On April 2, 2020 Oncolytics Biotech Inc. (NASDAQ: ONCY) (TSX: ONC), currently developing pelareorep, an intravenously delivered immuno-oncolytic virus, reported positive clinical data published in a peer-reviewed journal highlighting that the combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising efficacy signals in colorectal cancer patients with KRAS mutated tumors (Press release, Oncolytics Biotech, APR 2, 2020, View Source [SID1234556102]). The article, entitled "Elucidation of Pelareorep Pharmacodynamics in a Phase I Trial in Patients with KRAS Mutated Colorectal Cancer," authored by Dr. Sanjay Goel, Department of Medical Oncology, Montefiore Medical Center, Albert Einstein College of Medicine, Bronx, NY, et al., was published on March 10, 2020, in Molecular Cancer Therapeutics.

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The study enrolled 36 patients with KRAS mutation in a dose-escalation trial, of which 30 patients were assessable for response. The combination of FOLFIRI, bevacizumab and pelareorep was well tolerated, with promising signals of efficacy. Six patients received the recommended phase 2 dose (RP2D), at which a 50% overall response rate and a median overall survival (OS) of 25.1 months were observed, which compares favorably to the historical OS of 13.5 months (an 86% improvement). Among 30 evaluable patients, 6 (20%) had a partial response (PR) and 22 patients (73.3%) had stable disease (SD) as their best response, for a clinical benefit rate (PR +SD) of 93.3%.

Enhanced efficacy elicited by the administration of pelareorep was supported by evidence of an adaptive immune response occurring after each cycle of pelareorep treatment. Rapid maturation of dendritic cells was observed at 48 hours, from a baseline mean of 4.5% to a mean of 18.6% (4.1 fold change, p=0.000016), followed by an increase in absolute CD8 (2.4 fold change, p=0.00015) and CD4 (3.5 fold change, p=0.00015), on day 4. The most important observation was the activation of CD8 cells (CD8+ CD70+) on day 8, from a baseline mean of 1.5% to a mean of 18.8% (12.9 fold change, p=0.0009). These dramatic immune responses were only seen after pelareorep administration and not with the other medications alone, strongly suggesting that pelareorep is influencing these responses. In addition, on-treatment tumor biopsies revealed replicating virus (pelareorep), thereby demonstrating successful and efficient intravenous (systemic) delivery.

"Pelareorep combined with FOLFIRI, bevacizumab triggers a robust adaptive immune response, highlighting a unique pattern of dendritic cell maturation followed by CD8 T cell activation that was observed after every dose of pelareorep," said Dr. Rita Laeufle, Chief Medical Officer at Oncolytics Biotech. "Importantly, we have received great interest from key opinion leaders who are eager to work with pelareorep in gastrointestinal cancers, and this paper supports that interest. Our biomarkers of T cell clonality and CEACAM6, along with these promising efficacy findings, have allowed us to craft a clear clinical strategy in gastrointestinal cancers, and we look forward to providing updates on those plans in the near future."

Molecular Cancer Therapeutics, a monthly medical journal published by the American Association for Cancer Research (AACR) (Free AACR Whitepaper), Inc. (AACR) (Free AACR Whitepaper), strives to be the top choice for publishing the best science in the discovery and preclinical development of novel therapeutic agents for oncology. A copy of the paper can be found on our website: View Source

About Pelareorep

Pelareorep is a non-pathogenic, proprietary isolate of the unmodified reovirus: a first-in-class intravenously delivered immuno-oncolytic virus for the treatment of solid tumors and hematological malignancies. The compound induces selective tumor lysis and promotes an inflamed tumor phenotype through innate and adaptive immune responses to treat a variety of cancers and has been demonstrated to be able to escape neutralizing antibodies found in patients.

On April 2, 2020 Dilon Technologies Inc., a world class global leader in breast cancer treatment and diagnosis and owner of the Navigator Gamma Probes reported that it has acquired substantially all the assets of Dune Medical, including Dune Medical’s "MarginProbe" (Press release, Dune Medical Devices, APR 2, 2020, View Source [SID1234556800]).

