On September 12, 2022 Shasqi, a clinical-stage biotechnology company developing oncology therapeutics with its proprietary Click Activated Protodrugs Against Cancer (CAPAC ) platform reported it has opened the Phase 2 of their Phase 1/2a clinical study to further assess SQ3370 in anthracycline- naïve patients (Press release, Shasqi, SEP 12, 2022, View Source [SID1234619475]). The Phase 2 study follows the company’s presentation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress, held September 9-13, 2022, evaluating the safety, tolerability, maximum tolerated dose, and recommended Phase 2 dose for SQ3370 in patients with locally advanced and/or metastatic solid tumors (NCT04106492).

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"We are encouraged by the promising results from our Phase 1 study and preclinical data which indicate that click chemistry in humans has the potential to revolutionize cancer care by expanding the therapeutic index of anti-cancer therapies such as doxorubicin," said José M. Mejía Oneto, M.D., Ph.D., Founder and CEO of Shasqi. "We look forward to further exploring the safety and efficacy of our lead candidate SQ3370 at unprecedented dose levels in the Phase 2 study."

The Phase 1 clinical data were presented as a poster during the congress:

Abstract Title: Phase 1 Clinical & Immunologic Data of SQ3370 in Advanced Solid Tumors
Presentation Number: 1499P
Poster Session Title: Phase 1 Clinical & Immunologic Data of SQ3370 in Advanced Solid Tumors
Link to full poster details here.
Key Phase 1 study findings include:

SQ3370 was well tolerated among 27 DLT evaluable patients receiving up to 12x (1x equals 75mg/m2/cycle of Dox molar equivalents); maximum tolerated dose has not been reached
Among patients treated with a least one cycle of SQ3370, no protocol defined dose-limiting toxicities, including anthracycline myelosuppression and gastrointestinal (GI) toxicity, were observed and no treatment emergent adverse events (TEAEs) that led to death were considered related to SQ3370; the most frequent Grade ≥3 TEAE was anemia
The highest doses tested of SQ3370 led to immune activation in soft tissue sarcomas which are considered immunologically cold tumors, validating preclinical findings of SQ3370 previously published:
Increased cytotoxic T-cell activity observed at higher dose levels of SQ3370 indicate immune activation and a trend toward increase in tumor cell death in heavily pretreated patients
Immune activation has the potential to improve systemic activity of intra-tumoral administration of SQ3370 which will be explored in Phase 2
"Early data has shown that click chemistry allows for the release of doxorubicin at the tumor site to generate anti-tumor responses. Phase 1 results showing that SQ3370 is well-tolerated among a heavily pretreated patient population further validate this clinical approach and the importance of investigating SQ3370 as a potential treatment option in patients with anthracycline-sensitive- and other solid tumors," said Sant P. Chawla, M.D., FRACP, Principal Investigator, and Head, Sarcoma Oncology Center in Santa Monica, California."

Shasqi is excited to open the Phase 2 study of SQ3370 in anthracycline-naïve patients with advanced soft tissue sarcomas, relapsed or recurrent squamous-cell head and neck cancer, platinum refractory ovarian cancer recurrent and/or metastatic uterine carcinoma, or uterine sarcoma. For more information, visit www.shasqi.com

On September 12, 2022 Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) ("Corbus" or the "Company"), reported that Yuval Cohen, Ph.D., Chief Executive Officer of Corbus, will present virtually at the H.C. Wainwright 24th Annual Global Investment Conference (Press release, Corbus Pharmaceuticals, SEP 12, 2022, https://www.prnewswire.com/news-releases/corbus-pharmaceuticals-to-present-virtually-at-the-hc-wainwright-24th-annual-global-investment-conference-301621611.html [SID1234619474]). The hybrid conference will take place September 12-14, 2022.

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A livestream of the virtual presentation is available on-demand beginning today, Monday, September 12, 2022 at 7:00 AM ET for those who are registered to attend the conference and will be accessible for 30 days on the H.C. Wainwright conference platform. For more information, please visit the conference website.

On September 12, 2022 BioMed Valley Discoveries (BVD) reported that the first patient has been dosed in a phase II clinical trial of ulixertinib (BVD-523) in combination with hydroxychloroquine (HCQ) (Press release, BioMed Valley Discoveries, SEP 12, 2022, View Source [SID1234619473]). Ulixertinib is a first-in-class and best-in-class ERK inhibitor, with this clinical trial focusing on patients with advanced gastrointestinal malignancies and mutations in the MAPK pathway. This study builds upon the finding of the phase I study of the combination, which was completed at Huntsman Cancer Institute at the University of Utah.

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"Combining an ERK inhibitor with an autophagy inhibitor is anticipated to take advantage of the finding that tumors may become addicted to autophagy for survival in context of MAPK inhibition" said Brent Kreider, Ph.D., President of BioMed Valley Discoveries. "Given the favorable safety profile and efficacy seen with ulixertinib monotherapy, we believe that the combination with hydroxychloroquine has the potential to provide significant benefit to patients with advanced gastrointestinal malignancies."

The Phase II efforts build on a successful Phase Ib evaluating ulixertinib monotherapy as a novel targeted cancer treatment in cohorts of patients with genetic alterations that result in aberrant MAPK pathway signaling. Results from phase Ib demonstrated ulixertinib has an acceptable safety profile and early evidence of clinical activity against a wide range of RAS/MAPK pathway-driven cancers, including atypical alterations in BRAF.

