On June 30, 2021 Alpine Immune Sciences, Inc. (NASDAQ: ALPN), a leading clinical-stage immunotherapy company focused on developing innovative treatments for cancer and autoimmune/inflammatory diseases, reported a clinical trial collaboration and supply agreement with Merck (Press release, Alpine Immune Sciences, JUN 30, 2021, View Source [SID1234584500]). This collaboration will evaluate the safety and efficacy of Alpine’s ALPN-202, a first-in-class conditional CD28 costimulator and dual checkpoint inhibitor, in combination with Merck’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), the first anti-PD-1 therapy approved in the United States. The clinical trial, NEON-2, began dosing study participants in June 2021.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We are extremely pleased to collaborate with Merck, one of the world’s leading immuno-oncology companies," said Stanford Peng, M.D., Ph.D., President and Head of R&D of Alpine. "Our prior preclinical studies demonstrated that the combination of ALPN-202 and a PD-1 inhibitor can be particularly advantageous, and this collaboration will greatly enable our ability to pursue this opportunity in the clinic. This study, in conjunction with NEON-1, ALPN-202’s ongoing first-in-human monotherapy trial, will provide insights across a broad spectrum of cancers and lines of therapy."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About ALPN-202

ALPN-202 is a first-in-class, conditional CD28 costimulator and dual checkpoint inhibitor with the potential to improve upon the efficacy of combined checkpoint inhibition while limiting significant toxicities. Preclinical studies of ALPN-202 have successfully demonstrated superior efficacy in tumor models compared to checkpoint inhibition alone. NEON-1 (NCT04186637), a monotherapy study of ALPN-202 in patients with advanced malignancies, and NEON-2 (NCT04920383), a study of ALPN-202 in combination with KEYTRUDA (pembrolizumab) in patients with advanced malignancies, are currently enrolling.

On June 30, 2021 Again Life Italia S.r.l. ("ALI"), a pharmaceutical biotechnology company headquartered in Italy, and TannerLAC UK Limited ("TannerLAC"), a subsidiary of Tanner Pharma Group and commercialization leader in Latin America, reported the signing of a business partnership agreement for Latin America (Press release, Tanner Pharma Group, JUN 30, 2021, View Source [SID1234584516]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

With their global presence, ALI is dedicated to supporting cancer patients undergoing chemo and radiation therapy. Similarly, TannerLAC supports patients and biopharma companies by providing access to medicines in targeted markets.

Carolina Cortez, EVP of TannerLAC, commented, "We are very excited about the opportunity to work with Again Life Italia to improve the quality of life of patients in Latin America who experience side effects from chemo and radiation therapies."

Antonella Sardei, CEO of Again Life Italia, added, "Our partnership with TannerLAC is strategic to promote the products and the philosophy of Again Life Italia in Latin American countries and is in line with the company’s mission in supporting patients, especially those affected by side effects related to anticancer treatments, giving them the respect due to those who suffer."

The objective of the partnership is to leverage TannerLAC’s 18 years of experience to provide ALI’s innovative treatments to markets such as Argentina, Brazil, Chile, Colombia, Ecuador, Mexico and Peru.

On June 30, 2021 Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing an integrated companion diagnostic and therapeutic strategy for treating patients with cancer, reported that it has commenced an underwritten public offering of shares of its common stock (Press release, Celcuity, JUN 30, 2021, View Source [SID1234584501]). As part of the offering, Celcuity expects to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. All of the shares in the offering will be sold by Celcuity . The offering is subject to market and other 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Celcuity intends to use the net proceeds from the offering for working capital and general corporate purposes, which may include capital expenditures, research and development expenditures, clinical trial expenditures, expansion of business development activities and other general corporate purposes.

Jefferies and Cowen are acting as joint bookrunning managers for this offering. Canaccord Genuity is acting as the lead manager and Needham & Company is acting as the senior co-manager.

The shares are being offered by Celcuity pursuant to a registration statement on Form S-3 previously filed with and declared effective by the U.S. Securities and Exchange Commission. The offering is being made only by means of a prospectus. A preliminary prospectus supplement and accompanying prospectus related to the offering will be filed with the SEC. Copies of the preliminary prospectus supplement and accompanying prospectus relating to the offering may be obtained, when available, from the following: Jefferies LLC, Attention: Equity Syndicate Prospectus Departments, 520 Madison Avenue, 2nd Floor, New York, NY 10022; by phone at (877) 821-7388; or by email at [email protected]; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, email [email protected], telephone: 833-297-2926.

