On March 17, 2020 SkylineDx shares research showing that multiple myeloma (blood cancer) patients with a high risk or aggressive course of the disease are unlikely to benefit from current treatment approaches, including lenalidomide mono-therapy for maintenance when compared to observation only (Press release, SkylineDx, MAR 17, 2020, View Source [SID1234555660]). The Institute of Cancer Research (ICR) in London (UK), derived these results from the NCRI Myeloma XI trial with 329 patients and validated the findings in MRC Myeloma IX trial after which they published the findings in Nature Leukemia. The conclusion of the paper supports the use of so-called "molecular biomarkers" in the clinic to build a molecular profile of the patient’s cancer to better guide the most effective treatment strategy at diagnosis [2].

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The "aggressiveness" of the disease is measured with biomarkers per individual patient and translated into a standard-risk (normal course of the disease), a high-risk (progressive or more aggressive disease) and an ultrahigh-risk (fast progressive or most aggressive disease) profile. One of the biomarkers used is the MMprofiler with SKY92 algorithm. This biomarker reads the expression of 92 genes from the cancerous plasma cell and calculates if a patient is at high risk of progression, or in other words, if the cancer is more aggressive [2].

According to the published manuscript, the MMprofiler with SKY92 is independently able to predict the cancer’s aggressiveness in newly diagnosed patients. In 24.6% of patients, the SKY92 high-risk biomarker was present, resulting in a significant shorter period until disease progression (median of 16 months versus 33.8 months for non-SKY92 high-risk patients) and a significantly reduced overall outlook (50% of these high-risk patients died within 36.7 months versus a median that was not reached at 60 months for non-SKY92 high-risk patients). These results are regardless of induction treatment and posttransplant treatment strategy. Furthermore, if a patient bears the SKY92 high-risk marker, lenalidomide as maintenance therapy does not give the patient a significant longer relapse free period or a better overall outlook. That means that a patient can obtain the same result by being closely observed without taking the medicine and suffer accompanying adverse reactions [2].

"The publication by this esteemed group of researchers and clinicians is the independent confirmation that molecular biomarkers like SKY92 need to be adopted in clinical practice to avoid true fast progressing high-risk patients being missed at diagnosis," comments Dharminder Chahal, CEO of SkylineDx that developed the MMprofiler with SKY92 algorithm. "It shows that SKY92 identifies an additional 12% of high-risk patients for whom this information is currently not available but would impact their treatment decision. These patients need to be informed since they could clearly follow a different clinical path," concludes Dharminder Chahal.

On March 17, 2020 Pfizer Inc. (NYSE:PFE) reported investors and the general public to view and listen to a webcast of a conference call with investment analysts at 10 a.m. EDT on Tuesday, April 28, 2020 (Press release, Pfizer, MAR 17, 2020, View Source [SID1234555645]). The purpose of the call is to provide an update on Pfizer’s results, as reflected in the company’s First Quarter 2020 Performance Report, to be issued that morning.

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To view and listen to the webcast and view the Performance Report, visit our web site at www.pfizer.com/investors. Information on accessing and pre-registering for the webcast will be available at www.pfizer.com/investors beginning today. Participants are advised to pre-register in advance of the conference call.

You can also listen to the conference call by dialing either (866) 669-8582 in the United States and Canada or (702) 495-1304 outside of the United States and Canada. The password is "First Quarter Earnings".

On March 17, 2020 NeoPhore Limited, a small molecule cancer immuno-oncology company, reported the appointment of Dr Matthew Baker as Chief Executive Officer (CEO). Dr Baker was previously Vice President of Immunology at NeoPhore and will be succeeding Jeff Roix with immediate effect (Press release, NeoPhore, MAR 17, 2020, View Source [SID1234555661]).

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Dr Baker has more than 20 years’ experience in the pharmaceutical and biotechnology industries. Before joining NeoPhore, Dr Baker was Chief Scientific Officer of Denceptor Therapeutics Ltd, Abzena plc and was Chief Executive Officer and cofounder of Antitope Ltd. Prior to this, he served as Vice President for Biologics Discovery at Biovation Ltd. Dr Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK, after obtaining his PhD in cellular immunology at the University of Birmingham. Dr Baker is currently Non-Executive Director at Oxgene Ltd.

Commenting on today’s announcement Robert James, Chairman of Neophore said: "On behalf of the board and management I would like to thank Jeff for his contribution to NeoPhore and am very pleased to welcome Dr Matthew Baker as CEO. This is an exciting time for NeoPhore as it continues to develop its leading position in DNA mismatch repair (MMR) drug discovery. Matthew’s leadership skills and years of experience as a research expert in cell immunology will prove invaluable as NeoPhore enters the next phase of growth."

Newly appointed Chief Executive Officer, Dr Matthew Baker added: "Having been involved in the development of NeoPhore’s drug discovery programmes since June 2019, I am extremely excited by the technology and am delighted to take on the role of CEO. NeoPhore’s highly differentiated approach to targeting MMR has real potential to generate first-in-class next-generation immuno-oncology therapeutics. Together with the management team and board, I look forward to maximising the company’s pipeline of MMR drugs, as we progress from the lab to the clinic, ultimately improving outcomes for patients."

On March 17, 2020 Varian (NYSE: VAR) reported, Proton International at UAB has now treated its first cancer patient with the Varian ProBeam Compact proton therapy system (Press release, Varian Medical Systems, MAR 17, 2020, View Source [SID1234555646]). The center, a collaboration between The University of Alabama at Birmingham (UAB) and Proton International, opened in January 2020 and is the first proton therapy center in Alabama and one of only 35 proton therapy centers in the United States.

