On April 8, 2024 Calliditas Therapeutics AB (NASDAQ: CALT) (NASDAQ Stockholm: CALTX) ("Calliditas") reported that the Company has received a Notice of Allowance from the United States Patent and Trademark Office (USPTO) for patent application no. 16/760,910 entitled "Use of NOX Inhibitors for Treatment of Cancer" (Press release, Calliditas Therapeutics, APR 8, 2024, View Source [SID1234641897]). This Notice of Allowance is expected to result in the issuance of a U.S. patent once administrative processes are completed.

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The allowed claims cover a method of treating a solid tumor presenting resistance to PD-1 inhibitor immunotherapy by administering setanaxib in combination with a PD-1 inhibitor. The patent, when issued, will have an anticipated expiration date in 2038.

"This is a significant value enhancing event for the global setanaxib franchise and we are delighted that we are able to expand product protection for setanaxib in the important area of oncology," said CEO Renée Aguiar-Lucander.

Calliditas has corresponding applications in several additional territories around the world, including a pending patent application in Europe.

On April 8, 2024 Servier, a science driven company focused on developing transformative precision therapies for patients, reported promising preliminary data at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting 2024 (Press release, Servier, APR 8, 2024, View Source [SID1234641896]). These submissions also demonstrate Servier’s commitment to its One Innovation Engine approach to scientific advancements.

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Research to be presented includes biomarker data from a phase 1 dose escalation study of the anti-CD73 antibody (S095024, Sym024) alone or in combination with anti-PD-1. The data illustrates dose dependent target engagement in the tumor and reveals the potential of anti-CD73 to prevent adenosine-mediated tumor evasion.

"Biomarkers play a critical role in shaping the development of precision medicines, providing profound insights into the mechanisms of action behind therapeutic interventions," said Walid Kamoun, Vice President, Global Head of R&D Oncology at Servier. "As Servier has honed its oncology strategy, we are committed to leveraging our proven patient-selection centric approach to seamlessly connect the preclinical and clinical phases and, ultimately, deliver potentially transformative clinical benefits for patients in need."

Noteworthy, research also includes a Phase 1b multicenter study of anti-TIM3 (S095018, Sym023) in combination with anti-PD1 in patients with advanced/metastatic biliary duct cancer, which illustrates the safety of the combination as well as early anti-tumor activity.

"As a leading force in the rapidly evolving field of oncology, Servier distinguishes itself through a unique advantage: our private governance model. This empowers us to swiftly adapt and implement dynamic strategies, ensuring a sustained competitive edge," stated Claude Bertrand, Executive Vice President of Research and Development and Chief Scientific Officer at Servier. "As we participate in AACR (Free AACR Whitepaper) alongside leading minds in cancer research, we are committed to inspiring scientific advancements for the betterment of patients and survivors from bench to bedside."

To access Servier’s abstracts for AACR (Free AACR Whitepaper), please visit their website.

On April 8, 2024 SeekIn Inc., a leader in blood-based cancer early detection and monitoring technology, reported three additional validation studies that evaluate OncoSeek’s ability to detect more than nine cancer types and predict the tissue of origin with a tube of blood (Press release, SeekIn, APR 8, 2024, View Source [SID1234641895]). The data further validate the performance of OncoSeek with consistent results between the three new cohorts and the three previous cohorts of ~12,000 participants from China, the United States and Brazil. The results from three different platforms and two sample types indicate the generalization of OncoSeek’s capability for common protein marker platforms. The findings were presented at the session entitled ‘Multi-Cancer Early Detection Testing: Where Are We?’ at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in San Diego, one of the most significant oncology conferences highlighting the work of the best minds in cancer research from institutions all over the world.

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"SeekIn has demonstrated the performance of OncoSeek at international oncology conferences before. The data we are presenting this time are based on diverse protein tumor marker (PTM) platforms and new cohorts in both retrospective and prospective settings and in symptomatic patients," said Mao Mao, MD, PhD, Founder and CEO of SeekIn. "The consistently good clinical performance enables OncoSeek to work well as a low-cost, flexible and effective cancer early detection and early diagnosis technology worldwide, especially in low- and middle-income countries."

OncoSeek was established using artificial intelligence (AI) to distinguish cancer patients from non-cancer individuals by calculating the probability of cancer (POC) index based on the quantitative results of seven PTMs and clinical information, such as gender and age. It also predicts the possible affected tissue of origin (TOO) for those who have been detected with cancer signals in blood. OncoSeek was evaluated by a large retrospective study of 9,382 participants from China and the US. The methodology and clinical effectiveness of OncoSeek were published in eClinicalMedicine with DOI View Source in July, 2023.

