On December 19, 2024 Tolerance Bio, Inc., a biopharmaceutical company pioneering innovative approaches to increasing healthspan by preserving, restoring, and manipulating the function of the thymus, the master regulator of immune tolerance, reported the formation of its Scientific Advisory Board (SAB) and the completion of its oversubscribed $20.2 million seed financing round (Press release, Tolerance Bio, DEC 19, 2024, View Source [SID1234649226]).

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Tolerance Bio is developing an allogeneic, or "off the shelf," induced pluripotent stem cell (iPSC)-based thymus cell therapy platform as well as pharmacological thymus therapies to address immune-mediated diseases. These diseases are caused by abnormalities in immune tolerance, including cancer, autoimmunity, transplant rejection, infections, immune deficiencies, and allergies.

The Company announced the completion of its seed financing round with the addition of Pacific 8 Ventures to the previously announced syndicate led by Columbus Venture Partners, with participation from Criteria Bio Ventures, Sessa Capital, BioAdvance, Ben Franklin Technology Partners, and individual biotechnology investors.

To support the Company’s research and development (R&D) initiatives, Tolerance Bio also announced the formation of its Scientific Advisory Board (SAB).

"The Tolerance Bio team is humbled by the exceptional advisors and investors supporting our mission to preserve, restore and manipulate the thymus to address immune diseases and potentially increase longevity," said Francisco Leon, M.D., Ph.D., Co-Founder and Chief Executive Officer of Tolerance Bio. "Each advisor is a leader in their respective fields, providing the Company with unbiased insights and guidance as we advance our programs in immunology, oncology, and beyond. We are incredibly excited by the opportunities lying ahead."

Tolerance Bio’s SAB is comprised of the following members:

Dr. Holger Russ, Ph.D., is the Scientific Co-Founder of Tolerance Bio and its SAB Chairman. Dr. Russ is a pioneer in stem-cell derived thymic and beta cell generation. He is an Associate Professor in the Department of Pharmacology and Therapeutics at the Diabetes Institute of the University of Florida. He is also an Honorary Senior Research Fellow at the Institute of Metabolism & Systems Research at the University of Birmingham in the UK. Dr Russ’s research focuses on the generation of functional human thymic and pancreatic islets from pluripotent stem cells. He has made significant contributions to the field of regenerative medicine and is a co-inventor on eight patents in this area.

Dr. Megan Sykes, M.D., is the Michael J. Friedlander Professor of Medicine and Professor of Microbiology & Immunology and Surgical Sciences (in Surgery) at Columbia University. She is Director of the Columbia Center for Translational Immunology, Director of Research for the Transplant Initiative, and Director of Bone Marrow Transplantation Research at Columbia University Medical Center. Dr. Sykes has published more than 500 papers and book chapters during her research career, focusing on hematopoietic cell transplantation, organ allograft tolerance induction, xenotransplantation tolerance, and Type 1 diabetes. She has developed novel strategies for achieving GVL effects without GVHD following hematopoietic cell transplantation (HCT). One such approach provided safety and efficacy data in clinical trials of non-myeloablative haploidentical HCT that permitted the use of HCT for the intentional achievement of organ allograft tolerance in humans. Her work on xenogeneic thymic transplantation for tolerance induction has been extended into non-human primate and human studies. She has used mixed chimerism to reverse autoimmunity while replacing destroyed islets of Langerhans in Type 1 diabetes and developed novel "human immune system (HIS) mouse" models that allow personalized analysis of the pathogenesis of human immune disorders such as Type 1 diabetes. She has also used the HIS mouse model to understand human T cell repertoire development and assess the impact of stem cell-derived human thymic epithelial cells on human T cell development in a porcine thymus. Dr. Sykes is the Past President of the International Xenotransplantation Association, was President of the Federation of Clinical Immunology Societies (FOCiS) from 2022-2024, a recipient of the Medawar Prize, and a member of the National Academy of Medicine.

