On September 16, 2020 Exicure, Inc. (NASDAQ: XCUR), the pioneer in gene regulatory and immunotherapeutic drugs utilizing proprietary spherical nucleic acid (SNA) technology, reported that it will host a virtual Key Opinion Leader (KOL) event to present preliminary Phase 1b efficacy and safety data for its intratumoral product candidate, cavrotolimod, the company’s SNA-enabled TLR9 agonist being developed for the treatment of solid tumors, in combination with pembrolizumab (Press release, Exicure, SEP 16, 2020, View Source [SID1234565232]). The event will take place today from 10:30 am – 12:00 pm ET.

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The principal investigators of the Phase 1b portion of the trial, Dr. Steven O’Day and Dr. Shailender Bhatia, will be presenting and joining Exicure’s leadership team in discussing the clinical data and trial progress to date.

"We are excited by the durable responses we have seen in anti-PD-1 refractory patients, and look forward to further exploring the efficacy of cavrotolimod in these highly treatment refractory Merkel cell carcinoma and cutaneous squamous cell carcinoma patients," said Dr. Douglas Feltner, Chief Medical Officer of Exicure.

The event will be webcast live today, September 16th at 10:30 am ET through a link on the Events and Presentations section of Exicure’s website. An archived webcast will also be available on Exicure’s website following the event. To RSVP for the event, please use the link here (View Source) or email [email protected].

Description of the Trial

The objectives of the Phase 1b dose-escalation stage of the clinical trial were to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of cavrotolimod alone and in combination with pembrolizumab, and to identify a recommended Phase 2 dose. Cavrotolimod was dosed weekly for 8 weeks then every three weeks thereafter. Pembrolizumab was added to the treatment regimen starting in week three of the study. The first two weeks of the trial, the period in which only cavrotolimod was dosed, allowed for the assessment of cavrotolimod safety, tolerability, pharmacokinetics and pharmacodynamics alone. Efficacy was assessed every 12 weeks. Twenty patients have been enrolled and dosed in the dose-escalation stage of the trial consisting of: ten (10) melanoma patients, five (5) MCC patients, two (2) CSCC patients, two (2) head and neck squamous cell carcinoma patients, and one (1) leiomyosarcoma patient. At the

time of enrollment, 85% of patients were experiencing progressive disease while on anti-PD-1 antibody therapy.

Highlights from the data

Highlights from the data update include:

–Confirmed ORR 21% (4/19 patients) overall in the Phase 1b dose-escalation stage
–Confirmed ORR 33% (2/6 patients) in the highest dose cohort (32 mg), which was selected as Phase 2 recommended dose
–Overall responses occurred in two patients with advanced MCC and two patients with melanoma
–Three of four responders were progressing on anti-PD-1 therapy at the time of enrollment
–In addition to the four confirmed responses, target tumor shrinkage occurred in one CSCC patient and two melanoma patients. Systemic (abscopal) effects were observed, with regression in noninjected tumors distant from injected lesions.
–The cavrotolimod pharmacodynamic profile corroborated the efficacy data, as increased serum cytokines/chemokines, activated immune cells, and tumor infiltration by immune cells were observed.

The median duration of response has not been reached as all four confirmed responders have not progressed after a median follow-up of 11 months. The longest response to date is 16 months from initial dosing and is ongoing as of the data cut-off date.

Exicure continues to observe that cavrotolimod is well tolerated with 98% of all treatment-emergent adverse events (AEs) assessed as Grade 1 or 2 in severity. No treatment-related serious adverse events were reported to date. The most common adverse events were flu-like symptoms and injection site reactions, which are commonly expected effects from a TLR9 mechanism of action.

Updated guidance

Exicure expects to provide interim ORR results from the MCC and CSCC cohorts of the Phase 2 portion of the clinical trial in the first half of 2021 and final ORR results by year end 2021.

On September 16, 2020 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB), an innovative commercial stage biopharmaceutical company, reported the launch of its Hong Kong public offering (the "Hong Kong Public Offering"), which forms part of the global offering (the "Offering") of 10,564,050 new ordinary shares (the "Offer Shares" or "Shares") and listing of its ordinary shares on the Main Board of The Stock Exchange of Hong Kong Limited (the "Hong Kong Stock Exchange") under the stock code "9688" (Press release, Zai Laboratory, SEP 16, 2020, View Source [SID1234565231]).

