On November 10, 2021 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena", "Company"), a targeted oncology company focused on developing novel cancer therapies targeting key signaling pathways, reported financial results for the quarter ended September 30, 2021 (Press release, Ikena Oncology, NOV 10, 2021, View Source [SID1234595629]). The Company also provided an update across the organization and pipeline, including the acceptance of an IND for their TEAD inhibitor, IK-930, as they advance it towards initiation of a Phase 1 clinical trial for patients with tumors known to have high incidence of Hippo pathway genetic alterations.

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In addition to the Company’s progress on IK-930, Ikena is driving several programs targeting the RAS pathway. Emerging data from discovery and translational efforts have focused the team on key nodes in the RAS pathway that provide potential for clinical advancement of targeted therapies both as single agents and in combination to overcome therapeutic resistance in RAS mutated cancers. This work includes further efforts on ERK5 biology and chemistry optimization prior to candidate nomination, but also highlights new opportunities in the pathway. Multiple development candidates are expected to emerge from these RAS discovery programs over the next 18 months.

"Patients with mutations in the Hippo and RAS pathways represent cancer populations with significant unmet needs. At Ikena, we are committed to generating deep scientific support for our approach in these pathways and in the identification of therapies that could best treat their individual disease," commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. "The team has done tremendous work exploring TEAD biology, advancing IK-930, and generating robust translational data to optimize the clinical development plan. The IND acceptance is a foundational milestone for our targeted oncology portfolio and for our approach to biomarker-driven cancer treatments. The progress across the entirety of our pipeline demonstrates our commitment to science and medicine that will lead to better therapies with the best chance of helping patients."

Summary of Recent Pipeline Progress and Corporate Update

IK-930: TEAD Inhibitor in the Hippo Signaling Pathway

IND accepted by the Food and Drug Administration (FDA); clinical trial expected to initiate in the first quarter of 2022
Program data was shared at the AACR (Free AACR Whitepaper)-NCI-EORTC 2021 Virtual AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper)

Data highlighted translational methods using a novel assay developed by Ikena and suggested YAP/TAZ activity could be a potential biomarker in determining patients that could benefit from TEAD inhibition
Preclinical data showed the importance of the Hippo pathway in resistance to EGFR and MEK inhibition and the potential of therapeutic combinations for patients, supporting our plans to evaluate combinations of IK-930 in multiple tumor types
RAS Pathway: Progressing Multiple Targets and Novel Approaches

Ikena has been expanding its discovery and translational research efforts in the RAS pathway beyond ERK5, with a particular focus on targeting nodes in the pathway that have potential for monotherapy and combinations both intra-pipeline and with other targeted agents
Continued drug discovery and additional translational efforts are being conducted prior to potential ERK5 candidate nomination. The RAS pathway discovery programs are expected to result in multiple targeted oncology development candidates in the next 18 months
IK-175 & IK-412: AHR Inhibitor and Kynurenine Degrading Enzyme Programs in Collaboration with Bristol Myers Squibb

IK-175 is currently being evaluated in a Phase 1 study to assess its impact in solid tumors and in urothelial carcinoma though aryl hydrocarbon receptor (AHR) inhibition

The study expanded its monotherapy cohort in urothelial carcinoma earlier this year and recently completed the dose escalation of the combination of IK-175 with nivolumab
The combination arm expansion cohort in urothelial carcinoma is now open for enrollment, including nuclear AHR positive enriched subset of patients
Three posters on IK-175 will be presented at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Conference on November 12, 2021 highlighting translational data and a trial-in-progress presentation on the Phase 1 clinical trial design
IK-175 clinical data presentation is planned for a major medical conference in 2022
As previously reported, manufacturing lead times have been delayed for IK-412 and as such, Ikena and Bristol Myers Squibb are continuing to evaluate the best path forward
IK-007: EP4 Receptor Antagonist Currently in Phase 1 Clinical Trial

The IK-007 Phase 1 study in MSS colorectal cancer is on track to complete enrollment by the end of 2021; data will be submitted to a medical conference in 2022
An investigator-initiated trial (IIT) of IK-007 in combination with the chemotherapy agent eribulin in metastatic inflammatory breast cancer (IBC) led by Naoto Ueno, M.D., of the University of Texas MD Anderson Cancer Center was launched in September 2021

IBC is a rare, aggressive form of breast cancer with high unmet medical need
Increased COX-2 expression in the EP4 pathway has been associated with poor prognosis in IBC patients
Organizational Growth: Addition of Senior Clinical and Research Expertise

