tumor activity of Zeno monotherapy in NRG1+ cancer. The eNRGy trial consists of three cohorts: NRG1+ pancreatic cancer; NRG1+ non-small cell lung cancer; and other NRG1+ cancer. Further details, including current trial sites, can be found at www.ClinicalTrials.gov and Merus’ trial website at www.nrg1.com or by calling 1-833-NRG-1234.

About Zeno
Zeno is an antibody-dependent cell-mediated cytotoxicity (ADCC)-enhanced Biclonics that utilizes the Merus Dock & Block mechanism to inhibit the neuregulin/HER3 tumor-signaling pathway in solid tumors with NRG1 fusions (NRG1+ cancer). Through its unique mechanism of binding to HER2 and potently blocking the interaction of HER3 with its ligand NRG1 or NRG1-fusion proteins, Zeno has the potential to be particularly effective against NRG1+ cancer. In preclinical studies, Zeno potently inhibits HER2/HER3 heterodimer formation thereby inhibiting oncogenic signaling pathways, leading to inhibition of tumor cell proliferation and blocking tumor cell survival.

On June 29, 2023 Corvus Pharmaceuticals, Inc. (Nasdaq: CRVS), a clinical-stage biopharmaceutical company, reported new preclinical data for ciforadenant, the Company’s adenosine 2A receptor inhibitor, highlighting its mechanism of action and synergy with immune checkpoint inhibitors via combination with anti-CTLA-4 and anti-PD-1 therapies (Press release, Corvus Pharmaceuticals, JUN 29, 2023, View Source [SID1234632983]). The data is being presented in a poster at the 2nd Japanese Cancer Association and American Association for Cancer Research (AACR) (Free AACR Whitepaper) (JCA-AACR) Precision Cancer Medicine International Conference, which is taking place June 28-30, 2023 in Kyoto, Japan.

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"Our presentation at the JCA-AACR conference further supports the rationale for the synergistic combination of ciforadenant with checkpoint inhibitors to leverage multiple components of the immune response to cancer," said Richard A. Miller, M.D., co-founder, president and chief executive officer of Corvus. "We are exploring this combination in a Phase 1b/2 clinical trial that is being led by the Kidney Cancer Research Consortium. The clinical trial is exploring the potential of ciforadenant as a first line therapy for metastatic renal cell cancer in combination with anti-CTLA-4 and anti-PD-1 therapies, and is based on preclinical research published in 2018 demonstrating synergy when ciforadenant was combined with anti-CTLA-4 and anti-PD-1 therapies1. Enrollment in the clinical trial is ongoing and we plan to share initial data before the end of 2023."

Ciforadenant Data Presented at JCA-AACR Conference
The new ciforadenant preclinical data was presented by Dan Li, Ph.D., Senior Scientist at Corvus, in a poster session (abstract #12-1) today at the JCA-AACR conference. The poster is available to JCA-AACR attendees in the poster session and is also available on the Publications and Presentations page of the Corvus website. The poster presentation highlights preclinical data supporting the synergy between ciforadenant and immune checkpoint blockade (ICB), leading to a proinflammatory response:

Depletion of myeloid cells abolished the synergy of ciforadenant and ICB in a murine melanoma model.
The combination of ciforadenant with ICB upregulated the genes involved in the IL-12/STAT4 signaling axis, which leads to the development of CXCR3+ IFNγ-producing Th1 helper cells.
Ciforadenant treatment increased production of chemokine CXCL10, a ligand for recruitment of CXCR3+ Th1 helper cells into the tumor.
Ciforadenant modulated antitumor responses by turning the tumor microenvironment into the proinflammatory state.
The combination of ciforadenant with ICB promoted the production of several proinflammatory cytokines such as IL-6, TNFa, and IFNg.
About Corvus Pharmaceuticals
Corvus Pharmaceuticals is a clinical-stage biopharmaceutical company pioneering the development of ITK inhibition as a new approach to immunotherapy for a broad range of cancer and immune diseases. The Company’s lead product candidate is CPI-818, an investigational, oral, small molecule drug that selectively inhibits ITK and is in a mid-stage clinical trial for patients with T cell lymphoma. Its other clinical-stage candidates are being developed for a variety of cancer indications. For more information, visit www.corvuspharma.com.

About Ciforadenant
Ciforadenant (CPI-444) is an investigational small molecule, oral, checkpoint inhibitor designed to disable a tumor’s ability to subvert attack by the immune system by blocking the binding of adenosine in the tumor microenvironment to the A2A receptor. Adenosine, a metabolite of ATP (adenosine tri-phosphate), is produced within the tumor microenvironment where it may bind to the adenosine A2A receptor present on immune cells and block their activity.