On April 11, 2023 Guardant Health, Inc. (Nasdaq: GH), a leading precision oncology company, reported that it will present data from 14 studies highlighting advances in precision oncology and cancer screening at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting, April 14-19 in Orlando, Florida (Press release, Guardant Health, APR 11, 2023, View Source [SID1234629941]).

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"We look forward to sharing new data at AACR (Free AACR Whitepaper), in particular research demonstrating the tremendous possibilities of epigenomic analysis in biomarker discovery and cancer care," said Helmy Eltoukhy, Guardant Health chairman and co-CEO. "These presentations show how gaining deeper insights into the tumor microenvironment can help us identify new potential biomarker targets for therapy and predictive markers for treatment resistance, quantify circulating tumor DNA, and contribute to better-informed patient care."

Multiple studies to be presented at the meeting highlight the new GuardantINFINITY sequencing platform and demonstrate the utility of its methylation sequencing and epigenomic analysis capabilities in biomarker discovery, therapy selection and response monitoring. In particular, studies show that:

Methylome sequencing with a liquid-only approach using the GuardantINFINITY platform can quantify circulating tumor DNA level and change with greater sensitivity and precision than genomic sequencing, making longitudinal ctDNA monitoring accessible to a broader range of patients. (Abstract 3123)
Cancer genomics alone provides little information on tumor phenotype or functional state, which are governed by epigenetic mechanisms, notably methylation of regulatory regions. The analytical validation of the GuardantINFINITY genomic and epigenomic liquid biopsy platform showed its potential for ultra-sensitive ctDNA detection for minimal residual disease and recurrence surveillance, tumor fraction quantitation for therapy monitoring, oncogenic virus detection, immunogenotyping, epigenotyping, and tumor phenotype characterization, representing a new standard in biomarker discovery. (Abstract 6601)
Full List of Guardant Health Presentations

Abstract
Poster

Title

Product

Sunday, April 16 | 1:30 – 5:00 pm

1052

29

Background variability in plasma ctDNA levels in patients with advanced lung cancer in the absence of treatment

Guardant360

Monday, April 17 | 9:00 am – 12:30 pm

LB123

6

Poorer outcomes in EGFR L858R-driven NSCLC treated with osimertinib may be addressed with novel combination of BLU-945 and osimertinib

GuardantINFORM

Monday, April 17 | 1:30 – 5:00 pm

3331

6

Highly sensitive blood-based multi-cancer screening device with tiered specificity based on diagnostic workflow

Shield

3123

9

A method for quantifying circulating tumor DNA level and molecular response using methylome sequencing

GuardantINFINITY

3128

14

Using Kmerizer, a germline and somatic genotyper for immune associated complex alleles in GuardantINFINITY, for immunotherapy response prediction using cfDNA

GuardantINFINITY

3125

21

Validation of a bioinformatic model for classifying non-tumor variants in a cell-free DNA liquid biopsy assay

GuardantINFINITY

Tuesday, April 18 | 1:30 – 5:00 pm

5573

30

Use of circulating tumor DNA (ctDNA) for early assessment of treatment response in patients with non-small cell lung cancer (NSCLC): A real-world (RW) analysis incorporating baseline ctDNA level and molecular response

GuardantINFORM

4264

13

The genomic landscape of RET fusions in non-small cell lung cancer and the impact of co-occurring genomic alterations on the efficacy of selective RET inhibitors

Guardant360

CT278

18

ERBB2 amplification detected in ctDNA as a surrogate for tumor tissue FISH analysis of HER2 status in a phase 1 study with zanidatamab for the treatment of locally advanced or metastatic HER2 expressing cancers

Guardant360

Wednesday, April 19 | 9:00 am – 12:30 pm

6087

27

Mutation and co-mutation landscape of ERBB2 alterations in advanced NSCLC

Guardant360

6744

4

Cell-free DNA detection of alterations in the MAPK pathway in metastatic hormone receptor positive breast cancer: a multi-institutional analysis of incidence and clinical outcomes

Guardant360

6094

2

Longitudinal analysis of PARP inhibitor and platinum resistance in BRCA1/2m breast cancer using liquid biopsy

GuardantINFINITY

6601

6

Analytical validation of a robust integrated genomic and epigenomic liquid biopsy for biomarker discovery, therapy selection, and response monitoring

GuardantINFINITY

6603

8

BRCA1 promoter methylation in sporadic breast cancer patients detected by liquid biopsy

GuardantINFINITY

The full abstracts for Guardant Health and a list of all abstracts being presented at the meeting can be found at the AACR (Free AACR Whitepaper) website here.

