Ono Pharma Korea Co., Ltd.

SAN FRANCISCO, Sept. 4, 2024 /PRNewswire/ -- TippingPoint Biosciences, a therapeutic company focused on innovative drug discovery targeting the aberrant DNA in cancer cells, today announced pre-seed investment from the Pediatric Brain Tumor Foundation, Sontag Foundation, Yuvaan Tiwari Foundation, and BrightEdge, the impact investment and venture capital arm of the American Cancer Society. Continue Reading The investments will support TippingPoint's breakthrough work to target Diffuse Intrinsic Pontine Glioma (DIPG), a rare pediatric brainstem tumor that is untreatable and terminal, usually within months of diagnosis. TippingPoint's novel drug discovery platform is the first to target disease-specific interfaces in DNA packaging networks in cancer cells, also known as chromatin states, without affecting healthy states. Current approaches to address DNA packaging dysfunction target single chromatin factors that have broad functions across both disease and healthy cells, which leads to unwanted toxicities. Because TippingPoint's platform is able to specifically target the unique chromatin interactions in disease, they have successfully applied their technology to target DIPG cancer cells in the laboratory, which cancer researchers regard as a significant breakthrough. TippingPoint Biosciences secures backing from impact investors to find a cure for a rare pediatric brain tumor. Post this "We are committed to accelerating breakthrough treatments for DIPG and other fatal pediatric brain tumors," said Parvati Tiwari, President and Co-Founder of the Yuvaan Tiwari Foundation. "TippingPoint's innovative approach to targeting complex chromatin interactions offers real hope for new therapies. We're proud to back their efforts to transform the future of DIPG treatment." "We are proud to support the work being done by Tipping Point to further the American Cancer Society's mission to end cancer as we know it for everyone, said Alice Pomponio, VP, Innovation & Impact Investing / Managing Director, BrightEdge. It has been a privilege to support their journey from the beginning to where they are today, and we look forward to seeing a DIPG treatment benefit people with cancer in the future." "There will be no cure for DIPG without collaboration, and we're proud to come alongside other investors to back TippingPoint's novel search for new treatment pathways," said Pediatric Brain Tumor Foundation President and CEO Courtney Davies. "We believe their research focus promises to be transformative." The Sontag Innovation Fund, building on the reputation of the Sontag Foundation as one of the largest private funders of brain tumor research in North America, is thrilled with being part of TippingPoint's efforts. "We are excited to help support TippingPoint and their effort to use an innovative screening platform to identify new potential therapeutic options for DIPG and other diseases" said Scott Davis, Managing Director of the Sontag Innovation Fund. TippingPoint Bioscience's founder, Dr. Laura Hsieh, formerly a post-doctoral researcher in Dr. Geeta Narlikar's lab at the University of California San Francisco (UCSF), left the university to launch TippingPoint and accelerate the development of cancer therapeutics. TippingPoint raised its first investments in 2023, from early stage ventures like Mission BioCapital, ACS BrightEdge and SOSV's IndieBio, and won four golden or platinum ticket awards in pitch competitions sponsored by major pharmaceutical companies including ONO Pharma, Astellas, and Abbvie. Dr. Hsieh and the TippingPoint Biosciences team are currently conducting hit-to-lead studies to develop a new class of molecules for DIPG that are highly specific to the disease. They are diligently working to increase the potency and selectivity of their molecules so they can test them in mouse models in the near term with an eye on reaching first-in-human studies for DIPG patients in 4 years. "We are honored to receive these investments to further our drug development efforts for such a devastating disease like DIPG. In order to make significant breakthroughs in complex diseases like DIPG and really make a difference in patient lives, big bets need to be made on paradigm-shifting technologies like ours. The support in capital, expertise and networks with patient advocates and world-class researchers goes a long way for TippingPoint to continue development of much-needed therapeutics for DIPG and other complex diseases," said Dr. Laura Hsieh, CEO and Founder of TippingPoint Biosciences. About TippingPoint Biosciences TippingPoint Biosciences is an early-stage therapeutic company with a novel drug discovery