On May 12, 2022 Achieve Life Sciences, Inc. (Nasdaq: ACHV), a clinical-stage pharmaceutical company committed to the global development and commercialization of cytisinicline for smoking cessation and nicotine addiction, reported first quarter 2022 financial results and provided an update on the cytisinicline clinical development program (Press release, OncoGenex Pharmaceuticals, MAY 12, 2022, View Source [SID1234614475]).

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Recent Events & Highlights

Reported clinically robust and statistically significant Phase 3 topline results from the ORCA-2 clinical trial of cytisinicline in adult smokers

Following positive ORCA-2 results, Achieve updated its agreements with Silicon Valley Bank, providing access to an additional $10.0 million of capital

Cytisinicline development program overview presented at Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting

Appointed Dr. Vaughn Himes to Achieve’s Board of Directors

"Cytisinicline exceeded our expectations in the ORCA-2 trial by delivering impressive efficacy and tolerability in a difficult-to-treat population of smokers, who had lengthy and intense smoking histories, but who courageously attempted to quit smoking in the height of the COVID-19 pandemic," said John Bencich, Chief Executive Officer of Achieve. "We are delighted for those who were successful in ORCA-2 and inspired to continue our efforts to bring this important cytisinicline treatment to the FDA for review and potential approval as a new cessation option for the millions of people battling nicotine addiction."

Positive Phase 3 ORCA-2 Topline Results

The Phase 3 ORCA-2 trial of cytisinicline achieved statistically significant results in primary and secondary endpoints for both 6- and 12-week cytisinicline treatment compared to placebo, and was very well tolerated with single-digit rates of adverse events observed.

Subjects who received 12 weeks of cytisinicline treatment had 6.3 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 9-12 was 32.6% for cytisinicline compared to 7.0% for placebo.

Subjects who received 6 weeks of cytisinicline treatment had 8 times higher odds, or likelihood, to have quit smoking during the last 4 weeks of treatment compared to subjects who received placebo (p<0.0001). The abstinence rate during weeks 3-6 was 25.3% for cytisinicline compared to 4.4% for placebo.

Updated Debt Facility Agreement with SVB

In connection with the positive ORCA-2 trial results, Achieve received approval from Silicon Valley Bank to access the remaining capital available under its $25.0 million debt facility put in place in December 2021. Per the terms of the agreement, the remaining $10.0 million of commitments are being made available to the Company through April 30, 2023. Amounts drawn under the remaining commitments will incur interest at the greater of 3.50% and the WSJ prime rate, and will be subject to interest only payments through April 30, 2024, and then amortize fully over the following 24 months. No amounts have been drawn to date and the Company will have the discretion to make draws under the facility through April 30, 2023.

Cytisinicline Development Program Presented at SRNT Annual Meeting

An overview of the cytisinicline development program was included in the "Promising New Smoking Cessation Pharmacotherapies" Symposium during the Society for Research on Nicotine and Tobacco (SRNT) Annual Meeting on March 16, 2022.

Dr. Vaughn Himes Appointed to the Board of Directors

In March, Achieve announced the appointment of Vaughn B. Himes, PhD, to Achieve’s Board of Directors. Dr. Himes currently serves as the Chief Technology Officer at Seagen, where he leads the manufacturing, supply chain, process sciences, and quality functions. He has more than 30 years of experience in product development and commercialization in the pharmaceutical and biotech industry, including previous roles as Senior Vice President of Technical Operations at ZymoGenetics, and Vice President of Worldwide Manufacturing Operations at Corixa Corporation.

Financial Results

As of March 31, 2022, the company’s cash, cash equivalents, and restricted cash was $36.4 million. Total operating expenses for the three months ended March 31, 2022 was $7.2 million. Total net loss for the three months ended March 31, 2022 was $7.6 million. As of May 12, 2022, Achieve had 9,681,855 shares outstanding.

