On June 4, 2021 Amgen (NASDAQ:AMGN) reported updated results for investigational bemarituzumab in combination with chemotherapy from the Phase 2 FIGHT trial (Press release, Amgen, JUN 4, 2021, View Source [SID1234583500]). The trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or gastroesophageal junction cancers (GEJ). New data includes median overall survival (OS), a secondary endpoint that was reached with longer follow-up, as well as additional analyses of patient subgroups.

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With a median follow-up of 12.5 months, the addition of bemarituzumab to chemotherapy resulted in a median OS of 19.2 months versus 13.5 months for chemotherapy alone in all randomized patients (n=155, HR: 0.6; 95% CI: 0.38, 0.94). In an exploratory pre-specified subgroup analysis, in patients with >10% of tumor cells overexpressing FGFR2b by immunohistochemistry (IHC), the median OS for bemarituzumab was 25.4 months versus 11.1 months (n=96, HR: 0.41; 95% CI: 0.23, 0.74).

The incidence of all grade adverse events was similar in the bemarituzumab plus chemotherapy and chemotherapy only arm of the study (100% versus 98.7%, respectively). The incidence of corneal adverse events was higher in the bemarituzumab plus chemotherapy arm versus the chemotherapy arm (all grade AEs 67.1% versus 10.4%), with dry eye reported as the most common corneal event (26.3%). The majority of the corneal adverse events were reversible.

The results were presented today in an oral presentation at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting taking place virtually from June 4-8, 2021.

"Gastric cancer is the fourth leading cause of cancer death globally and 30% of frontline HER2-negative gastric cancer patients have tumors that overexpress FGFR2b," said David M. Reese, M.D., executive vice president of Research and Development at Amgen. "These updated results underscore the benefits that bemarituzumab plus chemotherapy may bring to patients who have been fighting this aggressive disease with chemotherapy alone. We now look forward to advancing bemarituzumab into Phase 3 development."

More than one million new gastric cancer cases are diagnosed annually, and gastric cancer is particularly prevalent in Asia.1,2 Approximately 80 to 85% of advanced gastric and GEJ cancers are HER2-negative, and approximately 30% of these tumors overexpress FGFR2b.3,4

"These updated results further validate our work on the role of FGFR2b overexpression in gastroesophageal cancer and demonstrate that treatment with bemarituzumab in combination with chemotherapy can deliver a clinically significant reduction in the risk of disease progression for patients whose tumors overexpress FGFR2b," said Daniel V.T. Catenacci, MD, PhD, medical oncologist and principal investigator at the University of Chicago.

In April 2021, bemarituzumab was granted Breakthrough Therapy Designation by the U.S. FDA based upon a subset of patients from the FIGHT trial who showed at least 10% of tumor cells overexpressing FGFR2b. Amgen continues to investigate the role of FGFR2b and will continue to work with regulatory agencies on next steps, including Phase 3 development, to bring this potential first-in-class therapy to patients.

About Bemarituzumab
Bemarituzumab (anti-FGFR2b) is a Phase 3 ready, potential first-in-class, investigational targeted antibody that is designed to block specific fibroblast growth factors (FGFs) from binding and activating FGFR2b, inhibiting several downstream pro-tumor signaling pathways and potentially slowing cancer progression. Bemarituzumab is being developed in gastric and GEJ cancer as a targeted therapy for tumors that overexpress FGFR2b. The company is also evaluating the potential for bemarituzumab in other cancers that overexpress FGFR2b.

Zai Lab (Shanghai) Co. Ltd. was granted an exclusive license to develop and commercialize bemarituzumab in Greater China, and Zai Lab collaborated with Five Prime on the Phase 2 FIGHT trial in Greater China.

About FIGHT
The FIGHT trial evaluated bemarituzumab plus chemotherapy (mFOLFOX6) versus chemotherapy alone in patients with FGFR2b-positive, HER2-negative frontline advanced gastric or GEJ cancer. In the study, treatment with bemarituzumab plus chemotherapy demonstrated clinically significant and substantial improvements in the primary endpoint of progression-free survival (PFS) and secondary endpoint of overall survival (OS) in the patient population in which at least 10% of tumor cells overexpressed FGFR2b. Additional analysis showed a positive correlation between benefit and the prevalence of FGFR2b+ tumor cells, affirming both the importance of the FGFR2b target and the activity of bemarituzumab against this target. The Breakthrough Therapy Designation was granted based upon this subset of patients who showed at least 10% of tumor cells overexpressing FGFR2b.

