On September 1, 2022 BCI Pharma reported that it will attend the XXVII EFMC International Symposium on Medicinal Chemistry in Nice from September 4-8, 2022 and present its promising research program targeting tumor-associated macrophages (Press release, BCI Pharma, SEP 1, 2022, View Source [SID1234621935]). Mode of action and efficacy data of its preclinical candidate will be discussed (Press release, BCI Pharma, SEP 1, 2022, View Source [SID1234621935]).

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On September 1, 2022 Alphamab reported its interim results for the six months ended June 30, 2022 (Press release, Alphamab, SEP 1, 2022, View Source [SID1234618980]).

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On September 1, 2022 Jacobio Pharma (1167.HK) reported that the company has dosed the first non-small cell lung cancer (NSCLC) patient with KRAS G12C and STK11 co-mutation in the Phase IIa trial of KRAS G12C inhibitor JAB-21822 in China (Press release, Jacobio Pharmaceuticals, SEP 1, 2022, View Source [SID1234618957]).

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JAB-21822 is a KRAS G12C inhibitor independently developed by Jacobio utilizing the allosteric inhibitor technology, which is now used as the front-line treatment for advanced or metastatic NSCLC patients with KRAS G12C and STK11 co-mutation.

In China, there are approximately 40,000 new patients with tumors harboring KRAS G12C mutation every year. STK11 is an in-parallel biomarker of KRAS G12C. According to relevant studies, non-small cell lung cancer patients with STK11 and KRAS G12C co-mutation receiving KRAS G12C inhibitor treatment have a higher objective response rate in clinical study.

"JAB-21822 is the first and only clinical stage drug approved for first-line treatment of STK11 and KRAS G12C co-mutated non-small cell lung cancer in China. JAB-21822 is independently developed by Jacobio, which has potential to bring better treatment options to patients based on efficacy and safety," said Dr. WANG Yinxiang, Chairman and CEO of Jacobio.

JAB-21822 is the best-in-class potential project for KRAS G12C inhibitors. The preliminary clinical date of the Phase I study of JAB-21822 published at the 2022 annual meeting of American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) shows that as of April 1, 2022, a total of 72 patients with advanced solid tumors were enrolled, and efficacy was assessed for 32 NSCLC patients with KRAS G12C mutation. The overall response rate (ORR) was 56.3% (18/32) and the disease control rate (DCR) was 90.6% (29/32).

Currently, JAB-21822 is simultaneously undergoing clinical trials for monotherapy and combination therapy in China, the United States and Europe, including the monotherapy for NSCLC with KRAS G12C mutation, pancreatic ductal carcinoma and colorectal cancer; the combination therapy with EGFR monoclonal antibody; and the combination therapy with JAB-3312, a self-developed SHP2 inhibitor of the Company.

About JAB-21822

JAB-21822 is a KRAS G12C inhibitor independently developed by the Company. The Company has initiated a number of Phase I/II clinical trials in China, the United States and Europe for patients with advanced solid tumors, including monotherapy for STK11 co-mutated non-small cell lung cancer in the front-line setting; combination therapy with SHP2 inhibitor, anti-PD-1 monoclonal antibody and Cetuximab.

On September 1, 2022 Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company with a robust pipeline of investigational therapeutics built on protein dysregulation expertise, reported that members of its senior management team will participate in the following upcoming investor conferences (Press release, Prothena, SEP 1, 2022, View Source [SID1234618952]):

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Citi’s 17th Annual BioPharma Conference on Thursday, September 8, 1×1 investor meetings will be held
Morgan Stanley 20th Annual Global Healthcare Conference on Tuesday, September 13, a fireside chat will be held at 5:15 PM ET
H.C. Wainwright 24th Annual Global Investment Conference on Wednesday, September 14, a fireside chat will be held at 9:00 AM ET
Cantor Neurology & Psychology Conference on Thursday, October 6, 1×1 investor meetings will be held
A live webcast of the fireside chats can be accessed through the investor relations section of the Company’s website at www.prothena.com. Following the live presentation, a replay of the webcast will be available on the Company’s website for at least 90 days following the presentation date.

On September 1, 2022 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a commercial-stage biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer, reported that a meeting of the Oncologic Drugs Advisory Committee ("ODAC") of the U.S. Food and Drug Administration ("FDA") has been scheduled for October 28, 2022 to review the Company’s Biological License Application ("BLA") for its product candidate, OMBLASTYS (omburtamab), an investigational radiolabeled antibody construct (Press release, Y-mAbs Therapeutics, SEP 1, 2022, View Source [SID1234618951]). Y-mAbs resubmitted the BLA for OMBLASTYS on March 31, 2022, and the FDA assigned a Prescription Drug User Fee Act ("PDUFA") goal date of November 30, 2022, for the completion of its priority review of the OMBLASTYS BLA.

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"We look forward to the October 28, 2022 meeting with the Advisory Committee, as well as to continuing our dialogue with the FDA about OMBLASTYS and the important data, which we believe supports approval," said Thomas Gad, President, and Interim Chief Executive Officer. "This is another key step towards providing a potential treatment for pediatric patients with CNS/leptomeningeal metastasis from neuroblastoma."

Researchers at Memorial Sloan Kettering Cancer Center ("MSK") developed omburtamab, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound.