On June 15, 2022 Vivoryon Therapeutics N.V. (Euronext Amsterdam: VVY; NL00150002Q7) (Vivoryon), a clinical stage company focused on discovery and development of small molecule medicines to modulate the activity and stability of pathologically altered proteins, reported financial results and the corporate update for the first quarter of 2022, ending March 31, 2022 (Press release, Vivoryon Therapeutics, JUN 15, 2022, View Source [SID1234615990]). The report is available on the Company’s website at View Source

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"In the first quarter of 2022, we continued to make meaningful progress, further advancing our unique QPCT/L inhibitor varoglutamstat to treat patients with Alzheimer’s disease through clinical development in Europe and the U.S., with both our European Phase 2b VIVIAD study and our U.S. Phase 2a/b study VIVA-MIND on track," said Dr. Ulrich Dauer, CEO of Vivoryon. "There still is an extremely high unmet medical need for safe, effective and widely available treatments against this devastating disease, and we at Vivoryon remain fully committed to playing an important role in making a real difference to patients and their families. We look forward to providing an update on varoglutamstat in the context of the VIVIAD interim safety analysis planned for mid-2022, where we anticipate to obtain important safety and tolerability data which will be key to our lead candidate’s further development."

Corporate Updates and Post-period Events

U.S. Phase 2a/b VIVA-MIND study (NCT03919162) for varoglutamstat in patients with early AD: actively enrolling patients, with currently eleven sites open and on track for an interim futility analysis planned for the first half of 2023.
European Phase 2b VIVIAD study (NCT04498650) for varoglutamstat in patients with mild cognitive impairment (MCI) and mild AD: actively enrolling patients, on track for an interim safety readout in mid-22, Vivoryon continues to anticipate final data in the second half of 2023.
Preparations for clinical development in Greater China, led by partner Simcere, ongoing with Clinical Trail Application for varoglutamstat approved by China’s Center for Drug Evaluation (CDE) of National Medical Products Administration (NMPA); preparations for Phase 1 and subsequent Phase 2 studies ongoing
Successful completion of a private placement in April 2022, raising gross proceeds of EUR 21 million, with net proceeds from the offering intended to be used to support the ongoing clinical development of lead candidate varoglutamstat, as well as for general corporate purposes; capital raise supported by a number of high-quality institutional investors from Europe and the U.S. as well as members of Vivoryon’s Executive and Non-Executive Boards.
Financial Results for Q1 of 2022

In the first quarter of 2022, research and development expenses amounted to EUR 5.8 million and increased compared to the first quarter of 2021 (EUR 4.3 million). This increase was mainly driven by costs associated with production cost for our compound varoglutamstat/PQ912 which is used in the VIVIAD trial as well as in the US trial VIVA-MIND which started in the fourth quarter of 2021.

General and administrative expenses decreased to EUR 0.8 million (Q1 2021: EUR 1.2 million). This decrease is largely attributable to consulting (Q1-2022: EUR 0.3 million, Q1-2021: EUR 0.6 million) and share based payment expense (Q1-2022: EUR 0.1 million, Q1-2021: EUR 0.2 million). The Company did not generate any licensing revenue in the reporting period.

Net loss of the period was EUR 6.4 million compared to EUR 5.4 million in the first quarter of 2021.

The Company held EUR 7.7 million in cash and cash equivalents as of March 31, 2022, respectively EUR 14.7 million as of December 31, 2021.

On April 1, 2022 the Company completed a private placement by way of accelerated book building. The gross proceeds of the offering amounted to approximately EUR 21.0 million.

All results are in line with management expectations.

Financial Guidance

Vivoryon updated its financial guidance following the capital raise completed in April 2022. According to current planning and estimates, Vivoryon expects that its existing cash and cash equivalents will be sufficient to fund its research and development expenses as well as the general and administrative expenses and cash flows from investing and financing activities at least through end of May 2023. This guidance does not include potential milestone payments from development partnerships, potential payments from licensing agreements and/or additional financing measures, as far as such payments have not yet been recognized in revenues. The financial guidance takes into account all costs to ensure sustainable study drug supply with varoglutamstat for the VIVA-MIND U.S. study.

Additional information regarding other relevant information is included in the financial statements as of December 31, 2021, which is included in the Company’s Annual Report 2021.

