On June 2, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, and UNICEF reported that they have signed a long-term agreement for the supply of COVID-19 vaccine on behalf of the COVAX Facility as part of the agreement announced in May 2021 (Press release, Moderna Therapeutics, JUN 2, 2021, View Source [SID1234583404]).

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Through this long-term agreement, UNICEF and its procurement partners including the Pan American Health Organization (PAHO) will have access to up to 34 million doses of COVID-19 Vaccine Moderna to be delivered in the fourth quarter 2021 and up to 466 million doses in 2022. All doses are offered at Moderna’s lowest tiered price, in line with the Company’s global access commitments.

"We are proud and humbled to be able to supply our vaccine through this long-term agreement with UNICEF in support of efforts to end this pandemic," said Stéphane Bancel, Chief Executive Officer of Moderna. "We share in the mission of the COVAX Facility to ensure global access to vaccines including in low- and middle-income countries around the world."

On April 30, the World Health Organization (WHO) issued an Emergency Use Listing (EUL) for Moderna’s COVID-19 vaccine to prevent COVID-19 in individuals 18 years of age and older.

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S.FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea and an Emergency Use Listing (EUL) from the World Health Organization (WHO).

Initial data from Moderna’s Phase 2 study in the U.S. showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). A booster dose of mRNA-1273.351, the Company’s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies. A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm.

On June 2, 2021 Can-Fite BioPharma Ltd. (NYSE American: CANF) (TASE:CFBI), a biotechnology company advancing a pipeline of proprietary small molecule drugs that address inflammatory, cancer and liver diseases, reported the Company’s Vice President of Business Development Dr. Sari Fishman will present at the BIO Digital International Convention and participate in one-on-one meetings with potential licensing and distribution partners on June 10-11 & 14-18, 2021 (Press release, Can-Fite BioPharma, JUN 2, 2021, View Source [SID1234583402]). Over 3,800 delegates from 2,300 companies are registered for BIO One-on-One Partnering.

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Can-Fite currently has out-licensing agreements for its Namodenoson and Piclidenoson drug candidates in several territories and has received approximately $20 million in upfront and milestone payments to date with additional potential milestone payments of up to approximately $130 million, plus double-digit royalties on net sales following regulatory approval.

"We look forward to productive meetings with potential partners in untapped territories for our drug candidates as we approach several milestones before year-end including announcing topline data from our Phase III psoriasis trial and Phase II COVID-19 study, as well as commencing a pivotal Phase III in liver cancer and a Phase IIb in NASH," stated Can-Fite CEO Dr. Pnina Fishman.

On June 2, 2021 Moderna, Inc. (Nasdaq: MRNA), a biotechnology company pioneering messenger RNA (mRNA) therapeutics and vaccines, reported that it has entered into an additional agreement with Lonza (SIX: LONN) to support drug substance manufacturing for its global supply chain (Press release, Moderna Therapeutics, JUN 2, 2021, View Source [SID1234583401]). The agreement will establish a new production line at Lonza’s Geleen site in the Netherlands, contributing to the supply of an additional 300 million doses of Moderna’s updated booster variant vaccine candidate, if authorized, per year, at a 50 µg dose.

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In addition to previously announced investments in drug substance manufacturing with ROVI in Granada, Spain, the Company now expects to be able to supply the equivalent of 600 million 50 µg doses per year from production within the European Union. Both new drug substance lines in the European Union are expected to be operational before the end of 2021.

"We thank our manufacturing partners for their work and their commitment and are proud to be building on the strong foundations we have established with Lonza to further increase our manufacturing capabilities in Europe," said Juan Andres, Moderna’s Chief Technical Operations and Quality Officer. "This additional production will help us continue to scale up our production as we continue to develop best-in-class variant boosters so we can help end this pandemic as fast as possible."

Moderna already works with ROVI and Recipharm (France) for fill/finish of COVID-19 Vaccine Moderna in Europe and recently entered into a Manufacturing Services and Supply Agreement with Samsung Biologics in South Korea to provide additional large scale, commercial fill/finish services. In the U.S., the Company also works with Lonza Portsmouth for drug substance production, and partners with Catalent, Baxter BioPharma Solutions, Sanofi and Thermo Fisher Scientific for fill/finish services. Additional manufacturing investments follow the Company’s commitment to increase production in late 2021 and early 2022 to support global supply of its COVID-19 vaccine.

When completed, the increased production, in addition to other investments at its owned and partnered manufacturing facilities, is expected to also result in an increase in safety stock of raw materials and finished product used to deliver committed volumes.

About the COVID-19 Vaccine Moderna

The COVID-19 Vaccine Moderna (referred to in the U.S. as the Moderna COVID-19 Vaccine) is an mRNA vaccine against COVID-19 encoding for a prefusion stabilized form of the Spike (S) protein, which was co-developed by Moderna and investigators from the National Institute of Allergy and Infectious Diseases’ (NIAID) Vaccine Research Center. The first clinical batch, which was funded by the Coalition for Epidemic Preparedness Innovations, was completed on February 7, 2020 and underwent analytical testing; it was shipped to the National Institutes of Health (NIH) on February 24, 42 days from sequence selection. The first participant in the NIAID-led Phase 1 study of the Moderna COVID-19 Vaccine was dosed on March 16, 63 days from sequence selection to Phase 1 study dosing. On May 12, the U.S Food and Drug Administration granted the Moderna COVID-19 Vaccine Fast Track designation. On May 29, the first participants in each age cohort: adults ages 18-55 years (n=300) and older adults ages 55 years and above (n=300) were dosed in the Phase 2 study of the vaccine. On July 8, the Phase 2 study completed enrolment.

