On June 2, 2021 BERG, a clinical-stage biotech that employs patient biology and artificial intelligence (AI) to research diseases and develop innovative treatments, reported results from a recently completed Phase 1 study of its investigational drug, BPM 31510 (novel ubidecarenone formulation) in recurrent glioblastoma multiforme (GBM) (Press release, Berg, JUN 2, 2021, View Source [SID1234583426]). The study will be presented at the 2021 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO) (Free ASCO Whitepaper) from June 4 – June 8, 2021, defining the details on identification of molecular analytes in plasma, buffy coat and urine and unveiling pathways to potentially predict clinically relevant responses to BPM 31510 in GBM patients undergoing treatment.

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"At BERG, we want to remove the stigma that brain cancer is a death sentence," said Dr. Niven R. Narain, CEO, President and Co-founder of BERG. "The limited drugs available today may not work for a patient’s unique biological footprint. The results from our study offer hope to patients, and hold promise for BERG’s BPM 31510, solving a serious unmet need in medicine today."

GBM is the most aggressive, malignant primary brain tumor, averaging 12-18 months of survival time upon diagnosis with only 25% of GBM patients surviving more than one year. Today, GBM-related tumors account for 17% of all tumors of the brain, and tend to occur between the ages of 45 and 70.

The study was conducted in collaboration with Seema Nagpal, M.D. Clinical Associate Professor of Neurology & Neurological Sciences, and Lawrence Recht, M.D., Professor of Neurology & Neurological Sciences, both of Stanford University School of Medicine, in addition to other Stanford Medicine researchers and in collaboration with BERG.

Details of the BERG presentation:

Session title

Abstract title

Presenters

Dates

Central Nervous System Tumors

2059: Comprehensive molecular pharmacodynamic assessment identifies response markers of intermediary metabolism associated with BPM 31510-IV treatment in advanced glioblastoma multiforme patients

Seema Nagpal, Rangaprasad Sarangarajan, Can Bruce, Greg M Miller, Leonardo O Rodrigues, Punit Shah, Richard Searfoss, Kennedy Ofori-Mensa, Vladimir Tolstikov, Bennett Greenwood, Valerie Bussberg, Michael A. Kiebish, Elder Granger, Niven R. Narain, Lawrence David Recht; Stanford University, Stanford, CA; Berg LLC, Framingham, MA

June 4, 2021 – June 8, 2021

Digital Program:

E-Poster

The Abstract is available online: View Source, and the Poster will be available to registered 2021 ASCO (Free ASCO Whitepaper) Virtual Scientific Program attendees starting Friday, June 4th.

In its commitment to serve patients afflicted with cancer, BERG has collaborated on other projects with leading institutions like MD Anderson Cancer Institute (clinical trials) and Harvard/BIDMC (Project Survival), among others.

On June 2, 2021 Bavarian Nordic A/S (OMX: BAVA, OTC: BVNRY) reported that the share buy-back program, which was announced and initiated on May 27, 2021, has now been terminated, as the intended number of shares under the program has been repurchased (Press release, Bavarian Nordic, JUN 2, 2021, View Source [SID1234583460]). The program was executed in accordance with the provisions of Regulation (EU) No. 596/2014 of the European Parliament and of the Council of 16 April 2014 on market abuse and supplementing Regulation (EU) 2016/1052 of 8 March 2016, which together constitute the Safe Harbour Regulation. The purpose of the program was to meet the Company’s obligations arising from the share-based incentive program for the Board of Directors and Executive Management.

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Under the program Bavarian Nordic A/S has bought back 31,747 shares, cf. the table below:

Transaction date Number of shares Average purchase price, DKK Transaction Value, DKK

The details for each transaction made under the share repurchase program have been attached to this announcement.

With the transactions stated above, Bavarian Nordic A/S owns a total of 117,627 own shares, corresponding to 0.18% of the share capital. The total amount of shares in the company is 63,736,804 including treasury shares.

On June 2, 2021 Kazia Therapeutics Limited (NASDAQ: KZIA; ASX: KZA), an oncology-focused drug development company, reported an update on recent progress with its two pipeline assets, paxalisib and EVT801 (Press release, Kazia Therapeutics, JUN 2, 2021, View Source [SID1234584522]).

