On July 30, 2024 Tempus AI, Inc. (NASDAQ: TEM), a leader in artificial intelligence and precision medicine, reported an expanded collaboration with Remix Therapeutics, a clinical-stage biotechnology company developing small molecule therapies to modulate RNA processing and address underlying drivers of disease (Press release, Tempus, JUL 30, 2024, View Source [SID1234645188]). The collaboration between Remix and Tempus began with the licensing of specific, de-identified data cohorts and has since expanded into a broader, strategic alliance.

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Remix is leveraging Tempus’ multimodal data to interrogate specific cohorts, including Adenoid Cystic Carcinoma (ACC) and Acute Myeloid Leukemia (AML) with Tempus’ data analytics platform, Lens. The newly expanded scope of work also includes next-generation sequencing support for Remix’s Phase I trial for REM-422, the company’s potent, selective, oral small molecule messenger RNA (mRNA) degrader.

To support its research, Remix is utilizing Tempus’ xT and xR assays to capture DNA and RNA data, as well as tracking treatment response on an exploratory research basis with xM Monitor, the company’s circulating tumor DNA (ctDNA) assay, which detects and monitors changes in circulating tumor fraction to determine response to therapy for patients with advanced cancers.

"We’re excited to work with a biotech like Remix that understands and embraces the value that Tempus’ multimodal data can bring to their important work," said Ryan Fukushima, Chief Operating Officer of Tempus. "We were able to quickly expand our collaboration and provide Remix with an array of our offerings that are uniquely positioned to support them in achieving their research and development goals."

"Tempus’ multimodal data, analytics, and sequencing support will be invaluable tools as we advance our lead candidate, REM-422, into the clinic," said Dominic Reynolds, Ph.D., Chief Scientific Officer of Remix. "This collaboration provides us with robust resources and data to propel our research forward, ultimately advancing our goal of creating meaningful new treatment options for patients."

On July 30, 2024 LTZ Therapeutics, an immunotherapy-focused biotech company, reported the completion of the company’s Series A financing of over $20 million, to advance the development of its Myeloid Engager pipeline to treat cancer and autoimmune diseases (Press release, LTZ Therapeutics, JUL 30, 2024, View Source [SID1234645187]). This round was led by new investor Lapam Capital and includes new investment participation from GL Ventures. In addition, the company has received continued investment from K2 Venture Partners and Shunwei Capital. The closing of this round brings LTZ’s total funding to approximately $50 million since the company was founded in 2022.

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Proceeds from the financing will be used to accelerate development of LTZ’s pipeline, supporting the company’s Investigational New Drug (IND) process, initiating the Phase 1 clinical study of LTZ’s lead asset LTZ-301 as well as the IND-enabling work of its second asset, LTZ-232. The company will also use the new capital to further advance other programs in discovery and to expand its team.

"This round represents an important step forward in the development of our novel Myeloid Engager Platform for cancer and other conditions with unmet medical needs," said Robert Li, Ph.D., Founder and CEO of LTZ. "At the heart of our approach is the fusion of reverse translational science with a deep understanding of tumor microenvironment (TME) biology, especially myeloid biology. We’ve made significant progress this past year, not only validating the company’s platform in various preclinical test systems including cancer patient-derived organoid models, but also advancing our lead asset LTZ-301 from discovery to an IND-enabling stage. We are thankful for the ongoing support of our scientific team, advisory board and our syndicate of investors, making all of our accomplishments possible."

Macrophages appear to be one of the most prevalent immune cell populations in TME of various hematologic and solid tumors. Therefore, effectively engaging and activating macrophages to kill cancer cells represents significant therapeutic potential for patients. Based on reverse translational research to inform new discoveries and the emerging myeloid biology of TME in a broad range of cancer types, LTZ is developing its own novel Myeloid Engager Platform to primarily enhance the phagocytic function of monocytes and macrophages to foster anti-tumor immunity.

"LTZ comprises a highly skilled and passionate team that brings together a unique complement of expertise," said Zhihua Yu, Founding Partner at Lapam Capital. "We are excited about the reverse translational approach LTZ is taking to maximize the drugability of their assets. LTZ’s Myeloid Engager Platform and their pipeline have the potential to greatly impact the future of immunotherapy development, aiming to rebalance the immune system and improve patient outcomes. The preclinical results thus far carry promising clinical benefits and suggest applicability of LTZ’s model for a wide spectrum of cancer indications (liquid and solid) and autoimmune diseases, where the unmet need is incredibly high."

On July 30, 2024 City of Hope, one of the largest and most advanced cancer research and treatment organizations in the United States, and Institute for Follicular Lymphoma Innovation (IFLI) reported a $2 million, three-year collaboration to study spontaneous remission in follicular lymphoma, the most common, slow-growing non-Hodgkin’s lymphoma (Press release, City of Hope, JUL 30, 2024, View Source [SID1234645186]).

