On August 12, 2021 Kronos Bio, Inc. (Nasdaq: KRON), a company dedicated to transforming the lives of those affected by cancer, reported recent business progress and second quarter financial results (Press release, Kronos Bio, AUG 12, 2021, View Source [SID1234586517]).

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"At our virtual R&D Day in May, we outlined our vision for expanding and driving progress in our pipeline of clinical programs that target dysregulated transcription factors and the regulatory networks within cancerous cells. This included unveiling the development strategy for our SYK inhibitor portfolio, which comprises entospletinib (ENTO) and LANRA. These differentiated clinical-stage investigational development candidates have the potential to address the mutations that are present in more than two-thirds of patients with AML," said Norbert Bischofberger, Ph.D., president and CEO. "We are poised to initiate our registrational Phase 3 trial later this year to support potential accelerated approval of ENTO in patients newly diagnosed with NPM1-mutated AML. With the recent FDA clearance of our IND for LANRA in relapsed or refractory FLT-3 mutant AML, we plan to launch our second SYK inhibitor clinical trial in the fourth quarter of 2021, when we also expect to report initial Phase 1 data from our trial of KB-0742, our potent oral, highly selective cyclin dependent kinase 9 inhibitor. I am proud of our Company’s momentum and anticipate multiple important inflection points in the coming months."

Recent Company Highlights

Received clearance from U.S. Food and Drug Administration (FDA) for the IND application of LANRA, a next-generation spleen tyrosine kinase (SYK) inhibitor. The first of two planned Phase 1/2 clinical trials is expected to initiate in Q4 2021 in patients with relapsed or refractor FLT3-mutated AML and will include a dose-escalation and an expansion cohort study design. The first stage will evaluate initial safety, pharmacokinetic (PK) and anti-leukemic activity of escalating once-daily doses of LANRA in combination with gilteritinib. Initial data from this first stage of the trial are anticipated to be available in the second half of 2022.
On track to initiate the Phase 3 trial of ENTO in the second half of 2021 with a pivotal data readout expected in the second half of 2023.
This trial will assess measurable residual disease (MRD) negative complete response (CR) as the primary endpoint to support potential accelerated approval in patients newly diagnosed with NPM1-mutated AML.
Anticipates reporting initial safety, PK and pharmacodynamic (PD) data from Phase 1 trial of KB-0742, a highly selective, orally bioavailable cyclin dependent kinase 9 (CDK9) inhibitor being developed to treat MYC-amplified solid tumors, in the fourth quarter of 2021. The company presented preclinical data for KB-0742 at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2021, which showed CDK9 inhibition on an intermittent dosing schedule with KB-0742 resulted in sustained inhibition of tumor growth in multiple types of solid tumors. The findings suggest that genomic amplification of MYC, a well-characterized transcription factor and a long-recognized driver of cancer, is a key factor of sensitivity to CDK9 inhibition.
Hosted a virtual R&D Day in May 2021 to discuss the company’s development strategy for the SYK inhibitors ENTO and LANRA, expectations for the upcoming Phase 1 data readout for KB-0742 and potential populations for expansion cohorts of a Phase 1/2 trial, along with an overview of the company’s differentiated drug discovery platform and future pipeline programs.
Second Quarter Financial Highlights

Cash, Cash Equivalents and Investments: As of June 30, 2021, cash, cash equivalents and investments totaled $419.3 million.

R&D Expenses: Research and development expenses were $19.8 million for the second quarter of 2021, which includes non-cash stock-based compensation expense of $3.4 million.

G&A Expenses: General and administrative expenses were $9.3 million for the second quarter of 2021, which includes non-cash stock-based compensation expense of $3.0 million.

Net Loss: Net loss for the second quarter of 2021 was $29.1 million, or $0.53 per share, including non-cash stock-based compensation expense of $6.4 million.

On August 12, 2021 Scandion Oncology A/S reported that it will publish its Half-year report on Thursday, 19 August 2021 before 09:00 CET (Press release, Scandion Oncology, AUG 12, 2021, View Source,c3395664 [SID1234586412]).