Dr. Camillo Ricordi, M.D., FNAI, is a Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, and Microbiology and Immunology at the University of Miami (UM), Florida, where he serves as Chief of the Division of Cellular Transplantation, Department of Surgery, Director of the Cell Transplant Center and Director Emeritus of the Diabetes Research Institute (DRI). Since 1993, he has been the Medical Director of the NIH-funded cGMP Advanced Human Cell and Biologic Product Manufacturing Facility, supporting global research and clinical applications. Dr. Ricordi is renowned for inventing groundbreaking technology to isolate islet cells from the human pancreas, revolutionizing islet transplantation for diabetes treatment. He led the first successful clinical islet allotransplants using purified donor islets, reversing diabetes through intra-hepatic infusion. This transformational procedure is now standard practice in clinical islet transplantation worldwide. In 1993, he joined the University of Miami to lead the DRI and Cell Transplant Center. Among his achievements, Dr. Ricordi led the first successful implantation of a bioengineered endocrine pancreas for patients with severe Type 1 Diabetes and chaired the NIH Phase 3 trial on islet transplantation. Currently, he serves as Chairperson of the International Steering Committee and Principal Investigator for two stem cell-derived islet transplant trials. A founding president of key professional organizations, Dr. Ricordi has received numerous accolades, including the World Prize in Surgery, the American Diabetes Association’s Outstanding Scientific Achievement Award, the Leonardo Da Vinci Award, and induction into the National Academy of Inventors. His extensive contributions include over 1,170 publications, 58,000 citations, 28 patents, and the bestselling book The Healthspan Code.

Dr. Jerome Ritz, M.D.’s research focuses on immune reconstitution after hematopoietic stem cell transplantation, cellular therapies, and cancer immunotherapy. Dr. Ritz has co-authored more than 450 scientific publications in peer-reviewed journals and contributed to numerous presentations at leading scientific conferences. From 1996 until June 2024, Dr. Ritz was Executive Director of the Connell and O’Reilly Families Cell Manipulation Core Facility (CMCF) at the Dana Farber Cancer Institute in Boston, Massachusetts. This GMP facility manufactures a variety of cellular products, including genetically modified hematopoietic stem cells, CAR T cells, NK cells, regulatory T cells, invariant NKT cells, and cancer vaccines for patients enrolled in early phase clinical trials. He is a Professor of Medicine at the Dana-Farber Cancer Institute, Brigham and Women’s Hospital, and Harvard Medical School, and continues to lead a research team at the Dana-Farber Cancer Institute.

Dr. Manasi Jaiman, M.D., MPH, is the global, mission-driven Chief Medical Officer of Aardvark Therapeutics, and an expert on cell therapy clinical development. Dr. Jaiman advances breakthrough therapies through the integration of medicine and technology, drawing from 15 years of clinical development, device development, regulatory filings, direct patient care, and scientific research. She was the Chief Medical Officer of ViaCyte, a beta cell therapy company acquired by Vertex in 2022. Through her expertise in stem cell therapy disease and diabetes, she developed the world’s first-in-human protocol using gene-edited cells in a medical device for Type 1 diabetes and successfully executed the clinical trials. Dr. Jaiman also developed the first outpatient clinical trial to study a bi-hormonal artificial pancreas in adults and pediatrics at MassGeneral Hospital, then led clinical trials utilizing the bionic pancreas device, now used at Beta Bionics.