For more information and updates from the meeting, follow Guardant Health on LinkedIn and Twitter or visit AACR (Free AACR Whitepaper) booth #2465.

On April 11, 2023 Genomic Testing Cooperative, LCA (GTC) reported that it will be presenting data at the 2023 American Association of Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting demonstrating that its targeted transcriptomic profiling correlates with immunohistochemistry (IHC)-based testing (Press release, Genomic Testing Cooperative, APR 11, 2023, View Source [SID1234629940]). Targeted transcriptomic data generated in GTC’s routine genomic profiling of tumors is used to quantify various IHC-based biomarkers including HER2, PD-L1, estrogen Receptor (ER), androgen receptor and others. GTC studies demonstrate that RNA sequencing of clinically relevant genes using next generation sequencing (NGS) provides reliable quantitative data that can be interpreted objectively. This data when used in artificial intelligence (AI) algorithms can predict levels of PD-L1 not only in tumor cells, but also in inflammatory cells. The current data suggests that transcriptomic data can replace the need for some IHC test and potentially may better address clinically relevant questions such as determining low HER2 level and others.

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"We believe that transcriptomic profiling is essential in today’s molecular profiling of cancers. Targeted transcriptomic allows us to focus on the clinically relevant genes and provides better dynamic range." stated Dr. Maher Albitar, founder, chief medical officer, and chief executive officer of GTC. "The generated data when used in AI algorithms allows us to develop new clinical applications and answer clinical questions that few years ago, we thought not possible to answer in routine clinical testing. GTC is leading in this field" added Dr. Albitar.

This data will be presented in the following three posters:

– Predicting PD-L1 status in solid tumors using transcriptomic data and artificial intelligence algorithms: Session Date and Time: Tuesday Apr 18, 2023 9:00 AM – 12:30 PM (4337 / 12)

– Real-world transcriptomic biomarkers as replacement for immunohistochemistry and FISH studies in breast cancer: Session Date and Time: Sunday Apr 16, 2023 1:30 PM – 5:00 PM(967 / 18)

– The molecular landscape of premenopausal versus postmenopausal breast cancer in patients without inherited predisposition mutations: Session Date and Time: Sunday Apr 16, 2023 1:30 PM – 5:00 PM (929 / 12)

Visit GTC booth #1775 at AACR (Free AACR Whitepaper) for more detail and highlights on this work and on how to become a member of the Co-Op.

On April 11, 2023 G1 Therapeutics, Inc. (Nasdaq: GTHX), a commercial-stage oncology company, reported that G1’s Chief Executive Officer Jack Bailey and other members of the Executive Team will participate in a fireside chat during the 22nd Annual Needham Virtual Healthcare Conference (Press release, G1 Therapeutics, APR 11, 2023, View Source [SID1234629939]). The fireside chat will take place on Tuesday April 18th at 1:30 PM EDT.

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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

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This meeting is being held virtually; the webcast of the event will be accessible on the Events & Presentations page of View Source

On April 11, 2023 Cellectis (the "Company") (Euronext Growth: ALCLS – NASDAQ: CLLS), a clinical-stage biotechnology company using its pioneering gene-editing platform to develop life-saving cell and gene therapies, reported that the first patient in Europe has been dosed in France with its in-house manufactured product candidate UCART22 and completed the 28-day Dose Limiting Toxicity period (Press release, Cellectis, APR 11, 2023, View Source [SID1234629937]).

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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

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"Our team has worked tirelessly to expand our BALLI-01 clinical study (evaluating UCART22) to Europe. Dosing our first patient in France with our UCART22 product candidate manufactured in-house is an important advancement for Cellectis" said Mark Frattini, M.D., Ph.D., Chief Medical Officer at Cellectis. "By targeting the CD22 antigen, we aim at offering a novel therapeutic alternative to patients living with relapsed/refractory B-cell ALL, including those patients who have relapsed or did not respond to CD19-directed therapy. "

UCART22 is an allogeneic CAR T-cell product candidate that targets CD22 and is evaluated in the BALLI-01 clinical study, a Phase 1/2a open-label study designed to evaluate the safety and clinical activity of the product candidate in patients with r/r B-cell ALL. UCART22 is currently the most advanced allogeneic CAR T-cell product in development for r/r B-cell ALL.

