On November 9, 2021 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 with three ongoing Phase 1 clinical trials, reported financial results for the third quarter ended September 30, 2021, and provided recent business highlights (Press release, Shattuck Labs, NOV 9, 2021, View Source [SID1234594797]).

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"We designed the ARC platform to simultaneously block immune checkpoint targets and activate immune costimulatory receptors in the TNF superfamily. The clinical data presented this week at SITC (Free SITC Whitepaper) demonstrate evidence of anti-tumor activity, target receptor binding, and dose-dependent immune activation specific to each of CD40 and OX40," said Taylor Schreiber, M.D., Ph.D., and Chief Executive Officer of Shattuck. "Both compounds have been well tolerated and are demonstrating predictable dose-response relationships in humans. The doses we have explored to date remain below the recommended Phase 2 doses of benchmark CD47 inhibitors and PD-L1 inhibitors, and we look forward to continuing dose escalation of both SL-172154 and SL-279252 into dose levels that we believe will maximize the pharmacodynamic activity and anti-tumor activity of each compound."

"We are very encouraged by the initial data from the Phase 1 trial of SL-172154. The data show an excellent safety profile, high CD47 receptor occupancy and clear evidence of CD40 engagement, which collectively differentiate SL-172154 from other CD47 inhibitors," said Nehal Lakhani, M.D., Ph.D., South Texas Accelerated Research Therapeutics (START) Midwest, Grand Rapids, MI. "We desperately need new therapies for late-stage ovarian cancer patients, particularly in the platinum resistant setting. The combined actions of CD47 inhibition and CD40 activation provided by SL-172154 represents a strategy that has not yet been examined in this disease and may initiate anti-tumor immune responses that could provide lasting benefits in late-stage ovarian cancer."

"SL-172154 is emerging as a highly differentiated CD47 inhibitor. The clinical data indicate that this compound can safely engage CD40 in a manner that has evaded other CD40-targeted biologics for over twenty years. At the same time, we can compare and contrast the relative potency of CD40 versus OX40 activation, and the clinical data indicate that CD40 targeting provides substantially more immunologic activity than OX40 activation. There are some parallels to these observations in the checkpoint space, where blockade of targets like LAG3, TIM3, and TIGIT has been far more subtle than blockade of CTLA-4 or PD-1," continued Dr. Schreiber. "The current data suggests that we may be coming close to a recommended Phase 2 dose selection for SL-172154 as monotherapy. We are excited to transition to the combination with liposomal doxorubicin in ovarian cancer, and with azacitidine and venetoclax in AML, and azacitidine in higher-risk MDS and TP53 mutant AML. More importantly, these data help to establish the ARC platform more broadly as a novel class of biologic medicine, which opens opportunities for the rest of our vast pipeline of candidates developed internally at Shattuck."

Third Quarter 2021 Recent Business Highlights and Other Recent Developments

Agonist Redirected Checkpoint (ARC) Platform Clinical-Stage Pipeline

Initial Data from Ongoing SL-172154 (SIRPα-Fc-CD40L) Phase 1 Dose-Escalation Clinical Trial in Platinum Resistant Ovarian Cancer Demonstrate Favorable Safety Profile and High Target Occupancy at the 36th Annual SITC (Free SITC Whitepaper) Meeting: The Phase 1 trial is an open-label, multi-center, dose-escalation study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154 administered intravenously in patients with platinum resistant ovarian cancer. Shattuck will continue dose escalation to 10mg/kg.

