On August 3, 2022 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported a corporate and financial update for the second quarter ended June 30, 2022 (Press release, G1 Therapeutics, AUG 3, 2022, View Source [SID1234617334]).

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"The second quarter of 2022 was a period of continued momentum across the G1 organization toward our mission of improving the lives of those impacted with cancer," said Jack Bailey, Chief Executive Officer of G1 Therapeutics. "For the first time, our sales team was in full control of COSELA, interacting with prescribers and driving usage and uptake. Thanks to the quality of these engagements, we experienced nearly 60 percent vial volume growth quarter over quarter – our highest quarterly growth rate since the initial launch period. In addition, our clinical team continued to execute on each of our ongoing clinical trials, including achieving important enrollment milestones in our Phase 3 trial of trilaciclib in patients with colorectal cancer and in our Phase 2 bladder cancer and mechanism of action trials."

Second Quarter 2022 and Recent Highlights

Financial

Achieved $8.7 Million in Net COSELA Revenue: G1 recognized total revenues of $10.6 million in the second quarter of 2022, including $8.7 million in net product revenue from sales of COSELA.
Ended the Second Quarter 2022 with Cash and Cash Equivalents of $144.0 Million: The Company’s current financial position is expected to be sufficient to fund G1’s operations and capital expenditures into 2024.
Clinical

Completed Enrollment in Pivotal Phase 3 Clinical Trial of Trilaciclib in Patients with mCRC: Enrollment in PRESERVE 1 is complete at 326 randomized patients; the trial was over-enrolled by approximately 10 percent to compensate for potential loss to follow up at trial sites in Ukraine. The primary endpoint is myeloprotection as measured by duration of severe neutropenia and the occurrence of severe neutropenia during induction. Key secondary endpoints include the effects of trilaciclib on chemotherapy-induced fatigue compared with placebo and the effect of trilaciclib on progression free survival and overall survival compared with placebo. Initial data including the primary endpoint of myeloprotection are expected in the first quarter of 2023. (Press release here)
Completed Enrollment in Phase 2 Clinical Trial Assessing the Mechanism of Action (MOA) of Trilaciclib in Neoadjuvant Breast Cancer: Enrollment is complete at 24 patients in the Phase 2 trial in early stage TNBC to confirm the mechanism of action of trilaciclib in modulating the anti-tumor immune response. The primary endpoints will assess the immune-based MOA, including the impact of trilaciclib on CD8+ T cells and regulatory T cells, or Tregs, in the tumor microenvironment. Secondary endpoints include pathological complete response (pCR), immune response, and profiling measures. Initial data from the primary endpoint are expected in the fourth quarter of 2022.
Achieved Target Patient Enrollment in Phase 2 Clinical Trial of Trilaciclib in Combination with Chemotherapy and Avelumab in Patients with Bladder Cancer (mUC): Target enrollment of 90 patients was achieved in PRESERVE 3; the last few consented patients are expected to enroll shortly. The trial builds on the strong rationale for trilaciclib in combination with chemotherapy and a checkpoint inhibitor (anti-PD-L1); preclinical and published data to date suggest potential for a synergistic effect in known immunogenic tumors. The primary endpoint is progression-free survival. Key secondary endpoints include overall survival, overall response rate, duration of response, and myeloprotection. Initial data including top line response rate and myeloprotection data are expected in the fourth quarter of 2022 followed by data on the primary endpoint of progression free survival in 2023.
Confirmed Expectation for Initial Data from Pivotal Phase 3 Trial of Trilaciclib in Triple Negative Breast Cancer (mTNBC) in the Second Half of 2023: Initial results including interim results for Overall Survival from PRESERVE 2, the Company’s ongoing line extension trial of trilaciclib in approximately 170 patients with PD-L1 positive and negative metastatic TNBC receiving first line gemcitabine and carboplatin, are expected in the second half of 2023. If the trial meets the interim analysis stopping rule, it will terminate, and we will report the topline results. If it does not, the trial will continue to the final analysis.
Confirmed Expectation for Initial Data in the Fourth Quarter of 2022 from Phase 2 Trial of Trilaciclib in Combination with an Antibody-Drug Conjugate (ADC): G1 has reiterated that it expects to release preliminary safety data in the fourth quarter of 2022 from a Phase 2 trial in combination with the antibody-drug conjugate (ADC) Trodelvy (sacituzumab govitecan-hziy) in patients with unresectable locally advanced or metastatic TNBC.
Medical