On June 15, 2022 Orion Corporation ("Orion") reported that it has entered into an agreement with Belgian private company Inovet BV ("Inovet") to acquire its wholly owned subsidiary V.M.D. NV and all companies belonging to V.M.D. NV’s group of companies (V.M.D. NV and its subsidiary companies collectively, "VMD") (Press release, Orion , JUN 15, 2022, View Source [SID1234616008]). VMD is a veterinary pharmaceuticals company specialised in medicines and health products for livestock. It also has a product portfolio for companion animals and minor species. VMD is headquartered in Arendonk, Belgium. VMD has production sites in Arques, France (manufacturing) and in Arendonk (packaging) as well as its own sales operations in Belgium, France, Hungary and Vietnam. VMD’s revenues in 2021 were EUR 61 million, and the group was profitable. Following this acquisition, the 181 employees of VMD will join the Orion Group.

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Through this acquisition, Orion’s Animal Health unit will expand its product portfolio and get a foothold in the livestock market, expand its own geographical presence to Western Europe and expand export markets, and gain a production unit that is specialised in manufacturing of veterinary medicines. The acquisition also supports Orion Group’s growth strategy.

The transaction price is approximately EUR 130 million debt free. The transaction will be funded from Orion’s cash reserves. The immediate cash flow impact of the transaction is approximately EUR 90 million. The transaction will have a positive impact on Orion Animal Health unit’s net sales and EBITDA starting from 2022. The impact on Orion Group’s net sales and operating profit is not material and the transaction does not impact Orion’s outlook for 2022, given on 10 February 2022. Orion will report VMD’s net sales as part of Orion Animal Health’s net sales as of June 2022.

The agreement was signed and the transaction was completed simultaneously today on 15 June 2022.

"We are pleased to welcome our new colleagues to the Orion team. With this acquisition, Orion Animal Health becomes a comprehensive animal health company with wider geographical presence and broad product portfolio covering both companion animals and livestock. In addition, we are strengthening our manufacturing capabilities," said Timo Lappalainen, CEO of Orion Corporation.

"I believe that becoming part of the Orion family ensures the further growth of our business. I have a very good feeling about the new collaboration with the Orion Animal Health unit – mindsets and spirits are very similar to ours. We are looking forward to joining forces and strengthening our presence in the consolidating animal health industry," said Jan Moons, CEO of Inovet.

V.M.D. NV, established in 1973, is a veterinary pharmaceuticals company headquartered in Arendonk, Belgium. Until the transaction it was a wholly owned subsidiary of the Belgian family-owned private holding company Inovet BV. VMD’s product portfolio consists of over 200 generic products which are sold in more than 120 countries. VMD has a production site in Arques, France, logistics and packaging operations in Arendonk as well as its own sales operations in Belgium, France, Hungary and Vietnam. VMD is currently expanding its manufacturing capacity at the Arques site. The companies Biové Laboratoires SAS, Biard SAS, V.M.D. Állatgyógyászati Kft and Inovet Indochine Co., Ltd. are part of VMD.

Webcast and conference call

A webcast and a conference call for analysts, investors and media will be held today on Wednesday, 15 June 2022 at 11.00 EEST. Please register and join the live webcast at View Source

Questions can be asked through the webcast chat function. A recording of the webcast and the presentation material will be available on Orion’s website View Source later today.

On June 15, 2022 Kymera Therapeutics, Inc. (NASDAQ: KYMR), a clinical-stage biopharmaceutical company advancing targeted protein degradation to deliver novel small molecule protein degrader medicines, reported thyat it has recently dosed the first patients in separate Phase 1 clinical trials evaluating the STAT3 degrader KT-333 and the IRAKIMiD degrader KT-413 (Press release, Kymera Therapeutics, JUN 15, 2022, View Source [SID1234616024]). The KT-333 trial includes patients with relapsed/refractory liquid and solid tumors, including T cell lymphomas and leukemia, and the KT-413 study is enrolling patients with relapsed/refractory B cell lymphomas, including MYD88-mutant diffuse large B cell lymphoma (DLBCL).

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"These programs demonstrate the potential for targeted protein degradation to target critical nodes that traditional modalities can’t effectively address, offering a precision medicine approach to challenging cancers," said Nello Mainolfi, PhD, Co-Founder, President and CEO of Kymera Therapeutics. "The initiation of dosing in these studies represents important progress for Kymera toward understanding the pharmacology and safety of these first-in-class investigational medicines, and we look forward to sharing initial dose escalation clinical data later this year."

About the KT-333 Clinical Program

A target long considered "undruggable," STAT3 is a transcriptional regulator that has been linked to numerous cancers and other inflammatory and autoimmune diseases. KT-333 is a potent and selective heterobifunctional small molecule protein degrader of the STAT3 protein in development for oncology indications.

The Phase 1 trial will evaluate the safety, tolerability, PK/PD and clinical activity of KT-333 in adult patients with relapsed and/or refractory lymphomas and solid tumors. The first stage of the study will explore escalating doses of KT-333. The second stage will consist of four expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-333 in relapsed and/or refractory peripheral T-cell lymphoma (PTCL), cutaneous T-cell lymphoma (CTCL), large granular lymphocytic leukemia (LGL-L), and solid tumors.