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Scandion Oncology’s executive management will host a webcast and conference call the same day at 10:00 CET presenting the results and a company update.

At the end of the presentation there will be a Q&A session.

The information was provided by the contact person above for publication on 12 August 2021.

On August 12, 2021 Elevation Oncology, Inc. (Nasdaq: ELEV), a clinical stage biopharmaceutical company focused on the development of precision medicines for patients with genomically defined cancers, reported financial results for the quarter ended June 30, 2021 (Press release, Elevation Oncology, AUG 12, 2021, View Source [SID1234586428]).

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"The second quarter marked a pivotal period for Elevation Oncology, with our debut in the public markets raising over $100 million which extends our cash runway into Q2 2023 and positions the Company to execute on our lead program, seribantumab, and build an industry leading precision oncology pipeline," said Shawn M. Leland, PharmD, RPh, Founder and Chief Executive Officer of Elevation Oncology. "Looking ahead, we anticipate completing enrollment of the first 20 patients in Cohort 1 of the tumor-agnostic Phase 2 CRESTONE study of seribantumab for patients with tumors harboring an NRG1 fusion later this year or in early 2022, and presenting the clinical data from the interim analysis in mid-2022 at a major medical conference. Through our recent coloration with Caris Life Sciences, we are identifying oncogenic fusions and driver mutations to enable pipeline expansion opportunities within genomically defined patient populations as part of our commitment to expand the potential of precision medicine."

Recent Business Highlights

Entered into a collaboration with Caris Life Sciences. In June 2021, Elevation Oncology and Caris announced a strategic collaboration to jointly discover and develop therapeutics targeted against oncogenic fusions and driver alterations. The two Companies will leverage genomic data from Caris’s leading WTS and WES molecular diagnostics platform, prioritize targets that are likely to be actionable driver alterations, and jointly discover and develop therapeutics to target them.

Completed a successful initial public offering (IPO). The Company’s common stock commenced trading on The NASDAQ Global Market under the ticker symbol "ELEV" on June 25, 2021. The IPO raised $106.5 million in gross proceeds, before deducting underwriting discounts and commissions and estimated offering expenses.

Strengthened corporate leadership. During the second quarter, the Company appointed Joseph Ferra as Chief Financial Officer, bringing to Elevation two decades of biopharma industry leadership including in investment banking and, most recently, as a public-company CFO. Further, Elevation Oncology appointed Michael Carruthers, an experienced biotech executive, to the Board of Directors and Chair of the Audit Committee.
Clinical Development and Pre-Clinical Data

Opened additional clinical trial sites in CRESTONE. There are now 26 trial sites that are open and enrolling across the US. Through the "just-in-time" clinical site model in partnership with Caris Life Sciences, Tempus, and US Oncology, there are over 400 available sites that can be activated within CRESTONE.

Established additional diagnostic partnerships. With the addition of Genomic Testing Collaborative, PathGroup, and Exactis, there are now a total of nine partnerships in place to support the identification and enrollment of patients with tumors harboring an NRG1 fusion in CRESTONE, including pre-existing partnerships with Ashion Analytics (now Exact Sciences), NeoGenomics, Caris Life Sciences, Strata Oncology, Tempus, and US Oncology.

Presented new preclinical data on additional tumor models harboring an NRG1 fusion. Along with its collaborators in the Marc Ladanyi laboratory at Memorial Sloan Kettering (MSK), the Company presented data at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting 2021. The preclinical data was in pancreatic and cholangiocarcinoma PDX models on the specific inhibition of HER3 with seribantumab to block NRG1 fusion signaling. These results further support the investigation of seribantumab for the treatment of any solid tumor harboring an NRG1 fusion regardless of fusion partner in the ongoing Phase 2 CRESTONE study.

Published a preclinical manuscript on the effect of seribantumab in NRG1 fusion models. A publication in Clinical Cancer Research highlights the specific inhibition of HER3 by seribantumab in preclinical NRG1 fusion in vitro and in vivo PDX models of lung and ovarian cancer. These results showed that seribantumab efficiently inhibited ligand-dependent activation of HER3 by NRG1 fusions, destabilizes the entire ERBB family signaling pathway including the activation of EGFR, HER2, and HER4, and established a predicted biologically effective dose range of seribantumab for tumors driven by an NRG1 fusion that provides confidence in the optimized clinical dose and schedule of 3g weekly being studied in the CRESTONE study.