Presented Data at the 2022 ASCO (Free ASCO Whitepaper) Annual Meeting Showing that Trilaciclib Helps Protect Patients with Extensive-Stage Small Cell Lung Cancer (ES-SCLC) Against Single- and Multilineage Myelosuppressive Events When Used Prior to Chemotherapy: Results of the analysis showed that throughout cycles one through four of first-line therapy, fewer patients with ES-SCLC treated with trilaciclib experienced single-lineage (neutrophil, red blood cell or platelet lineages) and multilineage myelosuppressive events (severe neutropenia, severe anemia, and severe thrombocytopenia)—and fewer events occurred per person—than patients who received placebo. (Press release here)
Presented Data at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) Describing the Economic Impact of Trilaciclib for Chemotherapy-Induced Myelosuppression in ES-SCLC): Data showed that from both the US provider and patient-caregiver perspectives, the use of trilaciclib prior to chemotherapy in patients with ES-SCLC is associated with fewer myelosuppressive AEs and less healthcare resource use, translating into lower total cost of care. (Poster available here)
Corporate

Announced Approval of COSELA with Simcere in China: The China National Medical Products Administration (NMPA) has conditionally approved COSELA (trilaciclib hydrochloride for injection), which was jointly developed for use in Greater China by Simcere and G1. As a result of receiving approval in China, G1 will receive a $13 million milestone payment. In total, G1 may receive up to $156M in total milestones, and double-digit royalties on annual net sales of COSELA in China (Press release here)
Announced Appointments of Norman E. "Ned" Sharpless, M.D. and Jacks Lee to Board of Directors: Dr. Sharpless, the former Director of the National Cancer Institute (NCI) of the National Institutes of Health, is an accomplished oncologist and seasoned public servant who has treated cancer patients, investigated the biologic basis of cancer, and has led academic institutions and government agencies including the NCI. (Press release here). Mr. Lee, the Senior Vice President – Manufacturing & Supply of Merck & Co., brings more than 30 years of experience in manufacturing and supply chain management in the life sciences industry, spanning across technical, operational, and strategic leadership roles in science-technology, engineering, quality, supply chain, and manufacturing. (Press release here)
Second Quarter 2022 Financial Results

As of June 30, 2022, cash and cash equivalents totaled $144.0 million, compared to $221.2 million as of December 31, 2021.

Total revenues for the second quarter of 2022 were $10.6 million, including $8.7 million in net product sales of COSELA and license revenue of $1.9 million. This license revenue is primarily related to revenue recognized from amounts to be reimbursed by EQRx and Simcere for costs associated with clinical trials.

Operating expenses for the second quarter of 2022 were $47.5 million, compared to $44.8 million for the second quarter of 2021. GAAP operating expenses include stock-based compensation expense of $5.6 million for the second quarter of 2022, compared to $5.7 million for the second quarter of 2021.

Cost of goods sold expense for the second quarter of 2022 was $1.0 million compared to $0.8 million for the second quarter of 2021, primarily due to an increase in product sales.

Research and development (R&D) expenses for the second quarter of 2022 were $20.8 million, compared to $18.8 million for the second quarter of 2021. The increase in R&D expenses was primarily due to an increase in clinical trial costs offset by a decrease in costs for manufacturing of active pharmaceutical ingredients and drug product to support clinical trials.

Selling, general, and administrative (SG&A) expenses for the second quarter of 2022 were $25.7 million, compared to $25.2 million for the second quarter of 2021. The increase in SG&A expenses was due to increased personnel costs related to headcount and an increase in insurance and other administrative costs. The increase is offset by a decrease in medical affairs costs, commercialization activities, professional and legal fees, and IT-related costs.

The net loss for the second quarter of 2022 was $39.4 million, compared to $39.4 million for the second quarter of 2021. The basic and diluted net loss per share for the second quarter of 2022 was $(0.92) compared to $(0.94) for the second quarter of 2021.

