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New Patient Guide from NCCN Jumpstarts Important Conversations About Anal Cancer

On June 21, 2021 The National Comprehensive Cancer Network (NCCN) reported the publication of new NCCN Guidelines for Patients Anal Cancer, in addition to recently updated patient guidelines for colon and rectal cancers (Press release, NCCN, JUN 21, 2021, https://www.prnewswire.com/news-releases/new-patient-guide-from-nccn-jumpstarts-important-conversations-about-anal-cancer-301316469.html [SID1234584199]). These new and updated resources are made possible through the NCCN Foundation. The books provide unbiased guidance from leading experts that provide people with cancer and their caregivers with a baseline understanding of management options and empower them to ask questions of their health care providers—particularly regarding complicated, stressful, or stigmatized topics.

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New NCCN Guidelines for Patients: Anal Cancer available for free at NCCN.org/patientguidelines
New NCCN Guidelines for Patients: Anal Cancer available for free at NCCN.org/patientguidelines
"Facing an anal cancer diagnosis can be overwhelming and filled with uncertainty. That’s why ACF partnered with NCCN to translate its evidence-based, expert-consensus clinical guidelines from the leading cancer hospitals in the country into a patient-friendly format," said Justine Almada, Co-Founder and Executive Director of the Anal Cancer Foundation, which sponsored publication of the new NCCN Guidelines for Patients: Anal Cancer. "This comprehensive guide empowers patients and their caregivers by providing them access to the same information as their doctors. The more individuals and families understand about anal cancer, its treatment, and side-effects, the better prepared they are to actively participate in their care and have meaningful conversations with their medical team about treatment and recovery."

"Patients with cancer in general need access to the most reliable, up-to-date information possible," explained Al B. Benson III, MD, FACP, FASCO, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, Chair of the NCCN Guidelines Panel for Colon/Rectal/Anal Cancers. "The NCCN Guidelines for Patients provide a framework for discussion and help people to formulate questions, while not replacing the personal interactions between a patient and their medical team."

"Clinical trials are helping us to understand the growing role for immunotherapy in treating anal cancer," added panel Vice-Chair Alan Venook, MD, UCSF Helen Diller Family Comprehensive Cancer Center. "We’re trying to get away from more toxic forms of chemotherapy that had been standard of care for this disease type for more than 50 years. Patients are also often surprised to learn that we most often avoid surgery when treating anal cancer, unlike in colon and rectal cancers."

According to the NCCN Guidelines for Patients: Anal Cancer:

Anal cancer incidence is on the rise in the United States and is strongly linked to the human papillomavirus (HPV).
Chemoradiation is the recommended primary treatment for most patients with non-metastatic anal cancer.
Immune checkpoint inhibitors are an option for second-line therapy with metastatic disease.
"No one should ignore symptoms or family history, because unfortunately we’re seeing many of these young patients diagnosed at later stages," said Dr. Benson. He and Dr. Venook cautioned that no one should be considered "too young" to be tested for colon, rectal, or anal cancers if they experience bleeding, significant weight loss/changes in bowel habits, or have an immediate family member diagnosed with one of these cancers.

Drs. Benson and Venook both stressed the importance of young people getting vaccinated against HPV in order to reduce their chances of developing anal cancer, along with cervical, oropharyngeal, and other cancer types.

The NCCN Guidelines for Patients are based on the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines) which are created by multidisciplinary teams of experts from across NCCN Member Institutions. NCCN Guidelines are the recognized standard for clinical direction and policy in cancer care and the most thorough and frequently updated clinical practice guidelines available in any area of medicine. The patient versions are presented in easy-to-read language and format—with charts, images, and a glossary of medical terms—and were found to be among the most trustworthy options for cancer patients seeking information online according to a recent independent study.

There are now more than 50 different books for patients and caregivers from NCCN covering every major type of cancer, along with topics like managing cancer-related distress, nausea and vomiting, and survivorship (both healthy living & cancer-related late and long-term effects), plus special considerations for adolescents and young adults across all cancer types. Printed versions are available for a nominal fee at Amazon.com in addition to the free digital versions at NCCN.org/patients.

About The Anal Cancer Foundation
The Anal Cancer Foundation (ACF) is dedicated to ending anal cancer and improving the lives of those affected by it. ACF programs raise awareness, accelerate early detection, improve quality of life, and support research to find a cure. To learn more, please visit analcancerfoundation.org.

iSpecimen Announces Closing of Initial Public Offering

On June 21, 2021 iSpecimen Inc. (Nasdaq: ISPC) ("iSpecimen" or the "Company"), an online marketplace for human biospecimens, reported the closing of its previously announced initial public offering of 2,250,000 shares of its common stock at a price of $8.00 per share, for gross proceeds of $18,000,000 before deducting underwriting discounts, commissions and offering expenses (Press release, iSpecimen, JUN 21, 2021, View Source [SID1234584198]). The shares of common stock began trading on the Nasdaq Capital Market under the ticker symbol "ISPC" on June 17, 2021.