Dr. Roland Kolbeck, Ph.D., is co-owner and the Chief Scientific Officer of Spirovant and an expert on biologic therapeutics in immune diseases. Dr. Kolbeck is an accomplished biotech executive specializing in respiratory sciences and drug discovery. His career spans more than 20 years of research and executive leadership experience, including Vice President and Head of Respiratory, Inflammation, and Autoimmune research at MedImmune/AstraZeneca. At MedImmune, he led the development of FASENRA, AstraZeneca’s first biological for the treatment of severe eosinophilic asthma, and contributed to the spinout of six pre/clinical-stage autoimmune assets. Previously, he held senior scientific roles at Peptimmune and Millennium Pharmaceuticals. Dr. Kolbeck also served as an Associate Professor in the Department of Pathology and Molecular Medicine at McMaster University from 2014-2022. He earned a PhD from the University of Regensburg and Max Planck Institute of Neurobiology, Munich.

On December 19, 2024 Arcus Biosciences (NYSE:RCUS), a clinical-stage, global biopharmaceutical company focused on developing differentiated molecules and combination therapies for patients with cancer, reported that Terry Rosen, Ph.D., chief executive officer, will present at the upcoming 43rd Annual J.P. Morgan Healthcare Conference in San Francisco, CA (Press release, Arcus Biosciences, DEC 19, 2024, View Source [SID1234649225]). The presentation will take place on Tuesday, January 14th, 2025, at 3:45pm PT.

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A live webcast of the presentation will be available by visiting the "Investors & Media" section of the Arcus Biosciences website at www.arcusbio.com. A replay will be available following the live event.

On December 19, 2024 PeproMene Bio, Inc. (PMB) reported an $11M investment from the Institute for Follicular Lymphoma Innovation (IFLI) to support the clinical development of PMB-CT01 (BAFF-R CAR T cell therapy) in patients with relapsed or refractory (r/r) follicular lymphoma (Press release, PeproMene Bio, DEC 19, 2024, View Source [SID1234649224]). The investment includes $6M USD upfront and an additional $5M USD in conditional tranched funding. Building on the promising results of PMB’s Phase 1 study, the expansion phase will now include patients with r/r follicular lymphoma, further evaluating the safety and efficacy of BAFF-R targeting CAR T cells in heavily pretreated patients.

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BAFF-R CAR T cell therapy was developed by City of Hope to provide an alternative or follow-on treatment option for the significant number of patients with B-cell malignancies that relapse after receiving standard of care medication including commercial CD19 CAR T cell therapy.

"There is a significant unmet need for effective treatments following CD19 CAR T therapy that are both safe and effective in heavily pretreated patients," said Hazel Cheng PhD., COO of PMB. "We are deeply committed to the ongoing scientific and clinical development of this potentially promising new cell therapy in r/r follicular lymphoma and other types of B cell malignancies."

"It’s truly encouraging that all six patients with non-Hodgkin lymphoma treated with PMB-CT01 have demonstrated 100% CR rate and only low-grade treatment emergent adverse events, specifically Grade 1 CRS and Grade 1 ICANS)," said Elizabeth Budde M.D., PhD., the trial’s principal investigator and associate professor of hematology at City of Hope, one of the largest and most advanced cancer research and treatment organizations in the U.S. "Most of the trial participants relapsed after CD19 CAR T therapy and/or presented with CD19 negative tumor. PMB-CT01 could therefore offer a viable therapeutic option for patients facing this challenging scenario. It is also noteworthy that BAFF-R CAR T might outperform the FDA approved CD19 CAR T cell therapies given its consistently favorable balance of efficacy-safety."

"PMB-CT01 shows tremendous potential in enhancing patient outcomes for Non-Hodgkin Lymphomas, particularly follicular lymphoma," stated Michel Azoulay, M.D., CMO of IFLI. "We are thrilled to back PeproMene Bio, Inc. in their exploration of PMB-CT01 for follicular lymphoma patients."