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Key Points

GBM AGILE pivotal study of paxalisib is recruiting ahead of expectations, with almost 25 sites now open to the paxalisib arm.
Paxalisib phase II study in newly diagnosed glioblastoma has seen the final patient complete drug treatment; a number of patients remain in follow-up.
EVT801 phase I study protocol has been submitted to the French regulatory agency for review.
Kazia CEO, Dr James Garner, commented, "Kazia has seen an exceptionally busy first half, with excellent progress across our clinical programs. In particular, the GBM AGILE study is performing ahead of our forecasts in terms of recruitment. As we move into the second half of the year, we anticipate conclusion of the paxalisib phase II study, initial data readouts from a number of the paxalisib investigator-initiated studies in other forms of brain cancer, and commencement of the first-in-human phase I study of EVT801."

GBM AGILE

Almost twenty-five sites are currently open to the paxalisib arm in the United States. The list includes prestigious centres such as Memorial Sloan Kettering Cancer Center, Henry Ford Cancer Institute, Columbia University Irving Cancer Research Center, Emory University Winship Cancer Institute, and the University of Florida. The first site in Canada is expected to open in August 2021, followed by the first European sites in Q4 CY2021.

To date, GBM AGILE has screened over 650 patients. This progress is expected to accelerate as new sites in new territories come on stream.

GBM AGILE is an international platform study design to identify effective therapies for glioblastoma. It is an adaptive study, that evaluates multiple therapies in parallel, and recruits only the number of patients needed in each arm to reach a definitive answer. With its innovative design and efficient operational infrastructure, GBM AGILE is faster and more cost-effective than conventional company-sponsored approaches, and data from GBM AGILE may be used as the foundation of a new drug application to FDA and other regulatory agencies. GBM AGILE has been designed and implemented by the Global Coalition for Adaptive Research, a world-leading consortium focused on adaptive clinical trials.

To date, three experimental therapies have joined GBM AGILE: Bayer’s regorafenib, Kazia’s paxalisib, and Kintara Therapeutics’ VAL-083. It is expected that paxalisib will recruit up to 200 patients in the study, with the actual number determined by emergent data from the study.

Kazia has brought forward the manufacture of an additional batch of paxalisib investigational product, and this is expected to be released for use in the study during early 4Q CY2021.

Paxalisib Phase II Study

The final patient in the paxalisib phase II study has experienced disease progression after approximately 2.3 years on treatment. A number of patients remain in follow-up and the study is expected to conclude in 2H CY2021. Kazia anticipates no further interim analyses at this stage, and instead expects to release final data once the necessary analyses are complete.

Paxalisib Investigator-Initiated Studies

Kazia has been advised of generally good progress across the ongoing investigator-initiated studies of paxalisib in other forms of brain cancer. As previously indicated, the company expects that the respective investigators will release initial data from several of these studies during CY2021.

EVT801 Phase I Study

The study protocol for a planned phase I study of EVT801 has been submitted to ANSM, the French regulatory agency. Kazia expects to receive feedback from the agency late in 3Q CY2021.

The initial batch of EVT801 investigational product has been manufactured and is ready for use. Two leading academic research hospitals in France have been selected as the initial trial sites, with the potential to expand to additional sites as the study progresses.

On June 2, 2021 Immune Therapeutics Inc. (OTC-PINK: IMUND) (the "Company") reported that the Company has received and signed a non-binding term sheet to enter into an agreement that would provide working capital and wipe out a significant portion of its long-standing Debt (Press release, Immune Therapeutics, JUN 2, 2021, View Source [SID1234583378]).

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The Company received the term sheet from existing Immune Shareholders to provide the funds necessary to complete the restructuring of Immune. According to the agreement, the investors will lend a minimum of $700,000 and a maximum of $1,500,000 to the Company in exchange for non-convertible promissory notes bearing interest at 5%.

In connection with the transactions above, to the extent a noteholder holds any warrants to purchase shares of common stock of Borrower ("Warrants"), Lender shall have the right to apply all or any portion of the Debt under this Note toward exercising such Warrants, upon the terms and subject to the conditions provided in the Warrants. Upon converting the warrants, the lenders have a one-year lock-up agreement with leak-out provisions.

