On October 20, 2023 BreakBio Corp., a biotech company dedicated to advancing innovative solutions in vaccine development for the treatment of cancer, reported that it has received Investigational New Drug (IND) approval from the U.S. Food and Drug Administration (FDA) for its investigational new personalized immunotherapy drug, BreakVax, on October 20, 2023 (Press release, Break Bio, OCT 20, 2023, View Source [SID1234644908]).

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This represents a significant milestone in the company’s commitment to addressing unmet medical needs and improving global health outcomes. This IND approval marks the culmination of extensive research and development by BreakBio Corp.’s dedicated team of oncologists, bioinformaticians, immunologists, and personalized cancer vaccine specialists.

BreakVax is a cutting-edge personalized peptide immunotherapy designed by mass spec, ML and manufactured per patient. Leveraging breakthrough technology and scientific expertise, BreakVax aims to provide a safe and effective treatment for solid cancers.

"We are thrilled to receive IND approval for BreakVax, as it underscores our unwavering dedication to advancing immunotherapies that have the potential to transform solid cancer treatments," said Roy de Souza, CEO of BreakBio Corp. "This milestone brings us one step closer to fulfilling our mission of improving survival rates, and aiming for cures for all solid cancers."

BreakBio Corp. remains committed to advancing BreakVax through the next stages of development, including our First In Human clinical trial in first indication (colorectal cancer) in 2024, with the ultimate goal of achieving the FDA’s Breakthrough Designation and making this personalized immunotherapy available to cancer patients who need it.

On October 20, 2023 BeiGene, Ltd. (Nasdaq: BGNE; HKEX: 06160; SSE: 688235), a global biotechnology company, reported the National Institute for Health and Care Excellence (NICE) of the United Kingdom (U.K.) has issued a final draft guidance (FDG) recommending BRUKINSA (zanubrutinib) for the treatment of eligible adult patients with (Press release, BeiGene, OCT 20, 2023, View Source [SID1234636171]):

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Untreated chronic lymphocytic leukemia (CLL) if there is a 17p deletion or TP53 mutation (high risk) or
Untreated CLL without a 17p deletion or TP53 mutation, and fludarabine-cyclophosphamide-rituximab (FCR) or bendamustine plus rituximab (BR) is unsuitable and
Relapsed or refractory CLL
"We are delighted that NICE has recognized the clinical and economic benefit of BRUKINSA for patients with CLL," said Dr. Robert Mulrooney, General Manager, U.K. & Ireland at BeiGene. "This follows the previous approval of BRUKINSA by NICE in July 2022 as the only cost-effective treatment for patients with Waldenstrom’s macroglobulinemia. Although we are a relatively new player in the U.K. market, we are rapidly establishing ourselves as a company that can make innovative cancer medicines accessible and affordable for U.K. patients."

As stated in the FDG, for the untreated CLL population that is high-risk or for whom FCR or BR is unsuitable and for the relapsed/refractory CLL population, zanubrutinib had lower incremental costs and more incremental quality adjusted life years compared with other BTK inhibitors. The committee considered that zanubrutinib is a cost-effective use of NHS resources in CLL.

"This decision represents a significant milestone for patients in England and Wales with CLL, the most common form of leukemia in adults," said Nick York, Patient Advocacy Healthcare Liaison Officer, U.K. Leukemia Care. "Despite continued treatment advances, many patients with CLL will relapse and need additional treatment options. Furthermore, a proportion of patients have a disease which is refractory to initial treatment."

BRUKINSA is the third BTKi for CLL to be recommended by NICE for routine commissioning.

"Zanubrutinib has demonstrated superior efficacy and a favorable safety profile in two global Phase 3 trials, SEQUOIA and ALPINE, in adult patients with CLL," said Dr. Talha Munir, consultant hematologist at Leeds Teaching Hospitals NHS Trust, Leeds, U.K.i,ii "The positive recommendation from NICE will allow patients with CLL in England and Wales to access this important new treatment option."

In addition, on October 9, 2023, BRUKINSA received approval by the Scottish Medicines Consortium for the treatment of adult patients with CLL in whom chemo-immunotherapy is unsuitable.

BRUKINSA is approved in more than 65 countries, including the U.S., China, EU, Great Britain, Canada, Australia, South Korea, and Switzerland, in selected indications and under development for additional indications globally. The global BRUKINSA development program includes more than 5,000 subjects enrolled to date in 29 countries and regions.

About Chronic Lymphocytic Leukemia (CLL)
A life-threatening cancer of adults, CLL is a type of mature B-cell malignancy in which abnormal leukemic B lymphocytes (a type of white blood cells) arise from the bone marrow and flood peripheral blood, bone marrow, and lymphoid tissues.iii,iv CLL is the most common type of leukemia in adults, accounting for about one-quarter of new cases of leukemia.iv,v Approximately 3,800 people in the U.K. are diagnosed with CLL every year.vi,vii

About BRUKINSA (zanubrutinib)
BRUKINSA is a small molecule inhibitor of Bruton’s tyrosine kinase (BTK) discovered by BeiGene scientists that is currently being evaluated globally in a broad clinical program as a monotherapy and in combination with other therapies to treat various B-cell malignancies. Because new BTK is continuously synthesized, BRUKINSA was specifically designed to deliver complete and sustained inhibition of the BTK protein by optimizing bioavailability, half-life, and selectivity. With differentiated pharmacokinetics compared to other approved BTK inhibitors, BRUKINSA has been demonstrated to inhibit the proliferation of malignant B cells within a number of disease relevant tissues.

