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Antengene Publishes Preclinical Research Paper on CD73 Small Molecule Inhibitor ATG-037 Combined with Selinexor in Cancer Gene Therapy

On September 14, 2026 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK) , a leading innovative, commercial-stage global biotech company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class medicines for autoimmune diseases, solid tumors and hematological malignancies indications, reported that a preclinical research paper evaluating the combination of ATG-037 (CD73 Small Molecule Inhibitor) and selinexor for the treatment of multiple myeloma (MM), conducted in collaboration with the Department of Hematology at Peking University Third Hospital, has been published in Cancer Gene Therapy, an international SCI journal under Springer Nature.

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Details of the Paper
Title: CD73 inhibitor enhances the antitumor activity of selinexor in multiple myeloma by restoring the activation of CD8+ T cells
Journal: Cancer Gene Therapy
DOI: 10.1038/s41417-026-01078-9

Study Design:

The research team first analyzed CD73 expression across multiple tumor cell lines following selinexor treatment, then tested the combination in vivo using a J558-inoculated BALB/c mouse model, with mice divided into a vehicle group, an ATG-037 monotherapy group, a selinexor monotherapy group and a combination-therapy group. Single-cell RNA sequencing was used to characterize immune cell subtypes and tumor-immune crosstalk, immunofluorescence staining was performed on tumor tissue, and a co-culture model of CD8+ T cells and multiple myeloma cell lines was established to confirm the mechanism behind the combination’s antitumor effect.

Key Findings:

Selinexor treatment was found to upregulate CD73 expression in the majority of tumors, a resistance-associated mechanism that the combination approach was designed to counter. In the mouse model, the combination therapy suppressed tumor growth with an inhibition rate of 62%, compared with 31% for ATG-037 monotherapy and 43% for selinexor monotherapy. Single-cell RNA sequencing showed that the combination synergistically potentiated CD8+ T cell activation by enhancing the interaction between CD8+ T cells and Enpp1+ cells via the CD80–CD28 signaling pathway, and the resulting increase in CD8+ T cell infiltration into tumor tissue was confirmed by immunofluorescence staining. In co-culture experiments, CD73 inhibition was shown to strengthen selinexor-mediated tumor cell killing by activating CD8+ T cells, with significantly elevated levels of Granzyme B (P=0.0252) and IFN-γ (P=0.0067) observed in the combination group.

Conclusion:

The study highlights the synergistic potential of combining selinexor with a CD73 inhibitor for enhancing CD8+ T cell-mediated tumor cytotoxicity in MM. Selinexor therapy upregulates CD73 in the TME, driving adenosine accumulation and an immunosuppressive state. Combined use of ATG-037 blocks this immunosuppressive feedback loop via suppression of CD73-dependent adenosine synthesis, restoring CD8+ T cell activation and proliferation while enhancing T cell cytotoxicity through activation of the CD80-CD28 costimulatory axis. These findings establish a novel, clinically feasible therapeutic paradigm for addressing drug resistance and refractory MM.

(Press release, Antengene, SEP 14, 2026, View Source [SID1234670836])

Sapience Therapeutics Announces FDA Acceptance of Investigational New Drug Application for ST316 in Familial Adenomatous Polyposis (FAP)

On September 14, 2026 Sapience Therapeutics, Inc., a clinical-stage biotechnology company dedicated to developing first-in-class peptide therapeutics targeting the underlying oncogenic and immune mechanisms driving cancer and pre-cancerous disease, reported that the U.S. Food and Drug Administration (FDA) has granted the Company an Investigational New Drug (IND) application for ST316 (IND 184073) for the treatment of familial adenomatous polyposis (FAP), a rare inherited disorder associated with the development of hundreds to thousands of precancerous colorectal polyps and a significantly increased risk of colorectal cancer.

ST316 has previously received Orphan Drug designation from the FDA for the treatment of familial adenomatous polyposis.

"We are pleased to reach this important regulatory milestone for ST316," said Barry Kappel, Chief Executive Officer of Sapience Therapeutics. "ST316’s unique mechanism of action is designed to selectively inhibit oncogenic β-catenin activity while avoiding the toxicities associated with broader Wnt pathway inhibition. The favorable safety and tolerability profile observed with ST316 monotherapy in the Phase 1 clinical study strengthens the potential of this differentiated approach, particularly in FAP, where long-term treatment requires a high bar for safety and tolerability. Together with supportive preclinical activity in FAP models of disease, we believe ST316 has the potential to become an important new therapeutic option for patients with this serious inherited condition."

