On September 22, 2016 Antibe Therapeutics Inc. ("Antibe") (TSXV: ATE, OTCQX: ATBPF), a commercial-stage pharmaceutical growth company, reported anti-cancer potential of its lead drug, ATB-346 (Press release, Antibe Therapeutics, SEP 22, 2016, View Source [SID:SID1234515305]). In a separate study earlier this year, ATB-346 was shown to be very effective in reversing colon and intestinal tumour growth in mice. Further to this study, a new publication has shown promising results in the chemoprevention and treatment of melanoma in mice. Melanoma is one of the most drug-resistant and invasive types of cancer, and both the incidence and mortality rates are increasing.

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"Although we remain focused on our ongoing human studies to advance ATB-346 as a treatment for pain and inflammation, we have compelling data from studies of colon cancer and now melanoma," commented John Wallace, Chief Scientific Officer of Antibe. "We are encouraged by these preliminary data and plan to continue this research in support of the potential advancement of ATB-346 into selected cancer indications."

In the new publication, Dr. Angela Ianaro’s laboratory at the University of Naples (Italy), in collaboration with Dr. Wallace, examined the possibility that ATB-346 may have greater beneficial effects in terms of reducing melanoma than naproxen, the most-prescribed nonsteroidal anti-inflammatory drug ("NSAID") in the USA. NSAIDs have been shown to reduce tumour growth, but they also cause significant gastrointestinal bleeding. In contrast, ATB-346 has been shown to be GI-safe in animal studies.

The effects of ATB-346 were first compared to naproxen in an in vitro melanoma model, and was found to be much more effective. The investigators then implanted melanoma cells into mice, and monitored the growth of tumours. Treatment with naproxen had a modest beneficial effect, reducing tumour volume by 23% and tumour weight by 20%. In contrast, treatment with an equivalent dose of ATB-346 was 3-times more effective, reducing tumour volume by 69% and tumour weight by 61%. Mechanistic studies confirmed that ATB-346 was more effective in promoting death (apoptosis) of cancer cells.

The article was published online in the September issue of the journal "Pharmacological Research" and can be found at: www.sciencedirect.com/science/article/pii/S1043661816304467

On September 22, 2016 Syros Pharmaceuticals (NASDAQ: SYRS) reported that the first patient has been dosed in the Phase 2 clinical trial of its lead drug candidate, SY-1425, a first-in-class selective retinoic acid receptor alpha (RARα) agonist, in genomically defined subsets of patients with relapsed or refractory acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome (MDS) identified using a novel biomarker discovered by its gene control platform (Press release, Syros Pharmaceuticals, SEP 22, 2016, View Source [SID:SID1234515304]).

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"This is an important milestone for Syros and for patients," said David A. Roth, M.D., Chief Medical Officer of Syros. "There has been little improvement in the treatment of AML and MDS for the past 20 years, and survival rates for these patients lag behind many other blood cancers. Treatment with SY-1425 represents a promising therapeutic strategy for subsets of AML and MDS patients with a novel biomarker that we discovered using our gene control platform. Our pioneering approach is designed to advance a new wave of medicines to control the expression of disease-driving genes in genomically defined subsets of patients to provide them with a profound and durable clinical benefit. Our goal is to rapidly advance this first-in-class therapy for these currently underserved patients."

Using its gene control platform, Syros discovered subsets of AML and MDS patients whose tumors have a highly specialized regulatory region of non-coding DNA, known as a super-enhancer, that is associated with the RARA gene, which codes for the RARα transcription factor. The super-enhancer is believed to lead to over-production of the RARα transcription factor, locking cells in an immature, undifferentiated and proliferative state. Syros further investigated this unique biology directly in patient tissues and conducted preclinical studies showing that the RARA super-enhancer is predictive of response to treatment with SY-1425 in preclinical models of AML. Based on that data, Syros is implementing a biomarker strategy for its Phase 2 trial that selects a subset of approximately 25 percent of AML and MDS patients who may respond to treatment with SY-1425.