platform to identify first-in-class drugs aimed at treating diseases related to dysfunctional DNA packaging (chromatin). TippingPoint Bio is the first to develop a screening platform to enable direct targeting of the defective chromatin in disease cells without affecting healthy cells. The platform can be applied to multiple disease areas like cancer, neurodegenerative diseases and developmental disorders. For more information, please visit . About the Pediatric Brain Tumor Foundation Since 1991, the Pediatric Brain Tumor Foundation has led the way in funding research into pediatric brain tumors, supporting families affected by this disease, and advocating for policies that help patients, survivors, and their loved ones. Dedicated wholly to addressing this rare disease and guided by the experiences of patients, survivors, their parents, and siblings, the Pediatric Brain Tumor Foundation meets families' needs along every step of their cancer journey. The foundation also funds and advocates for innovative projects that lead to vital discoveries, new clinical trials, and better treatments. About The Sontag Innovation Fund The Sontag Innovation Fund, a wholly-owned venture subsidiary of The Sontag Foundation, one of the largest private funders of brain cancer research in the United States, made the investment. The Sontag Innovation Fund invests in early stage and innovative technologies with the potential to drive cures and improve the quality of life or life expectancy for brain cancer patients. () About the Yuvaan Tiwari Foundation The Yuvaan Tiwari Foundation was established in 2021 by Parvati and Satya Tiwari to honor the legacy of their son Yuvaan (Yuvi). At age two, Yuvi was diagnosed with an aggressive and fatal brain tumor called diffuse midline glioma (DMG). Yuvi fought DMG bravely for seven months. The Yuvaan Tiwari Foundation accelerates high-impact research to find a cure for DMGs and other fatal pediatric brain cancers, while supporting patients and families along their journey. () SOURCE TippingPoint Biosciences

- Completed additional enrollment in Phase 1B dose-expansion cohorts for TP53 mutant (TP53m) Acute Myeloid Leukemia (AML) patients in the first quarter of 2024; updated combination data expected at the European Society of Hematology (EHA) 2024 Annual Meeting in June – - Randomized, controlled Phase 1B dose-expansion cohort in frontline Higher-Risk Myelodysplastic Syndromes (HR-MDS) patients expected to initiate enrollment in the second quarter of 2024 – - Presented preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting, demonstrating the potential therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy – AUSTIN, TX and DURHAM, NC., May 02, 2024 (GLOBE NEWSWIRE) -- Shattuck Labs, Inc. (Shattuck) (Nasdaq: STTK), a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease, today reported financial results for the quarter ended March 31, 2024 and provided recent business highlights. "We were pleased to see rapid enrollment to the expanded TP53m AML cohort in January. We also expect to see similarly rapid enrollment through the remainder of 2024 into the randomized and controlled expansion cohort in frontline HR-MDS patients,” said Taylor Schreiber, M.D., Ph.D., Chief Executive Officer of Shattuck. “We remain excited about the profile of SL-172154 in frontline AML and HR-MDS and are looking forward to sharing additional response and initial survival data in June. In addition to our clinical momentum, we have continued to advance our pre-clinical pipeline to create additional opportunities for growth and value alongside SL-172154. Our collaboration with Ono Pharma on compounds outside of oncology, and our recent oral presentation on a novel small molecule inhibitor of TRIM7 as a potential means to prevent and address acquired resistance to checkpoint inhibitors, are the first two examples of that strategy.” Clinical Milestones Expected in 2024 SL-172154 (SIRPα-Fc-CD40L) Objective response rates and duration of response based on the then-available data from the Phase 1B expansion cohorts of SL-172154 in combination with azacitidine (AZA) in frontline HR-MDS and frontline TP53m AML expected at the EHA 2024 Annual Meeting in June.Randomized, controlled Phase 1B dose-expansion cohort in frontline HR-MDS patients is expected to initiate enrollment in the second quarter of 2024. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-17254 at 3mg/kg in combination with AZA, SL-17254 at 1mg/kg in combination with AZA, or AZA as a monotherapy.Objective response rate and duration of response data based on the then-available data from the Phase 1B clinical trial of SL-172154 in combination with pegylated liposomal doxorubicin (PLD) in Platinum-Resistant Ovarian Cancer (PROC) expected mid-year 2024.Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC expected to complete enrollment in the second quarter of 2024, followed by initial data expected mid-year 2024. First Quarter 2024 Business Highlights and Other Recent DevelopmentsPreclinical Presented preclinical data at the 2024 AACR Annual Meeting: Demonstrated the potential therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy. These data were featured in an oral presentation during the 2024 AACR Annual Meeting. Results build on a recent publication in the journal Cancer Cell, where Shattuck’s preclinical anti-PD1 acquired resistance mouse model helped to elucidate the underlying biology of acquired resistance and identify a novel target, TRIM7. Shattuck expects that these efforts will support expansion of its oncology pipeline alongside lead program, SL-172154. Shattuck and Ono Enter into Collaboration Agreement: On February 13, 2024, Shattuck announced a strategic collaboration and license agreement with Ono Pharmaceutical Co., Ltd. (Ono) in which Shattuck will lead the research and preclinical development of certain compounds selected by Ono from its pipeline of bifunctional fusion proteins to a pair of prespecified targets for potential treatment of autoimmune and inflammatory diseases. Corporate Updates Shattuck Appoints Clay Siegall, Ph.D., and Kate Sasser, Ph.D., to its Board of Directors: On March 4, 2024, Shattuck announced the appointment of Clay Siegall, Ph.D. and Kate Sasser, Ph.D. to its Board of Directors, effective March 1, 2024. Both Dr. Siegall and Dr. Sasser are highly successful executives and scientific pioneers who bring valuable industry experience to Shattuck. First Quarter 2024 Financial Results Cash and Cash Equivalents and Investments: As of March 31, 2024, cash and cash equivalents and investments were $114.6 million, as compared to $135.5 million as of March 31, 2023.Research and Development (R&D) Expenses: R&D expenses were $16.3 million for the quarter ended March 31, 2024, as compared to $16.7 million for the quarter ended March 31, 2023.General and Administrative (G&A) Expenses: G&A expenses were $4.9 million for the quarter ended March 31, 2024, as compared to $5.1 million for the quarter ended March 31, 2023.Net Loss: Net loss was $18.5 million for the quarter ended March 31, 2024, or $0.37 per basic and diluted share, as compared to a net loss of $20.7 million for the quarter ended March 31, 2023, or $0.49 per basic and diluted share. Financial Guidance Shattuck believes its cash and cash equivalents and investments will be sufficient to fund its operations into 2026, beyond results from its Phase 1 clinical trials of SL-172154. This cash runway guidance is based on the Company’s current operational plans and excludes any additional capital that may be received, proceeds from business development transactions, and/or additional costs associated with clinical development activities that may be undertaken. About SL-172154 SL-172154 (SIRPα-Fc-CD40L) is an investigational ARC® fusion protein designed to simultaneously inhibit the CD47/SIRPα checkpoint interaction and activate the CD40 costimulatory receptor to bolster an anti-tumor immune response in patients with advanced cancer. Multiple Phase 1 clinical trials are ongoing for patients with PROC and patients with AML and HR-MDS: Ongoing Phase 1A/B Clinical Trial of SL-172154 in Frontline HR-MDS and Frontline TP53m AML Patients: This trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 in combination with AZA in both frontline HR-MDS patients and frontline TP53m AML patients. A randomized cohort in frontline HR-MDS patients is expected to initiate enrollment in the second quarter of 2024. Approximately 60 patients will be randomized in a 1:1:1 ratio to receive SL-172154 at 3mg/kg in combination with AZA, SL-172154 at 1mg/kg in combination with AZA, or AZA as a monotherapy.Ongoing Phase 1B Clinical Trial of SL-172154 in Combination with PLD in PROC Patients: This trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 at 3.0 mg/kg in combination with PLD in patients with PROC. The initial data from this Phase 1B clinical trial in PROC patients was presented in November 2023. Initial data suggest that SL-172154 improved the response rate relative to what would be expected from PLD alone, and SL-172154 had an acceptable safety profile in combination with PLD. Objective response rate and duration of response based on the then-available data from the Phase 1B clinical trial of SL-172154 in combination with PLD in PROC are expected mid-year 2024.Ongoing Phase 