On April 3, 2017 BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) reported that Mundipharma has obtained regulatory approval of Mundesine (Forodesine hydrochloride) for the treatment of relapsed/refractory PTCL (Peripheral T-Cell Lymphoma) by the Ministry of Health, Labor and Welfare in Japan (Press release, BioCryst Pharmaceuticalsa, APR 3, 2017, View Source [SID1234518417]). Mundesine is a Purine-nucleoside phosphorylase (PNP) inhibitor developed by BioCryst, under an exclusive license with Albert Einstein College of Medicine and Victoria Link Limited. The Ministry’s decision follows successful clinical trials and makes Japan the first country in the world to make Mundesine available for treatment of PTCL.

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In 2006, BioCryst entered into an exclusive sub-licensing agreement with Mundipharma for the development and commercialization of forodesine in the field of oncology. This agreement was amended and restated in 2011. As stated in their press release, Mundipharma is working to ensure that patients in Japan receive access to Mundesine as early as possible, which represents another positive step forward, as they strive to deliver more treatment options for cancer patients in Japan. Under the terms of the agreement with Mundipharma, BioCryst will receive tiered royalties ranging from the mid- to high-single digit percentages of net sales of Mundesine.

About Forodesine

Forodesine hydrocloride is an orally-available transition-state analog inhibitor of purine nucleoside phosphorylase (PNP), a purine salvage pathway enzyme that is essential for the proliferation of T-cells and B-cells. Typically, T-cells and B-cells are an essential part of the body’s immune system, but when they multiply uncontrollably they can cause various forms of cancer. Inhibiting PNP produces selective suppression of T-cells and B-cells, inducing apoptosis in both types of cells.

On April 3, 2017 AVEO Oncology (NASDAQ:AVEO) reported receipt of a $500,000 milestone payment from CANbridge Life Sciences Ltd., a biopharmaceutical company focused on developing western drug candidates in China and North Asia, related to a technology transfer milestone for AV-203, AVEO’s clinical-stage ErbB3 (HER3) inhibitory antibody candidate (Press release, AVEO, APR 3, 2017, View Source [SID1234518416]). AV-203 has demonstrated preclinical activity in a number of different tumor models including breast, head and neck, lung, ovarian and pancreatic cancers. CANbridge is planning clinical development of AV-203 in squamous cell esophageal cancer as its initial indication.

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"Receipt of this milestone payment from CANbridge reflects continued progress by our partner to engineer the manufacturing process for AV-203 in an effort to develop an antibody manufacturing process suitable for commercialization," said Michael Bailey, president and chief executive officer of AVEO. "We look forward to continued progress in this program, and with the balance of our partnered pipeline, including AV-380, a potentially disease modifying treatment for cachexia which is partnered with Novartis, and ficlatuzumab in development for squamous cell carcinoma of the head and neck and acute myeloid leukemia, which is partnered with Biodesix. With these programs advancing, we continue to focus on tivozanib, including continuing our execution of the TIVO-3 and TiNivo studies for our U.S. pivotal clinical strategy, and support of our licensee, EUSA Pharma, in its response to European regulators."

In March 2016, AVEO announced an exclusive collaboration and license agreement, granting CANbridge worldwide rights to AV-203, excluding the United States, Canada, and Mexico. Under the terms of the collaboration and license agreement, CANbridge paid AVEO an upfront payment of $1 million, and AVEO is also eligible to receive up to $133 million in reimbursement and milestone payments, assuming the successful achievement of specified development, regulatory and commercialization objectives. The transaction was awarded the 2016 Deal of the Year by RNDer, a leading Chinese publication providing value-added analysis for pharmaceutical and biotechnology companies conducting business in China. AVEO has retained North American rights to AV-203 and is also eligible for a tiered royalty, with a percentage range in the low double digits, on net sales of AV-203 in the partnered territories.