With its proprietary GMP manufacturing facilities in both Raleigh (North Carolina) and Paris (France), Cellectis has taken full control of UCART production and manufacturing timelines. Cellectis believes that its off-the-shelf treatment approach, coupled with its ability to manufacture UCART product candidates completely in-house, gives the Company a main advantage on the market: it potentially maximizes the chances for eligible patients to be treated without delay.

In December 2022, Cellectis presented positive preliminary clinical data for UCART22 in a Live Webcast, that support the continued administration of UCART22 after fludarabine, cyclophosphamide and alemtuzumab (FCA) lymphodepletion in patients with r/r B-cell ALL. The BALLI-01 study (evaluating UCART22) is actively enrolling patients with r/r B-cell ALL after FCA lymphodepletion. For more information, eligibility criteria and trial locations, please visit www.clinicaltrials.gov (NCT04150497) or contact [email protected]

On April 5, 2023, Eterna Therapeutics Inc., a Delaware corporation (the "Company"), entered into a purchase agreement (the "Purchase Agreement") and a registration rights agreement (the "Registration Rights Agreement") with Lincoln Park Capital Fund, LLC ("Lincoln Park"), pursuant to which Lincoln Park has committed to purchase up to $10.0 million of the Company’s common stock, par value $0.005 per share (the "Common Stock"), subject to certain limitations and satisfaction of the conditions set forth in the Purchase Agreement (Filing, 8-K, Brooklyn ImmunoTherapeutics, APR 11, 2023, View Source [SID1234629936]).

Upon the terms and subject to the satisfaction of the conditions set forth in the Purchase Agreement, the Company has the right, but not the obligation, to sell to Lincoln Park, and Lincoln Park is obligated to purchase, up to $10.0 million of Common Stock. Such sales of Common Stock by the Company, if any, are subject to certain limitations set forth in the Purchase Agreement, and may occur from time to time, at the Company’s sole discretion, over a period of up to 24-months, commencing on the date on which each of the conditions to Lincoln Park’s purchase obligations set forth in the Purchase Agreement have initially been satisfied (such date, the "Commencement Date"), including the effectiveness of a registration statement registering under the Securities Act of 1933, as amended (the "Securities Act"), the resale by Lincoln Park of shares of Common Stock that have been and may be issued by the Company to Lincoln Park under the Purchase Agreement. The Company has agreed to file such registration statement with the Securities and Exchange Commission (the "SEC") not later than 10 business days after the date of execution of the Purchase Agreement and the Registration Rights Agreement.

From and after the Commencement Date, the Company may from time to time, on any business day selected by the Company on which the closing sale price per share of Common Stock as reported on The Nasdaq Capital Market is not less than the "floor price" threshold set forth in the Purchase Agreement (each such business day, a "purchase date"), by written notice delivered by the Company to Lincoln Park, direct Lincoln Park to purchase up to 30,000 shares of Common Stock on such purchase date, at a purchase price per share that will be determined and fixed in accordance with the Purchase Agreement at the time the Company delivers such written notice to Lincoln Park (each, a "regular purchase"). The maximum number of shares the Company may sell to Lincoln Park in a regular purchase may be increased by certain amounts to up to 90,000 shares, with the applicable maximum share limit determined by whether the closing sale price per share of Common Stock as reported on The Nasdaq Capital Market on the applicable purchase date for such regular purchase equals or exceeds certain minimum price thresholds set forth in the Purchase Agreement, in each case, subject to adjustment for any recapitalization, non-cash dividend, forward or reverse stock split or other similar transactions as provided in the Purchase Agreement; however, Lincoln Park’s maximum purchase commitment in any single regular purchase may not exceed $1,000,000.

In addition to regular purchases, provided that the Company has directed Lincoln Park to purchase the maximum amount of shares that the Company is then able to sell to Lincoln Park in a regular purchase, the Company may, in its sole discretion, direct Lincoln Park to purchase additional shares of Common Stock in "accelerated purchases" and "additional accelerated purchases," as set forth in the Purchase Agreement. The purchase price per share of Common Stock sold in each such accelerated purchase and additional accelerated purchase, if any, will calculated in accordance with the pricing terms for an accelerated purchase and an additional accelerated purchase, as applicable, set forth in the Purchase Agreement. There are no upper limits on the price per share that Lincoln Park must pay for shares of Common Stock in any purchase under the Purchase Agreement.

