On November 26, 2024 Aclaris Therapeutics, Inc. (NASDAQ: ACRS), a clinical-stage biopharmaceutical company focused on developing novel drug candidates for immuno-inflammatory diseases, reported that members of the Aclaris management team will participate in a fireside chat during the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024 at 1:00 PM ET in New York, New York (Press release, Aclaris Therapeutics, NOV 26, 2024, View Source [SID1234648647]).

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A webcast of the fireside chat may be accessed through the "Events" page of the "Investors" section of Aclaris’ website, www.aclaristx.com. The webcast will be archived for at least 30 days on the Aclaris website.

On November 26, 2024 Poseida Therapeutics, Inc. (Nasdaq: PSTX) ("Poseida"), a clinical-stage allogeneic cell therapy and genetic medicines company advancing differentiated non-viral treatments for patients with cancer, autoimmune and rare diseases, reported that it has entered into a merger agreement to be acquired by Roche Holdings, Inc. ("Roche") at a price of $9.00 per share in cash at closing, plus a non-tradeable CVR to receive certain contingent payments of up to an aggregate of $4.00 per share in cash upon achievement of specific milestones (Press release, Poseida Therapeutics, NOV 26, 2024, View Source [SID1234648626]). This corresponds to a total equity value of approximately $1.5 billion on a fully diluted basis. The merger agreement has been unanimously approved by Poseida’s Board of Directors, and Poseida’s Board of Directors unanimously recommends that Poseida stockholders tender their shares in the tender offer.

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The proposed acquisition will establish a new core capability for Roche in allogeneic cell therapy, with lead opportunities focused on CAR-T programs covered by the existing strategic collaboration between Poseida and Roche in hematologic malignancies. It will include CAR-T programs for solid tumors and autoimmune diseases, along with Poseida’s genetic engineering platform and related preclinical medicines.

Poseida has pioneered a proprietary technology platform that includes a full set of non-viral capabilities to design, develop and manufacture allogeneic, T stem cell memory cells (TSCM)-rich CAR-T therapies. TSCM cells are considered ideal for CAR-T therapy because they are long-lived, multi-potent and self-replicating, with the potential for an improved safety and efficacy profile. This may offer benefits compared to other approaches, which either use a different cell type or drive T cell differentiation (and therefore less stemness) as part of the process to manufacture the CAR-T cells.

"Poseida has demonstrated the unique ability of its proprietary non-viral technology platform to create allogeneic, TSCM-rich CAR-T therapies with the potential to improve clinical outcomes and expand access to this important class of medicines. Most recently, this was highlighted by the compelling interim clinical data for P-BCMA-ALLO1 in patients with multiple myeloma," said Kristin Yarema, Ph.D., President and Chief Executive Officer of Poseida Therapeutics. "We have worked closely with Roche through our collaboration focused on hematologic malignancies, and we are excited to join Roche to work as colleagues together across our pipeline and future programs. Roche’s global capabilities in late-stage development and commercialization will enable patients worldwide to benefit from the transformative potential of allo CAR-T."

Poseida and its employees will join the Roche Group as part of Roche’s Pharmaceuticals Division.

Transaction Terms

Under terms of the merger agreement, Roche will commence a tender offer to acquire all of Poseida’s outstanding shares for a price of $9.00 per share in cash at closing, plus a non-tradeable CVR to receive up to an aggregate of $4.00 per share in cash, payable upon achievement of specified milestones.

The closing of the transaction is subject to customary closing conditions, including the tender of shares representing at least a majority of Poseida’s outstanding shares (other than shares held by Poseida, Roche or any of their respective subsidiaries, and any dissenting shares), the completion of regulatory review and other customary closing conditions. Upon the successful completion of the tender offer, Roche will acquire all remaining Poseida shares that are not tendered into the tender offer through a second-step merger at the same price of $9.00 per share in cash at closing, plus a non-tradeable CVR to receive up to an aggregate of $4.00 per share in cash, payable upon achievement of specified milestones.

The closing of the transaction is currently expected to take place in the first quarter of 2025.

