On August 22, 2023 Vincerx Pharma, Inc. (Nasdaq: VINC), a biopharmaceutical company aspiring to address the unmet medical needs of patients with cancer through paradigm-shifting therapeutics, reported that it has received clearance for its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) to initiate a Phase 1 clinical trial for VIP943 (Press release, Vincerx Pharma, AUG 22, 2023, View Source [SID1234634628]). Vincerx expects to enroll the first patient in the study early in the fourth quarter of 2023.

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"The IND clearance by the FDA is a significant step forward for the VIP943 development program, our first candidate from our antibody-drug conjugate (ADC) platform to enter clinical trials," said Ahmed Hamdy, M.D., Chief Executive Officer of Vincerx. "Our next-generation platform is designed to improve efficacy and address safety challenges associated with many ADCs. It combines an internalizing antibody binding to CD123, a novel KSPi payload, a selective and stable linker, and exclusive CellTrapper technology. We believe VIP943 has the potential to become a much needed treatment option for patients with acute myeloid leukemia (AML). We’re eager to start the clinical program and unlock the potential therapeutic benefits of this compound."

Dr. Hamdy concluded by saying, "2023 is shaping up to be a very positive year for Vincerx. Within the last eight months, we successfully filed two INDs (VIP236 and VIP943) and swiftly garnered clearance from the FDA within 30 days. We believe these accomplishments highlight the strength of our development, drug manufacturing, and regulatory expertise. Looking ahead, in addition to beginning our Phase 1 trial for VIP943, we also expect to provide preliminary results for VIP236 by late 2023 or early 2024. Collectively, these milestones support the potential for our strategy to develop small molecule and antibody-based conjugate therapies to improve the care of patients with cancer."

About VIP943

VIP943 is a novel ADC developed using Vincerx’s next-generation ADC technology designed to enhance intracellular accumulation of the KSPi payload (kinesin spindle protein inhibitor), potentially leading to higher efficacy, while limiting unwanted side effects. VIP943 binds to CD123, a validated target in myeloid malignancies. Once inside of the cell, it releases its KSPi payload. Vincerx’s CellTrapper technology ensures that the KSPi payload accumulates in the target cells, limiting uptake into non-target, non-dividing cells.

VIP943 has demonstrated increased survival and reduced tumor burden in AML (acute myelogenous leukemia) cell lines and patient-derived tumor models. In addition, Vincerx presented preclinical data on VIP943 at ASH (Free ASH Whitepaper) 2022 demonstrating superiority against Mylotarg, an approved ADC, with significantly improved safety in monkeys and better efficacy in a mouse model of acute leukemia. Preclinical data suggest that VIP943 does not induce significant cytokine release and demonstrated favorable safety in monkeys with an optimal drug, metabolism and pharmacokinetics profile.

The Phase 1 trial of VIP943 is intended to assess safety, pharmacokinetics/phamacodynamics, and preliminary efficacy of VIP943 in patients with advanced AML and myelodysplastic syndrome (MDS).

On August 22, 2023 Veracyte, Inc. (Nasdaq: VCYT) reported that new data published in JCO Precision Oncology suggest that gene expression signatures derived from the company’s Decipher Genomics Resource for Intelligent Discovery (GRID) database may help advance understanding of the genomic drivers impacting patient response to treatment for recurrent prostate cancer (Press release, Veracyte, AUG 22, 2023, View Source [SID1234634627]). The findings, from the Phase 2 STREAM study, suggest the potential to use transcriptomic signatures to identify patients in this setting who may benefit from more intensive salvage therapy as well as those who may need alternative care such as chemotherapy.

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"The STREAM study showed that, despite treatment with six months of androgen deprivation therapy and enzalutamide, nearly 50% of patients receiving radiation therapy for prostate cancer that has returned experience relapse within three years," said Andrew Armstrong, M.D., ScM, professor of Medicine and director of Research, Duke Cancer Institute Center for Prostate and Urologic Cancers, and senior/corresponding author for the manuscript. "Using the Decipher GRID database, we found that men in the STREAM study with luminal differentiated genotypes had excellent outcomes, while those whose tumors had a basal, luminal proliferating genotype or other specific genomic characteristics such as PTEN loss had a higher risk of recurrence despite these therapies."

