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Last update 15 Aug 2026

Sotigalimab

Last update 15 Aug 2026

Overview

R&D Status

Clinical Result

Translational Medicine

Overview

Basic Info

Drug Type

Monoclonal antibody

Synonyms

sotiga, APX 005, APX 005M

+ [5]

Target

CD40

Action

agonists

Mechanism

CD40 agonists(Tumor necrosis factor receptor superfamily member 5 agonists)

Therapeutic Areas

NeoplasmsDigestive System DisordersEndocrinology and Metabolic Disease+ [5]

Active Indication

Ovarian CancerRectal AdenocarcinomaAdvanced Sarcoma+ [14]

Inactive Indication

EGFR T790M Mutation Positive Non-Small Cell Lung CarcinomaEsophageal CarcinomaGastrooesophageal junction cancer+ [7]

Originator Organization

Epitomics, Inc.

Active Organization

Apexigen America, Inc.

Epitomics, Inc.

Pyxis Oncology, Inc.

Inactive Organization

Bristol Myers Squibb Co.

BioNTech US, Inc.

License Organization

Apexigen America, Inc.Nordic Society of Gynecologic Oncology

Yale Cancer Center

+ [2]

Drug Highest PhasePhase 2

First Approval Date-

RegulationOrphan Drug (United States)

Structure/Sequence

Sequence Code 23619516L

Source: *****

Sequence Code 524754917H

Source: *****

Clinical Trials associated with Sotigalimab

NCT05201001

/ WithdrawnPhase 2IIT

An Early Phase Randomized Trial of APX005M in BRCAwt Patients With Recurrent Ovarian Cancer

The overall objective is to demonstrate preliminary efficacy of APX005M-carboplatin-PLD and APX005M-radiotherapy-carboplatin-PLD combinations as treatment for relapsed BRCAwt ovarian cancer patients, where platinum combination therapy is an option.

Start Date07 Sep 2023

Sponsor / Collaborator

Swiss Go Trial Group

NCT05419479

/ SuspendedPhase 1/2IIT

Phase Ib Open-Label, Multicenter, Study Evaluating the Safety and Efficacy of 'Switch Maintenance' Combination Immunotherapy Using AB154, AB122, and Sotigalimab in Patients With Metastatic Pancreatic Cancer

This study is being done to test the safety and effectiveness of combining domvanalimab (AB154), zimberelimab (AB122), and APX005M with pancreatic cancer that has spread to other parts of body.
This research study involves immunotherapy. Immunotherapy triggers the body's immune system to fight cancer cells.
The names of the study drugs involved in this study are:
* Domvanalimab (also known as AB154)
* Zimberelimab (also known as AB122)
* APX005M

Start Date30 Nov 2022

Sponsor / Collaborator

Dana-Farber Cancer Institute, Inc.

[+2]

NCT04495257

/ CompletedPhase 1IIT

A Phase I Study of APX005M in Combination With Nivolumab and Ipilimumab in Treatment Naïve Patients With Advanced Melanoma or Renal Cell Carcinoma

This study is a Phase 1, open-label, single institution, dose escalation and dose expansion study to evaluate the efficacy, safety, and tolerability of APX005M in combination with nivolumab and ipilimumab in patients with advanced melanoma and RCC.

Start Date14 Sep 2020

Sponsor / Collaborator

Yale University

[+1]

100 Clinical Results associated with Sotigalimab

100 Translational Medicine associated with Sotigalimab

100 Patents (Medical) associated with Sotigalimab

Literatures (Medical) associated with Sotigalimab

01 Jan 2026·Cell Reports Medicine

CAR-T triggers TAM reeducation and adaptive anti-tumor response via TREM2 deficiency or CD40 agonist

Article

Author: Mai, Hanbing ; Tan, Jizhou ; Xi, Zhihui ; Yu, TianTian ; Gu, Yimei ; Liu, Yafang ; Liu, Haikuan ; Liu, Ting ; Fan, Wenzhe ; Yuan, Hui ; Zhang, Qiaoxuan ; Gao, Huixin ; Huang, Xianzhang

Chimeric antigen receptor (CAR)-T therapy targeting GPC3 shows unsatisfactory clinical efficacy in hepatocellular carcinoma (HCC). Combining clinical data and the immunocompetent orthotopic HCC model, we demonstrate that TREM2⁺ tumor-associated macrophages (TAMs) are critical mediators of GPC3-CAR-T resistance. We find that Trem2 deficiency synergizes with GPC3-CAR-T to enhance tumor control by expanding endogenous tumor-specific CD8⁺ T cells (not CAR-T amplification) and reeducating TAMs to an anti-tumor CXCL9^hi/SPP1^lo phenotype via metabolic reprogramming. Mechanistically, this combination enhances oxidative metabolism while suppressing glycolysis through JAK-STAT1 triggering, AMPK activation, and PI3K-AKT-mTOR inhibition. Crucially, Trem2 deficiency up-regulates CD40 expression, enabling CD40 agonism to phenocopy Trem2-deficiency effects via AMPK activation and STAT1-driven CXCL9 production. Notably, the clinical agonist sotigalimab similarly enhances human CD8⁺ T cell migration in vitro. Our findings highlight the significance of combining GPC3-CAR-T therapy with CD40 agonist as a critical pre-requisite for eliciting reeducation of TAMs and enhancing the efficacy of CAR-T therapy in HCC.