About Amgen Oncology
At Amgen Oncology, our mission to serve patients drives all that we do. That’s why we’re relentlessly focused on accelerating the delivery of medicines that have the potential to empower all angles of care and transform lives of people with cancer.

For the last four decades, we have been dedicated to discovering the firsts that matter in oncology and to finding ways to reduce the burden of cancer. Building on our heritage, Amgen continues to advance the largest pipeline in the Company’s history, moving with great speed to advance those innovations for the patients who need them.

At Amgen, we’re advancing oncology at the speed of life.

On June 3, 2021 Privo Technologies, Inc. ("Privo"), a biopharmaceutical company focused on optimizing state-of-the-art chemotherapies to be "Tough on cancer, Easy on patients", reported a poster presentation on the safety and efficacy of PRV111 in patients with early-stage Head and Neck Squamous Cell Carcinoma (HNSCC) at the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting held June 4-8, 2021 (Press release, Privo Technologies, JUN 3, 2021, View Source;utm_medium=rss&utm_campaign=privo-technologies-inc-presents-phase-ii-data-for-prv111-in-head-and-neck-squamous-cell-carcinoma-at-the-2021-asco-annual-meeting [SID1234586753]).

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The poster presentation is available in the 2021 ASCO (Free ASCO Whitepaper) Annual Meeting Library.

The details of the poster presentation are as follows:

Title: A phase II study of PRV111 nanoengineered cisplatin patch as a neoadjuvant therapy for early-stage oral squamous cell carcinoma (OSCC)

Speaker: Nishant Agrawal, M.D.

Poster Session: Head and Neck Cancer

Date and Time: June 4, 2021.

Abstract Number: 6056

Authors:
Nishant Agrawal, Evgeny Izumchenko, Kenneth Hodge, Simon Young, James C. Melville, Jonathan Shum, Dhafer Alsuwied, Vlad Sandulache, Michael Harris, Aaron Manzi, Manijeh Goldberg

Abstract Disclosures
Research Funding:
U.S. National Institutes of Health, Other Government Agency, Pharmaceutical/Biotech Company, U.S. National Institutes of Health

Background: OSCC is a devastating disease causing substantial morbidity and mortality. Despite advancements in the conventional therapeutic approaches, surgical resection often leads to permanent disfigurement, while radiotherapies and systemic platinum-based chemotherapy result in significant toxicities, affecting patient wellbeing and quality of life. Thus, development of novel therapeutic approaches is paramount to improve health outcomes and survival of patients with OSCC. Systemic toxicity is often dose limiting, but could be tentatively reduced by locoregional administration. We have developed PRV111, a nanotechnology based patch for local and regional delivery of highly concentrated potent cisplatin, designed to penetrate tumor tissue, reach and enter regional lymph nodes and avoid systemic circulation. Here we present the results of phase 1/2 CLN-001 trial, designed to improve efficacy and reduce toxicity by neoadjuvant treatment with PRV111.

Methods:A phase 1/2, single arm, open-label CLN-001 (NCT03502148) study has enrolled 12 patients with confirmed OSCC; unknown nodal involvement, no distant metastasis, and tumor size ≤ 4.0 cm. Three weeks prior to surgery, patients were administered 1 cycle of standalone neoadjuvant PRV111, consisting of up to 4 treatment visits (each visit dose: ≤12mg of cisplatin, each patch loading dose: 2mg of cisplatin). The primary endpoints were safety, efficacy and tumor reduction in ̃ 7 days by greater than 30%. Secondary endpoints included nanoengineered patch consistent and complete adhesion to mucosal surfaces and uniform drug release. Exploratory endpoints included immunogenesis/immunomodulation.