AVEO also announced today an update to its financial guidance. The Company believes its recently completed underwritten public offering, which yielded net proceeds of $15.5 million (on gross proceeds of $17.3 million), together with its existing cash resources, would be sufficient to fund its operations into the second quarter of 2018. This guidance excludes any potential partnership milestone payments to or from the Company, potential debt or equity financings, acceleration of existing debt principal payments under the term loan with Hercules which could result from non-compliance with the cash covenant of that agreement, or proceeds from any potential future partnership agreements.

As previously guided, top line data from the TIVO-3 trial, AVEO’s ongoing Phase 3 clinical trial of tivozanib in the third-line treatment of patients with refractory renal cell carcinoma (RCC), is anticipated in the first quarter of 2018.

On April 3, 2017 Novartis reported the European Commission has approved Tafinlar (dabrafenib) in combination with Mekinist (trametinib) for the treatment of patients with BRAF V600-positive advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Novartis, APR 3, 2017, View Source [SID1234518400]). The approval marks the first targeted treatment approved for the patient population, who previously had few treatment options, in all 28 member states of the European Union (EU), plus Iceland and Norway. Every year, it is estimated, up to about 36,000 people, or about 1-3% of patients with lung cancer, are diagnosed with BRAF V600-positive NSCLC worldwide[2],[3].

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"Today’s approval represents an important milestone for the lung cancer community, especially those patients living with the BRAF V600 mutation who previously had few options," said Bruno Strigini, CEO, Novartis Oncology. "At Novartis we are committed to bringing meaningful scientific advances that fill critical unmet needs to patients."

Today’s EU approval follows a positive opinion granted in February by the Committee for Medicinal Products for Human Use (CHMP), which was based on safety and efficacy of dabrafenib in combination with trametinib in a Phase II, three-cohort, multicenter, non-randomised and open-label study in which patients with stage IV BRAF V600E mutant NSCLC were enrolled (36 treatment-naïve [previously untreated] and 57 previously treated with chemotherapy).

For the primary endpoint of investigator-assessed overall response rate (ORR), 36 treatment-naïve patients receiving 150 mg of Tafinlar twice daily and 2 mg of Mekinist once daily demonstrated an ORR of 61.1% (95% confidence interval [CI]: 43.5%, 76.9%)[1]. In this population, 68% of patients had not progressed after 9 months[1]. The median duration of response (DoR) and progression free survival (PFS) in the previously untreated population were not yet reached at the time of approval[1]. In the previously treated population receiving the same dosage, patients demonstrated an ORR of 66.7% (95% CI: 52.9%, 78.6%)[1]. The response was durable with a median DoR reaching 9.8 months (95% CI: 6.9, 16.0)[1]. An in-depth analysis of data from the treatment-naïve cohort will be presented at an upcoming medical meeting.

The most common adverse events (incidence >20%) were pyrexia, nausea, vomiting, peripheral edema, diarrhea, dry skin, decreased appetite, asthenia, chills, cough, fatigue, rash, and dyspnoea[1].

The US Food and Drug Administration (FDA) granted Tafinlar + Mekinist Breakthrough Therapy designation for advanced or metastatic BRAF V600E-positive NSCLC patients in 2015 and Priority Review in November 2016. Combination use of Tafinlar + Mekinist is also approved in the US, Europe, Australia, Canada, and additional countries for patients with unresectable or metastatic melanoma whose tumors tested positive for the BRAF V600 mutation.

Novartis Commitment to Lung Cancer
Worldwide, lung cancer causes more deaths than colon, breast, and prostate cancer combined, and an estimated 1.8 million new cases of lung cancer are diagnosed each year[2], [4]. Among patients with NSCLC, roughly 30% have an actionable mutation that may be targeted with available therapies[5], [6], [7], [8]. To determine that treatment, medical organizations recommend biomarker testing for patients with lung cancer[9].

Novartis Oncology’s research into targeted therapies has helped transform treatment approaches for patients living with mutation-driven types of lung cancer. Patients with mutation-driven NSCLC may be candidates for treatment with targeted therapies[5].

Novartis continues its commitment to the global lung cancer community through ongoing studies, as well as the exploration of investigational compounds that target genetic biomarkers in NSCLC.