01 Feb 2025·Cancer research communications

A Phase 2 Study of Sotigalimab, a CD40 Agonist Antibody, plus Concurrent Chemoradiation as Neoadjuvant Therapy for Esophageal and Gastroesophageal Junction Cancers

Article

Author: Shankaran, Veena ; Chao, Joseph ; Sohal, Davendra ; Oberstein, Paul E. ; Rocha Lima, Caio Max Sao Pedro ; Noel, Marcus S. ; Crow, Mary ; Hsu, Frank J. ; Scott, Aaron J. ; Ko, Andrew H. ; Keenan, Bridget P. ; Yang, Xiaodong ; Fong, Lawrence ; Soto, Maira ; McRee, Autumn J. ; Filbert, Erin L.

Abstract:

Purpose::

Neoadjuvant chemoradiation (NCRT) followed by surgical resection represents a standard approach for patients with locally advanced esophageal/gastroesophageal junction (GEJ) cancers. Sotigalimab is a high-affinity CD40 agonist antibody capable of inducing and expanding antitumor immune responses by activating dendritic cells, T and B lymphocytes, NK cells, and M1 macrophages. This study examined the safety and efficacy of combining sotigalimab with NCRT in patients with esophageal or GEJ cancers.

Patients and Methods::

Patients with resectable (T1-3 Nx) adenocarcinoma or squamous cell carcinoma of the esophagus or GEJ were eligible. T1N0 and cervical tumors were excluded. Study treatment: weekly carboplatin/paclitaxel with concurrent radiation 5,040 cGy plus 3 to 4 doses of sotigalimab prior to Ivor Lewis esophagectomy. Primary efficacy endpoint was the pathologic complete response (path CR) rate.

Results::

Thirty-three patients were enrolled (adenocarcinoma 76%, squamous cell carcinoma 24%; and clinical stage III 67%). Ninety percent of patients received all planned doses of sotigalimab. The most common adverse events attributed to sotigalimab were nausea, fever/chills, fatigue, and cytokine release syndrome; most of these were grade 1 to 2. Grade ≥3 cytokine release syndrome was observed in 3 patients (9%). Twenty-five of the 29 efficacy-evaluable patients underwent an R0 resection (87.9%), with an overall path CR rate of 37.9% (11/29). Post-tumor samples demonstrated increased infiltration and activation of dendritic cells, monocytes, and cytotoxic T cells compared with baseline.

Conclusions::

Sotigalimab combined with NCRT for esophageal or GEJ cancers was generally well tolerated and achieved path CR rates that compare favorably with historical data and are promising for this treatment strategy. Clinical trial information: NCT03165994.

Significance::

The current study represents the first report to evaluate a CD40 agonist antibody in combination with concurrent chemoradiation in the neoadjuvant setting for patients with esophageal/GEJ cancers. This novel strategy was both safe and feasible, producing encouraging path CR rates that compare favorably with historical data. Our findings support the further evaluation of how immune-based therapies may be incorporated into perioperative treatment paradigms for upper gastrointestinal malignancies.

01 Feb 2024·Cytokine & growth factor reviews

Harnessing the potential of CD40 agonism in cancer therapy

Review

Author: Yang Zhou ; Ann Richmond ; Chi Yan

CD40 is a member of the tumor necrosis factor (TNF) receptor superfamily of receptors expressed on a variety of cell types. The CD40-CD40L interaction gives rise to many immune events, including the licensing of dendritic cells to activate CD8⁺ effector T cells, as well as the facilitation of B cell activation, proliferation, and differentiation. In malignant cells, the expression of CD40 varies among cancer types, mediating cellular proliferation, apoptosis, survival and the secretion of cytokines and chemokines. Agonistic human anti-CD40 antibodies are emerging as an option for cancer treatment, and early-phase clinical trials explored its monotherapy or combination with radiotherapy, chemotherapy, immune checkpoint blockade, and other immunomodulatory approaches. In this review, we present the current understanding of the mechanism of action for CD40, along with results from the clinical development of agonistic human CD40 antibodies in cancer treatment (selicrelumab, CDX-1140, APX005M, mitazalimab, 2141-V11, SEA-CD40, LVGN7409, and bispecific antibodies). This review also examines the safety profile of CD40 agonists in both preclinical and clinical settings, highlighting optimized dosage levels, potential adverse effects, and strategies to mitigate them.