"The prognosis for these patients is poor, and targeted approaches like SY-1425 offer hope for much-needed new therapies that attack the underlying biology of the disease and hopefully allow patients to live longer without the toxicities of traditional chemotherapy," said Rachel J. Cook, M.D., M.S., assistant professor of medicine at Oregon Health & Science University and an investigator in the trial. "We’re pleased to have enrolled the first patient in this clinical trial and look forward to further investigating SY-1425 for this newly identified subset of AML and MDS patients."

The Phase 2 clinical trial is a multi-center, open-label trial exploring safety and efficacy in relapsed or refractory AML or high-risk MDS patients who have been prospectively selected using the Company’s biomarker strategy. The trial is expected to enroll approximately 40 patients, and the primary endpoint of the trial will be overall response rate. The trial will also assess pharmacodynamic biomarkers, duration of response, safety and tolerability, and survival. Additional details about the trial can be found using the identifier NCT02807558 at www.clinicaltrials.gov.

SY-1425 is approved in Japan as Amnolake (tamibarotene) to treat a different form of AML known as acute promyelocytic leukemia (APL), in which it has a well-established efficacy and safety profile. Syros in-licensed SY-1425 to develop and commercialize it in North America and Europe for all cancers.

On September 22, 2016 argenx (Euronext Brussels: ARGX), a clinical-stage biopharmaceutical company focused on creating and developing differentiated therapeutic antibodies for the treatment of cancer and severe autoimmune diseases, today provided highlights from its lead pipeline programs, ARGX-113 and ARGX-110, during its R&D in New York City (Press release, arGEN-X, SEP 22, 2016, View Source [SID:SID1234515303]).

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"We are very pleased to announce today our strategic plan for driving forward our antibody pipeline through 2017; it includes several important value creating events including two Phase 2 studies in important autoimmune indications for ARGX-113 and two combination studies in serious hematological malignancies for ARGX-110," said Tim Van Hauwermeiren, CEO of argenx. "We’re particularly proud of the speed of our development plan and look forward to continuing to advance our entire pipeline rapidly towards becoming an integrated drug development company."

Members of argenx management as well as guest speakers Dr. James Howard from the University of North Carolina, Dr. Adrian Newland from The Royal London Hospital, and Dr. Owen O’Connor from Columbia University presented the following program highlights:

ARGX-113

ARGX-113 is a potential breakthrough therapy for the treatment of IgG-mediated autoimmune diseases. It is the Fc-portion of an antibody enhanced by argenx proprietary ABDEG technology to block the recycling receptor FcRn leading to fast depletion of IgGs, including autoimmune disease-causing IgG’s. In June 2016, argenx announced favorable safety and tolerability, and efficacy data from its Phase 1 multiple ascending dose study in healthy volunteers. Early pharmacodynamic results showed selective and potent IgG reduction of up to 85%.

Today, argenx announces further results from the Phase 1 study of ARGX-113, across multiple doses and dosing regimens, and its plan to advance ARGX-113 into Phase 2 studies in myasthenia gravis (MG) and immune thrombocytopenic purpura (ITP). argenx plans to open the MG study before the end of the year and the ITP study shortly thereafter.


ARGX-110

ARGX-110 is a SIMPLE Antibody that potently blocks CD70-induced tumor cell proliferation and tumor escape from immune surveillance. It is currently being studied in an ongoing Phase 1b expansion cohort in patients with relapsed/refractory T-cell lymphoma (TCL).

Today, argenx announced new patient anecdotes from its Phase 1b safety expansion cohort showing a favorable safety profile and biological activity in cutaneous T-cell lymphoma (CTCL) patients, evidenced by biomarker data and clinical disease score. The results established the Phase 2 dose and also refined the biomarkers to be used to assess the ongoing effects of ARGX-110 in TCL patients. The Company presented its plan to study ARGX-110 in two combination studies in TCL and AML, both with the respective standard of care. argenx aims to initiate at least one combination study before the end of the year.