1stOncology™: Cancer Intelligence Service – Page 3270 – 1stOncology is recognized as a Top 10 Global Pharma Analytic Provider

IN8bio Reports Third Quarter 2023 Financial Results and Provides Corporate Update

On November 9, 2023 IN8bio, Inc. (Nasdaq: INAB), a leading clinical-stage biopharmaceutical company developing innovative gamma-delta T cell therapies, reported financial results, operational highlights and recent corporate developments for the third quarter ended September 30, 2023 (Press release, In8bio, NOV 9, 2023, View Source [SID1234637372]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

Schedule Your 30 min Free Demo!

"We have continued to execute and to make impressive clinical progress across the breadth of our pipeline, which we shared at our recent Research & Development Day," said William Ho, CEO and co-founder of IN8bio. "Having completed enrollment in the dose escalation portion of the Phase 1 trial of INB-100 in hematologic malignancies and initiated enrollment for the Phase 2 trial of INB-400 in newly diagnosed glioblastoma, we are making strides towards our mission of exploring the full potential of gamma-delta T cells as a much-needed treatment option for cancer patients. We are encouraged by the positive data we have seen thus far and are excited to share additional clinical updates on our INB-100 and INB-200 programs at the upcoming SNO and ASH (Free ASH Whitepaper) meetings."

Business Highlights and Recent Developments

Presented two posters reporting biologic correlative data from the ongoing Phase 1 clinical trial of INB-200 in GBM and preclinical data on IN8bio’s iPSC gamma-delta T cell platform at SITC (Free SITC Whitepaper). The data presented from the INB-200 trial demonstrate the potential of single and repeat doses of DeltEx drug-resistant immunotherapy (DRI) to induce T cell persistence and sustained immune responses. Updated patient, enrollment and survival data from the ongoing INB-200 study will be presented at the SNO Annual Meeting on November 17, 2023. Data from IN8bio’s iPSC platform demonstrate the ability to kill multiple cancer types including ovarian cancer, GBM, CML and AML cell lines along with the potential to generate billions of iPSC-derived Vδ1+ T cells.

Completed dose escalation in the Phase 1 Trial of INB-100 in leukemia patients and will present clinical data at the upcoming ASH (Free ASH Whitepaper) Annual Meeting on December 11, 2023. Enrollment in the dose escalation phase of the Phase 1 clinical trial (NCT03533816) of INB-100 is now closed. The presentation at ASH (Free ASH Whitepaper) will highlight clinical data updating the efficacy results of INB-100 including complete responses (CRs) and durability.

Initiated enrollment for the company-sponsored Phase 2 trial of INB-400 in GBM. The Phase 2 clinical trial of INB-400 (NCT05664243), a genetically engineered gamma-delta T cell therapy, is open for enrollment and plans to enroll approximately 40 patients in "Arm A" of the study, in which autologous gamma delta cells will be used to treat patients with newly diagnosed GBM. The primary endpoint of the study is 12-month overall survival (OS) rate, and key secondary endpoints include tolerability, progression-free survival (PFS), overall response rate (ORR) and time to progression (TTP). The University of Louisville and The Cleveland Clinic are the first clinical sites activated to enroll patients. The company will present a poster at the SNO Annual Meeting.

Hosted R&D Day on October 12, 2023, highlighting IN8bio’s unique Gamma-Delta T cell platform. The event offered the opportunity to gain Key Opinion Leader (KOL) insights into IN8bio’s clinical programs. Featured presentations included those from IN8bio’s management team on gamma-delta T cells, IN8bio’s manufacturing capabilities, an overview of the INB-100, INB-200, and INB-400 clinical programs, as well as presentations from key oncology thought leaders Leo Luznik, M.D., Professor of Oncology at Johns Hopkins Medicine and Michael Bishop, M.D., Director of the David and Etta Jones Center for Cellular Therapy at the University of Chicago, featuring the topics of allogeneic transplantation and the challenges of leukemic relapse. A replay of the webcast event can be found here.

