On August 19, 2024 Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) ("Tiziana" or the "Company"), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, reported the appointment of Ivor Elrifi as its Chief Executive Officer (CEO), effective immediately (Press release, Tiziana Life Sciences, AUG 19, 2024, View Source [SID1234645990]).

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"We are delighted to welcome Ivor Elrifi as the new CEO of Tiziana Life Sciences," said Gabriele Cerrone, Founder and Executive Chairman of the Board. " Ivor has an invaluable track record in creating substantial value for biotech and pharma companies with his strategic vision in building intellectual property portfolios and transforming the IP into transformative business development deals and M&A transactions. Tiziana looks forward to creating further value with Ivor as we proceed with our human clinical trials."

Tiziana Life Sciences is currently focused on advancing intranasal foralumab through clinical trials for non-active Secondary Progressive Multiple Sclerosis (na-SPMS), Alzheimer’s Disease and ALS. Under Ivor’s leadership, the company aims to accelerate these programs and capitalize on opportunities to address significant unmet medical needs.

Ivor was formerly the global head of the Patent Group at Cooley since 2014 and before that the global head of Patents at Mintz Levin from 1999 – 2014. He has counseled companies in various key industries, including pharmaceutical, biotechnology, life sciences and medical device companies, research institutions, universities, hospitals and governments throughout the world, particularly in the US and Europe. Ivor has guided clients in developing and implementing intellectual property strategies and in the prosecution, licensing and enforcement of patents. He has extensive experience in advising clients on strategic transactional work and regularly counsels’ clients with respect to investments, business development and mergers and acquisitions, including acquisition transactions involving Novartis, Eli Lilly, Biogen and Astellas.

He has received various awards throughout his career, including being named an "LMG Life Sciences: Life Science Star," and ranked nationally in Chambers USA since 2007. Elrifi earned his B.S. and Ph.D. in Biology from Queen’s University and his J.D. from Osgoode Hall Law School.

"I am honored to lead Tiziana Life Sciences at this pivotal time in its growth trajectory," said Ivor Elrifi. "The company’s commitment to developing transformative therapies holds great promise, and I look forward to working with the talented team to advance our clinical programs and deliver value to patients and shareholders."

Mr. Elrifi succeeds Gabriele Cerrone, who was acting CEO and will remain in his role as Executive Chairman of the board and will continue to play a key role in advancing Tiziana’s scientific agenda.

About Foralumab

Foralumab, a fully human anti-CD3 monoclonal antibody, is a biological drug candidate that has been shown to stimulate T regulatory cells when dosed intranasally. At present, 10 patients with Non-Active Secondary Progressive Multiple Sclerosis (na-SPMS) have been dosed in an open-label intermediate sized Expanded Access (EA) Program with either an improvement or stability of disease seen within 6 months in all patients. The FDA has recently allowed an additional 20 patients to be enrolled in this EA program. In addition, intranasal foralumab is currently being studied in a Phase 2a, randomized, double-blind, placebo-controlled, multicenter, dose-ranging trial in patients with non-active secondary progressive multiple sclerosis (NCT06292923).

Activated T cells play an important role in the inflammatory process. Foralumab, the only fully human anti-CD3 monoclonal antibody (mAb), binds to the T cell receptor and dampens inflammation by modulating T cell function, thereby suppressing effector features in multiple immune cell subsets. This effect has been demonstrated in patients with COVID and with multiple sclerosis, as well as in healthy normal subjects. The non-active SPMS intranasal foralumab Phase 2 trial (NCT06292923) began screening patients in November of 2023. Immunomodulation by nasal anti-CD3 mAb represents a novel avenue for treatment of neuroinflammatory and neurodegenerative human diseases.

