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BERG to Present Latest Research to Improve Pancreatic Treatment at The European Society for Medical Oncology (ESMO) 2021 Congress

On September 16, 2021 BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments, reported its participation at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress, from September 16-21, 2021 (Press release, Berg, SEP 16, 2021, View Source [SID1234587852]). At the event, the company will unveil its most recent medical and clinical research developments for pancreatic ductal adenocarcinoma (PDAC) as part of its Project Survival longitudinal prospective clinical trial with Beth Israel Deaconess Medical Center (BIDMC), a research and teaching affiliate of Harvard Medical School (HMS).

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The presentation entitled "Identification of Novel Protein Biomarkers for FOLFIRINOX- Based Chemotherapy Response in Advanced Pancreatic Adenocarcinoma Using Patient Omics and Bayesian AI" is a coordinated effort based on BERG’s prospective pancreatic cancer biomarker and precision medicine program, as well as its Phase 2 Pancreatic cancer therapeutic program involving BPM 31510. As part of the research, BERG’s Interrogative Biology platform was used to identify relationships between patients receiving FOLFIRINOX chemotherapy treatment as well as additional therapies to identify biomarkers indicating overall survival.

"This multidisciplinary collaboration is an important step on the road to personalized treatment for pancreatic cancer," said Dr. A. James Moser, Co-Director of the Pancreas and Liver Institute at BIDMC, and Professor of Surgery at HMS. "This protein biomarker panel is a promising tool in the fight against this dreadful disease and may change the way chemotherapy is prescribed for patients around the world."

The research cohort was comprised of data accumulated from over 450 patients who were molecularly profiled to identify innovative biomarkers for the treatment and stratification of patients with pancreatic cancer.

"Understanding the biology of PDAC patients will be critical in increasing life expectancy for one of the most common and devastating types of pancreatic cancer," said Dr. Niven R. Narain, BERG Co-founder, President and Chief Executive Officer. "At BERG, we are committed to continuing to do the hard work to improve the quality of life, treatment, and patient stratification for those inflicted with pancreatic cancer. This week’s presentation is just the next step in our journey as we work to transform the treatment of this disease."

Pancreatic Cancer is the third leading cause of death of all cancers with only a 10% survival rate. Lack of early detection often leads to advanced diagnosis in most cases, resulting in devasting impacts on the family unit.

"Losing my father to this devastating disease put a fire in me to work tirelessly to help support research for early diagnoses and treatment after experiencing the effect of pancreatic cancer. BERG has led a bold conquest to use leading-edge technology to create both diagnostic and therapeutic approaches to improve the lives of patients and families. The partnership led by BERG and BIDMC has been the most forward-thinking collaboration in this area of medicine, it provides hopes and real solutions", said Kendra Bahneman Haywood, Executive Director, Alliance of Families Fighting Pancreatic Cancer (AFFPC).

Presentation Details:

Presentation Title

Poster
Display
Session
Number

Presenter

On-Demand

E-Poster Display
Dates

Identification Of Novel Protein
Biomarkers For FOLFIRINOX-Based
Chemotherapy Response In
Advanced Pancreatic Adenocarcinoma
Using Patient Omics And Bayesian AI

1485P

A.J. Moser

September 16-21,
2021

The Abstract is available online, and the Poster will be available to registered ESMO (Free ESMO Whitepaper) 2021 Congress attendees starting Thursday, September 16th.

Valo Health to Participate at the BofA Securities 2021 Virtual Tech Solutions for Drug Discovery Conference

On September 16, 2021 Valo Health, LLC ("Valo"), the technology company built to transform the drug discovery and development process using human-centric data and artificial intelligence driven compute, reported that its CEO and founder, David Berry, is participating on the "Tech Solutions: a Biotech Perspective" panel at the BofA Securities 2021 Virtual Tech Solutions for Drug Discovery Conference on September 20, 2021 at 9:00 AM Eastern Time (Press release, Valo Health, SEP 16, 2021, View Source [SID1234587851]).

