On June 22, 2021 vTv Therapeutics Inc. ("vTv", Nasdaq:VTVT) and Cantex Pharmaceuticals, Inc. ("Cantex") reported that they have entered into a licensing agreement under which Cantex has obtained exclusive worldwide rights to develop and commercialize azeliragon, vTv’s novel antagonist of RAGE (the receptor for advanced glycation endproducts) (Press release, vTv Therapeutics, JUN 22, 2021, View Source [SID1234584235]).

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Stephen Marcus, M.D., president and chief executive officer of Cantex, stated: "RAGE has been implicated in several serious cancer complications associated with increased mortality and decreased quality of life. Our team has deep expertise and a successful track record in transforming known drugs into innovative products with large clinical and commercial potential. As such, the opportunity to develop azeliragon, a phase 2-ready oral medication administered once daily, which has demonstrated a good safety profile in several Alzheimer’s disease trials, is an excellent fit for Cantex. We intend to move rapidly to prepare for clinical trials assessing the potential of azeliragon for the treatment of a number of complications associated with cancer."

"RAGE is a highly attractive target for the treatment of a wide spectrum of disorders," said Steve Holcombe, president and chief executive officer of vTv. "We believe Cantex is the right partner to further the development of azeliragon, which vTv had studied in Alzheimer’s disease, in new therapeutic indications. They have deep experience in clinical development and the proven capability of repurposing drug candidates for new indications."

Under the terms of the agreement, Cantex will be responsible for the development and commercialization of azeliragon and the companies will allocate downstream profits under a tiered arrangement.

About Azeliragon
Azeliragon, also known as TTP488, is an orally active, small molecule, antagonist of the receptor for advanced glycation endproducts (RAGE). vTv Therapeutics discovered azeliragon using its proprietary drug discovery platform, TTP Translational Technology, and developed it into phase 3. A broad range of evidence suggests that RAGE—ligand interactions lead to sustained inflammatory states that play a role in chronic diseases.

On June 22, 2021 Photocure ASA (OSE:PHO) reported that its partner Asieris Pharmaceuticals (Asieris) has administered the first European patient in its phase III clinical trial for APL-1702 (Cevira) (Press release, PhotoCure, JUN 22, 2021, View Source [SID1234584253]).

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Asieris announced dosing of the first patient in Europe in its multinational, multicenter, Phase III clinical trial called APRICITY that started last November. The photodynamic drug-device combination product APL-1702, Cevira, licensed to Asieris by Photocure, is being developed for a novel non-surgical treatment of cervical high-grade squamous intraepithelial lesions (HSIL).

"The multinational phase III clinical trial for Cevira is an important milestone towards a non-surgical treatment of high-grade cervical dysplasia. This step shows once more that our partner Asieris is making great progress and is on track with their clinical program and development of this innovative photodynamic drug-device combination," says Daniel Schneider, Chief Executive Officer of Photocure.

In China, the clinical trial application for APL-1702, Cevira multinational Phase III trial was approved by the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) in July 2020. Photocure reported Asieris’ dosing of the first patient in China on November 11, 2020 (View Source).

HSIL is a pre-cancerous condition caused by a persistent HPV infection. Each year there are approximately 10 million cases of high-grade disease and over 500,000 new cases of cervical cancer worldwide. In China, approximately 2% of women develop HSIL each year.

On June 22, 2021 Pear Therapeutics reported that it is taking the SPAC track, going public through a deal expected to provide about $400 million in new funding as the company looks to expand its prescription apps to a wider range of conditions (Press release, Pear Therapeutics, JUN 22, 2021, View Source [SID1234584359]).

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Those proceeds include $125 million gathered from private investments in Pear’s newfound public equity, plus $276 million held by Thimble Point Acquisition Corp., a blank-check company backed by the Pritzker Vlock Family Office, whose investment portfolio spans several medtech and biotech companies.

Following the closure of the deal—which represents a total pro forma equity value of about $1.6 billion—the newly combined Pear Holdings Corp. is expected to begin trading on the Nasdaq, under the ticker PEAR, before the end of this year with its current management in place.

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"In our view, Pear is at a commercial inflection point, with the potential for rapid expansion," President and CEO Corey McCann said in a statement.