In addition to targeting the terminal node of the RAS/MAPK pathway, ulixertinib’s highly selective kinase inhibition profile is expected to provide potential impact across a number of tumor types in both monotherapy and combination. Previous efforts have also established a recommended phase 2 dose in combination with palbociclib, with additional combination efforts ongoing.

About ulixertinib (BVD-523): Ulixertinib is a first-in class and best-in class small molecule inhibitor of extracellular signal-regulated kinase (ERK) family kinases (ERK1 and ERK2) that is being developed as a novel anti-cancer drug. ERK kinases are downstream components of the mitogen-activated protein kinase (MAPK) signaling cascade (RAS-RAF-MEK-ERK). Ulixertinib has demonstrated promising early efficacy for patients with tumors harboring alterations in the MAPK pathway.

About the study: This is an open-label, multicenter, prospective phase II basket trial assessing the efficacy of ulixertinib in combination with hydroxychloroquine in patients with advanced gastrointestinal malignancies. All patients recruited must have a mitogen-activated protein kinase (MAPK) activating mutation to be deemed eligible for trial participation. Each disease-based basket will open to enrollment in two-stages and includes pancreatic, colorectal, esophageal, gastric and cholangiocarcinomas . (Clinicaltrials.gov Number NCT05221320).

On September 12, 2022 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported that the company will present at the H.C. Wainwright 24th Annual Global Investment Conference on September 12-14, 2022 (Press release, Medivir, SEP 12, 2022, https://www.prnewswire.com/news-releases/medivir-to-present-at-the-hc-wainwright-24th-annual-global-investment-conference-301621947.html [SID1234619472]).

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On September 12, 2022 The National Comprehensive Cancer Network (NCCN) reported that has published new NCCN Guidelines for Patients: Marginal Zone Lymphoma (Press release, NCCN, SEP 12, 2022, View Source [SID1234619471]). A cancer of the lymphatic system, marginal zone lymphoma (MZL) is a type of non-Hodgkin B-cell lymphoma that is typically slow-growing, and comprises about 8% of non-Hodgkin lymphoma cases1.

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"As a result of its rarity, many people lack awareness of Marginal Zone Lymphoma. During the diagnosis phase, patients should consider the possibility of having their pathology reviewed at a medical center that sees a lot of lymphoma patients, in order to confirm the diagnosis" according to Leo I. Gordon, MD, Professor in Medicine, Northwestern University Feinberg School of Medicine and the Robert H. Lurie Comprehensive Cancer Center; Dr. Gordon is Vice-Chair of the panel that develops the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) for B-Cell Lymphomas, which include Marginal Zone Lymphoma.

NCCN Guidelines are the recognized standard for clinical direction and policy in cancer management; NCCN Guidelines for Patients take the same evidence-based clinical recommendations and present them in simple, easy-to-understand wording, alongside charts, images, and suggested questions to ask.

The patient guidelines for Marginal Zone Lymphoma guidelines are the latest in NCCN’s library of NCCN Guidelines for Patients, published through funding from the NCCN Foundation and available online free of charge. NCCN Guidelines for Patients provide information on nearly 60 cancer types, as well as topics such as treatment side effect management, mental distress, and survivorship. With this new guide, patients can understand the distinctive features of MZL, which can be lost in discussions of slow-growing (or "indolent") lymphomas in general.

MZL develops from immune cells called B cells. That meant management for MZL was particularly impacted during the early days of the COVID-19 pandemic, since some treatment options can reduce B-cell-produced antibodies, thereby lessening the overall immune system response. Now that providers can manage COVID-19 more effectively, MZL patients are less vulnerable to poor outcomes from infection.

MZL is generally diagnosed in people in their late 50s through mid-60s, although it can occur in the skin of persons as young as 20 to 30 years of age. It is often a chronic, non-fatal disease.

There are three main subtypes of MZL based on where they originated in the body, either in the spleen, bone marrow, or in lymphatic tissues throughout the body. "MZL can be extranodal, which can involve virtually any organ in the body, including skin, stomach, lung, prostate, or breast," said Andrew D. Zelenetz, MD, PhD, Medical Oncologist, Memorial Sloan Kettering Cancer Center; Chair, NCCN Guidelines Panel for B-Cell Lymphomas "Splenic MZL involves the spleen, blood, and bone marrow, and is sometimes associated with hepatitis C infection. And nodal MZL primarily forms in the lymph nodes. All three subtypes are managed differently."

Treatments are trending away from cytotoxic chemotherapy and toward more targeted chemotherapy and immunotherapy, with clinical trials using chimeric antigen receptor (CAR) T-cell therapy underway.

Dr. Gordon noted that "not everyone needs treatment right away, many people can be safely observed and spared unnecessary treatment-related toxicity."

NCCN Guidelines for Patients are available for free online at NCCN.org/patientguidelines and via the NCCN Patient Guides for Cancer App. Printed versions can be purchased through Amazon for a nominal fee.

Patients and advocates are eligible for complimentary admission to an upcoming NCCN event focused on the latest blood cancer treatment recommendations. The NCCN 2022 Annual Congress: Hematologic Malignancies will take place in New York City on October 14-15 as a hybrid event with the option to attend in-person or virtually. Visit NCCN.org/hem for more information.