On March 18, 2025 Sofinnova Partners, a leading European life sciences venture capital firm, in collaboration with Gustave Roussy, Europe’s leading cancer center, reported the creation of their first pioneering biotech company (Press release, Institut Gustave Roussy, MAR 18, 2025, View Source [SID1234651246]).

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!

Signadori Bio, developed with scientific founders Dr. Jean-Luc Perfettini and Professor Nathalie Chaput, is a breakthrough cell therapy platform focused on transforming cancer treatment. This milestone marks a significant achievement in their strategic partnership, aimed at accelerating biotech innovation through rigorous evaluation and development of scientific research.

Since the partnership’s inception in 2023, it has rigorously evaluated 50 promising projects. This has culminated in the creation of a groundbreaking biotech venture in the cell and gene space that is set to advance innovative approaches in oncology. More information will be released as the company comes out of stealth later this year. Additionally, several other promising projects are in the pipeline, showcasing the immense potential for future breakthroughs in cancer therapeutics.

"With cancer on the rise, particularly among younger populations, it’s critical that we fast-track the most promising scientific breakthroughs into tomorrow’s treatments. This partnership is a powerful example of how academia and investors can work together to drive innovation through new companies," said Professor Fabrice Barlesi, General Director of Gustave Roussy. "Gustave Roussy is at the forefront of cancer discovery. With Sofinnova’s expertise in company creation, we are now able to quickly translate these innovations into real-world therapies to benefit patients worldwide."

Matthieu Coutet, Partner at Sofinnova Partners and CEO of Signadori Bio, added: "Turning cutting-edge research into biotech success stories requires more than financing or scientific excellence—it demands the right ecosystem. By combining Gustave Roussy’s research power with Sofinnova’s proven ability to build and scale biotech ventures, we’re creating a direct path from lab to the clinic."

As these ventures progress, Sofinnova Partners and its academic collaborators remain committed to fostering the next generation of biotech companies and driving innovation in cancer therapeutics. This groundbreaking initiative, supported by Sofinnova’s Biovelocita II—a €165M biotech acceleration fund dedicated to identifying and developing cutting-edge scientific advancements from top institutes like Gustave Roussy. This effort is undertaken in close collaboration with the institute’s technology transfer office, Gustave Roussy Transfert.

On March 18, 2025 Vincerx Pharma, Inc. (Nasdaq: VINC) reported that it has entered into a non-binding letter of intent ("LOI") with Global Digital Holdings Inc., conducting business as QumulusAI, a privately-held, high-performance computing infrastructure company for artificial intelligence (AI), relating to a business combination between Vincerx and QumulusAI (Press release, Vincerx Pharma, MAR 18, 2025, View Source [SID1234651231]). The contemplated transaction would result in QumulusAI becoming a publicly traded company through a reverse triangular merger with Vincerx.

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!

Under the proposed terms, a subsidiary of Vincerx would merge into QumulusAI, with QumulusAI stockholders receiving shares of Vincerx common stock. Additionally, QumulusAI options, warrants, and other rights would be converted into options, warrants, and rights to acquire Vincerx common stock. The exchange ratio is intended to result in QumulusAI equity holders owning approximately 95% of the combined company, while Vincerx equity holders would own approximately 5%. The proposed transaction assumes a value for QumulusAI of approximately $285 million and a value for Vincerx of approximately $15 million, assuming zero cash (net of liabilities) at closing. As part of the transaction, to the extent requested by Vincerx, QumulusAI or its designees will invest up to $1.5 million in the equity of Vincerx prior to closing.

Following the closing of the business combination, the combined company’s board of directors would consist of seven members, all of whom would be designated by QumulusAI. QumulusAI would also determine the composition of senior management of the combined company following the closing.

The parties intend to negotiate a definitive business combination agreement that incorporates the provisions of the LOI as well as other terms and conditions typical for transactions of this nature. Conditions to execution of a definitive business combination agreement include satisfactory completion of due diligence by the parties and approval by the boards of directors of the parties. The parties have agreed to a 30-day exclusivity period to negotiate and enter into a definitive business combination agreement, which will include customary closing conditions such as board and stockholder approvals, regulatory approvals, effectiveness of a registration statement relating to the issuance of Vincerx common stock in the business combination and listing of the combined company’s common stock on Nasdaq.