Ikena recently added deep expertise in clinical development, clinical operations, and cancer biology to the leadership team:

Karim Malek, M.D.: Vice President, Clinical Development
Medical oncologist with over 30 years of experience both in the clinic and in research and development, with strong academic roots
Joined Ikena from Takeda Pharmaceuticals where he was the global clinical lead on multiple immune-oncology platforms and garnered an extensive background in clinical trial design and execution
Jennifer Schroeder, PMP: SVP Clinical Development Operations
Seasoned executive with nearly 25 years of experience ranging from start-ups to Fortune 500 companies
Served over a decade with Pfizer and was one of the founding business process owners where she helped implement clinical trial management systems and directed a globally focused team of seven leading enterprise-scale projects
Holly Koblish, Ph.D.: Vice President, Cancer Biology
Over 20 years of experience in oncology drug discovery, asset development and target selection
Extensive drug discovery background as a pharmacology leader at Incyte, where she participated in the discovery of pemigatinib and capmatinib, two medicines recently approved in the U.S. and abroad
Financial Results for the Quarter Ended September 30, 2021

As of September 30, 2021, the Company had cash and cash equivalents totaling $245.9 million, which will fund operations through 2023. Net cash used in operations was $18.0 million for the third quarter of 2021 as compared to $7.7 million for the third quarter of 2020.

Research and development expenses for the third quarter 2021 were $13.4 million, compared to $7.2 million for the third quarter 2020. The increase in research and development expense was primarily attributable to IND-enabling studies, manufacturing development costs and clinical trial start-up costs for IK-930, manufacturing costs for IK-175, the on-going IND-enabling studies for IK-412, and research activities for other discovery stage programs. In addition, research and development expenses related to personnel and overhead expenses increased due to an increase in headcount. This increase in research and development expenses was partially offset by a decrease in development activities for IK-007.

General and administrative expenses for the third quarter were $4.9 million, compared to $1.8 million for the third quarter 2020. The increase was primarily attributable to an increase in compensation expense due to an increase in headcount and in insurance expense, as well as general increases in audit, legal, consulting and facilities expenses to support our operations as a public company.

Net loss for the third quarter 2021 was $14.5 million, compared to $6.2 million for the third quarter.

On November 10, 2021 Excyte Biopharma reported its bispecific antibody YK012 (acceptance number: CXSL2200041) was officially approved by the Drug Evaluation Center of the State Drug Administration (Press release, Excyte Biopharma, NOV 10, 2021, View Source;lang=en [SID1234646274]). YK012 is an innovative bispecific antibody targeting CD3/CD19 for the treatment of recurrent/refractory B-cell non-Hodgkin lymphoma.

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The approval of IND this time marks the transition from research and development to clinical use of new drugs with bispecific antibody of Yike Si Te, and is an important milestone in the research and development pipeline of Yike Si Te new drugs.

YK012, a bispecific antibody targeted at CD3 and CD19, is a Class I innovative drug, which is developed based on the quality by design concept of innovative immune double antibody design and the FIST platform with unique advantages and characteristics of YK012. It is positioned as the best in class.

The preclinical study data of YK012 of Ekester showed that its safety and effectiveness were significantly better than the marketed product Blincyto: at the cytological level, YK012 differentiated between effector cells and target cells; T cells are crosslinked and activated when and only when target cells exist; The level of full-spectrum CRS cytokines (including IL-6, IL-2, etc.) released by induction was significantly lower than that of Blincyto; The half-life of the monkey is more than 200 hours, more than 100 times that of Blincyto. Compared with Blincyto’s continuous intravenous infusion for 24 hours, YK012 will be injected intravenously once every two weeks, greatly improving the convenience and compliance of patients. In addition, Yikester YK012 has achieved the expression yield above gram level, and the preparation process is simple and efficient, laying a good foundation for the follow-up industrialization.

Co-founder of Ecotech CEO Yuan Qing’an said, "Ecotech is committed to developing products with global commercial value and functional superiority. At present, the main obstacle to developing CD3 bispecific antibodies that mobilize T cells to kill tumor cells is the severe cytokine storm (CRS) The clinical safety problems caused. In response to this pain point, Ecotech has designed the FIST platform, which has significantly reduced the CRS level of such products through a variety of ways, and has significantly increased the half-life and yield. It has the characteristics of high efficiency, high yield, low toxicity, and ease of use. It is a new generation of products in the field of CD3 dual antibody.

