On May 27, 2021 Dynavax Technologies Corporation (Nasdaq: DVAX), a biopharmaceutical company focused on developing and commercializing novel vaccines, reported it has entered into a commercialization agreement with Bavarian Nordic for the marketing and distribution of HEPLISAV B [Hepatitis B Vaccine (Recombinant), Adjuvanted] in Germany with an expected launch in the fourth quarter of 2021 (Press release, Dynavax Technologies, MAY 27, 2021, View Source [SID1234580671]).

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In February 2021, the European Commission (EC) granted marketing authorization for HEPLISAV B for the active immunization against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older. HEPLISAV B is the only U.S. Food and Drug Administration (FDA) and EC approved hepatitis B vaccine for adults with a two-dose regimen that is completed in one month.

Hepatitis B is a highly infectious and potentially deadly virus with increasing infection rates, and over 250 million people infected worldwide. Hepatitis B can be prevented with effective vaccination. HEPLISAV B, with a two-dose regimen that takes only one month to complete and a statistically significantly higher seroprotection rate in head-to-head clinical trials, provides a unique opportunity to address known challenges with compliance, while delivering higher levels of protection compared to the three-dose regimen of the comparator vaccine.

Ryan Spencer, Chief Executive Officer of Dynavax, commented: "We are excited to work with Bavarian Nordic on the commercialization of HEPLISAV B in Germany. Their existing marketing and distribution network in Germany provides an excellent platform to make HEPLISAV B available to patients. The strong overlap with the existing target audience within general practitioners, occupational health groups and travel medicine specialists provides a good strategic fit and clear commercial synergies for the dedicated sales force Bavarian Nordic has established in Germany."

Paul Chaplin, President and CEO of Bavarian Nordic, commented: "We are pleased to expand our commercial footprint in the largest EU market by adding a complementary product to our marketing and distribution and we look forward to assisting Dynavax in a successful market entry in Europe later this year."

About Hepatitis B
Hepatitis B is a viral disease of the liver that can become chronic and lead to cirrhosis, liver cancer and death. The hepatitis B virus is 50 to 100 times more infectious than HIV,I and transmission is on the rise. There is no cure for hepatitis B, but effective vaccination can prevent the disease.

In adults, hepatitis B is spread through contact with infected blood and through unprotected sex with an infected person. The U.S. Centers for Disease Control (CDC) recommends vaccination for those at high risk for infection due to their jobs, lifestyle, living situations and travel to certain areas.II Because people with diabetes are particularly vulnerable to infection, the CDC recommends vaccination for adults age 19 to 59 with diabetes as soon as possible after their diagnosis, and for people age 60 and older with diabetes at their physician’s discretion.III Approximately 20 million U.S. adults have diabetes, and 1.5 million new cases of diabetes are diagnosed each year.IV

About HEPLISAV-B
HEPLISAV-B is an adult hepatitis B vaccine that combines hepatitis B surface antigen with Dynavax’s proprietary Toll-like Receptor (TLR) 9 agonist CpG 1018 adjuvant to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.

Important EU/EEA Product Information
HEPLISAV B is indicated for active immunisation against hepatitis B virus infection (HBV) caused by all known subtypes of hepatitis B virus in adults 18 years of age and older.

The use of HEPLISAV B should be in accordance with official recommendations.

It can be expected that hepatitis D will also be prevented by immunisation with HEPLISAV B as hepatitis D (caused by the delta agent) does not occur in the absence of hepatitis B infection.

For full E.U. Prescribing Information for HEPLISAV-B, click here.

Important EU/EEA Safety information
Do not receive HEPLISAV B if you have had a sudden life-threatening, allergic reaction after receiving HEPLISAV B in the past, or if you are allergic to any components of this vaccine, including yeast. Signs of an allergic reaction may include itchy skin, rash, shortness of breath and swelling of the face or tongue.

Appropriate medical treatment and supervision should be readily available in case of rare anaphylactic reactions following the administration of the vaccine.

The administration of HEPLISAV B should be postponed in subjects suffering from acute severe febrile illness.

Immunocompromised persons may have a diminished immune response to HEPLISAV B.

Because of the long incubation period of hepatitis B, it is possible for unrecognised HBV infection to be present at the time of immunisation. HEPLISAV B may not prevent HBV infection in such cases.

There are very limited data on the immune response to HEPLISAV B in individuals who did not mount a protective immune response to another hepatitis B vaccine.

As a precautionary measure, it is preferable to avoid the use of HEPLISAV B during pregnancy. Vaccination during pregnancy should only be performed if the risk-benefit ratio at the individual level outweighs possible risks for the fetus.

The most common patient-reported side effects reported within 7 days of vaccination were pain, swelling or redness at the injection site, feeling tired, headache, muscle aches, feeling unwell and fever.

Important U.S. Product Information
HEPLISAV-B is indicated for prevention of infection caused by all known subtypes of hepatitis B virus in adults age 18 years and older.

For full U.S. Prescribing Information for HEPLISAV-B, click here.

