On April 27, 2021 Leading BioSciences, Inc. a late-stage biopharma company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported the closing of its previously announced merger transaction with Seneca Biopharma, Inc. ("Seneca") (Press release, Neuralstem, APR 27, 2021, View Source [SID1234578595]). Seneca shareholders previously approved the transaction. The combined, publicly traded company will operate under the name Palisade Bio, Inc. ("Palisade Bio" or the "Company"), and its common stock is expected to commence trading on the Nasdaq Capital Market on April 28, 2021, under the ticker symbol "PALI."

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In addition, the Company has announced the closing of the previously announced private placement led by Altium Capital that included $20.0 million in cash plus the cancelation of outstanding principal and interest pursuant to the notes previously issued to the investor.

"This merger marks a tremendous milestone for all stakeholders in the newly formed Palisade Bio, a now publicly listed company with a promising pipeline of oral therapies for GI complications," said Tom Hallam, Ph.D., chief executive officer of Palisade Bio. "We are thrilled to have the added financial flexibility provided by Seneca and the private placement financing as we advance our drugs through clinical development. Our lead asset, LB1148, has already demonstrated efficacy signals in clinical trials that we believe may support a potential paradigm shift in the restoration of post-operative GI function following a wide range of common surgeries. There are more than six million of these procedures annually in the U.S. Now, as the combined company, Palisade Bio, we plan to build on this momentum with multiple clinical data readouts planned over the next 12 to 18 months."

Leading BioSciences Inc.’s management team will lead the merged company, Palisade Bio, following completion of the merger transaction. Palisade Bio will focus on developing therapeutics for broad GI disorders and complications. The Company’s lead asset, LB1148, is a patent-protected oral formulation of a protease inhibitor that neutralizes the activity of digestive proteases released from the gut during surgery. LB1148 has demonstrated the potential to improve restoration of normal GI function following major surgery and reduce certain postoperative complications such as abdominal adhesions. The FDA has granted LB1148 Fast Track Designation for treating postoperative GI dysfunction in pediatric patients who undergo open-heart surgery based on its potential to treat this serious condition, positioning LB1148 for potential accelerated approval and priority review. Palisade expects to initiate a Phase 2/3 study of LB1148 for the treatment of postoperative GI dysfunction associated with pediatric cardiovascular surgery and report Phase 2 data read-outs in GI surgery by year-end 2021.

Conference Call and Webcast Details:

Management will host a conference call and webcast with slides at 11:00 AM Eastern Time on Wednesday, April 28, 2021, for investors regarding this announcement with details as follows:

About LB1148

LB1148 is an oral formulation of a broad-spectrum serine protease inhibitor designed to neutralize the activity of potent digestive proteases released from the gut during surgery. Evidence suggests that the release of digestive proteases contributes to the temporary loss of normal gastrointestinal function and formation of postoperative adhesions. By inhibiting the activity of these digestive proteases, LB1148 has the potential to prevent damage to GI tissues, accelerate the time to return of normal GI function, and shorten the duration of costly post-surgery hospital stays

On April 27, 2021 Epigenomics AG (Frankfurt Prime Standard: ECX, OTCQX: EPGNY; the "company") reported, with approval of the Supervisory Board, to increase the company’s share capital through a rights issue using the Authorized Capital 2020/II (Press release, Epigenomics, APR 27, 2021, View Source [SID1234578594]). The share capital shall be increased from currently EUR 9,852,690.00 by up to EUR 1,970,538.00 to up to EUR 11,823,228.00 by issuing up to 1,970,538 new registered no par value shares of the company against cash contributions.

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The subscription price of the new shares was set at EUR 1.10. The new shares will be offered to the company’s shareholders as part of a public offering in Germany by way of indirect subscription rights during the subscription period, which is expected to run from 3 May 2021 to 17 May 2021. The subscription ratio will be 5:1. This means that for each 5 existing shares of the company, a subscription right for 1 new share is allocated. The company will strive to place new shares that are not subscribed during the subscription period with selected investors. M.M.Warburg & CO (AG & Co.) Kommanditgesellschaft auf Aktien is accompanying the transaction.

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)

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.

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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.

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.

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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.