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

On December 2, 2024 BriaCell Therapeutics Corp. (Nasdaq: BCTX, BCTXW) (TSX: BCT) ("BriaCell" or the "Company"), a clinical-stage biotechnology company that develops novel immunotherapies to transform cancer care, reported that the Data Safety Monitoring Board (DSMB), an independent group of experts who review and monitor safety data of a clinical study to determine if a study should continue, be modified, or be halted early, has completed its first review of safety events in patients enrolled in BriaCell’s pivotal randomized Phase 3 study of Bria-IMT plus an immune checkpoint inhibitor (CPI) combination regimen ( NCT06072612 ) (Press release, BriaCell Therapeutics, DEC 2, 2024, View Source [SID1234649126]). The DSMB issued a statement recommending continuation of the study in metastatic breast cancer patients. BriaCell’s pivotal Phase 3 study is currently being conducted under Fast Track Designation with the Food and Drug Administration (FDA).

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"We are pleased with the DSMB’s recommendation for the continuation of BriaCell’s Phase 3 study without any protocol modification as a significant milestone towards clinical advancement of our novel immunotherapy as a safe and effective treatment option for metastatic breast cancer patients," stated Dr. William V. Williams, BriaCell’s President & CEO.

"We strongly believe in the potential of our novel immunotherapy to transform cancer care for metastatic breast cancer patients, and the positive DSMB review reinforces our confidence in the potential use of the combination regimen in metastatic breast cancer patients," noted Giuseppe Del Priore, MD, MPH, BriaCell’s Chief Medical Officer.

On December 3, 2024 Caris Life Sciences (Caris), a leading next-generation AI TechBio company and precision medicine pioneer, reported that the company and collaborators from leading cancer centers, including those within the Caris Precision Oncology Alliance (Caris POA), will collectively present seven studies across a range of breast cancer types, including male breast cancer, at the San Antonio Breast Cancer Symposium (SABCS) from December 10-13, 2024 (Booth #1217) (Press release, Caris Life Sciences, DEC 2, 2024, View Source [SID1234648773]). The research highlights the capability of Caris’ extensive multimodal database to uncover new cancer insights, which may significantly influence a patient’s diagnosis, prognosis, treatment plan and therapeutic response.

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"The research being presented at this year’s San Antonio Breast Cancer Symposium is a testament to Caris’ continued commitment to data-driven molecular innovation and the power of our ever-expanding network of collaborators to answer some of today’s pressing questions in precision oncology," said Caris EVP and Chief Medical Officer George W. Sledge, Jr., MD. "More than half of the studies presented focus on male breast cancer, an often-overlooked form of breast cancer. The findings underscore the critical role of comprehensive profiling in cancer care and the power of large clinico-genomic datasets to enable the identification of new biomarkers with clinical implications across diverse tumor types, including rare cancers."

The research highlights the capability of Caris’ extensive multimodal database to uncover new cancer insights

"Our comprehensive molecular profiling coupled with rich clinical data is enabling Caris to help clinicians make the best treatment choices, researchers to discover novel cancer biology, and the biopharmaceutical industry to develop the next breakthrough medicines," said Caris President David Spetzler, MS, PhD, MBA. "Our vast real-world evidence from over 748,000 cases, including over 550,000 with matched molecular data and outcomes, enables our team and research collaborators to better understand the biological hallmarks of cancers and how they impact clinical outcomes, paving the way for personalized therapies and improved patient outcomes."

Spotlight Poster Presentations include:

A Caris study titled "Molecular and Immune Landscape of Metaplastic Triple Negative Breast Cancer Compared with Invasive Ductal Triple Negative Breast Cancer" (Presentation #PS17-02) will be featured in Concurrent Poster Spotlight Session 17, named "Early Triple Negative Breast Cancer," on Thursday, December 12, from 5:30 – 6:30 p.m. CST in the Stars at Night Ballroom 1-2. The study was performed in collaboration with Caris Precision Oncology Alliance (Caris POA) members Dana-Farber Cancer Institute, Norris Comprehensive Cancer Center, Legorreta Cancer Center at Brown University and Yale School of Medicine, as well as the Mayo Clinic.
In the featured study, the molecular and immunological landscapes of metaplastic triple-negative breast cancer (M-TNBC) were investigated using Caris’ Next-Generation Sequencing (NGS) technology. The results indicate that M-TNBC is associated with an aggressive disease biology, with differential molecular and immune features compared to invasive ductal TNBC. A better understanding of these differences may help inform disease outcomes, provide a rationale for tailored therapeutic approaches and guide the design of future treatments for M-TNBC, a rare and aggressive form of breast cancer.

