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 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 Moleculin Biotech, Inc., (Nasdaq: MBRX) ("Moleculin" or the "Company"), a clinical stage pharmaceutical company with a broad portfolio of drug candidates targeting highly resistant tumors, reported it has completed the latest (210 mg/m2) cohort in its European open label, single arm Phase 1/2 clinical trial of Annamycin for the treatment of relapsed or refractory acute myeloid leukemia ("AML"). A total of 19 patients have been treated in the US and Europe, and all results continue to show Annamycin to be safe, and, especially, all have shown Annamycin to be free of cardiotoxicity. Of those,10 have been treated at or above the FDA lifetime maximum anthracycline exposure.

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The Phase 1 portion of this clinical trial, which is described in more detail later in this press release, is designed to establish the safety of Annamycin and to determine the Recommended Phase 2 Dose to be used in the Phase 2 portion of the trial. While the Primary Endpoint of the Phase 1 portion is safety, a Secondary Endpoint is the assessment of efficacy generally defined as an improvement in bone marrow biopsy results sufficient to qualify patients for a potentially curative bone marrow transplant. The Company cautions not to place undue reliance on interim results.

The fourth cohort in Poland receiving a single dose of 210 mg/m2 in the Phase 1 dose escalation portion of the trial was completed with no adverse events and the trial will continue to the next cohort of 240 mg/m2. To date in the European trial, only one adverse event related to Annamycin has been reported; a patient experienced grade 2 mucositis (which resolved to grade 1 within 2 days). In the Company’s recently completed Phase 1 portion of a parallel US Phase 1/2 clinical trial, there were no unexpected serious adverse events (SAE) and no dose limiting toxicities (DLT) at any dose tested.

We refer to Annamycin as a "next generation anthracycline," because it is designed to provide enhanced therapeutic benefits when compared with traditional anthracyclines while reducing the potential for unwanted cardiotoxicity, or damage to the heart. This design intent has previously been validated with preclinical toxicology studies in animal models (as required by FDA) demonstrating Annamycin has little to no cardiotoxicity when compared with doxorubicin. Of the 19 patients treated thus far in both trials, none has shown any evidence of cardiotoxicity. This includes 10 patients in Poland who were treated at levels above the US maximum allowable cumulative anthracycline dose level (550 mg/m2), a limitation not imposed on our trial in Europe. If upheld in further studies, we believe this lack of toxicity would be an important differentiator between Annamycin and the currently approved anthracyclines, for which cardiotoxicity is a well-known treatment limitation.

Walter Klemp, Chairman and CEO of Moleculin commented, "Now that we are relying upon the European trial to establish an RP2D, and now that it is becoming apparent that the safety profile of Annamycin is even better than we expected, we will explore opportunities to increase the dosing increment between cohorts to speed up the establishment of the Recommended Phase 2 Dose or RP2D. We continue to target establishing the RP2D before the end of the year, but of course this will depend upon the continued rate of recruitment and the actual point at which we begin to see dose limiting toxicities."

The U.S. trial met its primary endpoint, demonstrating the safety of Annamycin in AML patients. Most importantly, all patients reflected the absence of cardiotoxicity (potential damage to the heart), as determined by echocardiograms, as well as cardiac health biomarkers, principally blood troponin levels. Based on testing to date, no patients in either the US or European trial have exhibited evidence of cardiotoxicity. Additionally, there were no unexpected serious adverse events (SAE) and no dose limiting toxicities (DLT) at any dose tested. Although a primary objective of the Phase 1 trial was to evaluate safety, the study also gathered data to support a preliminary assessment of the product’s efficacy. Among other things, the study recorded complete response (CR), partial response (PR), event-free survival (EFS), overall survival (OS; Kaplan-Meier), and time to and duration of remission/response. The Company reported efficacy in 33% of the US patients, even though the drug was dosed at what was expected to be sub-therapeutic levels. The evidence of efficacy consisted of 1 patient who achieved a "morphologically leukemia-free state," which the protocol defined as a CR with incomplete recovery of platelets or neutrophils, and another patient who had a substantial remission of leukemia cutis (a somewhat rare leukemia symptom), from diffuse to 3 lesions.
In all but one of the 7 relapsed patients treated in our Poland trial, a reduction in blasts in the bone marrow aspirate occurred. Of those 7, 2 qualified as PRs and 1 qualified as a bridge-to-transplant. In the last cohort, only 1 patient was relapsed, and that patient had a 33% reduction in bone marrow blasts. In all three patients in the 210 mg/m2 cohort (1 relapsed and 2 refractory), a reduction of circulating blasts to <2% was achieved during treatment.

On April 2, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel or highly differentiated biologics to treat diseases with significant unmet medical needs, particularly cancers and autoimmune disorders, reported that the first patient was dosed with TJC4 in a Phase 1/2a clinical trial evaluating its use in treating patients with relapsed or refractory acute myeloid leukemia (r/r AML) or myelodysplastic syndrome (MDS) in China (Press release, I-Mab Biopharma, APR 2, 2020, View Source [SID1234556100]). TJC4, also known as TJ011133, is an internally developed differentiated anti-CD47 monoclonal antibody that is designed to minimize inherent binding to normal red blood cells while preserving its strong anti-tumor activity.

