ProMIS Neurosciences Announces Fiscal Year 2017 Annual Results

On March 14, 2018 ProMIS Neurosciences, Inc. a biotechnology company focused on the discovery and development of precision treatments for neurodegenerative diseases, reported its operational and financial results for the year ended December 31, 2017 (Press release, ProMIS Neurosciences, MAR 14, 2018, View Source [SID1234525140]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Over the course of the past year, we have significantly advanced our lead product candidate for Alzheimer’s disease, PMN310, demonstrating its emerging best in class profile in direct head-to-head comparison with other amyloid beta-targeted antibody therapeutics", said Eugene Williams, ProMIS Executive Chairman.

ProMIS also initiated new programs to develop antibodies against novel therapeutic targets on TDP43 for amyotrophic lateral sclerosis (ALS) and frontotemporal dementia (FTD), tau protein for Alzheimer’s disease (AD), and alpha-synuclein for Parkinson’s disease (PD), representing important additional opportunities in neurodegenerative diseases.

For a narrated overview of fiscal year 2017 results and outlook for 2018, please click on the link below:

http://bit.ly/2FxBuUv

Corporate Highlights

During 2017, completed private placements providing aggregate gross proceeds of approximately $7,510,000.
Successfully completed validation of five therapeutic candidates for AD, all of which demonstrated the desired target profile of binding to soluble brain tissue extracts from AD patients without binding to plaque.
Designated PMN310 as the lead product candidate for AD and demonstrated that PMN310 displays the desired profile of selectively targeting amyloid beta oligomers in a preclinical study comparing PMN310 to other amyloid beta-directed antibodies for AD.
Successfully completed humanization of PMN310 (huPMN310) for further development as lead product candidate.
Initiated programs to identify novel therapeutic targets for AD, ALS and PD.
Filed a provisional patent application with the U. S. Patent and Trademark Office relating to a novel therapeutic target on misfolded forms of TDP43 and initiated development of antibodies selective for this target associated with toxic, aggregated forms of TDP43.
ProMIS’ sponsored research agreement with the University of British Columbia received a matching industry partnered grant from the Canadian Institute of Health Research (CIHR).
Common shares of ProMIS commenced trading on December 4, 2017 on the OTCQB Venture Market in the U. S. under the stock symbol "ARFXF".
On January 4, 2018, ProMIS announced that PMN310 shows potential for improved safety profile in direct comparison to other amyloid beta-directed antibodies. The observed lack of PMN310 binding to perivascular amyloid plaque in AD brain tissue may eliminate dose-limiting brain swelling seen with aducanumab, supporting administration of higher doses to AD patients, thereby leading to greater therapeutic potency of PMN310.
Exercises of common share warrants yield gross proceeds of $1,484,498.
Financial Results

Annual Results of Operations

The Company’s net loss for the year ended December 31, 2017 was $6,019,970, compared to a net loss of $3,454,975 year ended December 31, 2016. Included in the net loss amount for the year ended December 31, 2017 were non-cash expenses of $700,953, representing share-based compensation and amortization of an intangible asset, compared to $578,254 for the year ended December 31, 2016. The increase in the net loss for the year ended December 31, 2017 is related to the costs associated with developing the Company’s AD therapeutics program, increased contracted resources and associated costs, supporting its patent portfolio, associated general corporate expenditures and higher share-based compensation.

Research and development expenses for the year ended December 31, 2017 were $3,961,375, as compared to $1,865,507 in the year ended December 31, 2016. The increase in research and development expense for the year ended December 31, 2017 is primarily attributed to higher research program costs for the AD therapeutics program, consultants and increased contracted resources.

General and administrative expenses for the year ended December 31, 2017 were $2,061,387, as compared to $1,576,271 in the year ended December 31, 2016. The increased expenditures for 2017 reflect primarily higher share-based compensation, contracted resources and other professional fees.

Outlook

The Company’s top priority for 2018 is to focus on further differentiation of PMN310 as best in class therapy for AD and to continue to progress development of PMN310 for clinical trial initiation in 2019.

The Company will also continue to expand its program targeting TDP43 in ALS and FTD and its alpha-synuclein program for PD. ProMIS will actively seek a collaborative development partnership for both these opportunities.

10-K – Annual report [Section 13 and 15(d), not S-K Item 405]

AmpliPhi Biosciences has filed a 10-K – Annual report [Section 13 and 15(d), not S-K Item 405] with the U.S. Securities and Exchange Commission (Filing, 10-K, AmpliPhi Biosciences, 2018, MAR 14, 2018, View Source [SID1234524796]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Zymeworks Advances Clinical Candidate Incorporating Technology from Kairos Acquisition

On March 14, 2018 Zymeworks Inc. (NYSE/TSX: ZYME), a clinical-stage biopharmaceutical company developing multifunctional therapeutics, reported that ZW49 is the first product candidate selected for clinical development utilizing the ZymeLink antibody-drug conjugate (ADC) platform, acquired as part of the Company’s 2016 acquisition of Kairos Therapeutics (Press release, Zymeworks, MAR 14, 2018, View Source [SID1234529108]). ZW49 was developed by leveraging ZymeLink in combination with Zymeworks’ flagship Azymetric bispecific platform. The Company expects to file an Investigational New Drug (IND) application this year in order to begin clinical trials with ZW49 for patients with HER2-expressing cancers.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

