On April 6, 2023 Akoya Biosciences, Inc. (Nasdaq: AKYA) ("Akoya"), The Spatial Biology Company, reported that it will release financial results for the first quarter of 2023 after the market close on Monday, May 8th, 2023 (Press release, Akoya Biosciences, APR 6, 2023, View Source [SID1234629854]). Company management will host a conference call to discuss financial results at 5:00 p.m. ET.

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Investors interested in listening to the conference call are required to register online. It is recommended to register at least a day in advance. A live and archived webcast of the event will be available on the "Investors" section of the Akoya website at View Source

On April 5, 2023 Verismo Therapeutics, a clinical-stage CAR T company, Penn spinout, and pioneer of the novel KIR-CAR platform technology, reported that it has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for its investigational new drug, SynKIR-110, for the treatment of patients with mesothelioma (Press release, Verismo Therapeutics, APR 5, 2023, View Source [SID1234629889]).

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Fast Track designation is designed to facilitate the development and expedite the review of drugs intended to treat serious or life-threatening conditions and address unmet medical needs, thus enabling drugs to reach patients sooner. Clinical Programs with Fast Track designation may also be eligible to apply for Accelerated Approval and Priority Review if relevant criteria are met.

SynKIR-110 is an investigational new drug for the treatment of mesothelin-expressing mesothelioma, cholangiocarcinoma and ovarian cancer. Verismo Therapeutics is conducting a Phase 1 multicenter clinical trial in these tumor types to evaluate the safety, feasibility and anti-tumor activity of the SynKIR-110 (ClinicalTrials.gov Identifier: NCT05568680).

"We are thrilled to receive Fast Track designation from the FDA," said Dr. Bryan Kim, DMD, Co-Founder and CEO of Verismo Therapeutics. "This designation is an important milestone in our efforts to bring this potentially life-saving drug to patients who are in need of new treatment options."

Verismo Therapeutics is committed to developing innovative treatments for patients with serious and life-threatening conditions using its novel KIR-CAR platform.

For more information about SynKIR-110, please visit www.verismotherapeutics.com.

About the KIR-CAR Platform
The KIR-CAR platform is a dual-chain CAR T cell therapy and has been shown in preclinical animal models to be capable of maintaining antitumor T cell activity even in challenging solid tumor environments. DAP12 acting as a novel costimulatory molecule for T cells, aids additional T cell stimulating pathways, further sustaining chimeric receptor expression and improving KIR-CAR T cell persistence. This continued T cell function and persistence can lead to ongoing regression of solid tumors in preclinical models, including those refractory to traditional CAR T cell therapies. Furthermore, the KIR-CAR platform can be combined with many additional emerging technologies, such as in vivo gene engineering, advanced cell manufacturing and reprogramming, combinational therapies, and even allogeneic cellular therapies to provide the next-generation multimodal targeted immunotherapy for patients in need.

On April 5, 2023, TRACON Pharmaceuticals, Inc. (the "Company") entered into a second amendment with effect from March 31, 2023 (the "Loan Amendment") to the loan and security agreement, dated as of September 2, 2022 and amended December 22, 2022 (the "RGC Loan Agreement"), by and among the Company, each party to the RGC Loan Agreement from time to time a borrower thereunder, the lenders from time to time a party thereto and Runway Growth Finance Corp., as administrative agent and collateral agent for the lenders ("Lender") (Filing, 8-K, Tracon Pharmaceuticals, APR 5, 2023, View Source [SID1234629886]). The Loan Amendment amends the RGC Loan Agreement to, among other things, provide for the following terms: on or before April 15, 2023, if the Company has raised at least $25.0 million in net cash proceeds from certain equity or debt transactions prior to making such request, Lender may, in its sole and absolute discretion, allow or deny loaning to the Company an aggregate principal amount of $10.0 million, with the full amount funded in a single disbursement. If the loan described above is not made by April 15, 2023, the maturity date will be April 15, 2023, the RGC Loan Agreement will terminate on that date, and the Company will not be obligated to pay the prepayment fee described in the RGC Loan Agreement but the final payment fee described in the RCG Loan Agreement will become immediately due and payable.

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All other material terms, including the interest-only period and covenants in the RGC Loan Agreement remain unchanged.

The foregoing summary of the material terms of the Loan Amendment does not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Loan Amendment, a copy of which will be filed with the Company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2023.

On April 5, 2023 Foundation Medicine, Inc., a pioneer in molecular profiling for cancer, reported that the company and its collaborators will present a total of 10 studies at the 2023 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting from April 14-19 in Orlando, Florida (Press release, Foundation Medicine, APR 5, 2023, View Source [SID1234629852]).