The presentation will be webcast live and available for replay on the investor relations page of the Valo website.

Johnson & Johnson to Host Investor Conference Call on Third-Quarter Results

On September 16, 2021 Johnson & Johnson (NYSE: JNJ) reported that it will host a conference call for investors at 8:30 a.m. (Eastern Time) on Tuesday, October 19th to review third-quarter results (Press release, Johnson & Johnson, SEP 16, 2021, View Source;johnson-to-host-investor-conference-call-on-third-quarter-results-301379173.html [SID1234587850]). Joseph J. Wolk, Executive Vice President and Chief Financial Officer will host the call. The question and answer portion of the call will also include: Ashley McEvoy, Executive Vice President, Worldwide Chairman, Medical Devices; Jennifer Taubert, Executive Vice President, Worldwide Chairman Pharmaceuticals and Thibaut Mongon, Executive Vice President Worldwide Chairman, Consumer Health.

Investors and other interested parties can access the webcast/conference call in the following ways:

The webcast and presentation material are accessible at Johnson & Johnson’s website www.investor.jnj.com. A replay of the webcast will be available approximately three hours after the conference call concludes.
By telephone: for both "listen-only" participants and those financial analysts who wish to take part in the question-and-answer portion of the call, the telephone dial-in number in the U.S. is 877-869-3847. For participants outside the U.S., the dial-in number is 201-689-8261.
A replay of the conference call will be available until approximately 12:00 a.m. on November 2nd. The replay dial-in number for U.S. participants is 877-660-6853. For participants outside the U.S., the replay dial-in number is 201-612-7415. The replay conference ID number for all callers is 13722724.
The press release will be available at approximately 6:45 a.m. (Eastern Time) the morning of the conference call.
Please refer to www.investor.jnj.com for a complete list of currently planned earnings webcast/conference calls. Please note the four-quarter date of Tuesday, January 25th, 2022.

Bridge Biotherapeutics Presents Pre-Clinical Data of BBT-176 at the European Society for Medical Oncology (ESMO) Virtual Congress 2021

On September 16, 2021 Bridge Biotherapeutics (KQ288330), a clinical-stage biotech company, reported that an ePoster presenting pre-clinical data of BBT-176,[1] will be presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (ePoster identifier:1365TiP) (Press release, Bridge Biotherapeutics, SEP 16, 2021, View Source [SID1234587849]).

At the virtual event, the pre-clinical data and the trial design of the ongoing phase 1/2 clinical study for BBT-176 in non-small cell lung cancer (NSCLC) patients will be presented via an ePoster.

BBT-176, which is currently in the dose escalation phase of the phase 1/2 study, was designed to inhibit the signaling pathway of epidermal growth factor receptors (EGFR) with C797S triple mutations acquired after progression on third-generation EGFR inhibitors such as osimertinib.

The in vitro data from engineered Ba/F3 cells and the in vivo data from patient-derived xenografts confirmed that BBT-176 is efficacious in NSCLC with C797S EGFR mutations. As can be seen from the presented in vitro assay, compared to osimertinib, BBT-176 is potent against EGFR double mutations such as Del19/C797S (DC) and L858R/C797S (LC) as well as triple mutations such as Del19/T790M/C797S (DTC) and L858R/T790M/C797S (LTC). Also, a dose-dependent anti-tumor effect has been confirmed in patient-derived cell (PDC)-xenograft mice models harboring Del19/T790M/C797S (DTC) triple mutations.

In addition, BBT-176 showed in vivo efficacy leading to brain metastases inhibition in triple-mutant mice models, using the IVIS imaging platform. The brain metastases are found in approximately 20% of patients with stage IV NSCLC.

Encouraged by the non-clinical data demonstrating tumor regression efficacy in NSCLC with EGFR mutations, the first-in-human (FIH) study of BBT-176 was designed and patient dosing began in April 2021 under the IND of the U.S. and the Republic of Korea. Additional clinical trial sites in the U.S. to evaluate the efficacy and safety in diversified racial and ethnic groups particularly Caucasian patients are expected to open by the end of this year.