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Raju K. Pillai, M.D., City of Hope associate clinical professor, Department of Pathology, and director, Pathology Research Services Core Laboratories, and Steven T. Rosen, M.D., executive vice president and director emeritus of City of Hope’s comprehensive cancer center and its Beckman Research Institute, professor, Department of Hematology & Hematopoietic Cell Transplantation, and Ted Schwartz Family Distinguished Chair in Hematologic Malignancies, will lead the research. The collaboration aims to understand the tumor microenvironment in patients whose follicular lymphoma goes into remission without any treatment while being monitored over time.

City of Hope will analyze patient samples of follicular lymphoma and spontaneous remission of follicular lymphoma with leading-edge technologies, such as spatial proteomics and transcriptomics, as well as machine learning techniques to help explain why spontaneous remission of follicular lymphoma occurs in a rare number of patients and not in others. The study aims to determine the most relevant prognostic genetic, transcriptomic and microenvironmental factors involved in spontaneous remission of follicular lymphoma.

"Spontaneous remission in follicular lymphoma is not understood and we are excited and humbled to collaborate and support City of Hope’s prestigious team to leverage their expertise and suite of technologies and assays to better understand this phenomenon," said Michel Azoulay, M.D., M.B.A., IFLI’s chief medical officer. "IFLI is committed to funding innovative research projects, such as these important studies at City of Hope, to better understand follicular lymphoma and how we can improve treatments and outcomes for follicular lymphoma patients."

"The clinical spectrum of follicular lymphoma, which ranges from spontaneous regression on one end to highly aggressive disease at the other end, is influenced by the immune microenvironment to a large extent," Dr. Pillai said. "With IFLI’s support, we can study follicular lymphoma, leveraging City of Hope’s omics and spatial biology expertise to shed more light on why and how spontaneous remission occurs, with the goal that our discoveries will translate to advances in diagnostics and the next generation of therapies for patients with follicular lymphoma."

"I have shared the joy of my patients who have spontaneously achieved remission, and I have shared the worry, anguish and frustration of my patients whose follicular lymphoma has progressed or transformed," Dr. Rosen added. "I am thrilled to join with Dr. Pillai, IFLI and other collaborators to help answer the question ‘Why certain patients and not all?’"

On July 30, 2024 InnoCare reported that British Journal of Cancer, part of leading science journal Nature, recently published a paper entitled "Zurletrectinib is a next-generation TRK inhibitor with strong intracranial activity against NTRK fusion-positive tumors with on-target resistance to first-generation agents" (Press release, InnoCare Pharma, JUL 30, 2024, View Source [SID1234645185]). The journal concluded that zurletrectinib is a novel, highly potent next-generation TRK inhibitor with higher in vivo brain penetration and stronger intracranial activity than other next-generation agents.

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The paper pointed out that zurletrectinib displayed strong potency against TRKA, TRKB, and TRKC WT kinases, as well as acquired resistance mutations TRKA G595R and TRKA G667C. Zurletrectinib was more active than other FDA approved or clinically tested first generation (larotrectinib) and next-generation (selitrectinib and repotrectinib) TRK inhibitors against most TRK inhibitor resistance mutations. Similarly, zurletrectinib (1 mg/kg BID) inhibited tumor growth in xenograft models derived from NTRK fusion-positive cells at a dose 30 times lower when compared to selitrectinib.

The paper further demonstrated that, in a central nervous system (CNS) penetrant pharmacokinetic study in SD rats, zurletrectinib showed improved ability to penetrate the blood-brain barrier, reaching the brain more effectively than selitrectinib and repotrectinib. Zurletrectinib’s increased brain penetration was also translated into improved antitumor activity. In an orthotopic mouse glioma xenograft model carrying the TRKA G598R/G670A resistance mutation, zurletrectinib (15 mg/kg) significantly improved the survival of mice harboring orthotopic NTRK fusion-positive, TRK-mutant gliomas (median survival = 41.5, 66.5, and 104 days for selitrectinib, repotrectinib, and zurletrectinib respectively; P < 0.05), showing superior efficacy compared to repotrectinib (15 mg/kg) and selitrectinib (30 mg/kg) (P=0.0384 and 0.0022, respectively), with an excellent safety profile.

