On January 29, 2024 Theragent Inc., a comprehensive CDMO focused on advancing next-generation cell-based therapies, reported that its sponsor client, CellVax Therapeutics Inc., received clearance of its Investigational New Drug application (IND) by the U.S. Food and Drug Administration (FDA) for FK-PC101 (Press release, Theragent, JAN 29, 2024, https://theragent.com/cellvax-therapeutics-announces-fda-clearance-of-ind-application-for-fk-pc101-a-novel-personalized-cancer-immunotherapy/ [SID1234639686]). Patient recruitment for the randomized Phase II trial will begin in March of 2024, with first patient treatments expected in Q2 2024.

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FK-PC101 is CellVax’s novel personalized cancer immunotherapy intended to treat prostate cancer patients who have a high risk of recurrence after prostatectomy. It consists of patient’s own tumor cells which are collected during surgery, then modified in the laboratory. The modified cells express Major Histocompatibility Complex (MHC) Class II on their surface, which are then irradiated to make them replication incompetent and delivered as an individualized immunotherapy. Fernando Kreutz, CEO at CellVax, stated, "We are thrilled to receive FDA clearance of our FK-PC101 IND. We have worked diligently throughout the pre-IND and IND process with our reliable partner Theragent, as well as our other consultants, who have brought process development expertise, regulatory know-how, and alignment with our core values. As CellVax reaches this important milestone, it represents over 20 years of work from discovery to clinical development, creating a new class of therapy for the most in-need patients."

The trial, CELLVX-230, is a randomized, multicenter, open-label study of irradiated autologous cellular vaccine in men with high-risk prostate cancer post-radical prostatectomy. It will be conducted through a partnership with the Society of Urologic Oncology Clinical Trials Consortium (SUO-CTC), with Scott Eggener, MD (University of Chicago) as Principal Investigator. Patient recruitment will begin in March 2024, with a goal of up to 230 participants sourced from 21 pre-selected sites across the US. Theragent will be responsible for end-to-end manufacturing, release, and disposition of all clinical material out of its purpose-built, state-of-the-art CGMP cell therapy manufacturing facility in Arcadia, CA. "We are tremendously excited to partner with CellVax on this clinical trial. Theragent was founded specifically for this purpose – to bring paradigm-changing treatments to patients in need," said Dr. Yun Yen, President and CEO of Theragent.

Despite recent improvements in radiation, surgeries, and other therapies, up to 30% of patients may still experience recurrent prostate cancer after prostatectomy. After recurrence, the current standard of care is salvage radiotherapy and/or androgen deprivation therapy (ADT). FK-PC101 could delay the necessity for such treatments, if not prevent it entirely. The primary clinical endpoint for CELLVX-230 will be disease free survival (DFS), with the secondary endpoint being increased time to next treatment (TTNT).

CellVax has high ambitions for FK-PC101 as the company gears up for the Phase II clinical trial. Looking forward, CellVax’s corporate strategy has been specifically designed to ensure treatment accessibility. "We have thoughtfully assembled a disruptive corporate structure that could translate into a cost-effective cancer treatment for thousands of patients in the future," says Emerson von der Goltz, CellVax’s Chief Financial Officer.

On January 29, 2024 RenovoRx, Inc. ("RenovoRx" or the "Company") (Nasdaq: RNXT), a clinical-stage biopharmaceutical company developing novel precision oncology therapies based on a local drug-delivery platform, reported that it has closed a private placement (the "private placement" or the "financing") resulting in gross proceeds of approximately $6.1 million, before deducting offering expenses (Press release, Renovorx, JAN 29, 2024, View Source [SID1234639685]).

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The closing of this private placement extends RenovoRx’s cash runway as RenovoRx continues its ongoing pivotal TIGeR-PaC Phase III clinical trial, with a second interim analysis for this study to occur at the 52nd event (death), which is expected in late 2024.

