Nerviano Medical Sciences S.r.l. Announces a Poster Presentation on NMS-03602173 at 34th EORTC-NCI-AACR Symposium on Molecular Targets and Cancer Therapeutics

On October 25, 2022 Nerviano Medical Sciences Srl, a member of NMS Group and a clinical stage company discovering and developing innovative therapies for the treatment of cancer, reported that preclinical data from the Company’s asset NMS-03602173 will be reported in a poster presentation by Dr. Paola Magnaghi at the upcoming EORTC-NCI-AACR (Free EORTC-NCI-AACR Whitepaper) Symposium on Molecular Targets and Cancer Therapeutics (ENA 2022) which will be held October 26-28, 2022 at the CCIB in Barcelona (Press release, Nerviano Medical Sciences, OCT 25, 2022, View Source [SID1234623260]).

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Details of the upcoming presentation are as follows:

About NMS-03602173 (NMS-173)

NMS-173 is a second generation potent, covalent, selective, and orally available investigational new drug for the treatment of cancer patients with mutated IDH1 or IDH2. IDH1 and IDH2 mutations confer to these enzymes a neomorphic activity promoting the conversion of α-KG into 2-HG, an oncometabolite that induces a global epigenetic rewiring, leading to de-differentiation, stemness and tumorigenesis. NMS-173 potently inhibits mutant IDH1 and IDH2 thus resulting in the abrogation of 2-HG production in a variety of cells and in a number of in vivo mouse models including IDH mutant cholangiocarcinoma, glioma and AML models, with significant tumor growth inhibition and anti-tumor efficacy superior to FDA approved first generation inhibitors. Due to its covalent MOA, NMS-173 has high potential of sustained clinical responses compared to FDA approved drugs and can also potentially overcome resistance mechanisms to first generation IDH inhibitors. Notably, NMS-173 has received authorization to start phase I clinical studies in US and Europe in patients with IDH1 or IDH2 mutated solid tumors including low grade glioma.

Salubris announces deep collaboration with Anlong Bio on small nucleic acid drugs for hypertension

On October 25, 2022 Salubris Pharmaceuticals reported that it signed a co-development agreement with Anlong Bio. The two drugmakers will collaborate in the development of small nucleic acid drugs to treat hypertension (Press release, Salubris Pharmaceuticals, OCT 25, 2022, View Source [SID1234622550]).

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Anlong will be responsible for the early development using its proprietary ANOG small nucleic acid drug technology platform, while Salubris will oversee later development, clinical trials and marketing of the product.

Salubris will have exclusive rights to develop and commercialize the drug worldwide, and both companies will share the future market and commercial benefits.

Salubris was founded in 1998 and focuses on the cardio-cerebrovascular field. It also explores innovative drugs for the treatment of hypoglycemia, tumors, orthopedics, nephropathy and anti-infection. This collaboration marks Salubris’ first entry into the emerging field of nucleic acid drugs.

Entry into a Material Definitive Agreement

On October 25, 2022, Silverback Therapeutics, Inc. ("Silverback"), Sabre Merger Sub, Inc. ("Merger Sub") and ARS Pharmaceuticals, Inc. ("ARS Pharma"), reported that it entered into the Second Amendment (the "Amendment") to the Agreement and Plan of Merger and Reorganization, dated as of July 21, 2022, as amended on August 11, 2022 (the "Merger Agreement"), by and among Silverback, Merger Sub and ARS Pharma, pursuant to which the parties agreed to amend the Merger Agreement as follows (Filing, 8-K, Silverback Therapeutics, OCT 25, 2022, View Source [SID1234622488]):

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1.Section 8.5 of the Merger Agreement was amended and restated in its entirety to read as follows:

8.5 Parent Net Cash. Parent Net Cash, as finally determined pursuant to Section 1.6, shall not be less than $210,000,000 nor greater than $265,000,000; provided, however, that if Parent Net Cash is greater than $265,000,000, Parent may declare a Permitted Dividend in the amount of such excess to satisfy such condition."