The company’s ultimate goal is to provide a platform for clinically validated prescription digital therapeutics, or PDTs, either as stand-alone software treatments or alongside pharmaceuticals for major medical conditions, McCann said.

RELATED: SoftBank’s Vision Fund backs Pear Therapeutics in $80M VC round to forge new market paths for digital treatment apps

The private investment round includes participation from 5AM Ventures, Arboretum Ventures, Blue Water Science Advisors, Novartis’ dRx Capital, The Eleven Fund, FORTH Management, Health Innovation Capital, JAZZ Venture Partners, Neuberger Berman funds, Palantir, Pilot House, QUAD Investment Management, Sarissa Capital, Shanda Group, SoftBank Vision Fund 2, Temasek and Trustbridge Partners.

Earlier this year, Pear announced plans to make its digital therapies a little more tangible, with the addition of wearable sensors and activity trackers through a partnership with the medical smartwatch maker Empatica, plus a digital pill project with etectRx for tracking drug adherence.

Previously, Pear focused on treating addiction and substance use disorders by offering cognitive behavioral therapy through its FDA-cleared reSET and reSET-O software programs, with the latter focused on opioids.

RELATED: Pear Therapeutics launches digital insomnia app through direct-to-patient telehealth model

In November 2020, the former Fierce 15 winner launched its app for insomnia, Somryst, through a direct-to-patient telehealth model, combining telemedicine visits with the digital delivery of the prescription app.

Late last year also saw Pear raise $80 million in a venture capital round backed by SoftBank’s Vision Fund 2, among others, to help support the company’s push to secure reimbursement coverage for Somryst and its reSET offerings.

Around the same time, the Institute for Clinical and Economic Review—the U.S. drug pricing watchdog known as ICER—threw cold water on multiple digital therapeutics for opioid use disorder, including reSET-O, saying it could not find strong evidence that the apps provided benefits over long time periods.

Pear, meanwhile, pointed to real-world data showing that users were able to complete the software’s therapy modules outside of normal clinic hours, with 88% passing drug screenings and 85% remaining in active treatment for months. An additional, retrospective economic analysis showed fewer hospitalizations and emergency room visits.

RELATED: Pear Therapeutics to take digital treatments physical with sensor, activity tracker deals

Since then, the company raised another $100 million through a series D round closed in March. Its pipeline currently has 14 product candidates, including for alcohol use disorder, schizophrenia, post-traumatic stress disorder, bipolar disorder, anxiety and depression, as well as chronic pain, migraines, multiple sclerosis, cancer and a range of chronic conditions.

On June 21, 2021 Genmab reported the initiation of a share buy-back program to mitigate dilution from warrant exercises and to honor our commitments under our Restricted Stock Units program (Press release, Genmab, JUN 21, 2021, View Source [SID1234584186]).

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The share buy-back program is expected to be completed no later than June 30, 2021 and comprises up to 200,000 shares.

The following transactions were executed under the program from June 14, 2021, to June 18, 2021:

No. of shares

Average price (DKK)

Total value (DKK)

Accumulated through last announcement

Details of each transaction are included as an appendix to this announcement.

Following these transactions, Genmab holds 281,006 shares as treasury shares, corresponding to 0.43% of the total share capital and voting rights.

The share buy-back program is undertaken in accordance with Regulation (EU) No. 596/2014 (‘MAR’) and the Commission Delegated Regulation (EU) 2016/1052, also referred to as the "Safe Harbour Regulation." Further details on the terms of the share buy-back program can be found in our company announcement no. 11 dated February 23, 2021.

On June 21, 2021 GT Biopharma, Inc. ("GT Biopharma" or the "Company") (NASDAQ: GTBP), a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary natural killer (NK) cell engager (TriKE) protein biologic technology platform, reported that Dr. Jeffrey S. Miller will be giving an update on the progress of the GTB-3550 TriKE Phase I trial accompanying the Company’s corporate update presentation at the upcoming Raymond James Human Health Innovation Conference on Tuesday, June 22, 2021 at 11:20 AM ET (Press release, GT Biopharma, JUN 21, 2021, View Source [SID1234584203]).

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A live webcast of the event will be available by visiting the "Presentations" page in the Investors section of GT Biopharma’s website at www.gtbiopharma.com/news-media/presentations. A replay of the webcast will be archived for 30 days following the presentation.