On December 14, 2023 SELLAS Life Sciences Group, Inc. (NASDAQ: SLS) ("SELLAS’’ or the "Company"), a late-stage clinical biopharmaceutical company focused on the development of novel therapies for a broad range of cancer indications, reported that the first patients have been enrolled in the 60 mg dose cohort in its ongoing Phase 2a clinical trial of its novel and highly selective CDK9 inhibitor, SLS009, in combination with venetoclax and azacitidine (aza/ven) in patients with relapsed/refractory (r/r) acute myeloid leukemia (AML) who did not respond or stopped responding to venetoclax-based therapies (Press release, Sellas Life Sciences, DEC 14, 2023, View Source [SID1234638575]).

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A total of nine patients have been enrolled at the 45 mg safety dose level. Eight patients remain alive (one patient succumbed to sepsis having previously contracted COVID 19) and six continue treatment. The first enrolled patient achieved a complete response and is currently in the seventh month of treatment and the second enrolled patient is in the sixth month of treatment. Significant anti-leukemic effects (≥50% decrease in bone marrow blasts) were observed during treatment in five out of six assessable patients with no significant safety issues to date. No dose limiting toxicities (DLT) were observed in any of the patients. Topline data for the 45 mg cohort are expected around year-end 2023. Patients with AML that fail venetoclax-based therapies have limited treatment options and a poor prognosis with a median overall survival (mOS) of approximately 2.5 months.

"We are thrilled with the Safety Monitoring Committee advocating that we proceed to the recommended Phase 2 dose level of 60 mg after finding no safety concerns with the 45 mg cohort, which represents important progress in the clinical advancement of SLS009. Based on the encouraging efficacy data and safety profile that continues to emerge in the Phase 2a trial, we remain excited about the potential for SLS009 as a promising treatment option for the many AML patients with poor prognosis and limited alternatives currently available once they become resistant to venetoclax," said Angelos Stergiou, MD, ScD h.c., President and Chief Executive Officer at SELLAS. "To align with the FDA’s Project Optimus initiative, our dosing strategy in this next arm of the Phase 2a trial will include evaluation of two dosing regimens, 60 mg once per week and 30 mg twice per week. We look forward to sharing early data from this cohort as well as further clinical data of the 45 mg cohort around the end of this year or early next year."

The Phase 2a clinical trial of SLS009 is an open label, single arm, multi-center study that is designed to evaluate safety, tolerability, and efficacy at two dose levels, 45 mg and 60 mg, in combination with aza/ven. In the 60 mg dose cohort, patients will be randomized to one of two groups, 60 mg flat (fixed) dose once per week and 30 mg fixed dose two times per week. Each group will enroll 5 – 10 patients. In addition to safety and tolerability of SLS009 in combination with aza/ven, the primary endpoints are composite complete response rate (CRc) and duration of response (DOR). Additional endpoints include event free survival (EFS), OS, and pharmacokinetic (PK) and pharmacodynamic (PD) assessments. Venetoclax combinations with hypomethylating agents are a commonly used regimen in this target population but despite high efficacy (up to ~67% complete response rate), approximately one-third to one-half of patients do not respond to venetoclax based regimens, and among those who respond almost all eventually relapse.

SLS009 was recently granted orphan drug designation by the U.S. Food and Drug Administration in AML supported by the data from the Phase 1 study of SLS009 as a monotherapy that met all key study objectives. In the Phase 1 study one patient with AML achieved a complete response, making SLS009 the first CDK9 inhibitor to achieve a complete response in r/r AML as a monotherapy, and remained alive for 11 months as of the last follow up.

On December 14, 2023 Pfizer Inc. (NYSE: PFE) reported the successful completion of its acquisition of Seagen Inc. (NASDAQ: SGEN), a global biotechnology company that discovers, develops and commercializes transformative cancer medicines (Press release, Seagen, DEC 14, 2023, View Source [SID1234638574]). Pfizer completed its acquisition of all outstanding common stock of Seagen for $229 in cash per share, for a total enterprise value of approximately $43 billion.