RenovoRx insiders, including members of the management team and Board of Directors, participated in the private placement. Through the execution of this financing, RenovoRx sold an aggregate of 6,133,414 shares of common stock and warrants exercisable for up to an aggregate of 6,133,414 shares of common stock. Investors who are not insiders of RenovoRx paid $0.99 per share for the common stock and associated warrants, but RenovoRx’s management team and directors purchased shares and warrants at the market price for Nasdaq Stock Market purposes at $1.22 per share and associated warrant, reflecting their strong belief in the Company. The warrants are exercisable at a price equal to the per share price paid by the applicable investor and are exercisable for a period of five years following the closing of the private placement.

Shaun Bagai, CEO of RenovoRx, stated, "We are thrilled to start the new year with the closing of this important financing, especially in a challenging market climate. The net proceeds bolster our balance sheet and will allow us to drive our pivotal trial towards what we hope will be another positive interim analysis by the end of this year. We are particularly grateful for the participation in this financing from members of our board and management team as well as existing and new investors. With the net proceeds of this financing, in alignment with our consistent focus on efficient use of capital, we anticipate that we will be able to fund our operations through late 2024, even as we continue to explore additional capital raising opportunities. We are at a critical inflection point, and our efforts are laser focused on advancing multiple late-stage programs, reaching clinical milestones, and helping cancer patients live a longer, fuller life."

"Last year, I joined RenovoRx’s Board as a Director," said Dr. Robert J. Spiegel. "I have now chosen to join as an investor in this private placement financing. RenovoRx’s proprietary Trans-Arterial Micro-Perfusion (TAMPTM) platform has the possibility to extend across a variety of high unmet needs by expanding our pipeline into other difficult-to-treat solid tumor cancers with additional therapeutics."

The first interim analysis in RenovoRx’s pivotal Phase III TIGeR-PaC clinical trial at the 26th specified event, was completed in March 2023, and the Data Monitoring Committee (DMC) recommended a continuation of the study. The second interim analysis will occur at the 52nd of the specified events. The 52nd event is estimated to occur in late 2024. TIGeR-PaC is an ongoing randomized multi-center study in locally advanced pancreatic cancer (LAPC) using RenovoRx’s proprietary TAMP therapy platform to evaluate its first product candidate, RenovoGemTM, a novel oncology drug-device combination product. The study is comparing treatment with TAMP to the current standard of care of systemic intravenous chemotherapy.

The TIGeR-PaC study is prespecified to provide a primary endpoint of a 6-month Overall Survival benefit and secondary endpoints including reduced side effects versus standard of care. Interim analysis data was presented at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting and as a Late Breaker Oral Presentation at the 2023 European Society of Medical Oncology (ESMO) (Free ESMO Whitepaper) World Congress on Gastrointestinal Cancer.

The financing will also allow RenovoRx to begin to engage additional clinical trial sites in preparation for the Company’s Phase III CouGar study in bile duct cancer, which is the second late-stage clinical trial to evaluate RenovoGem in a difficult-to-access solid tumor cancer. RenovoRx has also identified other potential pipeline indication opportunities in non-small cell lung cancer, uterine tumors, glioblastoma, and sarcoma. The Company will require additional funding to fully pursue these opportunities.

Paulson Investment Company, LLC acted as the exclusive placement agent in connection with this financing.

"We are excited to assist RenovoRx in securing funding with Paulson’s high-net-worth clients for the Phase III study on its TAMP therapy for LAPC treatment," said Marta Wypych, Head of Investment Banking at Paulson Investment Company. "By doing so, we aim to facilitate the Company’s journey towards FDA approval, bringing forth this innovative combination therapy to the market for the well-being of pancreatic cancer patients."

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any securities nor will there be any sale of these securities in any state or other 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 other jurisdiction.