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"With the acquisition of the MarginProbe, Dilon will now offer the only FDA approved device for identifying positive margins during breast conservation surgery. MarginProbe’s patented RF technology differentiates cancerous versus healthy tissue in real-time. This allows surgeons to immediately remove additional tissue, helping to reduce avoidable surgeries" said Dilon’s Chairman, Bob Moussa, who continued, "The synergy between Dilon’s Navigator Gamma Probes and the MarginProbe will help patients and physicians answer the question, "did we get it all?" when that answer is most needed. In addition to the advantages to the patients, the reduction in re-excision rate will provide major savings to health care systems."

As a global provider of breast cancer solutions, Dilon’s Navigator Gamma Probes are used for radio-guided lymphatic mapping and tumor localization world-wide. "The combination of Dilon’s class leading Navigator Gamma Probes with the MarginProbe is a natural fit. Dilon’s already strong sales network is synergistic and well suited to expand the MarginProbe’s potential as the products are literally used side by side by the same physician; now they will be sold that way as well. The market in the United States alone exceeds $150m annually, and as a US based company, Dilon has a home field advantage in the MarginProbe’s biggest market. Luminaries and thought leaders have already adopted MarginProbe as their standard of care in the US. Our goal is to make MarginProbe the standard of care worldwide."

On April 2, 2020 Pfizer Inc. (NYSE: PFE) reported that the European Commission (EC) has approved RUXIENCE (rituximab), a monoclonal antibody (mAb) and biosimilar to MabThera (rituximab), for the treatment of non-Hodgkin’s lymphoma (NHL), chronic lymphocytic leukemia (CLL), rheumatoid arthritis (RA), granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA), and pemphigus vulgaris (PV).1,2,3 (Press release, Pfizer, APR 2, 2020, View Source [SID1234556103])

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"The approval of biosimilars such as RUXIENCE is an important development for the treatment of certain cancers and autoimmune conditions," said Igor Aurer, M.D., Ph.D., Professor of Medicine and Head of Hematology Division, University Hospital Centre Zagreb, Croatia. "It’s a step toward allowing clinicians an additional treatment option which can help improve access for patients in need of this established medicine."

The EC approval is based on a comprehensive data package which demonstrated biosimilarity of RUXIENCE to the reference product. This includes results from the REFLECTIONS B3281006 clinical comparative study, which evaluated the efficacy, safety and immunogenicity, pharmacokinetics and pharmacodynamics of RUXIENCE and found no clinically meaningful differences in safety or efficacy compared to the reference product in patients with CD20-positive, low tumor burden follicular lymphoma.4

"Biosimilars like RUXIENCE exhibit a similar safety and efficacy profile to the originator product and have the potential to improve treatment access while reducing healthcare costs," said Masum Hossain, regional president, Oncology International Developed Markets at Pfizer. "Building on our ongoing commitment to bring biosimilars to market, we look forward to making RUXIENCE available to patients in the EU in the coming months."

Biosimilars have been a significant catalyst for change for the healthcare industry over the last decade, with the potential to help create more sustainable healthcare systems. With more than 10 years of global in-market experience and a portfolio which now includes seven approved biosimilar products in Europe, Pfizer is proud to be a leader and at the forefront of this vital healthcare segment. This approval follows the positive recommendation from the Committee for Medicinal Products for Human Use (CHMP) in January 2020.5 RUXIENCE was recently made available to adult patients in the United States for the treatment of NHL, CLL, GPA and MPA and also launched in Japan in January 2020.

About RUXIENCE (rituximab biosimilar)

RUXIENCE is a monoclonal antibody (mAb) biosimilar to MabThera which works by targeting a protein called CD20, which is present on the surface of B lymphocytes, also known as B cells. When it attaches to CD20, rituximab helps destroy these B cells.

RUXIENCE safety information

Do not use RUXIENCE if you are allergic to rituximab or other proteins which are like rituximab or any of the other ingredients of this medicine, if you have a severe active infection at the moment or if you have a weak immune system.

RUXIENCE should also not be used if you have severe heart failure or severe uncontrolled heart disease and have rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris.