Data reported at SITC (Free SITC Whitepaper) was in 14 evaluable patients as of July 6, 2021, across four dose levels on two schedules: schedule 1 (day 1, 8, 15, 29, then every two weeks) at 0.1, 0.3 mg/kg and schedule 2 (weekly) at 0.3, 1.0, 3.0 mg/kg. To date, no dose limiting toxicities have been observed.
Preliminary pharmacodynamic parameters for SL-172154 demonstrate on-target, CD40-mediated immune activation. The binding of SL-172154 to CD40+ B cells and monocytes led to rapid activation and margination of these cells post infusion.
High target occupancy was observed on CD47+ leukocytes at the doses studied, with preferential binding to leukocytes as compared to red blood cells.
Cyclical increases in certain innate and adaptive serum cytokines were consistent with CD40 receptor engagement and activation following dosing. There were no notable increases in IL-6 or TNFα, or evidence of bell-shaped dose responses.
SL-172154 has been well tolerated at doses which achieve near-complete target occupancy for both CD40 and CD47, with evidence of on-target pharmacodynamic activity which has not yet plateaued, warranting further dose escalation.
Combination Study of SL-172154 with Liposomal Doxorubicin Expected to Begin First Half of 2022: A Phase 1B clinical trial of SL-172154 in combination with liposomal doxorubicin to evaluate safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamics is planned to begin enrolling in the first half of 2022. Shattuck continues to evaluate additional combination agents for SL-172154 for the treatment of patients with ovarian cancer.
Open IND for SL-172154 in AML and HR-MDS: Shattuck submitted an investigational new drug application to the U.S. Food and Drug Administration for a Phase 1A/B clinical trial for SL-172154 in patients with acute myeloid leukemia, or AML and, higher-risk myelodysplastic syndromes, or HR-MDS, in September. The IND is now open, and the trial will evaluate safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, as both monotherapy and in combination. In AML, Shattuck plans to evaluate SL-172154 in combination with both azacitidine and venetoclax. In both HR-MDS and TP53 mutant AML, Shattuck plans to evaluate SL-172154 in combination with azacitidine. Initial data from the trial are expected in the second half of 2022.
Continued Enrollment of SL-172154 Phase 1 Clinical Trial in Squamous Cell Carcinoma of the Head and Neck or Skin: Shattuck continues to enroll patients in a Phase 1 clinical trial for SL-172154, in patients with squamous cell carcinoma of the head and neck or skin. The Phase 1 trial is evaluating the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-172154, administered intratumorally as monotherapy. Initial dose-escalation data from the trial are expected in the first half of 2022.
Initial Data from Ongoing SL-279252 (PD1-Fc-OX40L) Phase 1 Dose-Escalation Clinical Trial in Advanced Solid Tumors Demonstrate Evidence of Anti-Tumor Activity at the 36th Annual SITC (Free SITC Whitepaper) Meeting: The ongoing Phase 1 trial is an open-label, multi-center, dose-escalation, and dose-expansion study to evaluate the safety, tolerability, pharmacokinetics, anti-tumor activity, and pharmacodynamic effects of SL-279252 as monotherapy in patients with advanced solid tumors. Today, Shattuck reported continued enrollment at the next dose level, 12 mg/kg.

Data reported at SITC (Free SITC Whitepaper) as of June 11, 2021, was in 43 patients, dosed intravenously, with 30 patients treated on schedule 1 (day 1, 8, 15, 29, then every 2 weeks) from dose level 0.0001-6 mg/kg, and 13 patients treated on schedule 2 (weekly) from dose level 0.3-3 mg/kg. SL-279252 was well-tolerated in heavily pretreated subjects with refractory solid tumors with no maximum tolerated dose reached. A total of 16 patients were treated at doses of 1 mg/kg or higher on schedule 1.
Best response was one confirmed partial response (iPR) (ocular melanoma, four prior systemic regimens, including PD-1 and CTLA-4 inhibitors) in a patient who remained on treatment for more than one year, and stable disease (iSD) in 12 patients (including 1 unconfirmed iPR). iSD for > 24 weeks occurred in 5/12 patients.
58% of patients had received PD-1/L1 therapy, and of available tumor biopsies most tumors lacked PD-L1 expression as measured by TPS.
SL-279252 exhibited high OX40 target engagement and OX40-dependent PD effects.
Shattuck is currently enrolling patients with known PD-L1 positive tumors at dose levels of 12 mg/kg, to fully characterize PK, PD, and anti-tumor activity.
Corporate Updates

Shattuck and Takeda Mutually Agree to Termination of Collaboration Agreement: In November 2021, Shattuck and Takeda mutually agreed to termination of the Collaboration Agreement for SL-279252 and SL-115154, originally executed in 2017. Shattuck is no longer required to satisfy any remaining performance obligations, the Company will not make any payments to or receive any future milestone or royalty payments from Takeda, and all options to license and rights of first negotiation held by Takeda under the Collaboration Agreement were terminated.
Changes to Shattuck’s Board: In October 2021, Shattuck announced changes to its board of directors.

