On June 15, 2020 Jazz Pharmaceuticals plc (Nasdaq: JAZZ) reported along with its partner PharmaMar (MSE: PHM) that the U.S. Food and Drug Administration (FDA) approved Zepzelca (lurbinectedin) for the treatment of adult patients with metastatic small cell lung cancer (SCLC) with disease progression on or after platinum-based chemotherapy (Press release, Jazz Pharmaceuticals, JUN 15, 2020, View Source [SID1234561103]).1 Zepzelca was approved under accelerated approval based on overall response rate (ORR) and duration of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.1

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The FDA approval of Zepzelca is based on monotherapy clinical data from an open-label, multi-center, single-arm study in 105 adult platinum-sensitive and platinum-resistant patients with SCLC who had disease progression after treatment with platinum-based chemotherapy.2 The data, which appeared in The Lancet Oncology May 2020 issue, showed that in patients with relapsed SCLC, Zepzelca demonstrated an ORR of 35 percent and a median duration of response of 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an independent review committee (IRC)).1

"Small cell lung cancer is a disease with limited treatment options, and the approval of Zepzelca represents an important advance for patients whose metastatic SCLC has progressed on or after platinum-based therapy," said Bruce Cozadd, chairman and CEO of Jazz Pharmaceuticals. "While patients may initially respond to traditional chemotherapy, they often experience an aggressive recurrence that is historically resistant to treatment. Jazz congratulates PharmaMar on the successful development of Zepzelca and we are proud to partner with them to bring this new therapy to the U.S. market, expanding our presence in oncology."

Zepzelca will be commercially available in the U.S. in early July. As previously announced in December 2019, PharmaMar and Jazz entered into an exclusive license agreement, which became effective in January 2020, granting Jazz U.S. commercialization rights to Zepzelca.

"Seeing first-hand the aggressive nature of SCLC and knowing that the large majority of those diagnosed will experience relapse, I am excited to see an effective new treatment demonstrating durable responses," said Dr. Jeff Petty, oncology specialist, Wake Forest Baptist Health. "For doctors, patients and their families, Zepzelca is an important and much-needed addition to the treatment landscape for relapsing SCLC."

"We are pleased to bring a new treatment choice to relapsed SCLC patients," said José María Fernández Sousa-Faro, PhD, president of PharmaMar. "The U.S. FDA accelerated approval of Zepzelca underscores its potential to fill an unmet need in this often-overlooked SCLC community."

Zepzelca is administered by an intravenous (IV) infusion delivering a 3.2 mg/m2 dose over the course of one hour, repeated every 21 days until disease progression or unacceptable toxicity.1 Zepzelca can be administered in an outpatient clinic and its dosing schedule of a single infusion every 21 days may result in less time a patient receives treatment in the clinic or hospital compared to other options.

The most common adverse reactions (≥20%), including laboratory abnormalities, are leukopenia, lymphopenia, fatigue, anemia, neutropenia, increased creatinine, increased alanine aminotransferase, increased glucose, thrombocytopenia, nausea, decreased appetite, musculoskeletal pain, decreased albumin, constipation, dyspnea, decreased sodium, increased aspartate aminotransferase, vomiting, cough, decreased magnesium and diarrhea.1

"In addition to the physical toll it takes on patients, a relapse of SCLC also takes a mental and emotional toll on the entire family," said Andrea Stern Ferris, president and CEO, LUNGevity. "The availability of Zepzelca presents new hope for patients and their loved ones, and we’re eager to see its impact on the SCLC community."

About the Phase 2 Monotherapy Trial
The Phase 2 trial of Zepzelca was an open-label, single-arm study, which enrolled a total of 105 SCLC patients at 26 hospitals in six European countries and the U.S.2 In the trial, platinum-sensitive and platinum-resistant patients were treated with Zepzelca 3.2 mg/m2, administered as a 60-minute IV infusion repeated every 21 days until disease progression or unacceptable toxicity. The primary endpoint, ORR, was 35 percent and the median duration of response was 5.3 months as measured by investigator assessment (30 percent and 5.1 months respectively, as measured by an IRC).1 Zepzelca was discontinued in 1.9 percent of patients and was delayed in 30.5 percent of patients due to an adverse reaction. Dose reductions for an adverse reaction occurred in 25 percent of patients.1

Investor Webcast on Wednesday, June 17, 2020 at 6:15 p.m. EDT
The company will host a webcast on Wednesday, June 17, 2020 at 6:15 p.m. EDT/11:15 p.m. IST to provide investors with an update on Zepzelca. The investor webcast will include an overview of SCLC, Zepzelca and launch plans from the company’s senior management.