"We believe this merger will allow us to create value for our stockholders by entering the AI space at a time of rapid growth," said Raquel Izumi, Ph.D., Acting Chief Executive Officer of Vincerx. "We also believe QumulusAI is well positioned to disrupt the data center space with its high-performance, energy-efficient infrastructure, addressing the escalating demand for AI compute resources. In parallel, we will continue pursuing efforts to monetize our remaining assets."

"We’re excited about a potential merger with Vincerx, a milestone we believe will accelerate QumulusAI’s mission to power the future of artificial intelligence," said Steve Gertz, Chairman of the Board. "This proposed transaction will strengthen our ability to deliver cutting-edge AI solutions with high scalability, efficiency, and reliability—essential for advancing the next generation of AI.

This transaction would bring access to public capital markets, helping to fund the growth of our High-Performance Computing as a Service (HPCaaS) bedrock and enabling QumulusAI to expand its on- and off-grid data center infrastructure. Our behind-the-meter, natural gas-powered data centers are designed to alleviate strain on the energy grid, while our HPCaaS solutions are purpose-built to meet the surging demand for AI development."

Chardan is acting as the exclusive financial advisor and Fox Rothschild is acting as legal advisor to QumulusAI.

On March 18, 2025 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) (Actinium or the Company), a pioneer in the development of targeted radiotherapies, reported a clinical program comprising of trials studying Actimab-A in combination with either KEYTRUDA (pembrolizumab) or OPDIVO (nivolumab) which are blockbuster immunotherapies known as PD-1 inhibitors which are approved in multiple solid tumor indications (Press release, Actinium Pharmaceuticals, MAR 18, 2025, View Source [SID1234651232]). KEYTRUDA developed and commercialized by Merck & Co. and OPDIVO developed and commercialized by Bristol Myers Squibb, collectively generated $38.8 billion in sales in 2024 across several solid tumor cancer indications. However, the efficacy of these drugs has shown to be limited by a certain type of cell known as MDSCs or Myeloid Derived Suppressor Cells which accumulate in the tumor microenvironment. MDSCs express the CD33 antigen which is targeted by Actimab-A. The rationale for studying Actimab-A in combination with either KEYTRUDA or OPDIVO is based on the premise that depleting MDSCs with Actimab-A will improve the efficacy of these drugs.

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!

MDSCs are immune-suppressive cells that help tumors evade immune detection and promote disease progression. They are overexpressed in the tumor microenvironment in several different solid tumors and associated with poor outcomes. They work by multiple mechanisms but most relevant to PD-1 inhibitors which work by keeping T-cells active is that MDSCs prevent T-cells from recognizing and attacking cancer cells. There is considerable preclinical scientific evidence in the literature that depleting MDSCs could be a viable strategy in improving the outcomes of PD-1 directed immunotherapy, however, there have been no viable clinical approaches that have been tried successfully to our knowledge. MDSCs are known to express the CD33 antigen which is the target of Actimab-A. Actinium has also generated published and unpublished preclinical data showing that Actimab-A can selectively deplete MDSCs in solid tumors. Actinium believes that in the clinic Actimab-A can deplete CD33 expressing MDSCs and hence improve the outcomes with PD-1 inhibitors such as KEYTRUDA and OPDIVO.

Actimab-A is Actinium’s lead radiotherapeutic that delivers Actinium-225, a potent alpha-emitter radioisotope payload that can produce lethal double strand DNA breaks to kill targeted cells. Actimab-A has been studied in over 150 patients in several clinical trials in Acute Myeloid Leukemia or AML. Based on its safety and tolerability, Actimab-A is under clinical development via an NCI CRADA in the front-line AML setting with an expected registrational study in combination with CLAG-M in relapsed/refractory AML expected to initiate in 2025.

The Actimab-A solid tumor program is comprised of several controlled, head-to-head clinical trials that will evaluate the combination of Actimab-A with KEYTRUDA versus KEYTRUDA alone, and Actimab-A with OPDIVO versus OPDIVO alone. The initial tumors that are being targeted are HNSCC or Head and Neck Squamous Cell Carcinoma and NSCLC or Non-Small Cell Lung Cancer with a separate trial for each indication. The patient population for these trials will be adults with PD-L1 expression and locally advanced metastatic HNSCC or NSCLC randomized to either Actimab-A alone or Actimab-A with a specific checkpoint inhibitor. The objective of each trial would be to evaluate the safety and tolerability as well as following endpoints including ORR – Overall Response Rate, PFS – Progression Free Survival and OS – Overall Survival. Further, the following biomarker data would be collected including the pattern of depletion of CD33+ MDSCs and T-Cell activity in peripheral blood. Actinium expects to present initial proof of concept clinical data from the first of these trials in the second half of 2025 as well as provide an update on the outlook for the rest of the trials in the Actimab-A solid tumor program.

