On December 16, 2021 invIOs (innovative Immuno-Oncology) GmbH, a privately held biotechnology company developing novel therapies for cancer, reported it will commence operations on 1 January 2022 (Press release, Apeiron Biologics, DEC 16, 2021, View Source [SID1234597288]).

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invIOs, a fully owned subsidiary of APEIRON Biologics AG has been assigned APEIRON’s innovative cancer immunotherapy activities and all related clinical and preclinical R&D projects.

invIOs’ CEO Peter Llewellyn-Davies and his management team have taken this step to realize the full potential of its cutting-edge development projects and to create an early clinical-stage focused entity to allow investors to benefit from significant upside potential, especially specialized international biotech investors.

The proprietary cell therapy technology platform for the modulation of intracellular Immuno-Oncology targets enables rapid treatment of patients using their own cells with short out-of-body time in an out-patient setting. The groundbreaking concept allows access to indications that have previously not been addressable by earlier cell therapy approaches.

The first clinically validated target is the immune master-checkpoint Cbl-b; the clinicalstage lead candidate APN401 will show results in the near term on safety with data from an ongoing Phase 1b trial to be finalized in Q2 2022. A discovery pipeline with two additional promising candidates could give rise to new effective therapies for cancer patients, namely INV441 aiming to activate TILs (tumor-infiltrating lymphocytes) in solid tumors and INV501, an oral small molecule for tumor specific immune activation.

Peter Llewellyn-Davies, CEO of invIOs, comments: "Our passion is to develop life-saving therapies for patients suffering from cancer where there currently exist only limited treatment options. invIOs’ highly experienced team has a proven track-record of taking drugs to market with a core competency in immuno-oncology. The new company is geared towards enabling innovation and growth and will facilitate access to funding from specialized investors and partners. invIOs’ novel approach represents an investment opportunity with significant upside potential and important benefits for healthcare professionals and patients."

invIOs is headquartered in Vienna, Austria and will streamline the development of novel therapies in immuno-oncology backed by the acumen of the existing team. Accordingly, all current APEIRON employees are assigned to invIOs.

On December 16, 2021 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on the treatment and prevention of cancer and infectious diseases, reported that the Company is participating in the LifeSci Partners 11th Annual Corporate Access Event, which will be held virtually from January 5-7, 2022, and the H.C. Wainwright BioConnect Conference, which will be held January 10-13, 2022 (Press release, Anixa Biosciences, DEC 16, 2021, https://ir.anixa.com/news/detail/989/anixa-biosciences-to-participate-in-upcoming-january-investor-conferences-lifesci-partners-annual-corporate-access-event-and-h-c-wainwright-bioconnect-conference [SID1234597287]).

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Participation and presentation details are below:

LifeSci Partners Corporate Access Event:
Dr. Amit Kumar, Chairman, President and Chief Executive Officer of Anixa Biosciences will present on a panel entitled, "Cancer Vaccines: Promises, Promises…Has Their Day Come?" on Friday, January 7th, 2:00 pm ET.
During the duration of the LifeSci Corporate Access Event, the Anixa Biosciences management team will be available for 1×1 meetings with interested investors. Register here to submit a meeting request or to hear the panel discussion.
H.C. Wainwright BioConnect Conference:
Anixa Biosciences will present at the H.C. Wainwright BioConnect Conference and a recording of the presentation will be accessible beginning January 10th at 7:00 am ET. To listen to the presentation, visit the Investor Relations/Events & Presentations portion of Anixa’s company website.
The Anixa Biosciences management team will be available for 1×1 meetings with interested investors. Register here for the conference.

On December 16, 2021 Alpine Immune Sciences, Inc. (Nasdaq: ALPN) and Horizon Therapeutics plc (Nasdaq: HZNP) reported an exclusive license and collaboration agreement for the development and commercialization of up to four preclinical candidates generated from Alpine’s unique discovery platform (Press release, Alpine Immune Sciences, DEC 16, 2021, View Source [SID1234597286]). The overall agreement includes licensing of a lead, potential first-in-class preclinical candidate, as well as a research collaboration to jointly generate additional novel candidates. These candidates include previously undisclosed multi-specific fusion protein-based therapeutic candidates for autoimmune and inflammatory diseases.