A live webcast of the presentation may be accessed from the Investors section of the Jazz Pharmaceuticals website at www.jazzpharmaceuticals.com. Please connect to the website prior to the start of the presentation to ensure adequate time for any software downloads that may be necessary to listen to the webcast. An archive of the webcast will be available for at least one week following the presentation on the Investors section of the company’s website at www.jazzpharmaceuticals.com.

More information about Zepzelca, including Full Prescribing Information and Patient Information, is available here. < View Source >

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 (SCLC) 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.

On June 15, 2020 Vaxart, Inc. ("Vaxart" or the "Company"), a clinical-stage biotechnology company developing oral recombinant vaccines that are administered by tablet rather than by injection, reported that effective it has appointed Andrei Floroiu as Chief Executive Officer (Press release, Vaxart, JUN 15, 2020, View Source [SID1234561102]). Mr. Floroiu is a highly experienced biopharma executive with a proven track record of value creation, with substantial financial, strategic and operational experience in the vaccine and biopharmaceutical industry. He has served as a member of Vaxart’s Board of Directors since April 2020 and will continue on the board while serving as Chief Executive Officer. Wouter Latour, MD will remain as Chairman of the Board and a director of the Company.

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"I am delighted to welcome Andrei to Vaxart and want to express my deepest confidence in him as we transition Vaxart’s leadership," said Dr. Latour. "It has been an honor to lead this incredibly talented team and advance the clinical programs of the Company for the last eight years, and the Board of Directors and I are looking forward to working with Andrei and the management team to drive the Company to the next stage of growth."

Mr. Floroiu was most recently with Agenus, Inc., an immuno-oncology and vaccine pioneer, where he held executive positions and was responsible for structuring strategic partnerships and other transactions, including the origination and execution of a $115 million royalty transaction based on GSK’s Shingrix vaccine. Prior to Agenus, Mr. Floroiu was a Managing Director at Exigo Capital providing strategic advice to C-suite executives and Boards. Mr. Floroiu also brings prior biopharma investment and advisory experience with The Invus Group, a leading healthcare investment firm, and McKinsey & Co, a leading management consultancy. Mr. Floroiu holds an MBA from the Wharton School, an MSc from the University of Maryland, and an Engineering degree from the Politechnica University of Bucharest.

"This is an exciting time for Vaxart, with tremendous prospects for growth and value creation in the new world ushered in by the coronavirus crisis," said Andrei Floroiu. "Wouter and the Vaxart team brought the company to the remarkable position of playing a potentially crucial role in the reopening of America, and the world, by rapidly advancing the development of what could be the most effective and most convenient COVID-19 vaccine. I am convinced that our work on COVID-19 will further validate the unique potential of Vaxart’s oral vaccine technology against other viral threats and as a rapid response pandemic platform. Our strong balance sheet, with almost $30 million in cash as of March 31st, enables us to intensify our efforts, while also building upon the interest in the Company’s disruptive vaccine platform."

"With Andrei’s appointment, we are pleased to have a seasoned executive with experience in vaccines and business development to build out the Company and set it on a path of sustainable growth," said Steven Boyd, a member of Vaxart’s Board of Directors. "As Vaxart’s largest institutional investor, and having personally known Andrei since we both worked at McKinsey, I have great confidence in his ability to generate substantial shareholder value by unlocking the Company’s tremendous potential. Vaxart has a strong balance sheet, a recurring royalty stream from Inavir marketed by Daiichi Sankyo to provide working capital, and multiple potential partnership opportunities."

On June 15, 2020 INmune Bio, Inc. (NASDAQ: INMB) (the "Company"), a clinical-stage immunology company focused on developing treatments that harness the patient’s innate immune system to fight disease, reported that the Medicines and Healthcare products Regulatory Agency (MHRA; the UK equivalent of the FDA) has given approval to initiate a Phase I clinical trial of INKmune, a novel therapy to prime the patient’s own NK cells to attack their cancer, in patients with high-risk Myelodysplastic Syndrome (MDS) (EUDRACT 2019-004820-40) (Press release, INmune Bio, JUN 15, 2020, View Source [SID1234561101]). This single center Phase I trial will be the first-in-man study using INKmune. Based on the current environment and timetable of its clinical site, INmune Bio is targeting the study initiation in the 2nd half of this year.

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"Patients with MDS are mostly elderly; in this population high-dose chemotherapy or bone marrow transplant are usually too toxic," said Dr. Marion Wood, consultant hematologist and the medical director for this INKmune program. "With this clinical trial, we hope to show that INKmune will provide an effective and better tolerated therapeutic option for those patients who are poorly served by current therapies." Patients with high-risk MDS will be enrolled to receive at least 3 doses of INKmune therapy via intravenous infusion, without the need for any type of conditioning therapy or pretreatment. The Phase I trial, called Laurel, will include at least 9 patients enrolled at a single center in the UK and has the capacity for an extension cohort.