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Presentation highlights:

Over the past several years, there has been great progress in the ability to identify shed pieces of tumor, called circulating tumor DNA (ctDNA), within a cancer patient’s blood. In partnership with South Australian Immunogenomics Cancer Institute, Saint Bartholomew’s Hospital and Genentech, Foundation Medicine researchers used its novel methylation sequencing research platform to detect ctDNA as a prognostic biomarker in overall survival for patients with metastatic castrate resistant prostate cancer (mCRPC). Results from ctDNA evaluation as early as 6 weeks post treatment initiation were comparable to prostate specific antigen (PSA) response in second line mCRPC, providing an early non-invasive readout that is independent of PSA for monitoring therapy response in late stage mCRPC.
Historical barriers in the study of small cell lung cancer (SCLC) include the relative lack of human tumors studied, limited real-world data, and the lack of access to longitudinal samples to understand tumor evolution. In partnership with Stanford University and Vanderbilt University Medical Center, Foundation Medicine researchers conducted what is believed to be the largest SCLC study known to date to provide an improved understanding of genetic subtypes in SCLC, including patient ancestry and biopsy site-specific patterns, and better inform mechanisms of transformation to SCLC from non-small cell lung cancer that may further guide the development of personalized therapies for subsets of patients with this fatal tumor.
"Our experience sequencing over one million patient samples has allowed us to continuously improve our approach and have high confidence in the genomic abnormalities we detect and the results we deliver," said Priti Hegde, PhD, chief scientific officer at Foundation Medicine. "We are committed to bringing high-quality, differentiated and sustainable solutions, like options for sensitive ctDNA monitoring, to our physician and researcher partners so that they can provide all patients with the best treatment options for their unique cancers."

The following is a list of abstracts that will be presented at the meeting. To access all abstracts being presented at AACR (Free AACR Whitepaper), please visit AACR (Free AACR Whitepaper).org.

Follow Foundation Medicine on Twitter and LinkedIn for more updates from #AACR23 and visit us in person at Booth #3053.

Abstract #

Title

Collaborator

Product

Posters

305

Sunday, April 16

1:30 – 5:00 PM

POLE variant detection and classification is critical for identifying patients who may benefit from immunotherapy

FoundationOneCDx and FoundationOneLiquid CDx

228

Sunday, April 16

1:30 – 5:00 PM

Recurrent mitochondrial mutations in thyroid cancer

FoundationOneCDx

931

Sunday, April 16

1:30 – 5:00 PM

Comprehensive analysis of 3,600 small cell lung cancer cases reveals rare genetic subtypes and multiple mechanisms of histological transformation

Stanford University & Vanderbilt University Medical Center

FoundationOneCDx,

Foundation Medicine & Flatiron Health’s Joint Clinico-Genomic Database

933

Sunday, April 16

1:30 – 5:00 PM

The landscape of treatment patterns in non-small cell lung cancer post EGFR TKI treatment described by real world data from 428 patients

Flatiron Health, One Oncology

Foundation Medicine & Flatiron Health’s Joint Clinico-Genomic Database

938

Sunday, April 16

1:30 – 5:00 PM

Outcomes of Molecular Tumor Board recommendations for cancer patients with progression on standard of care therapies in Saudi Arabia

King Abdulaziz Medical City, King Saud bin Abdulaziz University for Health Sciences, King Abdullah International Medical Research Center

FoundationOneCDx

966

Sunday, April 16

1:30 – 5:00 PM

Exploration of a novel HRD signature (HRDsig) as a biomarker for rucaparib benefit in ARIEL2

Clovis Oncology, Imperial College London

FoundationOneCDx

305

Monday, April 17

9:00 a.m. – 12:30 p.m.

Co-occurrence of alterations impacting telomere elongation

FoundationOneCDx

2289

Monday, April 17

9:00 a.m. – 12:30 p.m.

Predicting tumor somatic vs versus clonal hematopoiesis (CH) origin for short variants (SV) with FoundationOneLiquid CDx assay

FoundationOneLiquid CDx

3362

Monday, April 17

1:30 – 5:00 p.m.

Evaluation of circulating tumor DNA kinetics as a prognostic biomarker for overall survival in metastatic castrate resistant prostate cancer using a novel methylation sequencing research assay

South Australian Immunogenomics Cancer Institute, Genentech, St. Bartholomew’s Hospital

Research methylation assay

3395

Monday, April 17

1:30 – 5:00 p.m.

Clinical Impact of FGFR inhibitors on FGFR2 Fusion Positive Pancreatic Cancer

Ohio State University

FoundationOneCDx

On April 5, 2023 Avacta Group plc (AIM: AVCT), a life sciences company developing innovative, targeted oncology drugs and powerful diagnostics, reported that the first patient has been dosed in the fifth cohort of the first-in-human phase I trial (ALS-6000-101) of AVA6000 (Press release, Avacta, APR 5, 2023, View Source [SID1234629851]). This follows the approval of an amended clinical trial protocol by the Medical and Healthcare Products Regulatory Agency (MHRA) to allow for higher levels of dosing.

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Avacta’s Safety Data Monitoring Committee (SDMC), comprised of clinicians currently recruiting patients, has recommended that the phase Ia dose escalation clinical trial continues to a fifth dose cohort at 250mg/m2, following the favourable safety profile of AVA6000 generated in the study to date. Escalation to this level of dosing falls outside of the original clinical trial protocol, and therefore the protocol required amendment and approval by the MHRA, which has now been completed. This continued dose escalation is aimed at identifying a maximum tolerated dose (MTD) necessary to inform the dosing levels for the phase 1b and future studies.

Dr Alastair Smith, Chief Executive Officer of Avacta Group, commented: "We are very much encouraged by the positive safety and tolerability data emerging from the dose escalation phase 1a study of AVA6000. Following the recommendation from the SDMC, and approval by the MHRA, we are pleased to commence dosing in the fifth patient cohort of this trial. The recent confirmation of release of active chemotherapy in the tumour tissue and the safety data being generated in the ALS-6000-101 study are providing detailed insights into the pre|CISION platform which add significant value to the technology and confirm the tumour targeting potential of the pre|CISION platform."

This announcement has been approved for release by Alastair Smith, Chief Executive Officer of Avacta Group plc.