ST316 has already demonstrated encouraging clinical activity in an ongoing Phase 2 expansion study in second-line metastatic colorectal cancer (2L mCRC). As presented at AACR (Free AACR Whitepaper) 2026, and based on an April 13, 2026 data cutoff, 15 patients had been enrolled and treated with ST316 in combination with standard of care (FOLFIRI and bevacizumab), with a confirmed objective response rate (ORR) of 47%, including seven confirmed partial responses, and a disease control rate (DCR) of 93%. These results compare favorably to historical outcomes for FOLFIRI and bevacizumab in 2L mCRC patients, which have demonstrated an 11% ORR. Responses were observed across multiple patient subgroups, including those with RAS-mutated and RAS wild-type tumors, liver metastases, and prior bevacizumab exposure. In the 23-patient Phase 1 monotherapy portion of the study, ST316 demonstrated a favorable safety and tolerability profile, as previously disclosed at AACR (Free AACR Whitepaper) 2026. These results provide clinical validation of β-catenin/BCL9 pathway antagonism in humans and support the rationale for evaluating ST316 in other β-catenin-driven diseases, including FAP, where the pathway is uniformly activated.

Familial adenomatous polyposis (FAP) is a rare inherited condition, characterized by the development of numerous adenomatous polyps in the colon and rectum, typically resulting from mutations in the APC gene. Without intervention, individuals with FAP face a near-certain lifetime risk of developing colorectal cancer. Current management strategies rely heavily on intensive surveillance and prophylactic surgery, underscoring the need for effective medical therapies that can reduce disease burden and delay or prevent surgical intervention. FAP affects an estimated 1 in 5,000 to 10,000 individuals in the United States, according to the National Organization for Rare Disorders, and there are currently no FDA-approved medical therapies for the condition.

About ST316
ST316 is Sapience Therapeutics’ first-in-class β-catenin antagonist designed to selectively inhibit the oncogenic activity of β-catenin through blockade of its interaction with BCL9, a critical transcriptional co-activator in the Wnt/β-catenin signaling pathway. This selective mechanism is designed to spare normal Wnt-dependent processes such as intestinal stem cell renewal and bone homeostasis, the mechanistic basis for the dose-limiting gastrointestinal and bone toxicities seen with broad Wnt pathway inhibitors. Consistent with this rationale, ST316 has not been associated with any gastrointestinal or bone-related adverse events leading to dose reduction, interruption, or discontinuation among the 38 patients treated to date in the Phase 1 monotherapy (n=23) and Phase 2 FOLFIRI and bevacizumab combination cohort of the study (n=15). Aberrant β-catenin signaling is a key driver of numerous cancers and pre-cancerous diseases, including familial adenomatous polyposis (FAP). ST316 is currently being evaluated in an ongoing Phase 2 dose expansion study in second-line metastatic colorectal cancer (2L mCRC) in combination with standard-of-care therapy. ST316 has received Orphan Drug Designation from the U.S. Food and Drug Administration for the treatment of FAP.

(Press release, Sapience Therapeutics, SEP 14, 2026, View Source [SID1234670835])

Results from Phase III Study of Trastuzumab Botidotin versus T-DM1 in HER2-Positive Breast Cancer Published in JCO

On September 14, 2026 Sichuan Kelun-Biotech Biopharmaceutical Co., Ltd. ("Kelun-Biotech" or "the Company", 6990.HK) reported that results from the phase III registrational study of its novel human epidermal growth factor receptor 2 (HER2)-targeted antibody–drug conjugate (ADC) trastuzumab botidotin (舒泰莱) in HER2-positive unresectable or metastatic breast cancer (BC) have been published in Journal of Clinical Oncology (JCO, impact factor (IF)=44.7). Professor Xichun Hu and Professor Hongxia Wang of Fudan University Shanghai Cancer Center, and Dr. Junyou Ge, Director of the National Engineering Research Center of Targeted Biologics act as the co-senior authors. Professor Jian Zhang of Fudan University Shanghai Cancer Center, Professor Quchang Ouyang of Hunan Cancer Hospital, Professor Qingyuan Zhang of Harbin Medical University Cancer Hospital, Professor Huihui Li of Cancer Hospital of Shandong First Medical University, and Professor Xu Wang of Tianjin Medical University Cancer Institute and Hospital act as the co-first authors. These findings had previously been selected as a Late-Breaking Abstract (LBA) and presented as an oral presentation at the 2025 European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress.