On October 24, 2023 Novartis reported a very strong quarter, with double-digit sales and core operating income growth leading to a further upgrade to 2023 guidance (Press release, Novartis, OCT 20, 2023, View Source [SID1234636263]). We have successfully executed the spin-off of Sandoz, allowing us to fully focus on high-value innovative medicines. Our growth drivers, including Kesimpta, Entresto, Kisqali and Pluvicto, continue to perform well in the market. Our robust pipeline also continues to deliver, and we have achieved important innovation milestones for Pluvicto, iptacopan, remibrutinib and Lutathera. We are confident in our mid-term growth outlook and remain committed to creating value for our shareholders."

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On October 12, 2023 Scientists at the Translational Genomics Research Institute (TGen), part of City of Hope, in collaboration with SIWA Therapeutics Inc., reported results from a preclinical study that highlights the potential of SIWA318H, an advanced glycation end product (AGE)-targeting antibody, in the fight against pancreatic cancer (Press release, SIWA Therapeutics, OCT 12, 2023, View Source [SID1234636200]). The results appear in Scientific Reports, a Nature publication.

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Pancreatic cancer, especially pancreatic ductal adenocarcinoma (PDAC), has long been known for its aggressive nature and resistance to current treatment options. SIWA318H’s ability to selectively target senescent cells represents a new approach to treating the disease. Senescent cells within the tumor microenvironment have been identified as major contributors to tumor development, growth and therapy resistance. SIWA318H, an antibody specifically designed to target AGEs, offers a novel approach to eliminate these senescent cells and reshape the tumor microenvironment.

"These pre-clinical results suggest that SIWA318H is a promising new therapeutic against pancreatic cancer," said Lewis S. Gruber, CEO and co-founder of SIWA Therapeutics. "By reshaping the tumor microenvironment, our goal is to improve the efficacy of cancer treatments and potentially lead to better patient outcomes."

The study’s key findings reveal that SIWA318H has a remarkable ability to specifically attach itself to modified proteins associated with aging and cancer progression. It targets senescent cells, which are linked to these health issues, both in vitro and within living organisms. This ability to target senescent cells is an important part of how the drug works. Additionally, SIWA318H can trigger a process called antibody-dependent cell-mediated cytotoxicity (ADCC), which helps the immune system eliminate cancer cells.

In a study involving mice with pancreatic cancer, those treated with SIWA318H saw a significant reduction in tumor growth, increased survival, and an increased rate of complete remission compared to mice treated with a control antibody. Furthermore, the tumors treated with SIWA318H showed fewer senescent cells and less profibrotic cells, indicating a positive impact on the tumor’s surrounding environment.

"SIWA318H’s ability to selectively target senescent cells, coupled with its demonstrated efficacy in preclinical models, offers a glimmer of hope for a new approach to tackling this formidable disease," said Haiyong Han, Ph.D., a professor in the Molecular Medicine Division at TGen and the study’s senior author.

These findings also suggest that SIWA318H holds promise for potential use in combating aging-related issues and cancer.

On October 20, 2023 TME Pharma N.V. (Euronext Growth Paris: ALTME), a biotechnology company focused on developing novel therapies for treatment of cancer by targeting the tumor microenvironment (TME), reported that another patient has reached the 18-month survival mark after start of therapy increasing overall survival at 18 months (OS-18) to 67% in the GLORIA expansion arm for newly diagnosed glioblastoma patients receiving NOX-A12 with the VEGF inhibitor bevacizumab and radiotherapy (Press release, TME Pharma, OCT 20, 2023, View Source [SID1234636199]).

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This announcement provides an update to a recent disclosure by the company (October 10, 2023) at time of which the last patient had not yet passed the 18-month survival mark. The percentage of patients alive 18 months after the start of their therapy has thus increased from 50% to 67% (4 of 6 patients). Thus, the survival rate at 18 months of patients treated with NOX-A12 + bevacizumab (anti-VEGF) + radiotherapy outperforms by 13-fold the 18-month survival of 5% observed in the matched group of reference patients receiving standard of care1.

Median overall survival also continues to improve further and has already exceeded 18 months as the remaining patients in the GLORIA clinical trial continue to receive treatment or follow-up care2. For comparison, the matched standard of care reference cohort achieved a median overall survival of 10.5 months.

"We have reached a decisive moment in the development of our lead asset NOX-A12 in aggressive adult brain cancer with the achievement of an unprecedented 18-month survival rate of 67 percent in patients with chemotherapy refractory tumors not amenable to complete surgical resection," said Aram Mangasarian, CEO of TME Pharma. "We have been steadily building this compelling body of clinical evidence month by month to the point where NOX-A12-based therapies now have the potential to be the best available treatment for glioblastoma patients. It has been highly encouraging to see the data reach meaningful maturity enabling us to have a constructive discussion with regulators before the end of the year on the next steps in development and potential for access to an expedited regulatory pathway for approval of NOX-A12. We target having an IND in place and access to an expedited pathway by the end of Q1 2024, which we expect will attract significant interest from investors and potential partners."