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.

On December 3, 2024 MAIA Biotechnology, Inc., (NYSE American: MAIA) ("MAIA", the "Company"), a clinical-stage biopharmaceutical company developing targeted immunotherapies for cancer, reported that it has amended the 2021 clinical supply agreement with Regeneron for the expansion portion of THIO-101, its Phase 2 clinical trial evaluating THIO in sequential administration with cemiplimab (Libtayo) (Press release, MAIA Biotechnology, DEC 3, 2024, View Source [SID1234648777]). The new expansion will further assess the efficacy of MAIA’s lead asset, THIO, sequenced with immune checkpoint inhibitor (CPI) Libtayo (cemiplimab) for advanced non-small cell lung cancer (NSCLC) patients receiving third-line therapy who were resistant to previous checkpoint inhibitor treatments and chemotherapy.

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The original 2021 agreement between MAIA and Regeneron was designed to supply the original THIO-101 trial through the dose selection and safety evaluation process. The THIO-101 trial has been amended and expanded to further evaluate efficacy at the target dose and target third line patient population.

"In keeping with our clinical strategy for THIO, we look forward to continuing our collaboration with Regeneron to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. So far, THIO-101 has demonstrated favorable disease control, progression free survival, overall response rates, and we remain on track to achieve our overall survival goals," said MAIA Chairman and Chief Executive Officer Vlad Vitoc, M.D.

Under terms of the amended clinical supply agreement, MAIA continues to sponsor THIO-101 and Regeneron will provide Libtayo for the treatment of all patients in the trial including the additional patients in the THIO 101 expansion. MAIA holds an exclusive worldwide patent license to develop and commercialize THIO.

MAIA expects to start enrolling new patients in the expansion of THIO-101 in the near future.

The company continues to evaluate its regulatory strategy and believes that there could be an opportunity for an accelerated approval in the United States based on the ultimate outcome of the ongoing THIO 101 trial.

About THIO

THIO (6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in Non-Small Cell Lung Cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine (THIO) induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. THIO-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment with THIO followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. THIO is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101, a Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate THIO’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of THIO administered prior to cemiplimab (Libtayo) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of THIO administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of THIO using Overall Response Rate (ORR) as the primary clinical endpoint. Treatment with THIO followed by cemiplimab (Libtayo) has been generally well-tolerated to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

On December 3, 2024 Coherus BioSciences, Inc. (Coherus or the Company NASDAQ: CHRS,) reported that it has entered into an asset purchase agreement (the Agreement) dated December 2, 2024, with Intas Pharmaceuticals Ltd. (Intas) for the divestiture of the UDENYCA (pegfilgrastim-cbqv) franchise for up to $558.4 million (Press release, Coherus Biosciences, DEC 3, 2024, View Source [SID1234648743]). This includes an upfront payment of $483.4 million, to be adjusted for inventory at close, and $75.0 million in potential net sales milestone payments. Coherus plans to use a portion of the transaction proceeds to fully repay the entirety of the Company’s $230.0 million in existing convertible notes due April 2026 and $49.1 million to buy-out certain royalty obligations related to UDENYCA.

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"The proposed divestiture of UDENYCA represents the successful execution of our strategy to focus R&D and commercial resources on Coherus’ innovative immuno-oncology portfolio and to strengthen our financial position," said Denny Lanfear, Coherus Chairman and Chief Executive Officer. "We have created significant value with our UDENYCA franchise, and this proposed transaction allows us to monetize that value in order to maximize the opportunity ahead for LOQTORZI (toripalimab-tpzi), a novel PD-1 inhibitor with growing sales and the only FDA-approved treatment for nasopharyngeal carcinoma (NPC), allowing us to accelerate and advance the development of our I-O pipeline in combination with LOQTORZI."

"In addition, by paying off our convertible notes in their entirety, we will significantly improve our capital structure and align our operational footprint with our strategic focus. As we enter this new phase of growth, we are well positioned to drive significant value for both patients and shareholders as we advance our mission to extend cancer patient survival."

Terms of the Agreement
Under the terms of the Agreement filed as an exhibit to Coherus’ Current Report on Form 8-K today, Coherus will receive an upfront cash payment of $483.4 million, subject to closing adjustments for final inventory valuation, plus two net sales milestone payments totaling $75.0 million. In exchange, Intas will receive identified assets related to the UDENYCA franchise, including the UDENYCA pre-filled syringe, the UDENYCA autoinjector, and UDENYCA ONBODY and will assume identified liabilities. Accord BioPharma, Inc., the U.S. specialty division of Intas Pharmaceuticals, Ltd., focused on the development of oncology, immunology, and critical care therapies, plans to assume full responsibility for the UDENYCA franchise in the U.S. following the Agreement closing.

