On September 2, 2025 Philogen reported that Dr. Samuele Cazzamalli is presenting "From DNA-encoded chemistry to ACP3-targeted radioligand therapeutics against prostate cancer" (Press release, Philogen, SEP 2, 2025, View Source [SID1234655656]). In addition, Dr. Cristiano Pini will give an update on "Diagnostic Performance, Safety, and Pharmacokinetics of [68Ga]Ga-OncoACP3 in Prostate Cancer – Preliminary Results from a Prospective Phase I Clinical Trial" and Prof. Philippp Backhaus will give a presentation on "Theranostic targeting of the prostatic acid phosphatase (ACP3) with [68Ga]Ga-OncoACP3-DOTA and [177Lu]Lu-OncoACP3-DOTA in prostate cancer patients".

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Moreover, Dr. Fabrizia Gelardi will present "First-in-Human Phase I Study of [68Ga]Ga-OncoCAIX: Preliminary Results on Safety, Dosimetry, Pharmacokinetics, and Diagnostic Performance".

On September 2, 2025 SystImmune, Inc. (SystImmune), a clinical-stage biotechnology company, reported that two abstracts for iza-bren (izalontamab brengitecan), a potentially first-in-class EGFRxHER3 bispecific antibody drug conjugate (ADC), will be presented at the World Conference on Lung Cancer (WCLC) 2025 Annual Meeting taking place September 6 – 9 in Barcelona, Spain (Press release, SystImmune, SEP 2, 2025, View Source [SID1234655671]). Iza-bren is jointly developed by SystImmune and Bristol Myers Squibb under a collaboration and exclusive license agreement in territories outside of China.

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The safety and efficacy results of iza-bren as a monotherapy and in combination with Osimertinib in patients with advanced stages of EGFR mutated Non-Small Cell Lung Cancer will be presented at WCLC. The data highlights the continued progress of iza-bren clinical development and builds upon the previously reported clinical activity in lung, breast, and bladder cancer patients at ASCO (Free ASCO Whitepaper), ESMO (Free ESMO Whitepaper), and SABCS in 2023, 2024 and 2025.

"These data further enhance our confidence in iza-bren’s clinical activity across a wide range of tumors," said Jonathan Cheng, M.D., Chief Medical Officer of SystImmune. "We are particularly excited by the potential of iza-bren in combination with osimertinib as a first-line treatment for EGFR-mutated NSCLC. This approach may offer the opportunity for deeper and more durable responses in newly diagnosed patients, and we remain committed to advancing its development to address unmet needs in lung cancer."

Details of the presentations at WCLC are below:
Phase I/II Study of iza-bren (BL-B01D1) as Monotherapy in Patients with pre-treated Locally Advanced or Metastatic EGFR Mutated NSCLC
Session Title: OA10 – Optimizing Systemic Therapy; Bridging New and Old
Presentation: OA10.03
Speaker: Wenfeng Fang (Guangzhou, China)
Session Date & Time: Monday, September 8th, 2025, 3:30 PM-4:45 PM CEST

Phase II Study of iza-bren (BL-B01D1) Combo with Osimertinib in EGFR Mutated Locally Advanced or Metastatic NSCLC Patients
Session Title: OA10 – Optimizing Systemic Therapy; Bridging New and Old
Presentation: OA10.04
Speaker: Fei Zhou (Zhengzhou, China)
Session Date & Time: Monday, September 8th, 2025, 3:30 PM-4:45 PM CEST

About iza-bren
SystImmune, in collaboration with BMS outside of China, is developing iza-bren (BL-B01D1), a bispecific antibody-drug conjugate (ADC) that targets both EGFR and HER3 targets that are highly expressed in various epithelial cancers and are known to be associated with cancer cell proliferation and survival. Iza-bren’s dual mechanism of action blocks EGFR and HER3 signals to cancer cells, reducing proliferation and survival signals. In addition, upon antibody mediated internalization, iza-bren’s therapeutic payload is released causing genotoxic stress that leads to cancer cell death.

On September 2, 2025 Quince Therapeutics, Inc. (Nasdaq: QNCX), a late-stage biotechnology company dedicated to unlocking the power of a patient’s own biology for the treatment of rare diseases, reported that Dirk Thye, M.D., Quince’s Chief Executive Officer and Chief Medical Officer, will participate at the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Quince Therapeutics, SEP 2, 2025, View Source [SID1234655657]). Access to the company’s presentation will be available on Friday, September 5, 2025 beginning at 7:00 a.m. Eastern Time.