Before starting treatment with RUXIENCE, talk to your doctor, pharmacist or nurse if:

you have ever had or might now have a hepatitis infection. This is because in a few cases, RUXIENCE could cause hepatitis B to become active again, which can be fatal in very rare cases. Patients who have ever had hepatitis B infection will be carefully checked by their doctor for signs of this infection
you have ever had heart problems (such as angina, palpitations or heart failure) or breathing problems
you are pregnant, think that you might be pregnant or are planning to become pregnant
Tell your doctor, pharmacist or nurse if you are taking, have recently taken or might take any other medicines. This includes medicines obtained without a prescription and herbal medicines. In particular, tell your doctor if:

you are taking medicines for high blood pressure
you have ever taken medicines which affect your immune system – such as chemotherapy or immune-suppressive medicines
If you have been diagnosed with rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, also tell your doctor if:

you think you may have an infection, even a mild one like a cold. The cells that are affected by RUXIENCE help to fight infection and you should wait until the infection has passed before you are given RUXIENCE
you had a lot of infections in the past or suffer from severe infections
you think you may need any vaccinations in the near future, including vaccinations needed to travel to other countries. Some vaccines should not be given at the same time as RUXIENCE or in the months after you receive RUXIENCE
If you are not sure, talk to your healthcare professional before you are given RUXIENCE.

Like all medicines, RUXIENCE can cause side effects, although not everybody gets them. Most side effects are mild to moderate, but some may be serious and require treatment. Rarely, some of these reactions have been fatal.

Infusion reactions

RUXIENCE is given by intravenous infusion into your vein. During or within the first 24-hours of the infusion you may develop fever, chills and shivering. Less frequently, some patients may experience pain at the infusion site, blisters, itching, sickness (nausea), tiredness, headache, breathing difficulties, blood pressure raised, wheezing, throat discomfort, tongue or throat swelling, itchy or runny nose, vomiting, flushing or palpitations, heart attack or low number of platelets. If you have heart disease or angina, these reactions might get worse.

Tell the person giving you the infusion immediately if you develop any of these symptoms, as the infusion may need to be slowed down or stopped. You may require additional treatment such as an antihistamine or paracetamol.

Infections

You might get infections more easily during your treatment with RUXIENCE. Tell your doctor immediately if you get signs of an infection including:

fever, cough, sore throat, burning pain when passing urine or feeling weak or generally unwell
memory loss, trouble thinking, difficulty walking or sight loss – these may be due to a very rare, serious brain infection, which has been fatal (Progressive Multifocal Leukoencephalopathy or PML)
If you are being treated for rheumatoid arthritis, granulomatosis with polyangiitis, microscopic polyangiitis or pemphigus vulgaris, you will also find this information in the Patient Alert Card you have been given by your doctor. It is important that you keep this Alert Card and show it to your partner or caregiver. Your doctor will also give you a patient booklet with more detailed information on the risks and symptoms of infections and PML.

Skin reactions

Very rarely, severe blistering skin conditions that can be life-threatening may occur. Redness, often associated with blisters, may appear on the skin or on mucous membranes, such as inside the mouth, the genital areas or the eyelids, and fever may be present. Tell your doctor immediately if you experience any of these symptoms.

Other very common side effects of RUXIENCE treatment include:

If you are being treated for non-Hodgkin’s lymphoma or chronic lymphocytic leukemia:

bacterial or viral infections, bronchitis
low number of white blood cells, with or without fever or blood cells called "platelets"
feeling sick (nausea)
bald spots on the scalp, chills, headache
lower immunity – because of lower levels of antibodies called "immunoglobulins" (IgG) in the blood which help protect against infection
If you are being treated for rheumatoid arthritis:

infections such as pneumonia (bacterial)
pain on passing water (urinary tract infection)
allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion
changes in blood pressure, nausea, rash, fever, feeling itchy, runny or blocked nose and sneezing, shaking, rapid heartbeat, and tiredness
headache
changes in laboratory tests carried out by your doctor. These include a decrease in the amount of some specific proteins in the blood (immunoglobulins) which help protect against infection
If you are being treated for granulomatosis with polyangiitis or microscopic polyangiitis:

infections, such as chest infections, pain on passing water (urinary tract infections), colds and herpes infections
allergic reactions that are most likely to occur during an infusion, but can occur up-to 24-hours after infusion
diarrhea
coughing or shortness of breath
nose bleeds
raised blood pressure
painful joints or back
muscle twitches or shakiness
feeling dizzy
tremors (shakiness, often in the hands)
difficulty sleeping (insomnia)
swelling of the hands or ankles
If you are being treated for pemphigus vulgaris:

allergic reactions that are most likely to occur during an infusion, but can occur up to 24 hours after infusion
long lasting depression
loss of hair
RUXIENCE may also cause changes in laboratory tests carried out by your doctor. If you are having RUXIENCE with other medicines, some of the side effects you may get may be due to the other medicines.