Dr. Carrie Brownstein was appointed to the board and serves as a member of the Nominating and Corporate Governance Committee. Dr. Brownstein brings over 15 years of clinical research and development experience having held clinical leadership roles at Roche, Regeneron, Celgene and Cellectis and as a practicing pediatric hematologist oncologist.
Dr. George Golumbeski was appointed chairman of the Board. Dr. Golumbeski has served on Shattuck’s Board as an independent director since 2018. Dr. Golumbeski replaces Josiah Hornblower as chairman of the board. Mr. Hornblower resigned from the board in October 2021.
Third Quarter 2021 Financial Results

Cash Position: As of September 30, 2021, cash and cash equivalents and short-term investments were $290.2 million, as compared to $335.4 million as of December 31, 2020.
Research and Development (R&D) Expenses: R&D expenses for the third quarter ended September 30, 2021, were $15.1 million, as compared to $11.8 million for the third quarter ended September 30, 2020. The increase was primarily driven by increases in clinical development, personnel-related costs, and laboratory capabilities.
General and Administrative (G&A) Expenses: G&A expenses for the third quarter ended September 30, 2021, were $4.3 million, as compared to $2.5 million for the third quarter ended September 30, 2020. The increase was primarily driven by an increase in personnel related costs to support the operational expansion and costs associated with being a public company.
Net Loss: Net loss was $17.4 million for the third quarter ended September 30, 2021, or $0.41 per basic and diluted share, as compared to a net loss of $11.8 million for the third quarter ended September 30, 2020, or $1.54 per basic and diluted share.
2021 Financial Guidance

Shattuck believes its cash and cash equivalents and short-term investments will be sufficient to fund its operations into the second half of 2024, which is beyond results from its Phase 1 clinical trials of SL-172154 and SL-279252. The reduction in cash runway guidance from our last issued guidance is primarily attributable to increased clinical activities for SL-172154 and ongoing process development and manufacturing to support our ongoing and future clinical trials, including the development of a manufacturing process suitable for registrational trials. This cash runway guidance is based on the Company’s current operational plans and excludes any additional funding that may be received or business development or additional 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 cancers. Two Phase 1 clinical trials are ongoing, the first for patients with advanced and platinum resistant ovarian cancer (NCT04406623) and the second for patients with advanced squamous cell carcinoma of the head, neck or skin (NCT04502888).

About SL-279252

SL-279252 (PD1-Fc-OX40L) is an investigational ARC fusion protein designed to simultaneously inhibit the PD-1/PD-L1 checkpoint interaction and activate the OX40 costimulatory receptor to bolster an anti-tumor immune response receptor in patients with advanced solid tumors. A Phase 1 trial in patients with solid tumors and lymphoma is ongoing (NCT03894618).

On November 8, 2021 Xspray Pharma AB (publ) (Nasdaq Stockholm: XSPRAY) reported that the board of directors has resolved on a directed new share issue of 1,612,904 shares at a price of SEK 62 per share, corresponding to in total approximately SEK 100 million (Press release, Xspray, NOV 8, 2021, View Source [SID1234649574]).

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The board of directors of Xspray Pharma has, based on the authorisation granted by the annual general meeting on 20 May 2021, resolved on a directed new share issue of 1,612,904 shares. The subscription price in the directed new share issue is set to SEK 62 per share, which has been determined based on the volume-weighted average share price of Xspray Pharma’s share on Nasdaq Stockholm during the five-day period ending on 5 November 2021. The company receives approximately SEK 100 million through the directed new share issue.

The shares have been subscribed by Flerie Invest, a Swedish investment company in biotechnology and pharmaceuticals, founded by Thomas Eldered. As Xspray Pharma has chosen to increase its focus on the improved version of dasatinib, Dasynoc , the proceeds from the share issue will mainly be used to strengthen the development of the company’s presence in the US, primarily with the strategic marketing resources needed for the market launch of Dasynoc. Resources will also be invested in accelerating the development of the fast-growing portfolio.

"Xspray Pharma has a very promising and growing product portfolio where Dasynoc is now facing the application for market approval at the same time as HyNap-Nilo will undergo studies and registration-based studies. Several products in the early phase will also reach the clinical development stage within the next year. It is of course very gratifying that Flerie Invest, in this important phase for Xspray Pharma, chooses to invest in the company. Flerie Invest is a specialized and long-term investor whose management has a deep and broad competence and experience in commercial pharmaceutical production. They also have a very strong network of contacts in the global pharmaceutical industry. Flerie Invest will be a very valuable addition to Xspray Pharma’s shareholder base", says Per Andersson, CEO of Xspray Pharma.