The corresponding authors of the paper are Dr. Alexander Drilon, Department of Medicine, Memorial Sloan Kettering Cancer Center, New York, NY, USA, and Dr. Emiliano Cocco, Department of Biochemistry and Molecular Biology, University of Miami, Miller School of Medicine, FL, USA. The first author is Paolo Roa, Department of Biochemistry and Molecular Biology, University of Miami, Miller School of Medicine, FL, USA. Full text can be found in View Source

InnoCare is accelerating the registrational trial of zurletrectinib in China. The clinical study with zurletrectinib has covered NTRK fusion adult patients, adolescent patients and pediatric patients. Zurletrectinib has demonstrated good efficacy and safety profile, and overcome acquired resistance to the first generation TRK inhibitors, bringing benefit to patients who failed prior TRKi therapy.

On July 30, 2024 Takeda (TOKYO:4502/NYSE:TAK) reported earnings results for the first quarter of fiscal year 2024 (period ended June 30, 2024), with continued momentum in its Growth & Launch Products driving Core growth at CER and more than offsetting revenue impact resulting from significant losses of exclusivity that occurred in the previous fiscal year (Press release, Takeda, JUL 30, 2024, View Source;Strong-Performance-by-Growth-Launch-Products-Advancements-in-Promising-Late-Stage-Pipeline [SID1234645184]).

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The strong performance of Takeda’s Growth and Launch Product portfolio, which grew 17.8% at CER and represented 46% of total revenue, supports the company’s outlook for a return to sustainable revenue and profit growth in the near term and its ability to deliver life-transforming treatments and vaccines.

In addition, positive Phase 2b data presented in June for TAK-861 in narcolepsy type 1 and for mezagitamab (TAK-079) in immune thrombocytopenia (ITP), a rare immune-mediated bleeding disorder, underscore the promise of Takeda’s late-stage pipeline and the potential for strong revenue growth into the next decade and beyond.

Takeda chief financial officer, Milano Furuta, commented:
"Takeda has delivered a positive first quarter performance, with Growth and Launch Products driving overall revenue growth. Our results reflect strong commercial execution, with new launches, geographic expansion and lifecycle management enabling us to reach more patients and communities around the world.

"First quarter Core Operating Profit benefitted from this strong Growth and Launch Product performance, as well as from phasing of R&D investment, reduction in other OPEX and milder than anticipated VYVANSE generic erosion in the U.S.

"There is no change to our full-year FY2024 outlook announced in May. We expect the impact of generic erosion to accelerate in coming quarters and the phasing of our R&D investment will focus on the second half of the year due to the planned initiation of multiple Phase 3 programs. Foreign exchange has been a tailwind for revenue performance in the first quarter and we see potential upside to our revenue forecast if current foreign exchange rates continue."

FINANCIAL HIGHLIGHTS for FY2024 Q1 Ended June 30, 2024

(Billion yen, except percentages and per share amounts)

FY2024 Q1

FY2023 Q1

vs. PRIOR YEAR

(Actual % change)

Revenue

1,208.0

1,058.6

+14.1%

Operating Profit

166.3

168.6

-1.3%

Net Profit

95.2

89.4

+6.5%

EPS (Yen)

61

58

+5.6%

Operating Cash Flow

170.3

92.4

+84.3%

Adjusted Free Cash
Flow (Non-IFRS)

23.7

-207.5

N/A

Core (Non-IFRS)

(Billion yen, except percentages and per share amounts)

FY2024 Q1

FY2023 Q1

vs. PRIOR YEAR

(Actual % change)

vs. PRIOR YEAR

(CER % change)

Revenue

1,208.0

1,058.6

+14.1%

+2.1%

Operating Profit

382.3

326.3

+17.1%

+4.5%

Margin

31.6%

30.8%

+0.8pp

―

Net Profit

276.8

233.4

+18.6%

+3.9%

EPS (Yen)

176

150

+17.5%

+2.9%

FY2024 Outlook (unchanged from May 2024)

(Billion yen, except percentages and per share amounts)

FY2024
FORECAST

FY2024
MANAGEMENT GUIDANCE
Core Change at CER
(Non-IFRS)

Revenue

4,350.0

―

Core Revenue (Non-IFRS)

4,350.0

Flat to slightly declining

Operating Profit

225.0

―

Core Operating Profit (Non-IFRS)

1,000.0

Approximately 10% decline

Net Profit

58.0

―

EPS (Yen)

37

―

Core EPS (Yen) (Non-IFRS)

431

Mid-10s% decline

Adjusted Free Cash Flow (Non-IFRS)

350.0 – 450.0

Annual Dividend per Share (Yen)

196

Additional Information About Takeda’s FY2024 Q1 Results
For more details about Takeda’s FY2024 Q1 results, commercial progress, pipeline updates and other financial information, including key assumptions in the FY2024 forecast and management guidance as well as definitions of non-IFRS measures, please refer to Takeda’s FY2024 Q1 investor presentation (available at View Source)