Results from the second interim analysis of the NIH-led Phase 1 study of the Moderna COVID-19 Vaccine in the 56-70 and 71+ age groups were published on September 29 in The New England Journal of Medicine. On November 30, 2020, Moderna announced the primary efficacy analysis of the Phase 3 study of the vaccine conducted on 196 cases. On November 30, 2020, the Company also announced that it filed for Emergency Use Authorization with the U.S. FDA and a Conditional Marketing Authorization (CMA) application with the European Medicines Agency. On December 18, 2020, the U.S. FDA authorized the emergency use of the Moderna COVID-19 Vaccine in individuals 18 years of age or older. Moderna has also received emergency (or other conditional, interim or provisional) authorization for use of its COVID-19 vaccine from health agencies in Canada, Israel, the European Union, the United Kingdom, Switzerland, Singapore, Qatar, Taiwan, the Philippines, Thailand, Brunei, Paraguay, Japan, South Korea an Emergency Use Listing (EUL) from the World Health Organization (WHO).

Initial data from Moderna’s Phase 2 study in the U.S. showed that a single 50 µg dose of mRNA-1273 or mRNA-1273.351 given as a booster to previously vaccinated individuals increased neutralizing antibody titer responses against SARS-CoV-2 and two variants of concern, B.1.351 (first identified in South Africa) and P.1 (first identified in Brazil). A booster dose of mRNA-1273.351, the Company’s strain-matched booster, achieved higher neutralizing antibody titers against the B.1.351 variant of concern than a booster dose of mRNA-1273. Safety and tolerability profiles following third dose booster injections of 50 µg of mRNA-1273 or mRNA-1273.351 were generally comparable to those observed after the second dose of mRNA-1273 in the previously reported Phase 2 and Phase 3 studies. A manuscript describing these preliminary results was submitted as a preprint to medRxiv and will be submitted for peer-reviewed publication upon completion of the multivalent mRNA-1273.211 booster arm.

On June 2, 2021 Amplia Therapeutics Limited (ASX: ATX), ("Amplia" or the "Company"), a company developing new approaches for the treatment of cancer and fibrosis, reported that it has received new data from its collaboration with Professor Paul Timpson of the Garvan Institute of Medical Research, Sydney ("Garvan") (Press release, Amplia Therapeutics, JUN 2, 2021, View Source;[email protected] [SID1234583400]). The new data show that Amplia’s Focal Adhesion Kinase (FAK) inhibitor AMP945 is able to improve the anticancer activity of combined gemcitabine and Abraxane in an animal model of aggressive pancreatic cancer.

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Gemicitabine and Abraxane is a widely used first-line treatment for patients with pancreatic cancer. These new data show that adding intermittent doses of Amplia’s AMP945 to this standard-of-care therapy increases survival by 27% in the aggressive KPC pancreatic cancer animal model. This follows previous work showing that AMP945 enhances the activity of chemotherapy by increasing cell death and reducing cancer cell proliferation. The latest study showsthat these effectstranslate into a survival benefit in an animal model of pancreatic cancer.

In the recent experiment, pancreatic tumour tissue was grown subcutaneously in mice using an animal model of pancreatic cancer called the KPC model, a well-established and widely accepted model of the disease. Once the tumours were established, AMP945 was orally administered to the animals in between their doses of gemcitabine/Abraxane in order to make the tumours more susceptible to the effects of the chemotherapy. The median survival time of untreated mice was 18 days, while mice treated with AMP945 alone or with gemcitabine/Abraxane alone exhibited a median survival time of 23 days or 22 days respectively. By contrast, mice treated with a combination of AMP945 and gemcitabine/Abraxane had a median survival time of 28 days, representing a statistically significant 27% increase in median survival (P ≤ 0.001), relative to gemcitabine/Abraxane alone. * P ≤ 0.05; *** P ≤ 0.001 Commenting on the results, Professor Timpson noted that "The pancreatic cancer cells used in this experiment are extremely aggressive, so showing any beneficial effect on survival is very encouraging. A 25% improvement in survival in this model is very impressive and a level of improvement that we rarely see."

Dr. John Lambert, CEO of Amplia commented that "These data further underpin the rationale for our planned Phase 2 clinical trial in pancreatic cancer. Earlier data told us that adding AMP945 to gemcitabine and Abraxane increased cancer cell death and reduced proliferation, and this new data tells us that those effects actually translate into prolonged survival in this model. We are strongly encouraged by these results."

Amplia is currently using recently raised capital for a range of essential activities required to initiate the Phase 2 clinical trial in pancreatic cancer patients towards the end of this year.

This ASX announcement was approved and authorised for release by the Board of Amplia Therapeutics Limited.

On June 2, 2021 Agenus (NASDAQ: AGEN), an immuno-oncology company with an extensive pipeline of checkpoint antibodies, cell therapies, adjuvants, and vaccines designed to activate immune response to cancers and infections, reported that Jennifer Buell, PhD, President and COO of Agenus, will participate in a fireside chat at the Jefferies 2021 Virtual Healthcare Conference on Friday, June 4, 2021 from 10:30 a.m. to 10:55 a.m. ET (Press release, Agenus, JUN 2, 2021, View Source [SID1234583399]).

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Registration for the webinar can be done in advance at View Source

A replay will be available after the call on the Events & Presentations page of the Agenus website at View Source