Financial Guidance

G1 expects its current cash and cash equivalents of $144.0 million to be sufficient to fund its operations and capital expenditures into 2024.

Webcast and Conference Call

G1 will host a webcast and conference call at 8:30 a.m. ET today to provide a corporate and financial update for the second quarter 2022 ended June 30, 2022.

Please note that there is a new process to access the call via telephone. To register and receive a dial in number and unique PIN to access the live conference call, please follow this link to register online. While not required, it is recommended that you join 10 minutes prior to the start of the event. A live and archived webcast will be available on the Events & Presentations page of the company’s website: www.g1therapeutics.com. The webcast will be archived on the same page for 90 days following the event.

About COSELA (trilaciclib) for Injection

COSELA (trilaciclib) was approved by the U.S. Food and Drug Administration on February 12, 2021.

Indication
COSELA (trilaciclib) is indicated to decrease the incidence of chemotherapy-induced myelosuppression in adult patients when administered prior to a platinum/etoposide-containing regimen or topotecan-containing regimen for extensive-stage small cell lung cancer.

Important Safety Information
COSELA is contraindicated in patients with a history of serious hypersensitivity reactions to trilaciclib.

Warnings and precautions include injection-site reactions (including phlebitis and thrombophlebitis), acute drug hypersensitivity reactions, interstitial lung disease (pneumonitis), and embryo-fetal toxicity.

The most common adverse reactions (>10%) were fatigue, hypocalcemia, hypokalemia, hypophosphatemia, aspartate aminotransferase increased, headache, and pneumonia.

This information is not comprehensive. Please click here for full Prescribing Information. View Source

To report suspected adverse reactions, contact G1 Therapeutics at 1-800-790-G1TX or call FDA at 1-800-FDA-1088 or visit www.fda.gov/medwatch.

On August 3, 2022 BioMarin Pharmaceutical Inc. (NASDAQ: BMRN) (BioMarin or the Company) reported financial results for the second quarter ended June 30, 2022 (Press release, BioMarin, AUG 3, 2022, View Source [SID1234617364]).

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BioMarin Announces Record Revenues in Second Quarter 2022; Increases Full-year 2022 Top and Bottom-line Guidance
"Continued strong growth of VOXZOGO and solid contributions from our other franchises drove record revenues exceeding $1 billion in the first half of the year, leading us to increase our full-year 2022 top and bottom-line guidance," said Jean-Jacques Bienaimé, Chairman and Chief Executive Officer of BioMarin. "We also achieved many other significant milestones in the second quarter, including the CHMP’s positive opinion for conditional marketing authorization of Roctavian, the first gene therapy to be recommended for approval in Europe for hemophilia A. Assuming a positive decision from the European Commission, BioMarin’s commercial organization is ready to launch Roctavian in Europe in the third quarter. Based on the updated multi-year hemostatic efficacy observed to date following treatment with a single intravenous administration of Roctavian, we are on-track to resubmit the BLA in the U.S. to the FDA this September."

Mr. Bienaimé added, "In addition to continued robust demand for Voxzogo throughout the United States and Europe, underscored by today’s significant increase in full-year 2022 guidance for Voxzogo net product revenues to between $130 million and $160 million, we were thrilled to receive commercial approval in both Japan and Australia in the quarter. As we said previously, in 2022 we expect to return to double-digit revenue growth and profitability, and we are tracking to plan as demonstrated by record revenues in both the first and second quarters of this year."

Financial Highlights:

Total Revenues for the second quarter of 2022 were $533.8 million, an increase of 6% compared to the same period in 2021 despite continued erosion of the U.S. Kuvan market. The increase in Total Revenues was primarily attributed to the following:
Voxzogo commercial sales due to new patients initiating therapy in Europe and the U.S. following regulatory approvals by the European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) in the third and fourth quarters of 2021, respectively.
Higher Aldurazyme product revenues due to timing of product fulfillment to Sanofi. BioMarin Aldurazyme revenues are driven by the timing of when the product is released and control is transferred to Sanofi; partially offset by
Lower Kuvan product revenues primarily due to generic competition as a result of the loss of exclusivity in the U.S., consistent with expectations.
GAAP Net Income and Non-GAAP Income increased by $14.8 million and $11.6 million, respectively, for the second quarter of 2022 compared to the same period in 2021. The increase was primarily related to higher revenues partially offset by higher sales and marketing expenses to support the commercial launch of Voxzogo and pre-commercialization activities for Roctavian.
New Product Launches and Anticipated Approvals (Voxzogo and Roctavian)