IMPORTANT SAFETY INFORMATION (ISI)
About Tafinlar + Mekinist Combination
Combination use of Tafinlar + Mekinist in patients with unresectable or metastatic melanoma who have a BRAF V600 mutation is approved in the US, EU, Australia, Canada, and additional countries. The combination of Tafinlar and Mekinist is also approved for the treatment of advanced non-small cell lung cancer with a BRAF V600 mutation in Europe.

Tafinlar and Mekinist target different kinases within the serine/threonine kinase family – BRAF and MEK1/2, respectively – in the RAS/RAF/MEK/ERK pathway, which is implicated in non-small cell lung cancer (NSCLC) and melanoma, among other cancers. When Tafinlar is used with Mekinist, the combination has been shown to slow tumor growth more than either drug alone. The combination of Tafinlar + Mekinist is currently being investigated in an ongoing clinical trial program across a range of tumor types conducted in study centers worldwide.

The safety and efficacy profile of the Tafinlar + Mekinist combination has not yet been established outside of the approved indications.

Tafinlar and Mekinist are also indicated in more than 40 countries worldwide, including the US and EU, as single agents to treat patients with unresectable or metastatic melanoma with a BRAF V600 mutation.

Tafinlar + Mekinist Combination Important Safety Information
Tafinlar + Mekinist combination may cause serious side effects.

Tafinlar in combination with Mekinist should only be used to treat patients with a change (mutation) in the BRAF gene; therefore, doctors should test their patients before treatment, as patients without a BRAF mutation and with a RAS mutation can be at risk of increased cell proliferation in the presence of a BRAF inhibitor.

Doctors should also consider other treatment options for their patients if they had been previously treated with a BRAF inhibitor as single agent, as the limited data available have shown that the efficacy of Tafinlar + Mekinist is lower in these patients.

When Tafinlar is used in combination with Mekinist, or when Tafinlar is administered as monotherapy, it can cause new cancers (both skin cancer and non-skin cancer). Patients should be advised to contact their doctor immediately for any new lesions, changes to existing lesions on their skin, or signs and symptoms of other malignancies.

Tafinlar in combination with Mekinist, or Mekinist alone, can cause severe bleeding, and in some cases can lead to death. Patients should be advised to call their healthcare provider and get medical help right away if they have headaches, dizziness, or feel weak, cough up blood or blood clots, vomit blood or their vomit looks like "coffee grounds," have red or black stools that look like tar, or any unusual signs of bleeding.

Tafinlar in combination with Mekinist, or either drug alone, can cause severe eye problems that can lead to blindness. Patients should be advised to call their healthcare provider right away if they get these symptoms of eye problems: blurred vision, loss of vision, or other vision changes, seeing color dots, halo (seeing blurred outline around objects), eye pain, swelling, or redness.

Tafinlar in combination with Mekinist, or Tafinlar alone, can cause fever, which may be serious. When taking Tafinlar in combination with Mekinist, fever may happen more often or may be more severe. In some cases, chills or shaking chills, too much fluid loss (dehydration), low blood pressure, dizziness, or kidney problems may happen with the fever. Patients should be advised to call their healthcare provider right away if they get a fever above 38.5oC (101.3oF) while taking Tafinlar.

Tafinlar in combination with Mekinist, or Mekinist alone, can affect how well the heart pumps blood. A patient’s heart function should be checked before and during treatment. Patients should be advised to call their healthcare provider right away if they have any of the following signs and symptoms of a heart problem: feeling like their heart is pounding or racing, shortness of breath, swelling of their ankles and feet, or feeling lightheaded.

Tafinlar in combination with Mekinist, or Tafinlar alone, can cause abnormal kidney function or inflammation of the kidney. Abnormal kidney function may happen more often for patients with fever or too much fluid loss. Patients should be advised to call their healthcare provider right away if they have a fever above 38.5oC (101.3oF), decreased urine, fatigue, loss of appetite, or discomfort in lower abdomen or back. Tafinlar has not been studied in patients with renal insufficiency (defined as creatinine > 1.5 x ULN), therefore caution should be used in this setting.

