On September 6, 2018 Pfizer Inc. reported its invites investors and the general public to listen to a webcast of a discussion with Frank D’Amelio, Executive Vice President, Business Operations, and Chief Financial Officer, at the Morgan Stanley 16th Annual Global Healthcare Conference on Thursday, September 13, 2018 at 2:55 p.m. Eastern Daylight Time (Press release, Pfizer, SEP 6, 2018, View Source [SID1234529428]).

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!

To listen to the webcast, visit our web site at www.pfizer.com/investors. Information on accessing and pre -registering for the webcast will be available at www.pfizer.com/investors beginning today.

Visitors will be able to listen to an archived copy of the webcast at www.pfizer.com/investors.

On September 6, 2018 Checkpoint Therapeutics, Inc. ("Checkpoint") (NASDAQ: CKPT), a clinical-stage immuno-oncology biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for patients with solid tumor cancers, reported positive preliminary safety and efficacy data from an ongoing Phase 1/2 clinical trial of CK-101 (also known as RX518), a third-generation epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor (TKI) being evaluated in advanced non-small cell lung cancer (NSCLC) (Press release, Checkpoint Therapeutics, SEP 6, 2018, View Source [SID1234529736]). The data will be presented on Monday, Sept. 24, at 10:30 a.m. ET in a late-breaking oral presentation at the International Association for the Study of Lung Cancer (IASLC) 19th World Conference on Lung Cancer in Toronto.

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!

"These preliminary data demonstrate CK-101 is well-tolerated at the doses tested while also demonstrating encouraging anti-tumor activity, particularly in treatment-naïve EGFR mutation-positive lung cancer patients," said Melissa L. Johnson, M.D., Associate Director, Lung Cancer Research, Sarah Cannon Research Institute at Tennessee Oncology, PLLC, and study chair of the Phase 1/2 trial.

"The data to date demonstrate CK-101’s potential to be a highly effective mutant-selective EGFR inhibitor with the potential for a differentiated safety profile," said James F. Oliviero, President and Chief Executive Officer of Checkpoint Therapeutics. "We look forward to continuing to advance CK-101 towards a pivotal Phase 3 trial next year, positioning CK-101 to potentially be only the second third-generation EGFR inhibitor to enter the market."

The first-in-human, multicenter trial is evaluating CK-101 in NSCLC patients with EGFR mutations and other advanced malignancies (NCT02926768). Following dose escalation ranging from 100 mg to 1,200 mg/day in patients with any solid tumor where targeted EGFR was deemed reasonable, a first doseexpansion cohort was enrolled at 400 mg twice daily in patients with a confirmed diagnosis of either (1) EGFR mutation-positive advanced or metastatic NSCLC without prior exposure to EGFR-TKI therapy, or (2) T790M-positive advanced or metastatic NSCLC with disease progression on previous EGFR-TKI therapy. There was no limit on the number of prior lines of systemic therapy patients received prior to entering the study.

Key Data from the Abstract
As of June 2018, 37 patients had been treated with CK-101 in dose escalation and dose-expansion cohorts
and were evaluable for safety.
• No dose limiting toxicities (DLTs) or treatment
• The most common drug-related treatment-emergent adverse events (>10%) included nausea
(16%), diarrhea (14%), lacrimation increased (14%) and vomiting (11%).
In dose-expansion, 19 EGFR mutation-positive NSCLC patients were treated with CK-101 at a dose of 400
mg twice daily and were evaluable for response (RECIST v1.1). Eight patients achieved a partial response
(7 confirmed, 1 pending). Additional efficacy findings include:
• In eight treatment-naïve patients, six patients (75%) achieved a partial response.
• In six patients with brain metastases present at baseline, three patients achieved a partial
response.
• Higher drug exposures were associated with a higher response rate with a confirmed objective
response rate (ORR) of 55% (6/11) in patients achieving a maximum serum concentration (Cmax)
greater than 400 ng/mL.
• 100% (19/19) disease control rate was observed, with 84% (16/19) of patients experiencing target
lesion reduction versus baseline.
• Median duration of response and progression-free survival were not reached as of the data cutoff.
Enrollment in the trial is ongoing to identify the optimal dose to maximize therapeutic effect.

Oral Presentation
Details of the oral presentation at the IASLC 19th World Conference on Lung Cancer are as follows:
Title: CK-101 (RX518), a Third Generation Mutant-Selective Inhibitor of EGFR in NSCLC: Results of
an Ongoing Phase I/II Trial
Date / Time: Monday, Sept. 24, 2018 at 10:30am
Session: Novel Therapies in ROS1, HER2 and EGFR
Presenter: Melissa L. Johnson, M.D., Associate Director, Lung Cancer Research, Sarah Cannon
Research Institute at Tennessee Oncology, Nashville, Tenn.

The full abstract can be found on the conference website and is also available on the Publications page in
the Pipeline section of Checkpoint’s website, www.checkpointtx.com.

