Over 2 million people in backlog for cancer care

On June 1, 2020 Cancer Research UK reported that Around 2.4 million people in the UK are waiting for cancer screening, further tests or cancer treatment (Press release, Cancer Research UK, JUN 1, 2020, View Source [SID1234560745]).*

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"Delays to diagnosis and treatment could mean that some cancers will become inoperable. Patients shouldn’t need to wait for this to be over before getting the treatment they need." – Professor Charles Swanton
COVID-19 has caused enormous disruption to cancer services across the UK, including delays to cancer treatment, screening and diagnosis, and huge decreases in patients being urgently referred to hospital with suspected cancer symptoms.**

Delays to cancer screening have had the biggest impact on the total number, with a backlog of around 2.1 million people left waiting for breast, bowel or cervical screening. During this time, 3,800 cancers would normally be diagnosed through screening.

Urgent cancer referrals, often known as the two week wait, have been severely impacted with up to 290,000 people missing out on further testing, which would normally catch up to 20,300 cancers in the same time period.

There will also be a backlog of treatment to catch up on, with up to 12,750 fewer patients receiving surgery, 6,000 fewer for chemotherapy and 2,800 fewer receiving radiotherapy since lockdown began.***

‘COVID-protected’ safe spaces will be a crucial part of addressing the growing backlog and ensuring more people can safely receive treatment or be diagnosed quickly.

But this will only be possible if all cancer patients and healthcare staff – whether symptomatic or asymptomatic – are tested regularly for COVID-19.

Cancer Research UK has estimated that to test patients ahead of hospital appointments and cancer staff weekly, between 21,000 and 37,000 COVID-19 tests must be done each day across the UK. This means that doctors and nurses can care for their patients in a safe, ‘COVID-protected’ environment.****

A clear national plan for testing is needed to support the effective recovery and restoration of cancer services.

Michelle Mitchell, Cancer Research UK’s chief executive, said: "The enormous strain COVID-19 has placed on cancer services is of great concern to us. The NHS has had to make very hard decisions to balance risk, and there have been some difficult discussions with patients about their safety and ability to continue treatment during this time. But we’re over the peak of the pandemic now, and cancer care is starting to get up and running again as ‘COVID-protected’ spaces are being set up.

"To get cancer services back to normal levels while ensuring no one is put at risk, frequent testing of NHS staff and patients, including those without symptoms, is vital. We now need clear national leadership and guidance for the NHS to dramatically increase testing levels. At the moment, we don’t know who is responsible for making cancer services safe and it’s patients who are suffering in the meantime. The Government must work closely with the NHS to ramp up testing provision with rapid results, as quickly as possible once practical.

"Prompt diagnosis and treatment remain crucial to give people with cancer the greatest chances of survival and prevent the pandemic taking even more lives."

Professor Charles Swanton, Cancer Research UK’s chief clinician, said: "My colleagues and I have seen the devastating impact this pandemic has had on both patients and NHS staff. Delays to diagnosis and treatment could mean that some cancers will become inoperable. Patients shouldn’t need to wait for this to be over before getting the treatment they need.

"We can create a safer environment for both staff and cancer patients if testing efforts ramp up quickly with test results delivered back within 24 hours or less. We know that carrying COVID-19 while asymptomatic or pre-symptomatic is a major concern where healthcare worker staff and patients can transmit infection.

"We need at least weekly testing of healthcare workers and elective admissions to protect patients and staff from future spread and hospital-related complications. Staff in hospitals around the country are working extremely hard and with more testing of staff and patients – with and without symptoms – we will have hospitals and centres protected from COVID-19 where patients can be treated safely."

Paul Soderquist, 66 from Enfield, London was diagnosed with both lung and prostate cancer in 2019. He had surgery for lung cancer in February but his radiotherapy for prostate cancer has been put on hold due to COVID-19.

Paul said: "I was in the unusual position of getting two diagnoses within a few weeks and I count my blessings that I had my lung surgery earlier this year. I’m still being treated for prostate cancer, but it’s non-aggressive and I’ve been assured I will recover. I was due to have radiotherapy, but it’s been postponed until September because of the virus, although I’m still having injections to inhibit testosterone.

"I understand the reasons for the delay, and I know I’m in a queue, but things feel uncertain. My CT scan for both cancers in May has been put on hold too. So, I hope that there aren’t any problems because of that delay."

