On June 15, 2022 Oncotelic Therapeutics, Inc. ("Oncotelic" or the "Company") (OTCQB:OTLC), developer of treatments for rare and orphan indications, including Parkinson Disease and various cancers, reported that the Company presentation at BIO International Convention is now available at View Source (Press release, Oncotelic, JUN 15, 2022, View Source [SID1234616007]).

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The JVCo IPO- is on track for 2023 with anticipated minimum valuation of 200M / Range 1-5B
OT-101 is being combined with most known immunotherapies including MPM/Keytruda/ Merck, NSCLC/Tecentriq/Genentech, and others are in various stages of initiation
OT-10 treatment of high- risk COVID patients reduced mortality from 100% to 50%, p=0.003.

On June 15, 2022 Omega Therapeutics, Inc. (Nasdaq: OMGA) ("Omega") reported the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA) for the Company’s lead product candidate, OTX-2002, for the treatment of hepatocellular carcinoma (HCC) (Press release, Omega Therapeutics, JUN 15, 2022, View Source [SID1234616023]). OTX-2002, an Omega Epigenomic Controller, is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation.

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"This is an important milestone for our Company, an IND achieved in approximately 26 months since we started working on the early constructs in discovery which culminated in OTX-2002. We are excited that this represents the first of many anticipated IND applications and the transition of the company to its next stage," said Mahesh Karande, President and Chief Executive Officer of Omega Therapeutics. "This also marks a milestone regulatory submission for the first epigenomic controller, a new class of programmable mRNA therapeutics enabled by our OMEGA platform. We believe our approach to engineering epigenomic controllers has immense potential across a broad range of diseases, including HCC, which carries a 5-year survival rate of only 10%. We look forward to advancing OTX-2002 into the clinic and bringing it one step closer to patients in need."

The Company plans to initiate a Phase 1 clinical trial in the U.S. to evaluate OTX-2002, following FDA clearance.

About OTX-2002
OTX-2002 is a first-in-class Omega Epigenomic Controller in development for the treatment of HCC. OTX-2002 is a mRNA therapeutic delivered via lipid nanoparticles (LNPs) and is designed to downregulate c-Myc (MYC) expression pre-transcriptionally through epigenetic modulation while potentially overcoming MYC autoregulation. The MYC oncogene is associated with aggressive disease in up to ~70% of patients with HCC. An IND application has been submitted to the FDA.

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.