On June 2, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that Michael Amoroso, President and Chief Executive Officer, will present at the Jefferies Virtual Healthcare Conference on Thursday, June 3, 2021 at 10:30 a.m. ET (Press release, Abeona Therapeutics, JUN 2, 2021, View Source [SID1234583372]).

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A live and archived webcast of the presentation will be available on the investor section of the Abeona Therapeutics website at www.abeonatherapeutics.com.

On June 2, 2021 Pascal Biosciences Inc. ("Pascal" or the "Company") (TSXV:PAS) (OTC:BIMUF), a biotechnology company that specializes in cancer, cannabinoids, and Covid-19 reported the closing of the second tranche of the non-brokered private placement announced on November 2, 2020, January 19, 2021 and January 22, 2021 (the "Private Placement") (Press release, Pascal Biosciences, JUN 2, 2021, View Source [SID1234583388]). Participants included long-term shareholders, new shareholders, and Company insiders. "This financing will greatly help Pascal move our programs forward. It’s encouraging to see the confidence of our long term shareholders and we welcome our new shareholders", stated CEO Patrick Gray. "Mark van der Horst, our vice president of Corporate Communications, has done a great job of presenting the Pascal story, and we will continue to actively deliver positive messaging to investors."

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The second tranche consists of 1,900,000 units (each a "Unit") for gross proceeds of $190,000. The first tranche closed on February 8, 2021 and the Company issued 5,600,000 Units for gross proceeds of $560,000. Each Unit consists of one common share in the capital of the Company (each a "Share") and one Share purchase warrant (each a "Warrant"). Each Warrant entitles the holder to purchase one additional Share at a price of $0.15 per Share for a period of 24 months from the date of closing, subject to an exercise acceleration clause. Under the exercise acceleration clause, which the Company may exercise once the Units are free of resale restrictions and if the Company’s Shares are trading at or above a volume weighted average price of $0.40 for 10 consecutive trading days, the Warrants will expire upon 30 days from the date the Company provides notice in writing to the Warrant holders via a news release.

The Company paid $1,365 in finder’s fees related to the second tranche of the Private Placement.

Certain directors and officers of the Company acquired 1,255,000 Units under the Private Placement. Any such participation is considered to be a "related party transaction" as defined under Multilateral Instrument 61 -101 Protection of Minority Security Holders in Special Transactions ("MI 61-101"). The transaction will be exempt from the formal valuation and minority shareholder approval requirements of MI 61-101 as neither the fair market value of any shares issued to, or the consideration paid by such persons, will exceed 25% of the Company’s market capitalization.

The proceeds from the sale of Units will be added to working capital in furtherance of the Company’s business.

The securities issued under the Private Placement are subject to a four-month and one day hold period. The private placement is subject to final acceptance by the TSX Venture Exchange upon filing of final documents.

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 Global pharma major, Lupin Limited (Lupin) reported that the U.S. FDA has accepted the Biologics License Application (BLA) for its proposed biosimilar to Neulasta (pegfilgrastim) through a filing using the 351(k) pathway(Press release, Lupin, JUN 2, 2021, View Source [SID1234584117]).

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Pegfilgrastim has estimated annual sales of USD 3.66 billion in the U.S. (IQVIA MAT December 2020).

Commenting on the development, Vinita Gupta, CEO, Lupin said, "FDA’s acceptance of our BLA is a significant achievement and demonstrates our commitment to delivering products which increase access in areas of substantial medical need. This BLA expands our oncology portfolio, an area of increasing focus for Lupin. We look forward to the opportunity to bring affordable biologic options to patients and increasing access to this important treatment."

Nilesh Gupta, MD, Lupin said, "The pegfilgrastim filing is our first biosimilar filing in the U.S. and is a milestone in our research and innovation journey as we continue to focus on delivering unique and affordable solutions to alleviate disease burden. Biosimilars is a key part of our growth strategy and we are proud of the world-class achievements of our group.’’