Protalix BioTherapeutics Reports First Quarter 2020 Financial Results and Business Update

On June 1, 2020 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 financial results for the first quarter ended March 31, 2020, and provided a business update on recent corporate and clinical developments (Press release, Protalix, JUN 1, 2020, View Source [SID1234560744]). The Company’s management will discuss the financial results and provide a clinical, corporate and financial highlights on a conference call and live webcast scheduled for Monday, June 1, 2020 at 8:30 am Eastern Daylight Time (EDT).

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"The first quarter of 2020 has most certainly been transformational for Protalix, despite the COVID-19 pandemic that affected the global markets," said Dror Bashan, Protalix’s President and Chief Executive Officer. "I am proud to say that despite the pandemic, Protalix was able to keep the company running smoothly and adapt quickly to the changing environment."

"During the quarter, we were able to close a $43.7 million private placement," he continued. "Furthermore, the topline results from the completion of our Phase III BRIDGE study and the subsequent BLA submission for PRX–102 announced in May prove that Protalix has actually gained momentum by leaning into this unprecedented challenge. I am convinced now more than ever that our team is positioned for long-term success and look forward to continuing our momentum through the rest of this year and into 2021."

Conference Call and Webcast Information

The Company will host a conference call on Monday, June 1, 2020, at 8:30 am, Eastern Daylight Time, to review the clinical, corporate and financial highlights. To participate in the conference call, please dial the following numbers prior to the start of the call:

The conference call will also be broadcast live and available for replay for two weeks on the Company’s website, www.protalix.com, in the Events Calendar of the Investors section. Please access the Company’s website at least 15 minutes ahead of the conference to register, download, and install any necessary audio software.

First Quarter 2020 and Recent Business Highlights

Clinical and Regulatory Advancements

On May 28, 2020, the Company and its development and collaboration partner, Chiesi Global Rare Diseases, a unit of Chiesi Farmaceutici S.p.A., or Chiesi, announced the submission on May 27, 2020 of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for pegunigalsidase alfa, or PRX–102, for the treatment of adult patients with Fabry disease via the FDA’s Accelerated Approval pathway. PRX–102 was granted Fast Track designation by the FDA in January 2018. Upon the BLA approval, if approved, the Company will be eligible to receive a milestone payment from Chiesi.
On May 11, 2020, the Company announced positive topline results following the completion of its Phase III BRIDGE clinical trial of PRX–102 for the treatment of Fabry disease. The Phase III BRIDGE clinical trial, a 12-month open-label, single arm switch-over study evaluating the safety and efficacy of PRX–102, 1 mg/kg infused every two weeks, met its main objectives for safety and efficacy, and topline analysis indicated substantial improvement in renal function as measured by mean annualized estimated Glomerular Filtration Rate (eGFR slope) in patients switched from agalsidase alfa to PRX–102.
On February 6, 2020, Protalix and Chiesi announced the receipt of an agreement letter from the FDA for the Initial Pediatric Study Plan (iPSP) for PRX-102 for the treatment of Fabry disease, outlining an agreed-upon approach to address the needs of pediatric Fabry patients.
Corporate & Financial Developments

On March 16, 2020, the Company announced that it has agreed to conduct a feasibility study with Kirin Holdings Company, Limited, or Kirin, to evaluate the production of a novel complex protein utilizing ProCellEx. The Company received a non-refundable payment of $1.0 million and Kirin will provide research funding for the Company’s scientists to conduct cell line engineering and protein expression studies on the target protein.
On March 12, 2020, the Company entered into securities purchase agreements with certain existing and new institutional and other accredited investors in a private placement. Pursuant to such agreements, the Company issued and sold to the purchasers an aggregate of approximately 17.6 million unregistered shares of its common stock at a price per share of $2.485, or aggregate net committed proceeds equal to approximately $41.3 million. Each share of the Company’s common stock issued in the transaction was accompanied by a warrant to purchase an additional share of common stock at an exercise price equal to $2.36.
Financial Results

For the three months ended March 31, 2020, compared to the three months ended March 31, 2019

