On December 3, 2024 PharmaMar Group (MSE: PHM) reported that its licensing partner, Luye Pharma Group Ltd. has received conditional marketing approval for Zepzelca (lurbinectedin) from the China National Medical Products Administration (NMPA) for the treatment of adult patients with metastatic Small Cell Lung Cancer (SCLC) with disease progression during or after platinum-based chemotherapy (Press release, PharmaMar, DEC 3, 2024, View Source [SID1234648757]). China’s NMPA grants conditional approvals to medicines targeting diseases that are severely life-threatening and where there is no effective treatment.

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The NMPA conditional approval is based on the results from a single-arm, dose-escalation, dose-expansion clinical study conducted in China. The study was designed to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of lurbinectedin in Chinese patients with advanced solid tumors, including recurrent SCLC. This study confirms the efficacy and safety of lurbinectedin in Chinese patients following the basket trial data that the Food and Drug Administration (FDA) used to grant accelerated approval of lurbinectedin in USA; an open-label, multicenter, single-arm, monotherapy study in 105 adult patients with recurrent metastatic SCLC (including patients with platinum-sensitive and platinum-resistant disease).

The most recent data from 2022 indicates that Lung Cancer is the tumor with the highest incidence in China, with more than 1,000,000 new cases per year, and was the leading cause of cancer deaths with 733,291i. Specifically, globally, Small Cell Lung Cancer accounts for 10-15% of lung cancer diagnoses and is one of most aggressive forms of lung cancerii.

In addition to this approval of lurbinectedin in mainland China, it is already approved in Chinese territory in Hong Kong and Macau and totalling 17 regions around the world. In April 2019, PharmaMar and Luye Pharma signed an agreement for the development and commercialization of lurbinectedin in Small Cell Lung Cancer and potentially other indications in mainland China, Hong Kong, and Macau.

On December 3, 2024 Janux Therapeutics, Inc. (Nasdaq: JANX) (Janux), a clinical-stage biopharmaceutical company developing a broad pipeline of novel immunotherapies by applying its proprietary technology to its Tumor Activated T Cell Engager (TRACTr) and Tumor Activated Immunomodulator (TRACIr) platforms, reported that it has commenced an underwritten public offering of $300.0 million of shares of its common stock or, in lieu of common stock issued to certain investors that so choose, pre-funded warrants to purchase shares of its common stock (Press release, Janux Therapeutics, DEC 3, 2024, View Source [SID1234648775]). In addition, Janux expects to grant the underwriters a 30-day option to purchase up to an additional $45.0 million of shares of its common stock at the public offering price, less the underwriting discounts and commissions. All of the securities to be sold in the offering are to be sold by Janux. 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 the actual size or terms of the offering.

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BofA Securities, TD Cowen, Stifel, Cantor and William Blair are acting as joint book-running managers for the offering. Wedbush PacGrow, LifeSci Capital, BTIG and Jones are acting as co-managers for the offering.

The Company intends to use the net proceeds from the offering to advance clinical development of its internal product pipeline and for general corporate purposes.

The securities are being offered by the company pursuant to a Registration Statement on Form S-3 filed with the Securities and Exchange Commission (SEC) that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website, located at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this offering may be obtained, when available, from: BofA Securities, NC1-022-02-25, 201 North Tryon Street, Charlotte, North Carolina 28255-0001, Attention: Prospectus Department, or by email at [email protected]; TD Securities (USA) LLC, 1 Vanderbilt Avenue, New York, New York 10017, by telephone at (855) 495-9846 or by email at [email protected]; Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, California 94104, by telephone at (415) 364-2720, or by email at [email protected]; Cantor Fitzgerald & Co., Attention: Capital Markets, 110 East 59th Street, 6th Floor, New York, New York 10022, or by email at [email protected]; or William Blair & Company, L.L.C., Attention: Prospectus Department, 150 North Riverside Plaza, Chicago, Illinois 60606, by telephone at (800) 621-0687 or by email at [email protected].

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these 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 the registration or qualification under the securities laws of any such state or other jurisdiction.

On December 3, 2024 Priothera Ltd., a late-stage biopharma company pioneering the development of its oral sphingosine 1 phosphate (S1P) receptor modulator, mocravimod, as an adjunctive and maintenance therapy for hematologic malignancies, reported that it will present a Trial in Progress poster on the MO-TRANS Phase 3 study, at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting taking place December 7-10, 2024, in San Diego, California (Press release, Priothera, DEC 3, 2024, View Source [SID1234648758]).

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Priothera is investigating the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in patients with acute myeloid leukemia (AML) undergoing allogeneic hematopoietic cell transplantation (allo-HCT) in the pivotal MO-TRANS Phase 3 study.

Mocravimod’s unique dual mechanism of action modulates the S1P receptor 1 to retain alloreactive donor T-cells within lymphoid organs, enhancing the graft-versus-leukemia (GvL) effect to eliminate cancer cells, while preventing T-cell egress to peripheral tissues, thereby reducing the risk of graft-versus-host disease (GvHD). This innovative treatment approach offers a promising solution for patients at high risk of relapse following allo-HCT.

