On April 27, 2023 LamKap Bio reported that it has presented data on NILK-2301, NILK-2401 & NILK-3301 (Press release, LamKap Bio Group, APR 27, 2023, View Source [SID1234630610]).

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The American Association for Cancer Research (AACR) (Free AACR Whitepaper) hosted the AACR (Free AACR Whitepaper) annual meeting 2023 April 14-19, 2023. LamKap Bio is very pleased to have presented preclinical data on the combination of NILK-2301 (CEACAM5xCD3) and NILK-2401 (CEACAM5xCD47) as well as NILK-2301 and NILK-3301 (CEACAM5xCD28) bispecific antibodies for immunotherapy of patients with carcinoembryonic antigen-related cell adhesion molecule 5 (CEACAM5 aka CEA) expressing solid tumors.

"Combination of κλ bispecific antibodies targeting innate (CEAxCD47, NILK-2401) and adaptive immunity (CEAxCD3, NILK-2301 and CEAxCD28, NILK-3301) for next generation immunotherapy of CEA-expressing cancers" (abstract no. 5100) was presented on site in poster section 22 (board no. 3) on April 18, 1:30 PM – 5:00 PM.

On April 27, 2023 Gilead Sciences, Inc. (Nasdaq: GILD) reported its results of operations for the first quarter of 2023 (Press release, Gilead Sciences, APR 27, 2023, View Source [SID1234630607]).

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"Gilead’s track record of strong commercial and clinical execution continued through the first quarter of 2023. A 15% year-over-year revenue increase reflects growth in each of our core areas," said Daniel O’Day, Gilead’s Chairman and Chief Executive Officer. "Biktarvy outperformed once again, and Oncology revenue increased 59% year-over-year, driven by Trodelvy and Cell Therapy. We look forward to helping even more people with Trodelvy following the approval for pre-treated HR+/HER2- metastatic breast cancer, making this the third U.S. approval for Trodelvy in three years."

First Quarter 2023 Financial Results

•Total first quarter 2023 revenue decreased 4% to $6.4 billion compared to the same period in 2022, due to lower Veklury (remdesivir) sales, partially offset by increased sales in HIV and Oncology.
•Diluted Earnings Per Share ("EPS") increased to $0.80 for the first quarter of 2023 compared to $0.02 for the same period in 2022, mainly driven by the following items net of their related tax effect: a $2.7 billion in-process research and development ("IPR&D") impairment recorded in the first quarter of 2022, which did not repeat in 2023, partially offset by higher operating expenses, including higher acquired IPR&D expense and lower revenues in 2023.
•Non-GAAP diluted EPS decreased to $1.37 for the first quarter of 2023 compared to $2.12 for the same period in 2022, primarily driven by the following items net of their related tax effect: higher operating expenses, including higher acquired IPR&D expense, and lower revenues in 2023.
•As of March 31, 2023, Gilead had $7.2 billion of cash, cash equivalents and marketable debt securities, down from $7.6 billion as of December 31, 2022.
•During the first quarter of 2023, Gilead generated $1.7 billion in operating cash flow.
•During the first quarter of 2023, Gilead paid dividends of $969 million and repurchased $400 million of common stock.
Product Sales Performance
Total first quarter 2023 product sales decreased 3% to $6.3 billion compared to the same period in 2022. Total product sales, excluding Veklury, increased 15% to $5.7 billion in the first quarter of 2023 compared to the same period in 2022, primarily due to increased sales related to HIV, Cell Therapy, Trodelvy (sacituzumab govitecan-hziy) and Liver Disease.