Advisors
Centerview Partners LLC is serving as exclusive financial advisor to Poseida and Cooley LLP is serving as legal counsel. Citi is acting as financial advisor to Roche and Sidley Austin LLP is acting as legal counsel to Roche.

On November 26, 2024 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported an update on the phase III SKYSCRAPER-01 study, evaluating tiragolumab combined with Tecentriq (atezolizumab) compared to Tecentriq alone for patients with PD-L1-high, locally advanced or metastatic non-small cell lung cancer (NSCLC) (Press release, Hoffmann-La Roche, NOV 26, 2024, View Source [SID1234648622]).

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SKYSCRAPER-01 is a global phase III, randomised, double-blind study evaluating tiragolumab plus Tecentriq compared to Tecentriq alone in 534 patients with PD-L1-high previously untreated, locally advanced unresectable or metastatic NSCLC. Patients were randomised 1:1 to receive either tiragolumab plus Tecentriq or placebo plus Tecentriq, until disease progression, loss of clinical benefit, or unacceptable toxicity. The study did not reach the primary endpoint of overall survival at the final analysis. The overall safety profile observed remained consistent with longer follow-up, and no new safety signals were identified. The detailed data will be presented at a medical meeting in 2025.

Roche continuously reviews its study programmes to determine if any adjustments are necessary for the purposes of ongoing research. Roche will apply the same principles to this programme, with additional data from phase III studies across different settings or tumour types anticipated next year.

About tiragolumab
Tiragolumab is an investigational immune checkpoint inhibitor with an intact Fc region. Tiragolumab selectively binds to TIGIT, a novel inhibitory immune checkpoint which suppresses the immune response to cancer.

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1. Tecentriq is designed to bind to PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the re-activation of T cells. Tecentriq may also affect normal cells.

On November 24, 2024, Hanx Biopharmaceuticals (Wuhan) Co., Ltd. (hereinafter referred to as " Hanx Biopharmaceuticals ") from Wuhan, Hubei, reported the company submitted a prospectus to the Hong Kong Stock Exchange, intending to list on the main board of Hong Kong through an IPO (Press release, HanX Biopharmaceuticals, NOV 25, 2024, View Source [SID1234655966]).

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Hans Biotech , an innovative biotechnology company with proprietary expertise and experience in structural biology, translational medicine, and clinical development, is dedicated to discovering, developing, and commercializing first-in-class and/or best-in-class products for the precision treatment of cancer and autoimmune diseases, addressing global unmet medical needs. The company acquired an equity stake in Hangzhou Hans Biotech in 2017 and has since focused on proven therapeutic mechanisms.

As of November 18, 2024, Hans-Etienne has developed a pipeline of 10 drug candidates (eight in oncology and two in autoimmune disease in clinical or preclinical development) , including its core product HX009 (an independently developed PD-1/SIRPα bifunctional antibody fusion protein) , two key products HX044 and HX301, and seven preclinical-stage drug candidates, including antibody-drug conjugates, bsAbs, and mAbs, targeting the autoimmune and oncology markets. Hans-Etienne ‘s pipeline development strategy is based on validated targets and pathways, supported by molecules with unique target biology, translational evidence, clinical feasibility, and druggable structures. The company is positioned to provide next-generation immuno-oncology therapies, such as HX009, HX044, and HX016, to combat PD-1 resistance; first-in-class ADC molecule HX111, for the precision treatment of specific malignancies; and novel autoimmune therapies, such as the bsAb bifunctional antibodies HX035 and HX038.

Hansaitai ‘s core product, HX009, is an independently developed PD-1/SIRPα bifunctional antibody fusion protein. Phase I clinical trials for HX009 have been completed in Australia and China. The company is currently conducting two HX009 clinical programs in China: the HX009-I-01 China study (Phase Ib) for the treatment of advanced melanoma, and the HX009-II-02 China study (Phase I/II) for the treatment of R/R EBV+ non-Hodgkin’s lymphoma.