ThinkEquity, a division of Fordham Financial Management, Inc., acted as the sole book-running manager for the offering.

A registration statement relating to this offering was declared effective by the Securities and Exchange Commission ("SEC") on June 16, 2021. A final prospectus related to the offering was filed and is available on the SEC’s website at www.sec.gov. The offering was made only by means of a prospectus. Electronic copies of the final prospectus may be obtained from ThinkEquity, a division of Fordham Financial Management, Inc., 17 State Street, 22nd Floor, New York, New York 10004, by telephone at (877) 436-3673 and by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Innovent Announces the Approval of Pemazyre® (pemigatinib) in Taiwan Market for the Treatment of Adults with Previously Treated, Unresectable Locally Advanced or Metastatic Cholangiocarcinoma with a FGFR2 Fusion or Rearrangement

On June 21, 2021 Innovent Biologics, Inc. (Innovent) (HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases reported that the Taiwan market has approved Pemazyre (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement (Press release, Innovent Biologics, JUN 21, 2021, View Source [SID1234584197]). Pemazyre, discovered by Incyte and licensed to Innovent for development and commercialization in Mainland China, Hong Kong, Macau and Taiwan, is the first tyrosine kinase inhibitor approved for the treatment of cholangiocarcinoma, a type of biliary tract cancer, in Taiwan market. This is Innovent’s first approved small molecule drug and is also its fifth approved innovative drug.

The approval was based on the FIGHT-202 study, which is a Phase 2, multi-center, open-label, single-arm study (NCT02924376) evaluating the safety and efficacy of Pemazyre – a selective fibroblast growth factor receptor (FGFR) inhibitor – in adult (age ≥18 years) patients with previously treated, locally advanced or metastatic cholangiocarcinoma with documented FGFR2 fusion or rearrangement. The major efficacy outcome measure was overall response rate (ORR) determined by an independent review committee Per RECIST V1.1. Among the 107 patients with FGFR 2 fusion/rearrangement, the ORR was 35.5% (95% CI: 27%, 45%), including 3 complete responses. The median duration of response (DOR) was 9.1 months with responses lasting ≥ 6 months in 24 of the 38 (63%) responding patients and ≥ 12 months in 7 (18%) patients. The safety analysis, including 146 patients, demonstrated that pemigatinib was generally well tolerated. Hyperphosphatemia was the most common (60%) treatment-emergent adverse event (TEAE). TEAEs grade 3 or higher were reported in 64% of patients; the most frequent of which were hypophosphataemia (12%), arthralgia (6%), stomatitis (5%), hyponatraemia (5%), abdominal pain (5%) and fatigue (5%). For more information FIGHT-202, please visit View Source or https://www.thelancet.com/journals/lanonc/article/PIIS1470-2045(20)30109-1/fulltext.

Dr. Yongjun Liu, President of Innovent, stated: ‘The approval of Pemazyre in Taiwan market represents that Innovent has further broadened our product portfolio. In the future, Innovent will leverage the synergies of innovative drugs to explore more combination therapy opportunities to address unmet medical needs. ‘

Dr. Hui Zhou, Senior Vice President of Clinical Development of Innovent, stated: ‘Cholangiocarcinoma is the second most common primary liver cancer with a high incidence in Asia due to relatively widespread infection of HBV and parasites.’ He emphasized that a significant portion of patients receive an initial diagnosis of unresectable and/or metastatic status with limited therapy choice. Data from previous clinical trials of Pemazyre in participants with advanced cholangiocarcinoma with FGFR2 fusion as second line or later treatment has not only shown satisfactory safety results but also revealed compelling efficacy signals. With the refractory subjects being seen as the more challenging population and based on the promising data, we believe that patients with FGFR2 fusion or rearrangement may benefit from targeted therapies. The approval is a great clinical milestone, and we are looking forward to see the therapeutic contribution of Pemazyre in the treatment of eligible patients with cholangiocarcinoma in Taiwan market’, Dr. Zhou highlighted.

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumour originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas has been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced / metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including Pemazyre, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemazyre (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan. In March 2020, Innovent announced that the first patient was dosed in the pivotal registrational trial evaluating pemigatinib in patients with advanced cholangiocarcinoma in mainland China. In June 2021, Taiwan market approved Pemazyre (pemigatinib) for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement.

Pemazyre is a trademark of Incyte Corporation.

Gossamer Bio Announces Promotion of Richard Aranda, M.D., to Chief Medical Officer

On June 21, 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 that, Richard Aranda, M.D., previously Senior Vice President and Head of Clinical Development, will be promoted to Chief Medical Officer (Press release, Gossamer Bio, JUN 21, 2021, View Source [SID1234584196]). Dr. Aranda joined Gossamer in February 2018 with responsibilities including oversight of Clinical Pharmacology, Translational Medicine, and Pharmacovigilance.