The global launch of Voxzogo is actively underway, with market access and reimbursement progressing as anticipated. As of June 30, 2022, there were an estimated 446 children being treated with commercial Voxzogo globally, as compared to an estimated 284 children as of March 31, 2022. Of the estimated 446 children being treated with Voxzogo as of the end of the second quarter, 282 were from countries outside the U.S. and 164 were from the U.S. As of June 30, 2022, there were 20 active markets contributing to Voxzogo sales.
During the quarter, marketing authorization for Voxzogo was approved in both Japan and Australia, with commercial sales anticipated in these markets to begin in the third quarter of 2022. Japan accounts for approximately half of the 1,500 patient opportunity in the Asia-Pacific region.
During the quarter, the Company provided a top-line update on the Phase 2 randomized, double-blind, placebo-controlled Voxzogo study in infants and young children up to five years of age with achondroplasia at the 2022 Endocrine Society Annual Meeting (ENDO). BioMarin intends to initiate discussions on the favorable results from the study with regulatory health authorities to discuss next steps regarding efforts to expand access to Voxzogo treatment for this younger age group.
In the quarter, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion recommending conditional marketing authorization for Roctavian, for adults with severe hemophilia A. The Company expects a final approval decision, which is typically consistent with the CHMP recommendation, from the European Commission in the third quarter of 2022.
BioMarin is targeting a BLA resubmission for Roctavian by the end of September 2022. Typically, BLA resubmissions are followed by a 6-month review procedure. However, the Company anticipates three additional months of review may be necessary based on the number of data read-outs that will emerge during the procedure.
In July, at the International Society on Thrombosis and Haemostasis 2022 Congress, the Company reported that durable hemostatic efficacy was maintained over six years in the ongoing Phase 1/2 study with Roctavian in the 6e13vg/kg dose cohort, representing the longest duration of clinical observation with any gene therapy treatment for adults with severe hemophilia A.
Mid-stage Product Life Cycle Expansion Opportunities (Voxzogo and Roctavian)

Also at the ENDO meeting, the investigator-initiated study with Voxzogo in children with selected genetic causes of short stature, preliminary 6-month results from 12 subjects demonstrated a positive response in all subgroups with interindividual variability. The 52-week study is ongoing, and is expected to complete in 2023.
In the quarter, the Company’s interventional Phase 2 study with Voxzogo for the treatment of infants under the age of two who are at risk for foramen magnum compression completed enrollment. The study is investigating the safety of Voxzogo in infants at risk of requiring surgery to alleviate compression at the foramen magnum, the opening in the base of the skull through which the spinal cord passes. The study will also measure a secondary endpoint to evaluate the effect of Voxzogo on growth of the foramen magnum volume through MRI scans.
Product expansion opportunities with Roctavian are supported by a number of clinical studies currently underway. The Phase 3b study to evaluate Roctavian with prophylactic corticosteroids has completed enrollment and is expected to read-out in early 2023. Two additional studies, one investigating Roctavian treatment in those with active or prior inhibitors, as well as one study investigating Roctavian in people with pre-existing antibodies against AAV5, are actively recruiting at sites around the world.
Earlier-stage Development Portfolio (BMN 255, BMN 331, BMN 351, BMN 349, BMN 293 (DiNA-001))

