On January 23, 2024 InnoCare Pharma (HKEX: 09969; SSE: 688428), a leading biopharmaceutical company focusing on the treatment of cancer and autoimmune diseases, reported that the first pediatric patient has been dosed in clinical trial with its second generation pan-TRK inhibitor zurletrectinib at Sun Yat-sen University Cancer Center (Press release, InnoCare Pharma, JAN 23, 2024, View Source [SID1234639442]). This is the first time that zurletrectinib will be evaluated in a clinical study of pediatric (2 to 12 years old) patients, after demonstrating good safety and efficacy in adult and adolescent patients (12 to 18 years old).

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Zurletrectinib, developed by InnoCare, is a pan-TRK inhibitor which markedly inhibits the activity of the wild type TRKA, TRKB and TRKC, as well as mutant TRKA with resistant mutations G595R or G667C. Zurletrectinib could overcome acquired resistance to the first-generation TRK inhibitors.

InnoCare has been advancing the registrational trial of zurletrectinib in China and is expecting to submit the new drug application in the second half of 2024. An overall response rate (ORR) of 80-90%, indicating favorable efficacy, was observed in adult patients with various cancers carrying NTRK gene fusion who received dosages of 8 mg or more.

Dr. Jasmine, the Co-founder, Chairwoman, and CEO of InnoCare, said, "NTRK gene fusion is a driving factor for various adult and pediatric cancers. It is inspiring that we continue to make positive progress in our clinical research of zurletrectinib for patients of different ages with NTRK gene fusion. We expect to see our innovative assets benefit solid tumor patients in the near future."

In some rare tumor types, such as congenital infantile fibrosarcoma, the incidence of NTRK gene fusion is as high as 90%. NTRK gene fusion is associated with at least 19 tumor types in adults and children, including lung cancer, colorectal cancer, breast cancer, pancreatic cancer and melanoma.

On January 23, 2024 Shuttle Pharmaceuticals Holdings, Inc. (Nasdaq: SHPH), a discovery and development stage specialty pharmaceutical company focused on improving the outcomes of cancer patients treated with radiation therapy (RT), reported that Dr. Anatoly Dritschilo, Chief Executive Officer, will participate in a fireside chat and host one-on-one meetings with investors at the Lytham Partners 2024 Investor Select Conference, taking place virtually on February 1, 2024 (Press release, Shuttle Pharmaceuticals, JAN 23, 2024, https://www.prnewswire.com/news-releases/shuttle-pharma-to-participate-in-a-fireside-chat-at-the-lytham-partners-2024-investor-select-conference-on-february-1-2024-302042226.html [SID1234639441]).

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At the conference, Dr. Dritschilo will discuss details of the Company’s recent FDA approval to proceed with the Phase II clinical trial of Ropidoxuridine for treatment of patients with glioblastoma, as well as other key areas of progress as Shuttle aims to improve the lives of cancer patients by developing therapies that are designed to maximize the effectiveness of RT while limiting the side effects of radiation in cancer treatment.

Company Webcast

The webcasted fireside chat will take place at 1:15pm ET on Thursday, February 1, 2024. The webcast can be accessed at View Source or on the Company’s website at View Source The webcast will also be available for replay following the event.

1×1 Meetings

Management will be participating in virtual one-on-one meetings throughout the event. To arrange a meeting with management, please contact Lytham Partners at 1×[email protected] or register for the event at View Source

Further information on the conference is available at View Source

On January 23, 2024 Medivir AB (Nasdaq Stockholm: MVIR), a pharmaceutical company focused on developing innovative treatments for cancer in areas of high unmet medical need, reported invite to a conference call on the updated data from the ongoing phase 1b/2a study in advanced hepatocellular carcinoma (HCC) (Press release, Medivir, JAN 23, 2024, View Source [SID1234639440]). The data was presented at the ASCO (Free ASCO Whitepaper) (American Society of Clinical Oncology) GI (Gastrointestinal Cancers) Symposium in San Francisco on January 19. The conference call will be held today January 23, at 14.00 CET, to update on the results in the study and the plans moving forward, including feedback from extensive interactions with world renowned experts at the ASCO (Free ASCO Whitepaper) GI congress.

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The data (poster number 476P) from the ongoing fostrox + Lenvima study, presented on Friday January 19 by Dr Maria Reig from Hospital Clinic of Barcelona in Spain, showed that fostrox + Lenvima remains tolerable, with no new, unexpected safety events and that the clinical benefit continues to improve further, as the study progresses and data matures.

