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Protalix BioTherapeutics Completes Enrollment in Phase II Clinical Trial of OPRX-106 in Patients with Ulcerative Colitis

On November 29, 2017 Protalix BioTherapeutics, Inc. (NYSE American:PLX) (TASE:PLX), reported the completion of enrollment in the Company’s phase II clinical trial evaluating OPRX-106, the Company’s oral antiTNF product candidate, in patients with ulcerative colitis (UC) (Press release, Protalix, NOV 29, 2017, View Source;p=RssLanding&cat=news&id=2319080 [SID1234522311]). OPRX-106 is the Company’s proprietary plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). When administered orally and while passing through the digestive tract, the plant cells function as a natural delivery capsule, having the unique attribute of a cellulose cell wall, which makes them resistant to degradation compared to proteins produced via mammalian cell expression systems. The Company expects to report top-line results from this study in the first quarter of 2018.

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"Despite a number of approved treatments for ulcerative colitis, there remains a large unmet medical need in this patient population," said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer. "We look forward to reporting initial results from our phase II study, which may provide proof of concept data not only for OPRX-106 in the treatment of UC, but also for our oral-delivery protein technology. If successful, OPRX-106 will be the first ever oral protein treatment, as currently there are no other oral recombinant protein treatments available."

The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 in 19 patients with active mild to moderate ulcerative colitis. Patients have been randomized to receive 2 mg or 8 mg of OPRX-106 protein administered orally, once daily, for 8 weeks. Key efficacy endpoints of the study, in addition to safety, include relevant disease parameters of the drug, including Mayo score and rectal bleeding.

Daiichi Sankyo to Absorb Japan Research Subsidiary, Asubio Pharma Co., Ltd.

On November 29, 2017 Daiichi Sankyo Company, Limited (Headquarters: Chuo-ku, Tokyo; hereafter, Daiichi Sankyo) reported that at a Board of Directors Meeting held today a resolution was passed for an absorption-type merger (hereafter, the merger) with its research subsidiary Asubio Pharma Co., Ltd. (Office location: Kobe-shi, Hyogo Prefecture; hereafter, Asubio), effective April 1, 2018, and an absorption-type merger agreement dated today was concluded (Press release, Daiichi Sankyo, NOV 29, 2017, View Source [SID1234522308]).

As the merger is a simplified absorption-type merger with a wholly owned subsidiary company, some items and details are omitted in its disclosure.

1. Purpose of merger
Asubio mainly focuses on psychiatric and neurological diseases, immune and inflammatory diseases and regenerative medicine, conducting research based on its position as a drug discovery venture within the Daiichi Sankyo Group.
Daiichi Sankyo expects the integration of the venture spirit of Asubio into other research activities of Daiichi Sankyo to contribute to improving R&D productivity.

2. Summary of merger
(1) Merger schedule
Date of Board of Directors resolution (Asubio) November 29, 2017
Date of Board of Directors resolution (Daiichi Sankyo) November 30, 2017
Date of conclusion of merger agreement November 30, 2017
Date of merger (effective date) April 1, 2018
Note: For Daiichi Sankyo the merger is a simplified merger as stipulated in Article 796, Paragraph 2 of the Companies Act and for Asubio it is a short form merger as stipulated in Article 784, Paragraph 1 of the Companies Act. Therefore, neither company will hold a general shareholders meeting to approve the merger agreement.

(2) Form of merger
The form of the merger is an absorption-type merger with Daiichi Sankyo as the surviving company; Asubio will be dissolved.

(3) Allocations with merger
Since Asubio is a wholly owned consolidated subsidiary of Daiichi Sankyo, there will be no issuance of new shares or cash allocation with the merger.

(4) Handling of subscription rights to shares and bonds with subscription rights to shares of extinct company
Asubio has not issued any subscription rights to shares or bonds with subscription rights to shares.

3. Outline of merging companies
[Surviving company]
(1) Company name
Daiichi Sankyo Company, Limited
(2) Headquarters location
3-5-1, Nihonbashi Honcho, Chuo-ku, Tokyo, Japan
(3) Representative
Sunao Manabe, Representative Director, President and COO
(4) Type of business
Research & development, manufacture, sales, and marketing of pharmaceutical products, etc.
(5) Paid-in capital
50 billion yen
(6) Foundation date
September 28, 2005
(7) Number of ordinary shares issued
709,011,343
(8) Settlement of accounts
March 31
(9) Primary shareholders and percent of shares held (As of September, 2017)
・ The Master Trust Bank of Japan, Ltd. (trust account): 7.95%
・ Japan Trustee Services Bank, Ltd. (trust account): 6.80%
・ Nippon Life Insurance Company: 5.05%
・ JP MORGAN CHASE BANK 380055: 2.26%
・ Trust & Custody Services Bank, Ltd. as trustee for Mizuho Bank, Ltd. Retirement Benefit Trust Account re-entrusted by Mizuho Trust & Banking Co., Ltd.: 2.03%
(10) Financial position and operating results for immediately preceding business year (ending March, 2017) Japanese accounting standards
Net assets
888,519
million yen
Total assets
1,463,461
million yen
Net assets per share
1,336.57
yen
Revenue
629,151
million yen
Operating income
18,483
million yen
Ordinary income
40,976
million yen
Net income
10,479
million yen
Net income per share
15.61
yen

