On May 11, 2023 Bolt Biotherapeutics, Inc. (Nasdaq: BOLT), a clinical-stage biopharmaceutical company developing novel immunotherapies for the treatment of cancer, reported its financial results for the first quarter ended March 31, 2023 and provided a business update (Press release, Bolt Biotherapeutics, MAY 11, 2023, View Source [SID1234631490]).

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"We are pleased to be advancing our lead Boltbody ISAC, BDC-1001, into a broader Phase 2 program in four different HER2-positive solid tumor types, following the recent positive topline results from our Phase 1 dose-escalation trial. We are looking forward to presenting a comprehensive dataset at ASCO (Free ASCO Whitepaper) from this first-in-human study, in which BDC-1001 achieved target drug exposure levels, was well tolerated from a safety perspective and demonstrated objective clinical responses and long-term durability both as a single agent and in combination with nivolumab," said Randall Schatzman, Ph.D., Chief Executive Officer of Bolt Biotherapeutics. "As we prepare for Phase 2 studies in the U.S. and internationally, we look forward to investigating the benefits of BDC-1001 and our novel ISAC mechanism to aid HER2-positive cancer patients who are not benefitting from current therapeutic options. Additionally, the Bolt team is excited to be advancing our next program, BDC-3042, a proprietary Dectin-2 agonist antibody, into the clinic later this year."

Recent Highlights and Anticipated Milestones

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Topline BDC-1001 Phase 1 dose-escalation clinical data unveiled from a multi-center, multi-dose clinical trial in more than 100 patients. The data demonstrated BDC-1001 was well-tolerated at all dose levels and schedules. BDC-1001 achieved objective clinical responses as a monotherapy and in combination with the PD-1 inhibitor nivolumab across a diverse range of solid tumor types. Target drug exposure levels were achieved at or near the recommended Phase 2 dose (RP2D) by more frequent administration including every other week (q2w) and weekly (q1w) administration schedules.
Comprehensive first-in-human safety and efficacy data will be presented by Bob Li, M.D., Ph.D., MPH, medical oncologist, and principal investigator at Memorial Sloan Kettering Cancer Center (MSK) in a poster presentation at the upcoming 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting (ASCO 2023) on Saturday, June 3 in Chicago, Illinois.

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Phase 2 BDC-1001 studies in four HER2+ solid tumor types are planned to initiate in 2023 with trials conducted at clinical sites in the U.S., Europe, and South Korea. Phase 2 dose expansions will investigate BDC-1001 as a monotherapy in three separate cohorts of patients with colorectal, endometrial, and gastroesophageal cancer. A separate combination arm with nivolumab is expected to initiate following demonstration of monotherapy anti-tumor activity in each of the three tumor types. An additional study, a randomized two-arm Phase 2 clinical trial, will investigate BDC-1001 as monotherapy and in combination with pertuzumab in patients with HER2-positive metastatic breast cancer whose disease has progressed following treatment with Enhertu.
Under a new supply agreement with Roche announced in the first quarter of 2023, Roche will provide pertuzumab for the Phase 2 breast cancer study. Under a previously announced agreement, BMS will provide nivolumab for the Phase 2 expansion studies.

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New BDC-3042 data presented at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting in April 2023 in Orlando, Florida. BDC-3042 is an agonist antibody targeting Dectin-2, an immune-activating receptor expressed by tumor-associated macrophages (TAMs) in solid tumors. These preclinical data highlight recent findings on key characteristics of BDC-3042 in reprogramming Dectin-2-expressing TAMs, leading to the production of an array of pro-inflammatory cytokines and chemokines associated with anti-tumor immunity, and tumor growth inhibition in humanized mouse models of cancer, alone and in combination with a PD-1 checkpoint inhibitor.
BDC-3042 to enter the clinic in 2023 following completion of Investigational New Drug (IND)-enabling activities, and clearance of a U.S. IND to initiate first-in-human studies later in 2023.