"Combining new with previous results, OncoSeek achieved a sensitivity of 60% with a specificity of 93%, resulting in a significantly reduced false positive rate of 7% from that of 52% according to the conventional clinical method. This enables OncoSeek to be suitably applicable to three clinical applications: (i) screening for people who have no signs or symptoms of cancer, (ii) diagnosing those with symptoms to start cancer treatment as early as possible, and (iii) reducing false positive rates during personal health checks," said Dr. Mao. "More importantly, the fact that OncoSeek works well on three different platforms shows its extensibility to other PTM platforms, which will enable more flexible and affordable testing in technologically underdeveloped regions." With the demonstrated performance of OncoSeek on retrospective and prospective cohorts, SeekIn is pursuing additional prospective studies to evaluate performance in different applications. By providing an affordable and effective screening and diagnosis tool, OncoSeek has the potential to save countless lives by detecting and diagnosing cancer at an earlier stage.

On April 8, 2024 Ichnos Glenmark Innovation (IGI), an alliance between Ichnos Sciences Inc., a global fully-integrated clinical-stage biotech company developing multispecifics in oncology, and Glenmark Pharmaceuticals Ltd., reported preclinical data for its oncology asset ISB 2001 during the oral presentation at the annual American Association for Cancer Research (AACR) (Free AACR Whitepaper) 2024 (Press release, Ichnos Glenmark Innovation, APR 8, 2024, View Source [SID1234641894]). ISB 2001 is currently being tested in a Phase I clinical trial in r/r MM.

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The oral presentation showcased the results of ISB 2001 anti-myeloma activity in bone marrow aspirates from patients who were either newly diagnosed or suffer from r/r MM following multiples lines of treatment, including patients relapsing after CD38 and BCMA targeted therapies. This pre-clinical study shows the promise of ISB 2001 trispecific antibody targeting BCMA and CD38 against multiple myeloma, and CD3 on T cells. It illustrates IGI’s support in the fight against r/r MM.

"We are thrilled to present our preclinical findings for ISB 2001 at AACR (Free AACR Whitepaper)," said Lida Pacaud, MD, Chief Medical Officer of Ichnos Glenmark Innovation. "The development of ISB 2001 holds special significance for us as it is crafted utilizing our cutting-edge BEAT antibody engineering platform, a cornerstone of our pioneering approach to create innovative multispecific treatments for blood cancers and solid tumors."

ISB 2001 – Mechanism of Action

ISB 2001 is the first T cell-engaging antibody that simultaneously targets BCMA and CD38 on MM cells. It is a trispecific antibody based on BEAT (Bispecific Engagement by Antibodies based on the TCR) technology, a proprietary platform allowing maximal flexibility and manufacturability of full length multispecific antibodies. ISB 2001 combines three proprietary antigen-binding arms, each targeting a different antigen, with one arm binding to the epsilon chain of CD3 on T cells, and the other two binding BCMA and CD38 on MM cells. Its fragment crystallizable (Fc) domain was fully silenced to suppress Fc effector functions. ISB 2001 redirects CD3+ T lymphocytes to kill tumor cells expressing low to high levels of both BCMA and CD38. With two different tumor-associated antigens instead of one, ISB 2001 has increased binding specificity to MM cells due to enhanced avidity-based binding.

Other Impactful Preclinical Results

The oral presentation summarized the preclinical characterization of ISB 2001, while focusing on the features that enable ISB 2001 to overcome escape mechanisms.

ISB 2001 showed superior cytotoxicity in comparison with teclistamab, alnuctamab and EM-801 across cell lines with variable expression levels of both BCMA and CD38.
ISB 2001 showed minimal cytotoxicity reduction by soluble factors (sCD38, sBCMA, APRIL) compared to teclistamab, alnuctamab and EM-801, which exhibited cytotoxicity reduction to a much eater degree.
Superior tumor growth inhibition in MM xenograft models relative to teclistamab + daratumumab combination.
Maintained cytotoxicity against MM cell in bone marrow aspirates from two patients relapsing from CD38 or BCMA targeted therapies as well as demonstrated superior cytotoxicity against MM cells over teclistamab in newly diagnosed or r/r patients (as well as smoldering MM and Plasma Cell Leukemia patients).
In relapsed/refractory (r/r) MM patients, who received CD38 targeted therapy, daratumumab cytotoxicity was substantially reduced due to low CD38 expression, while ISB 2001 was still effective.