Conference Call Details

Achieve will host a conference call at 4:30 PM EDT, Thursday, May 12, 2022. To access the webcast, please use the following link 1Q22 Earnings Webcast. Alternatively, you may access the live conference call by dialing (877) 472-9809 (U.S. & Canada) or (629) 228-0791 (International) and referencing conference ID 3887417. A webcast replay will be available approximately two hours after the call and will be archived on the website for 90 days.

On May 12, 2022 Chinook Therapeutics, Inc. (Nasdaq: KDNY), a biopharmaceutical company focused on the discovery, development and commercialization of precision medicines for kidney diseases, reported financial results for the first quarter ended March 31, 2022 (Press release, Aduro Biotech, MAY 12, 2022, View Source [SID1234614474]).

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"During the first quarter of 2022, we made strong progress advancing our pipeline of clinical, research and discovery programs for rare, severe chronic kidney diseases. We continue to enroll patients in the phase 3 ALIGN and phase 2 AFFINITY trials for atrasentan as well as the phase 1/2 trial of BION-1301, and we are pleased to have recently initiated the phase 1 healthy volunteer trial of CHK-336, our first internally-discovered program for the treatment of primary and idiopathic hyperoxaluria," said Eric Dobmeier, president and chief executive officer of Chinook Therapeutics. "We look forward to the upcoming 59th ERA Congress being held May 19th – 22nd, where we will present clinical data from both our lead programs, atrasentan and BION-1301, in patients with IgA nephropathy (IgAN)."

Recent Accomplishments and Updates

Atrasentan

Atrasentan is a potent and selective endothelin A (ETA) receptor antagonist that has the potential to provide benefit in multiple chronic kidney diseases by reducing proteinuria and having direct anti-inflammatory and anti-fibrotic effects to preserve kidney function. The phase 3 ALIGN trial of atrasentan is currently enrolling patients with IgAN, and the phase 2 AFFINITY basket trial of atrasentan is currently enrolling patients with proteinuric glomerular diseases.

Enrollment of the phase 3 ALIGN trial of atrasentan continues to advance with the activation of new trial sites and expansion into additional countries. Chinook expects to report topline data from the six-month interim proteinuria endpoint analysis in 2023 to support an application for accelerated approval under Subpart H in the United States.

Chinook plans to present data from the IgAN patient cohort of the phase 2 AFFINITY trial in an oral presentation at the 59th ERA Congress on May 20, 2022, and provide a program update on atrasentan during an investor conference call and webcast at 4:15 pm EDT that day. Chinook has completed enrollment of the IgAN patient cohort of this trial, and continues to enroll the other three cohorts, including patients with focal segmental glomerulosclerosis (FSGS), Alport syndrome and diabetic kidney disease in combination with SGLT2 inhibitors.

Chinook will deliver a mini-oral presentation at the 59th ERA Congress on May 19, 2022 on preclinical mechanistic work describing atrasentan’s effect to block mesangial cell injury and the pathogenic transcriptional networks driving IgAN progression in a model system.

In March 2022, Chinook presented an overview of the phase 2 AFFINITY clinical trial at the 4th Annual Chronic Kidney Disease (CKD) Drug Development Summit.

In February 2022, Chinook delivered an encore trials-in-progress presentations on the phase 3 ALIGN and phase 2 AFFINITY clinical trials at the ISN World Congress of Nephrology 2022.

BION-1301

BION-1301 is a novel anti-APRIL monoclonal antibody currently in phase 1/2 development for patients with IgAN. BION-1301’s potentially disease-modifying approach to treating IgAN by reducing circulating levels of galactose-deficient IgA1 (Gd-IgA1) to prevent the formation of pathogenic immune complexes has been demonstrated preclinically as well as clinically in both healthy volunteers and patients with IgAN.

Chinook will present additional data from Cohort 1 of Part 3 in a mini-oral presentation at the 59th ERA Congress on May 19, 2022. After at least 24 weeks of treatment, all eight patients in Cohort 1 transitioned from IV dosing at 450 mg every two weeks to SC dosing at 600 mg every two weeks.