KT-333 was recently granted Orphan Drug Designation by the U.S. Food and Drug Administration for the treatment of PTCL. This designation provides incentives to encourage the development of medicines for rare diseases.

About the KT-413 Clinical Program

KT-413 is a potent and selective heterobifunctional small molecule protein degrader being developed for MYD88-mutant B cell lymphomas that has the potential to be the first precision medicine for these cancers. KT-413 degrades interleukin-1 receptor associated kinase 4 (IRAK4) and the immunomodulatory imide drug (IMiD) substrates Ikaros and Aiolos. It is being developed initially for the treatment of relapsed/refractory MYD88-mutant DLBCL, with the potential to expand into other MYD88-mutant indications.

The Phase 1 trial will evaluate the safety, tolerability, and PK/PD of KT-413 in patients with relapsed and/or refractory B-cell non-Hodgkin’s lymphomas. The first stage will explore escalating doses of single-agent KT-413. The second stage will consist of two expansion cohorts to further characterize the safety, tolerability, PK/PD and antitumor activity of KT-413 in relapsed/refractory MYD88-mutant and MYD88 wild-type DLBCL.

On June 15, 2022 Scandion Oncology (Scandion or "The Company"), a biotech company developing first-in-class medicines aimed at treating cancer which is resistant to current treatment options, reported a prospectus in connection with the rights issue of shares (the "Rights Issue") announced on June 1, 2022, for which the subscription period commences on June 16, 2022 (Press release, Scandion Oncology, JUN 15, 2022, View Source,c3585777 [SID1234615991]). The prospectus has today been approved and registered by the Danish Financial Supervisory Authority (Finanstilsynet).

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Summary of the Rights Issue

For one (1) existing share on the record date of June 13 2022, shareholders will receive one (1) subscription right, three (3) subscription rights entitle to subscription of one (1) share.
The subscription price is SEK 8.75 per new share, which, assuming the Rights Issue is fully subscribed, results in the Company receiving issue proceeds of approximately SEK 93.7 million before deduction of transaction costs.
Subscription and guarantee commitments have been received from principal owners and new investors amounting to approximately SEK 75 million, corresponding to approximately 80% of the issue proceeds.
For complete information on the Rights Issue, please see the published prospectus.

Prospectus

The prospectus has been prepared in connection with the forthcoming Rights Issue and has today, on June 15 2022, been approved and registered by the Danish Financial Supervisory Authority. The prospectus, including full terms and conditions, is available on the Company’s, Hagberg & Aneborn Fondkommission AB’s and Redeye’s respective websites (www.scandiononcology.com, www.hagberganeborn.se, www.redeye.se). The Swedish Financial Supervisory Authority (Finansinspektionen) will issue a certificate of European passport today, on June 15 2022. A summary of the prospectus in Swedish will be available on the above websites when the certificate is issued. Application forms for subscription without preferential rights will be available on the above websites as the subscription period commences.

Timetable for the Rights Issue

The record date for participating in the Rights Issue was June 13 2022. The last day of trading including the right to subscribe for shares was June 9. The first day of trading excluding the right to subscribe for shares was June 10 2022.

June 16 – June 28, 2022 Trading in subscription rights
June 16 – July 1, 2022 Subscription period
June 16 – until registration with the Danish Business Authority Trading in paid subscription shares (Sw. "BTA")
July 5, 2022 Estimated announcement of outcome in the Rights Issue
Advisers

Redeye AB acts as financial adviser and Horten Advokatpartnerselskab (as to Danish law) and Advokatfirman Schjødt (as to Swedish law) acts as legal advisers in connection with the Rights Issue. Hagberg & Aneborn Fondkommission AB acts as the issuing agent in the Rights Issue.

On June 15, 2022 Shionogi & Co., Ltd. and its European subsidiary, Shionogi B.V. (hereafter "Shionogi"), reported that Shionogi B.V. had signed an agreement with NHS England to begin an innovative subscription payment model reimbursement of Cefiderocol in England (Press release, Shionogi, JUN 15, 2022, View Source [SID1234616009]). In this model, companies are paid a fixed sum for antimicrobials based on a health technology assessment of their value to the NHS, rather than the volumes used.1 Shionogi welcomes the introduction of pull incentives to help bring urgently needed new antibiotics to market.

