Compugen Presents Preclinical Data for COM902 Anti-TIGIT Program at SITC 2019

On November 5, 2019 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported preclinical results from its COM902 anti-TIGIT program supporting its potential clinical use in various combinations with PD-1 inhibitors and COM701, a first-in-class PVRIG inhibitor (Press release, Compugen, NOV 5, 2019, View Source [SID1234550385]). The findings will be presented in a poster titled "COM902, a Novel Therapeutic Antibody Targeting TIGIT Augments T Cell Function and the Activity of PVRIG Pathway Blockade In Vitro and In Vivo" at the 34th Annual Meeting of the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) (SITC 2019) in National Harbor, Maryland, on Saturday, November 9, 2019.

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"These new preclinical data further substantiate our theory that TIGIT and PVRIG are part of a foundational immuno-oncology axis, the DNAM axis," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "We believe that a combined treatment of COM902 with COM701, our first-in-class PVRIG antibody, has the potential to enhance the clinical impact of cancer immunotherapy in patients unresponsive to approved treatments. We look forward to advancing COM902 to the clinic early next year."

Key findings in the poster include:

Broad expression of TIGIT and PVRIG ligands, PVR and PVRL2 in solid tumors.
Superior binding affinity of COM902 to T cells with similar and or greater in vitro function compared to several clinical anti-TIGIT antibodies.
Increased T cell activation by COM902 on tumor infiltrating lymphocytes (TILs), which was further enhanced by combination with COM701.
Reduced mouse melanoma tumor growth in TIGIT and PVRIG knockout mice with further tumor growth reduction in TIGIT/PVRIG double knockouts.
COM902 inhibited tumor growth and increased survival when combined with anti-PVRIG or anti-PD-L1 antibodies in a mouse model of colon cancer.
The poster will be available on Compugen’s website following the poster presentation.

About COM902

COM902, a high affinity, fully human antibody targeting TIGIT, was developed for combination treatment with COM701. Preclinical data demonstrate that TIGIT inhibition, either alone or in combination with other checkpoint inhibitors, can enhance T cell activation and increase anti-tumor immune responses. Parallel inhibition of TIGIT and PVRIG, the two coinhibitory arms of the DNAM-1 axis, results in synergistic effects on effector T cell function and tumor growth inhibition in various model systems that can be further increased with the addition of PD-1 blockade. Based on preclinical data these combinations may be clinically important for enhancing anti-tumor immune response and expanding the patient population responsive to checkpoint inhibition. The Company plans to initiate Phase 1 studies in patients with advanced malignancies in early 2020 pursuant to the FDA’s clearance of an investigational new drug application in October 2019.

Compugen discovered TIGIT in 2009 leveraging its immune checkpoint computational discovery platform through which PVRIG was also discovered. The TIGT discovery was published by Compugen in October 2009 in the Proceedings of the National Academy of Sciences (PNAS).

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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