On March 11, 2019 ASLAN Pharmaceuticals (Nasdaq:ASLN, TPEx:6497), a clinical-stage oncology-focused biopharmaceutical company developing novel therapeutics for global markets, and BioGenetics Co Ltd, a leading South Korean healthcare company, reported that they have expanded their strategic collaboration by entering into a new commercialisation agreement whereby both parties will partner to commercialise ASLAN003 in all indications in South Korea (Press release, ASLAN Pharmaceuticals, MAR 11, 2019, View Source [SID1234534264]).

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ASLAN will grant BioGenetics exclusive rights to commercialise ASLAN003 in South Korea in exchange for an upfront payment of US$1 million and up to US$8 million in sales and development milestones. ASLAN is also eligible to receive tiered double digit royalties on net sales from the high-teens to the mid-twenties range. BioGenetics will contribute to the global R&D costs incurred by ASLAN in the clinical development of ASLAN003 in acute myeloid leukaemia (AML) and will be responsible for obtaining initial and all subsequent regulatory approvals of ASLAN003 in South Korea.

ASLAN003 is an orally active, potent inhibitor of human dihydroorotate dehydrogenase (DHODH) that has the potential to be first-in-class in AML. ASLAN is currently conducting a phase 2a dose optimisation study of ASLAN003 in AML and expects to complete the study in the first half of 2019. ASLAN recently presented preliminary data from the study at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, in which ASLAN003 showed early signs of safety and efficacy in relapsed and refractory AML patients. In previous clinical studies, ASLAN003 has demonstrated potent inhibition of DHODH, a lack of toxicities associated with first generation inhibitors and other novel AML therapies, and the potential to induce differentiation in blast cells and applicability in a broad range of AML patients. ASLAN003 has been awarded orphan drug designation from the US Food and Drug Administration.

In 2018, the estimated five-year prevalence of leukaemia in South Korea was 10,9481. AML has previously been reported to be the most frequent subtype among all myeloid malignancies2 in South Korea.

Dr Carl Firth, Chief Executive Officer of ASLAN Pharmaceuticals, commented: "We believe that ASLAN003 has the potential to be a first-in-class therapy for AML and are pleased that BioGenetics has chosen to partner with us as we continue the phase 2 development of this important asset. We have already seen early signs of clinical activity and look forward to the read out from the first part of the ongoing study later this year."

JooHoon Ahn, Chief Executive Officer of Biopharma, BioGenetics, commented: "We are delighted to be partnering with ASLAN for the second time as we build a pipeline of innovative drugs that we believe have the potential to address significant unmet needs for Korean patients. We are excited by the data that ASLAN003 has generated to date and its potential in a broad range of AML patients."

The agreement for ASLAN003 is ASLAN’s second commercialisation agreement with BioGenetics. In February 2019, ASLAN signed an agreement with BioGenetics whereby both parties will collaborate to commercialise ASLAN’s lead asset, varlitinib, in all indications in South Korea.

ASLAN acquired the global rights to develop and commercialise ASLAN003 in May 2012 from Almirall. Under the terms of the agreement, ASLAN is required to pay Almirall a low double-digit percentage of all licensing revenues received.

On March 11, 2019 ArQule, Inc. (Nasdaq: ARQL) reported that Paolo Pucci, Chief Executive Officer, and Marc Schegerin, Senior Vice President and Head of Strategy, Finance and Communication, will participate in the 31st Annual ROTH Conference on March 17-19, 2019 in Dana Point, California (Press release, ArQule, MAR 11, 2019, View Source [SID1234534212]).

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On March 11, 2019 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported that it will hold a teleconference for shareholders on March 25, 2019 (Press release, Nymox, MAR 11, 2019, View Source [SID1234534198]).

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Management will discuss the Company’s current business progress with an update on its regulatory submission activities in the US and EU. Further details re time and coordinates and information for the call will be provided prior to the teleconference.

For more information please contact [email protected] or 800-936-9669.

On March 11, 2019 Pfizer Inc. (NYSE: PFE) reported that the United States (U.S.) Food and Drug Administration (FDA) has approved TRAZIMERA (trastuzumab-qyyp), a biosimilar to Herceptin (trastuzumab),1 for the treatment of human epidermal growth factor receptor-2 (HER2) overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma (Press release, Pfizer, MAR 11, 2019, View Source [SID1234534205]).

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The FDA approval was based on review of a comprehensive data package, which demonstrated a high degree of similarity between TRAZIMERA and the originator product. This includes results from the REFLECTIONS B327-02 clinical comparative study that was recently published in the British Journal of Cancer, which showed clinical equivalence, finding a high degree of similarity and no clinically meaningful differences between TRAZIMERA and the originator product in patients with first line HER2 overexpressing metastatic breast cancer.3

"Approximately 15-30% of breast cancers and 10-30% of gastric cancers are HER2-positive, which is associated with aggressive disease and poor prognoses for patients," said Dr. Mark Pegram, associate director for clinical research at the Stanford Comprehensive Cancer Institute, and director of the Breast Oncology Program at the Stanford Women’s Cancer Center.4 "With the availability of biosimilars like TRAZIMERA in the U.S., oncologists will have additional treatment options to choose from, which may help provide patients with greater access to the medicines they need."

