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Alligator Bioscience AB: Interim report January-March 2021

On April 27, 2021 Alligator Bioscience reported that Interim report January-March 2021 (Press release, Alligator Bioscience, APR 27, 2021, View Source [SID1234578593])

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High activity during the first quarter

"So far, 2021 has been characterized by high activity, with a research collaboration that validates our Discovery concept, and good progress of our clinical programs, with ATOR-1017 and mitazalimab entering clinical efficacy studies this year."

Malin Carlsson, Interim CEO Alligator Bioscience AB

SIGNIFICANT EVENTS JANUARY-MARCH

Pipeline:

New preclinical data were released in an abstract for a poster presentation at the AACR (Free AACR Whitepaper) Annual Meeting 2021, demonstrating that mitazalimab synergizes with chemotherapy.
Company:
Søren Bregenholt was appointed as new CEO to strengthen Alligator’s business development activities and clinical progress on an international level.
Oversubscribed rights issue generated proceeds of SEK 86 million before transaction costs.
SIGNIFICANT EVENTS AFTER THE END OF THE PERIOD

Alligator and the US biopharmaceutical company MacroGenics entered into a joint research collaboration to develop Neo-X-PrimeTM, next generation immune oncology therapy building on Alligator’s CD40 expertise.
The Annual General meeting was postponed to June 1, 2021.
The Nomination Committee proposed that the Annual General Meeting 2021 re-elects Anders Ekblom and Graham Dixon as board members, and that Hans-Peter Ostler, Eva Sjökvist Saers and Veronica Wallin are elected as new board members.
FINANCIAL SUMMARY

January–March 2021

Net sales, SEK 0.6 million (0)
Operating result, SEK -32.5 million (-44.9)
Result for the period, SEK -32.7 million (-42.9)
Earnings per share before and after dilution, SEK -0.38 (-0.60)
Cash flow for the period, SEK 40.4 million (108.4)
Cash and cash equivalents, incl. interest-bearing securities, SEK 143.7 million (103.3)

Compugen Publishes Preclinical Data Demonstrating Therapeutic Potential of COM902 in Cancer Immunology, Immunotherapy

On April 27, 2021 Compugen Ltd. (Nasdaq: CGEN), a clinical-stage cancer immunotherapy company and a leader in predictive target discovery, reported the publication of a peer-reviewed article titled "COM902, a Novel Therapeutic Antibody Targeting TIGIT Augments Anti-Tumor T Cell Function in Combination with PVRIG or PD-1 Pathway Blockade" in Cancer Immunology, Immunotherapy (Press release, Compugen, APR 27, 2021, View Source [SID1234578592]). The preclinical data discussed in the paper highlight the potential of COM902, Compugen’s anti-TIGIT therapeutic antibody, to enhance anti-tumor immune responses.

Article highlights include:

Development and characterization of COM902, a fully human anti-TIGIT antibody which binds specifically to TIGIT and disrupts the binding of TIGIT with PVR, the cognate ligand of TIGIT
Expression of TIGIT, a checkpoint within the DNAM-1 axis discovered in 2009 by Compugen and others, is induced on lymphocytes infiltrating the tumor microenvironment, including Tregs, effector T cells, and NK cells in diverse solid tumors
PVR is expressed in a large set of solid tumors
COM902, designed to have reduced Fc receptor engagement to avoid potential depletion of TIGIT-expressing effector T cells, does not demonstrate T cell depletion activity in-vitro or in-vivo, making it unlikely to elicit direct depletion of TIGIT-expressing effector T cells, which are important for anti-tumor activity
Blockade of TIGIT/PVR binding by COM902 enhances human T and NK cell function in vitro. This effect can be increased by dual blockade of COM902 with either an anti-PVRIG antibody, COM701, or an anti-PD-1 antibody
In vivo, in murine tumor models, COM902 combined with anti-PVRIG or anti-PD-L1 antibodies enhances anti-tumor lymphocyte responses and inhibits tumor growth
"This publication offers further validation of TIGIT as a potential novel target for cancer immunotherapies," said Anat Cohen-Dayag, Ph.D., President and CEO of Compugen. "These published data answer fundamental questions regarding TIGIT’s biology and demonstrate potential synergies with other immune checkpoints. Excitingly, we have observed the amplification of anti-tumor immune responses after dual blockade of TIGIT with either PVRIG or PD-1, which validates our clinical strategy to pursue combination approaches targeting these checkpoints. Furthermore, these data provide additional support that COM902 has the potential to improve outcomes for patients with advanced malignancies, expanding the reach of checkpoint inhibitors."