The MO-TRANS study (NCT05429632) is a multicenter, global, placebo-controlled trial enrolling patients with AML in complete remission (CR1), including those with intermediate or adverse risk, as well as patients of all risks in second complete remission (CR2). Patients are randomized to receive either mocravimod or a placebo in addition to standard of care. The primary endpoint of the study is relapse-free survival (RFS). Secondary endpoints include overall survival (OS) and the incidence of GvHD.

On December 3, 2024 Kairos Pharma Ltd. (NYSE American: KAPA), a clinical-stage biopharmaceutical company developing therapies to surmount current cancer drug resistance and immune suppression, reported the addition of City of Hope Cancer Center in Duarte, California to the Phase 2 clinical trial for ENV105 for castrate-resistant prostate cancer patients (Press release, Kairos Pharma, DEC 3, 2024, View Source [SID1234648776]).

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City of Hope Cancer Center is the first of several planned new centers to be added in the coming weeks to support the Company’s randomized trial for patients receiving either apalutamide or apalutamide+ENV105 combination therapy. The additional centers allow Kairos Pharma to test ENV105 in a broader patient population to identify blood markers that could help select patients expected to benefit most from ENV105 treatment. The trial is supported by Kairos Pharma Ltd. and a grant from the National Cancer Institute (NCI).

Kairos Pharma Chief Scientific Officer Dr. Neil Bhowmick said, "The preclinical findings suggest that ENV105 blocks a central mechanism of hormone therapy resistance. We are encouraged that we have multiple peer-reviewed articles in addition to receiving an NCI grant that supports the solid science behind this trial. We are fortunate to be working with the talented and experienced oncologists at City of Hope, who will be key participants in a trial that may provide patients with a new alternative to the current standard of care."

Kairos CEO Dr. John Yu added, "This is an important milestone in our mission to develop first-in-class approaches to address the inevitable resistance that develops in prostate cancer patients receiving hormone therapy, as it provides additional validation for the science behind ENV105. City of Hope is a first-class research institution, and we look forward to our continued collaboration with them."

On December 3, 2024 Protara Therapeutics, Inc. (Nasdaq: TARA), a clinical-stage company developing transformative therapies for the treatment of cancer and rare diseases, reported it will host a conference call and live webcast at 8:30 a.m. ET on Thursday, December 5, 2024, to review new data from an interim analysis of the ongoing Phase 2 open-label ADVANCED-2 trial of TARA-002 in patients with non-muscle invasive bladder cancer (NMIBC) (Press release, Protara Therapeutics, DEC 3, 2024, https://ir.protaratx.com/news-releases/news-release-details/protara-therapeutics-host-conference-call-and-webcast-review-new [SID1234648759]). The data will be featured during a poster session at the 25th Annual Meeting of the Society of Urologic Oncology on December 5, 2024, at 1:15 p.m. CT.

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The live call can be accessed by registering as a participant here. Upon registration, participants will receive conference call dial-in information. A live webcast of the event can be accessed by visiting the Events and Presentations section of the Company’s website: View Source A replay of the webcast will be archived for a limited time following the event.

About ADVANCED-2

ADVANCED-2 (NCT05951179) is a Phase 2 open-label trial assessing intravesical TARA-002 in NMIBC patients with carcinoma in situ or CIS (± Ta/T1) who are Bacillus Calmette-Guérin (BCG)-unresponsive (n≈100) and BCG-Naïve (n=27). The BCG-Unresponsive cohort has been designed to be registrational in alignment with the FDA’s 2024 BCG-Unresponsive Non-muscle Invasive Bladder Cancer: Developing Drugs and Biological Products for Treatment Draft Guidance for Industry. Trial subjects received an induction with or without a reinduction course of six weekly intravesical instillations of TARA-002, followed by a maintenance course of three weekly installations every three months.

About TARA-002

TARA-002 is an investigational cell therapy in development for the treatment of NMIBC and of LMs, for which it has been granted Rare Pediatric Disease Designation by the U.S. Food and Drug Administration. TARA-002 was developed from the same master cell bank of genetically distinct group A Streptococcus pyogenes as OK-432, a broad immunopotentiator marketed as Picibanil in Japan by Chugai Pharmaceutical Co., Ltd and also approved in Taiwan. Protara has successfully shown manufacturing comparability between TARA-002 and OK-432.

When TARA-002 is administered, it is hypothesized that innate and adaptive immune cells within the cyst or tumor are activated and produce a pro-inflammatory response with release of cytokines such as tumor necrosis factor (TNF)-alpha, interferon (IFN)-gamma IL-6, IL-10, IL-12. TARA-002 also directly kills tumor cells and triggers a host immune response by inducing immunogenic cell death, which further enhances the antitumor immune response.

About Non-Muscle Invasive Bladder Cancer (NMIBC)

Bladder cancer is the 6th most common cancer in the United States, with NMIBC representing approximately 80% of bladder cancer diagnoses. Approximately 65,000 patients are diagnosed with NMIBC in the United States each year. NMIBC is cancer found in the tissue that lines the inner surface of the bladder that has not spread into the bladder muscle.