On July 13, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported that Zepzelca (lurbinectedin) was added by the National Comprehensive Cancer Network (NCCN) to the Clinical Practice Guidelines in Oncology (NCCN Guidelines) for small cell lung cancer (SCLC) on July 7, 2020 (Press release, Jazz Pharmaceuticals, JUL 13, 2020, View Source [SID1234561832]).

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The U.S. Food and Drug Administration (FDA) approved Zepzelca under accelerated approval on June 15, 2020 for the treatment of adult patients with metastatic SCLC with disease progression on or after platinum-based chemotherapy.1 The approval was based on the data from the open-label, single-arm monotherapy trial. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

The NCCN Guidelines for SCLC now include lurbinectedin as a recommended regimen for both patients who relapse six months and less after prior systemic therapy and for patients who relapse more than six months after prior systemic therapy. For patients who relapse six months and less, lurbinectedin is a preferred regimen.

"We appreciate the decision by the NCCN to quickly incorporate Zepzelca into the Clinical Practice Guidelines in Oncology as it supports our commitment to ensuring that patients with relapsed small cell lung cancer are able to access this important new treatment option," said Robert Iannone M.D., M.S.C.E., executive vice president, research and development of Jazz Pharmaceuticals. "Zepzelca has the potential to fill an unmet need in relapsed SCLC where treatment options have been limited."

The NCCN, a not-for-profit alliance of 30 leading U.S. cancer centers devoted to patient care, research, and education, is dedicated to improving and facilitating quality, effective, efficient, and accessible cancer care so patients can live better lives. The intent of the NCCN Guidelines is to assist in the decision-making process of individuals involved in cancer care—including physicians, nurses, pharmacists, payers, patients and their families—with the ultimate goal of improving patient care and outcomes.

About Zepzelca (lurbinectedin)
Zepzelca, also known as PM1183, is an alkylating drug that binds guanine residues within DNA. This triggers a cascade of events that can affect the activity of DNA binding proteins, including some transcription factors, and DNA repair pathways, resulting in disruption of the cell cycle and eventual cell death.1

Zepzelca for injection 4 mg is a prescription medicine used to treat adults with a kind of lung cancer called small cell lung cancer that has spread to other parts of the body (metastatic) and who have received treatment with chemotherapy that contains platinum, and it did not work or is no longer working. Zepzelca is approved based on response rate and how long the response lasted. Additional studies will further evaluate the benefit of Zepzelca for this use.

Important Safety Information

Before receiving ZEPZELCA, tell your healthcare provider about all of your medical conditions, including if you:

have liver or kidney problems.
are pregnant or plan to become pregnant. ZEPZELCA can harm your unborn baby.
Females who are able to become pregnant:
Your healthcare provider should do a pregnancy test before you start treatment with ZEPZELCA.
You should use effective birth control (contraception) during treatment with and for 6 months after your final dose of ZEPZELCA.
Tell your healthcare provider right away if you become pregnant or think that you are pregnant during treatment with ZEPZELCA.
Males with female partners who are able to become pregnant should use effective birth control during treatment with and for 4 months after your final dose of ZEPZELCA.

are breastfeeding or plan to breastfeed. It is not known if ZEPZELCA passes into your breastmilk. Do not breastfeed during treatment with ZEPZELCA and for 2 weeks after your final dose of ZEPZELCA. Talk to your healthcare provider about the best way to feed your baby during treatment with ZEPZELCA.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Certain other medicines may affect how ZEPZELCA works.

What should I avoid while using ZEPZELCA?

Avoid eating or drinking grapefruit, or products that contain grapefruit juice during treatment with ZEPZELCA.

