On September 9, 2021 OncoBeta GmbH, a medical device company specialized in innovative epidermal radioisotope therapies reported the initiation of a phase IV international multi-centre study evaluating the Complete Response Rate of patients with non-melanoma skin cancer after treatment with Rhenium-SCT (Press release, OncoBeta, SEP 9, 2021, View Source [SID1234587567]).

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The EPIC Skin study (Efficacy of Personalised Irradiation with Rhenium-SCT- for the treatment of non-melanoma skin cancer) is based on the proven effect of the ß-emitter rhenium-188 in the treatment of basal cell (BCC) and squamous cell carcinomas (SCC)1,2. The Aim of the study is to further evaluate the efficacy of Rhenium-SCT as well as important Patient Reported Outcome Measures such as quality of life, treatment comfort and cosmetic outcomes.

OncoBeta has contracted the Australian based Contract Research Organization (CRO) Molecule2Market (M2M) for this significant international, multicentre clinical study (www.molecule2.com.au).

The study will enrol a minimum number of 175 adult patients with a confirmed histologically of stage I or II non-melanoma skin cancer to participate for 12 months, with a follow up period to 24 months. Study centres participating in the initiative are located in Australia, Austria, Germany and the United Kingdom. Enrolment for the EPIC-Skin trial is expected to open as soon as November 2021.

Dr. Gerhard Dahlhoff, Medical Director at OncoBeta GmbH stated: "Rhenium-SCT has proven to be effective and safe in previous studies. With this new study we want to further evaluate the efficacy and safety of the Rhenium-SCT at an international level in NMSC patients. This will be done in different centres under the same conditions."

"The initiation of the EPIC-Skin Study is a significant milestone for the Rhenium-SCT", said Shannon D. Brown III, CEO and Managing Director at OncoBeta GmbH "This will further demonstrate how effective and safe this therapy is. Furthermore, aligning with our company vision of focussing on quality of life, this study will also report on outcomes from the patient’s perspective."

About the Rhenium-SCT (Skin Cancer Therapy)
Non-melanoma skin cancer (NMSC) is the most common form of cancer in humans. The most common cause of NMSC is sun exposure, while other predisposing factors include genetic skin conditions and immunosuppressive diseases or treatments. The Rhenium-SCT is a non-invasive procedure, painless therapy3 providing for unparalleled aesthetic results2,4, even in cases otherwise considered difficult to treat.

The Rhenium-SCT utilizes the radioisotope Rhenium-188 in an epidermal application with optimal properties for the treatment of NMSCs (non-melanoma skin cancers). The specially designed device ensures the Rhenium-SCT compound never comes in direct contact with the patients’ skin and the application is safe and www.oncobeta.com simple for the applying physician. Most cases of non-melanoma skin cancers (Basal Cell Carcinomas and Squamous Cell Carcinomas) can be treated using the Rhenium-SCT in one single session3. Scar-free healing4 of the treated lesion area and the regeneration of healthy tissue occurs usually within a few weeks after treatment4.

On September 9, 2021 AbbVie reported that it will participate in the Morgan Stanley Virtual 19th Annual Global Healthcare Conference on Wednesday, September 15, 2021 (Press release, AbbVie, SEP 9, 2021, View Source [SID1234587458]). Richard A. Gonzalez, chairman and chief executive officer, Michael Severino, M.D., vice chairman and president, Robert A. Michael, executive vice president and chief financial officer, and Jeffrey R. Stewart, executive vice president, commercial operations, will present at 9:15 a.m. Central time.

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A live audio webcast of the presentation will be accessible through AbbVie’s Investor Relations website at investors.abbvie.com. An archived edition of the session will be available later that day.

