Bio-Techne To Present At The Stephens Nashville Investment Conference

On November 5, 2019 Bio-Techne Corporation (NASDAQ:TECH) reported that Jim Hippel, Chief Financial Officer, will present at the Stephens Nashville Investment Conference on Wednesday, November 13, 2019 at 9:45 a.m. CST (Press release, Bio-Techne, NOV 5, 2019, View Sourcenews/detail/164/bio-techne-to-present-at-the-stephens-nashville-investment-conference [SID1234550293]). The conference will be held at the Omni Nashville Hotel in Nashville, TN. A live webcast of the presentation can be accessed via Bio-Techne’s Investor Relations website at View Source or through the following link View Source

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ExCellThera announces publication in The Lancet Haematology highlighting excellent clinical results of ECT-001 in patients with haematological malignancies

On November 5, 2019 ExCellThera Inc., an advanced biotechnology company delivering molecules and bioengineering solutions to expand stem and immune cells for therapeutic use, reported the publication of full data from the first clinical trial using ECT-001 (single UM171-expanded cord blood) in patients with haematological malignancies (Press release, ExCellThera, NOV 5, 2019, View Source [SID1234550321]). The data were published in the peer-reviewed medical journal, The Lancet Haematology.

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The clinical trial findings indicate that ECT-001 cell therapy is feasible, safe (as suggested by the low transplant-related mortality, low incidence of severe acute graft-vs-host disease (GVHD), and absence of moderate to severe chronic GVHD) and allows for the use of small cords without compromising engraftment. In addition, ECT-001 has shown potential to overcome the disadvantages of unexpanded cord blood transplants while maintaining their benefits of low risk of chronic GVHD and relapse. The Lancet Haematology paper provides the first detailed analysis of the study results presented at the 60th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting (ASH 2018) in December 2018 and supports the recent advancement of the ECT-001 clinical program.

"We’re pleased that these important results from the first clinical trial using ECT-001 in haematological malignancies are now fully available to the broader bone marrow transplant community," said Dr. Guy Sauvageau, CEO and founder of ExCellThera, and co-senior author of the paper. "These results indicate that ECT-001 transplants combine the advantages of conventional grafts using bone marrow (low treatment-related mortality), peripheral blood (fast engraftment) and cord blood (greater accessibility, low relapse and chronic GvHD) in a single, low cost, easy to produce 7-day culture product, which could lead to a paradigm shift in bone marrow transplantation."

The FDA granted ECT-001 Orphan Drug Designation for the prevention of graft-versus-host disease in 2018 and Regenerative Medicine Advanced Therapy Designation in the treatment of hematologic malignancies in 2019. ECT-001 is currently being used for the treatment of blood disorders in other ongoing and approved clinical trials in the United States and Canada. ExCellThera also plans to initiate a European clinical trial as well as a pivotal, multi-centre clinical trial in the coming months.

Principia Biopharma Reports Third Quarter Financial Results

On November 5, 2019 Principia Biopharma Inc. (Nasdaq: PRNB), a late-stage biopharmaceutical company focused on developing novel therapies for immune mediated diseases, reported financial results for the third quarter ended September 30, 2019 (Press release, Principia Biopharma, NOV 5, 2019, View Source [SID1234550337]).

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"With our focus on execution, we made significant progress on our clinical programs during the third quarter. We also recently reported preliminary positive data from our ongoing Phase 2 pemphigus and Phase 1/2 immune thrombocytopenia (ITP) clinical trials with PRN1008. Following these announcements, we were able to execute a successful follow-on offering of common stock with gross proceeds of $241.5 million," said Martin Babler, president and chief executive officer of Principia Biopharma. "We are also pleased industry veteran Shawn Tomasello joined our Board of Directors as she brings an extensive track record in commercializing novel pharmaceutical products."

Third Quarter 2019 Financial Results

Cash Position: Cash, cash equivalents, and marketable securities were $161.2 million as of September 30, 2019, compared to $180.6 million as of December 31, 2018. In addition, in October 2019, we completed a follow-on public offering which resulted in net proceeds of $226.5 million after deducting underwriting discounts and commissions and estimated offering expenses.

Revenues: We did not recognize any collaboration revenue for the three months ended September 30, 2019, compared to $18.6 million for the same period in 2018. The $18.6 million recognized for the three months ended September 30, 2018 consisted of a portion of upfront fees and milestone payments from our Sanofi and AbbVie collaborations.

R&D Expenses: Total research and development expenses were $18.4 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.8 million, compared to $9.2 million for the same period in 2018, including stock-based compensation expense of $0.3 million. The increase in total research and development expenses was mainly driven by an increase in personnel-related expenses as we build out our R&D team, and an increase in PRN1008 program costs, due to the initiation of a global Phase 3 trial in patients with pemphigus in November 2018 and certain manufacturing campaigns to supply drug products for our PRN1008 clinical trials.

