KLRG1

NEWTON, Mass.--(BUSINESS WIRE)-- Abcuro, Inc., a clinical-stage biotechnology company developing therapies for the treatment of autoimmune diseases and cancer through precise modulation of cytotoxic T cells, today announced the completion of enrollment of the registrational Phase 2/3 MUSCLE clinical trial evaluating ulviprubart (ABC008) for the treatment of inclusion body myositis (IBM). “We continue to focus on advancing our product candidate ulviprubart to treat patients with IBM who currently have no treatment options and are therefore delighted to achieve another important milestone for this clinical program,” said H. Jeffery Wilkins, M.D., Chief Medical Officer of Abcuro. “Ulviprubart is a first-in-class therapy targeting KLRG1 and has great potential to transform the treatment paradigm for IBM where there is currently a significant unmet need. We look forward to sharing initial data from the Phase 2/3 MUSCLE trial in the first half of 2026.” "IBM is a tremendously debilitating disease which drastically and irreversibly reduces quality of life. Families are deeply affected as they witness their loved one's decline, while troubleshooting each facet of daily life to accommodate the condition. Living with IBM can make basic daily activities difficult and can negatively impact larger goals like maintaining hobbies and travel,” said Paula J. Eichenbrenner, MBA, CAE, Executive Director of The Myositis Association. "IBM patients have no recourse in the current therapeutic landscape. Exercise and physical therapy can preserve muscle and stave off disease progression, but only to a degree. The lack of disease-modifying treatment options places more burden on IBM families as they must help their loved ones to manage anxiety about the inevitable muscle loss they will endure and feelings of being trapped with this rare, catastrophic disease." The Phase 2/3 MUSCLE clinical trial (NCT05721573) is a global, randomized, double-blind, placebo-controlled, parallel multicenter registrational trial evaluating ulviprubart in patients with IBM. The objectives of the trial are to evaluate efficacy, safety, and tolerability of two dose levels of ulviprubart (0.5 mg/kg and 2.0 mg/kg) compared with placebo at 76 weeks in subjects with IBM followed by a 4-week safety follow-up period. About Ulviprubart Ulviprubart (ABC008) is a first-in-class anti-KLRG1 antibody product candidate capable of selectively depleting highly cytotoxic T cells, while sparing naïve, regulatory and central memory T cells. Ulviprubart is designed to treat diseases mediated by highly cytotoxic T cells, including the autoimmune muscle disease inclusion body myositis (IBM), T cell large granular lymphocytic leukemia (T-LGLL), and mature T cell malignancies. The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have each granted orphan drug designation to ulviprubart for the treatment of IBM. About Inclusion Body Myositis (IBM) IBM is an autoimmune disease in which highly cytotoxic T cells chronically attack muscle tissue leading to progressive weakness and limb muscle atrophy. Patients progressively lose muscle function, including loss of grip, dexterity and mobility. There are currently no available disease-modifying treatment options for IBM. Based on published epidemiology literature, it is estimated that there are more than 50,000 people with IBM across the US and Europe. About Abcuro Abcuro is a clinical stage biotechnology company developing first-in-class immunotherapies for the treatment of autoimmune diseases and cancer through precise modulation of highly cytotoxic T cells. The company’s lead program is ulviprubart (ABC008) and is currently in clinical trials for inclusion body myositis (IBM) and T cell large granular lymphocytic leukemia. For more information, visit us on LinkedIn and at abcuro.com.