Diamyd Medical AB reported its intention to carry out a directed share issue corresponding to approximately SEK 125-150 million through a so-called accelerated bookbuilding process (Press release, Diamyd Medical, SEP 9, 2021, View Source;ClipID=4062338 [SID1234587489]). The objective of the directed share issue is to support the Company’s ongoing establishment of its own manufacturing facility in Umeå and a precision medicine phase III trial with the diabetes vaccine Diamyd in individuals recently diagnosed with type 1 diabetes and who carry the genetic HLA type where efficacy has been shown in previous trials.
Diamyd Medical announces its intention to carry out a directed new share issue corresponding to a value of approximately SEK 125-150 million, directed at qualified investors, with deviation from existing shareholders’ preferential rights, based on the authorisation granted by the Annual General Meeting held on 26 November 2020 (the "Directed Share Issue"). Diamyd Medical has engaged G&W Fondkommission to investigate the possibilities to conduct the Directed Share Issue.

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The subscription price for the new shares in the Directed Share Issue is to be determined through an accelerated bookbuilding procedure, which will begin immediately after the announcement of this press release. The Directed Share Issue is contingent on a resolution by the Board of directors, which, alongside pricing and allocation of shares, is expected to occur prior the commencement of trading on Nasdaq First North Growth Market on 10 September 2021. The Board of directors may at any time choose to cancel the bookbuilding procedure, close earlier or later and refrain from executing the Directed Share Issue, in part of in full.

The proceeds from the Directed Share Issue will be used to achieve important milestones with a focus on initiating a precision medicine pivotal phase III trial with the diabetes vaccine Diamyd in all countries that will be included in the trial and for the ongoing establishment of Diamyd Medical’s manufacturing facility in Umeå, Sweden, for the production of the recombinant human protein GAD65, the active component of the therapeutic diabetes vaccine Diamyd. The phase III trial is designed to confirm the efficacy and safety of Diamyd in individuals recently diagnosed with type 1 diabetes and who carry the genetic HLA haplotype where efficacy is likely (approximately half of this target group). Approximately 330 patients will be recruited for the trial and the trial will be conducted at approximately 50 clinics in Europe and the US. The future CGMP-certified production process at the facility in Umeå is a central part of Diamyd Medical’s regulatory strategy for potential future conditional and accelerated market approvals for the diabetes vaccine Diamyd.

The Board has investigated the conditions for alternative financing solutions, including the main alternative, a rights issue, and in their analysis come to the conclusion that a directed issue is the best alternative for the Company, taking into account time and cost efficiency. The Board has taken into account the potential outcomes of various issue alternatives, including dilution for shareholders and the importance of strengthening the Company’s cash position prior to the planned start and operation of the phase III trial and the ongoing establishment of the manufacturing facility. Furthermore, the Board has considered the importance of seeking to diversify the shareholder base with additional insititutional/professional investors, and to further strengthen the financial position as a factor of strength in connection with partner discussions.

Adviser
G&W Fondkommission has been appointed financial adviser in connection with the Directed Share Issue. Aktieinvest FK AB is the issuing agent.

On September 09, 2021 TG Therapeutics, Inc. reported that Michael S. Weiss, the Company’s Chairman and Chief Executive Officer, will participate in a fireside chat during the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually September 13 – 15, 2021 (Press release, TG Therapeutics, SEP 9, 2021, View Source [SID1234587497]).

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The fireside chat will be available for on demand download beginning at 7:00 AM ET on Monday, September 13th, 2021, and will also be available on the Events page, located within the Investors & Media section, of the Company’s website at View Source

On September 9, 2021 Selecta Biosciences, Inc. (NASDAQ: SELB), a biotechnology company leveraging its clinically validated ImmTOR platform to develop tolerogenic therapies that selectively mitigate unwanted immune responses, reported that Selecta’s Chief Executive Officer, Carsten Brunn, Ph.D., will provide a corporate update and participate in one-on-one investor meetings at the H.C. Wainwright 23rd Annual Global Investment Conference to be held September 13-15, 2021 (Press release, Selecta Biosciences, SEP 9, 2021, View Source [SID1234587536]).

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The presentation will be available on-demand through the H.C. Wainwright conference portal, starting at 7:00 a.m. ET on Monday, September 13, 2021.

An archived webcast of the presentation will be accessible in the Investors & Media section of the company’s website at www.selectabio.com.