On August 27, 2020 Vaccibody reported that result of 2nd quarter 2020(Press release, Vaccibody, AUG 27, 2020, View Source [SID1234564136])

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Highlights:
Expansion of Vaccibody’s strategic focus to include Infectious Diseases
• Appointment of Gunnstein Norheim, Ph.D., as Director Infectious Diseases leading this new initiative
• VB C-02 trial with VB10.16 in combination with Roche’s immune-checkpoint inhibitor atezolizumab in advanced cervical cancer patients approved in all six participating countries, including Norway

Highlights after June 30th, 2020:
• Dosing of first patient in VB C-02 Phase II clinical trial with VB10.16 in combination with Roche’s immune-checkpoint inhibitor atezolizumab in advanced cervical cancer
• Vaccibody and Nektar Therapeutics dose first patient in Phase I/IIa trial arm evaluating VB10.NEO in combination with bempegaldesleukin (NKTR-214) and immune-checkpoint inhibitor in patients with head and neck cancer
• Finalization of patient enrolment in VB N-01 Phase I/IIa clinical trial with VB10.NEO neoantigen cancer vaccine in locally advanced or metastatic cancer patients

Michael Engsig, Chief Executive Officer at Vaccibody, comments: "This has been a very strong quarter in terms of bringing our projects forward. With the VB C-02 trial in advanced cervical cancer receiving approvals from relevant regulatory authorities in all the participating countries, followed by finalizing enrolment of the VB N-01 trial, this emphasizes our team’s ability to keep our operations running in spite of the challenging Covid-19 situation"

R&D update

VB10.NEO

VB10.NEO is an individualized neoantigen cancer vaccine:
• Clinical status: Phase I/IIa
• Cancer Indications: Melanoma, non-small cell lung cancer (NSCLC), clear renal cell carcinoma, urothelial cancer or squamous cell carcinoma of the head and neck (SCCHN),

Status and highlights
The good momentum in the screening and enrolment was maintained during the second quarter despite the Covid-19 situation. As per 21 August 2020 it was announced that the enrolment target of the 50 patients for the VB N-01 trial had been reached and the enrolment finalized. Patients have been enrolled across all six trial arms covering the respective indications. The best-in-class 100% manufacturing success of producing the VB10.NEO individualized vaccine for patients with a sufficient number of neoantigens continued.

VB10.16:

VB C-02 The clinical trial is based on VB10.16 + atezolizumab in advanced cervical cancer:

• Clinical status: Phase II
• Indication: HPV16+ advanced, non-resectable cervical cancer Status and highlights As per 30 June, four sites had been initiated in Belgium, Czech Republic and Norway and three were activated. Two patients were in screening and on 1 July, the first patient had received the first dose at the Oslo University Hospital in Norway.

Infectious Diseases Discovery and pre-clinical activities within infectious diseases have been initiated and early pre-clinical data are encouraging. Vaccibody’s strategic analysis and planning activities continue with the goal of presenting a comprehensive infectious disease strategy later in 2020.

Financial review

Income statement

The net result for 1H20 was a net loss of NOK 83.7 million compared to a NOK 39.1 million loss in 1H19. The increased loss was caused mainly by an increase in clinical development activities relating primarily to the inclusion and treatment of patients in VB N-01, a larger number of sites for accelerated patient recruitment, and expenses for preparations for the VB C-02 program.

Operating income

Total operating income amounted to NOK 2.6 million in 1H20 (NOK 5.7 million in 1H19) and consisted primarily of accrued grants from SkatteFUNN, a Norwegian government R&D tax incentive program.

Operating expenses
Total operating expenses amounted to NOK 95.1 million in 1H20 compared to NOK 45.8 million in 1H19. Employee expenses increased to NOK 20 million (1H19: NOK 11.5 million). The increase was primarily caused by the planned increase in employees.