YK012 is a new targeted drug developed by us for acute leukemia (ALL), non-Hodgkin’s lymphoma (NHL) and other B-cell dysplasia diseases, with the same mechanism as CAR-T. The data of preclinical pharmacodynamics model showed that YK012 had better efficacy than Blincyto while greatly improving the safety. It was only two months from the submission of the application to the approval of the product, which proved the adequacy and effectiveness of the pre-clinical research data and laid a solid foundation for the clinical trial. Therefore, for the promotion of YK012 clinical trial, we are full of expectations and actively explore the development of new indications.

Based on the FIST platform, EKST also develops other new products that are urgently needed in clinic‘ In order to be better and different, it is the purpose of developing each variety to be a good medicine that people can afford. We hope to benefit more patients through our efforts.

On November 10, 2021 Silverback Therapeutics, Inc. (Nasdaq: SBTX) ("Silverback"), a clinical-stage biopharmaceutical company leveraging its proprietary ImmunoTAC technology platform to develop systemically delivered, tissue targeted therapeutics for the treatment of cancer, chronic viral infections, and other serious diseases, reported financial results for the third quarter ended September 30, 2021, and provided a business update (Press release, Silverback Therapeutics, NOV 10, 2021, View Source [SID1234595088]).

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"In the third quarter, we provided our first interim clinical update for the dose escalation arms of the SBT6050-101 trial, establishing proof-of-mechanism for SBT6050 as evidenced by the activation of the innate and adaptive immune system in patients," said Laura Shawver, Ph.D., chief executive officer of Silverback. "In a short period of time, we have accumulated a robust clinical data set that has informed our development strategy. We are focused on advancing SBT6050 in patients with HER2-expressing cancers such as gastroesophageal and non-small cell lung, in combination with agents that we believe will maximize the therapeutic potential of our first-in-class TLR8 agonist conjugate. We also look forward to continuing to advance our pipeline, including SBT6290 for patients with bladder, triple negative breast, non-small cell lung, and head & neck cancers, and SBT8230 for patients with chronic hepatitis B virus."

Recent Business Updates:

SBT6050 (HER2-TL8 ImmunoTAC)

Interim clinical data presented at the European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Annual Meeting. In September 2021, Silverback presented interim clinical results from the ongoing Phase 1/1b study of SBT6050, including data that establish proof-of-mechanism through SBT6050’s ability to activate myeloid, T and NK cells, as well as evidence of SBT6050 payload localization in the tumor microenvironment. Adverse events reported were consistent with on-mechanism immune activation, and early signals of anti-tumor activity were observed.
Selected go forward dose of 0.3 mg/kg SBT6050 in combination with anti-PD-1 therapy in expansion cohorts. Silverback is prioritizing combination with Libtayo in gastroesophageal and non-small cell lung cancers and plans to initiate these expansion cohorts in the fourth quarter of 2021.
SBT6050 expanded clinical development strategy announced, leveraging combination with trastuzumab-containing regimens. In the first quarter of 2022, Silverback plans to initiate SBT6050-201, a Phase 1/2 study of SBT6050 combined with Enhertu, or with Herceptin and Tukysa with or without capecitabine, in patients with HER2-expressing or HER2-amplified cancers.
SBT6290 (Nectin4-TL8 ImmunoTAC)

SBT6290 Investigational New Drug application submitted to the U.S. Food and Drug Administration. Silverback remains on track to initiate the phase 1/1b trial in the first quarter of 2022, and plans to enroll patients with bladder, non-small cell lung, triple negative breast, and head and neck cancers in dose escalation.
SBT8230 (ASGR1-TLR8 ImmunoTAC for chronic HBV)

SBT8230 preclinical development continues with GLP toxicology studies expected to commence in the first quarter of 2022. Silverback will be providing a preclinical update on the SBT8230 program at the American Association for the Study of Liver Diseases (AASLD) 2021 conference held from November 12-14, 2021.
Third Quarter Financial Results

For the third quarter ended September 30, 2021, Silverback reported a net loss of $22.7 million, compared to a net loss of $8.1 million for the comparable period in 2020. For the nine months ended September 30, 2021, Silverback reported a net loss of $66.0 million, compared to a net loss of $19.9 million for the comparable period in 2020. Included in the net losses for the three and nine months ended September 30, 2021 were $5.0 million and $14.0 million of non-cash stock-based compensation, respectively, compared to $0.2 million and $0.4 million for the same periods in 2020, respectively.