– "The updated study results presented at ASCO (Free ASCO Whitepaper) GI has further strengthened our belief in the combination of fostrox + Lenvima as a potential treatment for patients with advanced HCC. The conference also enabled extensive interactions with global experts in HCC which provided important input regarding the design of our upcoming study. Expert guidance is of particular value when preparing for interactions with regulatory authorities to discuss final study design of the planned, registrational phase 2b study with accelerated approval intent," says Dr. Pia Baumann, CMO at Medivir.

Conference call for investors, analysts and the media

Presenters from Medivir: Jens Lindberg, CEO, Pia Baumann, CMO and Fredrik Öberg, CSO.

Time: Tuesday January 23, 2024, at 14.00 CET

To access the webcast and information about the teleconference, please click HERE!

The webcast will also be streamed via a link on the website: www.medivir.com/investors/calendar

The presentation will be available on Medivir’s website after the conference call.

The poster will also be available on Medivir’s website.

For additional information, please contact;
Magnus Christensen, CFO, Medivir AB
Telephone: +46 8 5468 3100
E-mail: [email protected]

About fostrox

Fostrox is a type of smart chemotherapy that delivers the cell-killing compound selectively to the tumor while minimizing the harmful effect on normal cells. This is achieved by coupling an active chemotherapy (troxacitabine) with a prodrug tail. The prodrug design enables fostrox to be administered orally and travel directly to the liver where the active substance is released locally in the liver. With this unique mechanism, fostrox has the potential to become the first liver-targeted, orally administered drug that can help patients with various types of liver cancer. A phase 1b monotherapy study with fostrox has been completed and a phase 1b/2a combination study in HCC is ongoing.

About primary liver cancer

Primary liver cancer is the third leading cause of cancer-related deaths worldwide and hepatocellular carcinoma (HCC) is the most common cancer that arises in the liver. Although existing therapies for advanced HCC can extend the lives of patients, treatment benefits are insufficient and death rates remain high. There are approximately 660,000 patients diagnosed with primary liver cancer per year globally and current five-year survival is less than 20 percent2. HCC is a heterogeneous disease with diverse etiologies, and lacks defining mutations observed in many other cancers. This has contributed to the lack of success of molecularly targeted agents in HCC. The limited overall benefit, taken together with the poor overall prognosis for patients with intermediate and advanced HCC, results in a large unmet medical need.

On January 23, 2024 Accent Therapeutics, a biopharmaceutical company pioneering a new class of small molecule precision cancer therapies, reported the completion of a $75 million Series C financing (Press release, Accent Therapeutics, JAN 23, 2024, View Source [SID1234639439]). The financing was led by Mirae Asset Capital Life Science, with participation from other new investors, Mirae Asset Capital, Mirae Asset Venture Investment, Bristol Myers Squibb and Johnson & Johnson Innovation – JJDC, Inc., as well as all existing investors, including The Column Group, Atlas Venture, Droia Ventures, GV, EcoR1 Capital, AbbVie Ventures, The Mark Foundation for Cancer Research, Timefolio Capital (formerly known as NS Investment) and others. In conjunction with the financing, Naveen Krishnan, MD, MPhil, Managing Director of Mirae Asset Capital Life Science will join the Company’s Board of Directors.

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Proceeds from the financing will be used to support the advancement of both lead programs –Accent’s first-in-class DHX9 inhibitor and a potentially best-in-class KIF18A inhibitor – through early clinical development including safety, pharmacokinetics and early efficacy studies.

"We are delighted to announce the backing of an exceptional investor syndicate who share our commitment to advancing innovative therapies for patients with cancer," said Shakti Narayan, PhD, JD, CEO of Accent Therapeutics. "These additional resources position us well to file INDs this year for both our DHX9 and KIF18A programs, and to rapidly progress them through early clinical development."

Accent is developing therapeutics for both novel and known, but suboptimally-addressed, high-impact oncology targets with the potential to benefit large patient populations. The company’s DHX9 inhibitor seeks to address indications with high unmet need, including BRCA loss of function cancers (breast, ovarian), mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) cancers (colorectal, endometrial, gastric) and additional undisclosed cancer types. Accent’s second lead program, a KIF18A inhibitor, could also potentially benefit a large patient population across several cancer indications with high unmet need, including ovarian cancer and triple negative breast cancer (TNBC).

