On April 19, 2021 MacroGenics, Inc. (Nasdaq: MGNX), a biopharmaceutical company focused on developing and commercializing innovative monoclonal antibody-based therapeutics for the treatment of cancer, reported that the Company will release its financial results for the first quarter of 2021 after the market closes on Thursday, April 29, 2021 (Press release, MacroGenics, APR 19, 2021, View Source [SID1234578186]). MacroGenics will host a conference call to discuss the financial results and recent corporate progress on Thursday, April 29, 2021 at 4:30 pm ET. The conference call can be accessed by dialing (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and providing the Conference ID# 5257004.

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The listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company’s website at View Source A recorded replay of the webcast will be available shortly after the conclusion of the call and archived on the Company’s website for 30 days following the call.

On April 19, 2021 ImmVira reported the preclinical study results of MVR-T3011 via intravenous administration through publication in a virtual poster at the AACR (Free AACR Whitepaper) annual meeting (Press release, Immvira, APR 19, 2021, View Source [SID1234578202]). MVR-T3011 is a replication competent and genetically modified oncolytic herpes simplex virus-1 expressing human interleukin-12 and anti-PD-1 antibody. ImmVira owns the global right for development and commercialization of MVR-T3011 via intravenous administration.

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Oncolytic virus(OV) has been proven to inhibit tumor growth in a number of superficial tumors through intratumoral injection. From clinical studies, intratumoral injection of OV has been proved to provide effective treatment against tumor via its abscopal effect, transitions from immunologically cold to hot tumor and combination with other cancer therapies. However, to advanced tumors, especially the lesions of multiple metastasis are ideally treated via a systemic route. At present, common types of viruses that have been studied clinically for intravenous administration are Vaccinia virus, Coxsackie virus and Reovirus etc. However, for various reasons, most virus types used in developing oncolytic viruses including HSV-1 and adenoviruses, have not been fully studied for intravenous administration preclinically and clinically.

In the preclinical study conducted by ImmVira, intravenous administration of MVR-T3011 demonstrated enrichment of viral DNA in tumor tissue. MVR-T3855, the surrogate of MVR-T3011 for mouse, was shown to significantly extend the survival time of several mouse with orthotopic tumors including primary and metastatic lung cancer and primary liver cancer, and repeated dose via intravenous administration has clearly enhanced antitumor effect. Furthermore, intravenous administration or intra-cavity of MVR-T3855 significantly delayed or prevented the formation of malignant ascites in mouse liver model. In terms of safety, the three-month pre-clinical study showed that the intravenous administration of MVR-T3011 and MVR-T3855 did not cause significant adverse reactions and had clinical significance. After administration, no histopathological change was found in non-target organs.

ImmVira submitted an IND application for MVR-T3011 intravenous administration to the U.S. FDA in January 2021 and expects to recruit patients in five leading U.S. research cancer centers within the next few weeks.

On April 19, 2021 Epizyme reported that The protein EZH2 has long been known as a major driver of prostate cancer because of its ability to inactivate genes that would normally suppress tumor growth (Press release, Epizyme, APR 19, 2021, View Source [SID1234578328]). Now, a team at Cedars-Sinai Cancer has shown in preclinical models of the disease that blocking EZH2 reduces resistance to immune-boosting checkpoint inhibitors—and they did it with the help of Epizyme, which won FDA approval for the first EZH2 blocker last year.

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The Cedars-Sinai team inhibited EZH2 in preclinical prostate cancer models, activating interferon-stimulated genes in the immune system. The interferons then boosted the immune response and reversed resistance to drugs that inhibit the checkpoint PD-1, they reported in the journal Nature Cancer.

By inhibiting EZH2 either genetically or with a chemical inhibitor donated by Epizyme, the researchers used a technique called "viral mimicry" to "reopen" parts of the genome that are typically inactive, they explained in a statement. That signaled the immune system to respond to PD-1 inhibition.

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Cedars-Sinai is now planning a clinical trial of Epizyme’s EZH2 inhibitor, Tazverik (tazemetostat), in prostate cancer. The researchers believe combining checkpoint inhibitors with EZH2 blockers may be a viable strategy, they said.

