Category: stem cell

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Biogen to acquire KPT-350 from Karyopharm

Karyopharm enters agreement for Biogen to acquire KPT-350

Karyopharm enters agreement for Biogen to acquire KPT-350, Stockwinners.com
Karyopharm enters agreement for Biogen to acquire KPT-350

Karyopharm Therapeutics (KPTI) announced its entry into an agreement for Biogen (BIIB) to acquire Karyopharm’s investigational oral SINE compound KPT-350 and other assets for the treatment of certain neurological and neurodegenerative conditions.

KPT-350 is a novel therapeutic candidate that works by inhibiting XPO1, resulting in reductions in inflammation and neurotoxicity, as well as increasing neuroprotective responses.

Under the terms of the agreement, Biogen is acquiring KPT-350 and other assets targeting certain neurological conditions, including amyotrophic lateral sclerosis.

In exchange, Karyopharm will receive a one-time upfront payment of $10M from Biogen and is eligible to receive additional payments of up to $207M based on the achievement by Biogen of future specified development and commercial milestones.

Karyopharm will also be eligible to receive tiered royalty payments from Biogen that reach low double digits based on future net sales of specified product candidates, including KPT-350.

KPTI closed at $10.45.

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Pluristem Therapeutics says its PLX cells ‘significantly inhibit’ cancer cell growth

Pluristem PLX cells ‘significantly inhibit’ cancer cell growth in new study

Pluristem PLX cells 'significantly inhibit' cancer cell growth in new study. Stockwinners.com
Pluristem PLX cells ‘significantly inhibit’ cancer cell growth in new study

Pluristem Therapeutics (PSTI) announced the publication of a peer-reviewed article in the journal Scientific Reports, from the publisher of Nature, titled, “Human Placental-Derived Adherent Stromal Cells Co-Induced with TNF-alpha and IFN-gamma Inhibit Triple-Negative Breast Cancer in Nude Mouse Xenograft Models.”

The article is based on studies which examined the effect of PLX cells that had been induced with tumor necrosis factor alpha and interferon-gamma, on the proliferation of over 50 lines of human cancerous cells.

The induction of the cells was carried out by adjusting their manufacturing process in order to transiently alter their secretion profile.

Data from the first study showed that the modified PLX cells exhibited an anti-proliferative effect on 45% of the tested cancer cell lines, with a strong inhibitory effect on various lines of breast, colorectal, kidney, liver, lung, muscle and skin cancers.

Comprehensive bioinformatics analysis identified common characteristics of the cancer cell lines inhibited by PLX cells.

This knowledge could potentially be used in the future for screening patients’ tumors to identify those patients most likely to show a positive response to treatment with PLX cells.

Based on these promising results, Pluristem conducted a pre-clinical study of female mice harboring human triple negative breast cancer, or TNBC.

TNBC is an aggressive form of breast cancer that does not respond to standard hormonal therapy due to a lack of estrogen and progesterone receptors. Current treatment for TNBC consists of a combination of surgery, radiation therapy, and chemotherapy, and yet the prognosis remains poor for patients with this type of breast cancer.

In this study, weekly intramuscular (IM) injections of the induced PLX cells produced a statistically significant reduction in mean tumor size in the treated group compared with the untreated group, with 30% of the treated mice exhibiting complete tumor remission.

In addition, a statistically significant reduction was seen in the percentage of proliferating tumor cells as well as in the level of blood vessels within the tumors.

Pluristem has filed patent applications relating to the technology for the induction of PLX cells and the use of these cells for the treatment of cancer.

PSTI  last traded at $1.62.

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Celgene is acquiring Impact Biomedicines for $7B

Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline

Celgene tumbles
Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline

Celgene (CELG) and privately held Impact Biomedicines announced the signing of a definitive agreement in which Celgene will acquire Impact Biomedicines, which is developing fedratinib for myelofibrosis and polycythemia vera.