PYX-201, an EDB+FN-specific tumor stroma-targeting ADC, demonstrates potent anti-tumor efficacy across multiple human cancers in PDX tumor models The PYX-201 target EDB+FN is found overexpressed across multiple human solid tumor types BOSTON, March 05, 2024 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, announced today that the company will present new preclinical data in four posters at the 2024 American Association for Cancer Research (AACR) Annual Meeting in San Diego, California, held from April 5 to 10, 2024. "Our preclinical research continues to support the broad potential of PYX-201, our innovative clinical stage ADC targeting EDB+FN, a protein associated with the stroma of solid tumors,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “Data from PDX tumor preclinical models has shown potent anti-tumor activity in multiple human cancer indications. We will also demonstrate that the overexpression of EDB+FN, the molecular target of PYX-201, is consistently observed in various human tumor types, with minimal expression observed in healthy tissue. For our PYX-106 program, we will also present encouraging preclinical data supporting the clinical opportunity of this immune-oncology therapeutic candidate to potentially demonstrate clinical activity in individuals that are not candidates for anti-PD-(L)1 approaches. Finally, we will present anti-tumor efficacy data supporting the potential for PYX-102 as a therapeutic candidate, and remain open to out-licensing opportunities for future development.” Poster titles are now available on the AACR website. Posters will be made available on the Pyxis Oncology website following presentations at the conference. Presentation details are as follows; times noted are Pacific time: PYX-201 Title: PYX-201, a stroma-targeting ADC composed of an anti-EDB+FN antibody conjugated to Auristatin0101, demonstrates strong anti-tumor efficacy across multiple human cancer indications in pre-clinical PDX tumor models Session Category: Experimental and Molecular TherapeuticsSession Title: Tumor MicroenvironmentSession Date and Time: Sunday, April 7, 2024, 1:30 PM - 5:00 PMLocation: Poster Section 29Poster Board Number: 28Published Abstract Number: 742 Title: EDB+FN is an attractive therapeutic target in oncology: Insights from protein expression analysis of solid tumors Session Category: Tumor BiologySession Title: The Tumor Microenvironment as a Drug TargetSession Date and Time: Monday, April 8, 2024, 1:30 PM - 5:00 PMLocation: Poster Section 13Poster Board Number: 16Published Abstract Number: 2908 PYX-106 Title: Gene expression correlation of immune checkpoint molecules Siglec-15 and PD-L1 varies widely by cancer indication Session Category: ImmunologySession Title: Immune Checkpoints and Inhibitory Molecules 1Session Date and Time: Monday, April 8, 2024, 9:00 AM - 12:30 PMLocation: Poster Section 3Poster Board Number: 24Published Abstract Number: 1373 PYX-102 Title: Targeting Murine or Human KLRG1 Exerts Potent anti-Tumor Efficacy Involving Both CD8+ T cells and NK cells Session Category: Tumor BiologySession Title: Macrophages, Neutrophils, and NK Cells in CancerSession Date and Time: Sunday, April 7, 2024, 1:30 PM - 5:00 PMLocation: Poster Section 7Poster Board Number: 19Published Abstract Number: 177 About Pyxis Oncology, Inc.Pyxis Oncology, Inc. is a clinical stage company focused on defeating difficult-to-treat cancers. The company is efficiently building next generation therapeutics that hold the potential for mono and combination therapies. PYX-201, an antibody-drug conjugate (ADC) that uniquely targets EDB+FN within the tumor stroma, and PYX-106, a fully human Siglec-15-targeting antibody designed to block suppression of T-cell proliferation and function, are being evaluated in ongoing Phase 1 clinical studies in multiple types of solid tumors. Pyxis Oncology’s therapeutic candidates are designed to directly kill tumor cells and to address the underlying pathologies created by cancer that enable its uncontrollable proliferation and immune evasion. Pyxis Oncology’s ADCs and immuno-oncology (IO) programs employ novel and emerging strategies to target a broad range of solid tumors resistant to current standards of care. To learn more, visit www.pyxisoncology.com or follow us on Twitter and LinkedIn. Forward-Looking StatementsThis press release contains forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995 and other federal securities laws. These statements are often identified by the use of words such as “anticipate,” “believe,” “can,” “continue,” “could,” “estimate,” “expect,” “intend,” “likely,” “may,” “might,” “objective,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “to be,” “will,” “would,” or the negative or plural of these words, or similar expressions or variations, although not all forward-looking statements contain these words. We cannot assure you that the events and circumstances reflected in the forward-looking statements will be achieved or occur and actual results could differ materially from those expressed or implied by these forward-looking statements. Factors that could cause or contribute to such differences include, but are not limited to, those identified herein, and those discussed in the section titled “Risk Factors” set forth in Pyxis Oncology’s Annual Report on Form 10-K for the year ended December 31, 2022, Pyxis Oncology’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023, Pyxis Oncology’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, Pyxis Oncology’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2023 and our other filings, each of which is on file with the Securities and Exchange Commission. These risks are not exhaustive. New risk factors emerge from time to time, and it is not possible for our management to predict