On November 21, 2024 Ascentage Pharma (6855.HK), a global biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily for malignancies, reported that findings from a phase Ib multicenter clinical trial (NCT04260022) of its third-generation BCR-ABL1 tyrosine kinase inhibitor (TKI) have been published in the November 2024 issue of JAMA Oncology, marking a milestone in global awareness concerning the agent (Press release, Ascentage Pharma, NOV 21, 2024, View Source [SID1234648557]).

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JAMA Oncology is among the most influential and high-ranking oncology publications, with a 2023 impact factor of 28.4. It is read widely by the clinical-oncology community, with 6.4 million original downloads or views per annum. In 2023, the journal accepted only about 155 (7%) of 2,223 research-article submissions.

Olverembatinib may help to address critical unmet clinical needs related to TKI treatment resistance and intolerance, which can impose formidable humanistic and economic burdens especially in heavily pretreated patients with suboptimal outcomes. For instance, arterial occlusive events (AOEs) constitute one salient and potentially dose-limiting treatment challenge with certain second- and third-generation TKIs.

This study (NCT04260022) randomly allocated 80 patients with chronic myeloid leukemia (CML) or Philadelphia chromosome-positive acute lymphoblastic leukemia (Ph⁺ ALL) to receive oral olverembatinib 30, 40, or 50 mg on alternate days. The study population was heavily pretreated: approximately 18% of patients had received two prior TKIs, 28% three, and 54% at least four. Forty-six patients (57.5%) had received ponatinib; 25 (31.3%), asciminib; and 11 (13.8%), both medications.1

Among all evaluable patients with chronic-phase CML (CP-CML), the complete cytogenetic response (CCyR) rate was approximately 61% and the major molecular response (MMR) rate, approximately 42%. Cytogenetic and molecular responses were similar irrespective of the presence of the T315I mutation, which confers resistance against imatinib and all second-generation TKIs.1

Importantly, approximately 58% of patients with prior ponatinib treatment failure achieved CCyR and about 37%, MMR. Corresponding values in patients with asciminib treatment resistance were 50% and 33%.1

Olverembatinib was also well tolerated, with leading (typically mild or moderate) treatment-emergent adverse events including elevated blood creatine phosphokinase and thrombocytopenia. There were no fatal treatment-related adverse events. Treatment-related AOEs were infrequent (3%) and mild or moderate (grade 1 or 2); no such olverembatinib-related event was considered serious.

"I am delighted to showcase the strength and progress of the ‘lead’ asset of Ascentage Pharma, which exemplifies the richness and diversity of our product pipeline of innovative, patient-centric therapies for a range of hematologic malignancies," said Dr. Yifan Zhai, Chief Medical Officer of Ascentage Pharma. "In the future, we will continue to advance these development programs in efforts to bring more treatment options to patients with unmet clinical needs around the world."

"One potential explanation for the response of olverembatinib in patients with ponatinib and asciminib resistance is its broad (pan-BCR::ABL1-kinase domain) mutational coverage," said principal investigator Elias Jabbour, MD, Professor of Leukemia at The University of Texas MD Anderson Cancer Center. "In studies to date, olverembatinib has shown greater sensitivity and clinical benefit against compound mutations – two or more mutations within the same allele of BCR::ABL1 – compared with other approved TKIs and the STAMP inhibitor asciminib."

Findings from this trial have also been presented at leading hematologic-oncology congresses around the world, including the 29th European Hematology Association (EHA) (Free EHA Whitepaper) Congress, which convened June 13-16, 2024, in Madrid; the 12th annual meeting of the Society of Hematologic Oncology, on September 4-7, 2024, in Houston, Texas; and the ESH-iCMLf 26th Annual John Goldman Conference on Chronic Myeloid Leukemia (Biology and Therapy), on September 27-29, 2024, in Prague. Updated results will be presented at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition, December 8, 2024 (6:00-8:00 PM), in San Diego, CA (poster/publication #3151).

"Publication of our trial results in JAMA Oncology represents a major milestone for olverembatinib, and the study established the recommended dose for our ongoing phase III registrational trial: POLARIS-2 [NCT06423911]," said Dr. Dajun Yang, Chairman & CEO of Ascentage. "We look forward to that trial and, in the future through our option agreement with Takeda, to potentially bring this medication to underserved populations around the world, including patients with CML or Ph⁺ ALL that is resistant to or intolerant of other medications."

On June 14, 2024, Ascentage signed an exclusive option agreement to enter into an exclusive license agreement with Takeda (www.takeda.com) for olverembatinib. In the event that Takeda exercises the option, Takeda would license the global rights to develop and commercialize olverembatinib in all territories outside of, among others, mainland China, Hong Kong, Macau, and Taiwan, China.