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The Company’s American depositary shares ("ADSs"), each representing one (1) ordinary share of the Company, will continue to be listed and traded on the Nasdaq Global Market ("Nasdaq"). Investors in the Offering will only be able to purchase ordinary shares and will not be able to take delivery of ADSs. Upon listing in Hong Kong, the ordinary shares listed on the Hong Kong Stock Exchange will be fully fungible with the ordinary shares represented by the ADSs listed on Nasdaq.

The Offering initially comprises 771,700 new Shares under the Hong Kong Public Offering and 9,792,350 new Shares for the international offering (the "International Offering"), representing approximately 7.3% and 92.7% of the total number of Shares in the Offering, respectively, subject to re-allocation and over-allotment. Subject to the level of any oversubscription in the Hong Kong Public Offering and pursuant to the clawback mechanism as described in the prospectus issued in Hong Kong, the total number of shares available under the Hong Kong Public Offering could be adjusted to up to a maximum of 3,591,800 new Shares, representing approximately 34% of the Offer Shares initially available under the Offering. In addition, the Company expects to grant the international underwriters an over-allotment option to purchase up to an additional 1,584,600 new Shares in the International Offering, representing not more than 15.0% of the Offer Shares initially available under the Offering.

The offer price for the Hong Kong Public Offering (the "Hong Kong Offer Price") will be not more than HK$648.00 per share (the "Maximum Offer Price"). The offer price for the International Offering tranche of the Offering (the "International Offer Price") may be set at a level higher than the Hong Kong Offer Price. The Company is expected to set the International Offer Price by September 22, 2020 Hong Kong time by making reference to, among other factors, the closing price of the ADSs on Nasdaq on the last trading day on or before September 21, 2020 and investor demand during the marketing process. The final Hong Kong Offer Price will be set at the lower of the final International Offer Price and the Maximum Offer Price of HK$648.00 per share. Shares will be traded in board lots of 50 shares.

The Company plans to use the net proceeds from the Offering for its core products, through strengthening R&D efforts and enhancing its commercialization capabilities, advancing its ongoing and planned clinical trials and preparation for registration filings of other drug candidates in its pipeline, exploring new global licensing and collaboration opportunities, funding working capital and other general corporate purposes.

Fully Electronic Application Process for the Hong Kong Public Offering

Zai Lab has decided to adopt a fully electronic application process for the Hong Kong Public Offering, with no printed copies of prospectuses or application forms to the public in relation to the Hong Kong Public Offering. A fully electronic application process is consistent with the way in which the Company’s users and stakeholders engage and interact with each other and the Company. As a company which has been highly committed to environmental, social and corporate responsibility matters since its founding, the Company believes such method will also help mitigate the environmental impact of printing and minimize the exploitation of natural resources, among others. The prospectus is available at the website of the Hong Kong Stock Exchange at www.hkexnews.hk and the Company’s website at www.zailaboratory.com.

The Company encourages applicants for the Hong Kong Public Offering to view its prospectus and apply online through the White Form eIPO service at www.eipo.com.hk, or apply through the CCASS EIPO service. The Hong Kong Public Offering will commence at 9:00 a.m. on Thursday, September 17, 2020 Hong Kong time and will close at 12:00 noon on Tuesday, September 22, 2020 Hong Kong time.

Potential applicants may call the enquiry hotline of Computershare Hong Kong Investor Services Limited if they have any question about making applications for the Hong Kong Offer Shares. The hotline number is +852 2862 8646, and will be open from 9:00 a.m. to 9:00 p.m. on Thursday, September 17, 2020, Friday, September 18, 2020 and Monday, September 21, 2020, from 9:00 a.m. to 6:00 p.m. on Saturday, September 19, 2020 and Sunday, September 20, 2020, and from 9:00 a.m. to 12:00 noon on Tuesday, September 22, 2020 Hong Kong time.

J.P. Morgan Securities (Far East) Limited (or its affiliates, as the case may be), Goldman Sachs (Asia) L.L.C. and Citigroup Global Markets Asia Limited (or its affiliate, as the case may be) are the joint sponsors, joint global coordinators, joint bookrunners and joint lead managers for the proposed Offering.

The International Offering is being made only by means of a preliminary prospectus supplement dated September 16, 2020 and the accompanying prospectus included in an automatic shelf registration statement on Form F-3ASR filed with the U.S. Securities and Exchange Commission (the "SEC") on March 29, 2019 and was subsequently amended and became automatically became effective upon filing with the SEC on January 21, 2020. The registration statement on Form F-3ASR and the preliminary prospectus supplement are available at the SEC website at: View Source Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained from: (i) J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-866-803-9204 or by email at [email protected], (ii) Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282 or by telephone at 1-866-471-2526, or (iii) Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 1-800-831-9146 or by email at [email protected].