Research and development expenses for the third quarter ended September 30, 2021 were $15.6 million, compared to $6.2 million for the same period in 2020. Research and development expenses for the nine months ended September 30, 2021 were $45.6 million compared to $15.7 million for the same period in 2020. The increases in the Company’s research and development expenses in 2021 were primarily attributable to the advancement of pipeline programs, including SBT6290 and SBT8230, through preclinical development and the continued clinical development of SBT6050. Silverback also incurred additional personnel-related expenses as operations grew in support of program advancements.

General and administrative expenses for the third quarter ended September 30, 2021 were $7.0 million, compared to $1.9 million for the same period in 2020. General and administrative expenses for the nine months ended September 30, 2021 were $20.4 million, compared to $4.1 million for the same period in 2020. The increases in general and administrative expenses were primarily attributable to an increase in personnel-related expenses due to increased headcount in 2021, including new executives, as well as increases in salaries, bonuses, and stock-based compensation. The increases in general and administrative expenses were also due to an increase in legal fees, professional fees, and other various general and administrative expenses as we now operate as a public company.

As of September 30, 2021, Silverback reported cash, cash equivalents, and investments of $340.6 million compared to cash and cash equivalents of $386.6 million at December 31, 2020, which is expected to fund operating expenses and capital expenditure requirements into 2024.

On November 10, 2021 Kaleido Biosciences, Inc. (Nasdaq: KLDO), a clinical-stage biotech company with a differentiated, small-molecule approach to treating inflammatory conditions and diseases by selectively targeting the resident microbiome to restore gut-immune homeostasis, reported the appointment of Alison Long, M.B.B.Ch., Ph.D., to its leadership team as Chief Medical Officer, effective December 15, 2021 (Press release, Kaleido Biosciences, NOV 10, 2021, View Source [SID1234595120]). In her new role, Dr. Long will be responsible for leading the development of Kaleido’s ongoing and future clinical programs, including the development of KB295 and KB109 in ulcerative colitis and chronic obstructive pulmonary disease, respectively.

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"Alison is an exciting addition to our team who will play a critical role as we continue preparations to advance our two lead programs into Phase 2 clinical trials under IND and CTA next year," said Dan Menichella, President and Chief Executive Officer of Kaleido. "Her extensive experience in drug development, which includes leading five clinical programs to regulatory approvals, will be invaluable as Kaleido moves towards advancing our Microbiome Metabolic Therapies into multiple indications. Additionally, she will lead our medical affairs team as well as support translational microbiome research and the development of further new drug development candidates."

"I am honored to be joining this talented team at Kaleido during a pivotal stage of growth for the Company," said Dr. Long. "There are significant opportunities to leverage the immunomodulatory potential of the human microbiome to treat disease. The data thus far has demonstrated Kaleido’s differentiated Microbiome Metabolic Therapy approach is the key to unlocking that potential. I look forward to working with the Kaleido team and applying important learnings from recent clinical readouts to continue this forward momentum and advancement of our clinical development activities."

Dr. Long has almost two decades of experience working in the pharmaceutical and biotechnology industry, and a proven track record developing therapies, which include five successful regulatory approvals over her career. She most recently served as interim Chief Medical Officer and Senior Vice President, Head of Clinical Development at Freeline Therapeutics, and was responsible for the clinical development, clinical operations, medical affairs, and regulatory functions of Freeline’s development programs. Prior to her role at Freeline, she served as Head of Clinical Research and Development at Spark Therapeutics, where she oversaw the scientific and clinical development of all programs, including gene therapy in Huntington’s and Pompe diseases, as well as Inherited Retinal Disorders. Dr. Long has also previously served as Vice President, Clinical Development, Hemophilia at uniQure, Vice President, Head of Clinical at Aegerion Pharmaceuticals, and Medical Director with Biogen, where she focused on the development and subsequent EU approval of Elocta. Prior to her executive positions, Dr. Long was a physician scientist at AFG Biosolutions and The Institute for Ethnomedicine, after spending 12 years as a practicing physician. She received her medical degree from the University of Witwatersrand, and Ph.D. in biodefense from George Mason University.

On November 10, 2021 Boundless Bio, a next-generation precision oncology company developing innovative therapeutics directed against extrachromosomal DNA (ecDNA) in aggressive cancers, reported that Chief Business Officer, Neil Abdollahian, will present at the Stifel 2021 Virtual Healthcare Conference which will be webcast on Wednesday, November 17th, 2021, at 12:20 p.m. PST/3:20 p.m. EST (Press release, Boundless Bio, NOV 10, 2021, View Source [SID1234595137]).

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