About CK-101
CK-101 (also known as RX518) is an oral, third-generation, irreversible kinase inhibitor against selective mutations in the EGFR gene. Activating mutations in the tyrosine kinase domain of EGFR, such as L858R and exon 19 deletion, are found in approximately 20 percent of patients with advanced non-small cell lung cancer (NSCLC).

Compared to chemotherapy, first-generation EGFR inhibitors significantly improved objective response rate and progression-free survival in previously untreated NSCLC patients carrying EGFR mutations. However, tumor progression could develop due to resistance mutations, often within months of treatment with first-generation EGFR inhibitors. The EGFR T790M "gatekeeper" mutation is the most common resistance mutation found in patients treated with first-generation EGFR inhibitors. The mutation decreases the affinity of first-generation inhibitors to EGFR kinase domain, rendering the drugs ineffective. Second-generation EGFR inhibitors have improved potency against the T790M mutation, but have not provided meaningful benefits in NSCLC patients due to toxicity from also inhibiting wild-type EGFR. Third-generation EGFR inhibitors are designed to be highly selective against both EGFR-TKIsensitizing and resistance mutations, with minimal activity on wild-type EGFR, thereby improving tolerability and safety profiles.

Checkpoint Therapeutics is developing CK-101 for the treatment of NSCLC patients carrying the susceptible EGFR mutations. These include the EGFR T790M mutation in second-line NSCLC patients, as well as the EGFR L858R and exon 19 deletion mutations in first-line NSCLC patients. Checkpoint holds an exclusive worldwide license (except with respect to certain Asian countries) to CK‐101, which it acquired from NeuPharma, Inc., in 2015.

On September 6, 2018 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB), a Shanghai-based innovative biopharmaceutical company, reported the pricing of its underwritten public offering of $150,000,000 of American Depositary Shares ("ADSs") representing ordinary shares of the Company (Press release, Zai Laboratory, SEP 6, 2018, View Source;p=RssLanding&cat=news&id=2366260 [SID1234530327]).

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!

Zai Lab sold 7,500,000 ADSs at a price of US$20.00 per ADS. Each ADS represents one ordinary share of Zai Lab. The gross proceeds to Zai Lab from the offering, before deducting underwriting discounts and commissions and other offering expenses, are expected to be approximately $150,000,000. In addition, Zai Lab has granted the underwriters a 30-day option to purchase up to an additional 1,125,000 ADSs at the public offering price, less underwriting discounts and commissions. The offering is expected to close on September 10, 2018, subject to customary closing conditions.

J.P. Morgan, Citigroup, Jefferies and Leerink Partners are acting as joint book-running managers for the offering.

A registration statement on Form F-1 relating to the securities sold in this offering has been filed with, and declared effective by, the U.S. Securities and Exchange Commission. Copies of the registration statement related to this offering can be accessed through the SEC’s website at www.sec.gov.

This offering is being made only by means of a prospectus. A final prospectus, when available, may be obtained from: (i) J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: 1-866-803-9204 or email: [email protected], (ii) Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or telephone: 1-800-831-9146 (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 1-877-821-7388, or by email at [email protected] or (iv) Leerink Partners LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, telephone: 1-800-808-7525 ex. 6132 or email: [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs or any other securities, nor shall there be any sale of ADSs in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On September 6, 2018 Twentyeight-Seven Therapeutics (28-7), a biotechnology company focused on modulating non-coding RNA (ncRNA) biology to develop treatments for cancer and other diseases, reported the successful completion of its $65 million Series A financing (Press release, Twentyeight-Seven Therapeutics, SEPT 6, 2018, View Source [SID1234529351]). Founding investor MPM Capital and Novartis Venture Fund co-led the financing. They were joined by additional investors including Johnson & Johnson Innovation – JJDC, Inc., Vertex Ventures HC, Longwood Fund, and Astellas Venture Management. The funding will be used to advance 28-7’s lead program, aimed at the discovery and development of small molecules that increase the levels of the tumor suppressor microRNA (miRNA), Let-7, into serious cancer indications.

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!

"This strong financing round was achieved thanks to the new biological understanding and impressive scientific data around non-coding RNA produced by our four scientific founders and the progress the 28-7 team has made since it was founded two years ago," said Kazumi Shiosaki, Ph.D., founding President and Chief Executive Officer, 28-7. "Our experienced investors realize the promise in this new field of therapeutics and in the robust leads produced by our founders, who have made many of the seminal discoveries in this field, and by the exceptional scientists within the company."

In addition, 28-7 announced that Shomir Ghosh, Ph.D., has joined as its Chief Scientific Officer. Most recently CSO and a founding scientist at IFM Therapeutics, Dr. Ghosh has 25 years of scientific research, drug discovery and development experience in biotech and large pharma, and has successfully delivered multiple compounds into preclinical and clinical development in the immunology, oncology and CNS therapeutic areas.

"I am incredibly excited to join 28-7 and support the advancement of its lead program," said Dr. Ghosh. "I look forward to working with Kazumi and our accomplished team and Board as we discover new ways to fight cancer and grow our operations."