Olverembatinib is currently approved in China for the treatment of adult patients with tyrosine kinase inhibitor (TKI)-resistant chronic phase CP-CML or accelerated-phase CML harboring the T315I mutation as confirmed by a validated diagnostic test. It is also approved for adult patients with CP-CML resistant to and/or intolerant of first- and second-generation TKIs. It remains investigational in other parts of the world.

Reference

1. Jabbour E, Oehler VG, Koller PB, et al. Olverembatinib after failure of tyrosine kinase inhibitors, including ponatinib or asciminib: a phase 1b randomized clinical trial. JAMA Oncol 2024. doi:10.1001/jamaoncol.2024.5157

About Ascentage Pharma

Ascentage Pharma (6855.HK) is a global, integrated biopharmaceutical company engaged in discovering, developing and commercializing therapies to address global unmet medical needs primarily in malignancies. On October 28, 2019, Ascentage Pharma was listed on the Main Board of the Stock Exchange of Hong Kong Limited with the stock code 6855.HK.

The company has built a rich pipeline of innovative drug candidates that includes novel, highly potent Bcl-2 and dual Bcl-2/Bcl-xL inhibitors, as well as candidates aimed at IAP and MDM2-p53 pathways, and next-generation TKIs. Ascentage Pharma is also the only company in the world with active clinical programs targeting all three known classes of key apoptosis regulators. The company has conducted more than 40 clinical trials in the US, Australia, Europe, and China, including 13 registrational studies (completed/ ongoing/planned).

Olverembatinib, the company’s first lead asset developed for the treatment of drug-resistant chronic myeloid leukemia (CML) and the company’s first approved product in China, has been granted Priority Review Designations and Breakthrough Therapy Designations by the Center for Drug Evaluation (CDE) of China National Medical Products Administration (NMPA). To date, the drug had been included into the China National Reimbursement Drug List (NRDL). Furthermore, olverembatinib has been granted Orphan Drug Designations (ODDs) and a Fast Track Designation (FTD) by the US FDA, and an Orphan Designation by the EMA of the EU.

To date, Ascentage Pharma has obtained a total of 16 ODDs from the US FDA and 1 Orphan Designation from the EMA of the EU for 4 of the company’s investigational drug candidates. Leveraging its robust R&D capabilities, Ascentage Pharma has built a portfolio of global intellectual property rights and entered into global partnerships and other relationships with numerous leading biotechnology and pharmaceutical companies such as Takeda, AstraZeneca, Merck, Pfizer and Innovent; and research and development relationships with leading research institutions such as Dana-Farber Cancer Institute, Mayo Clinic, National Cancer Institute and the University of Michigan.

The company has built a talented team with a wealth of global experience in the discovery and development of innovative drugs and fully functional commercial manufacturing and Sales & Marketing teams. One pivotal aim of Ascentage Pharma is to continuously strengthen its R&D capabilities and accelerate its clinical development programs, in order to fulfil its mission of addressing unmet clinical needs in China and around the world for the benefit of more patients.

On November 21, 2024 InxMed Co., Ltd, a clinical-stage biotechnology company developing innovative therapies against cancer treatment resistance and metastasis, reported that China National Medical Products Administration (NMPA) has granted Ifebemtinib (IN10018) Breakthrough Therapy designation (BTD) for the first-line (1L) treatment of non-small cell lung cancer (NSCLC) with KRAS G12C mutation in combination with garsorasib, a specific inhibitor of the KRAS G12C mutation (Press release, InxMed, NOV 21, 2024, View Source [SID1234648558]). This is the second BTD ifebemtinib received. In April 2022, ifebemtinib was granted its first BTD for the treatment of platinum-resistant ovarian cancer (PROC) in combination with PEG-liposomal doxorubicin (PLD).

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Ifebemtinib is a highly selective, orally administered, small molecule inhibitor for focal adhesion kinase, which has demonstrated significant clinical synergies with targeted therapies, immunotherapies, and standard chemotherapies.

The BTD is supported by the data from the Phase Ib/II study evaluating the efficacy and safety of ifebemtinib in combination with garsorasib for the 1L treatment of NSCLC with KRAS G12C mutation (NCT06166836). The results of the clinical trial were featured at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. The dual-oral regimen showed promising antitumor efficacy with a well-tolerated safety profile in 1L KRASG12C NSCLC. The objective response rate (ORR) was 90.3% and the disease control rate (DCR) was 96.8%. A total of 28 confirmed partial responses (PRs) and two stable diseases (SDs) were reported from 31 efficacy evaluable patients. All treated patients have achieved a follow-up visit of 9 months so far, and the median PFS has not been reached at the time of this report.