2.The proviso set forth in Section 4.1(b)(i) of the Merger Agreement was amended and restated in its entirely to read as follows:

"provided, however, that to the extent that Parent Net Cash is greater than $265,000,000, Parent shall be permitted to declare any such excess amount as a dividend (a "Permitted Dividend");"

3.Clause (i) in the definition of Parent Valuation was amended and restated in its entirety to read as follows:

"(i) if Parent Net Cash is greater than $240,000,000, the sum of (x) the Parent Equity Value plus (y) the amount by which, up to $25,000,000, Parent Net Cash exceeds $240,000,000."

The foregoing description of the Amendment is not complete and is qualified in its entirety by reference to the Amendment, which is attached hereto as Exhibit 10.1 to this Current Report on Form 8-K and incorporated herein by reference.

Celgenyx Closes $14 Million A Round for Off-the-Shelf Cell Therapies

On October 25, 2022 Hangzhou Celgenyx reported that it completed a $14 million Series A Round to support development of its off-the-shelf cell therapies, either through partnerships or its own R&D (Press release, Hangzhou Celgenyx, OCT 25, 2022, View Source [SID1234622467]). All of the capital was contributed by Vivo Partners from an RMB fund. Hangzhou Celgenyx is a development-stage biotech, dedicated to the acquisition and development of next-gen cell immunotherapies for malignant cancers. Celgenyx expects to complete construction of a 3000 square meter R&D center and GMP pilot production base in Hangzhou before the end of 2022.

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Provectus Biopharmaceuticals Expands Research Collaboration with The Rockefeller University to Investigate Clinical-Stage Immuno-Dermatology Agent PH-10 for Skin Inflammation

On October 25, 2022 Provectus (OTCQB: PVCT) reported that the Company has expanded its sponsored research program with James G. Krueger, MD, PhD, Co-director, Center for Clinical and Translational Science, D. Martin Carter Professor in Clinical Investigation, Senior Attending Physician, and head of the Laboratory of Investigative Dermatology at The Rockefeller University to investigate the potential for PH-10, a topical formulation of Provectus’ pharmaceutical-grade small molecule rose bengal sodium (RBS) drug substance, to directly alter the growth and differentiation of human keratinocytes, and to block cytokine-mediated signaling that creates different inflammatory skin diseases and may also be important in skin neoplasms (Press release, Provectus Biopharmaceuticals, OCT 25, 2022, View Source [SID1234622422]).

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PH-10 is an immuno-dermatology, multi-indication viable, clinical-stage pharmaceutical asset that the Company has used to treat more than 200 patients in multiple early- and mid-stage clinical trials for psoriasis and atopic dermatitis.

Dr. Krueger and the Laboratory of Investigative Dermatology plan to examine the effects of a wider range of PH-10 concentrations on human keratinocytes in vitro at the level of gene transcription. They also hope to determine PH-10’s interaction with and uptake by blood leukocytes, because these cells mediate inflammatory skin diseases and control or protect against some types of skin cancers.

The Kruger team previously elucidated several PH-10 mechanisms of action from work that it did as part of a Provectus clinical study of psoriasis, showing that:

PH-10 treatment significantly down-regulated IL-17A, IL-22, IL-26, IL-36, and keratin 16 genes,
Pathways significantly improved by PH-10 treatment included published psoriasis transcriptomes and cellular responses mediated by IL-17, IL-22, and interferons,
PH-10 treatment resulted in the downregulation of more than 500 disease-related genes, and
The expression of a wide-range of central "psoriasis-related" genes including IL-23, IL-17, IL-22, S100A7, IL-19, IL-36 and CXCL1 were effectively normalized to levels consistent with non-lesional skin.
A copy of the medical conference poster of this prior work by the Kruger team is available on Provectus’ website.