Upcoming Pipeline Milestones and Events

INB-100: Presenting updated Phase 1 trial clinical data from patients with hematological malignancies undergoing HSCT at the ASH (Free ASH Whitepaper) Annual Meeting on December 11, 2023.
INB-200: Complete enrollment of Cohort 3 in the Phase 1 trial; will present updated data at SNO on November 17, 2023 with longer-term follow-up at medical meetings throughout 2024.
INB-300: Present additional preclinical data demonstrating proof-of-concept for the nsCAR platform targeting CD33 and CD123 at a medical meeting in first half of 2024.
INB-400: Present a poster at the SNO Annual Meeting on November 17, 2023; file investigational new drug (IND) application for allogeneic arms (Arms B and C) of the Phase 2 trial in newly diagnosed and relapsed GBM in 2024.

Third Quarter 2023 Financial Highlights

Research and Development expenses: Research and development expenses were $3.8 million for the three months ended September 30, 2023, compared to $4.3 million for the comparable prior year period. The decrease was primarily due to a reduction in contract research organization expenses for INB-400 related to the IND filing in the prior year period, partially offset by increased personnel-related costs, including salaries, benefits, and non-cash stock-based compensation due to increased headcount.

General and administrative expenses: General and administrative expenses were $3.4 million for the three months ended September 30, 2023, compared to $3.1 million for the comparable prior year period. The increase was primarily due to an increase in professional services.

Net Loss: The Company reported a net loss of $7.2 million, or $0.23 per basic and diluted common share, for the three months ended September 30, 2023, compared to $7.4 million, or $0.34 per basic and diluted common share, for the comparable prior year period.

Cash: As of September 30, 2023, the Company had cash of $12.9 million, compared to $17.0 million as of June 30, 2023.

Illumina Reports Financial Results for Third Quarter of Fiscal Year 2023

On November 9, 2023 Illumina, Inc. reported its financial results for the third quarter of fiscal year 2023, which include the consolidated financial results for GRAIL (Press release, Illumina, NOV 9, 2023, View Source [SID1234637371]).

"While the environment remains challenging, I am confident in our ability to navigate it and position the company for long-term success," said Jacob Thaysen, Chief Executive Officer. "I came to Illumina for the opportunity presented by our core business. While I evaluate the company’s strategy, we will remain focused on driving on further placements of the NovaSeq X, which will boost consumables demand. We will also continue optimizing our operations and drive stronger execution."

Third quarter consolidated results
GAAP Non-GAAP (a)
Dollars in millions, except per share amounts Q3 2023 Q3 2022 Q3 2023 Q3 2022
Revenue $ 1,119 $ 1,115 $ 1,119 $ 1,115
Gross margin 61.1 % 64.3 % 65.4 % 68.4 %
Research and development ("R&D") expense $ 315 $ 325 $ 312 $ 324
Selling, general and administrative ("SG&A") expense $ 303 $ 146 $ 328 $ 336
Goodwill and intangible impairment
$ 821 $ 3,914 $ — $ —
Legal contingency and settlement $ (1) $ (11) $ — $ —
Operating (loss) profit $ (754) $ (3,657) $ 93 $ 102
Operating margin (67.3) % (327.9) % 8.3 % 9.2 %
Tax (benefit) provision
$ (28) $ 144 $ 35 $ 40
Tax rate 3.6 % (4.0) % 39.7 % 43.2 %
Net (loss) income $ (754) $ (3,816) $ 52 $ 54
Diluted (loss) earnings per share $ (4.77) $ (24.26) $ 0.33 $ 0.34

(a) See the tables included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.
During the third quarter of 2023, the company recognized $712 million in goodwill and $109 million in intangible asset (IPR&D) impairment related to the GRAIL segment. The goodwill impairment was primarily due to a decrease in the company’s consolidated market capitalization and a higher discount rate selected for the fair value calculation of the GRAIL reporting unit. The IPR&D impairment was primarily due to a decrease in projected cash flows and a higher discount rate selected for the fair value calculation of the GRAIL IPR&D asset. During the third quarter of 2022, the company recognized $3.91 billion in goodwill impairment related to the GRAIL segment.