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"We are extremely pleased to enter into this collaboration with Horizon, and look forward to working with its talented research and development team," said Stanford Peng, M.D., Ph.D., Alpine’s President and Head of R&D. "With our combined expertise, we hope to accelerate and expand the potential clinical impact of our discovery platform on autoimmune and inflammatory diseases."

"This partnership represents an opportunity to advance our research efforts, moving our mechanistic insights into innovative molecules utilizing Alpine’s expertise and proven ability to design multi-specific protein-based immunotherapies," said Elizabeth H.Z. Thompson, Ph.D., executive vice president, research and development, Horizon. "This collaboration will expand Horizon’s early pre-clinical pipeline with complementary mechanisms of action to our current clinical stage therapeutics and provide our first pre-clinical, multi-specific development candidate."

Under the terms of the agreement, Horizon will make an upfront payment to Alpine of $25 million as well as an equity investment in Alpine of $15 million at a 25 percent premium to the 30-day volume-weighted average share price. In addition, Alpine is eligible to receive up to $381 million per program, or approximately $1.52 billion in total, in future success-based payments related to development, regulatory and commercial milestones as well as tiered royalties on global net sales. Under the agreement, Alpine will advance candidate molecules to pre-defined preclinical milestones. Horizon will then assume responsibility for development and commercialization activities and costs.

Similar to changes at other peer companies, beginning in the fourth-quarter 2021, Horizon will no longer exclude upfront and milestone payments related to collaboration and license agreements from non-GAAP R&D expense, adjusted EBITDA and other non-GAAP financial measures and has filed a Form 8-K today with additional details.

On December 16, 2021 Abeona Therapeutics Inc. (Nasdaq: ABEO), a fully-integrated leader in gene and cell therapy, reported that it intends to offer and sell shares of its common stock and warrants to purchase common stock in an underwritten public offering pursuant to an existing shelf registration statement (Press release, Abeona Therapeutics, DEC 16, 2021, View Source [SID1234597284]). All of the securities in the offering are to be sold by Abeona. The offering is subject to market conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.

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Cantor Fitzgerald & Co. is acting as sole book-running manager for the offering, and A.G.P./Alliance Global Partners is acting as lead manager for the offering.

Abeona intends to use the net proceeds of the offering to fund continued clinical development of pipeline products, as well as for working capital and corporate purposes.

The securities described above are being offered pursuant to a shelf registration statement on Form S-3 (File No. 333-256850) that was filed with the Securities and Exchange Commission (the "SEC") on June 7, 2021 and amended on August 27, 2021 and October 19, 2021, and was declared effective by the SEC on October 22, 2021. The offering will be made only by means of the written prospectus and prospectus supplement that form a part of the registration statement. The preliminary prospectus supplement and the accompanying prospectus that form a part of the registration statement has been filed with the SEC and is available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus may also be obtained by contacting Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Ave., 4th Floor, New York, New York 10022, or by e-mail at [email protected].

The securities described above have not been qualified under any state blue sky laws. This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Abeona being offered, and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 16, 2021 Allergan Aesthetics, an AbbVie company (NYSE: ABBV), reported the successful completion of its acquisition of Soliton, Inc. (NASDAQ: SOLY) (Press release, AbbVie, DEC 16, 2021, View Source [SID1234597283]). The addition of Soliton and its technology complements Allergan Aesthetics’ portfolio of non-invasive body contouring treatments to now include a proven treatment for the appearance of cellulite.

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The RESONIC device initially received U.S. Food and Drug Administration (FDA) 510(k) clearance for the short-term improvement in the appearance of cellulite, and that clearance has now been expanded to long-term improvement up to one year. In recent clinical data submitted to the FDA, RESONIC demonstrated significant improvement in the appearance of cellulite and 97.6% of participants (n=67) found there was good improvement in the appearance of cellulite at 52-weeks post-treatment.

"We welcome the Soliton team to Allergan Aesthetics and the opportunity to offer health care providers and their patients a new, non-invasive option to reduce the appearance of cellulite," said Carrie Strom, President, Global Allergan Aesthetics and Senior Vice President, AbbVie. "In a recent survey of aesthetics consumers, cellulite was cited as a top 5 aesthetic concern, and this technology offers a new approach to treatment."

RESONIC has also received FDA 510(k) clearance for use in conjunction with laser for black ink tattoo removal in Fitzpatrick Skin Type I-III patients. For full safety information, please visit www.RESONIC.com/ISI.