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The clinical trial in China is a multi-center, open-label, single-arm study to evaluate the safety, tolerability, pharmacokinetics/pharmacodynamics and preliminary efficacy of TJC4 as a monotherapy in patients with r/r AML and MDS (CXSL1900039; NCT04202003;). I-Mab is also conducting a Phase 1 trial (NCT Number: NCT03934814) in the U.S. in patients with advanced solid tumors and lymphoma, with complete data from the dose escalation portion expected in the third quarter of 2020.

"We have been at full speed conducting clinical development of TJC4 in both U.S. and China," said Dr. Joan Shen, CEO of I-Mab. "Dosing the first patient in China represents another important milestone, both for our TJC4 program and for patients, as TJC4 stands out as a globally competitive, highly differentiated anti-CD47 asset for cancer treatment. Together with the Phase 1 dose escalation study of TJC4 in the U.S., we continue to leverage our clinical development capabilities and expertise to facilitate clinical validation of TJC4 in China and the U.S."

About CD47 and TJC4

CD47 is a glycoprotein over-expressed in a wide variety of cancers and delivers a "don’t eat me" signal to tumor-engulfing macrophages through its ligand SIRPα, and is one of the most promising immuno-oncology targets after PD-1 and PDL1.

TJC4 is a differentiated anti-CD47 monoclonal antibody and designed to minimize inherent binding to normal red blood cells by this class of monoclonal antibodies yet preserve its strong anti-tumor activities. Blockade of CD47 by TJC4 enables macrophages to engulf cancer cells. TJC4 recognizes a unique epitope on CD47 and exhibits minimal binding to red blood cells. The hematologic safety advantage of TJC4 has been demonstrated in a series of robust pre-clinical and toxicological studies including those in cynomolgus monkeys, while it maintains superb anti-tumor activities.

On April 2, 2020-Helix BioPharma Corp. (TSX: HBP) ("Helix" or the "Company"), an immuno-oncology company developing innovative drug candidates for the prevention and treatment of cancer, reported a corporate update (Press release, Helix BioPharma, APR 2, 2020, View Source [SID1234556099]).

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COVID-19
As countries across the globe face an unprecedented public health crisis due to COVID-19, Helix has taken various measures to protect the health and well-being of our staff while maintaining business continuity.

The office and laboratory of Helix in Canada have been following the recommendations of federal, provincial and regional authorities. This includes operating a safe and clean working environment, providing work at home facility and observing latest public health guidance such as ‘social distancing’. Except for a limited number of staff at the laboratory to maintain critical infrastructure operation, all Helix personnel are working from remote locations.

Clinical Development initiatives The Company’s U.S. Phase I L-DOS47 lung cancer study in combination with pemetrexed and carboplatin (LDOS001) has completed patient recruitment. Study reports are being compiled and an abstract has been submitted to a conference. As previously reported in the Company’s recently filed Q2 fiscal 2020 filings, the Company’s European Phase II L-DOS47 lung cancer study in Poland and Ukraine (LDOS003) no longer requires patient enrollment. The Company indicated that the first stage of the study related to dose escalation would be concluded and progression to the second stage of the study would only proceed if a third-party was willing to partner with the Company on the study and upon a confirmatory medical review.

The Company’s U.S. Phase 1b/II pancreatic study of L-DOS47 in combination with doxorubicin (LDOS006) continues to enroll patients and has dosed two patients. Given the COVID-19 crisis however, the Company expects patient enrollment will be impacted. Helix is working closely with the clinical trial site and the hospital to ensure best care is being provided to patients while ensuring Helix complies with their COVID-19 protocols.

Corporate initiatives COVID-19 has created significant uncertainty and has materially impacted equity markets globally at a time when the Company was in the planning process of up-listing to the U.S. and raising additional capital. Nevertheless, the Company continues to engage both U.S. and Canadian investment bankers and is preparing for a capital raise in combination with an up-listing on the NASDAQ. Though the Company previously expected to conduct road shows and face-to-face meetings with potential investors during the month of April 2020, COVID-19 has made it impossible to do so. Instead, the Company expects to conduct online meetings and conference calls.

The Company recently closed a $6,000,000 private placement which included the disposition of a 15.5% stake in the Company’s Polish subsidiary, Helix Immuno-oncology S.A. ("HIO"). As previously disclosed, the Company intends to fully divest its remaining 51.0% interest in HIO to raise additional capital to further fund the Company’s clinical development programs while retaining a licensing arrangement for future royalties and milestone payments.

As a result of the recent private placement the Company is in a sound financial position allowing management to operate as normally as possible, in light of COVID-19. Given that the duration and magnitude of the impact on the economy and the Company’s business from COVID-19 is unknown, the Company has implemented a review of 2 operations in order to reduce or defer spending where possible, while maintaining key clinical and business program priorities.

The Company thanks all its staff who responded quickly and professionally as well as all our stakeholders who continue to support our Company during these challenging times.