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"Cancer remains a leading cause of death, and one in three people in the U.S. will receive a cancer diagnosis in their lifetime. With one of the largest investments in Pfizer’s history, we are going all in on cancer with the goal of delivering breakthroughs that drastically improve the lives of people with cancer," said Dr. Albert Bourla, Pfizer Chairman and Chief Executive Officer. "With Seagen’s proprietary, world-leading Antibody-Drug Conjugate (ADC) technology, together with the scale and strength of Pfizer’s capabilities and expertise, we are poised to change the cancer treatment paradigm. We believe Oncology will be a significant growth driver for Pfizer and contribute meaningfully to the achievement of our near- and long-term financial goals."

Seagen is a world-leader in ADC technology, a transformative modality that is emerging as a powerful tool across a broad range of cancers designed to preferentially kill cancer cells and limit off-target toxicities. With the addition of Seagen’s four in-line medicines, ADCETRIS (brentuximab vedotin), PADCEV (enfortumab vedotin), TIVDAK (tisotumab vedotin) and TUKYSA (tucatinib), Pfizer’s industry-leading Oncology portfolio now includes over 25 approved medicines and biosimilars across more than 40 indications, including nine medicines that are either blockbuster or have the potential to be blockbuster.

With the addition of Seagen, Pfizer’s Oncology pipeline has doubled in size with 60 programs spanning multiple modalities, including ADCs, small molecules, bispecifics and other immunotherapies. Moving forward, Pfizer will leverage its leading protein engineering and medicinal chemistry capabilities to advance Seagen’s ADC technology, unlocking potential novel combinations and next-generation biologics.

"This is a great day for Pfizer, and, more importantly, for people living with cancer, as we bring together the game-changing science and top talent of Seagen and Pfizer to form a leading Oncology organization," said Chris Boshoff, Chief Oncology Officer and Executive Vice President, Pfizer. "Driven by science and a passion for improving and extending patients’ lives, together, we will work with urgency towards our common purpose to deliver transformative cancer medicines and bring new hope to people living with cancer everywhere."

As previously disclosed, to address U.S. Federal Trade Commission concerns, Pfizer has chosen to irrevocably donate the rights of royalties from sales of Bavencio (avelumab) in the U.S. to the American Association for Cancer Research (AACR) (Free AACR Whitepaper). This unrestricted donation will support AACR (Free AACR Whitepaper) in its mission to prevent and cure cancer through research, education, communication, collaboration, science policy, and funding for cancer research.

Guggenheim Securities, LLC served as Pfizer’s financial advisor and Wachtell, Lipton, Rosen & Katz and Arnold & Porter Kaye Scholer LLP served as Pfizer’s legal advisors. Centerview Partners LLC served as Seagen’s financial advisor and Sullivan & Cromwell LLP served as Seagen’s legal advisor. MTS Health Partners also provided financial advice to Seagen.

On December 14, 2023 Haystack Oncology, a Quest Diagnostics (NYSE: DGX) company, reported that it has entered into a collaboration with Rutgers Cancer Institute of New Jersey to use Haystack Oncology’s industry-leading personalized MRD technology (Haystack MRD) to help evaluate therapeutic response and provide molecular insights for a Rutgers Cancer Institute clinical trial examining early-stage triple-negative breast cancer (TNBC) patients undergoing treatment in the adjuvant setting with liposomal doxorubicin and carboplatin (Press release, Quest Diagnostics, DEC 14, 2023, View Source [SID1234638573]). Rutgers Cancer Institute together with RWJBarnabas Health is the state’s only National Cancer Institute-designated Comprehensive Cancer Center.

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"We’re excited to work with Rutgers Cancer Institute in their efforts to optimize therapeutic strategies for patients with early-stage breast cancer," said Dan Edelstein, Vice President and General Manager of Haystack Oncology. "With unparalleled sensitivity, Haystack MRD provides a tool for anticipating and evaluating treatment-related benefits to a greater depth than standard clinical and radiographic metrics, making it well-equipped to support clinical studies such as this, which are essential for advancing cancer care."

