BlossomHill Therapeutics to Present Updated Data from Ongoing Phase 1/2 SOLARA Trial of its Macrocyclic OMNI-EGFR™ Inhibitor, BH-30643, in EGFR-mutant NSCLC at the 2026 World Conference on Lung Cancer

On September 1, 2026 BlossomHill Therapeutics, Inc. (Nasdaq: BLSM), a clinical-stage biopharmaceutical company applying an intentional, chemistry-based approach to design and develop innovative small molecule medicines for the treatment of cancer, reported that updated data from the ongoing Phase 1/2 SOLARA trial describing anti-tumor activity of BH-30643 in patients with secondary epidermal growth factor receptor (EGFR) resistance mutations such as EGFR C797S will be shared as a mini-oral presentation on September 15, 2026 at the 2026 World Conference on Lung Cancer in Seoul, South Korea.

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"C797S is a widely recognized mechanism of resistance in EGFR-mutant lung cancer after progression on a third-generation EGFR inhibitor, such as osimertinib, yet there are currently no approved oral targeted therapies for these patients," said Geoff Oxnard, M.D., Chief Medical Officer of BlossomHill Therapeutics. "The anti-tumor activity observed with BH-30643 to date, including across a range of C797S co-mutations and prior treatment histories, is encouraging and supports its potential to address this significant unmet need. We look forward to presenting updated data at WCLC, including longer follow-up that will further inform the emerging clinical profile of BH-30643."

Presentation details:
Title: Anti-Tumor Activity of BH-30643, a Novel Macrocyclic EGFR TKI, in Patients With Secondary EGFR Resistance Mutations
Presenter: Dr. Hidehito Horinouchi, National Cancer Center Hospital, Tokyo, Japan
Date and time: Tuesday, September 15, 11:00 AM KST / Monday, September 14, 10:00 PM EDT
Session: MO12. Closing The Gaps In Driver Altered NSCLC: Moving Beyond Current Boundaries
Location: Room 202, ASEM Ballroom, 2F

The presentation will be available on the company’s Posters & Presentations page following the session: View Source

About BH-30643
BH-30643 is an investigational, novel, orally bioavailable, non-covalent, macrocyclic, brain active, mutant-selective, OMNI-EGFR inhibitor for the treatment of EGFR-mutant NSCLC. BH-30643 was designed to overcome the limitations of currently approved EGFR inhibitors, which were discovered over a decade ago without the current, modern understanding of the structure and protein dynamics of mutant EGFRs. In preclinical studies, BH-30643 demonstrated potent inhibitory activity across diverse EGFR mutation categories – classical activating mutations, on-target resistance mutations such as C797S with or without T790M, atypical mutations and exon 20 insertions – while maintaining marked selectivity over wild-type EGFR. BH-30643 has received Fast Track designation and is being evaluated in SOLARA, a global Phase 1/2, first-in-human clinical trial spanning more than 40 sites in 10 countries. Ongoing dose expansion cohorts are enrolling in both TKI-pretreated and TKI-naive settings, including a C797S resistance cohort. For additional information on SOLARA, including a list of study sites and how to enroll, please visit clinicaltrials.gov (NCT06706076).

About the SOLARA Trial
The Phase 1/2 SOLARA clinical trial (NCT06706076) is a global, open label, multicenter study assessing the safety, tolerability, pharmacokinetics, pharmacodynamics and preliminary anti-tumor activity of BH-30643 in patients with epidermal growth factor receptor (EGFR) mutant non-small cell lung cancer (NSCLC). Phase 1 will determine the recommended Phase 2 dose (RP2D) of BH-30643 as a monotherapy and in combination with chemotherapy. Phase 2 is designed to evaluate the antitumor efficacy and safety in specified cohorts determined by mutation subtypes and/or treatment history at the RP2D, as well as the population pharmacokinetics.

(Press release, BlossomHill Therapeutics, SEP 1, 2026, View Source [SID1234670520])

Kura Oncology to Participate in Three Investor Conferences in September

On September 1, 2026 Kura Oncology, Inc. (Nasdaq: KURA), a biopharmaceutical company focused on precision medicines for the treatment of cancer, reported that management will present at the following investor conferences:

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Wells Fargo Healthcare Conference
September 8, 2026
3:45 p.m. ET / 12:45 p.m. PT

Cantor Global Healthcare Conference
September 9, 2026
9:10 a.m. ET / 6:10 a.m. PT

Morgan Stanley Global Healthcare Conference
September 16, 2026
7:45 a.m. ET / 4:45 a.m. PT

Live audio webcasts will be available in the Investors section of Kura’s website at View Source, with archived replays available following all three events.