This randomized, open-label, multicenter phase III study was designed to evaluate the efficacy and safety of trastuzumab botidotin monotherapy versus trastuzumab emtansine (T-DM1) in patients with HER2-positive unresectable or metastatic BC who had received prior trastuzumab and taxane-containing regimens. A total of 365 patients were randomized 1:1 to receive trastuzumab botidotin or T-DM1. The primary endpoint was progression-free survival (PFS) assessed by blinded independent central review (BICR), and secondary endpoints included overall survival (OS), objective response rate (ORR), and duration of response (DoR).

As of the data cutoff date of April 26, 2025, with a median follow-up of 14.9 months, efficacy results showed:

Median PFS was significantly prolonged in the trastuzumab botidotin group compared with the T-DM1 group (11.1 months vs. 4.4 months; hazard ratio (HR) = 0.39) (Figure A), meeting the primary endpoint of the study; consistent PFS benefit was observed across all prespecified subgroups (Figure B).

Trastuzumab botidotin group demonstrated deeper and more durable tumor responses compared with T-DM1 group, with an ORR of 76.9% vs. 53.0% and a median DoR of 12.2 months vs. 5.7 months (Figure C).

OS data were not mature in both groups, but an OS benefit trend was observed in trastuzumab botidotin group, demonstrating a 38% reduction in the risk of death (Figure D).
In terms of safety, patients in the trastuzumab botidotin group had a low incidence of interstitial lung disease (ILD), and the incidences of hematologic, hepatic, and gastrointestinal toxicities were notably lower than those in the T-DM1 group, along with lower rates of serious adverse events (SAEs) and treatment discontinuations. The most common treatment-related adverse events (TRAEs) in trastuzumab botidotin group were ocular events, which could be recovered or reversed after management with standardized strategies.

The publication of the phase III results for trastuzumab botidotin in Journal of Clinical Oncology marks a major international academic breakthrough for a domestically developed HER2 ADC backed by high-level clinical evidence. This is the first phase III trial in China for a HER2 ADC compared head-to-head with T-DM1 with positive results. The data showed that trastuzumab botidotin demonstrated improvements in key efficacy endpoints including PFS, ORR, and DoR, along with a favorable safety profile. Based on these positive results, trastuzumab botidotin has been approved by China’s National Medical Products Administration (NMPA) for the treatment of second-line or later HER2-positive BC, becoming the first domestically developed HER2 ADC approved for this indication in China and providing a new treatment option for patients with HER2-positive advanced breast cancer.

About Trastuzumab botidotin(舒泰莱)

Trastuzumab botidotin is a differentiated HER2 ADC to treat advanced HER2+ solid tumors. As an innovative HER2 ADC developed by the Company, it conjugates a novel, monomethyl auristatin F (MMAF) derivative (a highly cytotoxic tubulin inhibitor, Duo-5) via a stable, enzyme-cleavable linker to a HER2 monoclonal antibody with a DAR of 2. Trastuzumab botidotin specifically binds to HER2 on the surface of tumor cells and is internalized by tumor cells, releasing the toxin molecule Duo-5 inside the cell. Duo-5 induces tumor cell cycle arrest in the G2/M phase, leading to tumor cell apoptosis. After targeting HER2, trastuzumab botidotin can also inhibit the HER2 signaling pathway; it has antibody-dependent cell-mediated cytotoxicity (ADCC) activity.

Based on the results of a multi-center, randomized, open-label, controlled Phase 3 KL166-III-06 study, trastuzumab botidotin was approved for marketing by the NMPA for adult patients with unresectable or metastatic HER2 positive BC who have received one or more prior anti-HER2 therapy. At a pre-specified interim analysis, trastuzumab botidotin monotherapy demonstrated a statistically significant and clinically meaningful improvement in the primary endpoint of PFS as assessed by the BICR compared with T-DM1; the beneficial trend for OS of trastuzumab botidotin was also observed.

Currently, the Company has initiated an open, multi-center Phase 2 clinical study of trastuzumab botidotin in the treatment of HER2+ unresectable or metastatic BC that previously received a topoisomerase inhibitor payload ADC.