Published a clinical manuscript. The Phase 1 dose escalation and expansion study for seribantumab monotherapy in patients with advanced solid tumors was published in Investigational New Drugs. The study was designed to evaluate the safety and tolerability of seribantumab monotherapy in patients with any solid tumor, not tumors harboring an NRG1 fusion. Seribantumab monotherapy was well tolerated across all dose levels and a maximum tolerated dose was not reached. Safety and PK data from this study support the 3g weekly dosing of seribantumab in the CRESTONE study which is the first study of seribnatumab in patients with tumors harboring an NRG1 fusion.
Upcoming Milestones

Complete enrollment of the first 20 patients in Cohort 1 of the Phase 2 CRESTONE study and conduct an interim analysis (Q4 2021 – Q1 2022)

Meet with the U.S. Food & Drug Administration to discuss the Phase 2 CRESTONE study (H1 2022)

Present clinical data from CRESTONE interim analysis at a major medical meeting (mid-2022)
Second Quarter 2021 Financial Results

As of June 30, 2021, the Company had cash and cash equivalents totaling $158.0 million, which is expected to fund current operations into the second quarter of 2023.

Research and development expenses for the second quarter 2021 were $3.9 million, compared to $3.0 million for the second quarter 2020. The increase in R&D expense was primarily related to an increase in clinical trial expenses associated with the CRESTONE study.

General and administrative expenses for the second quarter 2021 were $1.1 million, compared to $0.4 million for the second quarter 2020. The increase in G&A expense was primarily related to personnel costs, professional services and consulting, and other administrative costs.

Net loss for the second quarter 2021 was $5.1 million, compared to $3.4 million for the second quarter 2020.

About Seribantumab and NRG1 Gene Fusions

Seribantumab is a fully human IgG2 monoclonal antibody that binds to human epidermal growth factor receptor 3 (HER3). HER3 is traditionally activated through binding of its primary ligand, neuregulin-1 (NRG1). The NRG1 gene fusion is a rare genomic alteration that combines NRG1 with another partner protein to create chimeric NRG1 "fusion proteins". The NRG1 fusion protein is often also able to activate the HER3 pathway, leading to unregulated cell growth and proliferation. Importantly, NRG1 gene fusions are predominantly mutually exclusive with other known genomic driver mutations and are considered a unique oncogenic driver event associated with tumor cell survival.

NRG1 fusions have been identified in a variety of solid tumors, including lung, pancreatic, gallbladder, breast, ovarian, colorectal, neuroendocrine, cholangiocarcinomas, and sarcomas. In preclinical experiments, seribantumab prevented the activation of HER3 signaling in cells that harbor an NRG1 gene fusion and destabilized the entire ERBB family signaling pathway including the activation of HER2, EGFR, and HER4. In addition to extensive nonclinical characterization and testing, seribantumab has been administered to over 800 patients across twelve Phase 1 and 2 studies, both as a monotherapy and in combination with various anti-cancer therapies. Seribantumab is currently being evaluated in the Phase 2 CRESTONE study for patients with solid tumors of any origin that have an NRG1 fusion.

About the CRESTONE Study

Clinical Study of Response to Seribantumab in Tumors with Neuregulin-1 (NRG1) Fusions. CRESTONE is a Phase 2 tumor-agnostic "basket trial" of seribantumab in patients with solid tumors that harbor an NRG1 fusion and have progressed after at least one prior line of standard therapy. The primary objective of the study is to describe the anti-tumor activity and safety of seribantumab as a monotherapy specifically in patients whose solid tumor is uniquely driven by an NRG1 gene fusion. CRESTONE offers a clinical trial opportunity for patients with advanced solid tumors who have not responded or are no longer responding to treatment. Patients are encouraged to talk to their doctor about genomic testing of their tumor. CRESTONE is open and enrolling today in the United States. For more information visit www.NRG1fusion.com.