Results:PRV111 successfully met all clinical primary endpoints, as well as safety and efficacy objectives. It caused over 70% tumor reduction in ̃7 days with over 87% response rate across 10 subjects. No dose-limiting toxicities, serious adverse event, or systemic toxicities were reported and no locoregional recurrences were evident in 6 months. PRV111 induced ̃15 times increase in tumor infiltrating lymphocytes compared with the initial biopsy. Concentrations of cisplatin found in the tumor and regional lymph nodes were over 300 and 100 times higher respectively as compared with IV cisplatin, with only negligible amount of cisplatin found in the blood. Grade 1 or 2 oral and tongue pain induced by the treatment were the most common adverse events. Furthermore, 97.5% successful patch performance was achieved across 182 patches used in the study.

Conclusions: Adding neoadjuvent PRV111 to the care for patients with OSCC may improve the surgical outcome and increase event free survival. Given these encouraging results, future studies are needed to establish the application of this non-invasive platform in head and neck SCC and other epithelial cancers, including anal, colorectal, genitourinary, nasal, and skin. Clinical trial information: NCT03502148

On June 3, 2021 Crown Bioscience (CrownBio), a JSR Life Sciences Company, reported that they have entered into separate, yet complementary, portfolio license agreements with the ATCC and the U.S. Department of Health and Human Services, as represented by the National Cancer Institute (NCI) of the National Institute of Health (NIH) (Press release, Crown Bioscience, JUN 3, 2021, View Source [SID1234583642]). By entering into five-year agreements with these premier biomaterial resource providers, CrownBio clients will directly benefit from a priority status that will make cell lines more readily available with simplified logistics.

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Through its XenoSelect and OmniScreen panels, CrownBio already offers its clients highly customizable, broad in vitro screening panel services, paired with industry-leading bioinformatics capabilities and a breadth of established "matched" downstream in vivo models. CrownBio clients will now have access to an extended and unrivaled portfolio of cell lines, with the knowledge and peace of mind that all necessary licensing is in place.

The license agreement with ATCC grants CrownBio expedited access to more than 140 cell lines and associated datasets, as well as future access to an additional 4000 cell lines through an umbrella licensing structure. Similarly, to meet CrownBio’s ongoing global client needs for supplies of NIH cell lines, a new portfolio license has been signed with the NIH. With this agreement, CrownBio will provide access to 100 cell lines available through the NCI Repository of Tumors and Tumor Cell Lines and other sources, that were developed in NCI labs.

Henry Li, PhD, CSO of CrownBio said, "We greatly value our relationships with both ATCC and NIH, which are two of CrownBio’s largest cell line partners. We are excited that these new agreements will enable us to offer our clients expanded and prioritized cell line availability and supply. Together, these agreements exemplify CrownBio’s dedication to ensuring our clients have easy access to an industry-leading range of in vitro and in vivo models for drug discovery."

On June 3, 2021 Celdara Medical, LLC (Celdara), an experienced biopharma developer focused on launching promising products for the patients who need them most, reported a new strategic collaboration with the Global Virus Network (GVN), a coalition comprised of human and animal virologists from 63 Centers of Excellence and 11 Affiliates in 35 countries (Press release, Celdara Medical, JUN 3, 2021, View Source [SID1234583626]). As part of the Pandemic Security Initiative (PanSec) and the mission of the GVN, the two organizations will advance collaborative research on emerging and infectious diseases and fast spreading viral infections by identifying promising diagnostic tools, neutralizing antibodies, vaccines and drugs. An initial strategic focus will be on broad spectrum antivirals.

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PanSec is a public-private partnership, striving to ensure preparedness for the next pandemic. Celdara has a robust early stage anti-infectives pipeline and extensive experience in pre-clinical pharmaceutical development which forms the foundation from which the PanSec was launched.

"We are thrilled to work with GVN through our Pandemic Security Initiative, which seeks to deliver on the promise of innovation in universities, government labs and businesses to prepare and protect us from future infectious disease pandemics," said Dr. Jake Reder, Celdara’s cofounder and CEO. "The world was caught largely unaware by SARS-CoV-2; however, we believe history need not repeat itself with future viruses and epidemiological threats. One key learning from recent events is that no one institution, country or organization can solve a global disease threat alone. GVN has amassed a worldwide network which brings together the finest medical virologists to address the scientific challenges, issues and problems posed by pandemic viruses. Through the combined expertise of GVN, Celdara and PanSec, we can deliver on the most promising medical innovations and provide clinicians and first responders with powerful new medicines and tests."