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Boltbody ISAC collaborations with Genmab and Innovent to develop next-generation Boltbody ISACs continue to make progress. These collaborations are exploring proprietary linker-payloads from the Boltbody ISAC platform in combination with Genmab’s proprietary bispecific antibodies and with Innovent’s proprietary antibodies, respectively.
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Cash, cash equivalents, and marketable securities were $171.0 million as of March 31, 2023. Cash on hand, coupled with collaboration revenues, is expected to fund clinical milestones and operations through 2025.

Upcoming Events

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BDC-1001 poster presentation at the 2023 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, Ill.
Title: A phase 1/2 study of a first-in-human immune-stimulating antibody conjugate (ISAC) BDC-1001 in patients with advanced HER2-expressing solid tumors

Abstract ID: 2538

Abstract Category: Developmental Therapeutics—Immunotherapy

Presenter: Dr. Bob Li, medical oncologist, and principal investigator at MSK

Poster Session: Developmental Therapeutics—Immunotherapy

Details: Saturday, June 3, 2023, 8:00 – 11:00 a.m. CDT

Location: McCormick Place Convention Center, Chicago, Illinois

First Quarter 2023 Financial Results

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Collaboration Revenue – Collaboration revenue was $1.8 million and $0.8 million for the quarter ended March 31, 2023, and 2022, respectively. The increase in revenue for the comparative periods was due to increased activity in our collaborations with Genmab and Innovent as we fulfill our performance obligations.

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Research and Development (R&D) Expenses – R&D expenses were $14.6 million for the quarter ended March 31, 2023, compared to $18.4 million for the same quarter in 2022. The decrease in R&D expenses was due to lower manufacturing expenses related to the timing of batch production of our product candidates and lower contract service expenses as well as our pipeline reprioritization in June of 2022, offset by higher clinical expenses related to the ongoing BDC-1001 clinical trial.

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General and Administrative (G&A) Expenses – G&A expenses were $5.6 million for the quarter ended March 31, 2023, compared to $6.3 million for the same quarter in 2022. The decrease in G&A expenses was due to lower consulting and professional services expenses.

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Loss from Operations – Loss from operations was $18.4 million for the quarter ended March 31, 2023, compared to $23.9 million for the same quarter in 2022.

About the Boltbody Immune-Stimulating Antibody Conjugate (ISAC) Platform
Bolt Biotherapeutics’ Boltbody ISAC platform harnesses the precision of antibodies with the power of the innate and adaptive immune system to reprogram the tumor microenvironment to generate a productive anti-cancer response. Each Boltbody ISAC candidate comprises a tumor-targeting antibody, a non-cleavable linker, and a proprietary immune stimulant. The antibody is designed to target one or more markers on the surface of a tumor cell and the immune stimulant is designed to recruit and activate myeloid cells. Activated myeloid cells initiate a positive feedback loop by releasing cytokines and chemokines that attract other immune cells and lower the activation threshold for an immune response. This process increases the number of activated immune cells in the tumor microenvironment and promotes a robust immune response, with the goal of generating durable therapeutic responses for patients with cancer.

On May 11, 2023 Biodesix, Inc. (Nasdaq: BDSX), a leading data-driven diagnostic solutions company with a focus in lung disease, reported its financial and operating results for the first quarter ended March 31, 2023 and provided a corporate update (Press release, Biodesix, MAY 11, 2023, View Source [SID1234631489]).

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"Throughout the quarter we continued to make excellent progress and I am pleased with the start to the year. Looking at our financial performance, we reported total revenue of $9.1 million for the first quarter 2023, which represents growth of 38% compared to the first quarter of 2022, while core lung diagnostic revenue of $8.6 million grew by 86% over the comparable period," said Scott Hutton, President and Chief Executive Officer. "Importantly, the momentum seen in the first quarter and the continued growth in our core lung diagnostic testing business clearly indicates the clinical need and growing acceptance of our on-market tests."