Under the terms of the agreement, Celgene will pay approximately $1.1B upfront and up to $1.25B in contingent payments based on regulatory approval milestones for myelofibrosis.

Additional future payments for regulatory approvals in additional indications and sales-based milestones are also possible.

#Fedratinib, a highly selective JAK2 kinase inhibitor, was evaluated in 877 patients across 18 clinical trials.

Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline, Stockwinners.com
Celgene to acquire Impact Biomedicines, adds Fedratinib to pipeline

In a randomized, placebo-controlled, phase III pivotal trial for patients with treatment-naive myelofibrosis, fedratinib demonstrated statistically significant improvements in the primary and secondary endpoints of splenic response and total symptom score, respectively.

In an exploratory subgroup analysis, these improvements were observed regardless of a patient’s baseline platelet count. A multi-center, single-arm phase II trial evaluated fedratinib in myelofibrosis patients who were found to be resistant or intolerant to ruxolitinib, a JAK1/JAK2 inhibitor. In this second-line setting, fedratinib demonstrated clinically meaningful improvements in splenic response and total symptom score.

#JAKARTA-2 was stopped prematurely due to a clinical hold placed on the fedratinib program by the U.S. Food and Drug Administration after potential cases of Wernicke’s encephalopathy were reported in eight out of 877 patients receiving one or more doses. The FDA removed the clinical hold in August 2017.

Based on the reported benefit risk profile of fedratinib from the JAKARTA-1 and JAKARTA-2 clinical trials, regulatory applications in #myelofibrosis are planned beginning in the middle of 2018.

Myelofibrosis is a serious bone marrow disorder that disrupts body’s normal production of blood cells. The result is extensive scarring in one’s bone marrow, leading to severe anemia, weakness, fatigue and often an enlarged spleen.

Myelofibrosis is an uncommon type of chronic #leukemia — a cancer that affects the blood-forming tissues in the body. Myelofibrosis belongs to a group of diseases called myeloproliferative disorders.

 Many people with myelofibrosis get progressively worse, and some may eventually develop a more serious form of leukemia. Yet it’s also possible to have myelofibrosis and live symptom-free for years.
CELG closed at $104.99.

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Cellect Biotechnology reports stem cell breakthrough

Cellect Biotechnology announces successful transplant using ApoGraft

Cellect Biotechnology announces successful transplant using ApoGraft. Stockwinners.com
Cellect Biotechnology announces successful transplant using ApoGraft

Cellect Biotechnology (APOP) announced that it has successfully completed transplantation of the first group of three patients using Cellect’s ApoGraft technology in the company’s Phase I/II clinical trial and that after one month follow-up, all three patients have demonstrated complete acceptance of the stem cell transplant with no adverse events related to the study treatment, as determined by the clinical investigator, and no reported serious adverse events or suspected unexpected serious adverse reactions.

The Phase I/II, dose escalating, 4-cohort, open label clinical trial of up to twelve patients is designed to evaluate the safety, tolerability and efficacy of functionally selected donor derived mobilized peripheral blood cells that underwent the company’s ApoGraft process and were transplanted into patients with hematological malignancies in an allogeneic hematopoietic stem cell transplantation.

The primary endpoint of the study is overall incidence, frequency and severity of adverse events potentially related to ApoGraft at 180 days from transplantation. The company plans on recruiting a further three patients for the second cohort of patients following review of the independent data and safety monitoring board.

The company believes that these interim results of ApoGraft present the first signs of a breakthrough in stem cell transplantation.

The product is transplantable within less than 12 hours from donation through a simple process performed on the bedside after selective physiological elimination of immune reaction-causing cells.

The ApoGraft transplantation is intended to result in complete recovery of the patient’s immune system with no related safety concerns in contrast to the significant morbidity or even death causing standard medical procedure.

APOP closed at $7.12. It traded at $9.69 in pre-market trading.

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