Enrollment of Cohort 2 of Part 3 of the ongoing phase 1/2 trial of BION-1301 is ongoing. Patients in Cohort 2 receive a SC dose of 600 mg of BION-1301 every two weeks. Data from Cohort 2 is expected in the second half of 2022.

Chinook will present a trials-in-progress mini-oral presentation at the 59th ERA Congress on May 19, 2022 on the ongoing phase 1/2 trial of BION-1301.

In March 2022, Chinook presented a detailed overview of the BION-1301 program at the 4th Annual CKD Drug Development Summit.

In February 2022, Chinook delivered encore presentations on data from Cohort 1 of Part 3 as well as a trials-in-progress of the ongoing phase 1/2 trial of BION-1301 at the ISN World Congress of Nephrology 2022.

CHK-336

CHK-336 is an oral small molecule lactate dehydrogenase A (LDHA) inhibitor with liver-targeted tissue distribution that Chinook is developing for the treatment of patients with primary hyperoxaluria (PH), secondary hyperoxaluria due to increased endogenous oxalate production and idiopathic stone formation.

In April 2022, Chinook initiated dosing in a phase 1 clinical trial evaluating CHK-336 in healthy volunteers. Data from this trial is expected in the first half of 2023.

Precision Medicine Research & Discovery

Chinook is focused on the discovery and development of novel precision medicines for rare, severe chronic kidney diseases (CKDs) with defined genetic or molecular drivers of disease initiation and progression, and efficient development paths. Chinook has multiple preclinical programs across the discovery, target validation, lead identification and lead optimization stages to generate future clinical pipeline candidates. Chinook is leveraging its ongoing strategic collaboration with Evotec to identify and validate novel targets and enable patient stratification strategies through access to the NURTuRE CKD Patient Biobank, which provides comprehensive PANOMICS characterization of thousands of CKD patients with prospective clinical follow-up and retained bio-samples of urine and blood for exploratory biomarker analysis.

Chinook will deliver an oral presentation at the 59th ERA Congress on May 20, 2022 on the approach used in collaboration with Evotec to leverage the NURTuRE CKD biobank to generate mechanistic disease understanding for patient-centric, integrated target and biomarker discovery that will enable the development of novel precision treatments for CKD patient subsets.

In March 2022, Chinook participated in a panel on the challenges and opportunities in drug development for rare kidney diseases at the 4th Annual CKD Drug Development Summit.

Corporate

In April 2022, Chinook announced an outreach initiative in collaboration with the IgA Nephropathy Foundation and Komodo Health, leveraging data and technology to drive awareness of IgAN and engage key medical providers at nephrology practices across the U.S., with the goal of ensuring patients have access to optimal support and treatment options earlier in their disease journey.

In March 2022, Chinook announced the appointment of Dr. Mahesh Krishnan, group vice president of research and development at DaVita Inc., to its Board of Directors.

In January 2022, Chinook announced the appointment of Dr. Charlotte Jones-Burton as senior vice president of product development and strategy.

First Quarter 2022 Financial Results

Cash Position – Cash, cash equivalents and marketable securities totaled $330.0 million at March 31, 2022, compared to $355.1 million at December 31, 2021.

Revenue – Revenue for the quarter ended March 31, 2022 was $2.7 million compared to $0.4 million for the same period in 2021. The increase was primarily due to revenue recognized under Chinook’s license agreement with SanReno.

Expenses –

Research and development expenses for the quarter ended March 31, 2022 were $26.3 million compared to $25.7 million for the same period in 2021. The increase was primarily due to higher employee-related costs from increased staff to build out our clinical and development capabilities; increased spending for consulting and outside services; and an increase in facilities and other costs. These increases were partially offset by a decrease in licensing and contract research and manufacturing costs. The decrease resulted from an upfront fee of $3.3 million to Evotec International GmbH included in the quarter ended March 31, 2021 and lower costs from clinical trials initiated in 2021.

General and administrative expenses for the quarter ended March 31, 2022 were $7.9 million compared to $9.5 million for the same period in 2021. The decrease was primarily due to lower consulting and other professional services costs; lower employee-related costs; and a decrease in facilities and other costs. These decreases were partially offset by an increase in stock-based compensation expense resulting from new grants.