On August 20, 2024 Sonnet BioTherapeutics Holdings, Inc. (the "Company" or "Sonnet") (NASDAQ: SONN), a clinical-stage company developing targeted immunotherapeutic drugs, reported it has entered into a Master Clinical Collaboration Agreement (the "Agreement") with the Sarcoma Oncology Center, to advance the development of SON-1210, the Company’s proprietary, bifunctional version of human Interleukins 12 (IL-12) and 15 (IL-15), configured using Sonnet’s Fully Human Albumin Binding (FHAB) platform, in combination with chemotherapy for the treatment of metastatic pancreatic cancer (Press release, Sonnet BioTherapeutics, AUG 19, 2024, View Source [SID1234645988]).

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"We are very pleased to enter into this strategic development collaboration to advance SON-1210 with this prestigious organization and in a program that we believe has the potential to address a significant area of unmet need. We expect that this development approach will provide us with valuable information in a high-value cancer indication that will add to our growing body of data, which we believe will potentially drive value in our platform and enable us to preserve cash resources," commented Pankaj Mohan, Ph.D., Founder and CEO of Sonnet.

Dr. Hendifar, a renowned physician developing new therapies for pancreatic cancer and neuroendocrine tumors and Associate Professor of Medicine, Medical Director – Pancreatic Cancer, Co-Director – Hematology-Oncology Fellowship Program and Medical Director – Gastrointestinal Oncology Disease Research Group at Cedars-Sinai, added, "Pancreatic cancer incidence is growing worldwide and the advancements in the standards of care beyond chemotherapies has been limited. We believe a novel immunotherapy such as SON-1210 offers an exciting opportunity to improve outcomes for patients."

Under the terms of the Agreement, the IIOC, led by Dr. Sant Chawla, Director of the Sarcoma Oncology Center, in collaboration with Sonnet, will prepare a protocol and conduct an investigator-initiated Phase 1/2a clinical study to evaluate SON-1210 in combination with several chemotherapeutic agents including but not limited to liposomal irinotecan, 5-fluorouracil/leucovorin, and oxaliplatin ("NALIRIFOX") for the specific treatment of metastatic pancreatic cancer. NALIRIFOX is U.S. FDA-approved for the treatment of metastatic pancreatic cancer in the front-line and refractory settings. Sonnet will provide the study drug, SON-1210, and support services for the planned Phase 1/2a study.

"We are very excited to enter this collaboration with Sonnet. Cancers are hungry for albumin and albumin-bound drugs are taken up preferentially by cancer cells," added Dr. Chawla, a leading authority in medical treatment and clinical research for bone and soft-tissue sarcomas and sarcoma therapy. "We know this is a validated mechanism for enhancing efficacy and reducing toxicity and there are no immunotherapies approved for pancreatic cancer. SON-1210’s dual IL-12, IL-15 approach builds upon the success of SON-1010 in extending the cytokine half-life and turning cold tumors hot, which is being studied at our center as well.

John Cini, Ph.D., Chief Scientific Officer and a Co-Founder of Sonnet concluded, "Clinical trials using cytokines have had limited success to date due to their short half-lives, the inability to directly target cancer cells, and high rates of adverse events. Sonnet’s fully human albumin-binding platform has been specifically designed to address these issues. Based on our FHAB construct, we have shown that we can increase tumor-targeting and retention by 4-5 fold over unmodified cytokines. We are targeting pancreatic cancer, an area with tremendous unmet need, which has increased expression of the FcRn and GP60 receptors, as well as the SPARC complex. SON-1210, our bifunctional IL-12/IL-15 candidate, has been shown to increase immune activity and persistence in preclinical cancer models, and we are excited to initiate human studies with this unique candidate. SON-1210 may act synergistically with NALIRIFOX, the first new chemotherapy approved for front-line pancreatic cancer in over a decade."

Additionally, the Company recently participated in a Virtual Investor KOL Connect segment with Dr. Chawla and Dr. Hendifar. The KOL Connect segments are now available here.