HIV product sales increased 13% to $4.2 billion in the first quarter of 2023 compared to the same period in 2022, primarily driven by favorable pricing dynamics, as well as higher demand and lower inventory draw-downs.
•Biktarvy (bictegravir 50mg/emtricitabine 200mg ("FTC")/tenofovir alafenamide 25mg ("TAF")) sales increased 24% year-over-year in the first quarter of 2023, reflecting higher demand, as well as favorable pricing and inventory dynamics.
•Descovy (FTC 200mg/TAF 25mg) sales increased 20% year-over-year in the first quarter of 2023, primarily driven by higher demand and favorable pricing dynamics.
The Liver Disease portfolio sales, which includes chronic hepatitis C virus ("HCV"), chronic hepatitis B virus ("HBV") and chronic hepatitis delta virus ("HDV"), increased 6% to $675 million in the first quarter of 2023 compared to the same period in 2022, primarily driven by higher demand and timing of purchases in the U.S.
Cell Therapy product sales increased 64% to $448 million in the first quarter of 2023 compared to the same period in 2022.
•Yescarta (axicabtagene ciloleucel) sales increased 70% to $359 million in the first quarter of 2023, primarily driven by increased demand in relapsed or refractory ("R/R") large B-cell lymphoma ("LBCL").
•Tecartus (brexucabtagene autoleucel) sales increased 40% to $89 million in the first quarter of 2023, primarily driven by increased demand in R/R mantle cell lymphoma and R/R adult acute lymphoblastic leukemia ("ALL").
Trodelvy sales increased by 52% to $222 million in the first quarter of 2023 compared to the same period in 2022, primarily driven by increased adoption in metastatic triple-negative breast cancer in the United States and Europe, as well as the launch of the indication for pretreated HR+/HER2- metastatic breast cancer in the United States.
Veklury sales decreased by 63% to $573 million for the first quarter of 2023 compared to the same period in 2022, primarily driven by lower rates of COVID-19 related hospitalizations in all regions. Veklury sales generally reflect COVID-19 related rates and severity of infections and hospitalizations, as well as the availability, uptake and effectiveness of vaccinations and alternative treatments for COVID-19.
First Quarter 2023 Product Gross Margin, Operating Expenses and Effective Tax Rate
•Product gross margin was 77.8% for the first quarter of 2023 compared to 78.2% for the same period in 2022. Non-GAAP product gross margin was 86.2% for the first quarter of 2023 compared to 87.4% in the same period in 2022.
•Research and development ("R&D") expenses and non-GAAP R&D expenses for the first quarter of 2023 were $1.4 billion, compared to $1.2 billion in the same period in 2022. The increases in GAAP and non-GAAP R&D expenses were primarily driven by increased clinical activities.
•Acquired IPR&D expenses for the first quarter of 2023 were $481 million compared to $8 million in the same period in 2022, primarily driven by the acquisition of Tmunity Therapeutics Inc. ("Tmunity"), as well as upfront and milestone payments related to the collaborations with Arcellx, Inc. ("Arcellx") and Nurix Therapeutics, Inc. ("Nurix").
•Selling, general and administrative ("SG&A") expenses and non-GAAP SG&A expenses for the first quarter of 2023 were $1.3 billion, compared to $1.1 billion in the same period in 2022. The increases in GAAP and non-GAAP SG&A expenses were primarily due to Oncology commercial expansion and investments, higher Branded Prescription Drug fee, as well as higher corporate activities.
•The effective tax rate ("ETR") for the first quarter of 2023 was 24.3% compared to 107.9% for the same period in 2022. The decrease in ETR was primarily due to a $2.7 billion IPR&D impairment taken in the first quarter of 2022 related to assets acquired by Gilead from Immunomedics Inc. that did not repeat in 2023. Non-GAAP ETR for the first quarter of 2023 was 18.9% compared to 18.4% for the same period in 2022.

Guidance and Outlook

For the full-year, Gilead expects:

•Total product sales between $26.0 billion and $26.5 billion, unchanged from prior guidance.
•Total product sales, excluding Veklury, between $24.0 billion and $24.5 billion, unchanged from prior guidance.
•Total Veklury sales of approximately $2.0 billion, unchanged from prior guidance. Veklury sales are expected to be highly variable, depending on the frequency and severity of surges, and our guidance will continue to be updated on a quarterly basis as necessary.
•Diluted earnings per share between $4.75 and $5.15, compared to $5.30 and $5.70 previously.
•Non-GAAP diluted earnings per share between $6.60 and $7.00, unchanged from prior guidance.
Additional information and a reconciliation between GAAP and non-GAAP financial information for the 2023 guidance is provided in the accompanying tables. Also see the Forward-Looking Statements described below. The financial guidance is subject to a number of risks and uncertainties, including uncertainty around the duration and magnitude of the COVID-19 pandemic.
Key Updates Since Our Last Quarterly Release
Virology
•Presented positive Phase 1b proof-of-concept data for an investigational combination regimen of lenacapavir with broadly neutralizing antibodies teropavimab and zinlirvimab as a potential long-acting treatment regimen for HIV with twice-yearly dosing at the Conference on Retroviruses and Opportunistic Infections ("CROI") 2023. In addition, announced results from multiple collaborative studies evaluating novel investigational combinations and strategies as part of the HIV cure research program.
•Announced new real-world study data at CROI demonstrating Veklury use in hospitalized patients with COVID-19 was associated with a statistically significant reduction in mortality in the overall patient population, including immunocompromised patients. Real-world data analyses of Veklury from other sources are ongoing and may vary in their results or conclusions. Separate in vitro analyses were also presented that showed Veklury retains potent antiviral activity against recent Omicron subvariants.
•Presented new COVID-19 data at the European Congress of Clinical Microbiology and Infectious Diseases, including results from a Phase 1 study of obeldesivir (GS-5245), as an investigational oral therapy for the treatment of COVID-19. Additionally, presented findings from a Phase 3 study of Veklury in patients with severe renal impairment, as well as new real-world studies.
Oncology
•Received FDA approval of Trodelvy for the treatment of adult patients with unresectable locally advanced or metastatic HR+/HER2- breast cancer who have received endocrine-based therapy and at least two additional systemic therapies in the metastatic setting.
•Presented positive results from a three-year follow-up analysis of Tecartus in the Phase 2 ZUMA-3 study of patients with R/R ALL at the European CAR T-cell Meeting.
•Presented positive data from the Phase 2 TROPHY-U-01 study of Trodelvy for the treatment of metastatic urothelial cancer at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Genitourinary Cancers Symposium.
•Completed the acquisition of Tmunity, a clinical stage private biotech company, which provides preclinical and clinical programs, including an investigational "armored" CAR T technology platform that has the potential to be applied to a variety of CAR Ts to enhance anti-tumor activity, as well as rapid manufacturing processes.
•Announced primary overall survival results from the Phase 3 ZUMA-7 study for initial treatment of adult patients with R/R LBCL, which showed a statistically significant improvement for Yescarta in overall survival versus historical treatment.

Inflammation

•Exercised option to license investigational targeted protein degrader molecule NX‑0479 ("GS-6791") from Nurix. GS-6791 is a potent, selective, oral IRAK4 degrader with potential applications in the treatment of rheumatoid arthritis and other inflammatory diseases.

Corporate

•The company’s Board of Directors declared a quarterly dividend of $0.75 per share of common stock for the second quarter of 2023. The dividend is payable on June 29, 2023, to stockholders of record at the close of business on June 15, 2023. Future dividends will be subject to Board approval.
Certain amounts and percentages in this press release may not sum or recalculate due to rounding.

Conference Call

At 1:30 p.m. Pacific Time today, Gilead will host a conference call to discuss Gilead’s results. A live webcast will be available on View Source and will be archived on www.gilead.com for one year.

On April 27, 2023 Evaxion Biotech A/S (NASDAQ: EVAX) ("Evaxion" or the "Company"), a clinical-stage biotechnology company specializing in the development of AI-driven immunotherapies, reported the fourth quarter and full-year 2022 financial results and provided a business update (Press release, Evaxion Biotech, APR 27, 2023, View Source [SID1234630606]).