Tafinlar in combination with Mekinist, or Mekinist alone, can cause abnormal liver function. A patient may feel tired, lose appetite, yellow skin, dark urine colour, or discomfort in abdomen. The liver function abnormality needs to be assessed by laboratory test of the blood. Patients should consult their healthcare provider if they have such experience. Administration of Tafinlar or Mekinist should be done with caution in patients with moderate to severe hepatic impairment.

Elevations in blood pressure have been reported in association with Mekinist in combination with Tafinlar, or with Mekinist alone, in patients with or without pre-existing hypertension. Patients should be advised to monitor blood pressure during treatment with Mekinist and control potential hypertension by standard therapy, as appropriate.

Tafinlar in combination with Mekinist, or Mekinist alone, can cause inflammation of the lung tissue. Patients should notify their doctor if they experience any new or worsening symptoms of lung or breathing problems, including shortness of breath or cough.

Rash is a common side effect of Tafinlar in combination with Mekinist, or with Mekinist alone. Tafinlar in combination with Mekinist, or Mekinist alone, can also cause other skin reactions, which can be severe, and may need to be treated in a hospital. Patients should be advised to call their healthcare provider if they get any of the following symptoms: skin rash that bothers them or does not go away, acne, redness, swelling, peeling, or tenderness of hands or feet, skin redness.

Tafinlar in combination with Mekinist, or Mekinist alone, can cause muscle breakdown, a condition called Rhabdomyolysis. Patients experiencing muscle pain, tenderness, weakness, or a swelling of their muscles should contact their healthcare provide immediately.

Tafinlar in combination with Mekinist, or Tafinlar alone, can uncommonly cause an inflammation of the pancreas (pancreatitis). Patients should be promptly investigated if they experience unexplained abdominal pain and closely monitored if they re-start Tafinlar after a prior episode of pancreatitis.

Tafinlar in combination with Mekinist, or Mekinist alone, can cause blood clots in the arms or legs, which can travel to the lungs and can lead to death. Patients should be advised to get medical help right away if they have the following symptoms: chest pain, sudden shortness of breath or trouble breathing, pain in their legs with or without swelling, swelling in their arms or legs, or a cool or pale arm or leg.

Mekinist in combination with Tafinlar, or Mekinist alone, may increase the risk of developing holes in the stomach or intestine (gastrointestinal perforation). Treatment with Mekinist alone or in combination with Tafinlar should be used with caution in patients with risk factors for gastrointestinal perforation, including concomitant use of medications with a recognized risk of gastrointestinal perforation.

Tafinlar and Mekinist both can cause harm to an unborn baby when taken by a pregnant woman. Tafinlar can also render hormonal contraceptives ineffective.

The most common side effects of Tafinlar + Mekinist combination include fever, nausea, diarrhea, fatigue, chills, headache, vomiting, joint pain, high blood pressure, rash, and cough. The incidence and severity of fever is increased when Mekinist is used in combination with Tafinlar.

Patients should tell their doctor of any side effect that bothers them or does not go away. These are not all of the possible side effects of Tafinlar + Mekinist combination. For more information, patients should ask their doctor or pharmacist.

Patients should take Tafinlar + Mekinist combination exactly as their health care provider tells them. Patients should not change their dose or stop taking Tafinlar + Mekinist combination unless their health care provider advises them to. Mekinist should be taken only once daily (either in the morning or evening, at the same time as Tafinlar). The first and second doses of Tafinlar should be taken approximately 12 hours apart. Patients should take Tafinlar + Mekinist at least 1 hour before or 2 hours after a meal. Do not take a missed dose of Tafinlar within 6 hours of the next dose of Tafinlar. Do not open, crush, or break Tafinlar capsules. Do not take a missed dose of Mekinist within 12 hours of the next dose of Mekinist.

