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Peak Bio, Inc. Announces Filing of Provisional Patent Applications for PH-1, a Novel and Specific Immunomodulatory ADC payload platform targeting RNA splicing

Pleasanton, CA, Sept. 19, 2023 (GLOBE NEWSWIRE) -- Peak Bio, Inc. ("Peak Bio" or the "Company") (OTC PK: PKBO), is a clinical-stage biopharmaceutical company focused on developing and commercializing the next-generation of innovative therapeutics that aim to improve and address significant unmet medical need for patients with inflammatory, rare-specialty diseases and cancer.  

Peak Bio, Inc. today announced that it has filed provisional patent applications with the United States Patent and Trademark Office (USPTO) covering claims for the Company’s potent Thailanstatin payload platform specific to the spliceosome protein, SF3B1. These patent applications are the second set of applications related to the Company’s R&D toxin portfolio on Thailanstatin, termed PH-1. Previously, the USPTO had issued a patent (Patent No. US 10,815,246 B2) covering potent Thailanstatin drug payloads, non-cleavable and cleavable linkers, and antibody-drug conjugate (ADC) technology derived from it.

The new provisional patent, ANTIBODIES AND ANTIBODY-DRUG CONJUGATES AND METHODS OF USE, describe a novel PH-1 variant, termed PH1, that is to be used in certain of Peak Bio's ADC programs, most notably its named Trop2 PH1 ADC, as well as other potential future ADC programs. This new patent also describes Peak’s Trop2 antibody and composition of matter claims relating to the properties of a differentiated ADC derived from Peak’s novel anti-Trop2 antibody and PH1 payload This patent was filed to protect disclosures made during a poster session at AACR 2023 and is an important addition to the intellectual property portfolio surrounding our ADC technology, and significantly enhances the patent position for internal and future collaborator programs.  

Another new provisional patent, SYNTHETIC PROCESSES AND INTERMEDIATES, describes a novel synthetic process amenable for large scale synthesis of above payload to protect and enable CMC processes relating to Peak Bio’s Trop2 ADC program, and to enable future collaborations.

Peak Bio is developing a differentiated Trop2 PH1 ADC and is investigating collaborations for clinical development and/ or commercialization of this asset along with other collaboration opportunities that incorporate our novel payloads.

Stephen LaMond, PharmD, MBA, Peak Bio, Inc. Interim CEO and COO, commented, "We are pleased to announce our filing of our provisional patent and the continued progress with our oncology portfolio (ADCs) that incorporate our novel payloads.  We believe the strong interest in novel payloads and ADCs in general will continue given the need for novel and differentiated approaches to the treatment of cancers now and in the future.”

About Peak Bio, Inc.

Peak Bio, Inc. is a clinical-stage biopharmaceutical company focused on developing the next-generation of therapeutics to treat oncology and inflammatory orphan/rare diseases.

Peak Bio’s lead product candidate, PHP-303, is a 5th generation, small molecule, neutrophil elastase inhibitor currently awaiting initiation of a Phase II clinical study in the genetic orphan disease called Alpha1 anti-trypsin deficiency disorder (AATD). Peak Bio has successfully completed two Phase 1 clinical studies in human subjects: a single ascending dose trial (SAD) and a multiple ascending dose trial (MAD). The SAD and MAD PHP-303 clinical studies demonstrated a favorable safety profile, and a dose was established for Peak Bio’s upcoming clinical trials.

Peak Bio’s cancer platform consists of novel payloads/toxins in conjunction with an antibody-drug conjugate (ADC) platform that seeks to address a growing unmet need in cancer care.  Peak Bio’s current ADC approach has a dual mechanism of action that seeks to unite conventional and direct targeting of cancer cells with toxins while also engaging the immune system with the added potential to enhance cancer cell killing.  The Peak Bio payload seeks to stimulate the immune system by leaving behind immune memory cells that continue to kill cancer cells following the initial therapeutic intervention even in the absence of further ADC treatments. The potential for immune reengagement when the cancer reoccurs could be an exciting and important advancement in cancer care with this dual mechanistic approach to cancer therapeutics.  Peak Bio’s lead payload appears to be a poor substrate for multi-drug resistance (MDR) transporters which is a growing concern in the ADC field.

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect our current views about our plans, intentions, expectations, strategies, and prospects, which are based on the information currently available to us and on assumptions we have made. Forward-looking statements generally can be identified by terms such as “aims,” “anticipates,” “believes,” “contemplates,” “continues,” “could,” “estimates,” “expects,” “goal,” “intends,” “may,” “on track,” “opportunity,” “plans,” “poised for,” “possible,” “potential,” “predicts,” “projects,” “promises to be,” “seeks,” “should,” “target,” “will,” “would” or similar expressions and the negatives of those terms.

Although we believe that our plans, intentions, expectations, strategies, and prospects as reflected in or suggested by those forward-looking statements are reasonable, we can give no assurance that the plans, intentions, expectations, or strategies will be attained or achieved. Furthermore, actual results may differ materially from those described in the forward-looking statements and will be affected by a variety of risks and factors that are beyond our control. Such risks and uncertainties for our company include, but are not limited to: needs for additional capital to fund our operations, our ability to continue as a going concern; uncertainties of cash flows and inability to meet working capital needs; preclinical testing or early clinical results may not be predictive of the results or success of ongoing or later preclinical or clinical studies; identification, development and testing of the company’s product candidates and new platforms may take longer and/or cost more than planned, or our clinical studies may not be initiated or completed on schedule; risks inherent in drug development in general; difficulties enrolling patients in our clinical trials; failure to realize any value of our product candidates developed and being developed in light of inherent risks and difficulties involved in successfully bringing product candidates to market; inability to develop new product candidates and support existing product candidates; the approval by the FDA and EMA and any other similar foreign regulatory authorities of other competing or superior products brought to market; risks resulting from unforeseen side effects; risks associated with the impact of the COVID-19 pandemic; inability to obtain, maintain and enforce patents and other intellectual property rights or the unexpected costs associated with such enforcement or litigation; inability to obtain and maintain commercial manufacturing arrangements with third party manufacturers or establish commercial scale manufacturing capabilities; the inability to timely source adequate supply of our active pharmaceutical ingredients from third party manufacturers on whom the company depends; unexpected cost increases and pricing pressures and risks and other risk factors detailed in our public filings with the U.S. Securities and Exchange Commission (“SEC”), including our most recently filed Registration Statement on Form S-1 filed with the SEC and our most recently filed Annual Report on Form 10-K filed with the SEC. Except as otherwise noted, these forward-looking statements speak only as of the date of this press release and we undertake no obligation to update or revise any of these statements to reflect events or circumstances occurring after this press release. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.


Interim CEO and COO

Stephen LaMond, PharmD, MBA

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