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"Evaxion made excellent progress across its core AI technologies for vaccine target discovery in 2022 and early 2023, validated through the progress in the pipeline," said Per Norlén, Chief Executive Officer of Evaxion. "Looking back on our accomplishments, I’d like to highlight the initial proof-of-concept clinical trials in melanoma for EVX-01 and EVX-02, developed using our PIONEER artificial intelligence (AI)-platform, and our next-generation immuno-oncology candidate, EVX-03, scheduled to begin clinical testing in Q4 2023. We also announced another proprietary AI technology, ObsERV, targeting endogenous retroviruses (ERVs), which is planned to be incorporated into our personalized cancer vaccines. Over the last six months, as we have refined our development strategy and business focus, re-aligned our organization and extended our cash runway, I am grateful to the outstanding work of the team and remain impressed by the strength of Evaxion’s core AI-science."

Per concluded, "We recently reported promising clinical results from the Phase 1/2a EVX-02 study in melanoma at the 2023 annual meeting for the American Association for Clinical Research (AACR) (Free AACR Whitepaper). Looking ahead to the rest of the year, we plan to report final Phase 1/2a results and interim Phase 2 data from the EVX-01 program in melanoma. In addition, we intend to initiate recruitment in a Phase 1 study with EVX-03 in Q4 2023. We look forward to inform the investment community and our key stakeholders with further updates on our progress throughout the year."

Pipeline Updates

Technology advances:
Novel ObsERV technology — In March 2023, Evaxion reported the discovery of a novel new source of antigens for personalized cancer immunotherapy, based on endogenous retroviruses (ERVs). The AI-enabled technology has the potential to make "cold" tumors responsive to immunotherapy, which has the potential to broaden the patient population for immunotherapy significantly.

Novel mRNA vaccine delivery collaboration with Pantherna — In February 2023, Evaxion and Pantherna announced promising mRNA vaccine data. The preclinical data demonstrated that tumor neoantigens identified by Evaxion’s AI PIONEER platform could drive a strong immune response and lead to complete inhibition of tumor growth when delivered using Pantherna’s proprietary mRNA platform.

Program Overview
EVX-01 (1st generation, Peptide based vaccine, Phase 2 in melanoma) – The ongoing single-arm, multi-center trial (NCT05309421) is evaluating EVX-01 for the treatment of adults with metastatic melanoma in combination with the [PD-1 inhibitor/checkpoint inhibitor/CPI], KEYTRUDA.

The Company plans to present a full read-out of the previous Phase 1/2a study in 12 patients at the American Society for Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023, in which interim data demonstrated clinical response in six out of the first nine patients.
The Phase 2 study, initiated in September 2022, is expected to enroll up to 20 patients and report interim data in Q4 2023.
EVX-02 (2nd generation, DNA-based vaccine, Phase 1/2a in melanoma) – The single-arm, open-label study (NCT04455503) evaluated EVX-02 in combination with the CPI, nivolumab, in patients with advanced melanoma who had undergone complete surgical resection and were at high risk for recurrence.

Data presented at the 2023 AACR (Free AACR Whitepaper) meeting showed that all 10 patients who completed the full course of dosing with the EVX-02/CPI combination were relapse-free during the 12-month study period. The treatment also produced neoantigen-specific long-lasting T-cell immune responses involving both CD4+ and CD8+ T-cells. The EVX-02/CPI treatment combination was well tolerated, and only mild EVX-02-associated adverse events (AEs) were observed.
EVX-03 (3rd generation, DNA-based vaccine, Phase 1 study expected to begin in Q4 2023) – EVX-03 is a DNA-based personalized cancer immunotherapy that combines patient-specific neoantigens with personalized ERVs. Bringing these personalized antigens together into a single plasmid construct, armed with a genetic immune adjuvant, will enable Evaxion to develop an immunotherapy with the potential for inducing a robust and patient-specific immune response and for increased efficacy.

A clinical trial authorization (CTA) filing with the European Medicines Agency to evaluate the combination of EVX-03 and a CPI is anticipated to be filed in Q3 2023 and the Phase 1 study is anticipated to begin in Q4 2023 in patients with solid tumors.
Infectious diseases programs: based on Evaxion’s EDEN and RAVEN technologies

Technology advances:
EVX-B1 (S. aureus, preclinical) – Evaxion has demonstrated significant protection from S. aureus infection in both sepsis and skin infection models. The next step for this partnering-ready program is IND-enabling toxicology studies.