all risk factors, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements. In addition, statements that “we believe” and similar statements reflect our beliefs and opinions on the relevant subject. These statements are based upon information available to us as of the date hereof and while we believe such information forms a reasonable basis for such statements, such information may be limited or incomplete, and our statements should not be read to indicate that we have conducted an exhaustive inquiry into, or review of, all potentially available relevant information. These statements are inherently uncertain, and investors are cautioned not to unduly rely upon these statements. Except as required by law, we undertake no obligation to update any forward-looking statements to reflect events or circumstances after the date of such statements. Pyxis Oncology ContactPamela ConnealyCFO and COOir@pyxisoncology.com

Pyxis Oncology, which went public in fall 2021, is hoping tough decisions will help prioritize programs with the highest likelihood of success. Pyxis Oncology needs to pave a longer cash runway. To do so, the Pfizer-partnered antibody-drug conjugate (ADC) biotech is cutting 40% of staff, slimming its programs and looking to monetize royalty opportunities from a recently acquired company—among other cost-cutting measures. It’s a stark change from the recent headlines around ADC-focused companies, which have been snagging deals with Big Pharmas left and right. Pyxis, which went public in fall 2021, is hoping the tough decisions will help prioritize programs with the highest likelihood of success. The pipeline will continue to focus on lead tumor stroma-targeting ADC PYX-201 and secondary program PYX-106 in non-small cell lung cancer (NSCLC), with early-stage research programs paused. “In order to maximize PYX-201’s chances of success, as well as those of PYX-106, we are announcing a number of initiatives to extend our cash runway into 2026, which we believe is the responsible thing to do in the current funding environment,” CEO Lara Sullivan, M.D., said in a postmarket release Tuesday. “We believe the actions we are taking best position Pyxis Oncology for future success, with our current cash resources now taking us beyond important near-term 2024 readouts for our ongoing clinical trials.” PYX-201, which was in-licensed from Pfizer, is being tested in a phase 1 trial of patients with solid tumors at the moment. The fifth dose cohort recently opened for enrollment, and 15 people have been dosed in other groups so far. The company believes that the swift escalation in dosing “speaks to the potential safety profile” of the therapy. Preliminary phase 1 data are expected in the first half of 2024. “Based on data from Pfizer’s HER2 ADC previously under development with the same linker and payload and our preclinical experiments, we believe that at 3.6 mg/kg and above, we are approaching biologically active dose levels,” Sullivan said. PYX-106 was originally being targeted at a wider array of tumors, but Pyxis has decided to only include patients with NSCLC. Dosing had already gotten underway in a phase 1 test, so, with the “repositioning,” initial results are now anticipated in the second half of 2024. Pyxis said the update does not increase costs of the trial. Another med in the pipeline is sotigalimab, which came under Pyxis’ purview with the May acquisition of Apexigen and has been renamed PYX-107. The new owner has not yet decided the future for the CD40 agonist, which is being tested in phase 2 for melanoma and liposarcoma. But one thing is for sure, PYX-107 will have to wait until the phase 1 data for PYX-201 are available, Pyxis said. Then, the legacy Apexigen med “will be further assessed as part of portfolio evaluation.” As cash resources shift to the two main programs, Pyxis will say goodbye to 40% of its staff. The company's current workforce is estimated to be around 75 people, according to LinkedIn and Crunchbase. With $134 million in cash as of Sept. 30, the company expects the runway to last through the upcoming major milestones for the two main programs into early 2026, as long as it executes “continued financial discipline.” According to a third-quarter earnings report, the runway had previously been expected to last about a year without the changes. As for Apexigen, which was acquired in an all-stock transaction valued at around $10.7 million, Pyxis “has undertaken monetization efforts” for the company’s royalty streams. Sullivan and her team are also looking for partnerships for some of Apexigen’s programs that will not be advancing into the clinic under the Pyxis name, plus antibody and ADC platform technologies it has no use for that may bring in non-dilutive funding. In announcing the acquisition, Pyxis said Apexigen’s antibody-generation platform would be complementary to its existing linkers, payloads and conjugation chemistries. The buyer also seemed excited about Apexigen’s sotigalimab, calling it “a potential best-in-class phase 2 CD40 agonist.” But just over three months after the deal officially closed in August, it seems Pyxis is already offloading the very assets that made the Apexigen acquisition so attractive. This is not the first time Pyxis has had to take a hard reality check and slim down its pipeline from five main candidates. Pyxis paused two programs, an anti-CD123 therapy called PYX-203 and the anti-KLRG1 med PYX-102, in August 2022. Now, the company plans to evaluate partnering opportunities for the two programs. Another asset was scrapped completely last summer as well. Those moves left Pyxis with a runway extending into the second half of 2024. Pyxis emerged onto the public markets in October 2021 at around $13 per share. The company's shares closed Tuesday at $1.66 apiece.