On March 4, 2024 Nerviano Medical Sciences S.r.l. (NMS), a part of NMS Group S.p.A. (NMS Group) and Nerviano Medical Sciences, Inc. (NMS-US), a wholly owned subsidiary of NMS Group, focused on the discovery and development of oncology drugs and the largest oncological R&D company in Italy, reported that European Commission has granted Orphan Drug Designation (ODD) for NMS-03592088 for the treatment of Acute Myeloid Leukemia (AML), just a few weeks after the US Food and Drug Administration (FDA) approval (Press release, Nerviano Medical Sciences, MAR 4, 2024, View Source [SID1234640736]).

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NMS-0359288 is a next generation FLT3 inhibitor with superior activity and selectivity with respect to approved FLT3 inhibitor drugs and higher potency on the resistance mutation F691L opening opportunities for treatment of patients who failed prior FLT3 inhibitor treatment. NMS-03592088 is being evaluated as monotherapy in a Phase I/II study in relapsed/refractory FLT3 positive AML in Europe and US. Preliminary evidence of clinical activity was observed during the dose escalation phase when administered as salvage line therapy including patients with prior FLT3 inhibitors (AACR2023). Based on these results the Committee for Orphan Medicinal Products released its positive opinion stating that "the drug showed responses in heavily pretreated patients with acute myeloid leukaemia including those who have failed treatment with the currently authorized medicinal product. The Committee considered that this constitutes a clinically relevant advantage."

After having completed Phase I in Europe, the trial is currently enrolling patients in multiple Phase II cohorts (NCT03922100).

"As we expand our focus to embrace the orphan drug destination in the EU for NMS-03592088, following the ODD approval by FDA last December, we are determined to bring new therapies to AML patients. Our dedication to innovation for patients worldwide is strong ." said Lisa Mahnke, MD, PhD, CMO of NMS | CEO and Managing Director of NMS-US.

"We are diligently implementing strategies to accelerate the development of NMS-03592088 as a promising new therapeutic option for patients battling AML with very few options. The Orphan Drug Designation is a key regulatory milestone that acknowledges the potential of NMS-03592088 for positioning as next generation FLT3 inhibitor and reinforces our commitment to expedite its development through the approval process" said Elena Ardini, MSc, Asset Leader of NMS.

Orphan drug designation in the European Union (EU) is granted by the European Commission based on a positive opinion issued by the European Medical Association (EMA) Committee for Orphan Medicinal Products. The EMA grants orphan designation for the treatment, diagnosis or prevention of life-threatening or chronically debilitating diseases or conditions that affect fewer than five in 10,000 persons in the EU. Drugs that meet the EMA’s orphan designation criteria qualify for financial and regulatory incentives that include a 10-year period of marketing exclusivity in the EU after product approval, reduced regulatory fees, access to protocol assistance from the EMA during development and access to centralized marketing authorization.

On March 4, 2024, Nektar Therapeutics (the "Company") reported to have entered into a securities purchase agreement (the "Purchase Agreement") with TCG Crossover Fund II, L.P. (the "Purchaser"), for the private placement (the "Private Placement") of a pre-funded warrant (the "Pre-Funded Warrant") to purchase 25,000,000 shares of the Company’s common stock (the "Common Stock"), par value $0.0001 per share (the "Warrant Shares" and together with the Pre-Funded Warrant, the "Securities"), at a total purchase price of $30.0 million (or a purchase price of $1.20 per Warrant Share that can be issued upon exercise of the Pre-Funded Warrant) (Filing, 8-K, Nektar Therapeutics, MAR 4, 2024, View Source [SID1234640735]). The Pre-Funded Warrant will have an exercise price of $0.0001 per share of Common Stock. The holder of the Pre-Funded Warrant may not exercise the Pre-Funded Warrant if the holder, together with its affiliates, would beneficially own more than 9.99% of the number of shares of Common Stock outstanding immediately after giving effect to such exercise. The holder of the Pre-Funded Warrant may increase or decrease such percentages not in excess of 19.99% by providing at least 61 days’ prior notice to the Company. The aggregate gross proceeds for the Private Placement will be $30 million, before deducting expenses payable by the Company.

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The closing of the Private Placement is anticipated to occur on or before March 6, 2024 (the "Closing Date"), subject to the satisfaction of customary closing conditions. Pursuant to the Purchase Agreement, the Company also agreed to file a registration statement with the Securities and Exchange Commission (the "SEC") on or before the date that is ninety (90) days after the Closing Date for purposes of registering the resale of the Warrant Shares and to use its reasonable best efforts to have such registration statement to be declared effective within the time period set forth in the Purchase Agreement. The Company also agreed, among other things, to indemnify the Purchaser and the Purchaser’s affiliates against certain liabilities in connection with such registration statement and pay all fees and expenses (excluding any fees and expenses of counsel or other advisers to the Purchaser, and any underwriting discounts, brokerage fees and selling commissions incurred by the Purchaser) in connection with the filing of such registration statement and the registration of the Warrant Shares pursuant to such registration statement.

The Private Placement is exempt from registration pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and Rule 506(b) of Regulation D promulgated by the SEC thereunder, as a transaction by an issuer not involving a public offering. The Purchaser has acquired the Securities for investment only and not with a view to or for sale in connection with any distribution thereof, and appropriate legends have been affixed to the Securities issued in this transaction.