"We have been following Xspray Pharma for a long time and are impressed with the potential in the company’s unique technology. The recently decided focus on improved PKIs, and not pure generics, makes the company even more interesting. The improved drugs have the potential to provide fewer side effects and better effects and thus constitute essential therapies for affected patients. We therefore look forward to being involved in the company’s continued development", comments Thomas Eldered, founder and board member of Flerie Invest.

The board of directors has resolved on the issue by utilizing the authorisation granted by the annual general meeting and the reason for the deviation from the shareholders’ preferential rights is that the board of directors considers that the investment from Flerie Invest is for Xspray Pharma, and thus for its shareholders, the most advantageous way to raise capital in a time and cost-efficient manner and in the meanwhile onboarding a reputable, specialized and a long-term investor.

In its deliberations, the board of directors has further taken into account that there are no time- and cost-effective ways to successfully carry out a rights issue on terms favorable to the company, that the subscription price negotiated with Flerie Invest at arm’s length is not discounted but has been based on the volume-weighted average price of Xspray Pharma’s share during the five-day period ending on 5 November 2021, the last trading day before the issue resolution, and that Flerie Invest is not previously a shareholder in Xspray Pharma. The board of directors’ overall assessment is thus that there are good reasons to deviate from the preferential rights and carry out a directed new share issue.

Flerie Invest has, in connection with the share issue, agreed not to sell any shares in Xspray Pharma during a lock-up period of 360 days, subject to customary exceptions. In connection with the share issue, Xspray Pharma has agreed to a lock-up undertaking, with customary exceptions, on future share issuances for a period of 90 days.

Through the directed new share issue, the total number of shares and votes will increase by 1,612,904, from 19,067,504 to 20,680,408, which corresponds to a dilution of approximately 7.8 percent based on the total number of shares and votes in Xspray Pharma after the directed new share issue. The share capital increases with SEK 1,612,904, from SEK 19,067,504 to SEK 20,680,408.

Xspray Pharma has, in connection with the directed new share issue, appointed Advokatfirman Vinge as legal advisor.

On November 8, 2021 Kronos Bio, Inc, a company dedicated to transforming the lives of those affected by cancer, and Tempus, a leader in artificial intelligence and precision medicine, reported a multi-year collaboration that provides Kronos Bio with access to Tempus’ real-world genomic and transcriptomic data and data analytics tools (Press release, Kronos Bio, NOV 8, 2021, View Source [SID1234643240]).

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Under the agreement, Kronos Bio will have access to a number of precision medicine tools, including Tempus’ modeling lab, which houses a growing repository of molecularly profiled organoids. Access to such data and tools will help Kronos Bio accelerate the preclinical and clinical development of its current and future portfolio, by for example, using organoid models to generate biomarker hypotheses that can be tested in the clinic or in virtual molecularly defined patient cohorts drawn from Tempus’ extensive data sets.

The collaboration builds on an earlier agreement announced in February under which Tempus is performing molecular characterization of tumor samples from patients enrolled in Kronos Bio’s Phase 1/2 clinical study of the company’s CDK9 inhibitor KB-0742. Tempus will retrospectively sequence and analyze these patient samples to assess the relationship between MYC copy number, MYC expression levels and clinical response. Tempus will also explore a path to developing a companion diagnostic.

The expanded relationship leverages Kronos Bio’s deep expertise in transcriptional regulation and Tempus’ next-generation-sequencing capabilities, as well as drawing on each company’s computational biology capabilities. Kronos Bio also has the option to join Tempus’ TIME Trial Network, which supports rapid patient identification, site activation and enrollment of select clinical trials.

"With a shared commitment to improving patient outcomes, we are building upon our existing work with Kronos Bio to advance the company’s portfolio of clinical programs, including lanraplenib and KB-0742," said Marc Yoskowitz, executive vice president and chief strategy officer for Life Sciences at Tempus. "We look forward to harnessing the strength of our entire platform to support the discovery and development of novel cancer therapeutics."

The capabilities provided under the expanded agreement offer Kronos Bio the opportunity to access real-world data to further refine current understanding of transcription regulatory networks (TRNs), which could help accelerate clinical development.