Please refer to the European Summary of Product Characteristics for RUXIENCE for complete safety information.

On April 2, 2020 Phio Pharmaceuticals Corp. (Nasdaq: PHIO), a biotechnology company developing the next generation of immuno-oncology therapeutics based on its proprietary self-delivering RNAi (INTASYL) therapeutic platform, reported the closing of its previously announced registered direct offering of 1,713,064 shares of common stock, at a purchase price of $2.335 per share, for gross proceeds of approximately $4.0 million priced at-the-market under Nasdaq rules (Press release, Phio Pharmaceuticals, APR 2, 2020, View Source [SID1234556104]). Phio has also issued to the investors unregistered warrants to purchase up to an aggregate of 1,713,064 shares of common stock.

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The warrants have an exercise price of $2.21 per share of common stock, are exercisable immediately and will expire five and one-half years following the date of issuance.

The Company intends to use the net proceeds from the offering to fund the development of its immuno-oncology programs, other research and development activities and for general working capital needs.

The shares of common stock (but not the warrants or the shares of common stock underlying the warrants) were offered by the Company pursuant to a "shelf" registration statement on Form S-3 (File No. 333-224031) previously filed with the Securities and Exchange Commission (the "SEC") on March 29, 2018 and declared effective by the SEC on April 6, 2018. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered were filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail at [email protected].

The warrants described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act"), and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants, have not been registered under the Act, or applicable state securities laws. Accordingly, the warrants and underlying shares of common stock may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On April 2, 2020 Exact Sciences Corp. (NASDAQ: EXAS) reported it would be devoting significant patient education resources toward the ability to request Cologuard online through a telehealth provider (Press release, Exact Sciences, APR 2, 2020, View Source [SID1234556086]). During the COVID-19 pandemic, people are staying home to avoid spreading the virus. Telehealth offers a way to screen more people at home, even during a public health crisis.

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"Cancer doesn’t stop for anything. As the country faces a pandemic, we are letting people know they can request Cologuard online from a health care provider, without an office visit," said Kevin Conroy, Exact Sciences chairman and CEO. "While Americans are at home trying to prevent the spread of COVID-19 in their communities, they can address another pressing public health issue and get screened for colorectal cancer."

Colorectal cancer, the second leading cancer killer in the U.S.,1 is more treatable when detected early, making timely screening essential. 2 Despite this, an estimated 53,000 Americans will die this year from colorectal cancer.1 As the only FDA-approved stool DNA test for colorectal cancer, Cologuard found 92% of all colorectal cancers,3 including 94% in stages I and II4 in a large clinical study of patients 50 and older. The United States Preventive Services Task Force (USPSTF) recommends Cologuard as a screening test for average risk patients.5 Patients can use Cologuard without any preparation or changes in diet and medication. The Cologuard collection kit is delivered to a patient’s door, and home pick-up can be scheduled by calling Exact Sciences Laboratories’ 24/7 Customer Care Center at 1-844-870-8870. Test results are provided to the ordering physician in approximately 14 days.

People can visit Cologuardtest.com to learn more about telehealth options for their screening needs, including how telehealth providers can review patient information and risk factors and, if appropriate, prescribe Cologuard. Cologuard is intended to screen adults 45 years of age or older, who are at average risk for colorectal cancer. It is not a replacement for colonoscopy in high-risk individuals. Cologuard is available by prescription only.

Any positive Cologuard test result should be referred for a diagnostic colonoscopy. Recognizing it may be challenging to schedule a follow-up colonoscopy immediately during the COVID-19 pandemic, Exact Sciences is actively exploring ways we may be able to support patients as they navigate those next steps.

Exact Sciences’ testing labs remain operational at this time. Business continuity plans are in place at all sites to help sustain operations and ensure continuity of service for patients during this unprecedented time. Customer Care teams are available 24/7 to help patients complete their Cologuard collection kit and schedule an at-home pick-up by calling 1-844-870-8870. Cologuard kits can also be dropped at any UPS location.