About PMB-CT01

PMB-CT01 is a first-in-class, BAFF-R targeted, autologous CAR T cell therapy. BAFF-R (B-Cell Activating Factor Receptor), a member of the tumor necrosis factor (TNF) receptor superfamily, is the main receptor for BAFF and is expressed almost exclusively on B cells. Since BAFF-R signaling promotes normal B-cell proliferation and appears to be required for B-cell survival, tumor cells are unlikely to escape therapy via loss of the BAFF-R antigen. This unique characteristic makes BAFF-R CAR T therapy a highly promising option for treating B-cell malignancies. The BAFF-R CAR was constructed using anti-BAFF-R single-chain fragment variable (scFv) antibodies and second-generation signaling domains CD3ζ and 4-1BB. Our research has demonstrated that BAFF-R CAR T cells effectively kill human lymphomas and leukemias both in vitro and in animal models. PeproMene Bio has licensed intellectual property relating to PMB-CT01 from City of Hope.

On December 19, 2024 Aadi Bioscience, Inc. (NASDAQ: AADI) reported it has entered into an exclusive license agreement for development and global commercialization of a three-asset portfolio of preclinical, next-wave antibody-drug conjugates (ADCs), in collaboration with WuXi Biologics (2269.HK), a leading global Contract Research, Development and Manufacturing Organization (CRDMO), and HANGZHOU DAC BIOTECHNOLOGY CO., LTD. (HANGZHOU DAC), a global leader in ADC innovation (Press release, Aadi Bioscience, DEC 19, 2024, View Source [SID1234649223]).

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Per the terms of the license agreement, Aadi is granted exclusive rights to certain patents and know-how pertaining to three preclinical ADC programs leveraging HANGZHOU DAC’s CPT113 linker payload technology targeting each of Protein Tyrosine Kinase 7 (PTK7), Mucin-16 (MUC16) and Seizure Related 6 Homolog (SEZ6). Aadi will pay aggregate upfront payments of $44 million for in-licensing such ADC programs. Additionally, Aadi is obligated to pay cumulative development milestone payments of up to $265 million, cumulative commercial milestone payments of up to $540 million and single-digit royalties of sales.

To support this transaction, Aadi entered into a subscription agreement with certain qualified institutional buyers and accredited investors for a private investment in public equity ("PIPE") financing that is expected to result in gross proceeds of approximately $100 million, before deducting placement agent fees and other offering expenses. The Company is selling an aggregate of 21,592,000 shares of its common stock ("Common Stock") at a price of $2.40 per share, representing a premium of approximately 3.4% to the closing price on December 19, 2024 on Nasdaq, and pre-funded warrants ("Pre-Funded Warrants") to purchase up to an aggregate of 20,076,500 shares of Common Stock at a purchase price of $2.3999 per Pre-Funded Warrant share.

The syndicate was led by Ally Bridge Group, with participation from new investors OrbiMed, Invus, Kalehua Capital and other accredited investors, Tae Han co-founder of ProfoundBio, as well as existing investors, including Avoro Capital, KVP Capital and Acuta Capital Partners. The PIPE financing is expected to close in the first half of 2025, subject to stockholder vote and satisfaction of customary closing conditions.

"I’m thrilled to announce our partnership with WuXi Biologics and HANGZHOU DAC to bring forward this thoughtfully selected ADC portfolio. We were deliberate in identifying broadly expressed tumor targets where first-generation ADCs have already shown proof of concept. With our next wave ADC portfolio, we aim to build upon these earlier therapies to deliver improved outcomes for people living with cancer," said David Lennon, PhD, President and CEO of Aadi Bioscience. "The financing underscores the confidence our investors have in both the potential of this portfolio and the strength of Aadi’s management team."

About the ADC Portfolio

Each of the three ADC assets utilizes HANGZHOU DAC’s CPT113 ADC platform, which consists of a highly stable yet cleavable linker that delivers a Topoisomerase I (TOPO1) inhibitor payload. The CPT113 platform’s linker stability and novel payload has the potential to be highly competitive among the next generation ADC platforms.

To effectively leverage the CPT113 platform, Aadi selected tumor targets that are upregulated in high-potential cancer indications and where clinical efficacy has been demonstrated by first-generation ADCs.

