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.

On September 12, 2022 Linnaeus Therapeutics, Inc. (Linnaeus), a privately held clinical-stage biopharmaceutical company focused on the development and commercialization of novel small-molecule oncology therapeutics, reported the presentation of clinical biomarker data from its study of LNS8801 as a monotherapy and in combination with pembrolizumab at the 2022 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) Annual Meeting in Paris (Press release, Linnaeus Therapeutics, SEP 12, 2022, View Source [SID1234619469]).

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The poster was entitled, "A circulating, surrogate-systemic biomarker correlates with anti-tumor benefit on LNS8801 therapy" and was led by Dr. Justine Cohen of the University of Pennsylvania and a study investigator in the phase 1/2 clinical trial of LNS8801 (Abstract 5205).

Cohen et al have demonstrated that LNS8801 treatment results in an induction of a surrogate-systemic biomarker on the first day of treatment and that induction of this biomarker confirms target engagement and is associated with improved progression-free survival on LNS8801 treatment. Future clinical studies could use this biomarker to rapidly determine whether patients will receive benefit on LNS8801 therapy.

"We are pleased to showcase these data at ESMO (Free ESMO Whitepaper)," commented Patrick Mooney, MD, CEO of Linnaeus. "These data demonstrate that LNS8801 has target engagement at multiple dose levels and that target engagement correlates with patient benefit. Importantly, these data are consistent with the clinical activity we have seen in our ongoing studies of LNS8801 in patients with advanced cancer. We look forward to sharing efficacy data in the near term."

About LNS8801
LNS8801 is an orally bioavailable and highly specific and potent agonist of GPER whose activity is dependent on the expression of GPER. GPER activation by LNS8801 rapidly and durably depletes c-Myc protein levels. In preclinical cancer models, LNS8801 displays potent antitumor activities across a wide range of tumor types, rapidly shrinking tumors and inducing immune memory.

In the ongoing clinical study in humans, LNS8801 monotherapy has been safe and well tolerated. Additionally, LNS8801 has demonstrated target engagement, c-Myc protein depletion, and clinical benefit in patients with advanced cancers.

On September 12, 2022 SeekIn Inc, a leader in blood-based cancer early detection and monitoring technology, reported CE (Conformité Européenne) Mark approval for OncoSeek Multi-Cancer Detection Test and is now ready to launch this test in European Union and other countries that recognize CE mark (Press release, SeekIn, SEP 12, 2022, View Source [SID1234619468]).

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Early detection of cancer is paramount for improving treatment strategies and survival outcomes. Immunological measurement of blood-based tumor markers has been performed over many years on a large population of individuals in screening malignancies at early or preclinical stages. This method has significant advantages, including being non-invasive, automated, quantitative, objective, and relatively inexpensive compared with histology, endoscopy, and imaging. However, the relatively low sensitivity and specificity for early cancer identification have generally limited the widespread use of single biomarkers for screening purposes in a general population setting.

OncoSeek, a customized panel of seven selected protein tumor markers (PTMs) including AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1, quantified them on Roche cobas e411 instrument performing for 12 common cancers early detection. It established a multivariate algorism for cancer detection by integrating the measurement of these seven PTMs and age of the subject which was empowered by artificial intelligence technology. The results showed that OncoSeek significantly outperformed the traditional clinical method, representing a novel blood-based test for multiple cancer detection.

"This is a very cost-effective cancer early detection test, making it possible for some low-income people to receive cancer screening," Mao Mao, M.D., Ph.D., SeekIn’s founder and CEO, said in a statement. "Based on the analysis of ~10,000 plasma samples, with specificity at ~90%, the sensitivity of OncoSeek for cancer detection is almost two times higher than that of using current clinical method. At the same time, this method is very simple and fast, which can quickly and accurately issue a test report for the subject. CE Marking represents a significant milestone for SeekIn in bringing OncoSeek test to the patients and healthcare providers in Europe. We will continue our efforts to meet additional regulatory requirements in Europe, and to obtain regulatory approvals in the other territories such as China."

