On April 6, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company developing PVSRIPO, a novel viral immunotherapy that activates innate and adaptive immunity to facilitate a functional antitumor CD8+ T cell response, reported two upcoming poster presentations at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. The AACR (Free AACR Whitepaper) Annual Meeting will be held virtually April 10-15 and May 17-21, 2021 (Press release, Istari Oncology, APR 6, 2021, View Source [SID1234577606]).

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The full text of the following abstracts will be posted to the AACR (Free AACR Whitepaper) Online Planner at 12:01 a.m. ET on Friday, April 9 at aacr.org and the associated presentations will be made on Saturday, April 10 at the times indicated below. E-posters will be available at on the AACR (Free AACR Whitepaper) website at that time and on istarioncology.com.

Title: LUMINOS-101: Phase 2 study of PVSRIPO with pembrolizumab in recurrent glioblastoma
Abstract #: CT240
Presenter: Andrea True Kelly, Ph.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04479241

Title: LUMINOS-103: A basket trial evaluating the safety and efficacy of PVSRIPO in patients with advanced solid tumors
Abstract #: CT242
Presenter: Shannon R. Morris, M.D.
Session Title/Category: PO.CT08.02 – Phase II Clinical Trials in Progress
Date/time: April 10, 2021, 8:30 a.m. – 11:59 p.m. EDT
ClinicalTrials.gov Identifier: NCT04690699

For more information about Istari Oncology and their ongoing clinical trials and research in PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor, CD155), which is expressed on virtually all solid tumors and antigen-presenting cells. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III interferon-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On April 6, 2021 Leidos (NYSE: LDOS), a FORTUNE 500 science and technology leader, has scheduled a conference call for Tuesday, May 4, 2021, at 8 a.m. (ET) reported its first quarter financial results for the period ending April 2, 2021 (Press release, Leidos, APR 6, 2021, View Source [SID1234577605]). The company plans to issue its quarterly earnings press release before the conference call on May 4, 2021.

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The details for the earnings conference call follow:

Replay:

A telephone playback of the first quarter earnings conference call is scheduled to be available beginning at 11:30 a.m. (ET) on May 4, 2021, through 11:59 p.m. (ET) on May 11, 2021. The replay will be accessible by calling 877-660-6853 (International callers: +1-201-612-7415), and entering conference ID 13718327.

An archived version of the webcast will be available on the Leidos Investor Relations website at View Source

On April 6, 2021 Bio-Techne Corporation (NASDAQ: TECH) reported that management will host a conference call and webcast on Thursday, May 6, 2021, at 8:00 a.m. CDT to review third quarter 2021 financial results (Press release, Bio-Techne, APR 6, 2021, https://investors.bio-techne.com/news/detail/243/bio-techne-to-host-conference-call-on-may-6-2021-to-announce-third-quarter-2021-financial-results [SID1234577604]).

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Access to the discussion may be obtained as follows:

A recorded rebroadcast will be available for interested parties unable to participate in the live conference call by dialing 1-844-512-2921 or 1-412-317-6671 (for international callers) and referencing Conference ID 13718437.

The replay will be available from 11:00 a.m. CDT on Thursday, May 6, 2021 until 11:00 p.m. CDT on Sunday, June 6, 2021.

On April 6, 2021 ORPHELIA Pharma and Biocodex reported the execution of an exclusive distribution and marketing agreement for Kigabeq (vigabatrin) for most of the European Union territory, including France (Press release, ORPHELIA Pharma, APR 6, 2021, View Source [SID1234577603]).

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Kigabeq, the first pediatric form of vigabatrin developed by ORPHELIA Pharma, is notably indicated in the treatment of infantile spasms (West syndrome). Kigabeq is approved in Europe, where this medicine, intended exclusively for children, benefits from a centralized marketing authorization (Pediatric Use Marketing authorization, PUMA).

"We are very pleased to release this collaboration agreement with Biocodex", says Hugues BIENAYME, Founder and CEO of ORPHELIA Pharma, "With their long-standing experience in the field of pediatric epilepsy, Biocodex is certainly the best partner for Kigabeq distribution in Europe".

"With Kigabeq, the only pediatric presentation of vigabatrin, Biocodex is expanding its portfolio of drugs intended for rare and serious pathologies in children" adds Nicolas Coudurier, CEO of Biocodex, " Kigabeq and Diacomit (stiripentol, developed and marketed by Biocodex) are two drugs which address unmet medical needs for young patients affected by severe and resistant to treatment epilepsies".

"Our objective is to make Kigabeq available to all European clinicians, so that children affected by West syndrome can benefit." concludes Gilles ALBERICI, President of ORPHELIA Pharma, "Thanks to this agreement with Biocodex, Kigabeq will soon be prescribed in most of the European territory."

About Kigabeq

Kigabeq is the first pediatric formulation of vigabatrin, an essential anti-epileptic drug. Presented as soluble and scored tablets of 100 mg and 500 mg for oral or nasogastric administration, Kigabeq is notably indicated for the treatment of infantile spasms (West syndrome), an extremely serious epileptic encephalopathy of the infant. Kigabeq was developed exclusively for children and has been granted European Pediatric Marketing Authorization (PUMA).

About infantile spasms

West syndrome, or infantile spasms, is an extremely serious epileptic encephalopathy in infants that combines epileptic spasms, psychomotor deterioration and a hypsarrhythmic type electroencephalogram. It is a rare disease, with an estimated incidence of 5 per 10,000 births. It can occur in an infant with previously normal development or with a pre-existing delay; in all cases, infantile spasms severely hamper the psychomotor development. Pharmacological treatment should be started quickly to allow the spasms to stop and to improve the prognosis.

On April 6, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, APR 6, 2021, View Source [SID1234577602]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from March 29, 2021 to March 31, 2021:

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 202,977 shares as treasury shares, corresponding to 0.31% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.