News (Medical) associated with Sotigalimab

19 May 2025

·www.prnewswire.com

Intra-tumoral Cancer Therapies Market to Show Tremendous Growth at a CAGR of 31.3% During the Study Period (2020-2034) | DelveInsight

As per DelveInsight's estimates, among the 7MM, the US captured the highest market of intra-tumoral cancer therapies of nearly USD 74 million in 2024, which is expected to increase due to the launch of emerging therapies such as CAN-2409, RP1 (vusolimogene oderparepvec), SP-002 (ASN-002), Bizaxofusp (MDNA55), and others. LAS VEGAS, May 19, 2025 /PRNewswire/ -- DelveInsight's Intra-tumoral Cancer Therapies Market report includes a comprehensive understanding of current treatment practices, emerging intra-tumoral cancer therapies, market share of individual therapies, and current and forecasted intra-tumoral cancer therapies market size from 2020 to 2034, segmented into 7MM [the United States, the EU4 (Germany, France, Italy, and Spain), the United Kingdom, and Japan]. Key Takeaways from the Intra-tumoral Cancer Therapies Market Report Currently, only three Intra-tumoral Cancer Therapies are approved; namely, IMLYGIC (Talimogene laherparepvec/T-VEC; Amgen), approved in the US and Europe in 2015, DELYTACT (teserpaturev/G47Δ; Daiichi Sankyo) approved in Japan in 2021, and HENSIFY in Europe in 2019. As per DelveInsight's analysis, the total market size of intra-tumoral cancer therapies in the 7MM was USD 109 million in 2024 and is projected to grow during the forecast period (2025-2034). In 2024, the total cases of selected indication (based on current landscape and pipeline activity) were 8.9 million in the 7MM, which is anticipated to increase by 2034. Leading intra-tumoral cancer therapies companies, such as Janssen, Stamford Pharmaceuticals, Ascend Biopharmaceuticals, Replimune, Highlight Therapeutics, Cytovation ASA, Intensity Therapeutics, Ascendis Pharma, Treovir, Matica Biotechnology, QBiotics, NanOlogy, Lokon Pharma AB, EpicentRx, Medicenna Therapeutics, Philogen S.p.A., Candel Therapeutics, Lytix Biopharma, Verrica Pharmaceuticals, CEI-SCI, and others, and others, are developing novel intra-tumoral cancer therapies that are expected to enter the intra-tumoral cancer therapies market in the coming years. Some of the key intra-tumoral cancer therapies in the pipeline include INT230-6, Vusolimogene oderparepvec (RP1), Nidlegy (Daromun), G207, Ilixadencel (INTUVAX), Tigilanol tiglate, SP-002 (ASN-002), BO-112, Bizaxofusp (MDNA55), and others. In March 2025, NANOBIOTIX announced topline data from the completed dose-escalation portion of a Phase I study, conducted under the sponsorship of The University of Texas MD Anderson Cancer Center, evaluating JNJ-1900 (NBTXR3) activated by radiation therapy as a second-line or later (2L+) treatment for patients with locally advanced NSCLC eligible for re-irradiation. In March 2025, NANOBIOTIX announced an amendment to its global licensing agreement with Janssen Pharmaceutica NV. The amendment removes NANOBIOTIX's funding obligation for NANORAY- 312 and releases Johnson & Johnson from select future potential milestone payments while safeguarding NANOBIOTIX's path to sustainable cash flow through significant potential milestone payments. In March 2025, Candel Therapeutics and IDEA Pharma announced a strategic commercial partnership. Under this agreement, IDEA will provide strategic commercial input throughout the development and commercialization process for Candel's lead asset, CAN-2409. In January 2025, Lokon Pharma AB announced that the Food and Drug Administration (FDA) had granted Fast Track Designation (FTD) for the company's product candidate LOAd703 for the treatment of pancreatic cancer. In January 2025, Intensity Therapeutics announced that the Data Monitoring Committee (DMC) recommended the continuation of its Phase III sarcoma trial (INT230-6, INVINCIBLE-3) without modification based on data reviewed from July 2024 to December 2024. Some factors, such as the precedence of failure of emerging therapies, insufficient knowledge about Intra-tumoral Cancer Therapies , and several other drawbacks, might hinder the Intra-tumoral Cancer Therapies market growth. Discover which therapies are expected to grab the intra-tumoral cancer therapies market share @ Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Market Dynamics The intra-tumoral cancer therapies market dynamics are expected to change in the coming years. Various classes of intra-tumoral immunotherapies, including radioenhancer nanoparticles, recombinant fusion proteins, oncolytic therapy, gene therapy, synthetic dsRNA complexes, and others, are currently in preclinical and clinical development. These therapies increase drug concentration and availability within the tumor microenvironment while limiting systemic exposure and reducing the likelihood of immune-related side effects in other parts of the body. Intra-tumoral therapeutic strategies offer a powerful approach to in situ vaccine development, utilizing immune-stimulating agents to trigger local and systemic anti-tumor immune responses. Additionally, the ability of intra-tumoral immunotherapy combinations to elicit both T-cell and B-cell antitumor responses presents a potential strategy to overcome immune escape mechanisms, such as the loss of HLA-I expression on tumor cells, which are often associated with immune