The three-center, prospective Phase 2 STREAM study was led by Dr. Armstrong and Duke University colleague Rhonda L. Bitting, M.D. The trial evaluated the safety and efficacy of adding six months of enzalutamide to androgen deprivation therapy (ADT) and salvage radiotherapy in patients with rising prostate-specific antigen (PSA) following radical prostatectomy and radiotherapy (RT). A previous publication demonstrated that 51% of men remained free of disease at three years following treatment.

Using prostatectomy tissue from 31 study participants, all of whom had NCCN intermediate- (12.9%) or high-risk (87.1%) disease, researchers conducted a retrospective analysis using the Decipher GRID database to determine whether specific genomic signatures could help predict which patients would benefit from the aggressive therapy regimen, and which may require additional or alternative care.

Results suggest that patients in the study who experienced shorter progression-free survival (PFS) over three years had a luminal proliferating tumor subtype, loss of the PTEN gene and/or higher homologous recombination deficiency (HRD) signature scores. Patients with luminal differentiated or luminal A-type tumors and/or higher postoperative ADT responsiveness genomic signature scores were more likely to have durable responses and long-term remissions with the aggressive systemic regimen of ADT and enzalutamide combined with salvage radiotherapy.

"This study provides further evidence that the Decipher GRID database is a valuable tool to help researchers better understand the specific genomic signatures and factors that impact prostate cancer disease progression and individual responses to various treatment approaches," said Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.

The Decipher GRID database includes more than 100,000 whole-transcriptome profiles from patients with urologic cancers and is used by Veracyte and its partners to contribute to continued research and help advance understanding of prostate and other urologic cancers. GRID-derived information is available on a Research Use Only basis.

On August 22, 2023 Purple Biotech Ltd. ("Purple Biotech" or "the Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported financial results for the second quarter and six months ended June 30, 2023 (Press release, Purple Biotech, AUG 22, 2023, View Source [SID1234634626]).

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"During the second quarter of 2023 we continued to advance our lead clinical programs, CM24 in the treatment of pancreatic cancer and NT219 for head and neck cancer, while prudently managing our development and operating expenses. Our financial results in the first half of 2023 represent our clinical trials’ progress with recruitment at a pace faster than expected in our CM24 study. As we reprioritize our objectives from time to time, we have extended our cash runway into the first half of 2025," stated Purple Biotech CEO, Gil Efron.

"In the coming months, we look forward to announcing milestones including interim data from our randomized Phase 2 CM24 study as well as results from our Phase 1 NT219 dose escalation study. In addition, we are excited to commence work on IM1240, our newly acquired tri-specific antibody."

"I am excited to return to working with our dedicated team after my medical leave. I would like to thank Isaac Israel, the management, and our employees for their great work during my absence," Gil Efron added.

Financial Results for the three Months Ended June 30, 2023

Research and Development Expenses were $3.7 million, an increase of $1.7 million or 85%, compared to $2 million in the same period of 2022 mainly due to higher enrollment rate to our clinical trials.

Selling, General and Administrative Expenses were $1.4 million, a decrease of $0.1 million or 7%, compared to $1.5 million in the same period of 2022.

Operating Loss was $5.1 million, an increase of $1.5 million or 42% compared to $3.6 million in the same period of 2022 mainly due to higher research and development expenses.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $4.6 million, an increase of $1.6 million or 53%, compared to $3 million in the same period of 2022 mainly due to higher research and development expenses.

Net Loss for the three months ended June 30, 2023 was $5.2 million, or $0.25 loss per basic and diluted ADS, compared to a net loss of $3.6 million, or $0.2 loss per basic and diluted ADS, in the three months ended June 30, 2022. Adjusted net loss for the three months ended June 30, 2023 was $4.7 million, an increase of $1.7 million or 57% compared to $3 million in the three months ended June 30, 2022.

Financial Results for the Six Months Ended June 30, 2023

Research and Development Expenses were $7.2 million, a decrease of $0.8 million, or 10%, compared to $8 million in the same period of 2022. The decrease was mainly due to a decrease of $3.4 million in chemistry, manufacturing, and controls (CMC) expenses representing batch manufacturing in 2022, offset by an increase of $2 million in clinical expenses and $0.6 million in other research and development expenses in support of our growing clinical and development activities.