On January 29, 2024 PharmaMar (MSE:PHM) reported that it has presented at the ASCO (Free ASCO Whitepaper) Genitourinary Cancers symposium that has been held from the 25th to 27th of January in San Francisco, USA, two abstracts with Zepzelca (lurbinectedin) in Prostatic Small Cell and Neuroendocrine Carcinoma (SC/NEPC), and Metastatic Neuroendocrine Carcinomas of the genitourinary tract (Press release, PharmaMar, JAN 29, 2024, View Source [SID1234639684]).

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The poster presented by Dr. Haley M. Meyer et al., from Mayo Clinic Arizona is titled "Lurbinectedin in Prostatic Small Cell and Neuroendocrine Carcinoma". SC/NEPC is a high-grade, invasive malignancy that is distinct to Prostatic Adenocarcinoma and behaves similarly to Small Cell Lung Cancer (SCLC), and treatments in second-line and beyond are major clinical challenges. This study was carried out in four academic centers of eighteen highly pretreated metastatic patients with a median number of four prior systemic therapies administered before lurbinectedin. Clinical Benefit Rate was found in 56.3%, with Partial Response in 5 of 16 patients, 31%. The study concluded that lurbinectedin is a well-tolerated and active treatment option for patients with SC/NEPC.

Dr. Alan H. Bryce, M.D., C.P.E., Chief Clinical Officer of City of Hope Cancer Center, Phoenix, commented "the Partial Response rate of 31% and Stable Disease in an additional 25% is quite promising in this highly refractory disease population". Dr. Mohammad Jad Moussa from The University of Texas, MD Anderson Cancer Center, Houston, Texas, presented the poster "Clinical efficacy of lurbinectedin in Metastatic Neuroendocrine Carcinomas of the genitourinary tract: Multi-institutional real-world experience." Neuroendocrine Carcinomas (NEC) of the genitourinary (GU) tract, including Small Cell (SC) metastasic NEC (mNEC) and Large Cell (LC) NEC, are rare aggressive malignancies. The investigator reports the first multi-institutional data with fourteen patients treated with lurbinectedin in GU mNEC with encouraging responses close to those seen in SCLC, in previously treated bladder mNEC. Larger cohorts are needed to confirm the survival benefit and genetic analyses are warranted to identify characteristics of responders; the author concludes.

Highlighted studies at ASCO (Free ASCO Whitepaper) Gu 2024

PRODUCT TITLE LEAD AUTHOR ABSTRACT
Zepzelca (lurbinectedin) Lurbinectedin in Prostatic Small Cell and Neuroendocrine Carcinoma Haley M. Meyer ABSTRACT: 164 SESSION TYPE: Prostate Cancer POSTER: G14 DATE: January 25, 2024 11:30 – 13 :00 GMT-8
Clinical efficacy of lurbinectedin in Metastatic Neuroendocrine Carcinomas of the genitourinary tract: Multi-institutional real-world experience. Mohammad Jad Moussa Cousin ABSTRACT: 601 SESSION TYPE: Urothelial Carcinoma POSTER: G7 DATE: January 26, 2024 11:30 – 13:00 GMT-8

On January 29, 2024 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage company developing disruptive therapeutics for the treatment of patients with urgent unmet medical needs, reported the pricing of a public offering of (i) 4,375,000 shares of its common stock or pre-funded warrants in lieu thereof and (ii) two classes of warrants to purchase up to an aggregate of 8,750,000 shares of its common stock (the "Common Warrants") at a purchase price of $2.06 per share and associated Common Warrants (Press release, Panbela Therapeutics, JAN 29, 2024, View Source [SID1234639683]). The Common Warrants will have an exercise price of $2.06 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The Common Warrants do not have any alternative cashless exercise or other provisions to adjust their exercise price beyond customary proportionate adjustments for recapitalizations and similar events. The offering is expected to close on or about January 31, 2024, subject to customary closing conditions.

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Roth Capital Partners is acting as sole placement agent of the offering.