Dr. Avinash Desai, Actinium’s Chief Medical Officer, said, "The Actimab-A solid tumor program is highly novel and has the potential to address the high unmet need of patients receiving PD-1 checkpoint inhibitors whose cancer stops responding or progresses. Our preclinical data is highly encouraging and we believe this novel approach combining Actimab-A with PD-1 inhibitors has immense potential. We are greatly enthusiastic about these head-to-head trials, and eager to present our initial proof-of-concept results by the end of 2025."

Sandesh Seth, Actinium’s Chairman and CEO, said, "We have great enthusiasm for Actimab-A in combination with PD-1 checkpoint inhibitors given the large potential addressable patient population. MDSCs are over expressed in multiple solid tumors giving Actimab-A pan tumor potential in indications that are treated with checkpoint inhibitors. Per our initial estimates this represents a treatment population in excess of 500,000 patients. Together with our efforts in myeloid malignancies, this is another important program for Actimab-A. This year, clinical data from Actimab-A as a potential backbone therapy in radiation sensitive myeloid malignancies, and in solid tumors in combination with PD-1 checkpoint inhibitors, can establish its potential to become a leading blockbuster targeted radiotherapy."

On March 17, 2025 Orca Bio, a late-stage biotechnology company committed to transforming the lives of patients through high-precision cell therapy, reported positive results from the pivotal Phase 3 Precision-T study of Orca-T, its lead investigational allogeneic T-cell immunotherapy, in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL) (Press release, Orca Bio, MAR 17, 2025, https://orcabio.com/orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies/?utm_source=rss&utm_medium=rss&utm_campaign=orca-bio-announces-positive-results-from-the-pivotal-phase-3-study-of-investigational-orca-t-compared-to-allogeneic-stem-cell-transplant-for-the-treatment-of-hematologic-malignancies [SID1234651185]). Orca-T is manufactured using highly purified regulatory T-cells, hematopoietic stem cells and conventional T-cells derived from peripheral blood from either related or unrelated matched donors.

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!

In the randomized Precision-T study, Orca-T met the primary endpoint of a statistically significant improvement in survival free of moderate-to-severe chronic graft versus host disease (cGvHD) with Orca-T. At one year, the rate for patients who received Orca-T was 78% compared to 38% for patients who received a conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Patients in the Orca-T group achieved an estimated overall survival (OS) of 94% compared to 83% in the alloHSCT arm at one year.

"Today, treating patients with serious blood cancers using allogeneic stem cell transplants requires a difficult risk-benefit trade-off as clinicians aim to cure the disease while avoiding potentially deadly treatment-related toxicities, like GvHD," said presenting author Everett Meyer, M.D., Ph.D., hematologist and associate professor of medicine in Blood and Marrow Transplantation and Cellular Therapy at Stanford Health Care. "The Precision-T study showed double the rate of survival free from GvHD with Orca-T versus a conventional transplant, a relapse-free survival rate of 76% and no new safety concerns. These findings are highly encouraging and provide compelling new evidence as we work to solve for the critical factors contributing to the needs of this patient population."

Precision-T Study Results

In the study, all patients (n=187) with a median age of 43.5 years (range 19-65 years) were randomized 1:1 to Orca-T plus single-agent tacrolimus (TAC) or alloHSCT plus TAC methotrexate (TAC/MTX). Patients across both groups received myeloablative conditioning (MAC) and used a related or unrelated matched donor. Patients had a median follow-up time of 11.4 months (range 0.2-24.3 months) across both arms. Key results from the Precision-T study at one year are summarized below:

The primary endpoint of survival free of cGvHD was 78% (95% CI: 65%, 87%) in the Orca-T arm (n=93) and 38% (95% CI: 26%, 51%) in the alloHSCT arm (n=94) (HR 0.26; p<0.00001).
An interim analysis of the secondary endpoint of OS was 94% (95% CI: 86%, 97%) in the Orca-T arm and 83% (95% CI: 73%, 90%) in the alloHSCT arm (HR 0.49; p=0.11823).
An additional secondary endpoint of cumulative incidence of moderate-to-severe cGvHD was 13% (95% CI: 5%, 23%) and 44% (95% CI: 31%, 56%) in the Orca-T and alloHSCT arms, respectively (HR 0.19; p<0.00002).