The Company recorded revenues from selling goods of $5.0 million during the three months ended March 31, 2020, an increase of $1.5 million, or 43%, compared to revenues of $3.5 million for the same period of 2019. The increase resulted primarily from an increase of $0.8 million in sales of drug product to Brazil as well as an increase of $0.7 million in sales of drug substance to Pfizer Inc.
Revenues from license and R&D services for the three months ended March 31, 2020, were $16.6 million, an increase of $9.7 million, or 140%, compared to revenues of $6.9 million for the same period of 2019. Revenues from the license agreements represent the revenues recognized in connection with previously announced agreements with Chiesi. The increase is primarily due to revenues recognized in connection with the progress of the Company’s clinical trial that have been performed, and with revenues recognized in connection with an updated costs estimation throughout the trials until completion in the amount of $6.7 million.
Cost of goods sold was $3.4 million for the three months ended March 31, 2020, an increase of $1.4 million, or 68%, from cost of goods sold of $2.0 million for the same period of 2019. The increase is primarily due to an increase in sales of goods.
Research and development expenses were $10.3 million for the three months ended March 31, 2020, a decrease of $1.4 million, or 12%, compared to $11.7 million of research and development expenses for the same period of 2019. The decrease was primarily due to a decrease in costs related to manufacturing of our drug in development.
Selling, general and administrative expenses were $3.2 million for the three months ended March 31, 2020, an increase of $1.0 million, or 43%, compared to $2.2 million for the same period of 2019. The increase resulted primarily from a $0.6 million increase in compensation related costs and a $0.2 million increase in professional fees.
Net income for the three months ended March 31, 2020 was $1.7 million, or $0.10 per share, basic and diluted, compared to a net loss of $7.3 million, or $0.50 per share, basic and diluted, for the same period of 2019.

Henlius and Accord receive positive CHMP opinion for HLX02 oncological biosimilar (trastuzumab)

On June 1, 2020 Shanghai Henlius Biotech, Inc. (2696.HK) and Accord Healthcare Limited (Accord) reported that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency ( European Medicines Agency, EMA) issued a favorable opinion that recommended the market for the HLX02 biosimilar (trastuzumab injection) for the treatment of early HER-2-positive breast cancer, HER2-positive metastatic breast cancer and previously untreated HER-2-positive metastatic cancer Contains adenocarcinomas of the stomach or the transition area of ​​the esophagus into the stomach (Press release, Shanghai Henlius Biotech, JUN 1, 2020, View Source;816056005.html [SID1234560743]). According to the EMA-CHMP summary of this positive opinion, HLX02 is the reference product Herceptin (Trastuzumab) very similar. Data show that HLX02 is comparable to Herceptin in terms of quality, safety and effectiveness .

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HLX02 is a monoclonal biosimilar antibody (mAb) developed and manufactured by Henlius in accordance with biosimilar guidelines and will be marketed and marketed by Accord in Europe. The CHMP’s opinion is now being reviewed by the European Commission. A regulatory decision is expected over the next two to three months. As soon as a license is granted , a centralized marketing authorization is granted for all EU member states, Iceland, Norway and Liechtenstein .

Dr. Scott Liu , co-founder and CEO of Henlius , commented: "We are proud of CHMP’s favorable opinion on Henlius, as is the fact that Henlius’ capabilities in developing and manufacturing biological products are recognized by an international drug agency. We look forward to the launch of HLX02 as an alternative, high quality and affordable treatment option for patients with HER-2 positive breast cancer and gastric cancer. We will continue to work with Accord, make HLX02 more available in Europe and other regions, and continue to strive to support patients around the world. "

Dr. James Burt , Executive Vice President of Accord Europe and MENA added: "We are committed to providing oncology patients with access to safe, inexpensive drugs. The CHMP’s positive opinion is due to our in-depth expertise and our extensive portfolio of oncological therapies. Our agreement with Henlius reflects our longstanding commitment to biopharmaceutical development, research and manufacturing. "

EnGeneIC Announces Acceptance of Abstract to the Annual Meeting of the American Society of Clinical Oncology 2020

On June 1, 2020 EnGeneIC Limited, a clinical-stage biopharmaceutical company advancing its proprietary EDV nanocell platform for targeted cyto-immunotherapy in cancer, reported that an abstract on the Phase I/IIa clinical trial with EGFR-targeted EDV nanocells in patients with recurrent, metastatic pancreatic cancer has been accepted at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Scientific Program, which will be held from May 29-31, 2020 (Press release, EnGeneIC, JUN 1, 2020, View Source [SID1234560742]).