COM902 is currently being studied as monotherapy in a Phase 1 trial of patients with advanced malignancies (NCT04354246). The trial, which was initiated in 2020, is on track to report initial data in Q4 2021. In addition, the initiation of the dual combination study of COM701 with COM902 is expected as planned in H2 2021.

Geneseeq and AstraZeneca Collaborate to Build Guangzhou Bio-Diagnostics Innovation Center

On April 27, 2021 Geneseeq Technology Inc. ("Geneseeq"), a precision oncology diagnostics company, and AstraZeneca (LSE: AZN) (STO: AZN) (Nasdaq: AZN), a global biopharmaceutical company, reported their strategic collaboration to establish a Bio-Diagnostic Innovation Center in Guangzhou, China (Press release, AstraZeneca, APR 27, 2021, View Source [SID1234578591]). The center is expected to initiate an integrative and patient-centric program where disease diagnosis, treatment, and rehabilitation coexist. The center will combine Geneseeq’s expertise in developing clinical diagnostics tools, with AstraZeneca’s deep experience in oncology therapeutics development to produce innovative diagnostics platforms for cancer patients. The collaboration also outlines joint efforts to build a clinical diagnostics laboratory in Guangzhou International BIO-Island.

On April 23, 2021, AstraZeneca held an opening ceremony and twelve sub-forums for its Symposium Annual Meeting in Wuxi, China. The conference emphasized several meaningful collaborations with industry, clinical, and academic research partners in major therapeutic areas such as oncology, cardiology and nephrology. AstraZeneca’s Global Executive Vice President, the President of Greater China and International Business, Lei Wang, delivered the strategic collaboration announcement between AstraZeneca and Geneseeq at the signing ceremony. He emphasized the establishment of the Bio-Diagnostics Innovation Center, and the center’s planned R&D, educational, and promotional efforts to advance precision medicine access.

"The spotlight for the future of cancer care is on the full-course management approach to bring greater benefits to patients, including perioperative monitoring for early-to-mid stage cancers, and cancer early screening and detection," added by Dr. Yang Shao, the founder and CEO of Geneseeq China. "The theme of today’s conference – multi-faceted collaboration, is another necessary step to achieve this goal."

Geneseeq has provided NGS-based genetic testing service for cancer patients for more than seven years and is well-established in molecular diagnosis for late-stage cancers. For patients with early and mid-stage cancers, Geneseeq introduced SHIELDINGTM in 2021, a perioperative full-course minimal residual disease (MRD) test for solid tumors. The company plans to leverage the MRD dynamic monitoring technologies to guide adjuvant therapy, prognosis and recurrence surveillance to significantly improve patient outcomes and their quality of life.

Strengthening early cancer screening and detection correlates with an increased proportion of patients diagnosed at earlier stages, which effectively prolongs the overall survival of patients and reduces the family and socioeconomic burdens caused by cancer treatment. In the fight against cancer, early screening and detection have become one of Geneseeq’s key focuses. The company developed a multi-omics-based, early cancer screening model, MERCURY. Collaborating with top cancer centers, the preliminary data shows promising performance in liver, colorectal and lung cancer patients with a sensitivity of 80%-95% and a specificity of 98%. To further validate the MERCURY model, a large-scale clinical study was launched in 2020 and is expected to enroll 100,000 participants with a five-year follow-up plan.

Under its collaboration with AstraZeneca, Geneseeq will build its fourth core laboratory in South China, in addition to its laboratories in Nanjing, Shanghai and Beijing. The two companies hope to bring highly scalable and broadly applicable clinical diagnostic tools to cancer patients soon.

