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Alligator Bioscience Announces Positive Interim Results from Mitazalimab OPTIMIZE-1 Phase 2 Trial in Pancreatic Cancer Exceeding 50% Objective Response Rate

Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces strong interim results from the ongoing OPTIMIZE-1 Phase 2 trial of the company’s lead asset mitazalimab in 1st line metastatic pancreatic cancer.

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This open-label, multi-center study is assessing the safety and efficacy of mitazalimab (CD40 mAb) in combination with chemotherapy, mFOLFIRINOX, in previously untreated patients with metastatic pancreatic ductal adenocarcinoma. Within this pre-planned interim analysis for futility, data were assessed by the participating investigators and independent experts for the probability of a positive study at primary completion. The interim results demonstrate an objective response rate (ORR) of 52% in 23 evaluable patients, as per the Response Evaluation Criteria in Solid Tumors (RECIST 1.1). Disease control rate, the proportion of patients with objective response or stabilization of disease, was more than 90%. These data are noteworthy, especially in the light of an ORR of 31.6%[1] reported with FOLFIRINOX in a similar patient population.

Safety data confirm results from the Phase 1b dose escalation phase of the trial, which showed that mitazalimab in combination with mFOLFIRINOX was safe and well tolerated at the recommended dose of 900 μg/kg.

Based on these positive results, Alligator plans to initiate discussions with regulators in the US and Europe on potential accelerated development and approval pathway for mitazalimab in pancreatic cancer, while continuing patient enrolment in this ongoing trial. Top-line data from this trial are expected in Q1 2024.

"We are thrilled with these interim results, which demonstrate that mitazalimab combined with chemotherapy could offer a significant clinical benefit for pancreatic cancer patients over standard of care," said Søren Bregenholt, CEO of Alligator Bioscience. "We are very keen to progress our lead asset through the next stage of its development as quickly as we can, and we look forward to discussing with regulatory authorities the potential accelerated development and approval pathway for mitazalimab in pancreatic cancer. These strong interim data reconfirm out commitment to mitazalimab and supports broadening the mitazalimab clinical development program in additional tumor types."

"We are pleased with the signs of clinical activity observed in the OPTIMIZE-1 interim analysis and believe that mitazalimab in combination with chemotherapy warrants continued development for the treatment of pancreatic cancer patients, which is an area of high unmet need", said Prof. Jean-Luc van Laethem, coordinating principal investigator, Erasmus University Hospital, Brussels (BE), "we will continue enrolment, treatment and follow-up of patients to further characterize the progression-free and overall survival, as the study continues".

Alligator Bioscience and Orion Corporation announce the initiation of the second program of their Immuno-oncology Research Collaboration and License Agreement

Alligator Bioscience (Nasdaq Stockholm: ATORX) today announces an expansion to its research collaboration and license agreement with Orion Corporation, a global pharmaceutical company based in Finland, to discover and develop together new bispecific antibody cancer therapeutics.

The collaboration has been expanded to add the development of a second bispecific antibody using Alligator’s proprietary bispecific RUBY platform, where Alligator will provide validated monospecific binders for one target and Orion will do the same for the other target.

"We are excited to start another joint project with Alligator Bioscience and continue our development of new immuno-oncology treatments, which has started very well." said Outi Vaarala, Senior Vice President, R&D, of Orion Corporation.

"Our collaboration with Orion is progressing extremely well, with both companies making meaningful contributions to the first program and complementing each other’s scientific expertise," said Søren Bregenholt, PhD, CEO of Alligator Bioscience. "The initiation of this second project is a testament to the strength of Alligator’s technology platform, including our bispecific RUBY format."

Under the initial agreement signed in 2021, Alligator employs its proprietary phage display libraries and RUBY bispecific platform to develop immuno-oncology product candidates based on design criteria identified by Orion. Alligator remains eligible for development, approval and sales milestone payments of up to €469 million across the three potential programs, in addition to royalties if Orion exercises its options to continue development and commercialization of the resulting product candidates.

The initiation of the second program provides Alligator Bioscience with an upfront payment of €1.25 million, including the fee for its validated binders being made available, with an additional €500,000 payment being due to Alligator Bioscience when the technical feasibility of the bispecific antibody has been demonstrated in relation to the validated binders.