checkpoint therapy monoclonal antibody monotherapies. Furthermore, potential therapies are being investigated, and it is safe to predict that the treatment space will significantly impact the intra-tumoral cancer therapies market during the forecast period. Moreover, the anticipated introduction of emerging therapies with improved efficacy and a further improvement in the diagnosis rate are expected to drive the growth of the intra-tumoral cancer therapies market in the 7MM. However, several factors may impede the growth of the intra-tumoral cancer therapies market. The lack of standardized guidelines for intra-tumoral immunotherapy delivery results in variations in lesion selection, injection frequency, and needle technique, which directly affect treatment outcomes and safety. Patients are required to visit clinics for each dosing session, and the administration necessitates both trained radiologists and logistics support alongside skilled physicians. While research into intra-tumoral therapies has grown in recent years, several therapies, such as tilsotolimod/Ipilimumab, sotigalimab (APX005M), and vidutolimod (CMP-001), have failed clinical trials, impacting the market. Additionally, tumors with high intra-tumoral heterogeneity may lead to poorer clinical outcomes for patients. Intra-tumoral Cancer Therapies Therapeutics Market Although significant progress has been made in cancer treatment through methods like surgery, chemotherapy, radiation, immunotherapy, and targeted therapies, many of these treatments still face limitations such as systemic toxicity, inadequate tumor penetration, and poor targeting. These issues contribute to high mortality rates, underscoring the need for more precise and localized treatment options. Recently, cancer treatment strategies have increasingly focused on alternative delivery methods, including intra-tumoral administration. This approach is being actively researched, with several therapeutic candidates—such as immune receptor agonists, viral therapies, fusion proteins, monoclonal antibodies, and gene therapies—currently undergoing preclinical and clinical trials. Intra-tumoral immunotherapy, which involves directly delivering agents into or near the tumor site, is emerging as a promising approach. This strategy aims to boost localized immune responses while reducing systemic side effects. The first oncolytic virus, IMLYGIC (T-Vec; Amgen), was approved by the US FDA for treating unresectable melanoma lesions after surgery, following a Phase III trial. The European Commission approved the treatment of advanced melanoma in 2015. In 2019, Nanobiotix's HENSIFY (NBTXR3), a hafnium oxide nanoparticle therapy combined with radiation, received European approval for soft tissue sarcoma, with plans for data releases through 2025-2026 across multiple cancers. For STS the drug is approved in Europe but not yet launched. In Japan, DELYTACT (G47∆; Daiichi Sankyo) was granted conditional approval for malignant glioma, marking the first oncolytic virus for brain cancer, and is still under evaluation for its clinical benefits. IMLYGIC from Amgen is the first and only FDA-approved viral therapy that is injected directly into melanoma tumors. Despite the initial hype for this exciting intra-tumoral mode of cancer gene therapy, IMLYGIC's debut did not translate into much commercial success in the melanoma market. Limitations of the intra-tumoral administration, no statistically significant benefit in overall survival (OS), and the intense competition from immune checkpoint inhibitors (ICIs) due to their efficacy and manageable side effects are some of the main factors for ithe nsignificant revenues of this novel therapy. Learn more about the FDA-approved intra-tumoral cancer therapies @ Intra-tumoral Cancer Therapies Treatment Key Emerging Intra-tumoral Cancer Therapies and Companies The emerging pipeline of intra-tumoral cancer therapies is robust, including drugs from key players such as Candel Therapeutics (CAN-2409), Lytix Biopharma/Verrica Pharmaceuticals (LTX-315 [VP-315]), CEI-SCI (MULTIKINE), Philogen (Daromun [NIDLEGY; a combo of L19IL2 + L19TNF]), Replimune (RP2 and RP1 [vusolimogene oderparepvec]), Highlight Therapeutics (BO-112), Cytovation ASA (CY-101), Intensity Therapeutics (INT230-6), Ascendis Pharma (TransCon IL-2 β⁄γ), Treovir/Matica Biotechnology (G207), QBiotics (Tigilanol tiglate), NanOlogy (NanoPac), EpicentRx (AdAPT-001), Medicenna Therapeutics (Bizaxofusp [MDNA55]), and others. RP1 (vusolimogene oderparepvec), Replimune's lead product candidate, is based on a proprietary strain of Herpes Simplex Virus (HSV) engineered with a fusogenic protein (GALV-GP R-) and GM-CSF to enhance tumor killing potency, immunogenicity, and activation of a systemic antitumor immune response. In November 2024, Replimune announced that the FDA granted Breakthrough Therapy Designation (BTD) to RP1 in combination with nivolumab for the treatment of advanced melanoma in adult patients who have previously received an anti-PD1 regimen. Nidlegy is a biopharmaceutical product, proprietary to Philogen, designed for the treatment of skin cancer. It consists of two active ingredients, L19IL2 and L19TNF, which are manufactured independently and which are mixed prior to intralesional administration. In July 2024, Philogen and Sun Pharmaceutical announced that the European Medicines