BMN 255 for primary hyperoxaluria type 1, a subset of chronic renal disease: The Company was recently given permission by the FDA to move forward with the multiple ascending dose portion of the First-in-Human study with BMN 255. BioMarin believes the availability of a potent, orally bioavailable, small molecule like BMN 255 may be able to significantly reduce disease and treatment burden in certain people with chronic renal disease.
BMN 331 gene therapy product candidate for Hereditary Angioedema (HAE): The Company announced that it has dosed patients in the Phase 1/2 HAERMONY study to evaluate BMN 331, an investigational AAV5-mediated gene therapy for people living with HAE.
BMN 351 for Duchenne Muscular Dystrophy (DMD): Investigational New Drug application (IND)-enabling studies continue with BMN 351, an antisense oligonucleotide therapy for individuals with exon 51-skip-amenable DMD. BMN 351 was developed using familiar chemistry and superior biology, by targeting a novel, upstream, splice enhancer site demonstrating improved binding affinity and tolerability in preclinical models. Preclinical data suggest that restored expression of near-full-length dystrophin protein at levels of up to 40% will convert phenotypes from rapid loss to durable preservation of strength and ambulation. BioMarin expects to file an IND for BMN 351 in the winter.
BMN 349 for alpha-1 antitrypsin deficiency: Preclinical studies have demonstrated that BMN 349 is an orally bioavailable, small molecule that is titratable with rapid onset and high potency and efficacy. Preclinical results have strong implications for potential improvement of current management, particularly for severe liver disease requiring rapid action. BioMarin’s goal is to file an IND for BMN 349 in the second half of 2023.
BMN 293 (formerly DiNA-001) for MYBPC3 hypertrophic cardiomyopathy (HCM): Preclinical studies are underway with BMN 293 following a collaboration announced in 2020 with DiNAQOR, a gene therapy platform company, to develop novel gene therapies to treat rare genetic cardiomyopathies. Mutations in MYBPC3 are the most common cause of inherited HCM. Early investigations suggest that gene therapy-mediated gene transfer can lead to widespread expression of the gene product, cardiac myosin-binding protein C (MyBP-C), in cardiac tissue, which can normalize relaxation kinetics and potentially ameliorate the disease phenotype in individuals suffering from cardiomyopathy. BioMarin’s goal is to file an IND for BMN 293 in 2023.

All Financial Guidance items are calculated based on U.S. GAAP with the exception of Non-GAAP Income. Refer to Non-GAAP Information beginning on page 9 of this press release for a complete discussion of the Company’s Non-GAAP financial information and reconciliations to the corresponding GAAP reported information.

BioMarin will host a conference call and webcast to discuss second quarter and year to date 2022 financial results today, Wednesday, August 3, 2022 at 4:30 p.m. ET. This event can be accessed through this link or on the investor section of the BioMarin website at www.biomarin.com.

On August 3, 2022 Kura Oncology, Inc. (Nasdaq: KURA), a clinical-stage biopharmaceutical company committed to realizing the promise of precision medicines for the treatment of cancer, reported second quarter 2022 financial results and provided a corporate update (Press release, Kura Oncology, AUG 3, 2022, View Source [SID1234617380]).

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"We continue to advance our programs toward a series of important milestones later this year," said Troy Wilson, Ph.D., J.D., President and Chief Executive Officer of Kura Oncology. "For our menin inhibitor program, we have nearly completed our assessment of patients in the Phase 1b expansion cohorts of our KOMET-001 trial required to identify a recommended Phase 2 dose and remain enthusiastic about the potential for ziftomenib in the treatment of acute leukemias. We look forward to sharing the recommended Phase 2 dose later this year, pending FDA review, along with topline data from the Phase 1b study, followed by a more complete dataset at a medical meeting in the fourth quarter."

"For our farnesyl transferase inhibitor (FTI) program," Dr. Wilson continued, "we are encouraged by the preliminary safety and tolerability of tipifarnib in combination with the PI3Kα inhibitor, alpelisib, as well as early evidence of clinical activity observed in our KURRENT-HN trial. Meanwhile, we remain on track to initiate our KURRENT-LUNG trial of tipifarnib in combination with the EGFR inhibitor, osimertinib, later this quarter and submit an investigational new drug (IND) application for our next-generation FTI, KO-2806, by year end. And we approach these milestones from a position of financial strength, with $450 million in cash and investments that provide runway through 2024."