First Quarter 2023 Financial Results

For the three-month period ended March 31, 2023, as compared to the same period of 2022 (where applicable):

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Total revenue of $9.1 million, an increase of 38%, driven primarily by strong year-over-year growth in core lung diagnostics:
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Core lung diagnostic revenue of $8.6 million reflected a year-over-year increase of 86% driven primarily by the continued adoption of Nodify Lung nodule management tests;
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BioPharma Services revenue of $0.4 million decreased 55% year-over-year. Timelines for existing and new agreements continue to be impacted by delayed enrollment in clinical trials; entered the second quarter of 2023 with continued strong dollars under contract;
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COVID-19 testing revenue decreased by 99% year-over-year, and consistent with our revenue guidance. In connection with the expected expiration of the Public Health Emergency declaration, the Company will no longer provide COVID-19 diagnostic testing services commercially;
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First quarter 2023 gross profit of $5.9 million, or 65% gross margin as compared to 51% gross margin in the comparable prior year period primarily driven by the mix shift of sales to higher-margin core lung diagnostics and away from lower-margin COVID-19 testing;
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Operating expenses (excluding direct costs and expenses) of $22.3 million, an increase of approximately $4.5 million, or 25% as compared to the first quarter 2022 (includes non-cash stock compensation expense of $2.3 million as compared to $1.3 million);
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Approximately $3.0 million of the increase was attributable to increased sales and marketing costs to support core lung diagnostic sales growth including growth in the sales force, increased travel-related costs, and marketing programs to enhance product awareness;
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Approximately $1.6 million was associated with increased general and administrative expenses primarily associated with non-cash stock compensation costs;

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Net loss of $18.7 million and basic and diluted net loss per share of $0.24;
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Cash and cash equivalents of $25.3 million as of March 31, 2023;
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Scheduled milestone payment of $2.2 million paid in January 2023 to Integrated Diagnostics.
2023 Financial Outlook

The Company reaffirms our 2023 financial outlook and expects to generate between $52 million and $55 million in total revenue in 2023.

Conference call and webcast information

Listeners can register for the webcast via this link. Analysts wishing to participate in the question-and-answer session should use this link. A replay of the webcast will be available via the Company’s investor website approximately two hours after the call’s conclusion. Those who plan on participating are advised to join 15 minutes prior to the start time.

For a full list of Biodesix’s press releases and webinars, please visit biodesix.com.

On May 11, 2023 Bicycle Therapeutics plc (NASDAQ: BCYC) and Orano Med, two biotechnology companies respectively, reported pre-clinical results (Press release, Bicycle Therapeutics, MAY 11, 2023, View Source [SID1234631488]). Bicycle is pioneering a new and differentiated class of therapeutics based on its proprietary bicyclic peptide (Bicycle) technology and Orano Med is developing innovative radioligand therapies with lead-212 in oncology. The companies reported co-authored preclinical results of Pb-BCY20603, a Bicycle radio-conjugate (BRC) that binds with high affinity to the tumor antigen MT1-MMP and carries a chelate of lead-212, a potent alpha particle emitting radioisotope. The results were presented at TIDES 2023 in San Diego, CA and can be accessed here.

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"We are encouraged by the preclinical results that were presented at TIDES 2023 and are excited by the potent anti-tumor activity observed with this molecule," said Kevin Lee, Ph.D., Chief Executive Officer of Bicycle Therapeutics. "We estimate that on a dose per dose basis this prototype is over 1,000 times more potent than a comparator Bicycle toxin conjugate, demonstrating just how powerful targeted alpha therapy with lead-212 may be and providing further evidence that the unique properties of Bicycles make them a potentially powerful modality for precision guided delivery of radionuclide payloads."

Pb-BCY20603 showed tumor targeting in rodent tumor xenograft studies, with radioactivity levels of >45% Injected Dose (ID/g) 24 hours post injection. No body weight loss was seen in mice treated up to 30 μCi, and no significant changes were observed in hematology readout compared to vehicle treated mice. Pb-BCY20603 showed potent anti-tumor activity after a single dose of 5 μCi. Complete tumor regressions were seen after 3 dosing cycles of 10 μCi, given two weeks apart. Median survival was increased for each dosing group with 90% survival observed for the 3 cycles of 10 μCi, treatment at the end of the 100-day study. Importantly, the Bicycle displayed differentiated tumor penetration compared to a comparator antibody, highlighting an advantage of smaller molecules over larger biologics.