On August 12, 2021 Relay Therapeutics, Inc. (Nasdaq: RLAY), a clinical-stage precision medicine company transforming the drug discovery process by combining leading edge computational and experimental technologies, reported second quarter 2021 financial results and announced a collaboration with EQRx (Press release, Relay Therapeutics, AUG 12, 2021, View Source [SID1234586444]).

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"PI3Kα mutations have been a known oncogene for the past 20 years but this has been a very difficult drug discovery challenge to solve using conventional approaches. Leveraging our Dynamo platform, the Relay Therapeutics team has been able to create what we believe to be the first ever mutant selective inhibitor of PI3Kα, which offers the potential to address a significant unmet medical need," said Sanjiv Patel, M.D., president and chief executive officer. "Other programs in our pipeline continue to progress as anticipated, with RLY-4008, our FGFR2 inhibitor on track for an initial data disclosure later this year. We hope to demonstrate that our platform has achieved another breakthrough by potentially creating the first ever selective small molecule inhibitor of FGFR2. Finally, our new collaboration with EQRx announced today opens yet another avenue for our Dynamo platform to potentially impact the lives of more patients and generate value for our shareholders. This partnership allows us to utilize the scale and efficiencies of our machine learning and artificial intelligence capabilities against an expanded target landscape. We look forward to a productive remainder of 2021."

PI3Kα Mutant Selective Program Update

Phosphoinositide 3-kinase alpha (PI3Kα) is the most frequently mutated kinase in solid tumors. Approximately 60%-70% of the mutations in PI3Kα cluster at three amino acids (H1047, E542, and E545). Traditionally, the development of PI3Kα inhibitors has focused on the active, or orthosteric site. The therapeutic index of orthosteric inhibitors is limited by the lack of clinically meaningful selectivity for mutant versus wild-type PI3Kα and off-isoform activity. Toxicity related to inhibition of wild-type PI3Kα and other PI3K isoforms results in sub-optimal inhibition of mutant PI3Kα with reductions in dose intensity and frequent discontinuation. RLY-2608, the first allosteric, pan-mutant (H1047X, E542X and E545X), and isoform-selective PI3Kα inhibitor was designed to overcome these limitations.

Relay Therapeutics solved the full-length cryo-EM structure of PI3Kα, performed computational long time-scale molecular dynamic simulations to elucidate conformational differences between wild-type and mutant PI3Kα, and leveraged these insights to enable the design of RLY-2608. In biochemical assays, RLY-2608 inhibits H1047R, E542K, and E545K mutant PI3Kα activity with <10nM potency and 8-12x selectivity relative to wild-type PI3Kα. RLY-2608 is > 1000-fold selective over the β, δ, and γ PI3K isoforms in biochemical assays and demonstrates exquisite selectivity across a panel of 322 kinases.

This progress puts RLY-2608 on path to initiate a first-in-human clinical study in the first half of 2022. RLY-2608 is the lead program of multiple preclinical efforts to discover and develop mutant selective inhibitors of PI3Kα.

Strategic Collaboration with EQRx

Relay Therapeutics and EQRx entered a worldwide strategic collaboration to discover, develop, and commercialize novel medicines against validated oncology targets. Under the terms of the agreement, Relay Therapeutics will be responsible for the discovery phase through to Investigational New Drug application filing, while EQRx will be responsible for clinical development, regulatory and commercialization efforts of the product candidates developed pursuant to the collaboration. Relay Therapeutics and EQRx will equally share in the discovery, development and commercialization costs and the net profits from sales of any collaboration medicines, if approved. The collaboration will start with one program, but the companies can mutually agree to add additional programs to the collaboration in the future. Relay Therapeutics retains the right to develop any collaboration medicines in combination with its wholly-owned pipeline.

Other Recent Corporate Highlights

RLY-4008, a potent, selective and oral small molecule inhibitor of FGFR2, remains on track to report initial safety, tolerability and pharmacokinetics data across multiple dose levels before the end of 2021. Most patients to be reported on will be FGFR2 altered cholangiocarcinoma (CCA) patients with prior exposure to pan-FGFR inhibitor therapies. The disclosure will also include preliminary efficacy data focusing on FGFR2 fusion CCA pan-FGFR treatment naïve patients.