1B Clinical Trial of SL-172154 in Combination with Mirvetuximab Soravtansine in PROC Patients: This trial is evaluating the safety, pharmacokinetics, pharmacodynamic effects, and preliminary anti-tumor activity of SL-172154 administered in combination with mirvetuximab soravtansine in patients with PROC. Mirvetuximab soravtansine is an antibody-drug conjugate targeting folate receptor alpha (FRα), which provides for both direct tumor cell killing as well as enhanced macrophage phagocytosis through binding with Fc gamma receptors and has received accelerated approval in the United States for PROC patients whose tumors are shown to be FRα positive, defined as ≥75%, as determined by the VENTANA FOLR1 (FOLR1-2.1) Assay. Enrollment completion for the Phase 1B clinical trial of SL-172154 in combination with mirvetuximab soravtansine in PROC is expected in the second quarter of 2024, followed by initial data expected mid-year 2024. About Shattuck Labs, Inc. Shattuck Labs, Inc. (Nasdaq: STTK) is a clinical-stage biotechnology company pioneering the development of bi-functional fusion proteins as a new class of biologic medicine for the treatment of patients with cancer and autoimmune disease. Compounds derived from Shattuck’s proprietary Agonist Redirected Checkpoint, (ARC®), platform are designed to simultaneously inhibit checkpoint molecules and activate costimulatory molecules with a single therapeutic. The company’s lead SL-172154 (SIRPα-Fc-CD40L) program, which is designed to block the CD47 immune checkpoint and simultaneously agonize the CD40 pathway, is being evaluated in multiple Phase 1 trials. Shattuck has offices in both Austin, Texas and Durham, North Carolina. For more information, please visit: www.ShattuckLabs.com. Forward-Looking Statements Certain statements in this press release may constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, our expectations regarding: plans for our preclinical studies, clinical trials and research and development programs; plans for expansion of clinical trials; the anticipated timing of the results from our clinical trials; the anticipated timing and pace of enrollment in our clinical trials; the clinical benefit, safety and tolerability of SL-172154; the potential therapeutic utility of TRIM7 inhibition to prevent or reverse acquired resistance to immune checkpoint therapy; and expectations regarding the time period over which our capital resources will be sufficient to fund our anticipated operations. Words such as “may,” “might,” “will,” “objective,” “intend,” “should,” “could,” “can,” “would,” “expect,” “believe,” “design,” “estimate,” “predict,” “potential,” “develop,” “plan” or the negative of these terms, and similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While we believe these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward-looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties (including, without limitation, those set forth in our filings with the U.S. Securities and Exchange Commission (SEC)), many of which are beyond our control and subject to change. Actual results could be materially different. Risks and uncertainties include: global macroeconomic conditions and related volatility, expectations regarding the initiation, progress, and expected results of our preclinical studies, clinical trials and research and development programs; expectations regarding the timing, completion and outcome of our clinical trials; the unpredictable relationship between preclinical study results and clinical study results; the timing or likelihood of regulatory filings and approvals; liquidity and capital resources; and other risks and uncertainties identified in our Annual Report on Form 10-K for the year ended December 31, 2023, and subsequent disclosure documents filed with the SEC. We claim the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. We expressly disclaim any obligation to update or alter any statements whether as a result of new information, future events or otherwise, except as required by law. The Company intends to use the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD. Investor & Media Contact: Conor RichardsonVice President of Investor RelationsShattuck Labs, Inc.InvestorRelations@shattucklabs.com SHATTUCK LABS, INC. CONDENSED BALANCE SHEETS (In thousands) March 31, 2024December 31,2023 (unaudited)Assets Current assets: Cash and cash equivalents $76,005 $125,626 Investments 38,628 4,999 Prepaid expenses and other current assets 16,443 12,595 Total current assets 131,076 143,220 Property and equipment, net 12,830 13,804 Other assets 2,429 2,540 Total assets $146,335 $159,564 Liabilities and Stockholders’ Equity