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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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 Fertin Pharma reported $813 million deal for oral drug delivery Marlboro maker Philip Morris International is doubling down on its pharma ambitions with plans to snap up inhalation-specialist-turned-CDMO Vectura (Press release, Fertin Pharma, JUL 9, 2021, View Source [SID1234584769]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Philip Morris has aligned with Vectura’s board to acquire the company for £852 million ($1.2 billion) in cash. The arrangement puts Vectura shareholders in line to receive 150 pence per share, marking a 46% premium on the company’s 103-pence closing price on May 25, Philip Morris said in a release.

Adding a recent dividend payment into the mix, Vectura said the deal is valued at around £1.045 billion (about $1.45 billion). The sale is expected to close in the second half of the year.

The move follows Philip Morris’ February rollout of its "Beyond Nicotine" strategy, under which the tobacco giant aims to move beyond cigarette sales and into fields such as respiratory drug delivery and "selfcare wellness."

Philip Morris is banking on "Beyond Nicotine" to deliver at least $1 billion in net revenues by 2025, CEO Jacek Olczak said in a statement.

RELATED: Verona sells Chinese rights to inhaled drug for $40M upfront

But Philip Morris isn’t Vectura’s only suitor. The company in late May said it had accepted a buyout offer from prominent healthcare investment firm The Carlyle Group. In light of Philip Morris’ "superior proposal" per Vectura share, Vectura’s directors plan to recommend that shareholders accept the Philip Morris bid, the company said in its release.

Philip Morris’ 150 pence-per-share offer marks a roughly 10% increase over Carlyle’s ex-dividend offer of 136 pence, a Vectura spokesperson said over email.

For its part, Carlyle says it’s "considering its options" and will make another announcement down the line, potentially signaling an upcoming bidding war.

RELATED: With plant-based manufacturing, GSK partner Medicago takes COVID-19 vaccine production into the greenhouse

Vectura has 13 inhaled products on the market and generated £191 million (about $245 million) in 2020 sales, Philip Morris said. Vectura has also reinvented itself as a CDMO in recent years, bringing on Catalent veteran Will Downie as CEO in late 2019. Under the proposed deal, the companies aim to forge a pipeline of both prescription and over-the-counter products, Philip Morris said.

The Vectura purchase marks Philip Morris’ second pharma acquisition of the month. On July 1, oral drug delivery specialist Fertin Pharma said it had accepted a 5.1 billion Danish krone ($813 million) buyout bid from Philip Morris, which will see the tobacco giant gain access to manufacturing and R&D sites in Denmark, Canada and India, where Fertin employs around 860.

On July 9, 2021 Molecular Templates, Inc. (Nasdaq: MTEM, "Molecular Templates" or "MTEM"), a clinical-stage biopharmaceutical company focused on the discovery and development of proprietary targeted biologic therapeutics, engineered toxin bodies (ETBs), reported the dosing of the first subject in a Phase 1 study investigating MT-6402 in patients with PD-L1-positive solid tumors (Press release, Molecular Templates, JUL 9, 2021, View Source [SID1234584754]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are excited to have dosed the first subject in the Phase 1 study for MT-6402, a third generation ETB, which is being developed as a potential treatment for patients with PD-L1-positive cancers. MT-6402 utilizes both our proprietary de-immunized toxin scaffold and antigen seeding technology," said Eric Poma, Ph.D., CEO and CSO of Molecular Templates. "The PD-1/PD-L1 axis is central to many tumors and targeting that axis with a new mechanism of action has an opportunity to provide meaningful benefit to patients. We look forward to providing an update on this study by year-end 2021."

The Phase 1 study for MT-6402 is planned as a multi-center, open-label, dose escalation and dose expansion trial in the United States and outside of the United States. Patients with confirmed PD-L1 expressing tumors or confirmed PD-L1 expression in the tumor microenvironment will be eligible to screen for enrollment. The starting dose is 16 mcg/kg. Following determination of the maximum tolerated dose (MTD) or recommended Phase 2 dose, expansion cohorts are planned to evaluate MT-6402 as a monotherapy in tumor-specific and tumor-agnostic cohorts. For more information on the Phase 1 study for MT-6402, refer to ClinicalTrials.gov identifier: NCT04795713.

About MT-6402

MT-6402 is an ETB consisting of a single chain variable fragment (scFv) with affinity for PD-L1, fused to the enzymatically active de-immunized Shiga-like toxin-A subunit (SLTA) and a class I antigen derived from the human cytomegalovirus (HCMV) pp65 protein. MT-6402 was designed to induce potent anti-tumor effects via PD-L1 targeting through multiple mechanisms that may overcome the limitations of the existing PD-L1 antibody therapies. In MTEM’s preclinical studies, MT-6402 was found to specifically bind and kill both tumor and immune PD-L1 expressing cells in a manner consistent with SLTA mediated cellular cytotoxicity through ribosomal inactivation, independent of checkpoint inhibition. Additionally, MT-6402 alters the immunophenotype of targeted cells by delivering foreign class I antigen from CMV for presentation in complex with MHC class I, which may provoke a CMV-specific immune response against the targeted cells. MT-6402 may rehabilitate the tumor microenvironment (TME) and allow for immune recognition of tumors by destroying PD-L1-expressing immune cells in the TME.

On July 9, 2021 Vinings Holdings, Inc. (OTC PINK: NDYN), reported that it is changing its corporate name to "Coeptis Therapeutics, Inc." and updating its ticker symbol to "COEP" effective Monday, July 12, 2021 (Press release, Vinings Holdings, JUL 9, 2021, View Source [SID1234584755]). The name modification and ticker change will align the Company with its wholly-owned subsidiary, Coeptis Pharmaceuticals (together "Coeptis"), and its strategic focus on the development of innovative therapeutics and technologies that have the potential to disrupt conventional treatment paradigms and improve patient outcomes.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Our new corporate name, Coeptis Therapeutics, and updated ticker symbol reflect what has been and should continue to be a period of growth for the company and subsidiary, Coeptis Pharmaceuticals, that, we believe, will allow us to unlock numerous opportunities that offer the potential to translate into significant shareholder value," said Dave Mehalick, President and CEO of Coeptis Therapeutics. "Coeptis’ business model is designed around advancing the development and value potential of its current product portfolio, while actively targeting opportunities to expand its portfolio via partnerships with companies that have novel therapies in development or companies with technologies that improve the way that drugs are delivered to patients. Our previously announced option agreements with VyGen-Bio involving a cell therapy technology and an in vitro diagnostic targeting CD38-related cancers are emblematic of this business strategy and demonstrate our ability to identify and potentially cultivate such potentially transformative technologies."

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]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

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."