On December 31, 2024 Galera Therapeutics, Inc. (OTC: GRTX) reported that it has completed the acquisition of Nova Pharmaceuticals, Inc. ("Nova"), a privately held biotechnology company advancing a pan-NOS Inhibitor to treat patients with highly resistant forms of breast cancer, including metaplastic breast cancer and other refractory subsets of triple-negative breast cancer ("TNBC") (Press release, Galera Therapeutics, DEC 31, 2024, View Source [SID1234649368]).

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In support of the acquisition, a syndicate of investors led by Ikarian Capital has invested approximately $3 million to purchase Galera common stock. Galera’s new lead program is the Investigator-sponsored Phase 1/2 trial of a pan-NOS Inhibitor on top of standard-of-care nab-paclitaxel and alpelisib in metaplastic breast cancer. The Company’s cash balance at closing is anticipated to fund operations into 2026 and through data readout from its lead program in metaplastic breast cancer. A second trial is planned for this agent in TNBC in collaboration with the I-SPY 2 consortium. The Company intends to support a third trial of Avasopasem, one of its small molecule dismutase mimetics, in patients with hormone-receptor positive (HR+) advanced breast cancer who have become resistant to conventional therapy. This trial is expected to commence enrollment in the first half of 2025.

"Dismutase Mimetics and NOS inhibitors involve complementary pathways that play important roles in cancer, in the tumor microenvironment, in resistance to conventional chemoradiotherapy and in immuno-oncology," said Mel Sorensen, M.D., President & CEO of Galera. "Substantial mechanistic and preclinical rationale for both agents in solid tumors, especially in breast cancer, has been generated by the companies and their collaborators. Both product candidates are in clinical stage development, having been well-characterized in many patients both in oncologic and non-oncologic indications. Galera has decided to focus its near-term development on the hardest-to-treat subsets of advanced breast cancer."

The Company continues as Galera Therapeutics, Inc. (OTC:GRTX) and will be led by Dr. Sorensen, as President and Chief Executive Officer and Joel Sussman, as Chief Accounting Officer. A team of consultants comprising people from both Galera and Nova will manage the R&D of the company, in a capital efficient manner.

"I am excited about the ability to combine our technologies to address the unmet need of many breast cancer patients," said Par S Hyare CEO of Nova Pharmaceuticals. "This agreement allows Galera and our collaborators the opportunity to advance our product candidates to the next stage of clinical development. The investigators at Houston Methodist have presented data showing several responses in the ongoing trial and we look forward to the data readout in the next nine to fifteen months under the capable leadership of Galera’s team."

About the Proposed Transactions

Under the terms of the merger agreement and the securities purchase agreement, Galera has issued approximately 21.1 million shares of common stock plus pre-funded warrants exercisable for approximately 23 million shares of common stock, and approximately 119,318 shares of Series B non-voting (1:1000) convertible preferred stock in a private placement. At the closing, Galera stockholders will own approximately 55.2% of the common shares (assuming that the pre-funded warrants are exercised in full). The shares of Series B non-voting convertible preferred stock will be convertible into shares of common stock, subject to stockholder approval at a subsequent meeting of the Company’s stockholders. Following that approval, on an as-converted basis, the pre-acquisition Galera stockholders will own approximately 25% of the combined Company and the new investors and Nova stockholders will own approximately 75% of the combined Company (assuming that the pre-funded warrants are exercised in full).

The transaction was unanimously approved by the Board of Directors of both companies and by the stockholders of Nova.

The Board of Directors includes three current Galera board members, Mr. Larry Alleva and Mr. Kevin Lokay and Dr. Sorensen, and two additional board members selected by Nova, Mr. Michael Friedman and Dr. Nancy T. Chang. Mr. Friedman has an MBA from the University of Chicago and brings over 20 years’ experience in investment banking, in finance and in the life science industry to the Board of Galera. Dr. Chang is a PhD biochemist who has spent her career in leadership roles in academia, in large and small pharma companies and in the venture capital world and she has extensive experience in biopharma boards.

Stifel, Nicolaus & Company served as the financial advisor to Galera. Lucid Capital Markets, LLC has provided a fairness opinion to Galera’s Board of Directors. Sidley Austin LLP is serving as legal counsel to Galera. Cooley LLP is serving as legal counsel to Nova.

On December 31, 2024 Abeona Therapeutics Inc. (Nasdaq: ABEO) reported it has granted equity awards to new non-executive employees who joined the Company (Press release, Abeona Therapeutics, DEC 31, 2024, View Source [SID1234649367]). The equity awards were approved in accordance with Nasdaq Listing Rule 5635(c)(4).