[Extinct company]
(1) Company name
Asubio Pharma Co., Ltd.
(2) Office location
6-4-3 Minatojima-minamimachi, Chuo-ku, Kobe-shi, Hyogo Prefecture, Japan
(3) Representative
Yoshiharu Minamitake, President & CEO
(4) Type of business
Entrusted research & development of pharmaceuticals, etc.
(5) Paid-in capital
50 million yen
(6) Foundation date
October 16, 2009
(7) Number of ordinary shares issued
1,000
(8) Settlement of accounts
March 31
(9) Principal shareholders, percent of shares held
Daiichi Sankyo Company, Ltd.; 100%
(10)Financial position and operating results for immediately preceding business year (ending March 2017) Japanese accounting standards
Net assets
417
million yen
Total assets
5,753
million yen
Net assets per share
417,792.94
yen
Revenue
8,153
million yen
Operating income
2,870
million yen
Ordinary income
2,870
million yen
Net loss
32
million yen
Net loss per share
32,248.23
yen

4. Situation after merger
Asubio’s office and base of operations in Kobe will be closed and Daiichi Sankyo will take over its business and functions. There will be no change to Daiichi Sankyo’s company name, headquarters location, name and title of representative, type of business, paid-in capital or accounts settlement date with the merger.

5. Expected effect of merger on results
As the merger is with a wholly owned subsidiary, it will have a marginal effect on Daiichi Sankyo’s consolidated results.

ABX196

ABX196, a first-in-class iNKT agonist boosting the immune response in cancer

ABIVAX is currently developing ABX196, a state of the art immune enhancer candidate based on iNKT activation. This product is largely derived from the technology and exclusive patent rights transferred to ABIVAX by the Scripps Research Institute (La Jolla, CA), the University of Chicago (Chicago, IL) and the Brigham Young University (Salt Lake City, UT)

A phase I clinical trial in healthy volunteers has been completed and showed activation of iNKT cells. Based on these data, new immuno-oncology pre-clinical studies were conducted that demonstrated the potential of the product in oncology, in particular in turning tumors not responsive to anti-PD-1 (cold) to tumors responsive to anti-PD-1 (hot). As ABIVAX is focusing on the antiviral and anti-inflammatory therapeutic spaces and does not intend to play a role in the immune-oncology field, ABIVAX is seeking to out-license this interesting product candidate.

The characteristics of ABX196 are as follows:

ABX196 has been developed from a platform technology proprietary to ABIVAX that identifies "iNKT Agonists" that demonstrate immune enhancing effects in cancer models
ABX196 is a synthetic agonist (glycolipid) of iNKT (invariant Natural Killer T) cells, in a liposomal formulation
ABX196 is well characterized, with stability studies and full toxicity package (including non-human primate studies) conducted prior to the phase I clinical trial in healthy volunteers
Phase I showed ABX196 is well tolerated and triggered both humoral as well as iNKT immune responses in human volunteers
Pre-clinical data show that ABX196 enhances anti-tumoral activity when used alone and in combination with anti-PD-1 antibody, doxorubicin or sorafenib
ABX196 turns a cold (i.e. non-responding to anti-PD-1 antibody) tumor into a hot, responsive tumor in the mouse melanoma model, corresponding to an increase in survival time
ABX196 potentiates the anti-tumoral response to chemotherapy (doxorubicin) in the mouse melanoma model, corresponding to an increase in survival time
ABX196 controls tumor progression in an orthotopic hepatocellular cancer model in mice, again showing a prolongation of survival
In total, POC of anti-tumoral activities has been established in four preclinical cancer models
Easy-to-use liposome formulation, with scaled-up and controlled manufacturing
Strong IP protection and FTO: 5 patent families

Amphivena Receives Orphan Drug Designation for AMV564, a Novel CD33/CD3 T-Cell Engagement Therapy for the Treatment of Acute Myeloid Leukemia

On November 29, 2017 Amphivena Therapeutics Inc., a privately held biotechnology company developing a novel CD33/CD3 T cell engager for the treatment of Acute Myeloid Leukemia (AML) and Myelodysplastic Syndromes (MDS), reported that it has received Orphan Drug Designation from the U.S. Food and Drug Administration for its lead compound AMV564 for the treatment of AML (Press release, Amphivena Therapeutics, NOV 29, 2017, View Source [SID1234522341]).