The change in fair value of contingent consideration and contingent value rights liabilities for the quarter ended March 31, 2022 was a benefit of $1.0 million compared to expense of $1.8 million for the same period in 2021. The decrease in these non-cash expenses primarily resulted from a change in estimate of the potential future proceeds derived from the Merck collaboration.

Other –

A $10.0 million development milestone under the Merck collaboration was earned in the fourth quarter of 2021 and received in the first quarter of 2022. We expect to pay this milestone, net of taxes and expenses, to the CVR holders in the second quarter of 2022.

Net Loss – Net loss for the first quarter of 2022 was $31.7 million, or $0.54 per basic share, compared to a net loss of $37.2 million, or $0.88 per share for the same period in 2021.

On May 12, 2022 Bolt Biotherapeutics, Inc. (NASDAQ: BOLT), a clinical-stage biotechnology company pioneering a new class of immuno-oncology agents that combine the targeting precision of antibodies with the power of both the innate and adaptive immune systems, reported financial results for the first quarter ended March 31, 2022 and provided an update on recent business highlights (Press release, Bolt Biotherapeutics, MAY 12, 2022, View Source [SID1234614473]).

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"Our lead program, BDC-1001, for patients with HER2-expressing solid tumors is on track and we expect to complete both our monotherapy and combination dose escalation arms and select a recommended Phase 2 dose in the second half of 2022," said Randall C. Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "We continue to apply our expertise in myeloid biology to advance our diversified pipeline of novel Boltbody ISACs and our first-in-class Dectin-2 agonist antibody program. Our strong cash position and multiple collaborations with leading therapeutic antibody companies are expected to provide us with the funding to achieve key clinical milestones with our most promising candidates in a cash-efficient manner."

Recent Business Highlights

Boltbody ISAC BDC-1001 monotherapy and combination clinical trial arms are progressing on schedule with data anticipated in the second half of 2022 – BDC-1001, a HER2-targeting immune-stimulating antibody conjugate (ISAC), is being evaluated in dose escalation as a monotherapy and in combination with OPDIVO in an ongoing multi-center, multi-dose Phase 1/2 clinical trial. To date, BDC-1001 has demonstrated early signs of clinical disease control, a favorable safety profile, and changes in intratumoral biomarkers consistent with the novel mechanism of action.

Presented data from three preclinical pipeline programs at the 2022 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting – In April, Bolt Biotherapeutics scientists presented three posters at the AACR (Free AACR Whitepaper) Annual Meeting highlighting the Company’s proprietary pipeline, including BDC-2034, BDC-3042, and a PD-L1 Boltbody ISAC.

Advancing novel immuno-oncology pipeline focused on myeloid biology

On-track with IND-enabling studies with BDC-2034 – Bolt Biotherapeutics is currently conducting Investigational New Drug (IND)-enabling activities for BDC-2034, a novel CEA-targeted ISAC, including GLP toxicology studies and GMP manufacturing. Data presented at the 2022 AACR (Free AACR Whitepaper) Annual Meeting demonstrated activity in multiple preclinical cancer models.

On-track with IND-enabling activities with BDC-3042 – Bolt Biotherapeutics is currently conducting IND-enabling activities for BDC-3042. BDC-3042 is an agonist antibody that binds to and stimulates Dectin-2, a novel target found on tumor-associated macrophages across a broad range of solid tumors. Stimulating Dectin-2 leads to tumor macrophage reprogramming and anti-cancer activity. BDC-3042’s anti-tumor activity was demonstrated in humanized mouse models and presented in a poster at the AACR (Free AACR Whitepaper) Annual Meeting. The Company plans to initiate clinical development of BDC-3042 in 2023.

Ramping up corporate collaboration activity supporting future pipeline and offsetting R&D expenses – Bolt Biotherapeutics’ collaboration with Genmab A/S is exploring multiple bispecific ISACs, with Bolt Biotherapeutics having the option to develop and commercialize one product candidate. Bolt Biotherapeutics’ collaboration with Innovent Biologics, Inc. will develop three new Boltbody ISAC programs, with Bolt Biotherapeutics having the option to develop and commercialize two of the programs. Under these valued collaborations, all research and development expenses through clinical proof of concept will be funded by partners.