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On December 30, 2024, the Compensation Committee of Abeona’s Board of Directors granted restricted stock equity awards as a material inducement to employment to five individuals hired by Abeona, which equity awards relate to, in the aggregate, up to 28,600 restricted shares of Abeona common stock. One-third of the shares subject to such restricted stock awards will vest yearly on each anniversary of the Grant Date, such that the shares subject to such restricted stock awards granted to each employee will be fully vested on the third anniversary of the Grant Date, in each case, subject to each employee’s continued employment with Abeona on the applicable vesting dates.

On December 30, 2024 Immedica Pharma AB (Immedica), a leading global rare disease company, and Marinus Pharmaceuticals, Inc. (Nasdaq: MRNS), a pharmaceutical company committed to improving the lives of patients with seizure disorders, reported that they have entered into an agreement and plan of merger under which Immedica has agreed to acquire Marinus, by means of a tender offer and subsequent merger (Press release, Immedica Pharma, DEC 30, 2024, View Source [SID1234649366]).

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The acquisition complements and further strengthens Immedica’s global rare disease business by adding ZTALMY (ganaxalone) oral suspension, CV, a neuroactive steroid gamma-aminobutyric acid (GABA)-A receptor positive modulator, approved by the U.S. Food and Drug Administration (FDA) in March 2022 for the treatment of seizures associated with cyclin-dependent kinase-like 5 (CDKL5) deficiency disorder (CDD) in patients two years of age and older.

Transaction rationale and details in brief:

Adds global rights to ZTALMY, a commercial-stage rare neurology medicine approved by FDA, the European Commission (EC), the UK Medicines and Healthcare products Regulatory Agency (MHRA) and the National Medicines Product Administration (NMPA) in China with potential for further approvals worldwide.
Accelerates Immedica’s growth into the North American market, providing an immediate revenue-generating rare disease product and an experienced commercial team upon closing of the transaction.
Acquisition is expected to accelerate Immedica’s revenue growth, adding a commercial-stage asset in the United States, with the potential for further expansion globally.
Immedica to commence a cash tender offer to acquire all issued and outstanding shares of Marinus for USD 0.55 per share, corresponding to an implied enterprise value of approximately USD 151 Million.
Transaction is expected to close in Q1 2025.
"The acquisition of Marinus represents a transformative step in Immedica’s journey to further strengthen our position as a leading rare disease company. By adding ZTALMY to our portfolio, we significantly strengthen our capabilities and expand our presence in the United States, marking a new chapter in our mission to deliver impactful therapies for underserved patient populations," said Anders Edvell, M.D. Ph.D. and Chief Executive Officer of Immedica.

"Immedica is dedicated to addressing significant unmet medical needs in rare diseases, ensuring patients receive the innovative treatments they deserve. Within CDD, patients with refractory seizures face particularly challenging circumstances due to insufficiently effective existing therapies. The addition of ZTALMY allows us to offer a differentiated solution, with the potential to improve care and outcomes for these patients," he concluded.

"I am proud of the dedication and passion of our team at Marinus, which allowed us to deliver the first and only FDA-approved treatment for seizures associated with CDKL5 deficiency disorder in patients two years of age and older," said Scott Braunstein, M.D., Chairman and Chief Executive Officer of Marinus. "With a shared commitment to improving the lives of rare disease patients, this acquisition is expected to enable ZTALMY to make an even greater impact on patients, while providing meaningful value for Marinus’ stockholders."

Transaction details

Under the terms of the merger agreement, Immedica, through a wholly owned, direct subsidiary, will initiate a tender offer to acquire all the outstanding shares of Marinus common stock for a cash purchase price of USD 0.55 per share, representing a premium of 48% based on Marinus’ closing share price as of December 27th and a premium of 97%, based on the 30-day volume-weighted average price of USD 0.28 per share preceding the announcement of the transaction. The Board of Directors of Marinus has unanimously approved the transaction and recommended that the stockholders of Marinus tender their shares in the tender offer. Immedica has received an undertaking from each director and named executive officer of Marinus to tender their respective shares in favor of the transaction.

The transaction represents the culmination of Marinus’ review of strategic alternatives, which it announced on October 24, 2024, with the goal of maximizing value for its stockholders.

The closing of the tender offer will be subject to customary conditions, including the tender of shares which represent at least a majority of the total number of Marinus’ outstanding shares of common stock. Upon the successful completion of the tender offer, Immedica would acquire any shares of Marinus’ common stock not tendered through a second-step merger effected for the same per share consideration. The transaction is expected to close in Q1 2025.