Teclistamab is considered the next line of treatment in such patients. However, ISB 2001 consistently demonstrated increased cytotoxicity compared to teclistamab in bone marrow aspirates from both newly diagnosed and r/r patients, as well as in two patients with smoldering MM and plasma cell leukemia. Remarkably, ISB 2001 also induced stronger cytotoxic response in one patient relapsing after BCMA targeted therapy, suggesting that the dual targeting by ISB 2001 TCE can overcome the escape mechanisms.

The oral presentation and corresponding data are available for review here. More information about ISB 2001, and the rest of Ichnos’ pipeline can be found here.

On April 8, 2024 Edison Oncology Holding Corp. ("Edison Oncology"), a privately held biopharmaceutical company, reported the presentation of positive interim data from the company’s ongoing multicenter Phase 1/2a clinical trial of Orotecan (oral irinotecan HCL, VAL-413) at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) annual meeting (Press release, Edison Oncology, APR 8, 2024, View Source [SID1234641893]).

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"Intravenous irinotecan is a standard treatment for various pediatric cancers, but current intravenous regimens confine children to hospital infusion centers for 30-50% of their days during treatment, robbing them of their childhood experiences," explained Jeffrey Bacha, CEO of Edison Oncology.

"We’re delighted to share encouraging interim findings from our ongoing clinical trial. These results bolster the promise of Orotecan as an oral alternative to intravenous therapy. By enabling at home treatment, Orotecan holds the potential to significantly enhance quality of life and reduce treatment expenses for both pediatric and adult cancers."

Irinotecan (intravenous, i.v.) is a topoisomerase-I inhibitor approved by the FDA for the treatment of colorectal cancer and used ‘off label’ in the treatment of a several types of cancer including gastric cancers, neuroendocrine and adrenal tumors, pancreatic cancer, small cell lung cancer, cervical cancer, ovarian cancer, esophageal cancer, soft tissue sarcomas and bone cancer. Demonstration of clinical benefit across a range of tumors has made i.v. irinotecan a key component of many standard treatment protocols. However, for recurrent pediatric cancers, patients receiving irinotecan endure daily infusions for five to ten days every two weeks, exacerbating non-adherence to treatment schedules, negatively impacting their quality of life and driving up healthcare costs.

Efforts to develop oral regimens using the intravenous formulation have yielded promising results in terms of tumor response in prior clinical studies. Nonetheless, the poor taste of the intravenous formulation has resulted in reduced patient compliance and limited widespread adoption of oral irinotecan regimens.

Orotecan (oral irinotecan HCL, VAL-413) is a novel, patented, oral liquid formulation of irinotecan hydrochloride designed to deliver the drug orally with improved tolerability.

The current clinical trial is designed to evaluate safety, tolerability and efficacy of Orotecan given with oral temozolomide for treatment of recurrent pediatric solid tumors including but not limited to neuroblastoma, rhabdomyosarcoma, Ewing sarcoma, hepatoblastoma and medulloblastoma.

Patients up to 30 years of age with recurrent pediatric solid tumors may be eligible. During the first cycle of treatment, each patient receives four daily doses of Orotecan and one daily dose of the "off-the-shelf" i.v. preparation of irinotecan taken orally (IRN-IVPO) to allow for pharmacokinetic comparison. During all subsequent cycles patients receive Orotecan once daily in 5-day courses administered every 21 days.

The Company reported the following interim observations from the clinical trial:

The trial is currently enrolling the highest dose (110mg/m2/day) cohort, with no dose-limiting toxicity observed in the lower dose (90mg/m2/day) cohort. The 90mg/m2/day dose matches the dose of unformulated irinotecan i.v. given orally to more than two hundred patients across multiple published investigator-initiated pediatric cancer trials conducted over several years with promising outcome results.

Initial pharmacokinetic observations support equivalency between the Orotecan formulation and unformulated i.v. irinotecan given orally for both the parent compound and active metabolites SN-38 and SN-38 glucuronide.

Preliminary data suggests Orotecan oral formulation is palatable and suitable for protracted out-patient (at home) dosing for adolescent patients representing a potential significant improvement in quality of life and reduced cost of treatment vs. i.v. irinotecan. The longest treatment duration to date is twelve cycles of once-per-day oral dosing at home.
"We are grateful to the investigators, patients and families who have participated in this trial to date. These interim results are highly encouraging," said Mr. Bacha. "With the 90mg/m2/day Orotecan dose aligning with prior successful trials of unformulated i.v. irinotecan given orally coupled with pharmacokinetic equivalence and a palatable formulation suitable for outpatient dosing, we believe Orotecan holds immense potential to enhance the quality of life for patients while reducing treatment costs. These findings mark a significant advancement in our mission to improve outcomes for patients battling cancer."