Once the maximum tolerated dose (MTD) and the recommended phase 2 dose (RP2D) are determined, the company will initiate enrollment for the dose expansion cohort in the U.S. and the Republic of Korea. In parallel with the clinical development of BBT-176, the company will also continue to expand its NSCLC solutions, utilizing precision medicine accompanied by companion diagnostic devices.

"We are proud to present the exploratory efficacy data from our pre-clinical studies for BBT-176, our first-ever oncology pipeline, to both European and international oncologists," and "by accelerating our development of 4th generation EGFR TKIs, we will try our best to address the unmet medical needs of patients with NSCLC," stated Dr. Sang Yoon Lee, Chief Medical Officer of Bridge biotherapeutics.

The copy of the ePoster presented at the ESMO (Free ESMO Whitepaper) 2021 is available at: https://bit.ly/2YLgsw4.

Innovent Releases Phase 2 Results of Pemigatinib in Chinese Patients with Advanced Cholangiocarcinoma at ESMO Congress 2021

On September 16, 2021 Innovent Biologics, Inc. ("Innovent", HKEX: 01801), a world-class biopharmaceutical company that develops, manufactures and commercializes high-quality medicines for the treatment of cancer, metabolic, autoimmune and other major diseases, reported that the results of the Phase 2 study in Chinese patients with advanced cholangiocarcinoma were released today at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Congress 2021 (E-poster # 50P) (Press release, Innovent Biologics, SEP 16, 2021, View Source [SID1234587848]).

This study, which is a bridging study of the FIGHT-202, is a Phase 2, open-label, multi-center, single-arm study to evaluate the efficacy and safety of pemigatinib – a selective fibroblast growth factor receptor (FGFR) inhibitor – in Chinese patients with unresectable, advanced/recurrent or metastatic cholangiocarcinoma(CCA) with FGFR2 fusion/rearrangement that failed to prior systemic therapy. As of Jan 29, 2021, the data cutoff date, 3 subjects were enrolled and treated at 9mg pemigatinib in stage 1 to evaluate pharmacokinetic (PK) in Chinese population. The other 31 subjects with documented FGFR2 fusion or arrangement were enrolled in stage 2 and received 13.5mg pemigatinib. Subjects in both stages were orally given pemigatinib QD on a 2 weeks on/1 week off schedule until disease progression, unacceptable toxicity, withdrawal of consent, or physician decision. The primary endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST V1.1 in 31 patients enrolled in stage 2. 30 subjects in stage 2 were included in the efficacy evaluable population with 1 participant excluded due to inadequate FGFR2 aberrant frequency. Among 30 efficacy evaluable subjects, 15 of them had confirmed response assessed by IRRC, with an ORR of 50% (95%CI: 31.3%，68.7%). With a median follow up of 5.13 months, 13 patients were still in response, the median DOR was not reached (95%CI: 3.4, NR). As of the data cut off date, progression free survival (PFS) data remained immature as it was only observed in 6 patients, the disease control rate (DCR) was 100% (95%CI: 88.4%, 100%).

All 34 subjects in both stages were included for safety analysis. As of data cutoff date, each subject experienced at least 1 treatment-related adverse event(TRAE), the most common TRAE were hyperphosphatemia(73.5%), xerostomia(55.9%) and alopecia(50.0%), and 14.7% had grade 3 or higher TRAEs. Three participants had SAEs, which were rectal polyps, abnormal liver function and bile duct infection. There was no treatment discontinuation and deaths due to TRAE.