Important U.S. Safety Information (ISI)
Do not administer HEPLISAV-B to individuals with a history of severe allergic reaction (e.g., anaphylaxis) after a previous dose of any hepatitis B vaccine or to any component of HEPLISAV-B, including yeast. Appropriate medical treatment and supervision must be available to manage possible anaphylactic reactions following administration of HEPLISAV-B. Immunocompromised persons, including individuals receiving immunosuppressant therapy, may have a diminished immune response to HEPLISAV-B. Hepatitis B has a long incubation period. HEPLISAV-B may not prevent hepatitis B infection in individuals who have an unrecognized hepatitis B infection at the time of vaccine administration. The most common patient reported adverse reactions reported within 7 days of vaccination were injection site pain (23% to 39%), fatigue (11% to 17%) and headache (8% to 17%).

On May 27, 2021 AstraZeneca PLC ("AstraZeneca") reported that, on 26 May 2021, it successfully priced €800m ($1bn equivalent) of fixed rate notes with a coupon of 0.375%, maturing on 3 June 2029 (the "Notes") (Press release, AstraZeneca, MAY 27, 2021, View Source [SID1234580689]).

The Notes will be subject to special mandatory redemption if the acquisition of Alexion Pharmaceuticals, Inc. ("Alexion") (the "Alexion Acquisition") is not consummated on or before 12 March 2022 or, if prior to such date, AstraZeneca notifies the trustee that AstraZeneca will not pursue the consummation of the Alexion Acquisition.

AstraZeneca expects to use the net proceeds of the offering to fund a portion of the purchase price for the Alexion Acquisition, to pay or refinance a portion of Alexion’s indebtedness and to pay related fees and expenses, or for general corporate purposes.

The Notes will be issued under the $10,000,000,000 EMTN programme of AstraZeneca and AstraZeneca Finance LLC, which AstraZeneca filed with the UK Financial Conduct Authority on 24 May 2021, and admitted to listing on the UK Financial Conduct Authority’s Official List and to trading on the London Stock Exchange’s Main Market.

The Notes have not been registered under the U.S. Securities Act of 1933 and may not be offered or sold in the United States absent registration or an applicable exemption from registration.

This announcement shall not constitute an offer to sell or the solicitation of an offer to buy the Notes described herein, nor shall there be any sale of these Notes in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

The issuance of the Notes does not impact AstraZeneca’s financial guidance for 2021.

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On May 27, 2021 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported that members of the management team will present during a fireside chat at the 2021 Jefferies Virtual Healthcare Conference, being held June 1 – 4, 2021 (Press release, Altimmune, MAY 27, 2021, View Source [SID1234580705]).

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Details on the Jefferies fireside chat presentation are as follows:

Title : 2021 Jefferies Virtual Healthcare Conference

Presenters: Vipin Garg, Ph.D., Chief Executive Officer
Scot Roberts, Ph.D., Chief Scientific Officer
Scott Harris, M.D., Chief Medical Officer

Date/Time: Wednesday, June 2, 2021 at 11:30 am ET
A webcast link to the fireside chat presentation will be accessible on the Events section of the Altimmune website.

On May 27, 2021 Centessa Pharmaceuticals plc ("Centessa"), a clinical-stage company employing its innovative asset-centric business model to discover, develop and ultimately deliver impactful medicines to patients, reported the pricing of its initial public offering of 16,500,000 American Depositary Shares ("ADSs"), each representing one ordinary share at a public offering price of $20.00 per ADS (Press release, Centessa Pharmaceuticals, MAY 27, 2021, View Source [SID1234583241]). All of the ADSs are being offered by Centessa. The gross proceeds to Centessa from the offering, before deducting underwriting discounts, commissions and other estimated offering expenses, are expected to be approximately $330.0 million. In addition, the underwriters have been granted a 30-day option to purchase up to an additional 2,475,000 ADSs at the initial public offering price, less underwriting discounts and commissions. The shares are expected to begin trading on The Nasdaq Global Select Market under the ticker symbol "CNTA" on May 28, 2021. The offering is expected to close on June 2, 2021, subject to the satisfaction of customary closing conditions.

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Morgan Stanley, Goldman Sachs & Co. LLC, Jefferies, and Evercore ISI are acting as joint book-running managers for the offering.

A registration statement relating to these securities was declared effective by the Securities and Exchange Commission on May 27, 2021. The offering is being made only by means of a written prospectus. Copies of the final prospectus relating to the initial public offering can be obtained, when available, from: Morgan Stanley & Co. LLC, Attention: Prospectus Department, 180 Varick Street, 2nd Floor, New York, New York 10014; Goldman Sachs & Co. LLC, Attention: Prospectus Department, 200 West Street, New York, NY 10282, by telephone at (866) 471-2526 or by email at [email protected]; Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10012, by telephone at 877-821-7388 or by email at [email protected]; and Evercore Group L.L.C., Attention: Equity Capital Markets, 55 East 52nd Street, 35th Floor, New York, New York 10055, or by telephone at (888) 474 0200, or by email at [email protected].