Recent Highlights

Recommended Phase 2 dose for ziftomenib identified, pending FDA review – In May 2022, Kura announced that it completed enrollment of the 24 patients in the Phase 1b expansion cohorts of the KOMET-001 trial required to identify a recommended Phase 2 dose for ziftomenib. The two Phase 1b expansion cohorts – 200 mg and 600 mg – are each comprised of patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory acute myeloid leukemia (AML). The Company has nearly completed its assessment of the patients for efficacy, safety and tolerability as well as pharmacokinetics and exposure, and believes it has identified a recommended Phase 2 dose for ziftomenib, pending FDA review.

Additional 18 patients enrolled in KOMET-001 trial – Since May 2022, Kura has enrolled an additional 18 patients with NPM1-mutant or KMT2A-rearranged relapsed/refractory AML in the Phase 1b expansion cohorts as the Company prepares to transition into the Phase 2 registration-directed portion of the KOMET-001 trial and initiate a series of combination studies in the relapsed and frontline settings, pending determination of the recommended Phase 2 dose in consultation with the FDA. Kura believes data from all patients treated at the recommended Phase 2 dose will have the potential to contribute to the registrational patient population.

Preliminary activity observed in KURRENT-HN trial of tipifarnib plus alpelisib –Enrollment continues in the Phase 1/2 KURRENT-HN trial of tipifarnib in combination with the PI3Kα inhibitor, alpelisib, in patients with head and neck squamous cell carcinoma (HNSCC). The initial cohort includes patients who have PIK3CA-dependent HNSCC. In addition, the first patient has been dosed in a second cohort of patients with HRAS overexpression. Kura is encouraged by the preliminary safety and tolerability of the combination thus far, as well as early evidence of clinical activity. The Company believes the combination with alpelisib has the potential to increase the total addressable population for tipifarnib to as much as 50% of patients with HNSCC.

KURRENT-LUNG trial of tipifarnib plus osimertinib to initiate this quarter – Kura is preparing to initiate a Phase 1 KURRENT-LUNG trial of tipifarnib in combination with osimertinib in EGFR-mutated non-small cell lung cancer (NSCLC) later this quarter. Preclinical data, generated through a collaboration with INSERM (the French National Institute of Health and Medical Research), support the potential of tipifarnib to prevent emergence of resistance to osimertinib in EGFR-mutant NSCLC. The Company intends to perform initial clinical evaluation with tipifarnib while advancing its next-generation FTI, KO-2806, through IND-enabling studies.
Financial Results

Research and development expenses for the second quarter of 2022 were $24.3 million, compared to $21.1 million for the second quarter of 2021. The increase in R&D expenses was primarily due to increases in clinical trial costs related to the ziftomenib program and personnel costs.

General and administrative expenses for the second quarter of 2022 were $11.1 million, compared to $12.6 million for the second quarter of 2021. The decrease in G&A expenses was primarily due to decreases in personnel costs and professional
fees.

Net loss for the second quarter of 2022 was $34.8 million, compared to a net loss of $33.7 million for the second quarter of 2021.This included non-cash share-based compensation expense of $6.5 million, compared to $6.0 million for the same period in 2021.

Cash, cash equivalents and short-term investments totaled $450.3 million as of June 30, 2022, compared with $518.0 million as of December 31, 2021. Based on its operating plan, management expects that cash, cash equivalents and short-term investments will fund current operations through 2024.
2022 Milestones

Determine the recommended Phase 2 dose for ziftomenib in consultation with the FDA and report topline data from the Phase 1b study later this year.

Present updated data from KOMET-001 at a medical meeting in the fourth quarter.

Initiate the KURRENT-LUNG trial of tipifarnib and osimertinib in the third quarter.

Submit an IND application for KO-2806 in the fourth quarter.
Conference Call and Webcast

Kura’s management will host a webcast and conference call at 4:30 p.m. ET / 1:30 p.m. PT today, August 3, 2022, to discuss the financial results for the second quarter 2022 and to provide a corporate update. The live call may be accessed by dialing (888) 882-4478 for domestic callers and (323) 794-2590 for international callers and entering the conference ID: 8696904. A live webcast and archive of the call will be available online from the investor relations section of the company website at www.kuraoncology.com.