The Coherus Board of Directors unanimously recommends that Coherus shareholders vote in favor of the proposed UDENYCA divestiture described by the Agreement. A Coherus proxy statement relating to the proposed transaction will be filed with the Securities and Exchange Commission (the SEC) and mailed to Coherus shareholders when available.

The closing of the proposed transactions contemplated by the Agreement is subject to customary closing conditions, including approval by Coherus shareholders, expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, any required approval by the Committee on Foreign Investment in the United States (CFIUS) as well as certain other conditions. The proposed transaction is expected to close by the end of Q1 2025.

Financial Considerations of the Divestiture
Importantly, upon close of the proposed transaction, the Company expects to use tax attributes, which were previously not deemed realizable, to offset substantially all of the U.S. federal income taxes related to the divestiture.

Following close of the proposed transaction, Coherus plans to initiate a process to fully repay the Company’s outstanding $230.0 million in aggregate principal amount of 1.5% Convertible Senior Subordinated Notes due 2026.
At closing Coherus will pay $49.1 million to buy out the right to receive royalties on net sales of UDENYCA in accordance with the Revenue Participation Right and Sale Agreement with Coduet Royalty Holdings, LLC that commenced May 8, 2024.
The Company expects to realize substantial cost savings on a going forward basis by:

Paying off certain financial liabilities resulting in expected annual financing cash savings exceeding $10.0 million, with the remaining $38.7 million in secured debt (maturing May 2029) costing approximately $5 million to service annually;
Transferring certain full-time employees to Intas to support UDENYCA; and
Eliminating UDENYCA-related overhead and commercial expenses.
The Company plans to provide an updated Q4 2024 sales projection and Q1 2025 cash projection in early January 2025. However, current post-close cash runway projections exceed two years, past key data readouts expected in 2026.

Focus on Immuno-Oncology Portfolio and Key Upcoming Milestones
Coherus intends to strengthen and sharpen its focus on the advancement of its innovative, next-generation, immuno-oncology portfolio in combination with LOQTORZI.

LOQTORZI is a next-generation, differentiated PD-1 marketed in the U.S. in two indications. Coherus plans to maximize the value of this product by:

Continuing to build launch momentum as the first and only FDA-approved treatment for recurrent, locally advanced or metastatic NPC;
Developing new indications by combining LOQTORZI with internal pipeline assets to advance two drug candidates; and
Entering into capital-efficient external partnerships for additional label expansions. Additional partnerships evaluating LOQTORZI with novel promising cancer agents are planned for 2025.
Casdozokitug is a first-in-class, clinical-stage IL-27 antagonist, with demonstrated monotherapy activity in treatment-refractory non-small cell lung cancer (NSCLC) and clear cell renal cell carcinoma (ccRCC) and combination activity in hepatocellular carcinoma (HCC). The Company plans to:

Initiate a Phase 2 randomized trial of casdozokitug/toripalimab/bevacizumab in first-line (1L) HCC in Q4 2024;
Announce final data from its Phase 2 trial of casdozokitug/atezolizumab/bevacizumab in 1L HCC in Q1 2025; and
Report data from its Phase 1 study of casdozokitug/toripalimab in second to fourth line (2-4L) NSCLC in 1H 2025.
CHS-114 is a highly selective cytolytic CCR8 antibody that specifically binds and preferentially depletes CCR8+ tumor regulatory T cells (Tregs) with no off-target binding. Phase 1 dose escalation is complete, establishing safety and proof of mechanism. Coherus plans to:

Report Phase 1 monotherapy biopsy data as well as CHS-114/toripalimab combination safety data in head and neck squamous cell carcinoma (HNSCC) in 1H 2025;
Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L head and neck squamous cell carcinoma (HNSCC) in Q1 2025 with a first data readout expected in Q2 2026; and
Initiate a Phase 1b CHS-114/toripalimab combination dose optimization study in 2L gastric cancer in Q1 2025 with a first data readout expected in Q2 2026.
Advisors
J.P. Morgan Securities LLC is acting as Coherus’ financial advisor and Latham & Watkins LLP as legal counsel to Coherus.

Conference Call Information

When: Tuesday, December 3, 2024, starting at 8:00 a.m. Eastern Time

To access the conference call, please pre-register through the following link to receive dial-in information and a personal PIN to access the live call: https://register.vevent.com/register/BId14c70118ce44561902dd39c791136fa

Please dial in 15 minutes early to ensure a timely connection to the call.

Webcast Link: View Source

A replay of the webcast will be archived on the "Investors" section of the Coherus website at View Source