"The FDA’s designation of AMV564 as an orphan drug is an important milestone for us that will provide marketing protections and economic benefits at drug approval. Given the unique safety and efficacy profile that is emerging in the clinic, we believe our CD33-targeted T cell engager will be an important drug in the armamentarium for leukemia patients who have limited treatment options today," said Eric J. Feldman, M.D., Amphivena’s Senior Vice President of Clinical Development.

Amphivena is conducting a Phase 1 clinical study of AMV564 in relapsed or refractory AML. Amphivena plans to launch a Phase 1 clinical study in patients with MDS in early 2018. The company is also exploring the utility of AMV564 in solid tumors. In preclinical studies, this novel CD33/CD3 bispecific antibody demonstrated potent activity against AML patient samples that was independent of CD33 expression level, disease stage and cytogenetic risk. The antibody eliminated nearly all blasts from bone marrow and spleen in a stringent AML patient-derived xenograft murine model. In addition, Amphivena established a therapeutic window for AMV564 in cynomolgus monkeys, with rapid and sustained elimination of CD33-expressing cells during AMV564 dosing and rapid hematopoietic recovery following dosing.

Orphan Drug Designation is granted by the FDA Office of Orphan Drug Products to products that treat rare diseases. The FDA defines rare diseases as those affecting fewer than 200,000 people in the United States. Orphan Drug Designation provides the sponsor certain benefits and incentives, including a period of marketing exclusivity for the first marketing application, if regulatory approval is received for the designated indication, potential tax credits for certain activities and waiver of certain administrative fees.

Vedanta Biosciences Expands Network of Clinical Collaborations Supporting Development of Microbiome Therapeutics for Cancer Immunotherapy

On November 29, 2017 Vedanta Biosciences, an affiliate of PureTech Health (LSE: PRTC) developing a new category of therapies for immune-mediated and infectious diseases based on rationally designed consortia of human microbiome-derived bacteria, reported new translational medicine collaborations in cancer immunotherapy with Leiden University Medical Center and the University of South Alabama (USA) Mitchell Cancer Institute (Press release, Vedanta Biosciences, NOV 29, 2017, View Source [SID1234522340]). The Company also reported the expansion of its translational medicine collaborate on in cancer immunotherapy with NYU Langone Health and its Perlmutter Cancer Center. Researchers at these institutions have been collaborating with Vedanta Biosciences to analyze microbiome clinical data from interventional checkpoint inhibitor studies to identify microbiome signatures associated with response to immunotherapy and key mechanisms through which the gut microbiota modulate immunotherapeutic responses.

"Data from our ongoing clinical collaborations in melanoma show that gut bacteria signatures could help determine if a cancer immunotherapy will work," said Bruce Roberts, Ph.D., Chief Scientific Officer of Vedanta Biosciences. "We’re pleased to expand our research collaborations into others forms of cancer, with the ultimate goal of identifying ways to change the microbiome to increase the proportion of patients and types of cancer patients who respond to immunotherapies."

Under the agreement with Leiden University Medical Center, Vedanta Biosciences will work in collaboration with Ellen Kapiteijn, M.D., Ph.D., and Ed Kuijper, M.D., Ph.D., to understand the role of the microbiome in immunotherapeutic responses against a variety of cancers, including melanoma, head and neck, and bladder. The new collaboration with the USA Mitchell Cancer Center, led by Art Frankel, M.D., will analyze associations between the gut microbiome and responses to checkpoint inhibitor treatment in melanoma and cancers of the bladder and kidneys. Building on the existing translational work with NYU Langone in melanoma led by Jeffrey S. Weber, M.D., Ph.D., and Melissa Wilson, M.D., Ph.D., the expanded agreement adds collaborations in bladder cancer and lung cancer, led, respectively, by Arjun V. Balar, M.D., and Leena Gandhi, M.D., Ph.D.

Vedanta Biosciences’ immuno-oncology programs include lead product candidate, VE800, which has been shown in preclinical models to activate CD8+ T cells, a type of white blood cell that is the predominant effector in cancer immunotherapy, improve CD8+ T cell tumor infiltration, and improve survival in several cancer models in combination with checkpoint inhibitors. Vedanta anticipates filing an investigational new drug application (IND) for this candidate in 2018.