Second FDA approved clinical trial in patients with pancreatic cancer and metastatic colorectal

On December 18, 2022 ISK reported the official opening of its second FDA approved clinical trial in the US in patients with pancreatic cancer and metastatic colorectal cancer at Georgetown University in Washington, D.C (Press release, Immune System Key, DEC 18, 2022, View Source [SID1234625366]).

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Bloom Science to Present Live at Biotech Showcase 2023

On December 21, 2022 Bloom Science founder & CEO Christopher Reyes, PhD reported he will present live at Biotech Showcase 2023 on Tuesday January 10 at 2:45PM Pacific Time (Press release, Bloom Science, DEC 17, 2022, View Source [SID1234625484]).

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Biotech Showcase, produced by Demy-Colton and EBD Group, is an investor conference focused on driving advances in therapeutic development by providing a sophisticated networking platform for executives and investors that fosters investment and partnership opportunities. The conference takes place each year during the course of one of the industry’s largest gatherings and busiest weeks.

"We are delighted that Bloom Science will be joining us in San Francisco and presenting at Biotech Showcase this year," said Sara Demy, CEO of Demy-Colton. "Biotech Showcase is a prime occasion for life science entrepreneurs and investors to come together to discover the potential of innovative technologies that will drive the future of drug discovery."

TG ImmunoPharma (TGI) announces FDA clearance of IND application for TGI-2, a novel anti-PVRIG therapeutic antibody

On December 17, 2022 TG ImmunoPharma Co., Ltd. (Hefei, China), an innovative biotech company dedicated to the discovery of novel immunotherapeutic drugs and a leader in NK cell research globally, reported that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for TGI-2/NM1F, a novel anti-PVRIG therapeutic antibody used in patients with advanced solid tumors (Press release, TG Immunopharma, DEC 17, 2022, View Source [SID1234625369]). Currently, no drugs targeting PVRIG have been approved globally.

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TGI-2/NM1F is a humanized IgG1 monoclonal antibody targeting PVRIG for the treatment of malignant cancers. The antibody binds to PVRIG with high affinity to block the PVRIG/PVRL2 interaction and restore the antitumor immune functions of both NK cells and T cells. Preclinical data suggest that TGI-2/NM1F has a long half-life and is well tolerated at very high doses in nonhuman primates. Treatment with TGI-2/NM1F as a monotherapy demonstrates significant inhibition of tumor growth in human tumor xenograft mouse models, while it further enhances the antitumor effect in combination with a PD-1 inhibitor.

"It is a significant milestone for TGI, having received clearance from the FDA to advance TGI-2 into the clinical trials. TGI-2 offers remarkable antitumor function and good safety, with higher affinity and lower onset dose than its competitors, making it highly promising for clinical use," stated Zhigang Tian, PhD, members of Chinese Academy of Engineering and Academia Europaea, Founder of TGI. "We are excited to initiate a phase 1 clinical trial in multiple centers in the U.S. for patients with advanced solid tumors and for whom standard of care therapies are currently ineffective, which demand innovative drugs in the near future. In addition, IND in China is expected to be submitted soon.

OSE Immunotherapeutics Receives a €10 Million Payment Corresponding to the Second Tranche of the Financing Granted by the European Investment Bank

On December 16, 2022 OSE Immunotherapeutics reported a €10 million drawdown corresponding to the second tranche of the financing granted by the European Investment Bank (EIB) (Press release, OSE Immunotherapeutics, DEC 16, 2022, View Source [SID1234646947]). The finance contract was signed on February 12, 2021.

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After the drawdown of the first tranche in July 20211 , the Company had an option to access further 10 million euros, subject to the achievement of certain milestones. Following the achievement of those milestones, the Company wishes to reinforce its financial position until Q3 2023 by drawing on the second tranche of the facility, to finance its preclinical and clinical programs.

This second tranche will carry a fixed interest of 5% per year paid annually, with a maturity of five years.

