On November 25, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, reported preliminary clinical data from a Phase 2 clinical trial of its investigational anti-PD-1 antibody tislelizumab in combination with chemotherapy in patients with gastric/ gastroesophageal junction (G/GEJ) adenocarcinoma or esophageal squamous cell carcinoma (ESCC) that were presented in a poster at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Asia 2019 Congress in Singapore (Press release, BeiGene, NOV 25, 2019, View Source [SID1234551647]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

"In this trial, the combination treatment of tislelizumab and chemotherapy demonstrated durable responses and was generally well-tolerated in patients with G/GEJ adenocarcinoma or ESCC," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "Gastric cancer and esophageal cancer are among the most common cancer types worldwide, representing a high unmet need, particularly in China. We are excited to continue the late-stage development of tislelizumab in these and other highly prevalent cancers in Asia."

Updated Results of Tislelizumab in Combination with Chemotherapy in Patients with G/GEJ Adenocarcinoma or ESCC
Poster 128P

This open-label, multi-center Phase 2 trial (NCT03469557) of tislelizumab in combination with standard chemotherapy as a potential first-line treatment is being conducted in China and consists of one cohort of patients with G/GEJ adenocarcinoma and one cohort of patients with ESCC.

As of March 31, 2019, a total of 30 patients were enrolled in the trial, including 15 with G/GEJ adenocarcinoma and 15 with ESCC. Patients with G/GEJ adenocarcinoma were treated with tislelizumab at a dose of 200 mg and oxaliplatin on day one, and capecitabine twice daily on day one through 15 during each 21-day cycle. Patients with ESCC were treated with tislelizumab at a dose of 200 mg and cisplatin on day one, and fluorouracil (5-FU) on days one through five during each 21-day cycle.
At the time of data cutoff, eight patients remained on treatment, including four with G/GEJ adenocarcinoma and four with ESCC. Results included:

esmoasiapressrelease1_image1.jpg

As of data cutoff, seven patients (46.7%) with G/GEJ adenocarcinoma achieved a confirmed partial response (PR), and the objective response rate (ORR) (consisting of the aggregate of complete responses and PRs) in this cohort was 46.7%. In the cohort of patients with ESCC, seven patients (46.7%) achieved a confirmed PR, and the ORR in this cohort was 46.7%;

Median duration of response (DoR) was not mature in the G/GEJ adenocarcinoma cohort; median DoR was estimated as 12.8 months in the ESCC cohort;

Median progression-free survival (PFS) was 6.1 months and 10.4 months in the G/GEJ adenocarcinoma and ESCC cohorts, respectively;

Despite the long median follow up in both the G/GEJ adenocarcinoma cohort (15.4 months) and ESCC cohort (13.0 months), median overall survival (OS) had not been reached; in the G/GEJ adenocarcinoma cohort, the OS rate was 85% at six months and 62% at 12 months; in the ESCC cohort, the OS rate was 71% at six months and 50% at 12 months;

Treatment with tislelizumab in combination with the standard first-line chemotherapy was generally well tolerated in patients with G/GEJ adenocarcinoma and ESCC. Adverse events (AEs) reported were consistent with the known tolerability profile of PD-1 inhibitors in combination with chemotherapy;

Treatment-emergent adverse events (TEAEs) occurred in all patients and most TEAEs were mild or moderate in severity;

The most common TEAEs (≥ 40%) of any grade in all patients were anemia (60%), decreased appetite (56.7%), nausea (53.3%), asthenia (50%), leukopenia (43.3%), vomiting (43.3%), decreased neutrophil count (40%), and decreased platelet count (40%);

Grade 3-4 TEAEs occurred in 11 patients (G/GEJ adenocarcinoma, n=6; ESCC, n=5), with the most common being vomiting (16.7%), hyponatremia (13.3%), and increased aspartate aminotransferase (AST), decreased weight, decreased appetite, hypokalemia, anemia, leukopenia, neutropenia, and thrombocytopenia (one patient each);

Serious adverse events (SAEs) were reported in 13 patients (G/GEJ adenocarcinoma, n=5; ESCC, n=8); serious TEAEs reported in ≥2 patients in

esmoasiapressrelease1_image1.jpg

either cohort were increased blood bilirubin (G/GEJ adenocarcinoma, n=2), dysphagia (ESCC, n=3), and fatigue (ESCC, n=2); and

One patient with ESCC experienced a fatal AE of hepatic dysfunction mainly attributed to progressive disease, which may possibly have been related to study treatment or confounded by underlying HBV infection.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric / gastroesophageal junction (G/GEJ) cancer a Phase 3 clinical trial in first-line patients with ESCC; and a Phase 2 clinical trial in second- or third-line patients with HCC. The aforementioned trials are enrolling patients in multiple countries, including the United States, Europe, and China.

In addition to a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL) and a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic urothelial cancer, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with first-line nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a Phase 3 clinical trial in patients with localized ESCC; and a Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies have been enrolling patients primarily in China.

esmoasiapressrelease1_image1.jpg

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted and granted priority review by the China National Medical Products Administration (NMPA, formerly known as CFDA). BeiGene has full development and commercial rights to tislelizumab worldwide.