"Triple-negative breast cancer is a subtype of breast cancer that is aggressive by nature with a complex biology, therefore, the disease tends to have a worse prognosis," said Mridula George, MD, associate program director of Breast Medical Oncology at Rutgers Cancer Institute and principal investigator of the study, which is also open at select RWJBarnabas Health sites across New Jersey. "We are excited to use Haystack’s MRD technology to monitor treatment response in our clinical trial that could help inform future studies and novel approaches that will result in better outcomes for our patients."

On December 14, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported that it has completed patient enrollment in a Phase 2 study of CM24, a multi-functional immune checkpoint inhibitor, for the treatment of pancreatic ductal adenocarcinoma (PDAC) (Press release, Purple Biotech, DEC 14, 2023, View Source [SID1234638572]).

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The Phase 2 study (NCT04731467), in collaboration with Bristol Myers Squibb (BMS), is evaluating CM24 in combination with BMS’s nivolumab plus chemotherapy in PDAC patients as a 2nd line treatment as compared to chemotherapy alone. The primary endpoint is overall survival (OS). Approximately 60 patients have been enrolled through 18 centers in the U.S., Spain and Israel.

The trial was fully enrolled in advance of the anticipated 2024 timeline. An interim analysis of overall survival, the primary endpoint of the study is expected during 1H 2024 and topline analysis is expected in 2H 2024.

"Having completed patient enrollment, we now look forward to reporting overall survival results in 2024. We thank the patients and their families for participating in this important and promising study, which may advance CM24 toward a pivotal study for a population in dire need of an effective alternative. Survival rates in pancreatic cancer are unfortunately very low and with CM24’s novel CEACAM1 target, we believe we may have a positive impact on extending survival," stated Purple Biotech CEO, Gil Efron.

An estimated 60,000 people are diagnosed with pancreatic cancer in the U.S. alone with a 5-year survival rate of only 12%. In patients treated with chemotherapy as a 2nd line treatment, the 5-year survival drops to 3%.

On December 14, 2023 Nykode Therapeutics ASA (OSE: NYKD), a clinical-stage biopharmaceutical company dedicated to the discovery and development of novel immunotherapies, reported an expansion of the pipeline with a potential first-in-class preclinical oncology vaccine program aimed at preventing and treating colorectal cancer (Press release, Nykode Therapeutics, DEC 14, 2023, View Source [SID1234638571]).

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Colorectal cancer begins as a premalignant polyp that grows on the mucosal surface of the colon or rectum and transforms into malignancy. The disease development and screening programs represent an opportunity to identify and treat high-risk patients at early stages in addition to treating patients with developed malignancies.

Nykode’s novel vaccines are based on a careful selection and combination of highly expressed tumor associated antigens involved in the development and progression of colonic polyps to colorectal cancer. The program will incorporate Nykode’s 4th module proprietary second-generation technology to further optimize the immune responses tailored to diverse target populations. The program builds on Nykode’s differentiating competence of creating broad and robust CD8 T cell responses with the potential to break tolerance against tumor-associated antigens, as illustrated by data presented at Nykode’s recent Capital Market Day. Strong preclinical data generated in the discovery phase further supports the induction of potent CD8 T cell responses in both wild-type and HLA transgenic mice models.

"I am thrilled about this exciting addition to our pipeline, which underscores Nykode’s dedication to creating innovative solutions for an expanding range of patients in need of alternative therapies," said Mikkel W. Pedersen, Nykode’s Chief Scientific Officer.

"Additionally, it signifies our belief in the promise of cancer vaccines across all stages of cancer development." "The potential first-in-class program reaffirms Nykode’s vision of building a balanced cancer vaccine portfolio. We are excited about the transformative power of our next-generation technology with the potential to reduce the burden of colorectal cancer," commented Michael Engsig, CEO of Nykode.