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"We celebrate this first of many patients who will be treated at UAB with this advanced technology," said Will Ferniany, Ph.D., CEO of the UAB Health System. "The Varian ProBeam system is one of the most advanced tools available and our physicians are now able to improve care and precision of treatment for their cancer patients. With this technology, we will improve the quality of life for many cancer patients and their families in Alabama and the Southeast."

Dr. James Bonner, chairman of the UAB Radiation Oncology Department added, "This is a landmark moment for the patients of Alabama. After so many years of planning, we have been able to bring this technologically advanced treatment to the UAB Cancer Center."

Proton therapy is the most sophisticated radiotherapy technology available today. It uses protons, accelerated to about two-thirds the speed of light, or more than 100,000 miles per second, to destroy cancer cells, while minimizing exposure to nearby healthy tissues.

"We are pleased to have reached this important milestone for the patients of Alabama and the region," said Chris Chandler, CEO of Proton International. "Together with Varian and UAB, this public – private approach has resulted in the development of a unique service that otherwise may not have been available to patients. Varian’s commitment has resulted in enhanced care for patients."

"One of our primary goals at Varian is to improve cancer care for patients around the globe," said Kolleen Kennedy, president, Proton Solutions and chief growth officer at Varian. "Through our partnership with Proton International and UAB, cancer patients in Alabama now have access to the most advanced, efficient and effective treatment, closer to home."

The Varian ProBeam Compact system is the only clinical single room system capable of fully rotational intensity modulated proton therapy (IMPT). Treatments can be delivered with an unmatched combination of speed, flexibility and cost efficiency. The full-featured ProBeam Compact includes a cyclotron, high-definition pencil beam scanning technology for IMPT, a fully rotational gantry, robotic patient positioning tools, and a comprehensive suite of motion management tools. It incorporates cone beam CT imaging for positioning the patient based on high quality anatomical images with excellent soft tissue resolution, and Varian’s world-class Eclipse and ARIA software systems for the planning and managing of treatments.

On March 17, 2020 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, reported an update on the previously reported interim data from an ongoing phase I/II clinical trial, in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to evaluate 4D pharma’s lead oncology candidate, MRx0518, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), in patients with advanced malignancies who have previously responded and whose disease has then progressed on PD-1/PD-L1 inhibitors (Press release, 4d Pharma, MAR 17, 2020, View Source [SID1234555662]).

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The additional data has been presented to delegates of Chardan’s virtual 2nd Annual Microbiome Medicines Summit, on March 16, 2020. The data was presented by Duncan Peyton, CEO and Alex Stevenson, CSO, 4D pharma. The presentation provides additional detail on headline interim results from the phase I/II clinical trial announced on November 6, 2019. The trial is being conducted, and data compiled at MD Anderson, University of Texas, US.

The data is the first global clinical confirmation of a live biotherapeutic product (LBP) initiating a response in cancer patients. The patients in the live biotherapeutic clinical trial had all previously received multiple lines of treatment with little efficacy, exhausting all currently approved treatment options. 4D pharma believes that the data provide evidence that adding the Company’s product, MRx0518, to the checkpoint inhibitor treatment regimen can induce tumour responses in patients who have previously become refractory to these therapies. 4D believes that, if demonstrated in larger studies, the addition of MRx0518 to checkpoint therapy will enable approved checkpoint inhibitors to work more effectively, for a longer duration, and in a wider patient population.

The phase I/II 4D pharma study is an open label trial to evaluate the safety and preliminary efficacy of MRx0518 and KEYTRUDA in patients with renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC) and bladder cancer, who have developed resistance to PD-1/PD-L1 inhibitors. Checkpoint therapies, whilst capable of producing durable anti-tumour responses, are not effective in all patients. In addition, those who do respond can develop resistance over time, leading to disease progression. The study has been designed to investigate this effect in patients with advanced metastatic disease.

Clinical observations from the first six patients in part A were presented, including:

Two partial responses (PR) with evidence of tumor shrinkage who remain on study (one patient for over 10 months)
One patient with stable disease (SD), remains on study for over eight months
Evidence of increased tumor-infiltrating lymphocytes (TILs) following treatment
No drug related serious adverse events
Specifically, one stage IV NSCLC patient had received seven lines of therapy over nearly three years with little response. In this patient the combination of MRx0518 + KEYTRUDA achieved an overall 51% reduction in target tumors at last assessment. The patient has now been on drug for 41 weeks.

"The further interim data from the Phase I/II trial provide significant potential for fresh treatment options for oncology patients that have exhausted all other currently approved therapies," said Duncan Peyton, CEO, 4D pharma.

He added: "4D pharma is now delivering the first global clinical evidence of the therapeutic potential of oral live biotherapeutics in cancer. This confirms the significant impact of microbiome immuno-oncology to the pharmaceutical industry in providing additional treatments for patients with underserved needs and little available therapeutic options. This clinical validation of live biotherapeutics to impact diseases external to the gut significantly supports our wider clinical pipeline in other areas such as neurodegeneration and other cancers."

Recruitment for the trial continues to progress as expected, with recruitment for Part A now completed. 4D expects to announce data for all 12 Part A subjects in Q2 and to commence enrolment for Part B, which will expand the study based on the Part A data. It is expected that the study will be expanded to additional international trial locations and sites, initially in the US. 4D pharma also expects to discuss the findings from Part A and avenues for accelerated development with the regulatory agencies.