The proposed Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the Offering. This press release shall not constitute an offer to sell or the solicitation of an offer or an invitation to buy any securities of the Company, nor shall there be any offer or sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction. This press release does not constitute a prospectus (including as defined under the laws of Hong Kong) and potential investors should read the prospectus of the Company for detailed information about the Company and the proposed offering, before deciding whether or not to invest in the Company. This press release has not been reviewed or approved by the Hong Kong Stock Exchange or the Securities and Futures Commission of Hong Kong.

The price of the Shares of the Company may be stabilized in accordance with the Securities and Futures (Price Stabilization) Rules. The details of the intended stabilization and how it will be regulated under the Securities and Futures Ordinance (Chapter 571 of the laws of Hong Kong) will be contained in the prospectus of the Company dated September 17, 2020

On September 16, 2020 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics targeting infectious diseases and cancers based on its proprietary arenavirus platform, reported that HOOKIPA’s management team will participate and present at SVB Leerink’s CybeRx Series: Vaccine Forum, taking place September 23 – 24, 2020 (Press release, Hookipa Pharma, SEP 16, 2020, View Source [SID1234565230]):

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HOOKIPA Fireside Chat: Wednesday, September 23rd at 12:00 PM ET with Joern Aldag (CEO) and Igor Matushansky (CMO)

On September 16, 2020 Tempus, a technology company advancing precision medicine through the practical application of artificial intelligence in healthcare, and LabCorp (NYSE: LH), a leading global life sciences company, reported a collaboration with LabCorp’s drug development business, Covance (Press release, LabCorp, SEP 16, 2020, View Source [SID1234565229]). LabCorp will participate in Tempus’s TIME Trial Network and the companies will work together to accelerate patient enrollment for oncology clinical trials through an innovative, data-driven approach that aims to transform the clinical trial model and modernize how they are designed and executed.

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As novel therapies become increasingly targeted, identifying and enrolling patient populations have become a significant challenge for investigators and sites. Tempus offers a solution with its TIME Trial Program, which uses real-time clinical and molecular data to screen and match patients to biomarker-targeted trials. Institutions participating in The TIME Trial Network are able to initiate their trial on behalf of patients in as few as 10 days.

"The TIME Trial Program has achieved an unparalleled scale thus far, with over 50 provider networks and 2,500 oncologists included in its network," said Kim Blackwell, Chief Medical Officer of Tempus. "We’re excited to collaborate with LabCorp’s drug development business, Covance, and leverage their network of oncology sites and community physicians across the U.S., as well as their successful track record in executing some of the country’s most cutting-edge oncology trials. This collaboration furthers our mission to increase trial participation and ultimately bring the right treatment to the right patients at the right time."

"LabCorp’s drug development business has extensive experience in executing clinical trials and our leadership position in oncology, coupled with Tempus’ innovative clinical trial model, provides thousands of physicians and patients easier access to more therapeutics," said Dr. Paul Kirchgraber, CEO, LabCorp’s drug development business, Covance. "With oncology patient enrollment rates being in the single digits, it’s imperative that we find comprehensive approaches to accelerate oncology clinical trials and bring new treatments to patients faster. The combination of our capabilities will increase the ability to identify patients with specific genetic markers and link them to trial sites, thus greatly expanding access to hard-to-find patient pools for faster enrollment of the right patients for precision medicine oncology clinical trials."

To learn more about the TIME Trial Program, visit www.tempus.com/clinical-trial-matching.

On September 16, 2020 Merck (NYSE:MRK), known as MSD outside the United States and Canada, reported that members of management will host a virtual investor event following the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) Virtual Congress 2020 where they will highlight select datasets and give an overview of the company’s broad oncology portfolio on Sept. 22 at 8:00 am EDT (Press release, Merck & Co, SEP 16, 2020, View Source [SID1234565228]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at View Source

Merck’s Focus on Cancer
Our goal is to translate breakthrough science into innovative oncology medicines to help people with cancer worldwide. At Merck, the potential to bring new hope to people with cancer drives our purpose and supporting accessibility to our cancer medicines is our commitment. As part of our focus on cancer, Merck is committed to exploring the potential of immuno-oncology with one of the largest development programs in the industry across more than 30 tumor types. We also continue to strengthen our portfolio through strategic acquisitions and are prioritizing the development of several promising oncology candidates with the potential to improve the treatment of advanced cancers. For more information about our oncology clinical trials, visit www.merck.com/clinicaltrials.