In July 2021, Genentech initiated the cohort of RLY-1971/GDC-1971, an inhibitor of SHP2, in combination with GDC-6036, an inhibitor of KRAS G12C, in a Phase 1b trial.
Second Quarter 2021 Financial Results

Cash, Cash Equivalents and Investments: As of June 30, 2021, cash, cash equivalents and investments totaled approximately $671.2 million, compared to $678.1 million as of December 31, 2020. The change in cash reflects the receipt of Genentech’s $75 million upfront payment in the first quarter, partially offset by $25.1 million in net cash paid for the acquisition of ZebiAI and cash used to fund our operations. The Company expects its current cash and cash equivalents will be sufficient to fund its current operating plan into 2024.

R&D Expenses: Research and development expenses were $180.0 million for the second quarter of 2021, as compared to $21.7 million for the second quarter of 2020. $134.9 million was due to the acquisition of ZebiAI in April 2021. The additional increase of $23.5 million was primarily due to $12.3 million of additional employee related costs, including an increase in stock-based compensation of $8.2 million, $7.3 million related to our pre-clinical candidates and $2.5 million related to increased clinical trial expenses associated with RLY-1971 and RLY-4008.

G&A Expenses: General and administrative expenses were $14.4 million for the second quarter of 2021, as compared to $6.1 million for the second quarter of 2020. The increase of $8.4 million was primarily due to $5.8 million of increased personnel costs, including increased stock-based compensation of $3.9 million, to support our infrastructure and $2.6 million related to increases in other general and administrative expenses primarily attributed to an increase in insurance expense.

Net Loss: Net loss was $193.4 million for the second quarter of 2021, or a net loss per share of $2.10, as compared to a net loss of $26.7 million for the second quarter of 2020, or a net loss per share of $6.06.

On August 12, 2021 Monopar Therapeutics Inc. (Monopar or the Company) (Nasdaq: MNPR), a clinical-stage biopharmaceutical company primarily focused on developing proprietary therapeutics designed to extend life or improve the quality of life for cancer patients, reported second quarter 2021 financial results and recent business updates (Press release, Monopar Therapeutics, AUG 12, 2021, View Source [SID1234586463]).

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Recent Business Updates

Validive

Monopar’s Phase 2b/3 VOICE clinical trial of Validive (clonidine HCl mucobuccal tablet) for the prevention of severe oral mucositis (SOM) in patients undergoing chemoradiotherapy (CRT) for oropharyngeal cancer successfully reached its target of 20 activated clinical trial sites for the Phase 2b portion of the trial. Monopar plans to activate additional clinical trial sites, potentially including sites outside of the U.S. There is no FDA-approved prevention or treatment for CRT-induced SOM. The VOICE trial is on track for reaching interim analysis in the first half of 2022.
Camsirubicin and MNPR-202 and Related Analogs

The U.S. Food and Drug Administration cleared Monopar to proceed under its Investigational New Drug (IND) application with an open-label Phase 1b dose-escalation clinical trial evaluating camsirubicin plus growth factor support (pegfilgrastim) in patients with advanced soft tissue sarcoma (ASTS). Monopar anticipates dosing the first patient in the fourth quarter of 2021.
Monopar entered into a collaboration agreement with the Cancer Science Institute of Singapore, one of Asia’s premier cancer research centers, at the National University of Singapore (consistently ranked as one of the world’s top universities) to evaluate the activity of MNPR-202 and related analogs in preclinical models of multiple types of cancer. MNPR-202, a camsirubicin analog, was designed to retain the same potentially non-cardiotoxic backbone as camsirubicin but is modified at other positions which may enable it to be efficacious in certain cancers that are resistant to camsirubicin and doxorubicin. MNPR-202 and related analogs are covered under a newly issued U.S. composition of matter patent (US10,450,340).
MNPR-101 RIT and Related Compounds

Monopar and NorthStar Medical Radioisotopes, LLC (NorthStar) filed a provisional patent application with the U.S. Patent and Trademark Office (USPTO) titled "Bio-Targeted Radiopharmaceutical Compositions Containing Ac-225 and Methods of Preparation." Radiopharmaceutical therapy is a promising approach to treat cancer and other diseases using radioactive metals bound to proteins/antibodies to target and kill cells. Actinium-225 (Ac-225) is emerging as a radioactive isotope of choice for radiopharmaceuticals due to favorable properties such as its long half-life and selective induction of localized tumor cell death.