Cash, cash equivalents, and marketable securities were $246.8 million as of March 31, 2022 – Cash on hand, which includes long-term marketable securities, is expected to fund the completion of multiple key milestones and to fund operations into 2024.
Upcoming Events

At the 2022 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, Bolt Biotherapeutics’ Jason Ptacek, Ph.D., will present a poster entitled, "Characterization of tumor antigen expression and myeloid immune profiles to inform the development of immune stimulating antibody conjugates (ISACs)."
Title: Characterization of tumor antigen expression and myeloid immune profiles to inform the development of immune stimulating antibody conjugates (ISACs)​
Authors: Lisa K. Blum, Jason Ptacek, Heidi LeBlanc, Andrea Horvath, William G. Mallet, Bruce A. Hug, Michael N. Alonso, Edith A. Perez, David Dornan, Marcin Kowanetz ​
Abstract ID: 2557​
Abstract category: Developmental Therapeutics—Immunotherapy​
Presentation date: Sunday, June 5, 2022, 8:00 a.m. – 11:00 a.m. CDT

First Quarter 2022 Financial Results

Collaboration Revenue – Collaboration revenue was $0.8 million and nil for the three months ended March 31, 2022 and 2021, respectively. Revenue in 2022 was generated from the services performed under the R&D collaborations with Genmab A/S and Innovent Biologics, Inc.

Research and Development Expenses – R&D expenses were $18.4 million for the quarter ended March 31, 2022, compared to $14.1 million for the same quarter in 2021. The increase is primarily due to IND-enabling activities for BDC-2034 and continued progress in the clinical trial for BDC-1001, including an increase in consulting expenses and higher personnel expenses relating to an increase in headcount.

General and Administrative (G&A) Expenses – G&A expenses were $6.3 million for the quarter ended March 31, 2022, compared to $4.3 million for the same quarter in 2021, primarily due to increased expenses related to being a public company, including higher personnel expenses relating to increased headcount.

Loss from Operations – Loss from operations was $23.9 million for the quarter ended March 31, 2022, compared to $18.4 million for the same quarter in 2021.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
ISACs are a new category of immunotherapy combining the precision of antibody targeting with the strength of the innate and adaptive immune systems. Boltbody ISACs comprise three primary components: a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant to activate the patient’s innate immune system. By initially targeting a single marker on the surface of a patient’s tumor cells, an ISAC can create a new immune response by activating and recruiting myeloid cells. The activated myeloid cells start a feed-forward loop by releasing cytokines and chemokines, chemical signals that attract other immune cells and lower the activation threshold for an immune response. This reprograms the tumor microenvironment and invokes an adaptive immune response that targets the tumor, which can lead to the conversion of immunologically "cold" tumors to "hot" tumors with the goal of durable responses for patients with cancer.

On May 12, 2022 Imago BioSciences, Inc. ("Imago") (Nasdaq: IMGO), a clinical stage biopharmaceutical company discovering and developing new medicines for the treatment of myeloproliferative neoplasms (MPNs) and other bone marrow diseases, reported financial results for the first quarter ended March 31, 2022 and provided a corporate update (Press release, Imago BioSciences, MAY 12, 2022, View Source [SID1234614472]).

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"I am delighted by the clinical progress Imago has made, which was underscored by the completion of enrollment in the Phase 2 trial of bomedemstat for treatment of ET as well as positive interim data from our two Phase 2 trials in ET and MF presented at ASH (Free ASH Whitepaper) 2021 with additional data from these trials to be presented at the upcoming EHA (Free EHA Whitepaper) congress in June. In addition, the Fred Hutchinson Cancer Research Center has initiated dosing in a Phase 1/2 combination study of bomedemstat and atezolizumab for the treatment of small cell lung cancer and we remain on track to initiate our second combination study in the first half of 2022, which is a Phase 2 trial of bomedemstat and ruxolitinib for the treatment of MF," said Hugh Young Rienhoff, Jr., M.D., Chief Executive Officer of Imago BioSciences. "As we continue to assemble a seasoned leadership team, I am pleased to have had Mike join as Chief Operating and Business Officer, as Laura Eichorn transitioned from the Chief Operating Officer role into the Chief Financial Officer on a permanent basis. Looking ahead, Imago expects to initiate a registrational study of bomedemstat for the treatment of ET, subject to an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (FDA), around the end of 2022."