The two main products, HX301 and HX044, are in the clinical stage and focus on the treatment of cancer. HX301 is a multi-target kinase inhibitor targeting key pathways such as CSF1R, ARK5, FLT-3 and CDK4/6. Hans Aita has completed the Phase I clinical study of HX301 approved by the National Medical Products Administration, and plans to conduct a Phase II clinical study of HX301 in combination with temozolomide for the treatment of glioblastoma. HX044 is a novel dual-functional anti-CTLA-4 antibody SIRPα fusion protein designed to enhance the targeted efficacy of CTLA-4. Currently, the company is initiating a Phase I/IIa clinical study in Australia for the treatment of advanced solid tumor malignancies and has obtained the National Medical Products Administration’s acceptance notice for its clinical research in China.

On November 25, 2024 Shorla Oncology (‘Shorla’), a U.S.-Ireland specialty pharmaceutical company, reported that the FDA has approved IMKELDI (imatinib) oral solution, the first oral liquid form of imatinib to treat certain forms of leukemia and other cancers (Press release, Shorla Oncology, NOV 25, 2024, View Source [SID1234648642]).

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"We are thrilled to offer an oral solution option for patients with leukemia and other cancers, a meaningful advancement for thousands in need," said Sharon Cunningham, chief executive officer of Shorla. "Oral solutions may ensure more precise and consistent dosing, offering a convenient alternative to compounding for patients who have difficulty swallowing or require dosing tailored to body surface area."

Leveraging Shorla’s novel technology, IMKELDI is an advanced liquid formulation of imatinib designed to provide dosing accuracy. IMKELDI can help slow or prevent the growth of specific cancers, including chronic myeloid leukemia (CML) and acute lymphoblastic leukemia, myelodysplastic syndrome /myeloproliferative disease (MDS/MPD), and gastrointestinal tumors (GIST).

In 2024, an estimated 9,280 people will be diagnosed with CML1, over 10,000 with MDS/MPD2, and up to 6,000 with GIST3 in the U.S. Despite the proven clinical benefits of imatinib, patient adherence can be an issue,4,5 underscoring a critical unmet need for a more accessible, patient-friendly oral solution delivery system.

"This milestone marks our fourth FDA approval as we advance our mission to make existing oncology treatments better through formulation re-innovation," said Orlaith Ryan, chief technical officer and co-founder of Shorla. "Our team is dedicated to creating more patient-friendly options that address real needs in those suffering from cancer."

Rayna Herman, chief commercial officer of Shorla added, "At Shorla, every innovation is driven by our commitment to put patients first. IMKELDI is another step forward as we continue to expand our growing portfolio with products that prioritize accessibility and affordability."

1. Key Statistics for Chronic Myeloid Leukemia. American Cancer Society. Updated January 17, 2024. Accessed November 7, 2024. View Source
2. Key Statistics for Myelodysplastic Syndromes. American Cancer Society. Updated January 22, 2018. Accessed November 7, 2024. View Source
3. Key Statistics for Gastrointestinal Stromal Tumors American Cancer Society. Updated January 26, 2021. Accessed November 7, 2024. View Source
4. Yanamandra U, Malhotra P, Sahu KK, et al. Variation in Adherence Measures to Imatinib Therapy. J Glob Oncol. 2018;4:1-10. doi:10.1200/JGO.2016.007906
5. Al-Barrak J, Cheung WY. Adherence to imatinib therapy in gastrointestinal stromal tumors and chronic myeloid leukemia. Support Care Cancer. 2013;21(8):2351-2357. doi:10.1007/s00520-013-1831-6

About IMKELDI

IMKELDI is an oral solution of imatinib mesylate, a tyrosine kinase inhibitor, approved by the U.S. Food and Drug Administration for use in certain forms of leukemia (such as acute lymphoblastic leukemia and chronic myeloid leukemia) and other cancers in adults and pediatric patients as young as one year old. Featuring a convenient, palatable strawberry flavor and a stable formulation that does not require refrigeration, IMKELDI offers a patient-friendly, precise treatment option designed to improve adherence and accessibility.