"Accent’s focus on targeting cancer cell vulnerabilities in a specific and robust way really stood out as we were evaluating companies for our first investment, " remarked Naveen Krishnan, MD, MPhil, of Mirae Asset Capital Life Science. "They have assembled an incredible team with a successful track record of drug development, and we are excited to partner with the other seasoned investors to support Accent at this pivotal time."

About DHX9
Accent’s lead program is a first-in-class DHX9 inhibitor with the potential to address high unmet need indications not adequately served by existing therapies, including tumors with BRCA loss of function (breast, ovarian), mismatch repair deficient (dMMR) or microsatellite instability-high (MSI-H) cancers (colorectal, endometrial, gastric) and additional undisclosed cancer types representing large patient populations. DHX9 is a DNA/RNA helicase that has been reported to play important roles in replication, transcription, translation, RNA splicing, RNA processing, and maintenance of genomic stability. Hence, this enzyme represents a compelling novel oncology target as inhibition of DHX9 exploits key tumor vulnerabilities, resulting in cancer-specific death. Accent is currently conducting IND-enabling studies evaluating its DHX9 inhibitor.

About KIF18A
Accent’s second lead program is a potential best-in-class inhibitor for KIF18A which may address a large patient population across several cancer indications, including ovarian and triple negative breast cancer (TNBC). KIF18A is a mitotic kinesin motor protein critical for cell division in select tumors with chromosomal instability. A subset of tumor cells with an abnormal number of chromosomes (aneuploid) are sensitive to KIF18A and show rapid cell killing in vitro and in vivo upon KIF18A inhibitor treatment, while cells with normal numbers of chromosomes (euploid) are unaffected. Accent is planning to initiate IND-enabling studies for KIF18A in the first half of 2024.

On January 23, 2024 Caris Life Sciences(Caris), the leading next-generation AI TechBio company and precision medicine pioneer that is actively developing and delivering innovative solutions to revolutionize healthcare and improve the human condition using molecular science and AI, reported that the company and collaborators within the Caris Precision Oncology Alliance (POA) will collectively present eight studies across four tumor types at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium, January 25-27, 2024 in San Francisco (Press release, Caris Life Sciences, JAN 23, 2024, View Source [SID1234639438]). The findings demonstrate the continued and expanded capabilities of Caris’ comprehensive multi-modal database to enable novel insights into cancer that could have profound effects on a patient’s diagnosis, prognosis, care plan and response to treatment.

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"These presentations illustrate how our physicians, scientists and collaborators in the POA are leveraging real-world clinical evidence from over 593,000 lifetime clinical cases, including over 482,000 with matched molecular data and outcomes, in Caris’ unique AI-driven platform to deepen our understanding of cancer and to develop the next breakthrough medicines," said Chadi Nabhan, MD, MBA, FACP, Chairman of the Caris Precision Oncology Alliance. "Caris molecular profiling enables deep exploration of the genetic and immune landscapes of cancer, providing insights into which signaling pathways explain the pathobiology of disease and leading to more precise targeted therapy. That’s a major focus of the wide array of research Caris and our POA collaborators will proudly present at this year’s ASCO (Free ASCO Whitepaper) GU."

Oral Abstract:

A Caris study entitled "Differences in genomic, transcriptomic, and immune landscape of prostate cancer (PCa) based on site of metastasis (mets)" will be presented by Dr. Umang Swami from the Huntsman Cancer Institute on Thursday, January 25 at 4:20 p.m. PST during Rapid Oral Abstract Session A on Prostate Cancer in the Level 3 Ballroom. The research is a collaboration with the Huntsman Cancer Institute at the University of Utah and other POA members.

Compared to primary PCa, both visceral (liver and lung) and non-visceral (lymph node and bone) metastases had higher Androgen Receptor (AR) and interferon g signaling, upregulation of the E2F, G2M checkpoints and MYC target pathways, and were significantly less enriched in macrophage M2, NK, and regulatory T cells. Visceral metastases also had higher neuroendocrine (NEPC) scores and were less enriched for B cells and neutrophils. These data on the molecular and immunologic mechanisms of metastatic tropism in advanced PCa may facilitate future drug development.
Additional Presentations Reveal Potential Impact of Comprehensive Molecular Profiling

Caris will present additional data from studies demonstrating the critical role of comprehensive molecular profiling in the treatment of genitourinary cancers. Poster and abstract summaries highlighting this research will be available onsite at Caris’ booth (#8). The full abstracts will be available through Caris’ website beginning on January 23.