The foregoing summaries of the Private Placement, the Purchase Agreement and the form of Pre-Funded Warrant do not purport to be complete and are qualified in their entirety by reference to the Purchase Agreement and the form of Pre-Funded Warrant, which are filed as Exhibits 10.1 and 4.1, respectively, to this Current Report on Form 8-K and are incorporated herein by reference.

On March 4, 2024 Merck (NYSE: MRK), known as MSD outside of the United States and Canada, reported that Dr. Marjorie Green, senior vice president and head of oncology, global clinical development, Merck Research Laboratories, is scheduled to participate in a fireside chat at the Leerink Partners Global Biopharma Conference 2024 on Monday, March 11, 2024, at 12:40 p.m. ET (Press release, Merck & Co, MAR 4, 2024, View Source [SID1234640733]).

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Investors, analysts, members of the media and the general public are invited to listen to a live audio webcast of the presentation at this weblink.

On March 4, 2024 Iovance Biotherapeutics, Inc. (NASDAQ: IOVA), a commercial biotechnology company focused on innovating, developing, and delivering novel polyclonal tumor infiltrating lymphocyte (TIL) therapies for patients with cancer, reported that the U.S. Food and Drug Administration (FDA) lifted a partial clinical hold placed on the registrational IOV-LUN-202 trial investigating LN-145 TIL cell therapy in non-small cell lung cancer (NSCLC) (Press release, Iovance Biotherapeutics, MAR 4, 2024, View Source [SID1234640731]). In collaboration with the FDA and an independent data monitoring committee, Iovance developed additional safety and monitoring measures. Upon reviewing this proposal, the FDA has cleared Iovance to resume patient enrollment in IOV-LUN-202.

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The IOV-LUN-202 trial is investigating LN-145 in patients with advanced (unresectable or metastatic) NSCLC without EGFR, ROS or ALK genomic mutations who were previously treated with chemotherapy and anti-PD-1 therapy and at least one line of an approved targeted therapy if indicated by other actionable tumor mutations. Iovance expects to complete enrollment of approximately 120 patients in the IOV-LUN-202 registrational cohorts in 2025.

Preliminary data from the IOV-LUN-202 trial support the potential benefit of one-time TIL therapy, including the opportunity for more durable responses than available second line chemotherapies. Initial preliminary data were reported in July of 2023. An updated analysis in November of 2023 showed additional ongoing responses and duration of response greater than six months for 71% of the confirmed responders in the trial.

For more information about the IOV-LUN-202 trial please visit www.lungcelltherapy.com.

On March 4, 2024 Heidelberg Pharma AG (FSE: HPHA), a clinical stage biotech Company developing innovative Antibody Drug Conjugates (ADCs), and HealthCare Royalty (HCRx) reported that they have signed a royalty financing agreement (Press release, Heidelberg Pharma, MAR 4, 2024, View Source [SID1234640730]). Formal closing conditions that are expected to be fulfilled in a timely manner must still be met. Heidelberg Pharma is eligible to receive up to USD 115 million from the sale of its future royalties from worldwide sales of ZircaixTM (TLX250-CDx), a microdose radiopharmaceutical Positron Emission Tomography (PET) imaging agent for the diagnosis and follow up of clear cell renal cancer.

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ZircaixTM is a radiolabeled form of the antibody girentuximab which binds to the tumor-specific antigen CAIX on clear cell renal cell carcinomas. ZircaixTM also has potential as a PET diagnostic imaging agent for other tumor types. Heidelberg Pharma developed the antibody up to a first completed Phase III clinical trial prior to licensing it to Telix Pharmaceuticals Limited (Telix), an Australian company based in Melbourne, Australia, in 2017.

Telix completed the Phase III ZIRCON trial for ZircaixTM in the third quarter of 2022. A rolling Biologics License Application (BLA) submission to the US Food and Drug Administration (FDA) was announced by Telix in December 2023.

Key terms of the agreement between Heidelberg Pharma and HCRx:

Heidelberg Pharma will receive a USD 25 million upfront payment at closing
Heidelberg Pharma will receive a maximum of USD 75 million payment upon FDA approval of ZircaixTM
Heidelberg Pharma will receive a USD 15 million milestone payment if calendar year 2025 worldwide net product sales of ZircaixTM exceed a certain level
Following the receipt by HCRx of a maximum cumulative amount, royalty payments will revert to Heidelberg Pharma and HCRx will receive a low single digit royalty tail percentage thereafter
Prof. Dr. Andreas Pahl, Chief Executive Officer at Heidelberg Pharma, commented: "We are delighted to partner with HealthCare Royalty. This agreement will provide us with a non-dilutive financing based on expected royalty payments from the worldwide sales of ZircaixTM. The anticipated financial inflow will extend our cash reach substantially. We are well-positioned to accelerate and expand development of our proprietary pipeline candidates and ADC technologies."

"With this investment, we further pursue the goal of supporting innovative biopharmaceutical companies that will generate long-term value. We strongly believe in the potential of ZircaixTM to deliver value for patients worldwide and are pleased to partner with Heidelberg Pharma on this transaction." added Clarke Futch, founder, Chairman and Chief Executive Officer of HCRx.

Morgan Stanley & Co. LLC acted as sole structuring agent on the transaction. Goodwin Procter LLP and Görg Partnerschaft von Rechtsanwälten mbB acted as legal advisors to Heidelberg Pharma. McDermott Will & Emery LLP acted as legal advisors to HCRx.

Conference Call

Heidelberg Pharma will hold a conference call on 25 March 2024 with the publication of the Annual Report. At the financial results press conference the transaction will be explained in more detail and there will be an opportunity to ask questions.