Other operating expenses amounted to NOK 75.1 million in 1H20 (1H19: NOK 34.3 million), primarily due to a ramp-up of the ongoing VB N-01 program as well as expenses for preparations for the VB C02 clinical development program.Net financial income and expenses Net financial income and expenses increased to NOK 8.8 million in 1H20 compared to NOK 0.1 million in 1H19. The increase related primarily to currency gains on the Company’s cash held in EUR. Statement of financial position Cash At June 30, 2020, Vaccibody had a cash position of NOK 202.7 million compared to NOK 322.0 million at June 30, 2019. The change reflects the net results of the Company and cash received from the exercise of warrants. Equity At June 30, 2020, total equity amounted to NOK 192.7 million compared to NOK 320.3 million at June 390, 2019.

Outlook Three major clinical objectives for 2020 have already been reached, namely:
• Dose the first patient in the VB N-01 study arm with VB10.NEO in combination with Nektar Therapeutic’s bempegaldesleukin (NKTR-214)
• Complete the enrolment of patients into the Company’s VB N-01 clinical trial including the basket arm 5B which investigates VB10.NEO in combination with Nektar Therapeutic’s bempegaldesleukin (NKTR-214) Initiate enrolment in the VB C-02 trial investigating VB10.16 in combination with atezolizumab in patients with advanced or recurrent cervical cancer

An overview of Vaccibody’s outlook for the remainder of 2020 is provided in the table below. Further, Vaccibody will lay out its strategy for the Infectious Disease area later in 2020. Last, the Company is in continuous dialogue with academic and industrial entities and will announce new key collaborations and partnerships if or when they may occur.

Expected 2020 outlook and news flow regarding Vaccibody’s clinical trial R&D pipeline:At June 30, 2020, the Company had 3 074 986 active warrants outstanding to key employees and members of the board. According to the warrant contracts, any share split, such as the 1:5 split in July 2020, will have a neutral effect on the warrants, i.e. number of warrants are increased and the strike reduced by the split factor.

On August 27, 2020 Merck & Co reported that Drugs that block the checkpoint PD-1 to unleash an immune attack against cancer are effective in several tumor types, but figuring out why some patients don’t respond has been a challenge (Press release, Merck & Co, AUG 27, 2020, View Source [SID1234564134]). Now two separate teams have published research that could improve efforts to use immuno-oncology drugs in two of the hardest cancers to treat—lung cancer and glioblastoma.

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In the first study, researchers in China zeroed in on two cell-signaling pathways in glioblastoma that increase the production of PD-L1, a checkpoint protein that binds to PD-1 and cripples the immune system’s T cells. They discovered they could inhibit this process in mouse models of glioblastoma by combining an experimental compound from Merck, MK-2206, with an anti-PD-1 antibody. They published the study in the Journal of Experimental Medicine.

MK-2206 inhibits protein kinase B (AKT), which has long been a popular target in oncology research because of research showing that it promotes cancer cell survival and resistance to chemotherapy. Several trials of the drug were completed, and one that’s not sponsored by the company is ongoing in breast cancer. But a study published in 2019 concluded that MK-2206 had little clinical effect in breast cancer.

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Still, MK-2206 was of interest to the China research team because of its potential to be used in combination with PD-1 inhibitors. Their research showed that some glioblastoma patients have mutations that activate two pathways called Wnt and EGF signaling, which in turn activates the gene that makes PD-L1.

In the mouse models, MK-2206 alone boosted the number of T cells traveling to glioblastoma tumors, slowing tumor growth and prolonging survival, they reported. "Combining MK2206 with an anti-PD-1 antibody further enhanced T cell infiltration and was even more effective at blocking tumor growth," said co-senior author Jianxin Lyu, a professor at Wenzhou Medical University in China, in a statement.