Capital expenditures for free cash flow purposes were $45 million for Q3 2023. Cash flow provided by operations was $139 million, compared to cash flow used in operations of $(52) million in the prior year period, which included a one-time payment related to the litigation settlement with BGI. Free cash flow (cash flow provided by (used in) operations less capital expenditures) was $94 million for the quarter, compared to $(119) million in the prior year period. Depreciation and amortization expenses were $108 million for Q3 2023. At the close of the quarter, the company held $933 million in cash, cash equivalents and short-term investments. During the third quarter of 2023, the company used $750 million in cash to repay the outstanding principal of convertible notes that matured in August 2023.

Third quarter segment results
Illumina has two reportable segments, Core Illumina and GRAIL.

Core Illumina
GAAP Non-GAAP (a)
Dollars in millions Q3 2023 Q3 2022 Q3 2023 Q3 2022
Revenue (b)
$ 1,106 $ 1,110 $ 1,106 $ 1,110
Gross margin (c)
64.7 % 67.9 % 66.0 % 68.9 %
R&D expense $ 238 $ 253 $ 235 $ 252
SG&A expense $ 216 $ 66 $ 246 $ 262
Legal contingency and settlement $ (1) $ (11) $ — $ —
Operating profit
$ 262 $ 445 $ 249 $ 251
Operating margin 23.7 % 40.1 % 22.5 % 22.6 %

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

(b) Core Illumina revenue for Q3 2023 was flat as compared to Q3 2022, and flat on a constant currency basis. Amounts for Q3 2023 and Q3 2022 included intercompany revenue of $8 million and $5 million, respectively, which is eliminated in consolidation.
(c) The year-over-year decrease in gross margin was primarily driven by less fixed cost leverage on lower manufacturing volumes, product mix, as well as lower instrument margins and higher field service and installation costs due to the NovaSeq X launch, which is typical in a launch year.

GRAIL
GAAP Non-GAAP (a)
In millions Q3 2023 Q3 2022 Q3 2023 Q3 2022
Revenue $ 21 $ 10 $ 21 $ 10
Gross (loss) profit $ (27) $ (32) $ 6 $ 1
R&D expense $ 79 $ 74 $ 79 $ 74
SG&A expense $ 87 $ 81 $ 82 $ 75
Goodwill and intangible impairment
$ 821 $ 3,914 $ — $ —
Operating loss $ (1,015) $ (4,101) $ (155) $ (148)

(a) See Table 3 included in the "Results of Operations – Non-GAAP" section below for reconciliations of these GAAP and non-GAAP financial measures.

As previously stated, Illumina is committed to moving as quickly as possible through the legal and regulatory processes associated with its acquisition of GRAIL. At this point, Illumina expects decisions on its appeals from the US Court of Appeals for the Fifth Circuit by the end of 2023 and from the European Court of Justice (ECJ) in mid-2024.

Key announcements by Illumina since Illumina’s last earnings release
•Received order from the European Commission to divest GRAIL; Illumina is committed to resolving all issues in a timely manner, with the objective of achieving the maximum value for shareholders and the best outcome for GRAIL
•Launched TruSight Oncology 500 (TSO 500) ctDNA Version 2, a liquid biopsy assay that enables comprehensive genomic profiling of circulating tumor DNA; key improvements include a faster turnaround time of less than four days, higher sensitivity with lower input requirements, and a more streamlined workflow
•Opened new office and state-of-the-art Illumina Solutions Center in Bengaluru, India to grow the genomics market in the most populous country in the world, unlocking opportunities for advancing health care and combating the effects of climate change in South Asia
•Appointed Jacob Thaysen, Ph.D. as Chief Executive Officer and Dr. Steve Barnard as Chief Technology Officer
•Launched the 25B flow cell (300-cycle kit) for the NovaSeq X, enabling customers to generate tens of thousands of whole genomes per year at the lowest cost per sample of any Illumina platform

A full list of recent Illumina announcements can be found in the company’s News Center.