As previously announced, the Company successfully completed two IND-enabling toxicology studies of SON-1210 in non-human primates (NHPs), which demonstrated no overt toxicity in the GLP study apart from the expected, and mild, on-target changes in hematology and clinical chemistry parameters that resolved completely within 14 to 21 days post-dosing. A significant increase in interferon gamma (IFNγ), which was transient in nature, was noted as early as one day following administration, with no apparent increase in other proinflammatory cytokines. IFNγ is a well-known pharmacodynamic biomarker that is required for anti-tumor efficacy in preclinical models. Other signs of cytokine imbalance, or uncontrolled increase of pro-inflammatory cytokines (including TNF-α, IL-1β, and IL-6) were notably absent from all dose levels tested in the study.

About SON-1210

SON-1210 is an immunotherapeutic bifunctional drug candidate that links unmodified single-chain human IL-12 and human IL-15 with the albumin-binding domain of the single-chain antibody fragment FHAB separating the two cytokines with linkers to avoid steric hindrance. The FHAB single chain was selected to bind well at normal pH, as well as at an acidic pH that is typically found in the tumor microenvironment (TME). The FHAB technology targets tumor and lymphatic tissue, providing a mechanism for dose-sparing, enhanced PK, and an opportunity to improve the safety and efficacy profile of not only IL-12 and IL-15, but a variety of other potent immunomodulators using the platform. We believe these dual-targeting cytokines can orchestrate a robust immune response to many cancers and pathogens, particularly when presented together on the same molecule. Given the types of proteins induced in the TME, such as Secreted Protein Acidic and Rich in Cysteine (SPARC), several types of cancer such as non-small cell lung cancer, melanoma, head and neck cancer, sarcoma, and some gynecological cancers are particularly relevant for this approach. SON-1210 is designed to deliver IL-12 and IL-15 to local tumor tissue, with the intention of turning ‘cold’ tumors ‘hot’ by stimulating IFNγ, which activates both innate and adaptive immune cells in the TME, as well as increasing the production of Programed Death Ligand 1 (PD-L1) on tumor cells.

On August 20, 2024 Scorpius Holdings, Inc. (NYSE American: SCPX), ("Scorpius", or the "Company"), an integrated contract development and manufacturing organization (CDMO), reported the closing of its underwritten public offering of 14,375,000 shares of common stock (and/or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof), including full exercise of the underwriter’s over-allotment option (Press release, Scorpius BioManufacturing, AUG 19, 2024, View Source [SID1234645987]). Each share of common stock (or Pre-Funded Warrant) was offered at a public offering price of $1.00 per share (inclusive of the Pre-Funded Warrant exercise price), for gross proceeds of $14,375,000, before deducting underwriting discounts and offering expenses.

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The Company intends to use the net proceeds of the offering to fund working capital and for general corporate purposes.

ThinkEquity acted as sole book-running manager for the offering.

A registration statement on Form S-1 (File No. 333-280887) relating to the securities being offered was filed with the Securities and Exchange Commission ("SEC") and became effective on August 6, 2024. This offering is being made only by means of a prospectus. Copies of the final prospectus may be obtained from ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004. The final prospectus has been filed with the SEC and is available on the SEC’s website located at View Source

This press release shall not constitute an offer to sell or a solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On August 19, 2024 Purple biotech presented its corporate presentation (Presentation, Purple Biotech, AUG 19, 2024, View Source [SID1234645986]).

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On August 19, 2024 Peptomyc S.L., a company developing foundational mini-protein therapeutics for the treatment of cancer, reported that the Company has been issued a patent by the Hong Kong Patent Office protecting its Methods and Composition of Matter (Press release, Peptomyc, AUG 19, 2024, View Source [SID1234645985]).

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"We are delighted to announce further protection of our mini-protein therapeutics in Hong Kong. This patent grant strengthens our patent portfolio that protects our unique mini-protein therapeutics, which are able to inhibit MYC, the most dysregulated oncogene in human cancer, in the major geographical areas in oncology," said Laura Soucek, CEO at Peptomyc S.L.

The Company currently maintains over 10 different patent families worldwide covering applications protecting Peptomyc S.L. first-in-modality mini-protein therapeutics in multiple oncological indications, and counts on the services of ABG Intellectual Property and Dechert LLP for the protection of its IP assets.