28-7’s initial focus is on modulating miRNAs, which are short ncRNAs that inhibit target gene expression by suppressing mRNA translation and/or promoting mRNA decay. It is now well recognized that miRNAs are directly involved in cancer initiation, progression, and metastasis. 28-7’s technology does not focus on directly targeting the RNA itself or on developing oligonucleotides, but rather targets RNA modulating proteins (RMPs), enabling the use of small molecule drug candidates with broader access to cells and tissues. Let-7 is an miRNA that suppresses the translation of oncogenes in cells, and low levels of this miRNA are correlated with greater cancer aggressiveness. The company’s leading protein target is Lin28, an RMP that reduces the levels of Let-7, and has been shown to be an oncogene, promoting cellular transformation and tumorigenesis. 28-7 is developing first-in-class drugs that inhibit Lin28’s activity and thus raise levels of Let-7 for treatment of various cancers.

The company’s core technology comes from its four founding scientists, all leading researchers in RNA biology and cancer:

George Daley, M.D., Ph.D. ─ Dean of the Faculty of Medicine and Professor of Medicine, Biological Chemistry and Molecular Pharmacology, Harvard Medical School
Richard Gregory, Ph.D. ─ Professor of Biological Chemistry and Molecular Pharmacology, and Pediatrics, Harvard Medical School
Frank Slack, Ph.D. ─ Professor of Pathology, Harvard Medical School, Professor of Pathology and Director of Institute of RNA Medicine, Beth Israel Deaconess Medical Center
Piotr Sliz, Ph.D. ─ Associate Professor of Pediatrics and of Biological Chemistry and Molecular Pharmacology, Harvard Medical School
This founding group has been collaborating for years and has made substantial contributions to the science of ncRNA biology, including elucidating the role of ncRNAs in disease and identifying new RMP targets for drug discovery programs.

"Our founders have made important scientific contributions to the field of ncRNA biology, including the discovery of the Lin28/Let-7 pathway and its role in normal development, metabolism, and malignancy. Overall, our studies have established Lin28/Let-7 as a major regulatory pathway in stem cells and cancer," said George Daley, M.D., Ph.D., 28-7’s co-founder and Chairman of the company’s Scientific Advisory Board, and Dean and Professor of Medicine and Biological Chemistry and Molecular Pharmacology, Harvard Medical School. "We felt that the time was right to move these insights from the laboratory to pharmaceutical development, and we are very pleased by the progress the company achieved in the first two years of its existence. With this impressive round of funding and our continued support, 28-7 will unlock the therapeutic potential of our work."

In addition to Dr. Shiosaki, several investors will join 28-7’s Board of Directors, including:

· Luke Evnin, Ph.D. ─ Managing Director and co-founder, MPM Capital

· Briggs Morrison, M.D. ─ Executive Partner, MPM Capital and CEO of Syndax Pharmaceuticals, Inc.

· Carolyn Ng, Ph.D. ─ Principal, Vertex Ventures HC

· Michal Silverberg, M.B.A. ─ Managing Director, Novartis Venture Fund

On September 6, 2018 Replimune Group Inc. (NASDAQ: REPL), a biotechnology company developing oncolytic immunotherapies derived from its Immulytic platform, reported the U.S. Food and Drug Administration (FDA) has accepted the Company’s investigational new drug (IND) application for its lead product candidate, RP1, for patients with solid tumors (Press release, Replimune, SEP 6, 2018, View Source [SID1234529738]). The Company intends to open its ongoing Phase 1/2 clinical trial in the U.S. and begin enrolling patients in the fourth quarter of 2018. The clinical trial is currently ongoing in the U.K., as previously announced.

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 part one of the Phase 1/2 clinical trial, Replimune is assessing the safety and tolerability of RP1 administered alone in patients with advanced solid tumors. Following this dose escalation phase, further patients will receive RP1 in combination with nivolumab anti-PD1 therapy. In part two of the Phase 1/2 clinical trial, expected to initiate in the first half of 2019, Replimune intends to study the safety and efficacy of RP1 in combination with nivolumab in approximately 120 patients with metastatic melanoma, metastatic bladder cancer, microsatelite instability high cancers, and non-melanoma skin cancers. For each of the tumor types other than melanoma, patients will be naïve to immune checkpoint blockade, whereas in melanoma, patients both previously treated and previously untreated with immune checkpoint blockade will be enrolled. This clinical trial is a collaboration with Bristol Myers Squibb, which is providing nivolumab for use in the study.

RP1 is Replimune’s first Immulytic product candidate to enter the clinic and is based on a proprietary new strain of herpes simplex virus engineered to maximize tumor killing potency. This is intended to result in highly immunogenic cell death and robust activation of a systemic anti-tumor immune response.

About Oncolytic Immunotherapy
Oncolytic immunotherapy is an emerging class of cancer therapy which exploits the ability of viruses to selectively replicate in and kill tumors, while at the same time inducing a potent, patient-specific, anti-tumor immune response. Oncolytic viruses have the ability to induce a robust immune response against a patient’s particular complement of tumor antigens, including neo-antigens, in situ in the patient in an off-the-shelf format. While clinically active alone, oncolytic immunotherapy may have synergy with certain other treatments and, in particular, with immune checkpoint blockade therapies.