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.

On June 3, 2021 Novartis reported that More than two years after splashing out $2.1 billion on Endocyte, is pulling the curtain on full phase 3 data for the radiopharmaceutical it picked up in that deal (Press release, Novartis, JUN 3, 2021, View Source [SID1234583610]).

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The treatment, given alongside standard of care, added four months to the lives of patients with metastatic castration-resistant prostate cancer, helping them live a median of 15.3 months and reducing the risk of death by 38%. The combination nearly doubled the time patients had before their disease got worse, staving off cancer progression for a median of 8.7 months, while standard of care alone kept cancer at bay for 3.4 months.

It could help patients whose "prognosis isn’t terrific" and who have run out of treatment options, said Michael Morris, M.D., the lead author of the study and head of the Prostate Cancer Section at Memorial Sloan Kettering Cancer Center.

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RELATED: Novartis’ radioligand hits goal in phase 3 prostate cancer trial

The phase 3 data, to be presented this weekend at the annual meeting of the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper), come from 831 patients who received standard of care alone or along with the treatment, known by the unwieldy moniker of 177-Lu-PSMA-617.

The patients were "at the end of this disease’s course," Morris said. They had undergone chemotherapy and treatment with androgen receptor pathway inhibitors, a family of drugs that "works quite well." But after their cancer outsmarts those treatments and develops resistance, as many as 90% of these patients have no other options.

"Most of these patients will not have particularly good treatment options at all, save for a handful of those who might be receiving genetically defined therapies or radium," Morris said. "This is a space where a lot of people get supportive care … This drug will fill a real unmet medical need."

Side effects struck more patients taking 177Lu-PSMA-617 than those taking standard of care alone, with severe effects affecting about half of patients taking the radiopharmaceutical and just over two-thirds of those taking standard of care alone.

RELATED: Novartis bolsters radioligand stable with iTheranostics deal

That said, those effects were unsurprising, given the nature of the treatment and how sick the patients were, Morris said. The most common side effects affected nearly half of the patients and included fatigue and bone marrow suppression, which causes patients to produce fewer blood cells. About 40% of patients suffered dry mouth, but that’s typical for treatments that target the PSMA membrane protein because it is also found in the salivary glands, Morris said.

"We have experience in this drug from several other studies, both single-arm and comparison studies, that have been done previously … There was no new [safety] signal here," said Morris, who compared the treatment’s safety profile favorably to that of chemotherapy.

Radiotherapy is not new to cancer, but treatments like Novartis’ 177Lu-PSMA-617 deliver radiation more precisely than traditional radiotherapy, killing cancer cells while sparing healthy cells. Known as radioligand therapies, these medicines combine a small molecule or peptide that targets a protein found in cancer cells with a radioactive material that blocks tumor growth by damaging DNA. In the case of 177Lu-PSMA-617, the ligand zeroes in on PSMA in prostate cancer cells to deliver radiation from a radioactive isotope of lutetium.

"It allows us to actually deliver this high-dose radioactive lutetium directly to a cancer cell—very similar to DoorDash," said Jeff Legos, Ph.D., senior vice president, global head of oncology development at Novartis, during a press briefing.

RELATED: Novartis inks $2.1B Endocyte buyout, furthering radiotherapy push

As Novartis prepares a regulatory submission for the treatment, it has already set up its on-demand manufacturing process, which can deliver a treatment course two weeks after it’s ordered, said Susanne Schaffert, Ph.D., president of Novartis Oncology, during the briefing.

It’s not as simple as manufacturing small molecules or biologics, which can be stored on a shelf or in a refrigerator. Because the radiopharmaceutical decays so quickly, Novartis must account for the journey the treatment takes through the manufacturing site, to the hospital and the patient’s bedside.

"Time is of [the] essence given the short shelf life of the radioligand therapy, because it’s dependent on the level of decay," Schaffert said.