Marker Therapeutics to Present Multi-Tumor-Associated Antigen (mTAA)-Specific T Cell Manufacturing Robotics Data at the 2021 American Society of Gene & Cell Therapy (ASGCT) Annual Meeting

On April 27, 2021 Marker Therapeutics, Inc. (Nasdaq:MRKR), a clinical-stage immuno-oncology company specializing in the development of next-generation T cell-based immunotherapies for the treatment of hematological malignancies and solid tumor indications, reported that it will present data detailing a new robotics technology to aid in multi-tumor-associated antigen (mTAA)-specific T cell therapy manufacturing at the upcoming American Society of Gene & Cell Therapy (ASGCT) (Free ASGCT Whitepaper) Annual Meeting, taking place virtually May 11-14, 2021 (Press release, Marker Therapeutics, APR 27, 2021, View Source;cell-therapy-asgct-annual-meeting-301278520.html [SID1234578589]). The data will be presented by lead author Anastasiya Smith, Ph.D.

The presentation details how the robotic assistant prototype, co-designed by Marker Therapeutics and ABB Robotics, could in the future be integrated in a standard biosafety cabinet to collaborate with a human operator during mTAA-specific T cell manufacturing. The researchers found that the robotic assistant prototype was more precise and accurate than human operators in pipetting liquid and was more consistent in the number of cycles performed over a 1-hour test period, while the human operator’s performance deteriorated over time. The authors conclude that the future combination of process simplification with robotic automation may be able to address some of the challenges associated with cell therapy and make this therapy readily available to a larger patient population.

Presentation Details

Title: "Robotic Automation of T Cell Generation for the Treatment of Acute Myeloid Leukemia (AML)"
Authors: Anastasiya Smith, Ph.D., et al.
Session Type: Digital Poster Presentation
Session Date/Time: Tuesday, May 11, 2021, 8:00 a.m. – 10:00 a.m. ET
Session Title: Cell Therapies
Abstract: 772

The abstract is available on ASGCT (Free ASGCT Whitepaper)’s website and in an online supplement to the ASGCT (Free ASGCT Whitepaper) journal. The poster presentation will be available to ASGCT (Free ASGCT Whitepaper) registrants beginning May 11, 2021.

Benitec Biopharma Increases Previously Announced Bought Deal Offering of Common Stock to $12.9 Million

On April 27, 2021 Benitec Biopharma Inc. (NASDAQ: BNTC) ("Benitec" or "the Company"), a development-stage, gene therapy-focused, biotechnology company developing novel genetic medicines based on the proprietary DNA-directed RNA interference ("ddRNAi") platform, reported that, due to demand, the underwriter has agreed to increase the size of the previously announced offering and purchase on a firm commitment basis 3,036,366 shares of common stock of the Company at a price to the public of $4.25 per share, less underwriting discounts and commissions (Press release, Benitec Biopharma, APR 27, 2021, View Source [SID1234578588]). The Company has also granted the underwriter a 30-day option to purchase up to an additional 455,454 shares of common stock at the public offering price, less underwriting discounts and commissions. The offering is expected to close on or about April 30, 2021, subject to satisfaction of customary closing conditions.

H.C. Wainwright & Co. is acting as the sole book-running manager for the offering.

The gross proceeds of the offering are expected to be approximately $12.9 million, prior to deducting underwriting discounts and commissions and offering expenses payable by the Company and excluding the exercise of the underwriter’s option to purchase additional shares. The Company intends to use the net proceeds from the offering for the continued advancement of development activities for its product pipeline, general corporate purposes, and strategic growth opportunities.

The shares of common stock are being offered pursuant to an effective registration statement on Form S-3 (File No. 333-253259) that was filed with the U.S. Securities and Exchange Commission ("SEC") on February 18, 2021 and declared effective on February 26, 2021. The shares of common stock are being offered only by means of a prospectus supplement forming a part of the effective registration statement. A preliminary prospectus supplement and accompanying prospectus relating to the offering have been filed with the SEC and are available on the SEC’s website at www.sec.gov. A final prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and, upon filing, may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, New York, NY 10022, by email at [email protected] or by phone at (212) 856-5711.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.