ZEPZELCA can cause serious side effects, including:

Low blood cell counts. Low blood counts including low neutrophil counts (neutropenia) and low platelet counts (thrombocytopenia) are common with ZEPZELCA, and can also be severe. Some people with low white blood cell counts may get fever, or an infection throughout the body (sepsis), that can cause death. Your healthcare provider should do blood tests before you receive each treatment with ZEPZELCA to check your blood cell counts.
Tell your healthcare provider right away if you develop:
fever or any other signs of infection
unusual bruising or bleeding
tiredness
pale colored skin
Liver problems. Increased liver function tests are common with ZEPZELCA, and can also be severe. Your healthcare provider should do blood tests to check your liver function before you start and during treatment with ZEPZELCA.
Tell your healthcare provider right away if you develop symptoms of liver problems including:
loss of appetite
nausea or vomiting
pain on the right side of your stomach area (abdomen)
Your healthcare provider may temporarily stop treatment, lower your dose, or permanently stop ZEPZELCA if you develop low blood cell counts or liver problems during treatment with ZEPZELCA.

The most common side effects of ZEPZELCA include:

tiredness
low white and red blood cell counts
increased kidney function blood test (creatinine)
increased liver function blood tests
increased blood sugar (glucose)
nausea
decreased appetite
muscle and joint (musculoskeletal) pain
low level of albumin in the blood
constipation
trouble breathing
low levels of sodium and magnesium in the blood
vomiting
cough
diarrhea
These are not all of the possible side effects of ZEPZELCA.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here.

ZEPZELCA is a trademark of PharmaMar, S.A. used by Jazz Pharmaceuticals under license.

On July 13, 2020 Horizon Therapeutics plc (Nasdaq: HZNP) reported that its second-quarter 2020 financial results will be released on Wednesday, Aug. 5, 2020 (Press release, Horizon Therapeutics, JUL 13, 2020, View Source [SID1234561831]). Following the announcement, Horizon’s management will host a live webcast at 8 a.m. Eastern Time to review the Company’s financial and operating results.

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The live webcast and a replay may be accessed at View Source Please connect to the Company’s website at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. A replay of the webcast will be available approximately two hours after the live webcast.

On July 13, 2020 TRACON Pharmaceuticals (Nasdaq: TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with ex-U.S. companies to develop and commercialize innovative products in the U.S., reported that it will host a key opinion leader (KOL) webinar on envafolimab for the treatment of sarcoma on Friday, July 17, 2020, at 11:00 AM Eastern Time (Press release, Tracon Pharmaceuticals, JUL 13, 2020, View Source [SID1234561830]).

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The KOL webinar will feature a presentation by Robert Maki, M.D., Ph.D., of the University of Pennsylvania School of Medicine, who will discuss the current treatment landscape and unmet medical need in treating patients with sarcoma. Dr. Maki will be available to answer questions at the conclusion of the event.

TRACON’s Chief Executive Officer, Charles Theuer, M.D., Ph.D., will also provide an update on the Company’s lead product candidate, envafolimab, for treating patients with sarcoma. Envafolimab is a novel, single-domain antibody against PD-L1 that is administered by subcutaneous injection without the need for an adjuvant. Envafolimab is currently being studied in China in a Phase 2 registration trial as a single agent in MSI-H/dMMR colorectal cancer patients, in combination with gemcitabine and oxaliplatin in a Phase 3 registration trial in biliary tract cancer, as well as in several Phase 1 trials in the U.S. and Japan. Having agreed with the U.S. Food and Drug Administration (FDA) on trial design, TRACON intends to initiate the ENVASARC pivotal study of envafolimab in the sarcoma subtypes of undifferentiated pleomorphic sarcoma and myxofibrosarcoma in the second half of 2020.

You can register for the webinar by clicking here.

Dr. Maki is a graduate of Cornell University Medical College, and has a Ph.D. in Immunology from Cornell University Graduate School of Medical Sciences. He completed his internship and residency at Brigham and Women’s Hospital and fellowship in medical oncology at the Dana Farber Cancer Institute. Dr. Maki’s expertise includes the more than 70 types of bone and soft tissue sarcomas, and he is the co-author of Management of Soft Tissue Sarcoma, from Springer Books. Dr. Maki is Board certified in internal medicine and medical oncology, and treats patients at the Abramson Cancer Center at the University of Pennsylvania.