Beyond KRAS G12C inhibitors, Ifebemtinib has also shown significant therapeutic synergies when combined with a wide range of standard and emerging cancer treatments, such as anti-PD-(L)1 antibodies, other RAS-targeted inhibitors, EGFR inhibitors, and ADCs. InxMed is actively pursuing collaborations with innovating partners globally。

InxMed is currently conducting a registrational trial in platinum-resistant ovarian cancer in China, for which the company plans to submit a New Drug Application to the NMPA in 2025. InxMed also has multiple proof-of-concept trials ongoing in lung, colorectal, melanoma, and pancreatic cancers, some of which will progress into pivotal studies. Thus far, more than 600 subjects have been treated with ifebemtinib, and a favorable safety and tolerability profile has been observed.

On November 21, 2024 BriaCell Therapeutics Corp. (NASDAQ: BCTX, BCTXW) (TSX: BCT) a clinical-stage biotech company that develops novel immunotherapies to transform cancer care, reported that the first patient was dosed in its Phase 1/2 study (ClinicalTrials.gov identifier: NCT06471673 ) to evaluate the safety and efficacy of Bria-OTS, BriaCell’s personalized next generation immunotherapy (Press release, BriaCell Therapeutics, NOV 21, 2024, View Source [SID1234648542]). The study will investigate Bria-OTS alone and in combination with immune check point inhibitor tislelizumab (manufactured and supplied by BeiGene, Ltd. ) for the treatment of metastatic breast cancer. Bria-OTS is an enhanced form of Bria-IMT, currently in pivotal Phase 3 study for metastatic breast cancer.

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"Oncologists have been looking for treatments for our metastatic cancer patients who progress after treatment with antibody-drug-conjugates (ADCs) and immune check point inhibitors (CPIs)," stated Sant P. Chawla, MD, FRACP, Head of the Sarcoma Oncology Center in Santa Monica, CA, and Principal Investigator for the Bria-OTS study. "We are very impressed by the survival and clinical benefit data we have seen with Bria-IMT and are looking forward to helping develop this novel platform with the goal of improving patient outcomes."

"Dosing the first patient with Bria-OTS is a significant milestone for both BriaCell and cancer patients," stated Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer. "This represents a new chapter in cancer immunotherapy. This groundbreaking technology is a major advancement over prior approaches to cellular immunotherapy."

"Designed for superior efficacy and synergy with immune checkpoint inhibitors, Bria-OTS is a personalized and off-the-shelf cancer therapy," stated William V. Williams, MD, BriaCell’s President & CEO. "We are delighted that Dr. Chawla and his team of experts at the Sarcoma Oncology Center are supporting BriaCell as we bring our novel immunotherapy platform one step closer to delivering safe and effective treatment options for patients with melanoma, prostate and lung cancers."

The Phase 1/2 clinical trial will initially evaluate the safety and efficacy of Bria-OTS as monotherapy and, later, in combination with tislelizumab in advanced breast cancer. Key inclusion criteria include metastatic or locally recurrent breast cancer and at least two failed prior attempts of systemic therapy (e.g., chemotherapy). The study design will include a dose escalation monotherapy phase followed by an expansion phase that will include combination therapy with tislelizumab . Additionally, BriaCell plans to evaluate Bria-OTS+, a more advanced version of the immunotherapy platform, in prostate and other cancers.

On November 21, 2024 Intensity Therapeutics, Inc. (Nasdaq: INTS), ("Intensity" or the "Company") a late-stage clinical biotechnology company focused on the discovery and development of proprietary, novel immune-based intratumoral cancer therapies designed to kill tumors and increase immune system recognition of cancers, reported that it has entered into a securities purchase agreement with a single healthcare focused institutional investor for the issuance and sale of 1,237,113 shares of its common stock in a registered direct offering at a purchase price of $2.425 per share (Press release, Intensity Therapeutics, NOV 21, 2024, View Source [SID1234648559]).

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In a concurrent private placement (the "Private Placement" and together with the Registered Offering, the "Offerings"), the Company also agreed to issue to the same investor warrants to purchase up to 1,237,113 shares of its common stock (the "Common Warrants"). The Common Warrants have an exercise price of $2.95 per share, will be exercisable commencing six months from the date of issuance, and will expire five and one-half years following the date of issuance.

The gross proceeds from the Offerings, before deducting the placement agent’s fees and other offering expenses payable by the Company, are expected to be approximately $3 million. The Company expects to use the net proceeds from the Offerings for general working capital.