On November 25, 2019 LaVoieHealthScience (LHS), an integrated investor and public relations consulting agency focused on advancing health and science innovations, reported it is hosting a breakfast panel featuring senior health and investment executives titled, An Unvarnished Look at J.P. Morgan Week 2020, from 8:30 to 10:30 a.m. on Thursday, Dec. 19, 2019 at the Royal Sonesta in Cambridge, MA (Press release, LaVoieHealthScience, NOV 25, 2019, View Source;utm_medium=rss&utm_campaign=lhs-unvarnished-look-jpm-2020-panel [SID1234551646]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The panel is designed for CXOs, senior BD and communications executives at health companies to prepare them for and provide insights into the collection of biotech conferences held during the week of the J.P. Morgan 38th Annual Healthcare Conference, Jan. 12-16 in San Francisco. Panelists will examine the value of attending JPM Week, sharing in-depth insights based on personal experience.

Moderated by Donna LaVoie, President and CEO of LHS, the panel includes industry leaders:

Chris Garabedian, Chairman and CEO, Xontogeny, and Portfolio Manager, Venture for Perceptive Advisors
Daphne Zohar, Founder and CEO, PureTech Health
Milenko Cicmil, VP, Global Head of External Innovation & Partnering, Ipsen
Jon Civitarese, Managing Director, Investment Banking, SVB Leerink LLC
Topics to be discussed include:

The evolution of the J.P. Morgan Healthcare Conference
JPM Week 101: Who goes and why?
Is attending worth your company’s time and expense?
What is the value for large pharma companies versus smaller, private companies?
What is the best way to leverage JPM Week to tell an investable story that builds value?
Is it a good time to announce news? What kind of news matters?
Registration, breakfast and networking begin at 8:30 a.m., the panel discussion begins at 9 a.m. and a Q&A session will follow from 10 to 10:30 a.m.

On November 25, 2019 DelMar Pharmaceuticals, Inc. (Nasdaq: DMPI) ("DelMar" or the "Company"), a biopharmaceutical company focused on the development of new solid tumor cancer therapies, reported interim data on its two Phase 2 trials of VAL-083, the Company’s lead compound for the treatment of glioblastoma multiforme (GBM) (Press release, DelMar Pharmaceuticals, NOV 25, 2019, View Source [SID1234551645]). The data were presented in two posters at the 2019 Society for NeuroOncology Annual Meeting in Phoenix, Ariz.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

First-Line GBM

The first poster outlined the open-label, Phase 2 study of VAL-083 as a first-line treatment in newly-diagnosed, unmethylated GBM patients. This study has enrolled 23 out of a planned 30 patients as of the data cut-off date of November 2, 2019. For the 22 patients who had completed at least one cycle of treatment as of that date, median progression-free survival (PFS) with VAL-083 is currently 9.9 months (confidence interval, or CI 7.3-12.0 months). For the 18 patients initially receiving the intended treatment dose (30 mg/m2/day on days 1, 2 and 3 of a 21-day cycle) median PFS is currently 10.4 months (CI 6.0-12.0 months). While this is not a head-to-head trial, historically, temozolomide (TMZ) has been demonstrated to have 6.9 months PFS in unmethylated GBM patients. Other doses were also examined as part of the dose escalation aspect of the study, and all but the 20 mg/m2/day dose also demonstrated superior PFS to the historical comparator. A median of eight cycles of treatment has been received by all patients who had either completed treatment or remain in active treatment. Nine patients have received more than 10 cycles. This study is being conducted at Sun Yat-sen University Cancer Center in China.

Recurrent GBM

The second poster outlined interim data from two groups of patients receiving VAL-083 in the open-label, Phase 2 study in recurrent and adjuvant unmethylated GBM settings. The recurrent group is receiving second-line therapy with VAL-083 following TMZ failure. Sixty-two patients (out of a planned 83) have been enrolled as of the data cut-off of November 15, 2019, with 35 patients having received an initial dose of 40 mg/m2/day and 27 (out of a planned 48) having received an initial dose of 30 mg/m2/day (on days 1, 2 and 3 of a 21-day cycle). Median overall survival (mOS) for the 60 patients who have completed at least one cycle of treatment is currently 7.5 months (CI 6.0-11.5 months). For the 25 of those patients who initially received the intended treatment dose of 30 mg/m2/day, mOS is currently 10.6 months (CI 5.8-10.6 months). While this is not a head-to-head trial, historically lomustine, which is the most commonly used chemotherapy for these patients, has demonstrated a mOS of 7.2 months.

The second arm of this study, in which patients receive VAL-083 as adjuvant therapy following treatment with radiation and TMZ, was initiated in July 2019. As of the data cut-off of November 15, 2019, five patients (out of a planned 20) have been enrolled and all patients remain alive on continued therapy. The study in recurrent and adjuvant GBM is being conducted at M.D. Anderson Cancer Center in Houston, Tex.