Agency (EMA) validated the submission of the Marketing Authorization Application (MAA) for Nidlegy. CAN-2409 (Candel Therapeutics) is an investigational, off-the-shelf, replication-defective adenovirus designed to deliver the HSV thymidine kinase (HSV-tk) gene to a patient's specific tumor and induce an individualized, systemic immune response against the tumor. In March 2025, according to the company's corporate highlights, the preparations for Biologics License Application (BLA) for CAN-2409 in prostate cancer are underway, with submission expected in Q4 2026. The anticipated launch of these emerging therapies are poised to transform the intra-tumoral cancer therapies market landscape in the coming years. As these cutting-edge therapies continue to mature and gain regulatory approval, they are expected to reshape the intra-tumoral cancer therapies market landscape, offering new standards of care and unlocking opportunities for medical innovation and economic growth. To know more about intra-tumoral cancer therapies clinical trials, visit @ Intra-tumoral Cancer Therapies Intra-tumoral Cancer Therapies Overview Cancer is a highly diverse disease, with its signs, symptoms, and treatments varying across different types, making it crucial to create targeted therapies for individual patients. Current treatment options for cancer include immunotherapy, radiotherapy, chemotherapy, targeted drug therapies, and more. While these approaches have improved OS and patient outcomes, they still have limitations and are not effective for everyone. Researchers are therefore working to develop new treatments that can overcome these challenges, with intra-tumoral cancer therapies emerging as a promising strategy. Intra-tumoral immunotherapy represents an innovative approach, where sophisticated antibodies are directly injected into tumors instead of being administered intravenously. This method focuses on delivering immunostimulatory agents straight into primary or metastatic tumor sites to initiate or enhance an antitumor immune response. Normally, the immune system detects and eliminates early tumors, but in immunosuppressive tumor environments, malignant cells can proliferate undetected. Regulatory T cells (Tregs), drawn to the tumor by chemokines, suppress Antigen-Presenting Cells (APCs) that would otherwise trigger an immune attack on tumor antigens. Moreover, tumor cells often release anti-inflammatory and regulatory cytokines like TGF-β and IL-10, which promote tumor growth and inhibit dendritic cell (DC) activation. To counteract this immunosuppressive environment, immunostimulants can be introduced. These agents work by attracting immune cells to the tumor or by activating the immune system to recognize and destroy cancer cells. Immunostimulants activate immune cells in the presence of tumor antigens, allowing them to travel to lymph nodes, where they stimulate tumor antigen-specific T cells through cross-presentation. These activated T cells can then return to the tumor or spread to distant tumors, leading to the targeted destruction of cancer cells. Intra-tumoral Cancer Therapies Epidemiology Segmentation In 2024, the total indication-wise treated cases of Intra-tumoral Cancer Therapies were 3.3 million in the 7MM, which is anticipated to increase by 2034. The intra-tumoral cancer therapies market report proffers epidemiological analysis for the study period 2020–2034 in the 7MM segmented into: Total Cases of Selected Indications Indication-wise Target Patient Pool of Intra-tumoral Cancer Therapies Indication-wise Treated Cases of Intra-tumoral Cancer Therapies Scope of the Intra-tumoral Cancer Therapies Market Report Intra-tumoral Cancer Therapies Therapeutic Assessment: Intra-tumoral current marketed and emerging therapies Intra-tumoral Cancer Therapies Market Dynamics: Conjoint Analysis of Emerging Intra-tumoral Cancer Therapies Competitive Intelligence Analysis: SWOT analysis and Market entry strategies Unmet Needs, KOL's views, Analyst's views, Intra-tumoral Cancer Therapies Market Access and Reimbursement Discover more about intra-tumoral cancer therapies in development @ Intra-tumoral Cancer Therapies Clinical Trials Table of Contents Related Reports Oncolytic Virus Market Oncolytic Virus Market Size, Target Population, Competitive Landscape & Market Forecast – 2034 report deliver an in-depth understanding of oncolytic virus, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key oncolytic virus companies, including Targovax, Genelux, Imugene, EpicentRx, Replimune, Genelux Corporation, Candel Therapeutics, DNAtrix, SillaJen, Treovir, Lokon Pharma AB, Istari Oncology, CG Oncology, Amgen, Daiichio Sankyo, among others. 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About DelveInsight DelveInsight is a leading Business Consultant and Market Research firm focused exclusively on life sciences. It supports pharma companies by providing comprehensive end-to-end solutions to improve their performance. Get hassle-free access to all the healthcare and pharma market research reports through our subscription-based platform PharmDelve . Contact Us Shruti Thakur [email protected] +14699457679 Logo: SOURCE DelveInsight Business Research, LLP WANT YOUR COMPANY'S NEWS FEATURED ON PRNEWSWIRE.COM? 440k+ Newsrooms & Influencers 9k+ Digital Media Outlets 270k+ Journalists Opted In GET STARTED