A.G.P./Alliance Global Partners is acting as lead placement agent for the Offerings and Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-placement agent for the Offerings.

The Offerings are expected to close on or about November 22, 2024, subject to the satisfaction of customary closing conditions.

The shares (or common stock equivalents in lieu thereof) offered to the institutional investor described above are being offered pursuant to a registration statement on Form S-3 (File No. 333-280681), which was declared effective by the Securities and Exchange Commission (the "SEC") on July 11, 2024. The Offering is being made only by means of a prospectus which is a part of the effective registration statement. The Common Warrants will be issued in a concurrent private placement. A final prospectus supplement and the accompanying prospectus relating to the registered direct offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Additionally, when available, electronic copies of the final prospectus supplement and the accompanying prospectus may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022, or by telephone at (212) 624-2060, or by email at [email protected], or Brookline Capital Markets, a division of Arcadia Securities, LLC, 600 Lexington Avenue, 20th Floor, New York, NY 10022, or by telephone at (646) 256-5258, or by email at [email protected].

The private placement of the Common Warrants and the shares underlying the Common Warrants offered to the institutional investor will be made in reliance on an exemption from registration under Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Regulation D promulgated thereunder. Accordingly, the securities issued in the concurrent private placements may not be offered or sold in the United States except pursuant to an effective registration statement or an applicable exemption from the registration requirements of the Securities Act and such applicable state securities laws.

This press release does not constitute an offer to sell or a solicitation of an offer to buy the securities in this Offering, 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.

On November 20, 2024 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical stage company focused on developing next generation therapeutics to target difficult-to-treat cancers, reported positive preliminary data from the ongoing Phase 1 clinical dose escalation study evaluating PYX-201 in multiple types of solid tumors (Press release, Pyxis Oncology, NOV 20, 2024, View Source [SID1234648523]). PYX-201, the Company’s lead clinical drug candidate, is 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 (ECM).

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"These positive data represent a significant milestone for Pyxis Oncology as our novel ECM-targeting ADC, PYX-201, has demonstrated clinical responses by RECIST 1.1 in six tumor types of interest: HNSCC, ovarian, NSCLC, HR+/HER2- breast, TNBC, and Sarcoma. The breadth and depth of our clinical responses clearly indicate the potential of PYX-201 to provide meaningful clinical benefits to patients with difficult-to-treat cancers," said Lara S. Sullivan, M.D., President and Chief Executive Officer of Pyxis Oncology. "In addition to the monotherapy expansion studies we are launching in 1Q25 in HNSCC, I am thrilled to announce our new Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada) to evaluate the combination of PYX-201 and Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with HNSCC, HR+/HER2- breast, TNBC and Sarcoma with first patients expected to dose in 1Q25."

In this ongoing open-label, multicenter, dose-escalation Phase 1 trial of PYX-201, 80 patients have been enrolled and dosed across multiple solid tumor types to receive doses of PYX-201 ranging from 0.3 mg/kg up to 8.0 mg/kg. The trial’s main objectives are to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and preliminary efficacy of PYX-201. The current identified dose range for PYX-201 is 3.6 mg/kg to 5.4 mg/kg. The number of prior lines of cancer therapies for patients enrolled is a median of 4 lines and up to 10 lines in some patients. The data cutoff date for this data announcement was October 4, 2024.

Preliminary Phase 1 Clinical Response Data in Patients with Head and Neck Squamous Cell Carcinoma (HNSCC):

Significant clinical responses were observed in HNSCC. Among evaluable HNSCC patients treated at an identified dose range of PYX-201 from 3.6 – 5.4 mg/kg (n=6), a confirmed 50% objective response rate (ORR) was observed, including one confirmed complete response (CR) and two confirmed partial responses (PR) by RECIST 1.1.

"These encouraging preliminary clinical data demonstrate the potential for PYX-201 to yield meaningful responses in heavily pretreated patients with head and neck cancer along with several additional solid tumor types," said Glenn J. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School. "The patients in the study have endured multiple rounds of therapy before treatment with PYX-201. We believe the quantity and quality of the responses, including a complete response and PYX-201’s tolerability profile, highlight its promising potential across multiple indications with high unmet medical need, particularly in head and neck cancer."

Clinical Trial Collaboration Agreement with Merck’s KEYTRUDA (pembrolizumab)

The Company additionally announces that it has entered into a Clinical Trial Collaboration Agreement with Merck (known as MSD outside of the US and Canada), for a Pyxis Oncology-sponsored study of PYX-201 in combination with Merck’s anti-PD-1 therapy, KEYTRUDA (pembrolizumab) in patients with 1L and 2L head and neck squamous cell carcinoma (HNSCC), HR+/HER2- breast cancer, and triple-negative breast cancer (TNBC) and sarcoma.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme LLC, a subsidiary of Merck & Co., Inc., Rahway, NJ, USA. Pyxis Oncology and Merck each retain all commercial rights to their respective compounds, including as monotherapy or as combination therapies.