About OncoSeek

OncoSeek has been developed as a multiple cancer detection test that uses artificial intelligence to distinguish between cancer cases and healthy cases by calculating the probability of cancer (POC) index based on the plasma levels of seven PTMs (including AFP, CA125, CA15-3, CA19-9, CA72-4, CEA, and CYFRA21-1) and age of the subjects. OncoSeek is a non-invasive, efficient, and cost-effective approach for multi-cancer early detection (MCED).

On September 12, 2022 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), a biopharmaceutical company focused on the development, production and commercialization of recombinant therapeutic proteins produced by its proprietary ProCellEx plant cell-based protein expression system, reported that Dror Bashan, the Company’s President and Chief Executive Officer, will present in person on Wednesday, September 14, 2022 at 11:00 a.m. Eastern Daylight Time (EDT) at the H.C. Wainwright 24th Annual Global Investment Conference, a hybrid conference (Press release, Protalix, SEP 12, 2022, https://www.prnewswire.com/news-releases/protalix-biotherapeutics-to-present-in-person-at-the-hc-wainwright-24th-annual-global-investment-conference-301622194.html [SID1234619467]). The conference is being held on September 12-14, 2022 at the Lotte New York Palace Hotel in New York City. Virtual participation will also be available.

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Mr. Bashan will provide a live corporate overview at the conference, a webcast of which will be available on–line. The live presentation replaces the pre-recorded presentation announced by the Company on September 6, 2022.

Live Presentation and Webcast Details:

Wednesday, September 14, 2022 at 11:00 a.m. Eastern Daylight Time (EDT) in the Adams Room.
Company Link: View Source
Webcast Link: View Source
The live presentation webcast and the pre-recorded webcast will both be available for replay for at least two weeks on the Events Calendar of the Investors section of the Company’s website, at the above link.

The Company’s management will participate in one-on-one meetings with investors who are registered to attend the conference. If you are an institutional investor and would like to attend the Company’s presentation, registration for the conference is available at View Source Once your registration is confirmed, you will be prompted to log onto the conference website to request a one-on-one meeting with the Company.

On September 12, 2022 On Target Laboratories, Inc., a privately-held biotechnology company developing intraoperative molecular imaging agents to target and illuminate cancer during surgery, reported publication of results from the Phase 3 006 Study of CYTALUX (pafolacianine) injection for intraoperative imaging of folate receptor positive ovarian cancer in the peer-reviewed Journal of Clinical Oncology (Press release, On Target Laboratories, SEP 12, 2022, View Source [SID1234619466]).

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The research article reports that use of CYTALUX during ovarian cancer surgery demonstrated identification of additional ovarian cancer that was not identified with conventional means and not otherwise planned for resection. 150 patients in the safety analysis set received a single infusion of CYTALUX, resulting in 109 patients with folate receptor positive ovarian cancer comprising the full analysis set for efficacy. In 33% of patients*, near-infrared imaging with CYTALUX identified additional lesions which would have been left behind (P < 0.001, 95% CI [0.243, 0.427]). The rate was higher, at 39.7%, among patients who underwent interval debulking surgery (95% CI [0.270, 0.534]).

"This pivotal study indicates that CYTALUX may offer an important real-time adjunct to current surgical approaches for ovarian cancer," said Chris Barys, President and Chief Executive Officer of On Target. "We are grateful to the study participants and investigators for their important role in this research and are committed to continuing to pioneer the use and study of intraoperative molecular imaging to increase detection of malignant lesions during surgery."

"There are many limitations to current operative approaches of visual inspection and palpation, and I am encouraged that, in this clinical trial, near-infrared imaging with CYTALUX identified additional lesions in 33% of participants which would have been left behind," said Janos L. Tanyi, MD, PhD, an associate professor of Obstetrics and Gynecology in the Perelman School of Medicine at the University of Pennsylvania and principal investigator of the Phase 3 trial. "These results further the evidence that intraoperative molecular imaging may help surgeons achieve complete surgical resection of cancer."

* N=36 out of 109 folate receptor positive ovarian cancer patients. CYTALUX USPI describes the proportion of patients in which CYTALUX identified additional lesions in the "intent-to-image set" regardless of ovarian cancer status (N=36 out of 134, 27%)