Key announcements by GRAIL since Illumina’s last earnings release
•Collaboration with HCA Healthcare, Inc. to make GRAIL’s Galleri multi-cancer early detection (MCED) available to patients who meet screening criteria at select HCA Healthcare physician practices
•Published final results from PATHFINDER Study, which demonstrated that an earlier version of Galleri identified many cancer types that do not currently have recommended screening tests, enabled targeted cancer diagnostic evaluations, and supported diagnostic resolution for the majority of participants in less than three months
•Expanded pilot with Point32Health to offer Galleri to members meeting eligibility requirements, making Point32Health the first commercial health plan in the U.S. to offer Galleri in addition to recommended cancer screenings

A full list of recent GRAIL announcements can be found in GRAIL’s Newsroom.

Financial outlook and guidance
The non-GAAP financial guidance discussed below reflects certain pro forma adjustments to assist in analyzing and assessing our core operational performance, including the company’s Core Illumina and GRAIL segments. Please see our Reconciliation of Consolidated Non-GAAP Financial Guidance included in this release for a reconciliation of these GAAP and non-GAAP financial measures.

For fiscal year 2023, the company now expects consolidated revenue to decrease 2% to 3% compared to fiscal year 2022. The company now expects Core Illumina revenue to decrease 3% to 4% compared to fiscal year 2022. GRAIL revenue is now expected to be at the low end of the $90 million to $110 million range.

The company now expects GAAP diluted loss per share of $(6.67) to $(6.57) and non-GAAP diluted earnings per share of $0.60 to $0.70.

Conference call information
The conference call will begin at 2 p.m. Pacific Time (5 p.m. Eastern Time) on Thursday, November 9, 2023. Interested parties may access the live teleconference through the Investor Info section of Illumina’s website at investor.illumina.com. Alternatively, individuals can access the call by dialing 866.400.0049 or +1.323.794.2149 outside North America, both using conference ID 1991305. To ensure timely connection, please dial in at least ten minutes before the scheduled start of the call.

A replay of the conference call will be posted on Illumina’s website after the event and will be available for at least 30 days following.

Ikena Oncology Shares Initial Positive and Differentiated Dose Escalation Data from IK-930 Phase I Trial and Reports Third Quarter 2023 Financial Results

On November 9, 2023 Ikena Oncology, Inc. (Nasdaq: IKNA, "Ikena," "Company"), a targeted oncology company forging new territory in patient-directed cancer treatment, reported financial results for the quarter ended September 30, 2023, and provided a corporate update (Press release, Ikena Oncology, NOV 9, 2023, View Source [SID1234637370]). The Company also shared initial data from twenty-six (26) patients treated in the ongoing dose escalation portion of the Phase I clinical trial of IK-930, a novel, oral, potent, and highly selective Hippo pathway inhibitor.

"This early look at the IK-930 dose escalation data strongly supports our differentiated approach to targeting the Hippo pathway. Importantly, following the target biology and initially focusing on EHE has allowed us to observe clinical activity of IK-930 early in our dose escalation. Even in the projected efficacious exposure range and at doses with clinical activity, IK-930 has thus far circumvented the renal toxicity observed with pan-TEAD inhibitors," commented Mark Manfredi, Ph.D., Chief Executive Officer of Ikena. "Now, with IK-930’s safety profile allowing us to potentially dose patients to their optimal benefit, combined with sufficient capital to drive us through multiple data readouts, we are looking ahead to a series of rapid next steps with the program. We are increasing our focus on our targeted monotherapy indications, such as EHE and mesothelioma, and have growing confidence that as we continue the program IK-930 may be able provide the therapeutic window and clinical benefit these patient populations need."

IK-930 Dose Escalation Summary and Emerging Proof of Concept in EHE

IK-930 selectively binds TEAD1 and broadly represses oncogenic TEAD signaling as a potent Hippo-pathway inhibitor, a known suppressor pathway in cancers such as epithelioid hemangioendothelioma (EHE), mesothelioma, meningioma, and others. IK-930’s differentiated paralog selectivity and robust repressor activity in complex with VGLL4 are key characteristics supporting anti-tumor effect in preclinical models. IK-930 is designed to circumvent renal toxicity, potentially resulting in an optimized therapeutic index. Twenty-six patients with a range of solid tumors were treated in the dose escalation portion of the study as of October 31, 2023. The most common tumor type enrolled was EHE.