ImmunotherapyPhase 3Drug ApprovalFast TrackLicense out/in

08 Nov 2023

·www.fiercebiotech.com

To pave a longer runway, Pyxis to cut staff, reprioritize and offload brand-new Apexigen assets

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.

Phase 1AcquisitionADCPhase 2

07 Nov 2023

·www.globenewswire.com

Pyxis Oncology Announces Initiatives to Prioritize Lead ADC Program; Reports Financial Results for Third-Quarter 2023 and Provides Corporate Update

PYX-201 (a novel first-in-concept and first-in-class tumor stroma targeting antibody-drug conjugate [ADC] product candidate) Phase 1 trial progressing with fifth dose cohort at 3.6 mg/kg; data expected 1H 2024. PYX-106 (a fully human immunotherapy antibody candidate): Phase 1 trial now focusing on NSCLC and other tumor types; data expected 2H 2024. Cash runway extended to early 2026 due to cost reductions and portfolio prioritization, allows for preliminary data readouts from PYX-201 and PYX-106 programs. Balance sheet includes $134.4 million in cash, restricted cash, and short-term investments. BOSTON, Nov. 07, 2023 (GLOBE NEWSWIRE) -- Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company focused on developing antibody-drug conjugates (ADCs) and immune-oncology (IO) therapeutics to target difficult-to-treat cancers, today announced initiatives to extend its cash runway, reported financial results for the quarter ended September 30, 2023, and provided a corporate update. The company ended the third quarter of 2023 with approximately $134.4 million in cash, cash equivalents, restricted cash and short-term investments. “We are excited to begin dosing in the fifth cohort of our Phase 1 trial of our lead asset PYX-201, a first-in-class and first-in-concept tumor stroma targeting ADC against EDB-fibronectin in tumor stroma. We believe the progress we are making through the dose escalation portion of our trial speaks to the potential safety profile of our ADC drug candidate. Moreover, 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,” said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. “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. 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.” Pam Connealy, COO and CFO of Pyxis Oncology added, “In addition to the cost reductions announced today, which include a 40% decrease in headcount, we are also seeking additional non-dilutive funding through the potential monetization of our acquired Apexigen royalty streams. Additionally, we are evaluating partnerships of several assets that we have chosen not to move into the clinic and potential antibody and ADC platform technology collaborations. We believe this increased focus on our lead and secondary assets, in addition to the changes we are making to the PYX-106 program, gives us the best chance for success in bringing our novel ADC and IO candidates to the patients who need them. We appreciate the contributions from our dedicated team members that have enabled us to reach this point in our clinical programs.” Corporate Updates PYX-201: Fifth dose cohort open for enrollment in Phase 1 trial. To date, 15 subjects have been dosed with PYX-201 in the PYX-201-101 trial. The fifth dose cohort is expected to begin enrolling shortly and is planned to evaluate a 3.6 mg/kg dose administered once every three weeks. Management believes the efficient progression through dose escalation to date speaks to the potential safety profile of PYX-201, with preliminary Phase 1 data expected in 1H 2024.PYX-106: Phase 1 trial now focusing on NSCLC and other tumor types. Following analyses of data from a competing anti-Siglec-15 clinical trial and a review of internally generated preclinical results, Pyxis Oncology has decided to focus on enrolling additional patients with specific tumor types, including non-small cell lung cancer, in its ongoing Phase 1 trial. Currently, dosing is ongoing in the second cohort at a dose of 1.0 mg/kg. As a result of this repositioning of the trial, preliminary data from the PYX-106-101 trial is now anticipated in 2H 2024. Importantly, the repositioning of the trial has not increased the cost of the study.Cash runway extended to early 2026 due to cost reductions and portfolio prioritization. Pyxis Oncology plans to focus its cash resources on and around its two clinical-stage programs, extending its cash runway past key Phase 1 data readouts for PYX-201 and PYX-106, expected in 2024. Following a portfolio and business review, the company is announcing a reduction in overall headcount by approximately 40% and pausing funding of certain early-stage research programs. These initiatives are anticipated to extend Pyxis Oncology’s cash runway into early 2026. In addition, the company has undertaken monetization efforts for its acquired Apexigen royalty streams and has also undertaken initiatives for possible partnerships of several assets that we have chosen not to move into the clinic, and antibody and ADC