Advisors

MTS Health Partners LP is acting as Immedica’s exclusive financial advisor in connection with the transaction. Gibson, Dunn & Crutcher LLP is acting as legal counsel to Immedica and Fuchs Patentanwälte Partnerschaft mbB is acting as intellectual property counsel on this transaction, Barclays Capital Inc. is acting as Marinus´ exclusive financial advisor in connection with the transaction. Hogan Lovells LLP is acting as legal counsel to Marinus on this transaction.

About ZTALMY (ganaxolone) oral suspension

ZTALMY (ganaxolone) is a neuroactive steroid GABAA receptor modulator that acts on a well-characterized target in the brain known to have anti-seizure effects. It is a prescription medicine that has been approved by the U.S. FDA, EC, the MHRA, and the China NMPA for appropriate patients with CDKL5 deficiency disorder.

U.S. Prescribing Information for ZTALMY (ganaxolone) oral suspension CV.

European Union Summary of Product Characteristics for ZTALMY.

On December 30, 2024 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a life sciences company developing novel targeted oncology therapies and commercializing RenovoCath, a novel, FDA-cleared delivery system, reported its strong intellectual property (IP) position as it moves forward with commercial plans and clinical trial advancement in 2025, utilizing its novel Trans-Arterial Micro-Perfusion (TAMP) therapy platform (Press release, Renovorx, DEC 30, 2024, View Source [SID1234649365]).

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Earlier this year, RenovoRx published a new international patent application for its TAMP therapy platform to expand its IP portfolio. RenovoRx already holds strong IP including coverage of its proprietary TAMP therapy platform and RenovoCath delivery system, with 8 issued and 6 pending U.S. patents, and 10 issued and 7 pending patents outside of the US, including its international application published in 2024.

The new published international patent application WO2024102497 describes methods and tools for delivering treatments (including antibodies, nanoparticles, or charged molecules) directly to specific tissues. This is accomplished using micro-vessels (called the vasa vasorum) that supply the outer walls of larger blood vessels near the specific target tissue to be treated. This invention opens innovative and effective ways to target and deliver cancer treatments in local tissue beyond the current standard-of-care, systemic (intravenous "IV") treatment.

"Delivering therapeutics through micro-vessels around the artery via our novel Trans-Arterial Micro-Perfusion technique is central to our treatment paradigm and value proposition," said Ramtin Agah, MD, Chief Medical Officer and Founder of RenovoRx. "We already hold strong IP protection for our technology, and our 2024 pending patent further describes and seeks protection for the novelty of our approach."

TAMP is designed to ensure precise therapeutic delivery across the arterial wall near the tumor site to bathe the target tumor, while potentially minimizing a therapy’s toxicities versus systemic intravenous therapy. RenovoRx’s novel approach to targeted treatment offers the potential for increased safety, tolerance, and improved efficacy.

"As we move forward in 2025 with our commercial plans for RenovoCath and the advancement of our pivotal Phase III TIGeR-PaC clinical trial, both of which are driven by TAMP, it is important to highlight the strong IP foundation we have and continue to expand. The new patent application filed earlier this year would further the value that TAMP can offer the oncology community as an innovative and effective approach to drug delivery," said Shaun Bagai, CEO, RenovoRx. "Once approved, it will incrementally extend our IP coverage and increase the commercial value proposition for both TAMP and RenovoCath."

RenovoRx’s pivotal ongoing Phase III TIGeR-PaC clinical trial is evaluating its first product candidate, a novel investigational oncology drug-device combination utilizing the FDA-cleared RenovoCath device via TAMP for the intra-arterial administration of the chemotherapy gemcitabine. RenovoRx currently anticipates completion of both patient enrollment and the second interim analysis for TIGeR-PaC by the end of the first half of 2025.

Moreover, RenovoRx recently announced the receipt of its first purchase orders for RenovoCath devices. This milestone marks a positive continuation of RenovoRx’s previously announced efforts to commercialize RenovoCath as a standalone device to be used by doctors in accordance with its FDA-cleared instructions for use. RenovoCath is powered by TAMP.

About RenovoCath

Based on its FDA clearance, RenovoCath is intended for the isolation of blood flow and delivery of fluids, including diagnostic and/or therapeutic agents, to selected sites in the peripheral vascular system. RenovoCath is also indicated for temporary vessel occlusion in applications including arteriography, preoperative occlusion, and chemotherapeutic drug infusion. For further information regarding our RenovoCath Instructions for Use ("IFU"), please see: IFU-10004-Rev.-F-Universal-IFU.pdf.