(Press release, Kura Oncology, SEP 1, 2026, View Source [SID1234670519])

Pyxis Oncology to Participate in Upcoming Investor Conferences

On September 1, 2026 Pyxis Oncology, Inc. (Nasdaq: PYXS), a clinical-stage company developing next-generation therapeutics for difficult-to-treat cancers, reported that Tom Civik, Interim Chief Executive Officer and Director of Pyxis Oncology, will participate in fireside chats at three upcoming conferences.

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Wells Fargo 21st Annual Healthcare Conference in Boston, MA on Thursday, September 10, 2026, at 10:15 a.m. ET.

2026 Cantor Global Healthcare Conference in New York, NY on Friday, September 11, 2026, at 10:55 a.m. ET.

H.C. Wainwright 28th Annual Global Investment Conference in New York, NY on Monday, September 14, 2026, at 9:30 a.m. ET.

Live webcasts and replays of the fireside chats will be available on the Events & Presentations page in the Investor Relations section of Pyxis Oncology’s website, ir.pyxisoncology.com.

(Press release, Pyxis Oncology, SEP 1, 2026, View Source [SID1234670518])

Relmada Therapeutics to Participate at the Wells Fargo 21st Annual Healthcare Conference

On September 1, 2026 Relmada Therapeutics, Inc. (Nasdaq: RLMD, "Relmada" or the "Company"), a clinical-stage biotechnology company advancing innovative therapies for oncology and central nervous system disorders, reported that senior management will participate in one-on-one meetings at the Wells Fargo 21st Annual Healthcare Conference being held in Boston, MA, from September 8 – 10, 2026.

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Wells Fargo 21st Annual Healthcare Conference Details
Format: One-on-one Meetings
Date: September 8 – 10, 2026

If you are interested in arranging a 1×1 meeting with management at the conference, please contact your Wells Fargo representative.

(Press release, Relmada Therapeutics, SEP 1, 2026, View Source [SID1234670517])

Elevar Therapeutics to Share Camrelizumab/Rivoceranib Poster at International Liver Cancer Association Conference on Clinical Outcomes in Younger Age Patients with Unresectable Hepatocellular Carcinoma

On September 1, 2026 Elevar Therapeutics, Inc., a majority-owned subsidiary of HLB Co., Ltd. and a fully integrated biopharmaceutical company dedicated to elevating treatment experiences and outcomes for cancer patients, reported that in a post hoc analysis of its Phase 3 CARES-310 study, camrelizumab, an anti-PD-1 antibody, plus rivoceranib, an oral TKI, demonstrated a clinically meaningful progression-free survival (PFS) benefit across all age subgroups when compared to sorafenib in patients with unresectable hepatocellular carcinoma (uHCC).

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The poster, titled "Younger Age and Clinical Outcomes in Patients with Unresectable Hepatocellular Carcinoma Treated with Camrelizumab + Rivoceranib vs Sorafenib (CARES-310)," will be on display throughout the International Liver Cancer Association 2026 Annual Conference, which runs Sept. 3-5 at Le Plaza Hotel in Brussels. Elevar is sponsoring the conference’s welcome reception on Sept. 3., from 6:15-7:30 p.m. (CET).

"We remain deeply committed to gaining FDA approval and helping patients confronted with hepatocellular carcinoma, because the scientific data demonstrates that the combination of camrelizumab and rivoceranib shows consistent potential to extend survival when compared to currently approved treatments," said Dong-Gun Kim, chief executive officer of Elevar. "This post-hoc analysis of CARES-310 further demonstrates the broad potential of the combination. We are excited to share it with our peers at the ILCA Annual Conference."

The post-hoc, exploratory analysis concluded that:

Camrelizumab plus rivoceranib improved median overall survival (mOS) versus sorafenib in patients aged <50 years (21.5 vs. 15.2 months; HR 0.7; 95% CI, 0.47-1.06; P=0.0445*) and ≥50 years (23.9 vs. 15.2 months; HR 0.6; 95% CI, 0.47-0.77; P<0.0001), with a numerically longer mOS also observed in patients <40 years (24.2 vs. 15.2 months; HR 0.82; 95% CI, 0.4-1.72; P=0.2982)^.
Camrelizumab plus rivoceranib also improved mPFS versus sorafenib across age subgroups, including patients <50 years (5.5 vs. 2.7 months; HR 0.53; 95% CI, 0.37–0.77; P=0.0004), ≥50 years (6.2 vs. 3.7 months; HR 0.56; 95% CI, 0.45–0.72; P<0.0001), and <40 years (5.5 vs. 2.2 months; HR 0.56; 95% CI, 0.29–1.12; P=0.0485)^.
Treatment-related adverse events (TRAEs) were similar across age subgroups. The most common (≥5%) grade 3-4 TRAE was hypertension for camrelizumab plus rivoceranib and palmar-plantar erythrodysesthesia syndrome for sorafenib, regardless of age.