PTK7-CPT113 potentially represents a differentiated opportunity to be among the first next-wave ADCs in clinical development for high PTK7 expressing cancers, including non-small cell lung cancer (NSCLC), ovarian cancer and several other major indications.
mMUC16-CPT113 is the first ADC that targets membrane-bound portion of MUC16, a glycoprotein often overexpressed in cancers of female origin.
biSEZ6-CPT113 is designed to address the neuronal target, SEZ6, which is often overexpressed in cancers of neuroendocrine origin. biSEZ6-CPT113 utilizes a dual epitope binding, or biparatopic, approach which can potentially improve internalization and effectiveness of the ADC.
These assets were discovered through the collaborative efforts of WuXi Biologics and HANGZHOU DAC, utilizing the innovative antibody discovery platform provided by WuXi Biologics and advanced linker-payload technology provided by HANGZHOU DAC.

"Leveraging our advanced antibody discovery service, we’re glad to enable Aadi to accelerate the discovery of precision therapies targeting some of the most challenging cancers," said Dr. Chris Chen, CEO of WuXi Biologics. "This collaboration underscores our wide recognition as an industry leader in discovery service solutions, and further validates our ability to provide integrated discovery technology platforms for global partners to develop next-generation modalities. We look forward to partnering with Aadi and HANGZHOU DAC to expeditiously move these assets forward into clinical development and benefit patients worldwide."

"HANGZHOU DAC’s CPT-ADC platform is designed to enable next wave ADC capabilities that surpass first-generation technologies, including two programs already in clinical development in China," said Dr. Robert Y. Zhao, President and CEO of HANGZHOU DAC Biotechnology. "As a global leader in ADC innovation, we are excited to partner with Aadi and WuXi Biologics to deliver this promising portfolio to patients."

Aadi to Sell FYARRO for $100 Million, Cumulative Capital Expected to Fund Operations into Late 2028

In a separate agreement, KAKEN Pharmaceutical Co., Ltd., an R&D driven pharmaceutical company in Japan, has entered into a stock purchase agreement under which KAKEN will acquire Aadi Subsidiary, Inc. and all of its assets, including FYARRO (sirolimus protein-bound particles for injectable suspension) (albumin-bound) and associated infrastructure, including the majority of Aadi employees who support the FYARRO business. FYARRO is approved by the U.S. Food and Drug Administration (FDA) for the treatment of adult patients with locally advanced unresectable or metastatic malignant perivascular epithelioid cell tumor (PEComa), with cumulative revenue of $25.2 million reported over the prior four quarters ended September 30, 2024.

Per the terms of the agreement, Kaken will pay Aadi $100 million in cash at closing, subject to certain adjustments. The transaction is expected to close in the first half of 2025, subject to Aadi stockholder approval and certain closing conditions. Upon the closing of this transaction, KAKEN will also acquire the rights to the Aadi name and trademark.

"We are enormously proud of the impact FYARRO has had for people with PEComa, and Kaken’s capabilities, coupled with the proven track record of the Aadi team, ensures physicians and patients will continue to have access to this critical treatment," said Lennon.

The net proceeds from the PIPE financing and the sale of FYARRO, together with the Company’s existing cash, cash equivalents and marketable securities are expected to fund operations into late-2028, including anticipated clinical data readouts for the ADC portfolio.

Baiteng Zhao Appointed to the Board of Directors, Brings Significant ADC Expertise

Baiteng Zhao, PhD, joins Aadi’s board of directors. Zhao co-founded ProfoundBio, a clinical stage next-gen ADC developer, in 2018 and served as the Chairman and CEO of the company until it was acquired by Genmab for $1.8 billion in May 2024. Prior to ProfoundBio, Dr. Zhao worked at Seagen (now part of Pfizer) for more than eight years and was responsible for the modeling and simulation strategies for the development pipeline and supported preclinical and clinical development of ADC drug candidates.