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A webcast of the presentation will be accessible on the Events page under the News & Events heading of Quince’s Investor Relations website at ir.quincetx.com. An archive of the webcast will be available shortly following the end of the live event.

On September 2, 2025 Intensity Therapeutics, Inc. (Nasdaq: INTS) ("Intensity" or "the Company"), a late-stage clinical biotechnology company focused on the discovery and development of novel intratumoral cancer therapies that are designed to kill tumors and increase immune system recognition of cancers using its proprietary non-covalent conjugation technology, reported that it will participate in the H.C. Wainwright 27th Annual Global Investment Conference (Press release, Intensity Therapeutics, SEP 2, 2025, https://www.prnewswire.com/news-releases/intensity-therapeutics-inc-to-participate-in-fireside-chat-at-the-hc-wainwright-27th-annual-global-investment-conference-302543127.html [SID1234655672]). The conference is being held on September 8 – 10, 2025 at the Lotte New York Palace Hotel.

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Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

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Lewis H. Bender, President and CEO of Intensity Therapeutics will participate in a fireside chat with Dr. Swayampakula Ramakanth, Managing Director, Senior Healthcare Analyst at H.C. Wainwright. The fireside chat will be available on demand beginning Friday, September 5 at 7:00am ET for registered investors of the conference. To request a one-on-one meeting with Mr. Bender, and to register for the conference, click below: View Source

About INT230-6

INT230-6, Intensity’s lead proprietary investigational product candidate, is designed for direct intratumoral injection. INT230-6 was discovered using Intensity’s proprietary DfuseRx℠ technology platform. The drug consists of two proven, potent anti-cancer agents, cisplatin and vinblastine sulfate, and a diffusion and cell penetration enhancer molecule ("SHAO") that facilitates the dispersion of potent cytotoxic drugs throughout tumors, allowing the active agents to diffuse into cancer cells. These agents remain in the tumor, resulting in a favorable safety profile. In addition to local disease control and direct tumor killing, INT230-6 causes a release of a bolus of neoantigens specific to the malignancy, leading to immune system engagement and systemic anti-tumor effects. Importantly, these effects are mediated without immunosuppression, which often occurs with systemic chemotherapy.

On September 2, 2025 FibroGen, Inc. (NASDAQ: FGEN) reported it has completed the sale of its China subsidiary to AstraZeneca for a total consideration of approximately $220 million, consisting of $85 million in enterprise value and approximately $135 million in net cash held in China (Press release, FibroGen, SEP 2, 2025, View Source [SID1234655640]).

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"We are thrilled to announce the completion of the sale of FibroGen China to AstraZeneca and are thankful to the teams who worked relentlessly to bring this to a successful close. This transformative transaction substantially strengthens our financial position, and extends our cash runway into 2028, through important clinical milestones," said Thane Wettig, Chief Executive Officer of FibroGen. "With a rejuvenated capital structure, we are on track to commence the Phase 2 monotherapy trial of FG-3246 in mCRPC imminently as well as submit the Phase 3 protocol for roxadustat in anemia associated with lower-risk MDS in the fourth quarter of 2025. Additionally, I would like to express my personal gratitude to our FibroGen China colleagues for their unwavering commitment to the success of roxadustat and to AstraZeneca for being an excellent partner over the past 10 years in China."

The completion of the sale follows the fulfilment of all closing conditions. At closing, FibroGen repaid its term loan facility to investment funds managed by Morgan Stanley Tactical Value for approximately $81 million. The successful completion of the sale extends the Company’s cash runway into 2028.

FibroGen maintains its rights to roxadustat in the U.S. and in all markets not licensed to Astellas (other than China and South Korea). Following a positive meeting with the U.S. Food and Drug Administration (FDA), the Company intends to file the pivotal Phase 3 clinical trial protocol for roxadustat for the treatment of anemia in patients with LR-MDS and high transfusion burden in the fourth quarter of 2025.

In addition, FibroGen continues to advance the clinical development of its lead asset FG-3246, and its companion diagnostic FG-3180, and is on track to initiate the Phase 2 monotherapy trial of FG-3246 in patients with mCRPC in the third quarter of 2025.

BofA Securities, Inc. acted as exclusive financial advisor and Ropes & Gray LLP acted as primary legal advisor to FibroGen on this transaction.