G&A Expenses: General and administrative expenses were $5.0 million for the three months ended September 30, 2019, including stock-based compensation expense of $1.5 million, compared to $2.9 million for the same period in 2018, including stock-based compensation expense of $0.4 million. The increase in total general and administrative expenses was primarily driven by increased personnel-related expenses and headcount costs related to operating as a public company.

Net Income (Loss): For the three months ended September 30, 2019, net loss was $22.3 million compared to a net income of $6.7 million for the same period in 2018, as we did not recognize any collaboration revenue for the three months ended September 30, 2019.

Cytokinetics to Participate in the Credit Suisse 28th Annual Healthcare Conference

On November 5, 2019 Cytokinetics, Incorporated (Nasdaq: CYTK) reported that Fady I. Malik, M.D., Ph.D., Executive Vice President, Research & Development, is reported to participate in the Credit Suisse 28th Annual Healthcare Conference on Tuesday, November 12, 2019 at 12:05 PM MT at The Phoenician in Scottsdale, AZ (Press release, Cytokinetics, NOV 5, 2019, View Source [SID1234550353]).

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Bicycle Therapeutics to Present New Preclinical Data on BT7480, a Novel, Fully Synthetic Bicycle® Tumor-targeted Immune Cell Agonist, at the Society for Immunotherapy of Cancer’s 2019 Annual Meeting

On November 5, 2019 Bicycle Therapeutics plc (NASDAQ: BCYC) a clinical-stage biotechnology company pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycles) technology, reported that new preclinical data from BT7480, a potent tumor-targeted immune cell agonist (TICA) targeting Nectin-4 and agonizing CD137 (4-1BB), will be presented during speaker and poster sessions at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper)’s (SITC) (Free SITC Whitepaper) 2019 Annual Meeting on November 6-10, 2019 in National Harbor, MD (Press release, Bicycle Therapeutics, NOV 5, 2019, View Source [SID1234550369]).

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"Our novel and proprietary Bicycle tumor-targeted immune cell agonists, or TICAs, are fully synthetic approaches engineered to overcome the limitations of other immunomodulatory mechanisms," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "The constrained nature of Bicycles confers high affinity and selectivity and enables us to easily link tumor targeting Bicycles to Bicycles that agonize CD137, providing tumor-specific effects. In preclinical experiments with BT7480, we have shown these characteristics promote rapid tumor penetration and powerful anti-tumor activity. We believe that these features, along with the modular nature of the Bicycle platform, could position Bicycles at the cutting edge of next generation immuno-oncology treatments and we look forward to progressing BT7480 into IND-enabling studies."

BT7480 has shown very potent and tumor antigen dependent CD137 agonism in ex vivo experiments using patient-derived lung tumor samples that have intact immune microenvironments. In a Nectin-4 overexpressing syngeneic tumor model, 92% (n=24) of animals dosed with BT7480 experienced complete tumor regressions. Five of the complete responder animals were subsequently re-challenged with the same tumor cell implantation and no tumor growth was observed, implying development of immunogenic memory. In addition to these data on BT7480, the Company will also present preclinical data at SITC (Free SITC Whitepaper) on other emergent Bicycle TICA strategies.

Details on Bicycle’s SITC (Free SITC Whitepaper) presentations are as follows:

Session Title: Session 2: Novel Platforms and Innovation
Location: Cherry Blossom Ballroom
Oral Presentation Title: A novel fully synthetic dual targeted Nectin-4/4-1BB Bicycle peptide induces tumor localized 4-1BB agonism
Presenter: Nicholas Keen, Ph.D., Chief Scientific Officer of Bicycle Therapeutics
Date & Time: Wednesday, November 6, 2019 4:35 p.m. – 4:45 p.m. ET

Session Title: Novel Single-Agent Immunotherapies
Location: Prince George’s Exhibition Halls AB
Poster Presentation Title: A novel fully synthetic dual targeted Nectin-4/4-1BB Bicycle peptide induces tumor localized 4-1BB agonism
Abstract #: P782
Date & Time: Saturday, November 9, 2019, 7:00 a.m. – 8:30 p.m. ET

Session Title: Novel Single-Agent Immunotherapies
Location: Prince George’s Exhibition Halls AB
Poster Presentation Title: A novel fully synthetic dual targeted EphA2/4-1BB Bicycle peptide induces tumor localized 4-1BB agonism
Abstract #: P794
Date & Time: Saturday, November 9, 2019, 7:00 a.m. – 8:30 p.m. ET

The posters will be available on the Publications section of bicycletherapeutics.com following presentation.