On August 3, 2022 TransCode Therapeutics, Inc. (Nasdaq: RNAZ) ("TransCode" or the "Company"), the RNA oncology company, and The University of Texas MD Anderson Cancer Center ("MD Anderson"), reported a strategic alliance to advance TransCode’s pipeline of RNA-targeted oncology therapeutic and diagnostic candidates (Press release, TransCode Therapeutics, AUG 3, 2022, View Source [SID1234617396]).

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Through the alliance, TransCode and MD Anderson scientists will collaborate on preclinical studies to further validate TransCode’s therapeutic and diagnostic candidates and to expand the reach of TransCode’s discovery engine. The results of these studies will inform future clinical trials with these agents, including trials to be led at MD Anderson.

"RNA-based therapeutics offer exciting possibilities to treat cancer. We can now examine how regulatory RNAs affect signaling, both spatially and temporally, at the single-cell level in tumor cells, immune cells and stem cells — all critical for tumor progression, relapse and immune evasion," said principal investigator Sendurai Mani, Ph.D., Professor of Translational Molecular Pathology. "Our goals in collaborating with TransCode are to gain a deeper understanding of RNA-targeted therapies and to bring innovative new treatment options to our patients."

The collaboration has the potential to inform multiple clinical programs in TransCode’s pipeline, starting with its lead therapeutic candidate, TTX-MC138, designed to treat multiple metastatic cancers. Future clinical trials will be designed and led by Vivek Subbiah, M.D., Associate Professor of Investigational Cancer Therapeutics at MD Anderson.

"This strategic alliance offers the opportunity to further unlock the potential of our therapeutic pipeline by combining the promise of our image capable delivery platform and discovery engine with the unique talent and resources found at MD Anderson," said Zdravka Medarova, PhD, Co-Founder and CTO of TransCode.

Prior to a Phase I clinical trial, TTX-MC138 is scheduled to enter a first-in-human Phase 0 clinical trial designed to demonstrate delivery of the therapeutic candidate to metastatic lesions in patients with advanced solid tumors.

"We are acutely aware of the expectations that come with a therapeutic approach that has the potential to induce durable regressions of metastatic disease. We are committed to taking every opportunity to fulfill the promise of RNA in cancer," said Michael Dudley, Co-Founder and CEO of TransCode.

On August 3, 2022 Congenica, a UK-based digital health company that enables the rapid analysis and interpretation of genomic data, reported that it has selected the GenomOncology Precision Oncology Platform for the development of a novel ground-breaking CE-IVD Precision Oncology Solution (Press release, GenomOncology, AUG 3, 2022, View Source [SID1234617417]).

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Driven by the increasing adoption of cancer genomics and the growing need to individualize therapeutic recommendations, Congenica is developing a fully automated data analysis application, aimed at transforming the usability and scalability of genomic data for routine oncology clinical practice.

To further enrich decision support capabilities for this novel precision oncology solution, Congenica is collaborating with GenomOncology to provide regional therapy recommendations.

GenomOncology’s Precision Oncology Platform is designed to harmonize the latest precision oncology information, which includes an extensive set of annotations and ontologies, as well as curated public, licensed, and proprietary content and data sets. By incorporating this comprehensive knowledgebase, Congenica will have improved access to curated, precision oncology information from the United States, United Kingdom, European Union, and others, to yield data-driven insights and recommendations within their CDS.

Alistair Johnson, Chief Professional Services Officer at Congenica, said: "This collaboration signifies the expansion of Congenica’s Clinical Decision Support (CDS) Platform into oncology. Our novel product offers a fully automated future-proof end-to-end solution that unlocks the full potential of Next Generation Sequencing (NGS) in the clinical oncology space. GenomOncology brings extensive experience in precision oncology care, and its platform has been developed specifically to deliver clinical informatics solutions for cancer. We look forward to working with GenomOncology to further drive precision medicine, delivering high quality patient care and shaping the future of human health."

"Our partnership with Congenica enables us to expand opportunities for precision oncology care at the global level. The extensive information available within the GenomOncology Precision Oncology Platform, combined with the capabilities of the Congenica Clinical Decision Support Platform, will give clinicians and researchers the knowledge needed to provide their patients with the most appropriate care opportunities," said Brad Wertz, Chief Executive Officer at GenomOncology.