platform technologies, which may bring in additional non-dilutive funding.Acquisition of Apexigen completed and further sotigalimab development. On August 23, 2023, Pyxis Oncology announced the successful completion of its acquisition of Apexigen, Inc., in an all-stock transaction valued at approximately $10.7 million. Opportunity to advance clinical development of sotigalimab (which Pyxis Oncology has renamed PYX-107) will be further assessed as part of portfolio evaluation following preliminary data for our ongoing Phase 1 trial of PYX-201. Potential Upcoming Milestones PYX-201 (ADC targeting various solid tumors): Report preliminary Phase 1 data and PK/PD results in 1H 2024.PYX-106 (IO targeting various solid tumors): Report preliminary Phase 1 data and PK/PD results in 2H 2024.Updates on additional non-dilutive funding efforts as appropriate. Q3 2023 Financial Results As of September 30, 2023, Pyxis Oncology had cash and cash equivalents, including restricted cash, and short-term investments of $134.4 million (unaudited), which is now expected to fund operations into early 2026 and reflects continued financial discipline. Research and development expenses were $14.7 million for the three months ended September 30, 2023, compared to $19.0 million for the three months ended September 30, 2022. The period-over-period decline was primarily due to lower contract manufacturing and preclinical research costs, which were partially offset by increased clinical trial-related expenses for PYX-201 and PYX-106.General and administrative expenses were $10.7 million for the three months ended September 30, 2023, compared to $9.4 million for the three months ended September 30, 2022. The period-over-period increase was primarily due to higher stock-based compensation expenses, which were partially offset by lower professional and consultant fees.Net loss was $23.0 million, or $0.56 per common share, for the three months ended September 30, 2023, compared to $27.7 million, or $0.85 per common share, for the three months ended September 30, 2022. Net losses for the quarters ended September 30, 2023 and 2022 included $5.2 million and $4.4 million, respectively, related to non-cash stock-based compensation expense.As of September 30, 2023, the outstanding number of shares of common stock of Pyxis Oncology was 44,294,092. 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. 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 antibody-drug conjugates (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 Part II, Item 1A. of the Company’s Quarterly Report on Form 10-Q filed with SEC on August 11, 2023, and in our other filings with the SEC. 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. Investor ContactPam Connealy, CFO & COOir@pyxisoncology.com ---tables to follow--- Condensed Consolidated Statements of Operations and Comprehensive Loss(In thousands, except share and per share amounts)(Unaudited) Three Months EndedSeptember 30, Nine Months EndedSeptember 30, 2023 2022 2023 2022 Operating expenses: Research and development $14,687 $19,034 $37,979 $56,275 General and administrative 10,667 9,359 26,450 29,233 Total operating expenses 25,354 28,393 64,429 85,508 Loss from operations (25,354) (28,393) (64,429) (85,508)Other income, net: Interest and investment income 1,707 719 5,036 892 Sublease income 598 — 1,200 — Total other income, net 2,305 719 6,236 892 Net loss $(23,049) $(27,674) $(58,193) $(84,616)Net loss per common share - basic and diluted $(0.56) $(0.85) $(1.52) $(2.61)Weighted average shares of common stock outstanding - basic and diluted 41,331,806 32,561,228 38,379,401 32,444,072 Condensed Consolidated Balance Sheets(In thousands, except share and per share amounts)(Unaudited) September 30,2023 December 31, 2022 Assets Current assets: Cash and cash equivalents $14,715 $179,293 Marketable debt securities, short-term 118,252 — Restricted cash 1,472 1,472 Prepaid expenses and other current assets 4,655 5,847 Total current assets 139,094 186,612 Property and equipment, net 12,175 11,165 Intangible assets, net 22,294 — Operating lease right-of-use assets 13,129 13,602 Total assets $186,692 $211,379 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $3,310 $7,097 Accrued expenses and other current liabilities 16,629 24,537 Operating lease liabilities, current portion 1,204 — Deferred revenue 7,189 — Total current liabilities 28,332 31,634 Operating lease liabilities, net of current portion 20,414 18,921 Total liabilities 48,746 50,555 Commitments and contingencies Stockholders’ equity: Preferred stock, par value $0.001 per share, 10,000,000 shares authorized; zero shares issued and outstanding — — Common stock, $0.001 par value per share 44 34 Additional paid-in capital 408,635 373,225 Accumulated other comprehensive loss (105) — Accumulated deficit (270,628) (212,435)Total stockholders’ equity 137,946 160,824 Total liabilities and stockholders’ equity $186,692 $211,379