On June 3, 2021 Resverlogix Corp. ("Resverlogix") (TSX:RVX) and EVERSANA, the pioneer of next generation commercial services to the global life sciences industry, reported a partnership to support planned commercialization of apabetalone in the United States, Canada (where authorization has been granted to conduct clinical studies of apabetalone for COVID-19) and/or potentially expanding to additional global markets, as Emergency Use Authorization and/or a New Drug Application or equivalent is issued or approved (Press release, EVERSANA, JUN 3, 2021, View Source [SID1234583609]).

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In preparation for launch, Resverlogix will utilize EVERSANA’s fully integrated commercialization services that include market access, agency services, clinical and commercial field teams, medical science liaisons, channel management, patient services, health economics and outcomes research, and compliance, with each service optimized by data and predictive analytics.

Apabetalone is an investigational, phase 3 clinical candidate with safety data in more than 4,200 man years of treatment. As previously published, apabetalone has the potential to combat COVID-19 through a unique dual mechanism. First, apabetalone treatment prevents SARS-CoV-2 from infecting human cells; and second, it reducesthe inflammation and cytokine storm response, which can result in organ damage and long-term negative impacts. Apabetalone is also being studied for important benefits for patients with high-risk cardiovascular disease, chronic kidney disease and other indications while maintaining a well-described safety profile.

"With EVERSANA’s integrated commercialization solution, we are poised to swiftly and efficiently deliver apabetalone to patients who desperately need it," said Donald McCaffrey, President and CEO of Resverlogix. "We are proud to be on the front line with the global scientific medical community as we fight the ongoing threat of this and future pandemics."

"We believe in apabetalone’s potential to save the lives of patients still facing the tragic impact of COVID-19 and its numerous growing variants as well as the millions of patients facing multiple diseases that have the potential to be treated by this much-needed therapy," said Jim Lang, Chief Executive Officer of EVERSANA. "Our COMPLETE end-to-end commercialization engine is mobilized and ready to move swiftly in anticipation of authorizations and approvals."

There can be no assurance that regulatory approval will be obtained.

On June 3, 2021 Almac Group, the global contract development and manufacturing organization, is delighted to reported that the organization was named the 2020 "Pillar of the Community" by the Indian Valley Chamber of Commerce (Press release, Almac, JUN 3, 2021, View Source [SID1234583525]). The award was presented at the Chamber’s annual awards dinner, held this year on June 1 in Telford.

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The Pillar of the Community is awarded annually to a large business, actively involved in the Chamber that has demonstrated a significant commitment to the community by the company and its employees. Nominations are submitted by a Chamber Executive Committee, and the final decision to award Almac was made by the Chamber’s Board of Directors.

Almac was named this year’s Pillar of the Community due to the exceptional contributions of Almac and its employees during the COVID-19 pandemic. As an essential business, Almac continued its operations through the pandemic, ensuring no interruption in the supply chain of the hundreds of essential medicines the company supports through its integrated range of services across the drug development lifecycle. In addition, Almac contributed to over 140 treatment and vaccine options to combat COVID-19, notably supporting the Pfizer-BioNTech vaccine clinical trial, which upon authorization, has led to millions of vaccinations across the globe and a distinct turning point in the pandemic.

Mark Rohlfing, VP of Operations, Almac Clinical Services, accepted the award with remarks on behalf of Almac. He commented: "Almac’s mission is to advance human health, and we believe this extends to supporting the health and well-being of our local communities. Therefore, we are proud to support the Indian Valley community and Chamber of Commerce."

"We’re also proud to acknowledge that with this award, the Chamber has recognized the exceptional dedication of hundreds of Almac employees in Pennsylvania, whose contributions directly supported COVID-19 relief efforts, as well as the continued supply of hundreds of other essential medications for patients across the globe. Our people are essential to our success and we are grateful to the Chamber for acknowledging the impact of their hard work during unprecedented times."

Steven Hunsberger, Executive Director at Indian Valley Chamber of Commerce, commented: "We are thrilled to recognize Almac as the Indian Valley Chamber of Commerce’s 2020 Pillar of the Community. Through their contributions to human health and most recently, the COVID-19 pandemic, Almac has the distinction of providing significant service to not just our community, but the world. We are proud to watch them thrive in the Indian Valley and look forward to a continued prosperous future together."