"This partnership will bring together Kronos Bio’s knowledge and experience with transcriptional regulatory networks and Tempus’ sequencing expertise and exceptional data analytics tools and organoid models," said Jorge DiMartino, M.D., Ph.D., chief medical officer and executive vice president, Clinical Development at Kronos Bio. "We are looking forward to working together now and in the future, as we continue to progress our current clinical candidates, test rational combinations, and bring forward new ones, with the goal of getting medicines to patients as quickly as possible."

On November 8, 2021 Leadingtac Bio, a company in Zhangjiang Science City announced the completion of a Pre-A round of financing led by Yuan Sheng Venture Capital, with additional investment from long-time shareholder ZJ LEADING VC (Press release, Leadingtac Pharmaceutical, NOV 8, 2021, View Source [SID1234640717]). This funding round will be used primarily to advance the company’s first Protein Degrader pipeline for autoimmune disease treatment to the clinical research stage and to develop follow-on programs and pipelines, including oncology and other autoimmune diseases. With the previous angel round, Leadingtac has raised nearly 100 million RMB in cumulative early-stage financing.

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Leadingtac Bio was founded by Dr. Yan Feng in September 2019 in Zhangjiang Science Park. The company’s R&D direction is dedicated to the development of target protein degradation drugs and focuses on disease areas such as autoimmunity and oncology to address unmet clinical needs.

The target protein degradation drug is a bifunctional small molecule compound, a ligand that binds the target protein at one end and E3 ubiquitin ligase at the other. A Linker connects the ligands to form a complex that draws the target protein closer to the E3 ligase and promotes the ubiquitination of the target protein, which is then degraded through the ubiquitin-proteasome pathway to remove the disease-causing target protein. Targeted protein degradation drugs are characterized by high drug-forming ability, overcoming drug resistance, small dosage, low toxicity, and drug resistance. Therefore, this research direction has received close attention from domestic and international pharmaceutical companies and capital markets.

Since its inception, the company has taken the mission of "leading innovation, Thailand’s people", based on the source of innovation in new drug development, looking for new targets, using protein degradation technology to develop new small molecule drugs that are currently not drug-ready targets, to provide maximum therapeutic value for patients. As a result, we have developed a series of lead compounds with fully independent intellectual property rights based on our Nano-SPUD platform for specific protein ubiquitination and degradation drug discovery. The company’s fastest progressing project is the LT001 project for autoimmune diseases. The project has obtained expected results from a series of in vitro and in vivo experiments, such as degradation activity, pharmacokinetics, and efficacy, and has already carried out IND-enabling studies, which are expected to be submitted to IND at the end of 2022 and enter clinical trials in 2023. In addition, Leadingtac is also actively developing several pipeline projects.

Dr. Yan Feng, the founder of Leadingtac Bio, said, "As a significant direction for future drug development, the development of targeted protein degradation drugs (Protein Degrader) has received much attention from academia, the pharmaceutical industry, and the capital market in the past few years. As a newcomer in this field, Leadingtac has developed its R&D technology platform and pipeline within two years of its efforts. One of the pipelines will enter the clinical filing stage soon. In this financing round, Leadingtac was honored to receive the approval and lead investment from Yuan Sheng Venture Capital, and ZJ LEADING VC also decided to continue to invest. We are very grateful to our new and old investors for their recognition and support. This financing round will help to rapidly advance the clinical filing of Leadingtac’s first pipeline and also provide a strong guarantee for developing several subsequent projects, high-end talent team building, and site expansion. I believe that with the help of our investors and the efforts of the team at Leadingtac, we will be able to maximize our potential for new drug development and make greater contributions to the pharmaceutical field!"

Jay Chen, Founding Partner of Yuan Sheng Ventures, said, "We are pleased to invest in Leadingtac as the lead investor in this round. As a newcomer in the field of Protein Degrader, Leadingtac Bio has established a more mature technology platform, the first product has also started the filing of IND, and the subsequent product pipeline is various and has great potential for development. As a result, we believe Leadingtac Bio will have great international competitiveness in the future."

Yu Xiaoyong, the founding managing partner of ZJ LEADING VC, said, "We congratulate Leadingtac on the completion of this financing round. As the round angel investor of Leadingtac, we had the honor to work with Dr. Yan Feng two years ago to help Leadingtac plow through the new drug development track of protein degradation. Over the past two years, we have witnessed the continuous growth of Leadingtac’s team and the company together and have gained a deep understanding of the company’s continuous innovation powerhouse, which is why we have sufficient confidence in Leadingtac’s future development, and that is why we continue to invest in this round. We believe that after this round of financing, Leadingtac Bio will continue to achieve good results in the advancement of clinical filing projects, the layout of pipeline projects, and the reinforcement of the team."