(Press release, Kelun, SEP 14, 2026, View Source [SID1234670834])

Tyra Announces Pricing of $400 Million Underwritten Offering of Common Stock and Pre-Funded Warrants

On September 14, 2026 Tyra Biosciences, Inc. (Nasdaq: TYRA), a clinical-stage biotechnology company focused on developing next-generation precision medicines that target large opportunities in Fibroblast Growth Factor Receptor (FGFR) biology, reported the pricing of an underwritten offering of 9,079,000 shares of its common stock at a price of $22.03 per share and, in lieu of shares of common stock to certain investors, pre-funded warrants to purchase 9,078,529 shares of common stock at a purchase price of $22.029 per share, which equals the offering price per share of the common stock less the $0.001 exercise price per share of each pre-funded warrant. All of the shares of common stock and pre-funded warrants in the offering are being sold by Tyra. The gross proceeds to Tyra from the offering, before deducting the underwriting discounts and commissions and other offering expenses, are expected to be approximately $400.0 million. The offering is expected to close on September 15, 2026, subject to the satisfaction of customary closing conditions.

TYRA intends to use the net proceeds from this offering, together with its existing cash, cash equivalents and marketable securities, to advance its "dabogratinib 3×3" development strategy in low-grade upper tract urothelial carcinoma (LG-UTUC), intermediate-risk non-muscle invasive bladder cancer (IR NMIBC) and achondroplasia (ACH), as well as to support its preclinical and drug discovery programs, working capital and other general corporate purposes.

The offering was led by RA Capital Management, with participation by new and existing institutional investors, including Invus, Commodore Capital, BVF Partners, Janus Henderson Investors, Trails Edge Capital Partners, Integral Health Asset Management, TCGX, StemPoint Capital LP and multiple large investment management firms.

Jefferies, Guggenheim Securities, Cantor, Barclays and William Blair are acting as joint book-running managers for the offering. Wedbush PacGrow, Raymond James and Oppenheimer & Co. are acting as lead managers.

The shares of common stock and pre-funded warrants described above are being offered by Tyra pursuant to a shelf registration statement on Form S-3, including a base prospectus, filed with the Securities and Exchange Commission (SEC) and that became automatically effective on September 14, 2026. A prospectus supplement and accompanying prospectus relating to this offering will be filed with the SEC. When available, copies of the prospectus supplement and the accompanying prospectus relating to this offering may be obtained from: Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, New York, NY 10022, or by telephone at (877) 821-7388, or by e-mail at [email protected]; Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, New York, NY 10022, or by email at [email protected]; or Barclays Capital Inc. c/o Broadridge Financial Solutions 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-888-603-5847 or by email at [email protected]. Electronic copies of the prospectus supplement and accompanying prospectus will also be available on the website of the SEC at View Source

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or 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 jurisdiction.

(Press release, Tyra Biosciences, SEP 14, 2026, View Source [SID1234670833])

Sandoz issues EUR 500 million bond

On September 14, 2026 Sandoz (SIX:SDZ/OTCQX:SDZNY), the global leader in affordable medicines, reported the issuance of a EUR 500 million bond with a coupon of 4.835% and a maturity of 12 years, for general corporate purposes including the refinancing of existing debt.

Sandoz CFO Remco Steenbergen says: "The successful issuance of this 12-year EUR 500 million bond underlines the strength of our financial foundation at Sandoz and extends the maturity profile of our debt portfolio. Our proactive interest rate risk management substantially mitigated the impact of recent increases in market interest rates and enabled us to secure it at an attractive effective interest cost, below the bond’s contractual coupon. Through continued discipline in debt management, we have achieved a diversified, well-balanced maturity profile and meaningful reductions in funding costs."

Including this transaction, Sandoz expects to maintain an average annual interest rate on gross debt below 4%, further reinforcing its resilient capital structure through a debt maturity profile extending to 2038 and an average debt maturity of approximately six years, excluding bonds maturing through 2027.

Sandoz aims to maintain an investment grade credit rating and is rated Baa2 (positive outlook) by Moody’s and BBB (positive outlook) by S&P.

The transaction was supported by a bank syndicate consisting of Bank of America, Mizuho and SEB as active bookrunners and Citi, HSBC and Société Générale as passive bookrunners. Advestra and Linklaters acted as Sandoz legal advisors.

(Press release, Sandoz, SEP 14, 2026, View Source [SID1234670832])