RELATED: Merck’s oral cancer drug targeting STING boosts PD-1 immune blockade in mice

In the second study, a Spanish research team identified a non-coding RNA that helps lung cancer cells escape immune detection. Non-coding RNAs are produced in a part of the genome that’s often referred to as "junk DNA," because it doesn’t make proteins. So the role of these non-coding RNA molecules has been somewhat of a mystery.

Researchers at the University of Navarra in Pamplona studied 7,000 tumor samples and discovered that some lung cancer cells have extra copies of a gene that makes a non-coding RNA, which they dubbed amplified lncRNA associated with lung cancer-1 (ALAL-1). When they tamped down ALAL-1 in mice, tumor growth slowed, they reported in the Journal of Cell Biology.

ALAL-1 works by shuttling the enzyme USP4 into the cell nucleus, which influences the activity of more than 1,000 genes, the researchers discovered. That reduces signals that would normally attract cancer-killing immune cells, they said.

Inhibiting ALAL-1, therefore, "could have a ‘double-hit’ anti-tumor effect: on the one hand, by decreasing the autonomous capacity of cancer cells to survive and proliferate, and on the other hand, by promoting the ability of immune cells to infiltrate and attack the tumor," said co-author Maite Huarte of the University of Navarra in Pamplona, in a statement.

Huarte added that combining checkpoint inhibitors with drugs that block ALAL-1 could be a promising approach for treating lung cancer patients who fail to respond to immune-boosting drugs.

On August 27, 2020 ViewRay, Inc. (Nasdaq: VRAY) reported that the GenesisCare Foundation’s Compassionate Access Programme is now accepting patients for treatment on the MRIdian MRI-Guided Radiation Therapy System (Press release, ViewRay, AUG 27, 2020, View Source [SID1234564133]). The program, in collaboration with the University of Oxford, is available to eligible National Health Service (NHS) patients with localized pancreatic cancer and is designed to improve access to precision radiotherapy in the United Kingdom, where patients have variable access to this innovative treatment. This is particularly relevant for patients as the COVID-19 pandemic has reduced the availability and safety of surgery and chemotherapy.

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Eligible NHS patients who have medically inoperable, borderline operable, locally advanced and locally recurrent pancreatic cancer will be treated at GenesisCare’s center in Oxford using stereotactic ablative radiotherapy (SABR) on the U.K.’s first MRIdian machine free of charge. In addition, UK charity, the Pancreatic Cancer Research Fund is providing support for the cost of travel or accommodations associated with treatment.

Unlike conventional radiation therapy systems, MRIdian combines an MRI scanner with the radiation therapy system. This feature, together with other technical innovations, offers advantages for the delivery of safe and effective radiotherapy. These include the ability to see the tumor and surrounding tissue before and during treatment, allowing to adapt the therapy in response to changes in patient anatomy and tumor size between treatments, and to continuously track the tumor in real-time during treatment and pause the radiation if the tumor moves out of position. As a result, the system can deliver very high ablative radiation doses to the tumor while protecting the surrounding healthy tissue from damage.

Patients will be cared for on MRIdian using SABR techniques, also known as MRIdian SMART therapy, which deliver a high dose of radiation just to the tumor. The course of treatment is typically five daily sessions.

"MRIdian is at the cutting-edge of what is possible in radiotherapy technology. The ability to visualize the tumor more accurately, to follow it while it’s being treated and to adapt the plan every day means we can deliver the best possible outcomes," said Dr. James Good, Clinical Oncologist and Clinical Director of SABR at GenesisCare. "Patients with localized pancreatic cancer have variable access to precision radiotherapy, and during the COVID-19 pandemic, patients have been further disadvantaged by the reduced availability and safety of surgery and chemotherapy. The Compassionate Access Programme has two significant purposes. Firstly, to provide patients who otherwise would have limited, or sadly, no options with a viable treatment option. Secondly, to help demonstrate the effectiveness of this treatment, with the ambition to make it available for all patients in the future."

