On June 1, 2020 Immutep Limited (ASX: IMM; NASDAQ: IMMP) reported that new interim data from its ongoing Phase II TACTI-002 study (Press release, Immutep, JUN 1, 2020, View Source [SID1234560749]). This data relates to the cut-off date of 4 May 2020 and shows improving efficacy results. The results were presented as a poster short talk by trial investigator, Dr Enriqueta Felip, of Vall d’Hebron University Hospital in Barcelona, Spain, at the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting. The poster presentation from Dr. Felip is available on the company’s website (click here).

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TACTI-002 is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of the Company’s lead product candidate eftilagimod alpha ("efti" or "IMP321") with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line Head and Neck Squamous Cell Carcinoma (HNSCC) or Non-Small Cell Lung Cancer (NSCLC) in first and second line.

Immutep CSO and CMO, Dr Frederic Triebel said: "TACTI-002 is generating increasingly promising data from both the NSCLC and HNSCC arms of study, as patients continue to receive efti in combination with KEYTRUDA. Remarkably, one HNSCC patient has even achieved a complete response, bringing the total response rate to an improved 39% in this arm. This is an early indication that the efti in combination with pembrolizumab may more than double the proportion of HNSCC patients that respond to pembrolizumab monotherapy, which is usually 18% or less1."

Trial investigator, Dr. Felip said: "It is encouraging to see that patients continue to receive benefit from the combination treatment. We now expect progression free survival to be more than 9 months for patients with 1st line NSCLC, significantly longer than the 5-6 months delivered by pembrolizumab monotherapy. We are alo seeing deeper responses in both arms with patients responding after a number of months of treatment. The improving data in both HNSCC and NSCLC patients supports the use of efti in combination with pembrolizumab as a promising new therapeutic option for patients."

Stage 1 Part A (1st line NSCLC, N=17):

iORR of 53%, with 9 out of 17 patients reporting a Partial Response (iPR) according to iRECIST.

71% (12/17) of patients with target lesion decrease (tumour shrinkage responses in all PD-L1 subgroups. 4 out of 9 patients with PRs had a Tumour Proportion Score less than 50% (typically less responsive to anti-PD-1 monotherapy such as pembrolizumab)

41% (7/17) of patients were still under treatment at data cut-off, indicating an estimated median PFS more than 9 months

All three PD-L1 subgroups present, indicating the trial is a PD-L1 all comer study

About the TACT-002 Trial

TACTI-002 (Two ACTive Immunotherapies) is being conducted in collaboration with Merck & Co., Inc., Kenilworth, NJ, USA (known as "MSD" outside the United States and Canada). The study is evaluating the combination of efti with MSD’s KEYTRUDA (pembrolizumab) in up to 109 patients with second line head and neck squamous cell carcinoma or non-small cell lung cancer in first and second line.

The trial is a Phase II, Simon’s two-stage, non-comparative, open-label, single-arm, multicentre clinical study that is taking place in up to 12 study centres across the U.S., Europe, UK and Australia.

Patients participating in three parts:

Part A – First line Non-Small Cell Lung Cancer (NSCLC), PD-X naive

Part B – Second line NSCLC, PD-X refractory

Part C – Second line Head and Neck Squamous Cell Carcinoma (HNSCC), PD-X naive

TACTI-002 is an all comer study in terms of PD-L1 status, a well-known predictive marker for response to pembrolizumab monotherapy especially in NSCLC. PD-L1 expression is typically reported in three groups for NSCLC: < 1%, 1-49% and ³50% (Tumour Proportion Score or TPS). Patients with a high PD-L1 status are typically more responsive to anti-PD-1 monotherapy such as pembrolizumab, whereas those with low PD-L1 status are overall significantly less responsive. Pembrolizumab monotherapy is registered in the US and the EU for first-line NSCLC patients with a TPS score ³1% (US) and ³50% (EU), reflecting 65% and 30% of all first line NSCLC patients, respectively.

On June 1, 2020 G1 Therapeutics, Inc. (Nasdaq: GTHX), a clinical-stage oncology company, reported that the company has entered into a debt financing agreement with Hercules Capital, Inc. (NYSE: HTGC) for up to $100 million (Press release, G1 Therapeutics, JUN 1, 2020, View Source [SID1234560748]). G1 plans to use the proceeds to fund commercialization and further development of trilaciclib, its first-in-class investigational therapy designed to improve outcomes for people with cancer treated with chemotherapy.

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"We expect to file a New Drug Application for trilaciclib later this month for myelopreservation in small cell lung cancer. This financing strengthens our balance sheet as we prepare for commercial launch in our first indication and to execute a robust development plan to evaluate trilaciclib in additional tumor types," said Mark Velleca, M.D., Ph.D., Chief Executive Officer.

The $100 million credit facility from Hercules is available in four tranches: the first tranche of $30 million is available at loan closing, of which the company plans to utilize $20 million immediately, with the remaining $10 million available through March 31, 2021; the second tranche of $20 million will be available upon achievement of U.S. Food and Drug Administration approval of trilaciclib in small cell lung cancer and initiation of a registrational trial in metastatic colorectal cancer, to be available from January 1, 2021 through December 15, 2021; an additional tranche of $30 million will be available from April 1, 2021 through December 31, 2022, subject to certain terms and conditions, including in connection with net product revenues for trilaciclib; and a final tranche of $20 million will be available prior to December 31, 2022 to support strategic initiatives, subject to future approvals by Hercules.

The term loan has a 24-month interest only period from date of closing, extendible up to 42 months upon achievement of certain conditions. Maturity of the loan is 48 months from date of closing, extendible up to 60 months upon achievement of certain milestones.

"This structured investment represents a significant commitment from Hercules and provides an example of the breadth of our platform and our ability to finance life sciences companies through all stages of development. We are excited to begin our partnership with the G1 management team as they advance the New Drug Application for trilaciclib and prepare for a commercial launch," said Bryan Jadot, Senior Managing Director and Life Sciences Group Head for Hercules.

Armentum Partners acted as the company’s sole financial adviser in connection with the loan facility.

On June 1, 2020 Nanjing Legend Biotech reported that it has set a proposed range of $18-$20 per ADS for the offering, which would raise $350 million and value Legend at $2.6 billion (Press release, Legend Biotech, JUN 1, 2020, View Source [SID1234560746]). In 2017, Legend surprised the world when its anti-BCMA CAR-T therapy produced a 94% overall response rate in pretreated multiple myeloma patients. Six months later, Janssen Pharma paid $350 million upfront to partner the candidate. Janssen has added another $110 million in milestones so far, and it could make up to $1.3 billion in remaining payments.

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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."

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.