On November 8, 2021 iOnctura SA, a clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface, reported it has fully enrolled the metastatic uveal melanoma expansion cohort of the DIONE-01 study evaluating iOnctura’s lead compound, the selective PI3Kδ inhibitor IOA-244 (Press release, iOnctura, NOV 8, 2021, View Source [SID1234640243]).

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The DIONE-01 study entitled "A Study to Assess a PI3Kδ Inhibitor (IOA-244) in Patients with Metastatic Cancers" (NCT04328844) consists of two parts, A and B. In Part A, now complete, the objective was to determine the safety, tolerability, and dosage of IOA-244 in cancer patients to determine the predicted biologically effective dose range. Safety, PK and PD data from Part A will be presented as a poster (#405) at ESMO (Free ESMO Whitepaper) IO in Geneva between December 8-11, 2021.

Part B of the DIONE-01 study consists of expansion cohorts of patients with different tumor types, including patients with metastatic uveal melanoma. It will include the assessment of whether IOA-244 can increase the anti-tumor immune response in patients both as monotherapy and in combination with pemetrexed/cisplatin and an immune checkpoint inhibitor. The study will enroll up to 182 patients with uveal melanoma, cutaneous melanoma, NSCLC, mesothelioma, myelofibrosis, and NHL.

Within Part B, up to 26 patients with metastatic uveal melanoma will be recruited to determine the monotherapy activity of IOA-244. Patients with metastatic uveal melanoma currently have no approved treatment options. Positive outcome from this part of the trial is expected to support transition to subsequent registration studies for metastatic uveal melanoma. Interim data is expected in Q2 2022 with final top-line data scheduled for Q4 2022.

"iOnctura is entering a highly exciting phase as it progresses two tumor-stroma-immune interface targeting programs through clinical development. IOA-244 continues to demonstrate an unprecedented clinical profile among PI3Kδ inhibitors," said Catherine Pickering, CEO of iOnctura. "iOnctura is moving rapidly in the use of IOA-244 to treat a range of solid tumor types including metastatic uveal melanoma, an underserved cancer with no currently approved drug treatments and poor patient outcomes. We look forward to releasing early data from our preclinical and clinical evaluations of this exceptional molecule at ESMO (Free ESMO Whitepaper) IO."

Contacts

iOnctura
Catherine Pickering
Chief Executive Officer
T : +41 79 952 72 52
E: [email protected]

Press Relations
Jeremy Nieckowski
LifeSci Advisors
T: +41 79 699 97 27
E: [email protected]
iOnctura SA is clinical stage oncology company targeting core resistance and relapse mechanisms at the tumor-stroma-immune interface. iOnctura’s best-in-class drug development programs combine immune-mediated and direct anti-tumor activity to deliver molecules with superior clinical efficacy and safety in oncology. Its lead program, IOA-244 is the only semi-allosteric PI3Kδ specific, orally dosed, small molecule inhibitor that is being developed in solid and hematologic malignancies to address tumor and stroma induced immune suppression. IOA-244 is currently in a Phase 1 study which will support transition to subsequent registration studies. iOnctura’s second program, IOA-289, is an oral small molecule that inhibits the cross-talk between the tumor and its stroma and is in a Phase 1 study. iOnctura is backed by blue chip investors including M Ventures, Inkef Capital, VI Partners, Schroders Capital, and 3B Future Health Fund. For more information, please visit www.ionctura.com

IOA-244 is a PI3Kδ specific, orally dosed, small molecule inhibitor that overcomes tumor and stroma induced immune suppression. Its unique chemistry, semi allosteric binding mode and mechanism of action contribute to its unprecedented clinical profile. IOA-244 is currently in the cohort expansion phase of the DIONE-01 trial, a two-part, first-in-human dose study evaluating IOA-244 in solid tumors and hematologic malignancies and as a combination partner for conventional and immune-therapies.

Uveal melanoma (UM) is a rare malignancy arising within the uveal tract of the eye. There are approximately 7,000 newly diagnosed cases of uveal melanoma each year (around 2,000 in the United States). Over 50% of patients will progress to metastatic disease. Median overall survival is approximately 1 year for metastatic uveal melanoma and there are no approved therapies.