ZW49 is a novel bispecific ADC targeting two distinct domains of the HER2 receptor resulting in enhanced internalization and delivery of its proprietary ZymeLink cytotoxic payload. ADCs incorporating ZymeLink have demonstrated a greater therapeutic window (range of doses that are both efficacious and tolerable) in preclinical testing than those incorporating the commonly used ADC payloads DM1 or MMAE. As a result, ZW49 exhibited superior activity when assessed against other approved HER2-targeted therapies and Zymeworks’ previous internal ADC candidate, ZW33. Consequently, the Company will advance ZW49 in lieu of ZW33. Preclinical data on ZW49 and more generally on the ZymeLink ADC platform will be presented at the annual meeting of the American Association for Cancer Research (AACR) (Free AACR Whitepaper) to be held April 2018 in Chicago. Abstracts for these preclinical data were published today.

"The data generated by ZW49 clearly supported its designation as our second product candidate for clinical evaluation," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "With the addition of the complementary ZymeLink technology, including proprietary linkers and payloads, we have been able to further leverage the power of our Azymetric platform to create a differentiated molecule that we believe has the potential for best-in-class activity and tolerability."

Zymeworks, whose protein engineering expertise and resulting therapeutic platforms have resulted in a network of global biopharmaceutical partners, is keenly focused on developing its own portfolio of product candidates. Its lead compound, ZW25, is currently being assessed in an adaptive Phase 1 clinical trial and has shown promising single-agent anti-tumor activity in patients with heavily pretreated HER2-expressing cancers that have progressed after standard of care. Zymeworks continues to accelerate the development of ZW25 and is opening several new clinical sites across North America in 2018.

"With the advancement of ZW49, we now have a portfolio of agents with the potential to address the full spectrum of patients with HER2-expressing cancers," said Diana Hausman, M.D., Chief Medical Officer of Zymeworks. "This includes those underserved patients whose tumors express lower levels of HER2 and are ineligible for treatment with HER2-targeted therapies, such as trastuzumab, pertuzumab, and T-DM1."

About ADCs

Antibody-drug conjugates are a class of anti-cancer therapies intended to precisely target tumor cells in order to avoid the significant toxicities routinely associated with cancer treatments while simultaneously improving their efficacy. An ADC is an antibody connected, or conjugated, to a small molecule drug. It has three critical components: the antibody for targeting of specific cells, the cytotoxin (or payload) being delivered to induce cancer cell death, and the linker, which connects the two components together.

About ZW49

ZW49 is a biparatopic (a bispecific antibody that can simultaneously bind two non-overlapping epitopes on a single target) anti-HER2 ADC based on the same framework as ZW25 but armed with the company’s proprietary ZymeLink cytotoxic (potent cancer-cell killing) payload. ZW49 may mediate its therapeutic effect through a combination of mechanisms, including: increased HER2 receptor-antibody clustering and internalization leading to toxin-mediated cytotoxicity; dual HER2 signal blockade; increased binding and removal of HER2 protein from the cell surface; and potent effector function.

BioLineRx to Present at the 28th Annual Oppenheimer Healthcare Conference

On MArch 14, 2018 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company focused on oncology and immunology, reported that its Chief Executive Officer, Philip Serlin, will present a company update at the 28th Annual Oppenheimer Healthcare Conference on Tuesday, March 20, 2018 at 8:35 a.m. (EDT) (Press release, BioLineRx, MAR 14, 2018, View Source;p=RssLanding&cat=news&id=2337989 [SID1234524754]). The conference will be held at the Westin Grand Central Hotel in New York, NY.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

A live webcast of the presentation will be available on BioLineRx’s website. A replay will be available one hour after the presentation ends and will be accessible for three months following the presentation.

Alpine Immune Sciences Announces Poster Presentation at the 2018 AACR Annual Meeting

On March 14, 2018 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading immunotherapy company focused on developing treatments for cancer and autoimmune/inflammatory diseases, reported the company will present a poster at the 2018 American Association for Cancer Research (AACR) (Free AACR Whitepaper) ("AACR") Annual Meeting taking place April 14 – 18, 2018 in Chicago, Illinois (Press release, Alpine Immune Sciences, MAR 14, 2018, View Source [SID1234524752]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The poster, entitled "CD80 vIgD-Fc proteins combine checkpoint antagonism and costimulatory signaling for potent antitumor immunity," will highlight preclinical data evaluating a novel immuno-oncology molecule derived from the company’s vIgD platform. An abstract of the presentation will be available on AACR (Free AACR Whitepaper) website after March 14, 2018.

Presentation details are as follows:

Session Category:
Clinical Research

Session Title:

Immune Checkpoints 4

Session Date and Time:
Tuesday, April 17, 2018 – 1:00 PM – 5:00 PM

Location:
McCormick Place South, Exhibit Hall A, Poster Section 25

Poster Board Number:
5

A copy of the poster will be made available on the Company’s website after it is presented.