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The deal follows draft guidance from NICE issued in April, which recommended Cefiderocol within its marketing authorisation as an option to treat severe multidrug resistant aerobic Gram-negative bacterial infections. It also states that the drug should be reserved for difficult to treat resistant infections, where there are few alternative options, and can only be used either in the microbiology-directed (‘confirmed’) treatment setting, or as risk-based empiric treatment.5 NICE’s evaluation of Cefiderocol considered long-term population benefits, including the ‘insurance/diversity’ value of having additional antimicrobial treatment options available for the future, and the ‘enablement’ value associated with the continued ability to provide other healthcare (such as chemotherapy and surgical procedures), that might otherwise be jeopardised by increasing antimicrobial resistance.5

Cefiderocol is one of two antimicrobial products selected and made available as part of the scheme by NICE and NHS England6 because they address key disease areas of unmet need in the UK and internationally, treating serious infections including blood stream infection (BSI), sepsis and hospital or ventilator acquired pneumonia (HAP & VAP). Shionogi has entered into an initial three-year contract, with the option to extend, by agreement, for up to another seven years, receiving an annual, value-based payment.5

"We are delighted that NICE and NHS England have recognised the important role of Cefiderocol as an option to treat some of the most serious multidrug-resistant infections and its value to healthcare systems and society," said Mark Hill, SVP, Global Head of Market Access, Shionogi. "Antimicrobial resistance is becoming a significant global threat and subscription-style schemes like this help to ensure that antibiotics are used to benefit patients who need them and according to effective stewardship principles to limit the potential development of resistance."

While developing antibiotics is a long, costly and uncertain process, commercialisation can also be challenging. Once launched, there is often a low frequency of use driven by the need for stewardship to prevent resistance development. Low use leads to limited revenues, which in turn restricts continued commercialisation and new product research. As a result of these economic challenges, many large pharmaceutical companies are no longer active in the development and commercialisation of antibiotics, and several smaller biotech companies have filed for bankruptcy.2

"The introduction of this first of its kind pilot subscription reimbursement model reinforces the UK’s leadership position in creating a more predictable and sustainable market for new antibiotics," commented Takuko Sawada, Executive Vice President, Shionogi. "We hope that other countries will follow suit and introduce pull incentives to help address the challenges faced in bringing novel antibiotics to market."

Antimicrobial resistance (AMR) is a major health burden which urgently needs to be addressed. There are 700,000 deaths globally3, ~25,000 deaths per year in the EU7 and 5,000 deaths in England4 from infections with multidrug-resistant bacteria. Infections caused by carbapenem-resistant Gram-negative bacteria are often associated with a high mortality rate.8 If no action is taken, antibiotic resistance is predicted to result in 10 million deaths every year globally by 2050, at a cumulative cost to global economic output of 100 trillion USD.3

Resistant Gram-negative infections

The increasing resistance of many infections caused by Gram-negative bacteria to existing therapies, including carbapenem-resistant Enterobacterales and non-fermenting species such as P. aeruginosa, A. baumannii, and S. maltophilia, makes them difficult to treat and results in high mortality rates.9,10 The World Health Organization have identified carbapenem-resistant strains of Enterobacterales, P. aeruginosa and A. baumannii as the top priority in the research and development of new antibiotics.11 Cefiderocol is the first antibiotic to address all three major mechanisms of carbapenem-resistance and is an important treatment option to address this urgent unmet need.12

Cefiderocol

Cefiderocol is the world’s first siderophore cephalosporin antibiotic with a novel mechanism of entry through the outer membrane of Gram-negative pathogens by using the bacteria’s own iron uptake system to gain cell entry, acting like a Trojan horse.13 In addition to entering cells by passive diffusion through porin channels14, Cefiderocol binds to ferric iron and is actively transported into bacterial cells through the outer membrane via the bacterial iron transporters, which function to incorporate this essential nutrient for bacteria.15 These mechanisms allow Cefiderocol to achieve high concentrations in the periplasmic space where it can bind to penicillin-binding proteins and inhibit cell wall synthesis in the bacterial cells.13

Carbapenem resistance (CR) in Gram-negative bacteria is due to three main mechanisms:16

Beta-lactamases which cause enzymatic breakdown of beta-lactams
Changes in porin channels (through mutations and decrease in number) through which beta-lactams and other antibiotics diffuse into cells,
Overexpression of efflux pumps which occurs post-exposure and pumps antibiotics out of cells17
As a result of its novel structure and mechanism of cell uptake,18 Cefiderocol can overcome these three major mechanisms of CR.

Shionogi’s commitment to fighting antimicrobial resistance

Shionogi has a strong heritage in the field of anti-infectives and has been developing antimicrobial therapies for more than 60 years. Shionogi is proud to be one of the few large pharmaceutical companies that continues to focus on research and development in anti-infectives. (The company invests the highest proportion of its pharmaceutical revenues in relevant anti-infectives R&D compared to other large pharmaceutical companies19).