Differentiated Safety Profile

•
26 patients have been treated with IK-930 in dose escalation as of October 31, 2023
•
IK-930 is in the final stages of dose optimization; the tolerability profile observed thus far supports the hypothesis that IK-930’s selectivity could provide a wider therapeutic index for this new class of compounds
o
Proteinuria is an adverse effect of special interest as it may be an on-target effect of broad TEAD inhibition
o
Treatment-related proteinuria was recorded in 3 out of 26 dose escalation patients and was limited to grade 1-2
▪
The observed proteinuria did not result in dose reduction or treatment interruption; no proteinuria events were considered dose-limiting and in all cases was fully reversible
o
Other safety observations include:
▪
Frequent adverse events to date have been low-grade nausea, fatigue, and diarrhea, and have not required any dose reduction
▪
Two EHE patients with significant liver metastases experienced reversible liver enzyme elevation
•
One of these patients developed treatment-related grade 3 elevation, deemed dose limiting (the only DLT observed), and the patient remains on study after dose adjustment
•
The other patient experienced grade 3-4 elevation that was deemed possibly treatment related;
▪
Dose escalation is currently ongoing
o
15 patients were treated with doses within the projected efficacious exposure range and pharmacokinetic data showed some variability
▪
7 out of 15 patients were determined to reach efficacious exposure
▪
Target engagement in tumor, as determined by decreased TEAD gene signature, has been demonstrated in the efficacious dose range
▪
To minimize IK-930 exposure variability, a next generation formulation is now being evaluated in the dose escalation
▪
Recommended dosing for the next stage of the IK-930 program is expected to be determined in the near-term

Emerging Proof of Concept in EHE

Epithelioid hemangioendothelioma is a rare vascular sarcoma defined by gene fusions of either YAP or TAZ genes in the Hippo pathway with other transcriptional regulators. EHE is a slow-growing, invasive tumor with no approved treatment options and is challenging to measure due to diffuse infiltration of multiple organs. It can occur in multiple areas of the body, including the liver, lungs, bones, and blood vessels. People with EHE suffer symptoms that relentlessly affect their quality of life and are consistent with the site of the EHE growth, including liver failure, respiratory issues, and gastrointestinal symptoms, which are frequently accompanied by severe pain across the body. With no approved standard of care, there is substantial need for innovative treatments that can provide clinical benefit and symptom relief and slow or limit the progression of disease.

•
Seven patients with EHE have been treated with IK-930 in the dose escalation portion of the trial
o
7 out of 7 EHE patients reached stable disease as a best response so far as measured by RECIST
o
3 out of the 7 patients experienced tumor shrinkage in multiple target and non-target lesions
o
4 out of 7 highly symptomatic EHE patients enrolled across multiple dose levels reported symptomatic improvement and subjective improvement of quality of life such as improved energy, weight gain, and pain control
o
3 out of the 7 patients continue on treatment with time on treatment ranging from 18 to 26 weeks and ongoing
•
As a result of these initial tolerability and antitumor activity findings, enrollment in the dose escalation phase continues to progress in targeted populations including mesothelioma and meningioma, in addition to EHE
•
Based on preclinical data indicating IK-930 synergy with EGFR inhibitors to combat therapeutic resistance, a combination cohort for IK-930 and osimertinib in patients with EGFR-mutant non-small cell lung cancer (NSCLC) is planned to initiate in 2024
•
An additional data update from the IK-930 clinical program is planned for the second half of 2024
"EHE is a rare soft tissue sarcoma for which there is no known treatment. This tumor is 100% driven by the Hippo pathway which has motivated our initial development of IK-930 in EHE, despite the challenge of assessing the disease burden and treatment effects. The EHE patient community is one of the strongest I have worked with. The physicians, patients, and supportive community are deeply committed to finding innovative solutions in EHE, and we are immensely grateful for their partnership in these early days of the IK-930 clinical program," commented Sergio Santillana, M.D., Chief Medical Officer of Ikena.

