On December 3, 2024 K36 Therapeutics, Inc. ("K36"), a clinical-stage biotech company focused on developing its first-in-class MMSET / NSD2 inhibitor KTX-1001 for t(4;14) multiple myeloma, reported upcoming poster presentations outlining data from its KTX-1001 and KTX-1029 programs at the 66th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition held December 6-10, 2024 in San Diego, California (Press release, K36 Therapeutics, DEC 3, 2024, View Source [SID1234648774]).

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The KTX-1001 presentations will feature the first results from the dose escalation part of the Phase 1 study and characterization of the asset’s biochemical activity. A third poster will characterize the in vitro and in vivo efficacy of KTX-1029, a novel, potent, selective inhibitor of MMSET. Taken together, the results collectively support the mechanism of action and rationale for targeting MMSET in patients with multiple myeloma.

"I am excited to report on the clinical progress of KTX-1001, a potent, oral MMSET inhibitor being developed for multiple myeloma patients with translocation t(4;14). The dose-escalation phase of the clinical trial demonstrates an increase in KTX-1001 exposure by dose and a corresponding decrease in H3K36me2 biomarker, reflecting clear target engagement that is consistent with preclinical models" said Pierre Bories, MD, PhD, Hematologist, Early Phase Clinical Research Unit Hematology and Clinical Research, Onco-Occitanie Network, Toulouse University Cancer Institute Oncopole.

"We’ve seen significant momentum in enrollment since our first presentation at ASH (Free ASH Whitepaper) last year, highlighting the opportunity for KTX-1001 to meet the unmet need for oral therapies in high-risk patients," said Terry Connolly, Ph.D., President and Chief Executive Officer of K36. "I want to thank the patients, investigators, and their teams for their commitment to generating crucial data from our trial. KTX-1001 has shown a favorable tolerability profile, and promising clinical activity reinforcing its potential as a first in class targeted therapy for t(4;14) multiple myeloma patients who have exhausted standard treatments."

Additional presentation details are outlined below:

Title: First Results from the Dose Escalation Part of the Phase 1 Study of KTX1001, an Oral, First-in-Class, Potent Inhibitor of MMSET/NSD2 for Relapsed/Refractory Multiple Myeloma (RRMM)
Poster Number: 3370
Session Name: 654. Multiple Myeloma: Pharmacologic Therapies: Poster II
Date & Time: Sunday, December 8, 2024, 6:00 PM-8:00 PM PST

"This trial highlights the potential of personalized oral therapies like KTX-1001 to treat multiple myeloma with a targeted medicine designed for high-risk patients," said Benjamin Winograd, M.D. Ph.D., K36’s Chief Medical Officer. "The safety profile of the oral therapy at relevant doses allows us to move forward with the dose expansion phase of the trial. In 2025, we will combine our oral investigational drug with standard of care agents, starting with a proteasome inhibitor and IMiDS to continue the development of KTX-1001 for the treatment of t(4;14) patients"

Title: Characterization of the Biochemical Activity of KTX-1001, a Selective Small Molecule NSD2 Inhibitor, in Surface Plasmon Resonance (SPR)
Poster Number: 2205
Session Name: 802. Chemical Biology and Experimental Therapeutics
Date & Time: Saturday, December 7, 2024, 5:30 PM-7:30 PM PST

Describes a novel method for utilizing surface plasmon resonance (SPR) to interrogate the binding of KTX-1001 to the SET domain of MMSET.
These data demonstrate that one of the ways that KTX-1001 reduces H3K36me2 is by displacing S-adenosyl methionine (SAM), the cofactor responsible for donating the methyl groups to H3K36.
Title: KTX-1029, a Potent, Selective MMSET/NSD2 Inhibitor Is Effective in t(4;14) Multiple Myeloma Preclinical Models
Poster Number: 1878
Session Name: 651. Multiple Myeloma and Plasma Cell Dyscrasias
Date & Time: Saturday, December 7, 2024, 5:30 PM-7:30 PM PST

Describes the in vitro and in vivo efficacy of KTX-1029, a novel, potent, selective inhibitor of MMSET. KTX-1029 demonstrated efficacy in MM preclinical models as a single agent and in combination with the proteasome inhibitors bortezomib and carfilzomib in both PI-sensitive and -resistant settings.
The data generated with KTX-1029 compliments the data generated with the company’s orally-available clinical candidate, KTX-1001 and adds to the body of evidence for targeting MMSET in multiple myeloma patients with t(4;14) and for further exploration of combination regimens with multiple myeloma standards of care.
Full abstracts can be found at the ASH (Free ASH Whitepaper) Annual Meeting website at www.Hematology.org.

About KTX-1001
KTX-1001 is a novel, first-in-class, potent, and selective methyltransferase inhibitor of the catalytic activity of MMSET/NSD2. It is an orally administered small molecule developed initially for the treatment of relapsed and refractory multiple myeloma, with a focus on patients with the t(4;14) translocation. This inhibitor offers a promising avenue for addressing this challenging high risk patient population.

About the KTX-1001 Phase 1 Clinical Trial
The Phase 1 clinical trial is a single-arm, open-label study in subjects with relapsed and refractory multiple myeloma. It is a multi-part clinical trial with dose escalation followed by an expansion cohort in patients with the genetic translocation t(4;14) to evaluate the safety, tolerability, and preliminary efficacy of different doses of KTX-1001. For more information and participating centers visit NCT05651932.

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."