Current liabilities: Accounts payable $2,154 $1,587 Accrued expenses and other current liabilities 7,569 9,523 Deferred revenue 4,606 343 Total current liabilities 14,329 11,453 Non-current operating lease liabilities 3,193 3,406 Total liabilities 17,522 14,859 Stockholders’ equity: Common stock 5 5 Additional paid-in capital 453,636 451,006 Accumulated other comprehensive (loss) income (14) 4 Accumulated deficit (324,814) (306,310)Total stockholders’ equity 128,813 144,705 Total liabilities and stockholders’ equity $146,335 $159,564 SHATTUCK LABS, INC. CONDENSED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS (Unaudited) (In thousands, except share and per share amounts) Three Months Ended March 31, 2024 2023 Collaboration revenue$1,115 $57 Operating expenses: Research and development 16,264 16,667 General and administrative 4,895 5,051 Expense from operations 21,159 21,718 Loss from operations (20,044) (21,661) Other income 1,540 937 Net loss$(18,504) $(20,724)Unrealized (loss) gain on investments (18) 538 Comprehensive loss$(18,522) $(20,724) Net loss per share – basic and diluted$(0.37) $(0.49)Weighted-average shares outstanding – basic and diluted 50,566,394 42,439,204

The FDA's approval for Takeda's Eohilia, more national security accusations against WuXi AppTec and the closure of LianBio made our news this week. Takeda won FDA approval for Eohilia after a rejection in 2021. A group of U.S. lawmakers are seeking federal sanctions against WuXi AppTec and WuXi Biologics. LianBio, a prominent player in bringing foreign meds to China, will wind down. Plus more. 1. In stunning reversal, Takeda snags FDA approval for once-snubbed Eohilia after 'significant grassroots support' Takeda has surprisingly won the FDA’s backing for Eohilia, an oral suspension formulation of budesonide, for eosinophilic esophagitis (EoE). The Japanese pharma had previously abandoned the drug after an FDA rejection in late 2021. But the company refiled last fall after receiving “significant grassroots support” from the gastrointestinal and EoE communities, according to Takeda’s R&D chief Andy Plump, M.D., Ph.D. 2. Lawmakers urge White House officials to enforce sanctions on China's WuXi AppTec, WuXi Biologics: Reuters WuXi AppTec and WuXi Biologics appeared to be in deeper trouble amid unrelenting geopolitical tension between the U.S. and China. A group of bipartisan lawmakers are asking the U.S. federal government to sanction the two Chinese firms out of national security concerns, Reuters reported. The companies have previously refuted claims that they pose a national security threat. 3. LianBio lays off half of workforce as biotech begins to wind down LianBio, a company built on the business model of in-licensing novel drugs for the Chinese market, will shut down. The decision followed a four-month strategic review that found no alternative to the firm’s future. The company expects to delist from the Nasdaq around March 18. It'll return $528 million in cash to shareholders, and completely dissolve around 2027. 4. Japan's Ono Pharma taps Texas startup Shattuck for $227M bifunctional fusion protein deal Ono Pharmaceutical has penned a deal to tap into Shattuck Labs’ bifunctional fusion protein capabilities. For an undisclosed upfront payment and up to $227 million in milestones, Ono will select two targets in autoimmune and inflammatory diseases. The company will have an exclusive option to develop and commercialize multiple products. 5. Takeda powers toward pivotal trials after phase 2b narcolepsy win but pauses multi-indication dream Takeda’s narcolepsy candidate TAK-861 delivered a partial success in a phase 2b program. The oral orexin receptor 2 agonist showed promise in narcolepsy type 1 but didn’t move the needle in type 2 disease, which is a rarer, normally milder form. The company now plans to start phase 3 testing this year in the type 1 group. 6. VBI Vaccines sells hepatitis B vaccine candidate, manufacturing digs to partner Brii Biosciences for up to $33M China’s Brii Biosciences has decided to fully acquire a hepatitis B vaccine candidate, VBI-2601, from its partner VBI Vaccines. The move gives VBI $33 million and eliminates some $437 million in future milestone payments and additional royalties that Brii agreed to pay VBI under certain circumstances. Brii also gets manufacturing capabilities and certain rights to a VBI glioblastoma candidate. Other News of Note: 7. Samsung scores FDA de novo nod for sleep apnea feature on Galaxy smartwatches 8. Fool me thrice: FDA blasts Chinese API maker for 'misleading' investigators, making up testing records 9. Piramal API plant in Michigan hit with FDA Form 483 write-up