The standard drug development model doesn’t work for sporadic infectious diseases – without a market to provide returns there can be no private investment. Built on Celdara Medical’s successful business model, PanSec seeks to bridge this gap by unleashing innovation for patient and societal benefit by tapping into an existing innovation pipeline that spans the U.S. and beyond. Celdara has partnerships with research universities and institutions across the country and is harnessing their collective expertise as a part of the initiative.

"Our international network of academic virologists regularly generates important discoveries that have the potential to improve pandemic preparedness if they can be quickly and professionally developed. The partnership between the GVN and Celdara Medical will complement GVN’s work," said Christian Bréchot, President, GVN and Associate Vice President for International Partnerships and Innovation at University of South Florida (USF), Professor, Division of Infectious Disease, Department of Internal Medicine at the USF Health Morsani College of Medicine, the GVN Southeast U.S. Regional Headquarters. "Long before COVID appeared on the global stage, viruses caused millions of deaths each year. Since our founding in 2011, GVN’s coalition of eminent virologists from around the world have been working to identify and understand viruses, with a long term goal to prevent illness and death. We look forward to continuing our important work in collaboration with PanSec," said Prof. Robert Gallo, The Homer & Martha Gudelsky Distinguished Professor in Medicine, Co-Founder & Director of the Institute of Human Virology at the University of Maryland School of Medicine, and Co-Founder & Chairman of the International Scientific Leadership Board of the GVN.

On June 3, 2021 Protagonist Therapeutics ("Protagonist" or "the Company") (Nasdaq: PTGX), reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy Designation for its lead investigational new drug candidate, rusfertide, for the treatment of patients with polycythemia vera (PV) for the reduction of erythrocytosis in those patients who do not require further treatment for thrombocytosis and/or leukocytosis (Press release, Protagonist, JUN 3, 2021, View Source [SID1234583611]). Breakthrough Therapy Designation requires that the drug candidate treat a serious or life-threatening disease or condition. It also requires preliminary clinical evidence that indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. The designation has the potential to expedite the development and regulatory review process.

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"We are thrilled to receive the Breakthrough Therapy Designation for rusfertide in PV, a serious disease where the need for different and better treatment options is clear and pressing," said Suneel Gupta, PhD, Chief Development Officer at Protagonist. "Rusfertide is a natural hormone mimetic and may stand out as the first non-cytoreductive therapeutic drug for PV. We look forward to working closely with FDA regulators to advance and complete all relevant clinical studies, both ongoing and planned, as quickly as possible."

The designation for rusfertide was supported in part by promising data from the ongoing Phase 2 clinical trial in patients with PV, presented at the Annual Meeting of the American Society of Hematology (ASH) (Free ASH Whitepaper) in 2020. The data showed that when treated with rusfertide, a majority of patients were able to eliminate therapeutic phlebotomies, maintain a target hematocrit level of less than 45 percent, reverse iron deficiency, and experience symptom improvements. The FDA previously granted orphan drug status and Fast Track Designation to rusfertide in PV. Breakthrough Therapy Designation offers additional advantages over Fast Track Designation, including FDA actions to expedite both planned clinical trials and plans for expediting the manufacturing development strategy.

Updated data from the ongoing Phase 2 study has been selected for oral presentation at the upcoming annual meeting of the European Hematology Association (EHA) (Free EHA Whitepaper). This meeting will take place June 9 through 17 and will remain accessible until August 15, 2021.

About FDA Breakthrough Therapy Designation

Breakthrough Therapy Designation is an FDA program intended to expedite the development and regulatory review of investigational therapies that are designed to address serious or life-threatening conditions. The criteria for Breakthrough Therapy Designation requires preliminary clinical evidence that indicates that the candidate may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints. This designation provides the Company with more intensive FDA guidance on an efficient drug development program, and eligibility for other actions to expedite the FDA review, such as a rolling review of a New Drug Application (NDA), where the FDA may review sections of the NDA before the complete application is submitted. An NDA for a product candidate receiving Breakthrough Therapy Designation may also be eligible for priority review if the relevant criteria are met. Breakthrough Therapy Designation does not change the standards for approval. For more information, please visit the FDA website at www.fda.gov.