"We are delighted to welcome Baiteng to our Board. His deep expertise and successful track record in ADC development will be instrumental as we tenaciously move this exciting portfolio forward," said Caley Castelein, MD, Chair of the Board of Directors of Aadi Bioscience.

"I am thrilled to join the Board at this pivotal moment for Aadi," said Baiteng Zhao, PhD, Board of Directors of Aadi Bioscience and co-founder of ProfoundBio. "PTK7, MUC16 and SEZ6 represent highly promising targets that are commonly overexpressed in cancers with significant unmet therapeutic needs. Coupled with an advanced linker-payload platform that has the potential to enable next-gen ADCs, I believe Aadi is uniquely positioned to make a meaningful impact on patient outcomes. I look forward to collaborating with the leadership team and fellow Board directors to advance these innovative programs and drive transformative progress for patients."

Advisors

Leerink Partners is serving as financial advisor to Aadi on the sale of FYARRO and the licensing of the ADC portfolio. Jefferies LLC is acting as exclusive placement agent for the PIPE financing. Wilson Sonsini Goodrich & Rosati, P.C. is serving as legal counsel to Aadi. McDermott Will & Emery LLP is serving as legal counsel to Kaken. Cooley LLP is serving as legal counsel to Jefferies LLC. Nomura Securities Co., Ltd. is serving as financial advisor to KAKEN.

Conference Call Information

The Aadi management team is hosting a conference call and webcast tomorrow, Friday, December 20th at 8:00 AM EST (5:00 AM PST) to discuss these updates. Participants may access a live webcast of the call and the associated slide presentation on these data through the "Investors & News" page of the Aadi Bioscience website at aadibio.com. To participate via telephone, please register in advance at this link. Upon registration, all telephone participants will receive a confirmation email detailing how to join the conference call, including the dial-in number along with a unique passcode and registrant ID that can be used to access the call. A replay of the conference call and webcast will be archived on the Company’s website for at least 30 days.

Additional Information for Stockholders

This communication relates to the proposed sale of FYARRO and the proposed PIPE financing and may be deemed to be solicitation material in respect of such transactions. In connection with these proposed transactions, Aadi will file a Proxy Statement with the SEC. This communication is not a substitute for the Proxy Statement or any other documents that Aadi may file with the SEC or send to Aadi stockholders in connection with the proposed transactions. Before making any voting decision, investors and securityholders are urged to read the Proxy Statement and all other relevant documents filed or that will be filed with the SEC in connection with the proposed transactions as they become available because they will contain important information about the proposed transactions and related matters.

Stockholders may obtain a copy of the Proxy Statement and other documents the Company files with the SEC (when they are available) through the website maintained by the SEC at www.sec.gov, as well as on the Investor and News section of Aadi’s website at www.aadibio.com.

Certain stockholders of Aadi holding approximately 36% of Aadi’s outstanding shares, as of the date hereof, including members of its board of directors and related entities, have entered into voting and support agreements in favor of KAKEN Pharmaceutical and Aadi, pursuant to which such stockholders have agreed to vote in favor of the stock purchase transaction with KAKEN Pharmaceutical and the other transactions described above.

Participants in the Solicitation

Aadi and its respective directors and executive officers may be deemed to be participants in the solicitation of proxies from the stockholders of Aadi in connection with the proposed transactions. Information about Aadi’s directors and executive officers is set forth in Aadi’s definitive proxy statement filed with the SEC on April 26, 2024, and in subsequent filings made by Aadi with the SEC. Other information regarding the interests of such individuals, as well as information regarding Aadi’s directors and executive officers and other persons who may be deemed participants in the proposed transactions, will be set forth in the Proxy Statement and other relevant materials to be filed with the SEC when they become available. You may obtain free copies of these documents as described in the preceding paragraph.

