On July 9, 2021 ABL Bio, Inc. (KOSDAQ: 298380), a clinical-stage biotech developing bispecific antibody technology for immuno-oncology and neurodegenerative diseases, reported the publication of pre-clinical data highlighting the safety and anti-tumor efficacy of ABL503/TJ-L14B in the Journal for ImmunoTherapy of Cancer(JITC) (Press release, ABL Bio, JUL 9, 2021, View Source [SID1234584756]).

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Jointly developed with I-Mab (NASDAQ: IMAB), ABL503 is a bispecific antibody combining PD-L1 checkpoint pathway with 4-1BB agonistic activity to overcome the current limitation of PD-(L)1 therapy and 4-1BB related toxicity. Using ABL’s Grabody-T bispecific antibody platform technology, ABL503 induces 4-1BB activation only in the presence of PD-L1 expressing tumors to minimize the risk of 4-1BB related peripheral toxicity. ABL503 is currently being evaluated in a Phase 1 study in the U.S. in patients with locally advanced or metastatic solid tumors (NCT04762641).

The paper, "Novel anti-4-1BB X PD-L1 bispecific antibody augments anti-tumor immunity through tumor-directed T-cell activation and checkpoint blockade," was published in collaboration with Su-Hyung Park, PhD, Professor at the KAIST Graduate School of Medical Science and Engineering. The paper highlights key in vitro and in vivo research that demonstrate ABL503’s potential as a promising immunotherapeutic agent against cancer.

In the study, ABL503 induced complete tumor regression in humanized mice, which was superior to anti-PD-L1 or anti-4-1BB monotherapy. Moreover, no tumor growth was observed in these mice when they were rechallenged at 40 days after their first ABL503 treatment, demonstrating that ABL503 treatment yields a prolonged anti-tumor response despite a short-term administration schedule.

In addition, ABL503 was well-tolerated following a repeated high dose administration of ABL503 in monkeys. Monkeys treated with ABL503 exhibited overall good tolerance with normal liver functions.

"These published data validate our Grabody-T platform technology to achieve anti-tumor efficacy with a low risk of off-tumor liver toxicity and support the therapeutic value of ABL503 as a potential best-in-class treatment for cancer," said Sang Hoon Lee, PhD, CEO of ABL Bio. "We have great expectations for the program and look forward to further evaluating ABL503 in our Phase 1 study with I-Mab."

On July 9, 2021 OSE Immunotherapeutics reported a €10 million payment corresponding to the first tranche of the financing granted by the European Investment Bank (EIB) (Press release, OSE Immunotherapeutics, JUL 9, 2021, View Source [SID1234646979]). The finance contract was signed on February 12, 2021.

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The finance contract allows the Company to borrow up to €25 million. The second and third tranches, respectively of €10 million and €5 million, may be drawn at the hand of the Company, subject to the achievement of specific clinical steps.

This type of financing, granted by the EIB and benefiting from a guarantee from the European Commission within the framework of the European Fund for Strategic Investments (known as the "Juncker Plan"), aims to support development research and innovation projects developed by companies with high growth potential.

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

The first tranche is associated to the issuance of warrants to the EIB giving right, in the event of exercise, to the subscription of 850,000 shares of the Company (i.e. 4.44% of the share capital on an undiluted basis). Warrants are not the subject of an application for admission to trading on any market.

The subscription price is €0.01 per warrant, i.e, €8,500.
In order to limit the dilutive impact over time, 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 9 July 2026, 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. 9 July 2033).

The subscription price for the new shares upon exercise of the warrants was set at 10.59 euros per share, i.e. a discount of 2.5% compared to the volume-weighted average of the three trading days preceding the pricing.

In accordance with the warrant agreement, 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 4.44% (corresponding to its theoretical holding percentage post-allocation and exercise of the warrants subscribed in the context of the first 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 850,000 new Company’s shares issued upon exercise of all the warrants at a price of 10.59 euros per new share, the gross proceeds of the issue, issue premium included, will amount to 9,001,500 euros.

On 9 July 2026, 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 EUR 15 million, provided that the Company retains a cash level of at least EUR 10 million. 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.

On July 9, 2021 RhoVac AB ("RhoVac"), a Swedish cancer immunotherapy company, reported on July 9th 2021, that its Safety Monitoring Committee has conducted a planned interim safety review of its clinical phase IIb trial in prostate cancer, known as BRaVac (Press release, RhoVac, JUL 9, 2021, View Source [SID1234584757]). The safety profile of RV001 was excellent and the Safety Monitoring Committee concluded the trial can continue without modifications.

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RhoVac started the clinical phase IIb trial (BRaVac) with the company’s drug candidate, RV001, late 2019, in prostate cancer patients with a biochemical recurrence (a rise in PSA) after curative intent therapy. In November of 2020, RhoVac was awarded Fast Track Designation by the FDA for RV001 in this cancer indication. RhoVac currently estimates finalizing the patient recruitment for the study no later than September this year, and after that the study will run to completion, which is estimated to take 9-12 months after the closing of the recruitment. The objective of the study is to show that RV001 can significantly prevent or delay disease progression in these patients, something for which no standard therapy is available today. As planned, an interim safety review was conducted today by the Safety Monitoring Committee, and no unexpected adverse events have been identified, confirming excellent safety, in concurrence with the previous clinical phase I/II findings.

RhoVac CEO, Anders Månsson, comments: "We had never anticipated anything but a clean safety review. Nevertheless, it is great to get further confirmation that our drug has a safety profile that makes it suitable for treating symptomless cancer patients who have already undergone local curative intent therapy, with an aim to prevent cancer recurrence. Also, the fact that we have excellent patient compliance in the study in spite of the pandemic circumstances, is a sign of how motivated these patients are to receive the treatment. This will add to the interest we already experience in our drug candidate".

This disclosure contains information that RhoVac is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 14:20 CET.

On July 9, 2021 HAMLET Pharma reported that All required milestones and deliverables to date are without any significant deviations (Press release, HAMLET Pharma, JUL 9, 2021, View Source;utm_medium=rss&utm_campaign=hamlet-pharmas-achievements-are-emphasized-after-eu-evaluation-the-company-has-fully-achieved-its-milestones-and-secured-the-second-payment [SID1234584810]). This is particularly impressive in light of the global Corona virus pandemic.

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To date, the beneficiary has succeeded in manufacturing the Investigational Medicinal Product (IMP) Alpa1H. The company has demonstrated non-clinical improvement of therapeutic efficacy of other cancer drugs like Mitomycin C and Epirubicin, when combined with Alpa1H and successfully continued with the Phase I/II study of Alpha1H in bladder cancer patients.

There is evidence of good financial management in this project. The amount of financial resources utilized to date is proportionate to the achievements of the project to date".

Hamlet Pharma will now receive the second payment from the EIC Accelerator Horizon 2020 fund of approximately 6,7 million SEK. The third payment is expected at the end of the program.

This disclosure contains information that Hamlet is obliged to make public pursuant to the EU Market Abuse Regulation (EU nr 596/2014). The information was submitted for publication, through the agency of the contact person, on 09-07-2021 09:47 CET.

On July 9, 2021 TG Therapeutics, Inc. (NASDAQ: TGTX), reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the Ladenburg Thalmann 2021 Healthcare Conference being held virtually (Press release, TG Therapeutics, JUL 9, 2021, View Source [SID1234584742]). The fireside chat is scheduled to take place on Wednesday, July 14, 2021 at 12:30 PM ET.

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A live webcast of each presentation will be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source Following each event, an archive file will be available for thirty days.