Sales, General and Administrative Expenses were $3.0 million, compared to $2.9 million in the same period of 2022, an increase of $0.1 million.

Operating Loss was $10.3 million, a decrease of $0.6 million, or 6%, compared to $10.9 million in the same period of 2022.

On a non-IFRS basis (as reconciled below), adjusted operating loss was $9 million, a decrease of $1 million, compared to $10 million in the same period of 2022, mainly due to a decrease in research and development expenses.

Net Loss for the six months ended June 30, 2023 was $10.0 million, or $0.49 loss per basic and diluted ADS, compared to a net loss of $10.9 million, or $0.61 loss per basic and diluted ADS, in the same period of 2022. The decrease in net loss was mainly due to a decrease of $0.6 million in operating expenses. Adjusted net loss for the six months ended June 30, 2023 was $8.8 million, a decrease from $10.0 million in the six months ended June 30, 2022.

As of June 30, 2023, Purple Biotech had cash and cash equivalents and short-term deposits of $18.0 million. This cash position provides a cash runway into the first half of 2025.

During the six months ended June 30, 2023, the Company sold, under the Open Market Sale Agreementsm with Jefferies LLC, approximately 479,000 ADSs, at an average price of $1.83 per ADS. Net proceeds to the Company were approximately $0.85 million, net of direct issuance expenses.

On August 22, 2023 Nascent Biotech, Inc. (OTCQB:NBIO) ("Nascent Biotech", "Nascent", or the "Company"), a clinical-stage biotechnology Company whose business is focused in the therapeutic monoclonal antibody space, reported that the Company has been cleared by the FDA to begin Phase II clinical trials for brain cancer (Press release, Nascent Biotech, AUG 22, 2023, View Source [SID1234634625]). This milestone allows the Company to continue advancing Pritumumab through the regulatory clinical processes in its use against Brain Tumors including Glioblastoma.

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Nascent CEO, Sean Carrick, commented, "this is an exciting development milestone for Nascent. Phase I data was shown to be safe in five ascending independent cohorts. The data also suggested favorable clinical outcomes in various stages of disease development, that we hope to build upon in Phase II and better understand just how effective this treatment can be for patients suffering with brain cancer". The summarized Phase I data can be seen here in the poster presented at ASCO (Free ASCO Whitepaper) 2023.

Nascent Biotech therapeutic antibody Pritumumab (PTB) is a natural human antibody originally isolated from lymph nodes of a patient with cervical cancer. This monoclonal antibody targets cell surface Vimentin (also referred to as ectodomain vimentin), shown to be expressed on the surface of epithelial cancers. PTB is used as a targeted immunotherapy that binds to the tumor and recruits the immune system to eliminate cancer cells.

On August 22, 2023 Isofol Medical AB (publ), (Nasdaq Stockholm: ISOFOL), reported that the company’s interim report for January–June 2023 is now available on the company’s website, www.isofolmedical.com (Press release, Isofol Medical, AUG 22, 2023, View Source [SID1234634624]).

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The information in the press release is intended for investors.

Second quarter, April–June 2023
Net revenue amounted to TSEK 0 (4,027) and other revenue to TSEK 0 (0)
The result for the period amounted to TSEK -7,507 (-54,033)
Earnings per share amounted to SEK -0.05 (-0.33)
Cash and cash equivalents at June 30 amounted to TSEK 156,767 (277,727)
First half of the year, January-June 2023
Net revenue amounted to TSEK 721 (8,033) and other revenue to TSEK 23 (1)
The result for the period amounted to TSEK -21,902 (-101,907)
Earnings per share amounted to SEK -0.14 (-0.63)
Significant events during the second quarter 2023
On April 28, Isofol informed that the company is starting preclinical evaluation of arfolitixorin in a research collaboration with Oncosyne AS in Norway.
On 7 June, Isofol informed that the board has decided to co-opt Anders Edvell to the board after board member Jan-Eric Österlund leaves the board at his own request.
On 21 June, Thomas Andersson resigned as CEO at his own request.
On June 22, the board appointed Roger Tell as acting CEO of the company.

Significant events after the event of the period

On July 4, the conclusions from the in-depth analysis of the AGENT study were presented. The results from the analysis support the hypothesis that a different dose and administration regimen may have the potential to improve the efficacy of the drug candidate arfolitixorin for colorectal cancer.