Exploratory endpoints at one year include the rate of relapse-free survival which was 76% and 74% in the Orca-T and alloHSCT arms, respectively (HR 0.80, p=0.49). The cumulative incidence of non-relapse mortality was 3% in the Orca-T arm and 13% in the alloHSCT arm. Additionally, the cumulative incidence of Grade 3 or 4 acute GvHD was 6% and 17% in the Orca-T and alloHSCT arms, respectively.

No new safety issues were identified with Orca-T. Grade ≥ 4 infections per CTCAE scoring were noted in 6% and 10% of patients in the Orca-T and alloHSCT arms, respectively.

Orca-T was manufactured in Orca Bio’s centralized GMP facility and delivered to patients at 19 treatment centers across the U.S., with all infusions occurring within a vein-to-vein time of 72 hours or less.

"Approximately 46,000 people are diagnosed with AML, ALL and MDS in the U.S. each year, but only a fraction of them receive an allogeneic stem cell transplant within the current paradigm," said Rawan Faramand, M.D., Blood and Marrow Transplant and Cellular Immunotherapy, Moffitt Cancer Center. "Additional treatment options are needed, and the introduction of a cell therapy like Orca-T that leverages a precision-based approach could pave the way for a new standard of care for patients with various hematologic malignancies."

"These exciting results underscore Orca Bio’s vision of transforming the treatment landscape for patients living with serious blood cancers, potentially standardizing curative treatment for diseases like AML, ALL and MDS," said Ivan Dimov, Ph.D., co-founder and chief executive officer at Orca Bio. "We are working closely with the FDA and expect to submit a Biologics License Application this year. These results support the validity of our high-precision platform as we continue to advance our robust pipeline of allogeneic cell therapies for the treatment of hematologic malignancies, autoimmune diseases and beyond."

Orca Bio is grateful to the patients and families, donors and trial site investigators who participated in the Precision-T study.

The complete results will be presented on April 2, 2025, at the 51st Annual Meeting of The EBMT in Florence, Italy.

About Precision-T
Precision-T (NCT05316701) is a randomized, open-label multi-center study that evaluated the safety, efficacy and tolerability of Orca Bio’s lead investigational allogeneic T-cell immunotherapy, Orca-T, compared to conventional allogeneic hematopoietic stem cell transplant (alloHSCT). Orca Bio received guidance from the U.S. Food and Drug Administration on the design of Precision-T, which evaluated Orca-T in patients with acute myeloid leukemia (AML), acute lymphoblastic leukemia (ALL), high-risk myelodysplastic syndrome (MDS) and mixed-phenotype acute leukemia (MPAL). There are 19 leading treatment centers participating in the trial, which enrolled 187 patients across the U.S.

On March 17, 2025 CEL-SCI Corporation ("CEL-SCI" or the "Company") (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of a best-efforts offering of 16,000,000 shares of its common stock (or pre-funded warrants ("Pre-Funded Warrants") in lieu thereof) (Press release, Cel-Sci, MAR 17, 2025, View Source [SID1234651204]). Total gross proceeds from the offering, before deducting the placement agent’s fees and other offering expenses, are expected to be approximately $2,560,000. The offering is expected to close on March 18, 2025, subject to satisfaction of customary closing conditions.

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!

The Company intends to use the net proceeds from the offering to fund the continued development of Multikine, general corporate purposes, and working capital.

ThinkEquity is acting as sole placement agent for the offering.

The securities will be offered and sold pursuant to a shelf registration statement on Form S-3 (File No. 333-265995), including a base prospectus, filed with the U.S. Securities and Exchange Commission (the "SEC") on July 1, 2022, and declared effective on July 15, 2022. The offering will be made only by means of a written prospectus. A final prospectus supplement and accompanying prospectus describing the terms of the offering will be filed with the SEC on its website at www.sec.gov. Copies of the prospectus supplement and the accompanying prospectus relating to the offering may also be obtained, when available, from the offices of ThinkEquity, 17 State Street, 41st Floor, New York, New York 10004.

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.