Similar to prior experience with VAL-083, myelosuppression has been the most common adverse event observed. Four subjects have experienced a serious adverse event (SAE) possibly related to VAL-083 in the newly-diagnosed group, eleven subjects have experienced a possibly drug-related SAE in the recurrent group, and no patients have experienced a possibly drug-related SAE in the adjuvant group as of the relevant data cut-off dates.

During a review of the data, which was conducted at the SNO conference, Dr. David Reardon, clinical director of the Center for Neuro-Oncology at the Dana-Farber Cancer Institute, Professor of Medicine at the Harvard Medical School and member of DelMar’s Scientific Advisory Board stated, "Putting it into the perspective of what has benefitted our patients historically, which has been a cytotoxic treatment approach like Delmar’s VAL-083, we have had other classes of anticancer therapies that have unfortunately been quite disappointing. So, with VAL-083 we have a mechanism of action that has a proven track record and a rationale for why it may be superior to what we have currently. All of those factors explain why it has been challenging to move the bar in this disease. That said, I think there is some reason to be hopeful that this has a likelihood of further confirming the signals we have seen so far."

Dr. Nick Butowski, director of translational research in neuro-oncology and a researcher at the Brain Tumor Center and also a member of DelMar’s Scientific Advisory Board added, "Upon reviewing the analysis from both studies, mechanistically, survival data-wise, imaging-wise, quality of life and safety data are all very intriguing and exciting. Obviously, we need to see the completed data and then move on to the next steps."

Saiid Zarrabian, CEO of DelMar Pharmaceuticals stated: "We continue to be encouraged with the interim outcomes for both of our ongoing Phase 2 trials of VAL-083 in GBM. Our first-line treatment study continues to show outstanding results and we are particularly pleased to see VAL-083 at the 30 mg dose currently showing a full three months longer progression-free survival. This represents a PFS improvement of around 50% over temozolomide, the current standard of care. We are also encouraged by the 30 mg dose in the recurrent patient cohort, currently showing an improvement to median overall survival of more than three months, or approximately 47%, over historical published results from the current standard of care. We look forward to providing subsequent updates in 2020 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) and American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) conferences."

The Company’s current cash resources are expected to be sufficient to fund the Company’s planned operations into the fourth quarter of calendar year 2020, and to allow for funding to top-line results for our newly-diagnosed and recurrent setting studies, and for full enrollment for the adjuvant study arm patients.

On November 25, 2019 Innovation Pharmaceuticals (OTCQB:IPIX) ("the Company"), a clinical stage pharmaceutical company, is reported to inform shareholders the Company received notification from the Food and Drug Administration (FDA) that a waiver has been granted eliminating the need to study Brilacidin, for the prevention of Severe Oral Mucositis in Head and Neck Cancer (HNC) patients receiving chemoradiation, in pediatric populations (Press release, Innovation Pharmaceuticals, NOV 25, 2019, View Source [SID1234551644]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

The granting of this waiver now enables the Company to develop Brilacidin in a more focused manner in adult patient populations where Oral Mucositis has the greatest impact.

In other news, the Company will provide shortly an update on continuing clinical development of Brilacidin for Inflammatory Bowel Disease, including the status of planned clinical work in Ulcerative Proctitis/Ulcerative Proctosigmoiditis.

On November 25, 2019 Onconova Therapeutics reported the closing of its previously announced public offering of an aggregate of 55,000,000 shares of Onconova’s common stock (or common stock equivalents), together with accompanying common stock warrants, at a public offering price of $0.20 per share and associated warrant (Press release, Onconova, NOV 25, 2019, View Source [SID1234551643]). Each share of common stock (or common stock equivalent) was sold in the offering together with a common stock warrant to purchase one share of common stock at an exercise price of $0.20 per share. The common stock warrants are exercisable immediately and will expire five years from the date of issuance. The offering was led by healthcare dedicated funds, including Knight Therapeutics Inc., along with officers and directors of Onconova.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

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

                  Schedule Your 30 min Free Demo!

H.C. Wainwright & Co. acted as exclusive placement agent for the offering.

The gross proceeds to Onconova from this offering are $11.0 million, before deducting the placement agent’s fees and other estimated offering expenses payable by Onconova, and assuming none of the warrants issued in this offering are exercised.

Onconova anticipates using the net proceeds from the offering to fund the development of its clinical and preclinical programs, for other research and development activities and for general corporate purposes, which may include capital expenditures and funding working capital needs.

The securities described above were offered by Onconova pursuant to a registration statement (File No. 333-234360) previously filed with and declared effective by the Securities and Exchange Commission (the "SEC") on November 21, 2019. A prospectus relating to the securities offered was filed with the SEC on November 25, 2019 and is available on the SEC’s website at View Source Electronic copies of the final prospectus relating to the offering may be obtained by contacting H.C. Wainwright & Co., LLC, 430 Park Avenue, 3rd Floor, New York, NY 10022, by calling (646) 975-6996 or by emailing [email protected] or at the SEC’s website at View Source