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The abstract, titled, "Interim Data: Phase I/IIa study of EGFR-targeted EDV nanocells carrying cytotoxic drug PNU-159682 (E-EDV-D682) with immunomodulatory adjuvant EDVs carrying α-galactosyl ceramide (EDV-GC) in patients with recurrent, metastatic pancreatic cancer," provides early data from nine patients in the ongoing open label Phase IIa study, the Carolyn Trial, in patients with treatment-refractory metastatic pancreatic cancer. To date, the EDVs carrying the cytotoxic drug and immune adjuvant have been well tolerated and demonstrated an excellent safety profile. Further, early signs point to durable response in patients in this extremely difficult-to-treat patient population, possibly related to the development of an innate and adaptive immune response as a result of direct cytotoxic effects on drug resistant tumor cells.

Professor Vinod Ganju, the Principal Investigator on the study at Frankston Private Hospital, Melbourne, said, "There have been no significant advances in the treatment of pancreatic cancer and the mortality rate remains very high. The EDV therapeutic is showing a remarkable safety profile and some patients have had prolonged periods of disease control without toxicity. Currently, modifications to dose and schedule are ongoing with the goal of achieving further substaintial improvement in anti-tumour efficacy."

Dr. Himanshu Brahmbhatt, Joint-CEO of EnGeneIC, stated, "this is the first time a super-cytotoxic drug designed to overcome serious multi-drug resistance in late stage cancers, has been safely delivered in patients. One aspect of the EDV’s unique mechanism of action was recently published in Cancer Cell in March 2020 and the associated cover art depicts the cyto-immunotherapeutic pathway in pictorial form (Cancer Cell, 37: 354-370 (2020)."

Details of abstract can be found at the ASCO (Free ASCO Whitepaper) Meeting Library.

Abstract Number: 4632
Title: "Interim Data: Phase I/IIa study of EGFR-targeted EDV nanocells carrying cytotoxic drug PNU-159682 (E-EDV-D682) with immunomodulatory adjuvant EDVs carrying α-galactosyl ceramide (EDV-GC) in patients with recurrent, metastatic pancreatic cancer"

Session: Gastrointestional Cancer, Gastroesophageal, Pancreatic, and Hepatobillary

Trial: View Source

BERG Presents Results of Phase 1 Clinical Study in Glioblastoma at 2020 American Society of Clinical Oncology (ASCO) Meeting

On June 1, 2020 BERG, a clinical-stage biotech company that uses Artificial Intelligence (AI) to research diseases and develop innovative treatments, reported results from a Phase 1 clinical study of its investigational drug, BPM 31510 (novel ubidecarenone formulation) in glioblastoma (GBM) (Press release, Berg, JUN 1, 2020, View Source [SID1234560741]). The study, presented at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper), highlights safety, tolerability and the impact of BPM 31510-IV influence on metabolism in patients, supporting planned Phase 2 clinical development.

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"At BERG, we understand the toll cancer takes not only on a patient, but also their loved ones, and we want to lead in the battle to fight the disease," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "BPM 31510 is a unique therapeutic modality targeting cell metabolism that is consistent with our proprietary Interrogative Biology platform. We are excited at the opportunities the findings will have in refining clinical development among multiple cancer indications, especially in brain cancers."

GBM is a destructive type of brain cancer often acknowledged for its steep morbidity and mortality rates. There are few effective treatment options available in the marketplace, thus substantiating the urgent need for novel therapeutic approaches to improve outcomes for this disease. BPM 31510 is a unique therapeutic modality which specifically targets cell metabolism and shifts the cancer’s glycolytic dependency toward mitochondrial oxidative phosphorylation. When applied, it induces oxidative stress and causes cell death, specifically of cancer cells. BPM 31510 serves as particularly relevant indication for GBM’s glycolytic dependency.

The study was led by Seema Nagpal, M.D. Clinical Associated Professor of Neurology & Neurological Sciences, and Lawrence Recht, M.D., Professor of Neurology & Neurological Sciences, both of Stanford University School of Medicine, with other Stanford Medicine researchers and in collaboration with BERG.

Details of the BERG presentation:
This Poster is available to registered 2020 ASCO (Free ASCO Whitepaper) Virtual Scientific Program attendees and can be viewed at:
View Source

In its commitment to serve patients afflicted with cancer, BERG has collaborated on other projects with leading institutions, like MD Anderson Cancer Institute (clinical trials) and Harvard/BIDMC (Project Survival), among others.