A Caris study titled "Mechanisms of Resistance to Trastuzumab Deruxtecan in Breast Cancer Elucidated by Multi-omic Molecular Profiling" (Presentation #PS13-09) will be featured during Concurrent Poster Spotlight Session 13, named "Molecular Determinants of Therapeutic Response and Resistance – Spotlight on CDK 4/6i and ADCs" on Friday, December 13 from 7:00 – 8:30 a.m. CST in the Stars at Night Ballroom 1-2. Caris EVP and Chief Medical Officer George W. Sledge Jr., MD will present results of the study conducted by Caris scientists.
In this study, whole transcriptome sequencing (WTS), immunohistochemistry and real-world clinical data were analyzed for more than 2,000 Trastuzumab Deruxtecan (T-DXd)-treated breast cancer samples. This multi-omic approach revealed a clinically relevant mechanism of resistance to T-DXd, a drug widely used in the treatment of metastatic HER-2 low and HER2-positive breast cancer. In T-DXd-treated patients, clinical outcome was a function of trastuzumab target expression and expression of ABCC1, the gene encoding the multidrug resistance protein-1 (MRP1). These results increase our understanding of how T-DXd resistance develops and may help oncologists tailor treatment plans for breast cancer patients accordingly.

Additional Presentations Reveal Potential Impact of Comprehensive Molecular Profiling
Poster and abstract summaries highlighting the Caris research presented at SABCS 2024 will be available onsite at Caris’ Booth #1217. The full abstracts will be available on the Caris website at the event’s conclusion.

Molecular landscape of HR+/HER2- male breast cancer (MaBC) compared with female breast cancer (FeBC) (Presentation Number: P1-01-16)
This study aimed to identify the molecular and immune differences between HR+/HER2- male and female breast cancer. NGS-based analysis of more than 8,200 breast cancer samples indicated that HR+/HER2- male breast cancer has a distinct mutational and immunological profile compared to its female counterpart. These findings suggest important differences in tumor biology between men and women with HR+/HER2- breast cancer. A better understanding of these differences may help in the design of future clinical trials and the development of treatments for men with HR+/HER2- breast cancer.

Spliceosome Mutations (Smut) in Metastatic Breast Cancer (MBC): An Analysis of a De-centralized Clinical Trial and Large Clinical-Genomic Dataset (Presentation Number: P1-01-20)
In this study, spliceosome mutations were analyzed in metastatic breast cancer (MBC) using data from the PRISMM (Patient Response to Immunotherapy using Spliceosome Mutational Markers) trial and Caris’ large clinical-genomic dataset. This analysis found that patients with spliceosome mutations do not have significant responses to immunotherapy. HR+/HER2- MBC had the highest frequency of spliceosome mutations and was associated with genomic aberrations of endocrine resistance, an immune-cold phenotype, and worse overall survival. These findings underscore the importance of molecular profiling in patients with MBC.

Prognostic implications of oncogenetic pathway alterations in advanced male breast cancer(Presentation Number: P1-05-21)
Male breast cancer has a distinct molecular and immune landscape compared to female breast cancer, but the prognostic implications of these differences have previously been unclear. In this study, 17,759 breast tumors were tested using WES and WTS to assess the effect of gene alterations on male breast cancer-related survival. Results showed that select genomic alterations have different prognostic significance in male and female breast cancer, suggesting that breast cancer in men may have a unique trajectory that differs from female breast cancer. Further investigation of sex-defined differences in breast cancer may help tailor future therapeutic strategies.

Comprehensive characterization of androgen receptor in male breast cancer (Presentation Number: P1-03-22)
While the estrogen receptor (ER) is well-studied in breast cancer, the role of the androgen receptor (AR) is less understood, particularly in male patients. This study aimed to characterize the molecular and immunological features associated with AR gene expression in male breast cancer. Comprehensive molecular profiling revealed that specific genomic alterations and immune markers are associated with AR expression. Further investigations of these features may assist in clinical trial design for men with breast cancer.