In addition, the Company is negotiating with former employees, current management, directors, and other accounts payable and hopes to settle shortly. Closing the transactions contemplated by the Letter of Intent is subject to several conditions being satisfied, including completing due diligence.,

Earlier this year, the Company successfully restructured its toxic convertible promissory Note in default since May of 2018 issued by Iliad Research & Trading, L.P., for $425,000.00 on October 20, 2017. The Note carried 22% percent interest default interest and was convertible into common shares of Immune stock at a 60% discount to market.

The Note was purchased by Global Reverb Corp and a shareholder in November of 2020. The parties agreed to restructure the balance of $697,000 (reflecting the total principal, interest, and penalties) associated with the instrument. Under the terms of the restructuring, the lenders canceled the existing Iliad Note. Two new notes were issued; one to Global Reverb and one to the shareholder. The notes are for one year with a one-year extension bearing 5% interest. There is no conversion feature on the restructured balance.

The agreement provides for filing a 14A Proxy within 30 days of closing the agreement and funding. The 14A will provide for a new slate of 5 Directors and Officers. To appoint Turner & Stone LLP as auditors of the Company to hold office until the conclusion of the next general meeting at which accounts are laid before the Company. To conduct any other business properly brought before the Annual Meeting. The lenders will appoint two advisors to the Board until the shareholders during the transaction.

"The restructuring of the notes and funding is a significant achievement for the Company, and we are thankful that our existing lenders agreed that a restructuring would benefit the Company and its growth initiatives. The restructuring improved our balance sheet and was one of the critical next steps in our strategic plan as we are continually working and uplifting. We believe that the amendment of these notes and additional funding is a key accomplishment and that our current market cap does not accurately reflect the value of the Company and the emerging opportunity in biotech," stated Kevin Phelps, Company CEO.

On behalf of the Board of directors of Immune- many of whom are investing alongside you – thank you for your investment and continued shareholder support. We look forward to sharing our progress with you in the coming weeks.

This news release includes "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including, without limitation, statements about the reverse stock split, authorized shares reduction and the related timing of implementation and effects thereof. Forward-looking statements are statements other than statements of historical fact. These forward-looking statements are generally identified by the words "believe," "expect," "anticipate," "estimate," "intend," "plan," "may," "should," "could," "will," "would," and "will be," and variations of such words and similar expressions, although not all forward-looking statements contain these identifying words. Although we believe the expectations and forecasts reflected in the forward-looking statements are reasonable, we can give no assurance they will prove to have been correct. They can be affected by inaccurate or changed assumptions or by known or unknown risks and uncertainties.

On June 2, 2021 Servier and MBC Biolabs reported that awarded the Servier Spark Award* June 2021 to Sardona Therapeutics, a biotech that develops small molecules blocking the interaction between an RNA-binding protein and its target RNAs (Press release, Servier, JUN 2, 2021, View Source;utm_medium=rss&utm_campaign=sardona-therapeutics-winner-of-the-servier-spark-award [SID1234583394]). This award will allow Sardona Therapeutics to continue developing its preclinical program in oncology, in indications such as triple negative breast cancer.

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Sardona Therapeutics develops small molecules targeting an original signaling pathway to block the proliferation of cancer cells harboring a combination of biomarkers. The indications targeted by this approach are in particular hard-to-treat tumors and resistant to standard treatments, such as triple negative breast cancer or glioblastoma.

The biotech’s research work is aligned with Servier’s commitment to support innovation in Oncology: "Sardona Therapeutics’ approach corresponds to what Servier wishes to encourage in terms of innovation. It matches with Servier’s strategy in Oncology, which notably involves the discovery of new signaling pathways to treat hard-to-treat tumors." said Olivier Nosjean, Head of Open Innovation and Scientific Affairs at Servier.

*The Spark Award (also known as Golden Ticket) is part of Servier’s sponsorship with MBC Biolabs. This award allows the winning start-up to have access to MBC Biolabs’ facilities, by covering the operating costs of a researcher for one year, thus giving the wining biotech the means to focus all its efforts on their scientific development. This prize is also intended to forge links between the winning biotech and Servier’s research teams, by opening a scientific dialogue.