Pfizer has a robust portfolio of potential biosimilar candidates in mid- to late-stage development.5 TRAZIMERA is Pfizer’s first oncology monoclonal antibody (mAb) biosimilar and Pfizer’s fifth biosimilar to be approved by the FDA.2,6,7,8,9 TRAZIMERA was also approved for use in the EU in July 2018 for the treatment of HER2 overexpressing breast cancer and HER2 overexpressing metastatic gastric or gastroesophageal junction adenocarcinoma.10

About TRAZIMERA (trastuzumab-qyyp)

TRAZIMERA is a monoclonal antibody (mAb) biosimilar of the originator biologic medicine, Herceptin, which targets HER2, a protein found on the surface of some cancer cells which can stimulate the cells to divide and grow.11 TRAZIMERA locks on to the HER2 protein and blocks the receptors, stopping cell division and growth.10

As part of the REFLECTIONS clinical trial program, TRAZIMERA has been studied in nearly 500 patients and across more than 20 countries to date.12,13,14,15,16

TRAZIMERA IMPORTANT SAFETY INFORMATION

Possible Serious Side Effects With TRAZIMERA (trastuzumab–qyyp)

Not all people have serious side effects, but side effects with TRAZIMERA therapy are common.

Although some people may have a life-threatening side effect, most do not.

Your doctor will stop treatment if any serious side effects occur.

TRAZIMERA is not for everyone. Be sure to contact your doctor if you are experiencing any of the following:

HEART PROBLEMS

These include heart problems—such as congestive heart failure or reduced heart function—with or without symptoms. The risk for and seriousness of these heart problems were highest in people who received both trastuzumab and a certain type of chemotherapy (anthracycline). In a study of adjuvant (early) breast cancer, one patient died of significantly weakened heart muscle. Your doctor will check for signs of heart problems before, during, and after treatment with TRAZIMERA.

INFUSION REACTIONS, including:

Fever and chills
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Pain (in some cases at tumor sites)
Headache
Dizziness
Shortness of breath
These signs usually happen within 24 hours after receiving TRAZIMERA.

Be sure to contact your doctor if you:

Are a woman who could become pregnant, or may be pregnant

TRAZIMERA may result in the death of an unborn baby or birth defects. Contraception should be used while receiving TRAZIMERA and after your last dose of TRAZIMERA. If you are exposed to TRAZIMERA during pregnancy or within 7 months of becoming pregnant, you are encouraged to report TRAZIMERA exposure to Pfizer at 1-800-438-1985.

Have any signs of SEVERE LUNG PROBLEMS, including:

Severe shortness of breath
Fluid in or around the lungs
Weakening of the valve between the heart and the lungs
Not enough oxygen in the body
Swelling of the lungs
Scarring of the lungs
Your doctor may check for signs of severe lung problems when he or she examines you.

Have LOW WHITE BLOOD CELL COUNTS

Low white blood cell counts can be life threatening. Low white blood cell counts were seen more often in patients receiving trastuzumab plus chemotherapy than in patients receiving chemotherapy alone.

Your doctor may check for signs of low white blood cell counts when he or she examines you.

Side Effects Seen Most Often With trastuzumab

Some patients receiving trastuzumab for breast cancer had the following side effects:

Fever
Feeling sick to your stomach (nausea)
Throwing up (vomiting)
Infusion reactions
Diarrhea
Infections
Increased cough
Headache
Feeling tired
Shortness of breath
Rash
Low white and red blood cell counts
Muscle pain
Some patients receiving trastuzumab for metastatic stomach cancer had the following side effects:

Low white blood cell counts
Diarrhea
Feeling tired
Low red blood cell counts
Swelling of the mouth lining
Weight loss
Upper respiratory tract infections
Fever
Low platelet counts
Swelling of the mucous membranes
Swelling of the nose and throat
Change in taste

You should contact your doctor immediately if you have any of the side effects listed above.

On March 11, 2019 Stemline Therapeutics, Inc. (Nasdaq: STML), a commercial-stage biopharmaceutical company focused on the development and commercialization of novel oncology therapeutics, reported that it has exclusively licensed worldwide rights to develop and commercialize a novel, oral, selective small molecule RET (rearranged during transfection) kinase inhibitor from the CRT Pioneer Fund LP, a £70 million specialist oncology investment fund managed by Sixth Element Capital, a UK based fund manager (Press release, Stemline Therapeutics, MAR 11, 2019, View Source [SID1234534227]). The RET inhibitor was rationally designed by scientists at Cancer Research UK Manchester Institute at the University of Manchester (United Kingdom). The preclinical compound has been designated SL-1001 and is expected to enter the clinic in 2020.

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RET kinase genetic alterations have been found in a diverse range of cancers and, we believe, is a clinically validated target in multiple indications. SL-1001 is an oral RET kinase inhibitor that has demonstrated potent, selective, preclinical anti-cancer activity, both in vitro and in vivo, in RET-driven tumor models.

"SL-1001 is an ideal strategic fit for us, given its targeted mechanism of action and potential for streamlined development," commented Stemline’s CEO, Ivan Bergstein. He continued, "Building upon our team’s proven track record of success, culminating with the recent ELZONRIS approval, we intend to advance SL-1001 swiftly through the clinical and regulatory process with an eye towards achieving our goal of helping more patients succeed in their fight against cancer."

Robert James, Managing Partner at Sixth Element Capital said, "We are delighted to have partnered SL-1001 with Stemline. We are confident that Stemline’s skills and resources will take the project forward rapidly and offer an alternative treatment option to patients with cancer driven by RET kinase".