First Quarter 2022 Highlights

Announced results of preliminary discussions with the U.S. Food and Drug Administration (FDA), about key trial design parameters for a registration-directed Phase 3 program of bomedemstat for the treatment of ET. Based on these discussions, we believe a two-arm trial comparing bomedemstat to best available therapy may provide the basis for regulatory approval for the second-line treatment of ET. Subject to final review of the Phase 3 protocol, we have alignment on the study population of patients with ET, viz., those patients who are intolerant of or resistant to hydroxyurea, the agents in the control arm and the composite primary endpoint of durable normalization of platelet and white counts and hemostasis in the absence of progression. Based on completion of enrollment for the Phase 2 clinical trial in ET, and subsequent End of Phase 2 meeting, we expect to submit a final protocol for a registrational Phase 3 pivotal program in 2022, with the first patient dosed thereafter. With positive results from the pivotal clinical program, we would expect to submit applications for regulatory approval with the FDA and the EMA for ET.
Announced completion of enrollment in the Phase 2 trial of bomedemstat for the treatment of ET with 73 patients enrolled on May 3, 2022. To be enrolled in the Phase 2 ET trial, patients had to be intolerant of, or inadequately managed by treatment with one standard-of-care drug, generally hydroxyurea, and also had one or more high-risk prognostic factors, such as being over 60 years of age or having a history of clotting or bleeding events. Primary endpoints of this clinical trial are safety and tolerability, as well as the reduction of platelet count to ≤400 x 109/L, in the absence of any clotting or bleeding events. We are also evaluating several exploratory endpoints, including reduction in mutant allele frequency and prevention of transformation to MF or acute myeloid leukemia. In this Phase 2 trial, as well as our Phase 2 MF trial, we have used platelet count as a biomarker of bomedemstat activity on megakaryocyte function, allowing for individualized dosing. Patients from this trial are eligible to transition into an ongoing Phase 2 Extension Study initiated in 2021 enabling the collection of long-term safety and pharmacodynamic data.
Expanded Executive Leadership. In March 2022, Imago announced the appointments of Michael Arenberg as Chief Operating and Business Officer and Laura G. Eichorn as our Chief Financial Officer. Mr. Arenberg succeeds Ms. Eichorn as COO and is charged with leading strategic operations, investor relations, commercial development and business development of Imago. Ms. Eichorn has transitioned from interim Chief Financial Officer to serving in that role on a permanent basis.
Recent Highlights

Announced that the Fred Hutchinson Cancer Research Center has dosed the initial participant in an investigator-sponsored Phase 1/2 study of bomedemstat in combination with atezolizumab (Tencentriq) in people newly diagnosed with extensive stage small cell lung cancer (ES-SCLC). The study is being led by Rafael Santana-Davila, M.D., associate professor in the University of Washington School of Medicine and Joseph Hiatt, M.D., Ph.D., of Fred Hutchinson Cancer Center ("Fred Hutch"), and in collaboration with the National Cancer Institute (NCI) funded Fred Hutch Lung Specialized Project of Research Excellence. This single-center, open-label study is designed to assess the safety, dose-limiting toxicity, and progression-free survival of bomedemstat in approximately 34 patients with ES-SCLC. More information on this trial can be found on www.clinicaltrials.gov under the identifier NCT05191797.
Announced Data Presentations at the Upcoming 27th EHA (Free EHA Whitepaper) Congress. In May 2022, Imago announced that two abstracts have been accepted for poster presentation at EHA (Free EHA Whitepaper), to be presented on June 10, 2022: "A Phase 2 Study of The LSD1 Inhibitor IMG-7289 (Bomedemstat) For The Treatment Of Essential Thrombocythemia (ET)"; and "A Phase 2 Study of IMG-7289 (Bomedemstat) in Patients With Advanced Myelofibrosis."
Anticipated Upcoming Milestones