On July 13, 2020 NextCure, Inc. (Nasdaq: NXTC), a clinical-stage biopharmaceutical company committed to discovering and developing novel, first-in-class immunomedicines to treat cancer and other immune-related diseases, reported an interim update for the Phase 2 portion of its NC318 monotherapy phase 1/2 trial (Press release, NextCure, JUL 13, 2020, View Source [SID1234561829]).

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Based on the current enrollment criteria and clinical response data, at this time the company does not plan to advance the non-small cell lung cancer (NSCLC) and ovarian cancer cohorts into the stage 2 portion of the Simon 2-stage trial. The analysis of biomarker data for these cohorts has been delayed and is not yet complete. The company will evaluate whether to pursue additional monotherapy studies in NSCLC and ovarian cancer after a review of that information. The company continues to enroll in head and neck squamous cell carcinoma (HNSCC) and triple-negative breast cancer cohorts. One confirmed partial response has been observed in HNSCC and this indication has been advanced to the stage 2 portion of the Simon 2-stage trial. The company is continuing to assess Siglec-15 (S15) biomarker data as a basis for patient selection.

"While the monotherapy data in the NSCLC and ovarian cancer cohorts are disappointing, we continue to evaluate patient selection criteria for our ongoing NC318 clinical trials," said Michael Richman, NextCure’s president and chief executive officer. "We expect to provide an NC318 clinical data update and additional biomarker data in the fourth quarter of 2020."

NextCure also announced that Kevin N. Heller, M.D., the company’s chief medical officer, has resigned, effective August 4, 2020 to pursue a new opportunity. Dr. Heller will serve as a consultant to the company. The company has initiated a search for a new chief medical officer.

"We thank Kevin for all of his work on behalf of the company and look forward to his continued support as a clinical consultant," said Mr. Richman.

About the Phase 2 Portion of the NC318 Phase 1/2 Clinical Trial

The Phase 2 component of the Phase 1/2 clinical trial is designed as a single-arm trial to evaluate the efficacy of NC318 at a 400 mg dose administered every two weeks. NextCure expects to enroll up to 100 patients with NSCLC, ovarian cancer, head and neck cancer and triple-negative breast cancer. The primary endpoints are safety and tolerability, and secondary endpoints include response rate, progression-free survival, duration of response and overall survival.

About NC318

NC318 is a first-in-class immunomedicine against S15, a novel immunomodulatory target found on highly immunosuppressive cells called M2 macrophages in the tumor microenvironment and on certain tumor types including lung, ovarian and head and neck cancers. In preclinical research, it was observed that S15 promoted the survival and differentiation of suppressive myeloid cells and negatively regulated T cell function, allowing cancer to avoid immune destruction. In preclinical studies, NC318 blocked the negative effects of S15. NextCure believes NC318 has the potential to treat multiple cancer types.

On July 13, 2020 Vaxart, Inc. (NASDAQ: VXRT), a clinical-stage biotechnology company developing oral vaccines that are administered by tablet rather than by injection, reported that it has raised gross proceeds of approximately $90 million through its At-the-Market (ATM) facility with participation based on interest received from RA Capital Management and Invus (Press release, Aviragen Therapeutics, JUL 13, 2020, View Source [SID1234561828]). The company sold approximately 11.2 million shares at $7.98 per share, the market price at the time of sale. SVB Leerink is acting as lead sales agent and B. Riley FBR is acting as co-sales agent for the ATM facility.

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The additional funds raised through the ATM facility will support the clinical and preclinical development of Vaxart’s product candidates, to conduct clinical trials, to manufacture its products, and for general corporate and working capital purposes.

The shares of common stock described above were sold by the Company pursuant to an automatically effective shelf registration statement on Form S-3 (File No. 333-239751), filed with the Securities and Exchange Commission on July 8, 2020, which included a prospectus relating to the ATM facility. Copies of the prospectus may be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, Massachusetts 02110, or by telephone at (800) 808-7525, ext. 6218, or by email at [email protected]. Electronic copies of the prospectus are also available on the SEC’s website at View Source

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