Phase 1ADCFinancial StatementAcquisition

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R&D Status

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Indication	Highest Phase	Country/Location	Organization	Date
Ovarian Cancer	Phase 2	United States	Pyxis Oncology, Inc.	23 Aug 2023
Rectal Adenocarcinoma	Phase 2	United States	Apexigen America, Inc.	24 Apr 2020
Melanoma, Cutaneous Malignant	Phase 2	Poland	Apexigen America, Inc.	12 Jun 2019
Melanoma, Cutaneous Malignant	Phase 2	Spain	Apexigen America, Inc.	12 Jun 2019
Unresectable Melanoma	Phase 2	Poland	Apexigen America, Inc.	12 Jun 2019
Unresectable Melanoma	Phase 2	Spain	Apexigen America, Inc.	12 Jun 2019
Advanced Sarcoma	Phase 2	United States	Apexigen America, Inc.	20 Mar 2019
Locally Advanced Soft Tissue Sarcoma	Phase 2	United States	Apexigen America, Inc.	20 Mar 2019
Esophageal Carcinoma	Phase 2	United States	Apexigen America, Inc.	06 Oct 2017
Gastrooesophageal junction cancer	Phase 2	United States	Apexigen America, Inc.	06 Oct 2017

Clinical Result

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Study	Phase	Population	Analyzed Enrollment	Group	Results	Evaluation	Publication Date


NCT02706353 (AACR2026)	Phase 1/2	Metastatic melanoma	32	Intratumoral sotigalimab + pembrolizumab	slbvdoavwm(qxmmvsbyzm) = The most common adverse events (AEs) related to sotigalimab were injection-site reactions, pruritus, and fatigue. Sotigalimab was well tolerated; common adverse events were injection-site reactions, and fatigue. uzptoxpxnr (trzkgeeons ) View more	Positive	21 Apr 2026
NCT02706353 (P710, CTgov)	Phase 1/2	Metastatic melanoma	34	mas+APX005M+Pembrolizumab (Phase 1: Dose Escalation)	yakfgemyul = fnrqfwuidu smscezixsr (ycguhvwwfi, bkmsiqtvkk - ykeqdtpahq)	-	21 Nov 2025
				APX005M+Pembrolizumab (Phase 2: Dose Expansion)	yakfgemyul = lgmtzyvqxt smscezixsr (ycguhvwwfi, jieixjztwx - zwijluiwsn) View more
NCT03165994 (Phase 2 Study of Sotigalimab, Pubmed \| Cancer Res Commun)	Phase 2	Gastrooesophageal junction cancer Neoadjuvant	-	Sotigalimab + Chemoradiation	wsaangrlxt(csfjdftylc) = most of these were grade 1 to 2; Grade ≥3 cytokine release syndrome was observed in 3 patients (9%) xgbbjkgxpw (pxxufnugcm ) View more	Positive	01 Feb 2025
NCT03389802 (CTgov)	Phase 1	Glioblastoma Multiforme \| Childhood Central Nervous System Neoplasm \| Diffuse Intrinsic Pontine Glioma ... View more	32	APX005M treatment for recurrent or refractory primary malignant CNS tumor patients (Stratum 1)	vydshlxbsx = vkiufuvgik vrkmwwovht (bgvhxsxskd, wdckpiqhes - qqpknlmahp)	-	10 Oct 2024
				APX005M treatment for newly diagnosed DIPG patients (Stratum 2)	ghmkowxugh = mrfiefaaao xthmyrhhqe (bfqiemtgyb, siprbfxgsk - pjqebzycld)
ASTRO2024	Not Applicable	Rectal Cancer	-	Sotigalimab + SCRT + FOLFOX	xeoxlsacur(tofptgfrzm) = n=7 shimzbgrzn (lrertckxtb ) View more	-	01 Oct 2024
				SCRT + FOLFOX
NCT02706353 (ESMO2024) Manual	Phase 1/2	Metastatic melanoma First line cDCs \| B cells \| monocytes	32	Sotigalimab Pembrolizumabzumab	azpplwppqt(unwknangns) = oswzronejh elbpvdcfjn (vaaffytksg ) View more	Positive	16 Sep 2024
NCT03165994 (Phase 2 Study of Sotigalimab \| 1361, CTgov)	Phase 2	Esophageal Carcinoma \| Gastrooesophageal junction cancer \| Malignant neoplasm of gastro-oesophageal junction	34	Sotigalimab	ztkuvmyxvm = badzunlqlb ioczjdytsu (hsqlfdhgif, plkprngppz - gdvkerkioe) View more	-	02 May 2024
NCT04337931 (CTgov)	Phase 2	Melanoma, Cutaneous Malignant \| Metastatic melanoma \| Unresectable Melanoma	45	sotigalimab (Cohort 1)	qobkihzkwd = gcjsnmjdmv kxkudorlag (bpswsewtzy, aijkklghvh - hwjgfganzr) View more	-	22 Dec 2023
				sotigalimab (Cohort 2)	qobkihzkwd = dwisduyhqm kxkudorlag (bpswsewtzy, sftixmosqf - afdakjqjvy) View more
NCT03123783 (Phase II of CD40 agonistic antibody sotigalimab (APX005M), CTgov)	Phase 1/2	metastatic non-small cell lung cancer \| Metastatic melanoma	140	nivolumab+APX005M (Phase 1b Escalation)	zrrbjceafm = garhawlmri scwjhofpib (fbdzrrnbws, picurznxtn - zpofqvkppo) View more	-	05 Dec 2023
				nivolumab+APX005M (Cohort 1 (Arm)/inNSCLC (Phase 2))	ehkifzlelj = vlxczlziwx sazzvhyuya (zmqpasmrve, datggsgsfd - zvmkvkpyrf) View more
NCT03165994 (1361, SITC2023)	Phase 2	Locally Advanced Gastroesophageal Junction Adenocarcinoma Neoadjuvant	-	Sotigalimab	agpvsrhgbe(hmpodlrvyr) = xtrwumvmbx zxjvqhxrpe (mixelsoque )	Positive	02 Nov 2023

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