"The promising preclinical results of Pb-BCY20603 confirm the potential of targeted alpha therapies to open new perspectives for patients with difficult to treat cancers," said Julien Dodet, Chief Executive Officer of Orano Med. "We are convinced that alpha therapies, combined with innovative vectors such as Bicycle peptides, are the future of radiopharmaceutical therapies, providing an increased cytotoxic potential against cancer cells with limited toxicity to surrounding healthy cells. This reinforces Orano Med’s commitment to make lead-212 based therapies available to the medical community and patients worldwide."

These data build on previously published studies demonstrating the precision-guided potential of Bicycles. Imaging data were also reported from two separate independent research groups. At the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, an independent team from Johns Hopkins published data from an EphA2 binding Bicycle in an orthotopic pancreatic cancer model (Sharma, et. al., Non-invasive detection of pancreatic adenocarcinoma using Ga-88 labelled EphA2 targeting peptide). In addition, a separate independent research team (Duan, et al., Clinical Cancer Research, 2023) demonstrated specific and sensitive imaging of a Nectin-4 targeted Bicycle observed in Nectin-4 positive metastases in human patients, despite the molecule not being optimized for this purpose. These data provide further evidence to support the ability of Bicycles to fully penetrate and bind to their targets deep into tumors providing additional confidence in the platform’s potential clinical utility.

On May 11, 2023 Aura Biosciences Inc. (NASDAQ: AURA), a clinical-stage biotechnology company developing a novel class of virus-like drug conjugate (VDC) therapies for multiple oncology indications, reported its financial results for the first quarter ended March 31, 2023, and provided clinical development and operational highlights (Press release, Aura Biosciences, MAY 11, 2023, View Source [SID1234631487]).

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"We are encouraged by our recent interactions with the FDA in support of our global Phase 3 trial designed to enable us to develop the first vision preserving targeted therapy for the treatment of patients with early-stage choroidal melanoma, a disease with a high unmet medical need and no approved therapies," said Elisabet de los Pinos, Ph.D., Chief Executive Officer of Aura. "With a strong balance sheet, we are well-positioned to execute and advance our pipeline to meaningful clinical milestones."

Recent Pipeline Developments

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Aura is planning to initiate a potentially registration-enabling Phase 3 clinical trial in 1H 2023 to evaluate the safety and efficacy of Belzupacap Sarotalocan (bel-sar) for the first-line treatment of adult patients with early-stage choroidal melanoma (CM), a life-threatening rare disease with no approved therapies.
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The Phase 3 clinical trial design incorporates guidance and feedback from the FDA following a recent Type C meeting.

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The FDA recommended that the Phase 3 trial follow a standard three-arm randomized, controlled and masked design. The trial is intended to enroll approximately 100 patients and it will be randomized 2:1:2 to receive investigational therapeutic regimen bel-sar, low dose regimen bel-sar or a sham control. The primary efficacy analysis is planned to be a time to event composite endpoint that will compare the tumor control and visual acuity of the therapeutic regimen group to sham when the last patient meets 12 months of follow up.

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Enrollment is complete in the Phase 2 trial evaluating suprachoroidal (SC) administration of bel-sar for the first-line treatment of adult patients with early-stage CM. Updated interim data of patients treated with the therapeutic regimen intended to be used in the Phase 3 trial is on track to be presented in 2H 2023.

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Enrollment is ongoing for the Phase 1 trial of bel-sar for the treatment of non-muscle invasive bladder cancer (NMIBC). This represents an area of high unmet need with approximately 80,000 patients diagnosed in the United States every year. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in June 2022.

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The Phase 1 multi-center, open-label clinical trial is expected to enroll approximately 23 adult patients. The trial is designed to assess the safety and tolerability of bel-sar as a single agent. The primary endpoint of the Phase 1 trial is the incidence and severity of treatment-related adverse events, serious adverse events and/or the incidence of dose-limiting toxicities. The trial will provide histopathological evaluation after the local treatment to support bel-sar’s biological activity. Aura expects to report initial Phase 1 data in 2H 2023.

