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.

On December 16, 2021 Neogene Therapeutics, Inc., a preclinical stage biotechnology company pioneering a new class of fully individualized T cell receptor (TCR) therapies to treat cancer, reported the appointment of Raphaël Rousseau, M.D., Ph.D. as Chief Medical Officer (Press release, Neogene Therapeutics, DEC 16, 2021, View Source [SID1234597282]). Dr. Rousseau brings more than 20 years of extensive experience in oncology drug development, including engineered T cell therapies, in both academia and the biotechnology industry. He joins Neogene’s executive team and will be based in its U.S. headquarters in Santa Monica.

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"We’re thrilled to welcome Raphaël at this crucial and exciting time in our company’s growth. He is a strong leader, who has led teams across all phases of development and has successfully built and executed multiple global clinical programs," said Carsten Linnemann, Ph.D., President, Chief Executive Officer and co-founder of Neogene. "Raphael’s broad experience with cell therapy and neo-antigen targeting drug modalities will be critical in helping us to diversify our pipeline and advance our programs into the clinic with the goal of bringing T cell therapies to patients across a broad spectrum of solid tumors."

Dr. Rousseau most recently served as Executive Vice President, Head of Product Development, and Chief Medical Officer at Gritstone bio, where he was responsible for the company’s global clinical development strategies and expansion of its neoantigen-based immunotherapies. He led the buildout of the clinical development organization and execution of Gritstone’s clinical strategy including conducting several phase 1 and phase 2 clinical trials. Prior to Gritstone bio, Dr. Rousseau served as the Global Franchise Head of Pediatrics at Genentech and Roche, where he successfully led a global development and study management team and served as the Chair of the Development Review Committee for early and late-stage pediatric asset reviews. While at Genentech, he oversaw the clinical development of the company’s oncology portfolio from first-in-human to registrational trials for several pediatric hematology and oncology indications. Prior to joining industry, Dr. Rousseau was a Professor of Medical and Pediatric Oncology at the Université Claude Bernard in Lyon, France, and the head of the pediatric translational research program at Léon Bérard Cancer Center. There, he created and led the first European academic consortium for the conduct of a phase 1 study using CD19-targeting CAR T cells for the treatment of pediatric high-risk leukemias. Earlier in his career, Dr. Rousseau was a fellow at Baylor College of Medicine in Houston, where he worked with Dr. Malcolm Brenner at the Center for Cell and Gene Therapy. Dr. Rousseau received a Ph.D. in Therapeutic Biotechnologies from the Université Denis Diderot and an M.D. from the Université René Descartes in Paris. He is board certified in pediatrics and has a sub-specialty certification in pediatric hematology-oncology.

"I’m proud to be joining the Neogene team, which has been making great strides in the field of neoantigen-directed T cell therapy, and excited about helping advance our pioneering research into the clinic to potentially help patients who currently have limited treatment options," said Dr. Rousseau. "This is a field that I am extremely passionate about, and I am excited to apply my expertise in successfully advancing these promising therapies into clinical trials as we work to change the solid cancer treatment paradigm."

On December 16, 2021 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune diseases, reported it has signed a Manufacturing Service Agreement (MSA) with Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation (CDMO), to manufacture IMP761 ahead of clinical testing (Press release, Immutep, DEC 16, 2021, View Source [SID1234597281]).

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IMP761, Immutep’s preclinical candidate for autoimmune diseases is an immunosuppressive agonist antibody to LAG-3. It has now been tested in a Th1-driven autoimmune disease setting, oligoarticular juvenile idiopathic arthritis, as a proof of concept which has been published in the peer-reviewed Pediatric Journal in Oct 2021.1

Northway Biotech is a European specialist manufacturer of recombinant proteins and monoclonal antibodies, with manufacturing sites in Lithuania and the United States. Under the agreement, Northway has already started developing a GMP-compliant manufacturing process of IMP761 and will manufacture IMP761 in large scale bioreactors. The process is based on a pharmaceutical-grade, stable GS knockout CHO K1 cell line system that has been shown to produce product yields of IMP761 in small scale setup. The work is undertaken at Northway’s Vilnius, Lithuania facility with the potential to expand the agreement to include further process scale up and cover commercial supply in the future.

After completion of the required preclinical development, the material produced will be used for Immutep’s clinical trials of IMP761. Planning for further pre-clinical and clinical development is ongoing.

Commenting on the agreement, Marc Voigt said: "We are very excited to be partnering with Northway Biotech to develop a GMP manufacturing process for IMP761. As a targeted immunosuppressive antibody, IMP761 has the potential to address the root cause of autoimmune diseases by specifically silencing the autoimmune memory T cells accumulating at the disease site, known to express LAG-3. We are very pleased to be moving IMP761 towards clinical trials."