Under the Purchase Agreement, the Company will control the timing and amount of sales of Common Stock to Lincoln Park, if any. Lincoln Park has no right to require the Company to sell any shares of Common Stock to Lincoln Park, but Lincoln Park is obligated to make purchases as the Company directs, subject to certain conditions set forth in the Purchase Agreement. Actual sales of shares of Common Stock to Lincoln Park, if any, will depend on a variety of factors to be determined by the Company from time to time, including, among others, general market conditions, the trading prices for the Common Stock, and determinations by the Company as to the appropriate sources of funding for the Company and its operations.

Under applicable Nasdaq listing rules, the aggregate number of shares of Common Stock that the Company may issue to Lincoln Park under the Purchase Agreement cannot exceed 19.99% of the shares of Common Stock issued and outstanding immediately prior to the execution of the Purchase Agreement (the "Exchange Cap"), unless (i) the Company first obtains stockholder approval to issue shares of Common Stock in excess of the Exchange Cap in accordance with applicable Nasdaq listing rules, or (ii) at the time the Company has issued shares of Common Stock equal to the Exchange Cap and at all times thereafter, the average price per share of Common Stock for all shares of Common Stock sold by the Company to Lincoln Park under the Purchase Agreement equals or exceeds $3.6094 per share (representing the lower of the official closing price of the Common Stock on Nasdaq on the trading day immediately preceding the date of the Purchase Agreement and the average official closing price of the Common Stock on Nasdaq for the five consecutive trading days ending on the trading day immediately preceding the date of the Purchase Agreement, as adjusted under applicable Nasdaq rules to take into account the issuance of shares of Common Stock to Lincoln Park for non-cash consideration as payment of the commitment fee described below), such that the Exchange Cap limitation would no longer apply to issuances and sales of Common Stock by the Company to Lincoln Park under the Purchase Agreement under applicable Nasdaq listing rules.

Additionally, Company may not direct Lincoln Park to purchase any shares of Common Stock under the Purchase Agreement if such purchase would result in Lincoln Park beneficially owning more than 4.99% of the issued and outstanding shares of Common Stock.

There are no restrictions on future financings, rights of first refusal, participation rights, penalties or liquidated damages in the Purchase Agreement or Registration Rights Agreement, except the Company is prohibited, subject to certain exceptions, during the term of the Purchase Agreement or 90 days following the effective date of the termination of the Purchase Agreement, whichever concludes earlier, from entering into an agreement to effect an "equity line of credit" or other similar offering in which the Company may issue and sell Common Stock, from time to time over a certain period of time, at future determined prices based on the market prices of the Common Stock at the time of each such issuance and sale. Lincoln Park has agreed not to engage in any short sales of the Common Stock or hedging transaction that establishes a net short position in the Common Stock during the term of the Purchase Agreement.

As consideration for Lincoln Park’s commitment to purchase shares of Common Stock in accordance with the Purchase Agreement, the Company has issued 73,659 shares of Common Stock to Lincoln Park as a commitment fee.

The Purchase Agreement and the Registration Rights Agreement contain customary representations, warranties, conditions and indemnification obligations of the parties. The Company has the right to terminate the Purchase Agreement at any time with one business day’s prior written notice to Lincoln Park, at no cost or penalty.

The foregoing description of the Purchase Agreement and the Registration Rights Agreement is only a summary and is qualified in its entirety by reference to the full text of the Purchase Agreement and the Registration Rights Agreement, copies of which are attached hereto as Exhibit 10.1 and Exhibit 10.2, respectively, and incorporated herein by reference. The representations, warranties and covenants contained in such agreements were made only for purposes of such agreements and as of specific dates, were solely for the benefit of the parties to such agreements and may be subject to limitations agreed upon by the contracting parties.

The offer and sale of the Common Stock pursuant to the Purchase Agreement have not been registered under the Securities Act or any state securities laws. The Common Stock may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements. Neither this Current Report on Form 8-K, nor the exhibits attached hereto, is an offer to sell or the solicitation of an offer to buy the Common Stock described herein or therein.

In the Purchase Agreement, Lincoln Park represented to the Company that it is an "accredited investor", as defined in Rule 501 promulgated under the Securities Act, and the Company’s offer and sale of the Common Stock under the Purchase Agreement are being made in reliance upon the exemptions from the registration requirements of the Securities Act pursuant to Section 4(a)(2) thereof and Rule 506(b) of Regulation D promulgated thereunder.

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