"The EHE community is excited by this early data from IK-930, the first targeted agent for patients with EHE, and we eagerly await more data. Rare cancers, like EHE, present significant challenges for drug developers, and we are encouraged by Ikena’s commitment to this program. We are grateful for the participation of EHE patients, caregivers, and physicians in the trial, and we look forward to continuing our partnership with Ikena," commented Tammy Silverthorne, Executive Director of The EHE Foundation.

Summary of Additional Recent Pipeline Progress and Corporate Updates

IK-595: MEK-RAF Molecular Glue

•
IK-595 clinical trial anticipated to initiate by year end 2023
•
Additional preclinical updates were presented at the 5th Annual RAS-Targeted Drug Development Conference in September and AACR (Free AACR Whitepaper)-NCI-EORTC AACR-NCI-EORTC (Free AACR-NCI-EORTC Whitepaper) International Conference on Molecular Targets and Cancer Therapeutics (EORTC-NCI-AACR) (Free ASGCT Whitepaper) (Free EORTC-NCI-AACR Whitepaper) in October

IK-175: AHR Inhibitor in Collaboration with Bristol Myers Squibb

•
The Phase 1 clinical trial in urothelial carcinoma has completed enrollment and the program is eligible for opt-in from Bristol Myers Squibb through early 2024

Corporate Updates

•
In August 2023, the Company acquired Pionyr Immunotherapeutics, Inc. ("Pionyr"), a privately held biotech company, in an all-stock transaction
o
Ikena acquired all of Pionyr assets, including approximately $43 million in net cash in exchange for shares of Ikena stock at price of $7.15 per share
o
The valuation for the transaction was determined solely by net cash available at closing
•
The Company believes that cash at hand will be sufficient to meet its operating requirements into 2026 through multiple data events for both IK-930 and IK-595

Financial Results for the Quarter Ended September 30, 2023

As of September 30, 2023, Ikena had $196.9 million in cash, cash equivalents and marketable securities. Net cash used in operating activities was $19.9 million for the three months ended September 30, 2023, as compared to $17.2 million of cash used in operating activities for the same period in 2022.

Collaboration revenue was $1.2 million and $6.4 million for the three months ended September 30, 2023 and 2022, respectively. The decrease in revenue of $5.2 million was primarily due to an increase in manufacturing activities as a result of the substantial completion of manufacturing efforts related to the IK-412 program during the three months ended September 30, 2022.

Research and development expenses were $14.7 million and $18.9 million for the three months ended September 30, 2023 and 2022, respectively. The decrease in research and development expenses of $4.2 million was primarily due to decreases in clinical trial costs related to IK-175 and decreases in other discovery stage programs as a result of the Company prioritizing its focus on advancing its clinical stage programs, partially offset by costs incurred to wind down Pionyr clinical trials.

General and administrative expenses were $6.0 million and $5.4 million for the three months ended September 30, 2023 and 2022, respectively. The increase in general and administrative expenses of $0.6 million was primarily attributable to an increase in legal expenses.

Ichnos Sciences Data Selected For Presentation at the 65th ASH Annual Meeting

On November 9, 2023 Ichnos Sciences, a global clinical-stage biotechnology company developing innovative multispecific antibodies for oncology, reported that three abstracts highlighting data on its leading oncology assets have been selected for presentation at the upcoming 65th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting and Exposition (Press release, Ichnos Sciences, NOV 9, 2023, View Source [SID1234637369]). The meeting will be held December 9-12, 2023, in San Diego, California.

These abstracts discuss three assets—ISB 2001, ISB 1342 and ISB 1442—each of which have been granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of multiple myeloma and are currently in global Phase 1 clinical studies. The data to be presented will demonstrate the innovative approach of Ichnos’ proprietary BEAT platform1 to target tumor cells via the engagement of different immune cell subtypes. This approach holds promise to be a curative therapy for patients experiencing relapsed or refractory multiple myeloma who need new treatment options.