RELATED: ESMO (Free ESMO Whitepaper): Early days, but Amgen’s BiTE drug in prostate cancer shows encouraging activity

Checkpoint inhibitors have been approved to treat several cancer types, but they’ve been largely disappointing in prostate cancer. Hence several research groups have been exploring combination strategies. They include the University of Texas MD Anderson Cancer Center, which published research in 2019 showing early evidence that combining checkpoint inhibition with anti-TGF-beta drug could be effective in prostate cancer.

More recently, bispecific antibodies have shown early promise in prostate cancer. Last September, Amgen presented data from a phase 1 study of AMG 160, a bispecific targeting PSMA and CD3 on T cells. The company said that 68.6% of patients experienced a decline in PSA, and eight out of 15 patients evaluated showed stable disease.

Regeneron is also developing a bispecific antibody for prostate cancer, targeting PSMA and CD28. The drug is being tested as a solo therapy and in combination with Regeneron’s PD-1 inhibitor Libtayo in a phase 1/2 clinical trial enrolling men with metastatic castration-resistant prostate cancer.

As for Epizyme’s EZH2 inhibitor, Tazverik, its path to market hasn’t been perfectly smooth. An advisory committee to the FDA questioned its efficacy and safety in its initial indication, metastatic or locally advanced epithelioid sarcoma. Still, the company got the go-ahead to market the drug in adult patients with the rare cancer last January. Then the FDA added follicular lymphoma to the label in June. The drug’s takeoff has been slower than expected, however, largely because the pandemic has prevented face-to-face interactions between the sales force and physicians.

The company is currently testing Tazverik in several other cancer types, including as a combination with standard-of-care treatments in castration-resistant prostate cancer.

On April 19, 2021 Zai Lab Limited ("Zai Lab" or the "Company") (NASDAQ:ZLAB, HKEX: 9688), an innovative commercial stage biopharmaceutical company, reported that it has commenced an underwritten public offering of $750,000,000 of American depositary shares ("ADSs"), each representing one ordinary share of the Company (Press release, Zai Laboratory, APR 19, 2021, View Source [SID1234578187]). All ADSs will be offered by Zai Lab. Zai Lab expects to grant the underwriters a 30-day option to purchase additional ADSs. Investors have an option to receive ordinary shares of the Company ("Shares") in lieu of ADSs in this offering only, and such option will not be available to purchasers of the additional ADSs.

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J.P. Morgan Securities LLC, Goldman Sachs & Co. LLC, Jefferies LLC, Citigroup Global Markets Inc., SVB Leerink LLC and Guggenheim Securities, LLC are acting as joint book-running managers for the ADS offering. J.P. Morgan Securities plc, Goldman Sachs (Asia) L.L.C., Jefferies Hong Kong Limited, Citigroup Global Markets Limited and Guggenheim Securities, LLC are acting as joint book-running managers in respect of any ordinary shares issued to investors electing to receive ordinary shares in lieu of ADSs. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed.

The offering will be made pursuant to a shelf registration statement on Form S-3ASR, which became automatically effective upon filing with the U.S. Securities and Exchange Commission ("SEC") on April 19, 2021. A preliminary prospectus supplement related to the proposed ADS offering is being filed with the SEC.

Copies of the registration statement on Form S-3ASR, the preliminary prospectus supplement and the accompanying prospectus may be obtained from: (i) J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, New York 11717, via telephone at 1-866-803-9204 or via email at [email protected], (ii) Goldman Sachs & Co. LLC, Prospectus Department, 200 West Street, New York, NY 10282, telephone: 1-866-471-2526, facsimile: 212-902-9316 or by emailing [email protected], (iii) Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York 10022, or by telephone at 1-877-821-7388 or via email at [email protected], (iv) Citigroup Capital Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717 or by telephone at 1-800-831-9146 and (v) SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at 1-800-808-7525 ex. 6105 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy ADSs, Shares or any other securities, nor shall there be any sale of ADSs or Shares 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 April 19, 2021 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that it will report its 2021 first quarter financial results on Tuesday, May 4, 2021 after the close of the financial markets (Press release, Jazz Pharmaceuticals, APR 19, 2021, View Source [SID1234578203]). Company management will host a live audio webcast at 4:30 p.m. ET/9:30 p.m. IST to discuss first quarter 2021 financial results and provide a business and financial update.

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Interested parties may access the live audio webcast via the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. A replay of the webcast will be archived on the website for at least one week.