On April 3, 2017 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the phase III ALUR study met its primary endpoint, demonstrating that Alecensa (alectinib) significantly improved progression-free survival (PFS) in people with anaplastic lymphoma kinase (ALK)-positive advanced (metastatic) non-small cell lung cancer (NSCLC) who had progressed following treatment with one prior line of both platinum-based chemotherapy and crizotinib, compared with chemotherapy (Press release, Hoffmann-La Roche, APR 3, 2017, View Source [SID1234518398]).1 The peer-reviewed data will be published later this year.

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"We are pleased to announce that the results of the phase III ALUR trial further support the use of Alecensa as a treatment for people with ALK-positive lung cancer who, after having progressed on both chemotherapy and crizotinib, are in need of new treatment options", said Sandra Horning, MD, Chief Medical Officer and Head of Global Product Development. "The results of this trial will support our access discussions with global health authorities as we seek to bring Alecensa to patients faster."
Alecensa received conditional marketing authorisation from the European Commission in people with ALK-positive NSCLC previously treated with crizotinib on 16 February 2017,2 based on the results of the phase I/II NP286733 and NP287614 studies. Alecensa is also approved as a monotherapy (alone) for people with ALK-positive NSCLC who have progressed on or are intolerant to crizotinib in the US and nine other countries globally.5 In addition, Alecensa is approved in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).6
Alecensa is also being explored as a first-line treatment option with the phase III ALEX study comparing Alecensa to crizotinib in ALK-positive NSCLC.7 The ALEX study is expected to report data in the first half of 2017.
Approximately 75,000 people globally are diagnosed with ALK-positive NSCLC every year.8,9,10 It is a distinct form of lung cancer commonly diagnosed in younger people (median age 52),11 and in women (approximately 54% of cases).12 ALK-positive NSCLC is also generally found in those with a light or non-smoking history. 13
About the ALUR study1

ALUR (NCT02604342) is a randomised, multi-centre, open-label phase III study evaluating the efficacy and safety of Alecensa versus chemotherapy (pemetrexed or docetaxel) in people with ALK-positive NSCLC previously treated with one prior line of both platinum-based chemotherapy and crizotinib. People were randomised (2:1) to receive either Alecensa or chemotherapy. The primary endpoint of the ALUR study is PFS and secondary endpoints include: overall survival (OS), central nervous system (CNS) objective response rate (ORR) in people with measurable brain metastases at baseline and median time to CNS progression. The multicentre study was conducted in 119 people across 15 countries.
About the NP28673 and NP28761 studies

NP28673 is a phase I/II global, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 138 people with ALK-positive NSCLC whose disease progressed on crizotinib.3 NP28761 is a phase I/II North American, single arm, open-label, multicentre trial evaluating the safety and efficacy of Alecensa in 87 people with ALK-positive NSCLC whose disease progressed on crizotinib.4 A pooled analysis from the NP28673 and NP28761 studies showed that Alecensa shrank tumours in 52.2% (95% CI: 39.7%, 64.6%) of people with advanced ALK-positive NSCLC whose disease had progressed following treatment with crizotinib (overall response rate; ORR).3,4 The NP28673 study also showed that Alecensa extended the time that people lived without their disease worsening or death (PFS) by a median of 8.9 months3 (95% CI: 5.6, 12.8), while the NP28761 study demonstrated a median PFS benefit of 8.2 months14 (95% CI: 6.3, 12.6) with Alecensa.
In addition, a pooled analysis of the two studies showed that Alecensa shrank CNS tumours that were measurable in 64% of people (95% CI: 49.2%, 77.1%), and 22% (n=-29) achieved a complete response of their measurable and non-measurable CNS tumours.15
About Alecensa