EVX-B2 (N. gonorrhoeae, preclinical) – In June 2022, Evaxion announced gonorrhea as a new bacterial vaccine candidate for N. gonorrhoeae. In September 2022, Evaxion announced that the Company, in collaboration with the UMass Chan Medical School, had received a grant from the U.S. National Institutes of Health (NIH) for the development of a lead vaccine candidate.

EVX-V1 (Cytomegavirus/CMV, preclinical) – In December 2022, Evaxion and ExpreS²ion initiated the discovery phase of a joint research collaboration to develop a next generation CMV vaccine candidate that elicits both cellular and humoral antibody responses; this phase will be jointly funded until 2025. After that, the parties could expand the research collaboration into a Development and Commercialization agreement.

Expected milestones in 2023

Q2 2023 – Full readout EVX-01 Phase 1/2a – to be presented at ASCO (Free ASCO Whitepaper) in June 2023
Q4 2023 – Report interim results from EVX-01 Phase 2 trial
Q4 2023 – Initiate patient recruitment in a Phase 1 study for EVX-03
Full Year 2022 Financial Results

Cash position: As of December 31, 2022, cash and cash equivalents were $13.2 million as compared to $32.2 million as of December 31, 2021. This along with capital raised in Q1 2023 of $4.2 million, is anticipated to be sufficient to fund operations into December 2023.
Research and Development expenses were $17.1 million for the year ended December 31, 2022 as compared to $19.6 million for the year ended December 31, 2021. The decrease was primarily related to a decrease in spending on clinical trials, net of grant income and preclinical product candidates countered by an increase in employee-related costs.
General and Administrative expenses were $8.2 million for the year ended December 31, 2022 compared to $6.3 million for the year ended December 31, 2021. The increase was primarily related to professional fees incurred by the corporate functions as a listed company.
Net loss was $23.2 million for the year ended December 31, 2022 or ($0.98) loss per basic and diluted share as compared to $24.5 million, or ($1.26) loss per basic and diluted share for the year ended December 31, 2021.
Based on the Company’s current cash position, with a cash runway until beginning of December and the need for further funding, our auditors EY have provided an emphasis of matter in their auditors report that there exists substantial doubt about the Company’s ability to continue as a going concern.

Webcast and Conference Call

Evaxion will host a webcast and conference call today, April 27, at 8:30 am EDT.

To dial in for the conference call, please use the following details:

US: 877‑407‑0792
International: +1‑201‑689‑8263
Conference ID: 13727933
Alternatively to access the audio webcast, please visit the events page of Evaxion’s website at: View Source

On April 27, 2023 Elicio Therapeutics, a clinical-stage biotechnology company developing a pipeline of novel immunotherapies for the treatment of cancer and other diseases, reported the first patient has been dosed in the Phase 1/2 study of ELI-002 7P (AMPLIFY-7P) in KRAS/NRAS mutated solid tumors at Northwell Health Cancer Institute and the Feinstein Institutes for Medical Research, New York (Press release, Elicio Therapeutics, APR 27, 2023, View Source [SID1234630604]).

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ELI-002 7P is an investigational therapeutic cancer vaccine that was created with Elicio’s proprietary lymph node-targeting Amphiphile (AMP) technology to treat cancers driven by seven common mutations in KRAS representing 25% of all solid tumors. Most other KRAS-targeted therapeutics in development — particularly small molecule KRAS inhibitors — target fewer mutations, potentially limiting the number of patients that can be treated.

Interim data from the AMPLIFY-201 study evaluating the 2-peptide formulation of ELI-002 in mKRAS pancreatic and colorectal cancer patients including the effects of dose on proof-of-concept safety, antitumor biomarkers, relapse-free survival, and immune mechanism of action endpoints is anticipated to be presented at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in June 2023.