About the TIGeR-PaC Clinical Trial

TIGeR-PaC is an ongoing Phase III randomized multi-center study evaluating the proprietary TAMP (Trans-Arterial Micro-Perfusion) therapy platform for the treatment of Locally Advanced Pancreatic Cancer (LAPC.) RenovoRx’s first product candidate using the TAMP technology, is a novel investigational oncology drug-device combination utilizing the Company’s FDA-cleared RenovoCath device for the intra-arterial administration of chemotherapy, gemcitabine.

The first interim analysis in the Phase III clinical trial was completed in March 2023, with the Data Monitoring Committee recommending a continuation of the study. The study’s primary endpoint is an Overall Survival benefit with secondary endpoints including reduced side effects versus standard of care. The second interim analysis for this study will be triggered by the 52nd event (i.e., patient death), which is estimated to occur in late 2024 or early 2025. The second interim data readout would follow thereafter, with the timing for such readout depending on customary factors such as time needed for analysis. RenovoRx is also aiming to complete patient enrollment in the TIGeR-PaC study in the first half of 2025.

On December 30, 2024 Halozyme Therapeutics, Inc. (NASDAQ: HALO) (Halozyme) reported that Bristol Myers Squibb received U.S. Food and Drug Administration (FDA) approval for Opdivo Qvantig (nivolumab and hyaluronidase-nvhy) co-formulated with Halozyme’s ENHANZE drug delivery technology for subcutaneous use in most previously approved adult, solid tumor intravenous (IV) Opdivo indications as monotherapy, monotherapy maintenance following completion of Opdivo plus Yervoy (ipilimumab) combination therapy, or in combination with chemotherapy or cabozantinib (Press release, Halozyme, DEC 30, 2024, View Source [SID1234649364]). Opdivo Qvantig is the first and only subcutaneously administered PD-1 inhibitor.

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The subcutaneous administration of Opdivo Qvantig is faster, with a three- to five-minute administration time compared to 30 minutes for IV Opdivo.* Subcutaneous administration may offer flexibility to receive treatment where it is best for patients and their providers, may reduce steps required for preparation and time needed for administration.

"We are pleased Opdivo Qvantig, which is co-formulated with our ENHANZE drug delivery technology, is now FDA-approved as the first and only subcutaneously administered PD-1 inhibitor in the U.S.," said Dr. Helen Torley, president and chief executive officer of Halozyme. "This approval represents our ninth co-formulated product and is yet another example of how Halozyme’s innovative ENHANZE technology is enabling greater flexibility and optionality for patients."

The FDA approval is based on the results from the Phase 3 randomized, open-label CheckMate-67T trial, which was a noninferiority trial evaluating Opdivo Qvantig co-formulated with Halozyme’s proprietary recombinant human hyaluronidase (rHuPH20), compared to intravenous Opdivo, in adult patients with advanced or metastatic clear cell renal cell carcinoma who received prior systemic therapy. In the trial, noninferiority was demonstrated for the co-primary endpoints of time-averaged concentration over 28 days (Cavgd28) and minimum concentration at steady state (Cminss) of Opdivo Qvantig vs. IV Opdivo. The geometric mean ratio (GMR) for Cavgd28 was 2.10 (90% CI: 2.00-2.20) and the GMR for Cminss was 1.77 (90% CI: 1.63-1.93). As a key powered secondary endpoint, the overall response rate (ORR) in the Opdivo Qvantig arm (n=248) was 24% (95% CI: 19-30) compared with 18% (95% CI: 14-24) in the IV Opdivo arm (n=247) showing that Opdivo Qvantig has similar efficacy compared to IV Opdivo as assessed by Blinded Independent Central Review (BICR).

Select Safety Profile from CheckMate-67T

Serious adverse reactions occurred in 28% of patients receiving Opdivo Qvantig. The most frequent serious adverse reactions reported in >1% of patients who received Opdivo Qvantig were pleural effusion (1.6%), pneumonitis (1.6%), hyperglycemia (1.2%), hyperkalemia (1.2%), hemorrhage (1.2%) and diarrhea (1.2%). The most common adverse reactions (reported in ≥10% of patients) were fatigue (20%), musculoskeletal pain (31%), pruritus (16%), rash (15%), arthralgia (12%) and cough (11%). Fatal adverse reactions occurred in 3 (1.2%) patients who received Opdivo Qvantig; these included myocarditis, myositis, and colitis complications. Study therapy was discontinued in 10% of patients due to adverse reactions. The safety profile of Opdivo Qvantig was comparable with the safety profile of IV Opdivo.