Alecensa (RG7853/AF-802/RO5424802/CH5424802) is an oral medicine created at Chugai Kamakura Research Laboratories and is being developed for people with NSCLC whose tumours are identified as ALK-positive. ALK-positive NSCLC is often found in younger people who have a light or non-smoking history.13 It is almost always found in people with a specific type of NSCLC called adenocarcinoma.13 Alecensa is currently approved in the United States, Europe, Kuwait, Israel, Hong Kong, Canada, South Korea, Switzerland, India, Australia and Taiwan for the treatment of advanced (metastatic) ALK-positive NSCLC whose disease has worsened after, or who could not tolerate treatment with, crizotinib and in Japan for people whose tumours were advanced, recurrent or could not be removed completely through surgery (unresectable).5,6
In a pooled analysis of CNS endpoints from studies NP28673 and NP28761, Alecensa demonstrated activity in brain metastases, indicating that the drug may be taken up in the brain.14 The brain is protected by the blood-brain barrier, a network of tightly joined cells that line the inside of the blood vessels in the brain and spinal cord.16 One of the ways the blood-brain barrier prevents molecules from affecting the brain is to actively eject them from the barrier through a process known as ‘active efflux’.17 The active efflux system does not recognise Alecensa, which means that it may travel into and throughout brain tissue.3,4
The global phase III ALEX study of Alecensa includes a companion test developed by Roche Diagnostics. Alecensa is marketed in Japan by Chugai Pharmaceutical, a member of the Roche Group.
About Roche in lung cancer

Lung cancer is a major area of focus and investment for Roche, and we are committed to developing new approaches, medicines and tests that can help people with this deadly disease. Our goal is to provide an effective treatment option for every person diagnosed with lung cancer. We currently have four approved medicines to treat certain kinds of lung cancer and more than ten medicines being developed to target the most common genetic drivers of lung cancer or to boost the immune system to combat the disease.

On April 2, 2017 Precision-Biologics Inc. reported an abstract reporting data on the company’s neo-antigen program has been accepted for an oral presentation at the upcoming 110th Annual Meeting of the American Association of Clinical Research (AACR) (Free AACR Whitepaper) in Washington D.C., April 1-5, 2017 (Press release, Precision Biologics, APR 2, 2017, View Source [SID1234518432]).

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"Precision Biologics continues to make progress with our preclinical and clinical programs," said Philip M. Arlen, President and CEO of Precision Biologics. "As this study demonstrates, our novel, humanized IgG1 monoclonal antibody, NEO-201, specifically targets a neoantigen expressed on a broad range of solid tumors. Tumor cell killing, antibody-dependent, cell-mediated cytotoxicity (ADCC), was significantly enhanced when NEO-201 was combined with an allogenic source of natural killer cells provided by NantKwest (Nasdaq:NK)."

Patrick Soon-Shiong, MD, Chairman and CEO of NantCell added, "These results highlight the potential to synergistically improve the response of antibody therapy when used in combination with NantKwest’s off-the-shelf natural killer cells." Dr. Soon-Shiong continued," Neoantigen targeting is an attractive, emerging therapeutic approach to next generation cancer care and NEO-201, with specificity to tumor tissues and not normal tissues, offers the potential to further improve response rates and look to transitioning this NEO-201/NK cell combination into human clinical trials targeting ovarian, GI and other cancer types as quickly as possible."

Presentation Summary
Preclinical characterization of a novel monoclonal antibody targeting a neo-antigen expressed in ovarian and GI malignancies

Abstract #3025,View Source!/4292/presentation/5981
Presenter: Kristen Zeligs, MD Walter Reed National Military Medical Center, Bethesda, MD
Monday, April 3, 2017, 4:05-4:20PM, Ballroom A-B

This oral presentation will present preclinical data demonstrating the potential benefit of targeting the NEO-201 neoantigen in both cancer cell lines as well as patient’s tumors. NEO-201 monoclonal antibody was shown to mediate ADCC activity, which was further enhanced when used with allogenic natural killer cells in tumor cell lines expressing the NEO-201 neoantigen. The NEO-201 antigen is expressed on numerous solid tumors with minimal expression on healthy tissue. The company plans to move this program into human clinical trials in the near future.
In October 2015, NantCell Inc., a subsidiary of NantWorks, LLC, acquired a majority stake in Precision Biologics with a $50 million investment. NantCell made the investment to further its efforts to activate the human immune system to treat the biology of cancer and avoid the toxic effects of standard chemotherapy. With Precision Biologics proprietary library of cancer vaccines, NantCell is working on developing compounds that could change the way cancer is detected and treated.