Survival outcomes in patients (pts) with prostatic cancer (PCa) based on pathologically confirmed sites of metastasis (January 25; Poster C7, Abstract 72)
Examination of 6,069 PCa specimens in Caris’ CODEai multi-modal database showed that metastasis to the liver was associated with overall survival significantly shorter than metastasis to the lung, arguing against combining them into the single category of visceral metastases as a stratification factor in randomized clinical trials.

Correlation of PIM kinases with tumor immune microenvironment and clinical presentation of metastatic hormone-sensitive prostate cancer
January 25; Poster J19, Abstract 211)
In a study of 44 patients with treatment-naive metastatic hormone-sensitive prostate cancer (mHSPC), there was a strong association of high expression of PIM kinases with increased MAPK activation score, T cell inflamed score, inflammatory, PSA, AR, MHC class I and MHC class II gene expression, and differential immune cell infiltration. However, this did not significantly translate to a worse clinical presentation of mHSPC. A better understanding of these differences with additional research may provide a rationale for tailored therapeutic approaches for PIM-expressing mHSPC.

The influence of the germline HSD3B1 adrenal-permissive variant (c.1100 C) on somatic alteration landscape, transcriptome, and immune-cell infiltration in prostate cancer (January 25; Poster K3, Abstract 215)
In a study of 5,421 prostate cancer biopsies from the Caris Life Sciences database, the homozygous adrenal-permissive HSD3B1 variant (c.1100 CC) was characterized by elevated AR signaling and MAPK activation and a unique immune-cell regulatory landscape, with higher B7-H3 expression, increased intratumoral dendritic cells and decreased immunosuppressive neutrophils, suggesting that B7-H3–targeted therapies might be effective against this class of cancer.

The opposing effects of Class 1B and Class 2 FOXA1 mutations in prostate cancer (January 25; Poster K4, Abstract 216)
Alterations in the FOXA1 transcription factor are present in 16% of prostate cancers (PCa), but different alterations exhibit divergent molecular and clinical profiles. In a study of more than 4,000 primary and metastatic PCa samples, missense mutations in the Wing2 region of FOXA1 (a.a. 248-269) had better response to androgen deprivation therapy (ADT), whereas mutations in a.a. R219, a highly conserved DNA contact residue, were associated with a neuroendocrine phenotype and showed poor survival with ADT.

Canonical Wnt signaling pathway (WSP) alterations in metastatic prostate cancer (January 25; Poster K9, Abstract 221)
In a study of 4,150 total PCa samples, 722 with aberrant canonical Wnt signaling (WSP-act), WSP-act tumors had pronounced upregulation of ROR1 gene expression and augmented levels of M2 macrophages, suggesting that ROR1 may contribute to immune evasion in WSP-act mPCa.

Comprehensive analysis of targetable alterations in urachal cancer by NGS
(January 26; Poster K7, Abstract 663)
In a comprehensive characterization the molecular and immune landscape of urachal cancer (UrC), UrC tumors rarely harbored predictive markers of response to immunotherapy, suggesting limited efficacy in this patient population. However, the recurrence of MAPK alterations and associated pathway activation in UrC warrants further investigation of MAPK-targeted therapies in prospective clinical trials.

IL-6 and PIM1 expression in renal cell carcinoma
(January 27; Poster K11, Abstract 470)
Based on the hypothesis that an IL-6/JAK/STAT pathway regulates the expression of PIM1 in renal cell carcinoma (RCC) as in pancreatic and breast cancer, the transcriptomes of RCC samples in the Caris multi-modal database were analyzed, showing that PIM1 expression was significantly increased in metastatic relative to primary RCC. IL-6 expression was up to 6.5-fold higher in RCC patients with PIM1 overexpression. Outcomes data showed that PIM1 overexpression was associated with decreased overall survival for RCC patients independent of treatment received. Since multiple FDA-approved agents are available that target this pathway, further investigation is warranted to determine the efficacy of these agents in pre-clinical models and clinical trials of RCC.
The POA includes 90 cancer centers, academic institutions, research consortia and healthcare systems, including 42 NCI-designated cancer centers, collaborating to advance precision oncology and biomarker-driven research. 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.