PYX-201 Development Plans in Head and Neck Squamous Cell Carcinoma (HNSCC)

The Company expects to initiate the following HNSCC Phase 1 expansion studies:

•
PYX-201 and KEYTRUDA combination dose escalation and expansion study in 1L and 2L HNSCC with preliminary clinical data readout expected in the second half of 2025;

•
PYX-201 monotherapy study in 2L and 3L HNSCC patients who are platinum and PD-1 inhibitor experienced, with preliminary clinical data readout expected in the second half of 2025; and
•
PYX-201 monotherapy study in 2L and 3L HNSCC patients who are EGFR and PD-1 inhibitor experienced, with preliminary clinical data readout expected in first half of 2026.

Preliminary Phase 1 Clinical Response Data in Additional Solid Tumor Types:

Encouraging confirmed and unconfirmed responses were observed in five additional solid tumor types: ovarian cancer, non-small cell lung cancer (NSCLC), HR+/HER2- breast cancer, triple-negative breast cancer (TNBC), and sarcoma.

PYX-201 Development Plan in Additional Tumor Types

Exploratory PYX-201 Phase 1 monotherapy expansion cohorts are planned in ovarian cancer, NSCLC, HR+/HER2- breast cancer, TNBC, and sarcoma, with preliminary clinical data expected in the second half of 2025.

The Company also expects to initiate the following clinical combination studies:

•
PYX-201 and KEYTRUDA combination study in HR+/HER2- breast cancer, TNBC, and sarcoma with preliminary clinical data expected in the second half of 2025 and the first half of 2026.
•
Preclinical studies of PYX-201 in combination with other agents in ovarian cancer and NSCLC to commence in 2025 to be followed by clinical studies with preliminary clinical data expected in 2026.

Summary of Preliminary Phase 1 Safety and Pharmacokinetics (PK) Data:

PYX-201 demonstrated favorable preliminary tolerability profile data with low incidence of dose discontinuation, interruptions or delays due to treatment-related adverse events (TRAE). Low incidence of Grade 3 or Grade 4 payload-related TRAEs within the identified dose range reinforce PYX-201’s differentiated construct enabling enhanced molecular stability and differential expression of Extradomain-B (EDB) in tumor tissue with negligible expression in normal tissues. The low incidence of Grade 1 or Grade 2 adverse events points to an attractive safety, given that it has been well tolerated and suitable for both monotherapy and combination therapy development.

With respect to PK data, PYX-201 demonstrated increased stability in circulation, which we believe is due to its proprietary design of site-specific conjugation chemistry as compared to certain approved val-cit-monomethyl auristatin E (MMAE) ADCs with non-site-specific conjugation chemistry.

"PYX-201 is an innovative investigational therapy designed with a unique extracellular mechanism of action, unlike any other ADC currently on the market or in development. These initial clinical data, demonstrating tumor shrinkage across a broad range of solid tumors with a differentiated safety profile indicate a significant opportunity to further develop PYX-201 across a variety of tumor types in both the mono and combo therapy settings," said Anthony Tolcher, M.D., FRCPC, FACP, Founder and Chief Executive Officer of NEXT Oncology and PYX-201 Study Investigator. "Additionally, the encouraging safety data support the potential for PYX-201 to be safely combined with other agents, including checkpoint inhibitors, to drive further patient responses."

Additional details and analyses beyond what have been included in this press release will be presented during the Company’s preliminary PYX-201 Phase 1 data investor event today.

In-person and Virtual Investor Event Information

Pyxis Oncology will host a virtual and in-person investor event to discuss the preliminary Phase 1 data today, Wednesday, November 20, 2024, at 4:30 p.m. ET at Venue 42 by Convene, located at 5 Times Square in New York City. Anyone interested in attending the live event should RSVP to .

Pyxis Oncology’s members of executive management team will be joined by the following physician thought leaders to discuss preliminary data from the Phase 1 trial:

•
Anthony Tolcher, M.D., FRCPC, FACP, Founder and Chief Executive Officer, NEXT Oncology
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Glenn J. Hanna, M.D., Director, Center for Cancer Therapeutic Innovation (Early Drug Development Program) and Center for Salivary and Rare Head and Neck Cancers at Dana-Farber Cancer Institute, and Associate Professor of Medicine, Harvard Medical School