"Ichnos’ work is built on a foundation of believing a cure is attainable and recognizing that there is a wide space in oncology for original thinking when it comes to developing efficient, disease-specific treatments," said Lida Pacaud, M.D., Chief Medical Officer of Ichnos Sciences. "Our scientific platform leverages the power of the human immune system in the fight against cancer, and we are glad to be granted the opportunity to share our data on this approach thus far at the upcoming ASH (Free ASH Whitepaper) Annual Meeting."

Visit the Ichnos Sciences booth (#305) at the ASH (Free ASH Whitepaper) Annual Meeting to learn more about Ichnos’ proprietary BEAT platform, expanding pipeline of assets in hematological and solid tumor malignancies, partnership opportunities and more.

More information about Ichnos presentations is detailed below:

Title Details (All in Pacific Time)
Poster Presentation: Trial in Progress: A Phase 1, First-in-Human, Dose Escalation and Dose-Expansion Study of a BCMAxCD38xCD3 Targeting Trispecific Antibody ISB 2001 in Subjects with Relapsed / Refractory Multiple Myeloma (RRMM) Sunday, December 10, 2023, 6:00 PM-8:00 PM
San Diego Convention Center, Halls G-H
Session: 653. Multiple Myeloma: Prospective Therapeutic Trials: Poster II
Publication Number: 3396
Poster Presentation: Dose Escalation of ISB 1342, a Novel CD38xCD3 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM) Sunday, December 10, 2023, 6:00 PM-8:00 PM
San Diego Convention Center, Halls G-H
Session Name: 652. Multiple Myeloma: Clinical and Epidemiological: Poster II
Publication Number: 3339
Poster Presentation: Initial Results From the Dose Escalation Phase1/2 of ISB 1442, a Novel CD38 Biparatopic x CD47 Bispecific Antibody, in Patients with Relapsed / Refractory Multiple Myeloma (RRMM) Monday, December 11, 2023, 6:00 PM-8:00 PM
San Diego Convention Center, Halls G-H
Session Name: 652. Multiple Myeloma: Clinical and Epidemiological: Poster III
Publication Number: 4707

The full ASH (Free ASH Whitepaper) 2023 Annual Meeting abstracts are available for review at: View Source
Follow Ichnos on LinkedIn for more updates throughout the conference.

HOOKIPA Pharma Reports Third Quarter 2023 Financial Results and Recent Business Highlights

On November 9, 2023 HOOKIPA Pharma Inc. (NASDAQ: HOOK, ‘HOOKIPA’), a company developing a new class of immunotherapeutics based on its proprietary arenavirus platform, reported financial results and business highlights for the third quarter of 2023 (Press release, Hookipa Biotech, NOV 9, 2023, View Source [SID1234637368]).

"I am pleased by the consistent and strong data within our HB-200 program; not only is our mechanism delivering powerful antigen-specific T cell responses, but it has also helped our patients continue their fight against cancer with promising objective response rate and disease control rate. With these encouraging data, we are busy finalizing plans for the randomized trial expected to begin next year," said Joern Aldag, Chief Executive Officer at HOOKIPA Pharma. "We also have significant, and achievable, upcoming milestones across our portfolio of programs, a testament to the potential of arenaviral platform technology to address unmet needs in cancer and infectious diseases."