Monopar and NorthStar filed a provisional composition of matter patent application titled "Urokinase Plasminogen Activator Receptor-Targeted Radiopharmaceutical" covering a radiotherapeutic consisting of Monopar’s proprietary antibody MNPR-101 bound to Ac-225 via the metal binding agent PCTA. This radioimmunotherapeutic (RIT) has demonstrated 98% radiochemical purity and high stability, and has the potential to be a highly selective, potent treatment for a variety of cancers, severe COVID-19, and other diseases characterized by aberrant urokinase plasminogen activator receptor expression.
Additions to Monopar’s Executive Management Team

Monopar appointed Andrew Cittadine, MBA, as its Chief Operating Officer. Mr. Cittadine is an experienced healthcare executive and serial entrepreneur who has founded or led multiple healthcare businesses from concept through acquisition by Fortune Global 1000 firms. These include founding two successful diagnostic imaging companies, Sensant Corp. and American Biooptics, where he also served as CEO, and led both through stock or asset acquisitions by Siemens and Olympus, respectively. He also served as CEO of a critical care company, SonarMed, which was acquired by Medtronic. Mr. Cittadine brings to Monopar considerable leadership experience, including managing manufacturing and quality systems implementation, executing multi-center clinical trials, and achieving regulatory clearances for new technologies in both the U.S. and Europe.

Monopar appointed Octávio Costa, MD, as its Chief Medical Officer. Dr. Costa joined Monopar with over 30 years of experience overseeing clinical development, clinical operations, development strategy and global medical affairs. He has extensive Phase 1 through Phase 4 clinical development expertise and related regulatory experience. Dr. Costa’s previous roles include positions of increasing responsibility in clinical development at Merck, Celgene, Novartis and most recently as Chief Medical Officer at Rafael Pharmaceuticals. He has played an important role in the development and life-cycle management of significant marketed oncology products, including the blockbuster product REVLIMID (lenalidomide) in Latin America.
Results for the Second Quarter Ended June 30, 2021, Compared to the Second Quarter Ended June 30, 2020

Cash and Net Loss

Cash and cash equivalents as of June 30, 2021, were $24.3 million. Monopar anticipates that its current cash and cash equivalents will fund the Company’s major programs at least through September 2022, including: completing the Phase 2b portion of the VOICE clinical trial and commencing of the Phase 3 portion; funding the camsirubicin Phase 1b clinical trial; continuing advancement of the MNPR-101 RIT program including related compounds; continuing the development of MNPR-101 and related technologies in cancer; and developing MNPR-202 and related analogs in various cancers. The Company plans to raise additional funds and/or engage a partner within the next 12 months to complete the VOICE clinical program and continue the camsirubicin clinical development beyond the Phase 1b clinical trial.

Net loss for the second quarter of 2021 was $2.1 million or $0.17 per share compared to net loss of $1.4 million or $0.14 per share for the second quarter of 2020.

Research and Development (R&D) Expenses

R&D expenses for the second quarter of 2021 were $1.4 million compared to $0.8 million for the second quarter of 2020. This increase of $0.6 million was primarily attributed to increases of (1) $0.3 million for VOICE clinical trial expenses, (2) $0.2 million for R&D personnel expenses, and (3) $0.1 million for planning of the Phase 1b camsirubicin clinical trial including regulatory and manufacturing-related expenses.

General and Administrative (G&A) Expenses

G&A expenses for the second quarter of 2021 were $0.6 million, essentially the same as the G&A expenses for the second quarter of 2020.