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Beyond early-stage CM, Aura continues to build its ocular oncology franchise. Aura’s goal is to initiate clinical development in choroidal metastasis, an indication with a high unmet medical need and no approved therapies, as the second ocular oncology indication. Aura received Fast Track Designation from the Oncology Division of the FDA for this indication in February 2023, and the Investigational New Drug application was opened in January 2023. Aura is on track to initiate start-up activities for the Phase 2 trial in 2H 2023.

Recent Corporate Events

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Enhanced Senior Leadership Team. In March 2023, Aura appointed Patrick Nealon as SVP, Clinical Development Operations. Mr. Nealon brings over 20 years of biopharmaceutical industry experience, leading the clinical development of therapeutics across multiple disease areas. Mr. Nealon will be responsible for overseeing all aspects of clinical operations as Aura transitions into late-stage clinical development.

First Quarter 2023 Financial Results

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As of March 31, 2023, Aura had cash and cash equivalents and marketable securities totaling $173.5 million. Aura believes its current cash and cash equivalents and marketable securities are sufficient to fund its operations into 2025.

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Research and development expenses increased to $14.4 million for the three months ended March 31, 2023 from $8.3 million for the three months ended March 31, 2022, primarily due to ongoing clinical costs associated with the progression of our Phase 2 study and CRO costs associated with the start of our global Phase 3 trial, manufacturing and development costs for bel-sar, and higher personnel expenses from growing headcount.

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General and administrative expenses increased to $5.0 million for the three months ended March 31, 2023 from $4.5 million for the three months ended March 31, 2022. General and administrative expenses include $1.1 million and $1.0 million of stock-based compensation for the three months ended March 31, 2023 and 2022, respectively. The increase was primarily driven by personnel expenses, as well as increases in general corporate expenses related to growth of the Company.

Net loss for the three months ended March 31, 2023 was $17.5 million compared to $12.8 million for the three months ended March 31, 2022.

On May 11, 2023 Ariceum Therapeutics (Ariceum), a private biotech company developing radiopharmaceutical products for the diagnosis and treatment of certain hard-to-treat cancers,and UCB (EURONEXT BRUSSELS: UCB), a global biopharmaceutical company, reported an exclusive, strategic research collaboration agreement to identify and develop novel systemic targeted radiopharmaceuticals for the treatment of solid tumors and immune-related diseases (Press release, Ariceum Therapeutics, MAY 11, 2023, View Source [SID1234631486]).

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Under the terms of the research collaboration, UCB and Ariceum will utilize each other’s proprietary technology platforms to enable the discovery of peptide-radioisotope conjugates as potential therapeutics for immune-related diseases and cancer. Ariceum will also gain access to UCB’s expertise to discover novel synthetic macrocyclic peptides using its mRNA-display technology platform, ExtremeDiversity. UCB will benefit from Ariceum’s expertise in the field of radiochemistry and labelling technology to enhance its ability to explore how this technology might lead to the discovery of highly differentiated products for immune-related diseases. Both companies will have the opportunity to explore several targets under this research collaboration.

Manfred Rüdiger, PhD, Chief Executive Officer of Ariceum Therapeutics, said: "We are excited about this strategic collaboration between UCB and Ariceum which aims to broaden Ariceum’s pipeline with potentially several new programs at discovery stage. Through this partnership, Ariceum will have access to a unique library that will be used to screen against targets of interest for oncology for which current targeted approaches have failed, while working with UCB on enabling targeted systemic radiotherapy approaches in other areas of severe diseases."

Dhaval Patel, Chief Scientific Officer of UCB, commented: "The collaboration with Ariceum further enhances our strategic drug discovery capabilities and provides UCB with the opportunity to learn and explore the potential of this modality in our drive to continuously innovate. We look forward to working with Ariceum’s scientists and are eager to leverage the technology platforms and disease expertise at each company."