Business Highlights and Recent Developments

Oncology

In October, HOOKIPA announced positive preliminary Phase 2 data on additional patients for HB-200 in combination with pembrolizumab, in patients with recurrent/metastatic Human Papillomavirus 16-positive (HPV16+) head and neck cancers, which was consistent with the preliminary data HOOKIPA announced in May 2023. Data from the ongoing study (NCT04180215), which was presented at the European Society for Medical Oncology Congress 2023, showed a 42 percent objective response rate for 19 evaluable checkpoint inhibitor (CPI)-naïve patients treated with HB-200 in combination with pembrolizumab. These data represent a doubling of the historical response rate (19 percent) reported for pembrolizumab alone and are consistent with previously reported data from the Phase 2 trial. HOOKIPA is preparing to start a randomized trial of HB-200 in combination with pembrolizumab in the 1st-line setting for patients with recurrent/metastatic HPV16+ head and neck cancers in mid-2024.
Enrollment continued in the ongoing Phase 1/2 study (NCT05553639) of HB-300 for the treatment of advanced prostate cancer. HB-300 is an arenaviral immunotherapy that targets two well-defined self-antigens of prostate cancer, prostatic acid phosphatase (PAP) and prostate-specific antigen (PSA). Initial safety, tolerability and immunogenicity data from the ongoing Phase 1 study of HB-300 are expected in the first half of 2024.
HOOKIPA’s HB-700 program, in collaboration with Roche, is progressing to an expected Investigational New Drug (IND) application filing in the first half of 2024. HB-700 is a novel arenaviral immunotherapy for KRAS-mutated cancers, including the five mutations that are the primary causes of lung, pancreatic and colon cancers.
Infectious disease

In August, The Journal of Infectious Disease, published peer-reviewed preclinical data on HB-400, an investigational therapeutic vaccine for chronic hepatitis B (HBV). The data show that HB-400 (NCT05770895) induced robust, HBV-specific T cell and antibody responses in non-human primates and cleared detectable serum HBV antigens in a mouse model for chronic HBV infection, with near elimination of detectable HBV antigen positive hepatocytes in the liver. HB-400 currently being evaluated in a Phase 1 trial and is one of two independent development programs in HOOKIPA’s collaboration and license agreement with Gilead Sciences, Inc. Gilead is solely responsible for further development and commercialization of the HBV product candidate.
HOOKIPA’s HB-500 program, also partnered with Gilead, is progressing towards an anticipated IND filing in the fourth quarter of 2023 and is expected to commence a Phase 1 clinical trial in 2024. HB-500 is a novel arenaviral vaccine that will be assessed as part of a potential functional curative regimen for HIV.
Anticipated Milestones

Phase 2 HB-200 in HPV16+ head and neck cancers
1st-line follow-up data in combination with pembrolizumab: H1 2024
Start of 1st-line randomized study in combination with pembrolizumab:
mid-2024 (Fast Track designation)
Phase 1 HB-300 in prostate cancer
Preliminary safety and immunogenicity data: H1 2024
HB-700 in KRAS-mutated cancers: IND filing H1 2024
HB-400 in hepatitis B: to be determined by Gilead
HB-500 in HIV: IND filing Q4 2023
Third Quarter 2023 Financial Results
Cash Position: HOOKIPA’s cash, cash equivalents and restricted cash as of September 30, 2023 was $108.1 million compared to $113.4 million as of December 31, 2022. The decrease was primarily attributable to cash used in operating activities, partly offset by funds resulting from the follow-on financing in June 2023.

Revenue: Revenue was $6.9 million for the three months ended September 30, 2023 and $2.2 million for the three months ended September 30, 2022. This increase was primarily due to higher partial recognition of the upfront and milestone payments under the Gilead and Roche collaborations, cost reimbursements for activities related to the preparation of a first human trial under the Roche collaboration, partially offset by lower cost reimbursements received under the Restated Gilead Collaboration Agreement.

Research and Development Expenses: HOOKIPA’s research and development expenses were $24.6 million for the three months ended September 30, 2023, compared to $18.3 million for the three months ended September 30, 2022. The primary drivers of the increase in research and development expenses by $6.3 million were higher clinical study expenses for our HB-200 program and increased spending for our Roche partnered program.

General and Administrative Expenses: General and administrative expenses amounted to $4.9 million for the three months ended September 30, 2023 and the three months ended September 30, 2022, respectively. General and administrative expenses remained constant.

Net Loss: HOOKIPA’s net loss was $19.1 million for the three months ended September 30, 2023, compared to a net loss of $18.3 million for the three months ended September 30, 2022. This increase was primarily due to an increase in research and development expenses.