The BLA submission is supported by similarity data from analytical, pharmacokinetic, pharmacodynamic and immunogenicity studies.

Dr. Cyrus Karkaria, President, Lupin Biotech said "With significant investment in our biotechnology division over the years, we remain committed to bringing much-needed innovative products to market. This milestone further encourages us to continue advancing our robust Biosimilars pipeline across the globe to provide effective, affordable alternative for consumers."

On June 2, 2021 Alpine Immune Sciences, Inc. (NASDAQ:ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported the appointment of industry veteran Zelanna Goldberg, M.D., M.A.S. as its Chief Medical Officer (Press release, Alpine Immune Sciences, JUN 2, 2021, View Source [SID1234583373]). Dr. Goldberg joins Alpine from Iovance Biotherapeutics, where she was Senior Vice President, Clinical Science.

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"We are very enthusiastic about the addition of Zelanna to the Alpine team, particularly as we pursue an expanding scope of clinical development activities across oncology and inflammatory disease indications," said Stanford Peng, M.D., Ph.D., President and Head of Research and Development at Alpine. "Zelanna is an experienced clinical development executive with a commitment to helping patients with life-threatening and debilitating diseases."

"I am thrilled to join Alpine and lead the clinical strategy and development of the company’s extremely promising pipeline, including ALPN-101, ALPN-202, and ALPN-303," said Dr. Goldberg. "I look forward to integrating within the research and development team to continue to advance these unique therapies and those that are coming next from Alpine’s directed evolution platform to meaningfully improve the lives of patients with cancer and life-threatening auto-immune diseases."

Dr. Goldberg brings over 20 years of industry and clinical practice experience, including strategic and/or operational responsibility for multiple therapeutic products such as dacomitinib (Vizimpro), palbociclib (Ibrance), and avelumab (Bavencio). Most recently, Dr. Goldberg was Senior Vice President, Clinical Sciences at Iovance Biotherapeutics, where she oversaw multiple aspects of the clinical development program of lifileucel (LN-145). Prior to Iovance, Dr. Goldberg held roles of increasing responsibility at Sunesis, Oxigene and Pfizer, where she was the global clinical lead for multiple assets. Prior to entering industry, Dr. Goldberg was an Associate Professor in the Department of Radiation Oncology at the University of California, Davis Medical Center.

Dr. Goldberg received her M.D. degree from University of Toronto Faculty of Medicine. Dr. Goldberg completed her residency in Radiation Oncology at Ontario Cancer Institute/Princess Margaret Hospital-University of Toronto, and her post-doctoral training in radiosensitizing drugs at Stanford University.

Disclosure of Inducement Grant under Nasdaq Listing Rules

The compensation committee of Alpine’s board of directors granted Dr. Goldberg an option to purchase 160,000 shares of common stock. The option will vest with respect to 25% of the shares underlying the option on the one-year anniversary of Dr. Goldberg’s employment start date of June 1, 2021, and the remaining 75% of the shares underlying the option will vest in equal monthly installments over the 36-month period following the one-year anniversary of Dr. Goldberg’s employment start date, subject to her continued service to Alpine through each relevant vesting date. In addition, pursuant to the terms of Alpine’s change of control and severance policy, if there is a change of control and, upon or during the 12 months after the change of control, Dr. Goldberg’s employment is terminated either (i) by Alpine without cause or (ii) by Dr. Goldberg for good reason, the option will become fully vested and exercisable. The option has a ten-year term and an exercise price of $10.29, equal to the per share closing price of Alpine’s common stock as reported by Nasdaq on June 1, 2021.

The stock options were granted outside Alpine’s 2018 Equity Incentive Plan as an inducement material to Dr. Goldberg entering into employment with Alpine in accordance with Nasdaq Listing Rule 5635(c)(4). The terms and conditions of the option are generally consistent with those in Alpine’s 2018 Equity Incentive Plan.