The principal investigator, Prof. Jian Zhou, from Fudan University Zhongshan Hospital, stated, "Intrahepatic Cholangiocarcinoma is the second most common type of cancer originated from liver. For advanced disease, the first line recommended therapy is gemcitabine plus cisplatin with an ORR of 26% and median overall survival (mOS) of 11.7 month, whose limited efficacy needs to be improved. For patients who failed the first line therapy, ASC+mFOLFOX will be administrated with an mOS of 5-6 months. There is an urgent need in drugs that can vastly change the landscape of treatment for intrahepatic cholangiocarcinoma. FGFR2 fusion/rearrangement is the most common FGFR alteration in intrahepatic cholangiocarcinoma, which is usually accompanied with more rapidly growth status. Pemigatinib is a selective FGFR1/2/3 inhibitor and has been proved with an positive efficacy and tolerable safety profile in studies conducted outside of China. This bridging study was aiming at evaluating the efficacy and safety in Chinese intrahepatic cholangiocarcinima patients. With this result of meeting a primary end point, I hope pemigatinib will provide a new and better therapy option for patients with intrahepatic cholangiocaricinoma once approved."

Dr. Hui Zhou, Senior Vice President of Innovent, stated "Innovent has multiple clinical trials of pemigatinib for the treatment of cholangiocarcinoma and other types of tumors. Currently our New Drug Application (NDA) of pemigatinib to National Medical Products Administration（NMPA）in China has been accepted and pemigatinb was approved in Taiwan market in June, earlier this year. The data presented at the ESMO (Free ESMO Whitepaper) Annual Meeting indicated that pemigatinib was highly effective and tolerable in Chinese patients with recurrent or metastatic CCA with FGFR2 fusion/rearrangement. In the future, we will conduct in-depth clinical development of pemigatnib to explore potential treatments in other indications. We are looking forward to providing novel therapies for more cancer patients in the future."

About Advanced Cholangiocarcinoma and FGFR2 Rearrangement

Cholangiocarcinoma is a malignant tumor originated from biliary epithelium cells and it is categorized as intrahepatic or extrahepatic based on anatomical location of origin. The incidence of cholangiocarcinoma has been increasing progressively over the past decade. Surgery is the first priority for patients with resectable disease. However, most cholangiocarcinomas patients have been in advanced and/or metastatic status at diagnosis and lost the chance for surgical resection. The treatment options for patient who relapse after surgery or have advanced or metastatic disease are limited and the recommended therapy method is systemic chemotherapy with gemicitabine plus cisplatin, which has a medium overall survival of less than a year.

Aberrant signaling through FGFR resulting from gene amplification or mutation, chromosomal translocation, and ligand-dependent activation of the receptors has been demonstrated in multiple types of human cancers. Fibroblast growth factor receptor signaling contributes to the development of malignancies by promoting tumor cell proliferation, survival, migration, and angiogenesis. Results from early clinical studies of selective FGFR inhibitors, including Pemazyre, have shown a tolerable safety profile for the class and preliminary signs of clinical benefit in participants with FGF/FGFR alterations.

About Pemazyre (pemigatinib)

In April 2020, the U.S. Food and Drug Administration (FDA) approved Incyte’s Pemazyre (pemigatinib), a selective, oral inhibitor of FGFR isoforms 1, 2 and 3, for the treatment of adults with previously treated, unresectable locally advanced or metastatic cholangiocarcinoma with a fibroblast growth factor receptor 2 (FGFR2) fusion or rearrangement as detected by an FDA-approved test. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

In Japan, Pemazyre is approved for the treatment of patients with unresectable biliary tract cancer with a FGFR2 fusion gene, worsening after cancer chemotherapy. In Europe, Pemazyre is approved for the treatment of adults with locally advanced or metastatic cholangiocarcinoma with a FGFR2 fusion or rearrangement that have progressed after at least one prior line of systemic therapy. Pemazyre is marketed by Incyte in the United States, Europe and Japan.

In December 2018, Innovent and Incyte entered into a strategic collaboration for three clinical-stage product candidates discovered and developed by Incyte, including pemigatinib (FGFR1/2/3 inhibitor). Under the terms of the agreement, Innovent has received the rights to develop and commercialize the three assets in Mainland China, Hong Kong, Macau and Taiwan.

Pemazyre is a trademark of Incyte Corporation.