*All P values are one sided.
^Median follow-up time is 22.1 months.

Lead poster author Arndt Vogel, M.D., Ph.D., scientist in the Division of Gastroenterology and Hepatology at Toronto General Hospital Research Institute, and a medical oncologist at the UHN-Princess Margaret Cancer Centre at the University of Toronto, will present the poster #P-106 during the conference Poster Tour, Friday, Sept. 4, 10:30-11 a.m.

"The analysis of camrelizumab plus rivoceranib by age subgroups provides further evidence that the combination has potential to improve outcomes across diverse healthcare settings," said Dr. Vogel. "It has also been investigated across early, intermediate, and advanced stages of HCC, both alone and in combination with locoregional therapies, and has consistently demonstrated clinically meaningful antitumor activity together with a manageable safety profile. These findings highlight the potential of this regimen to become an important component of multidisciplinary HCC management."

For more information about Elevar, visit Elevartx.com.

About Hepatocellular Carcinoma

Hepatocellular Carcinoma (HCC) is the most common type of liver cancer and most frequently develops in people with chronic underlying liver inflammation, which may be from viral and non-viral causes. HCC typically has a poor prognosis with limited treatment options and continues to be a diagnosis with an ongoing urgent medical need. More than 800,000 people worldwide are diagnosed with liver cancer each year and it is also a leading cause of cancer deaths, accounting for more than 700,000 annually, according to the American Cancer Society.

About Rivoceranib

Rivoceranib, an oral small-molecule tyrosine kinase inhibitor (TKI), is a highly selective inhibitor of vascular endothelial growth factor receptors (VEGFRs), a primary pathway for tumor angiogenesis. VEGFR inhibition is a clinically validated target to limit tumor growth and disease progression. Rivoceranib is currently being studied as a monotherapy and in combination with chemotherapy and immunotherapy in various solid tumor indications. Several clinical studies were completed in patients with uHCC (in combination with camrelizumab), gastric cancer (as a monotherapy and in combination with paclitaxel), adenoid cystic carcinoma (as a monotherapy) and colorectal cancer (in combination with Lonsurf). Rivoceranib, under the name apatinib (Aitan), was the first TKI approved in gastric cancer in China (October 2014). It was also approved in China in combination with camrelizumab as a first-line treatment for unresectable or metastatic HCC (January 2023). The drug has been studied in more than 6,000 patients worldwide and was well tolerated in clinical trials with a comparable safety profile to other TKIs and VEGF inhibitors. Orphan drug designations have been granted for gastric cancer (U.S., EU and South Korea), adenoid cystic carcinoma (U.S.) and uHCC (U.S. and EU). Elevar Therapeutics, Inc. holds the global rights (excluding China) to rivoceranib and has partnered for its development and marketing with HLB-LS in South Korea. Hengrui Pharma, is the license-holder of rivoceranib in the Chinese -territory. As previously disclosed, in July, Elevar received a Complete Response Letter from the FDA regarding its NDA for rivoceranib in combination with camrelizumab due to deficiencies identified during an inspection of the manufacturing site. Elevar is working closely with Hengrui to address the identified issues and prepare for resubmission of the application.

About Camrelizumab

Camrelizumab (SHR-1210) is a humanized monoclonal antibody that binds to the programmed death-1 (PD-1) receptor. Blockade of the PD-1/PD-L1 signaling pathway is a therapeutic strategy showing success in a wide variety of solid and hematological cancers. Camrelizumab is developed by Hengrui Pharma and has been studied in more than 5,000 patients. Currently, 50 clinical trials are underway in a broad range of tumors (including liver cancer, lung cancer, gastric cancer and breast cancer, etc.) and treatment settings. Camrelizumab, under the brand name AiRuiKa, is currently approved for eight indications in China, including monotherapy for the treatment of HCC (second-line), in combination with rivoceranib as a treatment for HCC (first-line), relapsed/refractory classic Hodgkin’s lymphoma (third-line), esophageal squamous cell carcinoma (second-line) and nasopharyngeal carcinoma (third-line or further) and in combination with chemotherapy for the treatment of non-small cell lung cancer (non-squamous and squamous), esophageal squamous cell carcinoma and nasopharyngeal carcinoma in the first-line setting. The U.S. Food and Drug Administration granted Orphan Drug Designation to camrelizumab for advanced HCC in April 2021 and by the EMA in August 2024. In October 2023, Elevar licensed camrelizumab for commercialization from Hengrui Pharma worldwide excluding Greater China and Korea.

(Press release, Elevar Therapeutics, SEP 1, 2026, View Source [SID1234670516])