No Offer or Solicitation

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities nor a solicitation of any vote or approval with respect to the proposed transactions or otherwise, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

The offer and sale of securities of Aadi described above are being made in a transaction not involving a public offering and the securities have not been registered under the Securities Act of 1933, as amended, and may not be reoffered or resold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements. Concurrently with the execution of the subscription agreement, the Company and the investors entered into a registration rights agreement pursuant to which the Company has agreed to file, following the closing of the PIPE financing, a registration statement with the SEC registering the resale of the shares of Common Stock and the shares of Common Stock underlying the Pre-Funded Warrants sold in the PIPE financing.

On December 19, 2024 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported a portfolio prioritization, focusing resources on advancing its lead clinical program, PYX-201, a first-in-concept antibody-drug conjugate (ADC) with a microtubule inhibitor (optimized auristatin) payload that uniquely targets Extradomain-B Fibronectin (EDB+FN), a non-cellular structural component within the tumor extracellular matrix (Press release, Pyxis Oncology, DEC 19, 2024, View Source [SID1234649222]).

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In November 2024, Pyxis Oncology reported positive preliminary data from the ongoing Phase 1 dose-escalation study of PYX-201, evaluating its safety and efficacy in multiple solid tumor types. Among patients with HNSCC, PYX-201 achieved a confirmed 50% objective response rate (ORR) based on RECIST 1.1 criteria, including one complete response and a disease control rate (DCR) of 100% in six heavily pretreated HPV-positive and HPV-negative evaluable patients with a median of four prior lines of therapy.

Across six solid tumor types of interest at therapeutically active dose levels, including HNSCC, ovarian, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma, PYX-201 (n=31) achieved a 26% ORR in the Phase 1 trial, with dose-dependent responses observed including patients who had previously progressed on taxanes. The data supports further development in both monotherapy and combination therapy expansion trials, including a frontline HNSCC study in combination with pembrolizumab, with patient dosing in both the monotherapy and combination therapy trials expected to begin in early 2025.

The portfolio prioritization further supports a robust development plan for PYX-201 in several dose expansion studies, including monotherapy in 2/3L HNSCC, in combination with pembrolizumab in 1/2L+ HNSCC, as well as pembrolizumab combination studies in other solid tumors including HR+/HER2- and triple-negative breast cancer. Preliminary data from these cohorts is expected across both the second half of 2025 and the first half of 2026.

Details on the PYX-201 Phase 1 dose-escalation trial and preliminary data presented in November are available on the Events & Presentations page in the Investor Relations section of Pyxis Oncology’s website at ir.pyxisoncology.com.

Pipeline Prioritization

Pyxis Oncology’s second clinical program, PYX-106 — a fully human IgG1 monoclonal antibody targeting Siglec-15 — is being deprioritized to allocate resources toward advancing the lead asset, PYX-201. As a result, Pyxis Oncology has decided to suspend further clinical investment in PYX-106, which was in-licensed from Biosion Inc., with Biosion retaining rights for Greater China.

To date, the Phase 1 monotherapy trial of PYX-106 enrolled 45 patients with advanced solid tumors. PYX-106 was observed as generally safe and well-tolerated across all tested doses, ranging from 0.5 mg/kg to 22.5 mg/kg. At this time, a maximum tolerated dose has not been established. The pharmacokinetic and pharmacodynamic results demonstrated dose-proportional pharmacokinetics, a half-life of 9 to 11 days, no detection of antidrug antibodies in a variety of heavily pretreated solid tumors across tested dose levels.

"Deprioritizing the PYX-106 clinical program as a monoclonal antibody represents a strategic and judicious use of our resources, allowing us to focus on advancing PYX-201," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "We are excited about the potential of PYX-201, an innovative, first-in-concept ADC uniquely designed to target the tumor extracellular matrix. The positive preliminary PYX-201 Phase 1 data we presented last month reinforces our confidence in the promise of this program, particularly in addressing unmet needs in HNSCC in both monotherapy and combination therapy settings."