Peak Bio, Inc. (“Peak Bio” or the “Company”) (OTC PK: PKBO), is a clinical-stage biopharmaceutical company focused on developing the next-generation of therapeutics to treat oncology and inflammatory orphan/rare diseases.
Pleasanton, CA, Aug. 23, 2023 (GLOBE NEWSWIRE) -- Peak Bio Inc. (“Peak Bio” or the “Company”) (OTC PK: PKBO), is a clinical-stage biopharmaceutical company focused on developing the next-generation of therapeutics to treat oncology and inflammatory orphan/rare diseases.
At the heart of Peak Bio’s Oncology platform is our antibody-drug-conjugates (ADC) pipeline incorporating novel payloads/toxins that are used in conjunction with antibodies to precisely seek out and destroy cancer cells, thus developing a pipeline of novel therapies to address the growing unmet needs in cancer care. Preclinically, the Company’s PH-1 platform of toxins exhibit a dual mechanism of action combining both conventional and direct targeting of cancer cells with antibody-conjugated toxin while also engaging the immune system with a toxin with immunomodulatory properties to enhance cancer cell killing. In addition, 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.
After some encouraging proof-of-concept (POC) data for Peak Bio’s proprietary ADC approach was presented at AACR 2021, the Company was motivated to explore a pipeline of potentially differentiated ADCs as investigational therapeutics in oncology.
Details of the recent AACR 2023 poster are as follows:
Poster Title and Number: Rationale for the development of a differentiated Trop2 ADC (#6297)
Session Category and Title: Chemistry/ Experimental and Molecular Therapeutics; Growth Factor Receptors as Therapeutic Targets
Abstract Link:https://aacrjournals.org/cancerres/article/83/7_Supplement/6297/721032
These data highlight the rationale for the clinical development of Trop2 PH1 ADC as an investigational therapeutic for the treatment of solid cancers. Trop2 ADCs, conjugated with PH1 toxin at a drug-to-antibody (DAR) ratio of 4, demonstrated single digit nanomolar potency in eight different solid tumor indications. A proprietary Trop2 PH1 ADC (antibody-linker-toxin), had equal or better on-target potency than first-in-class (FIC) Trop2 ADC. The unique design of the Trop2 PH1 ADC resulted in minimal off-target effects and demonstrated a differentiated safety profile versus first-in-class ADCs Furthermore, Trop2 PH1 ADCs exhibited more potent TGI at a lower DAR and dose, than FIC, in gastric cancer model.
A copy of the poster is available on the Investors & Media section of the Peak Bio, Inc. website at https://peak-bio.com/posters-publications/
Stephen LaMond, PharmD, MBA, Peak Bio, Inc. Interim CEO and COO, commented, “We are pleased to announce our continued progress with our oncology portfolio (ADCs) that incorporate our novel payloads. The positive pre-clinical data strongly supports our corporate goal to seek an IND for this program. 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 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 unites 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 stimulates the immune system and leaves 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, 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.
Contact:
Stephen LaMond, PharmD, MBA
Interim CEO and COO
Peak Bio, Inc.
steve.lamond@peak-bio.com