Palisade Bio Announces $2.5 Million Registered Direct Offering and Concurrent Private Placement Priced Above Market Under Nasdaq Rules

On December 30, 2022 Palisade Bio, Inc. (Nasdaq: PALI), a clinical stage biopharmaceutical company advancing therapies for acute and chronic gastrointestinal (GI) complications, reported that it has entered into definitive agreements with institutional investors for the purchase of 1,052,631 shares of common stock (or certain pre-funded warrants in lieu thereof) in a registered direct offering and concurrent private placement, at a purchase price per common share of $2.375 (Press release, Palisade Bio, DEC 30, 2022, View Source [SID1234625873]). Certain investors will receive unregistered pre-funded warrants in the private placement in lieu of common stock, subject to beneficial ownership limitations. The company has also agreed to issue to the investors, in the private placement, unregistered warrants to purchase up to 1,052,631 shares of common stock (the "Common Warrants"). These Common Warrants will have a term of five (5) years and an exercise price of $2.375 per share. Accordingly, the company entered into agreements to sell (i) an aggregate of 513,842 shares of registered common stock and pre-funded warrants to purchase common stock, (ii) pre-funded warrants that are not registered to purchase an aggregate of 538,789 shares of common stock, and (iii) 1,052,631 unregistered Common Warrants. The closing of the offering is expected to take place on or about January 4, 2022, subject to the satisfaction of customary closing conditions.

Ladenburg Thalmann & Co. Inc. is acting as the exclusive placement agent for the registered direct and private placement offerings.

Palisade Bio intends to use the net proceeds from the financing for working capital and general corporate purposes.

The shares of common stock (and registered pre-funded warrants in lieu thereof) (but not the unregistered pre-funded warrants, nor the Common Warrants or the shares of common stock underlying such unregistered pre-funded warrants and Common Warrants) offered in the registered direct offering are being offered and sold by the Company pursuant to a "shelf" registration statement on Form S-3 (Registration No. 333-263705), including a base prospectus, previously filed with and declared effective by the Securities and Exchange Commission ("SEC") on April 26, 2022. The offering of the shares of common stock (and registered pre-funded warrants in lieu thereof) in the registered direct transaction are being made only by means of a prospectus supplement that forms a part of the registration statement. A final prospectus supplement and an accompanying base prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website located at View Source Electronic copies of the prospectus supplement and accompanying base prospectus may also be obtained, when available, by contacting Ladenburg Thalmann & Co. Inc. at Attn: Prospectus Department, 640 Fifth Avenue, 4th Floor, New York, NY 10019 or by e-mail at [email protected].

The unregistered pre-funded warrants, the Common Warrants (and the shares of common stock underlying such unregistered pre-funded warrants and Common Warrants) are being offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Act") and/or Regulation D promulgated thereunder, and such securities have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Act and such applicable state securities laws. Palisade Bio has agreed to file a registration statement with the SEC registering the resale of the shares of common stock issuable upon the exercise of the unregistered pre-funded warrants and Common Warrants.

Entry into a Material Definitive Agreement

On December 30, 2022, Cellectar Biosciences, Inc. (the "Company") reported to have entered into an Amended Agreement of Lease (the "Amended Lease"), with CAMPUS 100 LLC (the "Landlord") (Filing, 8-K, Cellectar Biosciences, JAN 4, 2023, View Source [SID1234625794]).

Under the Amended Lease, the Company will continue to lease 3,983 square feet of rentable area on the second floor of a building located at 100 Campus Drive in Florham Park, New Jersey, commencing on March 1, 2023 (the "New Commencement Date") until April 30, 2029 (the "New Expiration Date). The Company also has an option to extend the term of the Amended Lease for one additional 60-month period.

Under the terms of the Amended Lease, the Company’s previously paid security deposit of $75,000 will be reduced to $23,566 and the aggregate rent due over the term of the Amended Lease is approximately $918,000, which will be reduced to approximately $893,000 after certain rent abatements. The Company will also be required to pay its proportionate share of certain operating expenses and real estate taxes applicable to the leased premises.

The foregoing description of Amended Lease does not purport to be complete and is subject to, and qualified in its entirety by reference to, the full text of the Lease, which will be filed as an exhibit to the Company’s Annual Report on Form 10-K.

6-K – Report of foreign issuer [Rules 13a-16 and 15d-16]

On December 30, 2022 4D pharma plc (AIM: DDDD) (in administration), a pharmaceutical company leading the development of Live Biotherapeutic products (LBPs), a novel class of drug derived from the microbiome, reported an update on developments since the announcement of the suspension of its shares from trading on the AIM market of the London Stock Exchange and the appointment of David Pike and James Clark of Interpath Advisory as joint administrators (the "Joint Administrators") on 24 June 2022 (Press release, 4d Pharma, DEC 30, 2022, View Source [SID1234625715]).

The Joint Administrators are working with the Company’s advisers on proposals to rescue 4D pharma, exit administration and return the Company to the control of its directors, with the intention of lifting the suspension and restoring trading in the Company’s ordinary shares.

To that end, a circular is today being posted to the Company’s shareholders which contains a notice of General Meeting to be held on 16 January 2023. The relevant sections of the circular are set out in full below and a copy of the circular will be made available on the Company’s website in due course (View Source).