"Recent research has shown that MDS patients who survive beyond two years are those with good NK cell activity (Tsirogianni et al 2019). INKmune has been shown to boost the function of NK cells from MDS patients in laboratory experiments. We will target those patients whose NK cells demonstrate a response to INKmune in the laboratory. This is part of our precision approach to immunotherapy," said Dr. Mark Lowdell, CSO of INmune Bio and discoverer of the science behind INKmune. "We are excited to be able to test it as a treatment in this group of patients facing an unmet therapeutic need."

"Professor Lowdell and his team in the UK have worked closely with the MHRA to get this trial through regulatory approval, despite the challenges of the COVID-19 pandemic," said RJ Tesi MD, CEO of INmune. "The INKmune program is the second oncology platform entering the clinic for INmune Bio."

On June 15, 2020 Constellation Pharmaceuticals, Inc., (Nasdaq: CNST) a clinical-stage biopharmaceutical company using its expertise in epigenetics to discover and develop novel therapeutics, reported that it has commenced an underwritten public offering of 4,000,000 shares of its common stock (Press release, Constellation Pharmaceuticals, JUN 15, 2020, View Source [SID1234561100]). All of the shares are being offered by Constellation. In addition, Constellation expects to grant the underwriters a 30-day option to purchase up to an additional 600,000 shares of its common stock sold in the public offering.

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J.P. Morgan, Jefferies, Cowen and RBC Capital Markets are acting as joint book-running managers for the offering. SunTrust Robinson Humphrey is acting as lead manager and Baird is acting as co-manager for the offering. 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, or as to the actual size or terms of the offering.

The shares are being offered by Constellation pursuant to an automatically effective shelf registration statement that was filed with the Securities and Exchange Commission ("SEC") on December 9, 2019.

This offering is being made only by means of a prospectus and prospectus supplement that form a part of the registration statement. A preliminary prospectus supplement relating to and describing the terms of the offering is expected to be filed with the SEC and, if and when filed, copies of the preliminary prospectus supplement relating to the offering may be obtained for free by visiting the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting: J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, telephone: (866) 803-9204; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at 877-821-7388 or by email at [email protected]; Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, Attn: Prospectus Department, by email at [email protected] or by telephone at (833) 297-2926; or RBC Capital Markets, LLC, Attention: Equity Capital Markets, 200 Vesey Street, New York, New York 10281, by telephone at (877) 822-4089 or by email at [email protected]. The final terms of the offering will be disclosed in a final prospectus supplement to be filed with the SEC.

On June 15, 2020 BerGenBio ASA (OSE:BGBIO), a clinical-stage biopharmaceutical company developing novel, selective AXL kinase inhibitors for severe unmet medical need, reported that its abstract has been accepted for oral virtual presentation at the 3rd Annual Next Gen Immuno-Oncology Congress, which takes place from 25-26 June 2020 (Press release, BerGenBio, JUN 15, 2020, View Source [SID1234561099]).

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The presentation to be given by Prof. Hani Gabra MD PhD, CMO BerGenBio, will provide an update of results from a phase II trial (BGBC008), evaluating bemcentinib in combination with MSD’s Keytruda (pembrolizumab) in previously treated non-small cell lung cancer (NSCLC) patients with confirmed progression, including positive top line clinical and translational data from stage 1 of Cohort B in patients having failed prior immune checkpoint therapy.

The presentation will be available on the Company website in the Presentations section on 25 June: www.bergenbio.com/investors/presentations/

Title: Targeting AXL to leverage checkpoint immunotherapy: ​Updated results of the BGBC008 phase II study of bemcentinib and pembrolizumab in recurrent NSCLC

Date and time: 25 June 2020, 10am EST

Session name: Targeted Antibodies and Cellular Therapy

About AXL

AXL kinase is a cell membrane receptor and an essential mediator of the biological mechanisms underlying life-threatening diseases. In cancer, AXL suppresses the body’s immune response to tumours and drives cancer treatment failure across many indications. AXL expression defines a very poor prognosis subgroup in most cancers. AXL inhibitors, therefore, have potential high value at the centre of cancer combination therapy, addressing significant unmet medical needs and multiple high-value market opportunities. Research has also shown that AXL mediates other aggressive diseases.

About Bemcentinib

Bemcentinib (formerly known as BGB324), is a potentially first-in-class selective AXL inhibitor in a broad phase II clinical development programme. Ongoing clinical trials are investigating bemcentinib in multiple solid and haematological tumours, in combination with current and emerging therapies (including immunotherapies, targeted therapies and chemotherapy), and as a single agent. Bemcentinib targets and binds to the intracellular catalytic kinase domain of AXL receptor tyrosine kinase and inhibits its activity. Increase in AXL function has been linked to key mechanisms of drug resistance and immune escape by tumour cells, leading to aggressive metastatic cancers.