Data updates for bomedemstat in MF and ET at EHA (Free EHA Whitepaper) on June 10, 2022
Anticipate initiating Phase 2 combination study of bomedemstat with ruxolitinib in MF in 1H 2022
Expect an End-of-Phase 2 meeting with FDA for bomedemstat in ET in 2H 2022
Expect data updates for the bomedemstat Phase 2 trials in ET and MF at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting in December 2022
First Quarter 2022 Financial Results

Cash and Cash Equivalents: As of March 31, 2022, Imago had cash and cash equivalents and short-term investments of $205.8 million, compared to $82.7 million as of March 31, 2021 and $217.4 million as of December 31, 2021.
Research & Development (R&D) Expenses: R&D expenses for the quarter ended March 31, 2022 were $12.5 million (including stock-based compensation expense of $0.7 million) as compared to $4.8 million for the same period in 2021. The overall increase in R&D expenses was primarily related to increased manufacturing costs of drug supplies for our ongoing and planned clinical trials, continued clinical development activities in separate Phase 2 clinical trials for ET and MF, commencement of a Phase 2 extension study started in the second half of 2021 for the long-term follow-up of patients from the ongoing ET and MF clinical trials, and an increase in personnel-related costs, particularly with respect to an increase in the number of research and development employees, including stock-based compensation expense, as we ramped up our operations.
General and Administrative (G&A) Expenses: G&A expenses for the quarter ended March 31, 2022 were $4.0 million (including stock-based compensation expense of $0.7 million) as compared to $2.4 million for the same period in 2021 primarily due to increasing expense associated with operating a publicly traded company and personnel-related costs.
Net Loss: Net loss for the quarter ended March 31, 2022 was $16.4 million compared to $7.1 million for the same period in 2021.

On May 12, 2022 Xenetic Biosciences, Inc. (NASDAQ:XBIO) ("Xenetic" or the "Company"), a biopharmaceutical company focused on advancing innovative immune-oncology technologies addressing hard to treat oncology indications, reported its financial results for the first quarter of 2022 and provided a business update (Press release, Xenetic Biosciences, MAY 12, 2022, View Source [SID1234614471]).

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"Our strategic focus throughout the first quarter was working towards the completion of our exclusive license agreement with CLS Therapeutics ("CLS") to develop its interventional DNase based oncology platform. This platform was extremely attractive to us as we realized that adding the licensed programs could expand and enhance our oncology pipeline, provide an accelerated path to the clinic, create the potential for value-driving clinical and regulatory milestones, and position us as an emerging clinical-stage company," commented, Jeffrey Eisenberg, Chief Executive Officer of Xenetic. "Our team, along with advisors and preeminent key opinion leaders in this space, will make it a priority to advance the systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers, as quickly and efficiently as possible."

DNase Oncology Platform: Targeting Neutrophil Extracellular Traps ("NETs") to improve cancer therapies with a focus on advancing systemic DNase program into the clinic as an adjunctive therapy for locally advanced or metastatic cancers.

The Company’s interventional DNase based oncology platform is aimed at improving outcomes of existing treatments, including immunotherapies. The exclusive license to CLS’ intellectual property for uses of DNases in cancer include systemic co-administration of DNases along with standard therapies, including chemotherapy, radiation and checkpoint inhibitors, or along with conventional chimeric antigen receptor (CAR) T therapies. In addition, the licenses cover "DNase-armored" CAR T therapies in which novel CAR T products are engineered to secrete DNases into the tumor microenvironment to potentially improve T-cell infiltration, activity and persistence.