Molecular and immunological characterization of HER2-low, HER2 ultra-low, and HER2-null male breast cancer (Presentation Number: P3-01-25)
This final study aimed to determine whether there are differences in molecular and immunological features between HER2-low, HER2-ultra-low and HER2-null/negative breast cancer in males. Generally, these three HER2 subtypes in men shared genomic features, suggesting that their disease biology may be similar across the spectrum of what historically has been considered HER2-negative disease. Differences were noted, however, between these HER2 subtypes in their tumor immune microenvironments and warrant further investigation. These findings expand our current understanding of the HER2 spectrum in male breast cancer.
The Caris POA includes 96 cancer centers, academic institutions, research consortia and healthcare systems, including 47 NCI-designated cancer centers, who collaborate to advance precision oncology and biomarker-driven research. Caris and POA members work together to establish and optimize standards of care for molecular testing through innovative research focused on predictive and prognostic markers that improve the clinical outcomes for cancer patients.

On December 2, 2024 Rakovina Therapeutics Inc. (TSX-V: RKV, the "Company" or "Rakovina Therapeutics"), a biopharmaceutical company committed to advancing new cancer therapies based on novel DNA-damage response technologies, reported that its previously announced private placement has been further upsized to $3 million, based on strong indications of interest from potential investors in the financing (Press release, Rakovina Therapeutics, DEC 2, 2024, View Source;utm_medium=rss&utm_campaign=rakovina-therapeutics-increases-private-placement-offering-to-3-0-million [SID1234648760]).

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The Offering is structured as units priced at $0.06 each, with each unit consisting of one common share and one warrant to purchase a common share. Each warrant entitles the holder to purchase one additional common share at a price of $0.10 per share, exercisable for a period of 24 months. Rakovina retains the right to accelerate the warrant exercise period if the 20-day volume-weighted average price of its shares exceeds $0.30.

The Company plans to use the proceeds to continue the discovery and advancement of novel cancer treatments by leveraging collaborations with two proprietary Artificial Intelligence (AI) platforms: the Deep Docking AI platform and the Variational AI Enki Platform. The Company also plans to continue the development of its kt-3000 series through collaborations and partnerships with biotech and pharma companies.

The Offering is subject to all necessary regulatory approvals, including acceptance from the TSX Venture Exchange. The Units will be sold on a non-brokered "private placement" basis in accordance with applicable Canadian securities laws and under applicable exemptions from prospectus and registration requirements, and the securities will be subject to resale restrictions for a period of four months plus one day from the date of issue.

On December 2, 2024 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion"), a clinical-stage TechBio company specializing in developing AI-Immunology powered vaccines, reported that it will present preclinical Proof-of-Concept for its precision cancer vaccine concept, targeting non-conventional ERV (endogenous retrovirus) tumor antigens shared across patients at the ESMO (Free ESMO Whitepaper) Immuno-Oncology Congress, taking place from December 11-13, 2024, in Geneva, Switzerland (Press release, Evaxion Biotech, DEC 2, 2024, View Source [SID1234648746]).

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The data to be presented stems from studies in human cells and mouse tumor models. The studies investigated human T-cell responses and mouse tumor growth inhibition induced by precision ERV vaccine targets identified using Evaxion’s AI-Immunology platform.

AI-Immunology can select ERV antigens for precision therapeutic cancer vaccines, offering therapeutic options for multiple specific cancer types and potentially enabling treatment for patients who are unresponsive to conventional cancer immunotherapy.

The new concept of deploying ERVs as vaccine targets allows for designing precision cancer vaccines that could be effective across diverse immune system characteristics, making them suitable for a wide range of patients. Evaxion plans to utilize this now preclinically validated concept to design new precision vaccine candidates to complement our existing pipeline of personalized cancer vaccines.

Conference presentation details:

Abstract title: AI-designed cancer vaccines: antigens from the dark genome are promising cancer vaccine targets
Poster#: 124P
Location: Foyer Mezzanine
Date/Time: December 12, 2024, at 12.30 CET/06.30 EST
Presenter: Daniela Kleine-Kohlbrecher, Senior Project Manager at Evaxion