Vladas Algirdas Bumelis, CEO of Northway Biotech said: "We have a long and successful history of developing processes to facilitate efficient and scalable production for new and promising products. Our team in Vilnius is looking forward to applying their world-class skills and state-of-the-art equipment to develop a manufacturing process including GMP manufacturing for Immutep’s IMP761."

André Markmann, VP Business Development of Northway Biotech, added: "We are proud to be selected by Immutep as CDMO to support Immutep´s fight against autoimmune diseases which impair so many patients globally."

On December 16, 2021 Innate Pharma SA (Euronext Paris: IPH; Nasdaq: IPHA) ("Innate" or the "Company") reported that the first patient was dosed in a Phase 1/2 clinical trial (NCT05086315), evaluating IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager, in patients with relapsed or refractory acute myeloid leukemia (R/R AML), B-cell acute lymphoblastic leukemia (B-ALL) or high risk-myelodysplastic syndrome (HR-MDS) (Press release, Innate Pharma, DEC 16, 2021, View Source [SID1234597280]).

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The purpose of the dose escalation and dose expansion study, which is sponsored by Sanofi, is to evaluate the safety, pharmacokinetics, pharmacodynamics and initial clinical activity of IPH6101/SAR443579, Innate’s lead ANKETTM asset, in various CD123-expressing hematological malignancies.

This trial is supported by positive pre-clinical results presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) 2021 Congress, which demonstrated the CD123-targeted molecule’s potent antitumor activity against AML, including evidence supporting greater anti-leukemia activity compared with an anti-CD123 antibody. IPH6101/SAR443579 had sustained pharmacodynamic effects in non-human primates, combining efficient depletion of CD123-expressing cells with minor systemic cytokine release in comparison to T-cell engagers. As expected, it also had a favorable safety profile.

"We’re pleased with the initiation of the clinical trial for IPH6101/SAR443579, which is the first ANKETTM asset to enter the clinic. ANKETTM is our new multi-specific NK cell engager platform, which has the potential to engage NK cells through NKp46 and CD16, and more broadly, generate an entirely new class of molecules to induce synthetic immunity against cancer," said Joyson Karakunnel, MD, MSc, FACP, Chief Medical Officer of Innate Pharma. "We look forward to continuing to advance this platform given the critical role NK cells play in the cancer immunity cycle."

The start of the trial has triggered a milestone payment from Sanofi to Innate, which is part of a previously announced research collaboration with Sanofi. Under the agreement, the companies collaborate on the generation and evaluation of up to two bispecific ANKETs, using technology from Innate and Sanofi’s proprietary bispecific antibody formats as well as tumor targets. The companies are currently working on the second research program under the agreement.

More information about the Phase 1/2 trial can be found here.

About ANKETTM:

ANKETTM (Antibody-based NK cell Engager Therapeutics) is Innate’s proprietary platform for developing next-generation, multi-specific natural killer (NK) cell engagers to treat certain types of cancer. The Company’s latest innovation, its tetra-specific ANKETTM molecule, is the first NK cell engager technology to engage two NK cell activating receptors (NKp46 and CD16), a tumor antigen and the interleukin-2 receptor (by an IL-2 variant, IL-2v), via a single molecule. This molecule leverages the advantages of harnessing NK cell effector functions against cancer cells and also provides proliferation and activation signals targeted to NK cells.

In pre-clinical studies, Innate’s tri-1 and tetra-specific ANKETTM technologies promote potent NK cell activation, cytotoxicity and efficient control of tumor growth in pre-clinical models. This versatile fit-for-purpose technology is creating an entirely new class of molecules to induce synthetic immunity against cancer.

About IPH6101/SAR443579:

In the first research program of the Sanofi collaboration, IPH6101/SAR443579, the first NKp46/CD16-based NK cell engager using Innate’s proprietary multi-specific antibody format, has shown antitumor activity in pre-clinical models, including supportive pharmacokinetic/pharmacodynamic (PK/PD) and safety data in non-human primate studies leading to its selection as a drug candidate for development.

About the Innate-Sanofi agreement:

The Company has a research collaboration and licensing agreement with Sanofi to apply Innate’s proprietary technology to the development of innovative multi-specific antibody formats engaging NK cells through the activating receptors NKp46 and CD16 to kill tumor cells.

Under the terms of the license agreement, Sanofi will be responsible for the development, manufacturing and commercialization of products resulting from the research collaboration. Innate Pharma will be eligible to up to €400m in development and commercial milestone payments as well as royalties on net sales.