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

On May 27, 2021 Aptevo Therapeutics Inc. ("Aptevo") (NASDAQ:APVO), a clinical-stage biotechnology company focused on developing novel immuno-oncology therapeutics based on its proprietary ADAPTIRTM and ADAPTIR-FLEXTM platform technologies reported that the company has initiated the expansion phase of lead anti-leukemia drug candidate, APVO436, in adult patients with acute myeloid leukemia (AML) with a multi-center, multi-arm trial using the active recommended dose identified in the dose escalation phase (Part 1) of the study (Press release, Aptevo Therapeutics, MAY 27, 2021, View Source [SID1234583271]). During Part 1, APVO436 exhibited a manageable side effect profile, encouraging single agent activity and a promising benefit to risk profile in relapsed AML patients. The Company has plans to submit data from the dose escalation phase for publication later this year.

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The dose expansion phase (Part 2), has been rationally designed to further evaluate the tolerability and clinical impact potential of APVO436 for indications of unmet and urgent medical need. During Part 2, the dose expansion phase of the study, a total of 90 AML patients will be enrolled into 5 cohorts of 18 patients each, as explained in the detailed and publicly available study information provided at CinicalTrials.gov (NCT03647800) The study will be conducted under an FDA-approved IND and has been Central IRB-approved. Patient enrollment is anticipated to commence in June. The goal of the expansion phase is to evaluate the safety and tolerability of APVO436 at the recommended Phase 2 dose level, when it is used as an adjunct to the standard of care and to obtain a preliminary assessment of the anti-leukemia activity of APVO436 containing experimental monotherapy and combination therapy modalities.

Protocol-specific training has started for the participating academic cancer centers in the US. Aptevo is planning to conduct Part 2 of the study at up to 20 clinical trial sites.

"The greatest challenge in AML is relapsed or refractory disease. For relapsed or refractory AML, there is no consensus on a single re-induction regimen" explained Dr. Fatih Uckun, leukemia expert and Chief Clinical Advisor. "By combining APVO436 with the standard of care, Aptevo hopes to develop an innovative approach that improves outcomes for patients with relapsed AML, who generally have a dismal prognosis," he stated.

Dr. Uckun explained further: "In addition, newly diagnosed AML patients with inherent drug resistance who have documented residual leukemia after standard frontline chemotherapy regimens, have a very poor prognosis and are in urgent need of therapeutic innovations. Part 2 of the Aptevo study will therefore seek proof of concept in the use of APVO436 as part of frontline multimodality regimens would enable the eradication of residual leukemia cells that have escaped standard chemotherapy. To this end we will carefully study the tolerability and clinical activity of APVO436 when used as rationally designed in each of the 5 cohorts of Part 2 of our Phase 1B study."

Overview of Cohorts

In Cohort 1, AML patients in relapse will be treated with the standard chemotherapy drug cytarabine or the standard chemotherapy triple drug combination MEC (mitoxantrone, etoposide, cytarabine) plus APVO436. Also treated in this cohort will be patients with primary refractory AML whose leukemia failed to respond to frontline standard induction chemotherapy.

In Cohort 2, AML patients in first relapse will receive a combination of APVO436 + venetoclax + azacitidine. Also included in this cohort will be newly diagnosed AML patients with a poor prognosis who will receive this novel combination as their frontline induction regimen.

In Cohort 3, AML patients with poor prognosis who are newly diagnosed will receive their frontline chemotherapy to induce a remission and APVO436 will be added if there is evidence of residual leukemia remaining. Also included in this cohort will be AML patients who experienced an early first relapse within 1 year of receiving their frontline chemotherapy. Such patients are generally known to have a dismal outcome.

In Cohort 4, AML patients in 1st remission who have evidence of residual leukemia, also known as minimal residual disease (MRD), will receive the standard drug oral azacytidine in combination with APVO436.

In Cohort 5, AML patients in 2nd remission who are MRD+ will be treated with APVO436 monotherapy.

"New treatments are urgently needed for frontline adverse risk and relapsed AML populations and I look forward to working with Dr. Uckun and other investigators for a step-wise evaluation of the clinical potential of APVO436", says Dr. Justin Watts, Associate Professor of Medicine at the University of Miami Sylvester Comprehensive Cancer Center.

"This week has been exciting for Aptevo, as we announced both positive results from the dose escalation part of our Phase 1 trial and the initiation of the expansion phase. We are particularly excited about the fact that APVO436 did not cause severe neutropenia in any of the AML patients treated so far. This is a potentially paradigm-shifting discovery as it provides the unique opportunity to integrate APVO436 into standard treatment regimens that inherently cause severe neutropenia," said Mr. Marvin White, President and CEO of Aptevo. "The initiation of Part 2 in our APVO436 study emphasizes our commitment to advance our ADAPTIR and ADAPTIR-FLEX platforms as integral parts of a novel standard of care for the most difficult-to-treat forms of cancer. We look forward to sharing interim data from Part 2 of the trial, later this year."