"This key milestone highlights our expansion to more of the patient population with common KRAS and NRAS mutations who could potentially benefit from smart vaccines that engage the lymph node, the ‘brain center’ of the immune response," said Christopher Haqq, M.D., Ph.D., Elicio’s Executive Vice President, Head of Research and Development, and Chief Medical Officer. "Our clinical experience with AMP vaccines will be important to rapidly advance the development of broad-spectrum ELI-002 7P, targeting seven mutations G12D, G12V, G12R, G12C, G12S, G12A and G13D in patients with high relapse risk, KRAS-driven, cancers who have minimal residual disease following surgery and chemotherapy."

Robert Connelly, Elicio’s Chief Executive Officer, added, "The dosing of the first patient in AMPLIFY-7P, our second ongoing clinical trial, is a testament to the dedication of our team and study collaborators in exploring the potential of ELI-002 as a universal, all-stage immunotherapeutic for treating and preventing mKRAS-driven tumors. We believe there is a path for its use as a monotherapy and a combination therapy in different clinical settings, so we intend to move quickly, conducting a safety run-in bridging from the 2-peptide to the 7-peptide formulations before initiating the Phase 1b and randomized Phase 2 studies, which we hope will inform our plans for a combination trial and provide supporting evidence for expedited development pathways with regulatory agencies."

The current standard of care for patients who remain positive for a biomarker following surgery and initial treatment is observation to monitor for relapse, which has a near certain probability of occurring. In pancreatic ductal adenocarcinoma (PDAC) patients who have positive circulating tumor DNA (ctDNA) post-surgery, relapse occurs in 80%–85% of cases despite ‘curative’ resection with a median time of 9.9 months to recurrence. In colorectal cancer (CRC) patients who have positive ctDNA post-surgery, radiologic recurrence was detected in approximately 79% of cases with a Kaplan Meier estimate of 0% survival at 3 years. These relapse and recurrence rates highlight the great unmet need for novel therapies in this window of opportunity where patients are being monitored for progression by CT scans and standard therapies have already been completed.

About AMPLIFY-7P

AMPLIFY-7P (NCT05726864) is a Phase 1/2 study to assess the efficacy of ELI-002 7P a therapeutic cancer vaccine containing seven KRAS and NRAS peptide-based antigens (G12D, G12R, G12V, G12A, G12C, G12S, G13D). This study builds on existing data obtained from the ongoing AMPLIFY-201 trial. In Phase 1a the recommended Phase 2 dose of the immune stimulatory oligonucleotide (Amph-CpG-7909) will be evaluated in combination with two different dose levels of the seven-peptide formulation. Completion of Phase 1a will inform the recommended dose for Phase 1b and Phase 2 for ELI-002 7P. Phase 1b will feature three dose expansion cohorts and will evaluate preliminary evidence of biomarker response. The Phase 2 portion of the study will enroll additional patients and will be randomized 2:1 (ELI-002 7P vs observation) to further evaluate anti-tumor activity and will seek to determine whether ELI-002 7P improves relapse-free survival. Subjects randomized to the observation group will receive the same safety and efficacy evaluations and will also be able to elect to cross-over to ELI-002 7P treatment if disease progression is confirmed.

On April 27, 2023 bluebird bio, Inc. (Nasdaq: BLUE) reported that the Company’s first quarter financial results, including commercial, regulatory and operational updates, will be released pre-market on Tuesday, May 9 (Press release, bluebird bio, APR 27, 2023, View Source [SID1234630603]).

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In addition, members of the management team will participate in the following upcoming investor conferences:

BofA Securities 2023 Health Care Conference, Thursday, May 11, at 8:15 a.m. PT at the Encore Hotel, Las Vegas, NV
Goldman Sachs 44th Annual Global Healthcare Conference, Monday, June 12, at 4:40 p.m. PT at the Waldorf Astoria Monarch Beach Resort & Club, Dana Point, CA
To access the live webcasts of bluebird bio’s presentations, please visit the "Events & Presentations" page within the Investors & Media section of the bluebird bio website at View Source Replays of the webcasts will be available on the bluebird bio website for 90 days following the events.