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, or any solicitation of an offer to buy, these securities 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 June 30, 2021 Medsenic, a clinical-stage biopharmaceutical company focused on the discovery and development of novel indications and formulations of arsenic salts for the treatment of severe autoimmune diseases, reported that it has entered into an exclusive licensing agreement with Australian company Phebra for the development of their patented OATO formulation (Oral Arsenic Trioxide) in the treatment of autoimmune diseases (Press release, Phebra, JUN 30, 2021, View Source [SID1234584517]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

This agreement is a major step in paving the way for the marketing of a second generation of Medsenic’s drug candidates, until now dispensed as an intravenous solution (Arscimed). Phebra’s expertise in drug development, together with Medsenic’s clinically validated scientific discoveries, will confirm further the efficacy of arsenic trioxide observed in a phase 2 study, by switching to the novel and patient administered oral form (OATO).

"We are delighted with this partnership with Phebra, a global reference player renowned for its unique expertise in the development and formulation of critical care medicines and a specific expertise in arsenic-based drugs. This exclusive agreement reflects Medsenic’s commitment to pursue the development of its pipeline of drug candidates targeting autoimmune diseases ; it will allow us to initiate our Phase 3 clinical trial for the treatment of cGvHD and to develop our products in new indications such as systemic sclerosis", said Prof. François Rieger, President and co-founder of Medsenic, who added: "The robust formulation of Arscimed is a real paradigm shift in that it will bring expected comfort to patients with chronic graft-versus-host disease."

"We are impressed by the clinical results obtained by Medsenic with its product Arscimed in the treatment of cGvHD as an intravenous solution. We are confident that the properties of arsenic trioxide observed in various clinical studies have the potential to revolutionize the therapeutic management of autoimmune diseases where there remains a huge unmet medical need. With our novel patented oral formulation, we will contribute to a significant improvement in patient care, avoiding frequent hospital stays, painful injections and potentially less adverse side effects," said Dr Mal Eutick, President of Phebra.

About the ATO :

Arsenic trioxide has the dual property of increasing cellular oxidative stress, to the point where it induces the programmed death of activated cells (enhanced apoptosis) and of modulating their production of proinflammatory cytokines. It thus has a specific long-term immunomodulatory effect on activated cells of the innate immune system, without affecting its normal components, as demonstrated in animal models without autoimmune pathology, and with perfectly controlled side effects. It probably acts at an upstream coordination level of the immune cascade, since a correction of all parameters signaling the autoimmune cascade is observed in various animal models of autoimmunity.

Research programs are being developed to understand the positive effects of arsenic trioxide in human clinical trials. MEDSENIC has provided initial proof of concept in a Phase 2a clinical trial for the treatment of severe systemic lupus erythematosus, followed by positive results in the treatment of cGvHD in Phase 2 (75% success rate in the full analysed population). Medsenic has demonstrated that its arsenic trioxide-based treatment has minimal toxicity and proven efficacy, leading to its wider application in other autoimmune diseases.

On June 30, 2021 Cytovation AS, a clinical stage immune-oncology company focused on the development of its first-in-class tumorolytic agent CyPep-1, reported that it has entered into a clinical trial collaboration and supply agreement with MSD to evaluate the safety and efficacy of CyPep-1 in combination with KEYTRUDA (pembrolizumab), MSD’s anti-PD-1 therapy (Press release, Cytovation, JUN 30, 2021, View Source;utm_medium=rss&utm_campaign=cytovation-announces-clinical-collaboration-with-msd-to-evaluate-its-first-in-class-tumorolytic-agent-cypep-1-in-combination-with-keytruda [SID1234584502]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Cytovation will first expand its ongoing monotherapy Phase I/II "CICILIA" clinical trial, to evaluate safety of CyPep-1 in combination with KEYTRUDA, in a 15-patient cohort. Subsequently, clinical evaluation will proceed into a Phase II trial that will evaluate the efficacy and safety of the combination in up to 90 patients with advanced head and neck squamous cell carcinoma (HNSCC), melanoma, or triple-negative breast cancer (TNBC). Initial results from the safety study are expected early next year with the Phase II trial scheduled to start shortly thereafter.

Lars Prestegarden, MD, PhD, CEO of Cytovation, commented: "Early clinical data for CyPep-1 monotherapy have shown a strong safety profile and encouraging anti-tumor activity that are consistent with our preclinical data, where we have also seen a highly synergistic effect of CyPep-1 with checkpoint inhibitor therapy. We are very pleased to be collaborating with MSD as we explore the potential of this combination in patients."

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

About CyPep-1

CyPep-1 is a proprietary first-in-class tumorolytic agent engineered to selectively target tumor cell membranes based on their altered molecular composition relative to normal cells. CyPep-1 eliminates cancer cells by forming pores in the plasma membrane, releasing cancer specific antigens to the immune system, promoting an inflammatory microenvironment, and inducing a tumor-specific immune response by in situ vaccination.

Preclinical data suggest this mode of action is highly synergistic with checkpoint inhibitors.