The licensed DNase platform is designed to target NETs, which are weblike structures composed of extracellular chromatin coated with histones and other proteins. NETs are expelled by activated neutrophils, in response to microbial or pro-inflammatory challenges. However, excessive production or reduced clearance of NETs can lead to aggravated inflammatory and autoimmune pathologies, as well as creation of pro-tumorigenic niches in the case of cancer growth and metastasis.

A substantial amount of scientific literature has implicated NETs in the context of cancer pathogenesis and resistance to cancer therapies (including chemo, radio, and immunotherapies such as checkpoint inhibitors and cell therapies). In published reports, elevated levels of NETs have been a biomarker associated with poor prognosis in patients with a variety of cancers.

In addition, resistance to existing therapeutic agents can involve the release of immunosuppressive signaling factors from NETs, or physical barriers created by NETs which can impede the infiltration, activity, and survival of cytotoxic T cells in the tumor microenvironment.

Published pre-clinical models have demonstrated the effectiveness of systemically administered DNase, alone or in combination with other agents, for the elimination of NETs and prevention of tumor growth and metastasis.

Adoptive transfer of CAR T cells has emerged as one of the most promising advances in cancer immunotherapy. Engineered CAR T cells, designed to recognize cancer-associated antigens, are capable of sustained and selective killing of tumor cells, with substantial reduction of tumor burden. CAR T therapies have exhibited remarkable clinical success against hematological malignancies but thus far have failed to demonstrate success in the context of solid tumors. Recent approaches to CAR T design include "armored" CAR-T cells, so named because they can express additional factors to resist immunosuppression or degrade physical components of the tumor’s extracellular matrix, including NETs. The Company plans to conduct pre-clinical research with the goal of demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications.

Program Highlights:

In April 2022, executed exclusive license and sublicense agreements with CLS Therapeutics to develop its interventional DNase based oncology platform, which is aimed at improving outcomes of existing treatments, including immunotherapies.
Advancing toward first-in-human study with IND filing targeted for the end of 2023.
Systemic DNase program initially targeting multi-billion-dollar indications including pancreatic carcinoma.
DNase armored CAR T program focused on demonstrating that armoring CAR T cells to secrete DNase can support depth and durability of response against solid tumor indications.
XCART Platform Technology: Significantly differentiated, proprietary approach to personalized CAR T lymphoma therapy targeting tumor-specific neoantigens that target independently of CD19 or other surface antigens that are common to both normal and malignant B-cells.

Program Highlights:

Advancing preclinical efforts through ongoing research and development collaborations including with The Scripps Research Institute and other institutions in the U.S. covering design and implementation of the pre-clinical development program, as well as activities supporting process development for clinical manufacturing.
Bolstered intellectual property portfolio with issuance of a U.S. patent covering the co-administration of XCART-derived CAR T cells, together with a personalized vaccine designed to enhance the effectiveness of the CAR T therapy.
PolyXen Platform Technology: Patent-protected platform technology designed for protein or peptide therapeutics, enabling next-generation biological drugs by prolonging a drug’s circulating half-life and potentially improving other pharmacological properties.

Program Highlight:

Royalty payments of approximately $0.4 million were received in the three months ended March 31, 2022, representing an approximate 103.4% increase over the same period in 2021 as Takeda’s sublicensee continued its worldwide launch of the product.
Summary of Financial Results for First Quarter 2022

Net loss for the quarter ended March 31, 2022 was approximately $1.6 million. Research & development expenses for the three months ended March 31, 2022 increased by approximately $0.5 million, or 74.9%, to approximately $1.1 million from approximately $0.6 million in the comparable quarter in 2021. The increase was primarily due to the Company’s increase in spending related to XCART U.S. pre-clinical development efforts. General and administrative expenses for the three months ended March 31, 2022 decreased by approximately $23,000, or 2.5%, to approximately $0.9 million from approximately $0.9 million in the comparable quarter in 2021. The decrease was primarily due to lower consulting costs offset by an increase in legal costs related to the CLS transaction during the three months ended March 31, 2022 compared to the same period in 2021.

The Company ended the quarter with approximately $16.2 million of cash.