Gross proceeds, before deducting placement agent fees and commissions and offering expenses, are expected to be approximately $9.0 million. The company intends to use the net proceeds from the offering for the continued clinical development of its product candidates, working capital, business development and other general corporate purposes, which may include repayment of debt.

The securities described above are being offered pursuant to a registration statement on Form S-1 (File No. 333-276367), as amended, that was declared effective by the U.S. Securities and Exchange Commission ("SEC"), on January 26, 2024. The offering is being made solely by means of a prospectus. Copies of the accompanying prospectus relating to and describing the terms of the offering may be obtained, when available, at the SEC’s website at www.sec.gov or by contacting Roth Capital Partners, LLC, 888 San Clemente Drive, Suite 400, Newport Beach, CA 92660 or by email at [email protected].

This press release does not and shall not constitute an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of these securities in any state or other 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 other jurisdiction. Any offer, if at all, will be made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement.

On January 29, 2024 NANOBIOTIX (Euronext : NANO –– NASDAQ: NBTX – the ‘‘Company’’), a late-clinical stage biotechnology company pioneering physics-based approaches to expand treatment possibilities for patients with cancer, reported achievement of operational requirements in NANORAY-312, an ongoing pivotal Phase 3 study evaluating potential first-in-class radioenhancer NBTXR3 for elderly patients with head and neck cancer, resulting in a $20M milestone payment from strategic partner Janssen Pharmaceutica NV ("Janssen"), a Johnson & Johnson company (Press release, Nanobiotix, JAN 29, 2024, View Source [SID1234639682]).

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"This first milestone payment related to our ongoing pivotal Phase 3 study evaluating NBTXR3 for patients with head and neck cancer represents another step forward in our pathway to bring NBTXR3 to registration," said Laurent Levy, Nanobiotix co-founder and chairman of the executive board. "We look forward to continued collaboration with Janssen as we work to deliver the potential benefits of NBTXR3 to millions of patients around the world."

This $20M represents the first applicable development milestone from the global licensing agreement executed between Nanobiotix and Janssen (For more details, please consult the press release dated 4 December 2023).

About NBTXR3
NBTXR3 is a novel, potentially first-in-class oncology product composed of functionalized hafnium oxide nanoparticles that is administered via one-time intratumoral injection and activated by radiotherapy. Its proof-of-concept was achieved in soft tissue sarcomas for which the product received a European CE mark in 2019. The product candidate’s physical mechanism of action (MoA) is designed to induce significant tumor cell death in the injected tumor when activated by radiotherapy, subsequently triggering adaptive immune response and long-term anti-cancer memory. Given the physical MoA, Nanobiotix believes that NBTXR3 could be scalable across any solid tumor that can be treated with radiotherapy and across any therapeutic combination, particularly immune checkpoint inhibitors.

Radiotherapy-activated NBTXR3 is being evaluated across multiple solid tumor indications as a single agent or in combination with anti-PD-1 immune checkpoint inhibitors, including in NANORAY-312—a global, randomized phase III study in locally advanced head and neck squamous cell cancers. In February 2020, the United States Food and Drug Administration granted regulatory Fast Track designation for the investigation of NBTXR3 activated by radiation therapy, with or without cetuximab, for the treatment of patients with locally advanced HNSCC who are not eligible for platinum-based chemotherapy—the same population being evaluated in the phase III study.

Given the Company’s focus areas, and balanced against the scalable potential of NBTXR3, Nanobiotix has engaged in a collaboration strategy to expand development of the product candidate in parallel with its priority development pathways. Pursuant to this strategy, in 2019 Nanobiotix entered into a broad, comprehensive clinical research collaboration with The University of Texas MD Anderson Cancer Center to sponsor several phase I and phase II studies evaluating NBTXR3 across tumor types and therapeutic combinations. In 2023 Nanobiotix announced a license agreement for the global co-development and commercialization of NBTXR3 with Janssen Pharmaceutica NV.