"We are thrilled to support this ground-breaking program, working with GenesisCare and the University of Oxford," said Dr. Martin Fuss, Chief Medical Officer at ViewRay. "Facilitating pancreatic cancer patient access to the MRIdian SMART therapy provides a safe and effective treatment for this deadly disease and the hope for longer survival for patients in the U.K."

The program is made possible through charitable funding from the GenesisCare Foundation, the Pancreatic Cancer Research Fund and ViewRay, the manufacturer of the MRIdian system. The initiative is also supported by a team of expert clinicians and the University of Oxford, who share a commitment to expanding the role of MRI-guided radiotherapy for pancreatic cancer through clinical trials.

More information about the program, eligibility criteria and paperwork to refer patients can be found at genesiscare.com/uk/cap.

Currently 38 MRIdian systems are installed at hospitals around the world, where they have treated nearly 10,000 patients with a wide variety of solid tumors. MRIdian is also the focus of numerous ongoing research efforts and has been the subject of hundreds of peer-reviewed publications, scientific meeting abstracts and presentations. For a list of treatment centers, please visit: View Source

On August 27, 2020 Sirtex Medical ("Sirtex"), a leading manufacturer of targeted liver cancer therapies, reported that Sirtex and its shareholders, China Grand Pharmaceutical and Healthcare Holdings Limited (CGP), have been issued a "Notice of Drug Clinical Trial Approval" by the National Medical Products Administration (NMPA) of the People’s Republic of China (Press release, Sirtex Medical, AUG 27, 2020, View Source [SID1234564132]).

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The notice confirms that SIR-Spheres Y-90 resin microspheres meet the relevant requirements for drug registration in China. With this confirmation, Sirtex is approved to file a New Drug Application (NDA) in the country.

"We are grateful to the members of CGP, Sirtex China and our Global Regulatory, Quality Assurance, Operations and Medical teams for their dedicated work in achieving this approval from the NMPA and navigating the complex regulatory process," said Kevin R. Smith, Chief Executive Officer of Sirtex. "This is a critical milestone toward allowing us to provide a valuable treatment option to people with liver cancer in China."

The announcement marks an important step in Sirtex’s journey to gain market entry into China, thanks to the company’s collaboration with its shareholder, CGP.

"We are proud of our team’s accomplishment and work to achieve this goal," said Weikun Tang, Ph.D., General Manager of Sirtex China. "We are excited for the opportunity to work together with CGP to bring SIR-Spheres Y-90 resin microspheres to our country’s patients."

On August 27, 2020 Lantern Pharma (NASDAQ: LTRN), a clinical stage biopharmaceutical company using its proprietary RADR artificial intelligence ("A.I.") platform to transform the pace, risk and cost of oncology drug discovery and development, and identify patients who will benefit from its targeted oncology drug candidates, reported that Panna Sharma, CEO and President, will provide company updates at the following investor events in September (Press release, Lantern Pharma, AUG 27, 2020, View Source [SID1234564131]):

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The LD Micro 500
Date/Time: September 1, 2020 at 2:40 p.m. ET

MedInvest AI, Big Data & Digital Health Conference
Date/Time: September 9, 2020 at 10:40 a.m. ET

Colliers Institutional Investor Conference
Date/Time: September 10, 2020 at 9:00 a.m. ET to 5:00 p.m. ET (1×1 only; no presentation)

H.C. Wainwright 22nd Annual Global Investor Conference
Date/Time: September 15, 2020 at 4:30 p.m. ET

AI 2020, 13th Annual BioPharm America Conference
Fireside Chat: Using AI to Optimize Drug Selection and Development, hosted by Zacks Investment Research John Vandermosten
Date/Time: September 21, 2020 at 11:45 a.m. ET
All meetings and presentations will be held virtually. Investors and media interested in meeting with Panna Sharma should contact Marek Ciszewski, J.D., at: [email protected] or +1.628.777.3167. Registered conference attendees may also request meetings through the respective conference registration system.