"Dr. Richard Aranda’s clinical development expertise has been vital to Gossamer since inception," said Faheem Hasnain, Chairman, co-founder and CEO of Gossamer Bio. "Dr. Aranda is an experienced drug developer and clinician, and under his continued strong leadership, I am confident that Gossamer is best positioned for success."

Prior to joining Gossamer Bio, Dr. Aranda was Vice President of Clinical Development at Receptos, Inc. (Celgene Corporation), from 2015 to 2018, where he contributed to the late-stage development programs for ozanimod (Zeposia) in multiple sclerosis and inflammatory bowel disease (IBD) and RPC4046 in eosinophilic esophagitis. Before joining Receptos, from 2011 to 2015, Dr. Aranda was Vice President of Medical-Science and Inflammation at Novo-Nordisk, Inc., where he played a key role in advancing several biologic product candidates through Phase 1 to proof-of-concept studies in rheumatoid arthritis (RA), systemic lupus erythematosus and IBD. Dr. Aranda began his industry career at Bristol Myers Squibb in 2001, where he held roles of increasing scope and responsibility, including serving as the Global Medical Lead for abatacept (Orencia), as well as Early Development Team Lead for early-stage immunology product candidates. As the Global Medical Lead, Dr. Aranda contributed to the development and approval of Orencia for the treatment of RA and juvenile arthritis and the exploration of Orencia in other immune-mediated disorders.

Before joining the pharmaceutical industry, Dr. Aranda was on the faculty of the Division of Digestive Diseases and West Los Angeles Veterans Affairs, University of California, Los Angeles (UCLA) School of Medicine where he was involved in patient care and laboratory based immunological research. Dr. Aranda received his medical training at Harbor-UCLA and clinical fellowship and immunology research training through the UCLA integrated Gastroenterology Training Program. He received his M.D. from Stanford Medical School and his undergraduate degree from the University of California, Santa Cruz.

Paige, Oxford University and UK NHS Partners Win Government Funding to Evaluate Paige Prostate Cancer Detection System

On June 21, 2021 Paige, a global leader in AI-based diagnostic software in pathology, reported that the Company, Oxford University and National Health Service (NHS) regional partners in the United Kingdom have won the prestigious Phase 4 Artificial Intelligence in Health and Care award from the NHS Accelerated Access Collaborative to study Paige Prostate prospectively in a real-world cancer laboratory setting (Press release, Paige AI, JUN 21, 2021, View Source [SID1234584195]).

Under the award, leaders in uropathology at Oxford University Hospitals, Coventry and Warwickshire University Hospitals Trust, and North Bristol Trust, will develop system adoption guidelines for Paige Prostate, a clinical-grade artificial intelligence (AI)-based diagnostic software system that aids pathologists in detecting, grading and measuring prostate tumors in biopsies obtained from patients at risk of prostate cancer,1 and other similar systems. These adoption guidelines will enable further roll-out of AI technologies and advanced algorithms across the NHS to aid in the diagnosis of complex diseases.

"Paige is proud to be working with this multidisciplinary team of experts to demonstrate the impact of digital pathology tools in routine clinical use," said Leo Grady, Ph.D., Chief Executive Officer of Paige. "Alongside our partners, we look forward to potentially ushering in a new era of clinical diagnostics powered by AI-enabled technologies to benefit patients and cellular pathology laboratories throughout the NHS."

The Phase 4 award, which is restricted to mature market-authorized CE-IVD products and is the most advanced award category, will enable Paige and its partners to demonstrate clinical or economic utility of Paige Prostate with respect to its real-world implementation and use in the NHS. Additionally, the parties aim to demonstrate clinical and economic impact of Paige Prostate in the NHS and/or social care setting to help inform reimbursement and procurement decisions and facilitate adoption.

"At Paige we believe that best practice guideline development and successful adoption of this new technology is best led by pathologists," said Margaret Horton, Ph.D., Business Lead for UK and Europe at Paige and co-investigator in the study. "In addition to measuring and quantifying the health economics benefits of Paige Prostate, we have the unique opportunity as industry to work alongside patients, pathologists and urologists in this study to show how Paige Prostate impacts diagnostic reporting and the patient experience."

"With published clinical evidence, and our own initial experiences with Paige Prostate on challenging tissue samples, Paige Prostate is an ideal candidate system for investigating the patient and system-level benefits of artificial intelligence in NHS cellular pathology," said Clare Verrill, Associate Professor at Oxford University, Lead in Prostate Pathology, Consultant in Cellular Pathology at the Oxford University Hospital NHS Trust, and principal study investigator for the Phase 4 award. "Now is the time to take technologies from simulated clinical settings to embedding in the routine reporting workflow and measure the impact on patient care. By sharing our findings in the professional community, my hope is for widespread benefits from AI with fewer barriers to routine adoption of these powerful systems."

For additional information, read the article from the Oxford Biomedical Research Centre.