The second tranche is linked to the issuance of warrants to the EIB giving right, in the event of exercise, to the subscription of 550,000 shares of the Company (i.e., 2.97% of the share capital on an undiluted basis). Warrants are not the subject to an application for admission to trading on any market.
The subscription price is €0.01 per warrant, i.e., €5,500.

In order to limit the dilutive impact and except in the event of the occurrence of an early exercise event (notably a change of control, including the loss of a significant holding by the current management shareholders, or other events of default, including a significant change in the current governance not approved by the EIB), the warrants will only be exercisable from 16 December 2027, i.e. five years from the drawdown of the relevant tranche and at the latest at the end of a period of twelve years following their issue (i.e. 16 December 2034).

The subscription price for the new shares upon exercise of the warrants was set at 7.19 euros per share, i.e. corresponding to the volume-weighted average of the three trading days preceding the pricing, without discount.

In accordance with the warrant agreement, as with the first tranche, the EIB has an anti-dilution clause allowing it to benefit from additional warrants, in the event of a capital increase of the Company at a price less than €20 per share, after application of a deductible on the first 1,500,000 shares to be issued. In such a case, the Company would have to allocate additional warrants to the EIB allowing it to remain at a potential capital level of 2.97% (corresponding to its theoretical holding percentage post-allocation of these 550.00 warrants and exercise of these warrants subscribed in the context of the second tranche of funding).

The shares to be issued upon exercise of the warrants will be subject to an application for admission to trading on Euronext Paris. On the basis of 550,000 new Company’s shares issued upon exercise of all the warrants at a price of 7.19 euros per new share, the gross proceeds of the issue, issue premium included, will amount to 3,954,500 euros, thereby strengthening the Company’s equity.

On 16 December 2027, the EIB has the option to ask the Company to buy back its warrants at market value (less the exercise price of the warrants) up to a maximum of 15 million euros provided that the Company retains a cash level of at least 10 million euros. Otherwise, the EIB’s put option will be exercised on a number of warrants allowing the Company to maintain a cash level of 10 million euros. This put option also applies in the event of a change of control, understood as the holding of more than 33% of the capital or the taking of control by a third party (other than the current key managers). The Company may substitute an existing shareholder or a third party to buy back these warrants at market value. The Company has a call option allowing it to buy back the EIB warrants at market value (less the exercise price of the warrants) in the event of a public offer by a third party resulting in the exit of the management shareholders, for a period of one month following such exit. The Company also has a right of first refusal allowing it to buy back the EIB’s warrants if the latter wishes to sell them to a third party.

Following the drawdown of this second tranche, the financial debt amounts to 26 M€.

iPSirius Wins $2M Award from European Innovation Council to Develop a Novel Stem Cell Vaccine to Help Cancer Patients Worldwide

On December 19, 2022 iPSirius reported the company got $2M Award from European Innovation Council to Develop a Novel Stem Cell Vaccine to Help Cancer Patients Worldwide (Press release, iPSirius, DEC 16, 2022, https://bioinformant.com/ipsirius/ [SID1234640999]).

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Pivotal to the company bringing these new cancer vaccines to the clinic is the innovative technology that won a very competitive Pathfinder Award from the European Innovation Council. This secured $2M to translate the technology to the clinic. The European Innovation Council gives out the EIC Pathfinder award to "support research teams to develop emerging breakthrough technologies".

"We are very grateful to European Innovation Council for this necessary financial support that will accelerate access of our stem cell vaccine pipeline to the clinic. Our team at iPSirius is eager to develop off-the-shelf, cell-based vaccines that can improve the quality of life for patients with aggressive cancers worldwide. We hope that these new cancer vaccines will be transformative to the field of cancer therapy," said co-Founder and Chief Medical Officer, Prof Ali Turhan.

iPSirius is addressing key challenges in treating non-immunogenic solid tumors, based on the immunogenic properties of stem cells.

More details can be found at the company website, www.iPSirius.com.