On August 13, 2021 A3P Biomedical AB reported that the publication of the STHLM3 MRI trial including 12,750 men has been fast tracked and is now published in the renowned peer-reviewed scientific publication The Lancet Oncology1 (Press release, A3P Biomedical, AUG 13, 2021, View Source [SID1234586570]).

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Results from the STHLM3 MRI trial, published in The Lancet Oncology, demonstrated that the combination of A3P Biomedical’s proprietary blood test Stockholm3 with Magnetic resonance imaging (MRI) in a population based prostate cancer screening program decreases unnecessary biopsies by 74% compared to standard of care, while maintaining detection of significant cancer.

Furthermore, Stockholm3 reduces MRI procedures with 36% compared to PSA. These significant improvements may enable population-based prostate cancer screening.

"To get fast track publication in The Lancet Oncology in addition to winning first prize for best abstract at the recent EAU2 congress shows the significance of the data. A considerable reduction in unnecessary biopsies as well as MRI procedures, which creates bottlenecks, is a major improvement and provides the basis for accelerating the implementation of general prostate cancer screening. The evidence for the Stockholm3 test is based on clinical trials on more than 80,000 men", said David Rosén, CEO at A3P Biomedical.

The STHLM3 MRI-trial is a randomized screening-by-invitation trial, comparing the standard test PSA with the Stockholm3 blood test when used with MRI-targeted or systematic biopsies for prostate cancer detection. 12,750 men in the age of 50-74 years participated in the trial. Compared to standard screening by PSA and systematic biopsies, Stockholm3 combined with MRI-targeted biopsies was associated with 74% fewer unnecessary biopsy procedures and 69% fewer overdiagnosed low-grade cancers, while maintaining detection of significant cancer.

The AUC (area under the receiver-operating characteristic curve) for significant cancer in the standard biopsy arm was 0.76 (95%CI 0.72-0.80) and 0.60 (95%CI 0.54-0.65) for Stockholm3 and PSA, respectively, equalling a 27% improvement in AUC. Furthermore, by using Stockholm3 instead of PSA prior to MRI, the number of MRI procedures were reduced by 36% and the unnecessary biopsies were reduced an additional 18%.

Current standard of care starts with PSA testing. However, the poor specificity of PSA leads to unnecessary biopsies and overdiagnosis of low-grade prostate cancers, which has been a major barrier to the use of PSA in population-based screening.

"The healthcare providers in the Nordics that already transitioned to Stockholm3 have demonstrated that in clinical practice even better results are achieved than in clinical screening trials; 100% more aggressive cancers found, 50% reduction of unnecessary biopsies and 17 to 25% lower costs. A3P Biomedical is committed to making the Stockholm3 test available worldwide and look forward to work with current and new partners to improve men’s health and quality of life", David Rosén further commented.

About Stockholm3
Stockholm3 is a blood test that combines protein markers, genetic markers, clinical data, and a proprietary algorithm, to predict the risk of aggressive prostate cancer. In clinical practice, Stockholm3 finds 100%more aggressive prostate cancers and reduces 50%of unnecessary biopsies compared to current practice with PSA (1).

Stockholm3 has been evaluated in clinical studies with more than 80,000 men. Data from the latest pivotal study, a randomized study including 12,750 men, was published in The Lancet Oncology in 2021. Multiple studies have been published in high-impact journals, including a previous study with 58,000 men, published in The Lancet Oncology in 2015 (1).

Based on robust peer-reviewed clinical data, leading Nordic healthcare providers such as Capio S:t Görans Hospital in Sweden and Stavanger University Hospital in Norway have replaced PSA with Stockholm3. Patients benefit from a more precise test (increasing sensitivity and specificity) and healthcare providers also benefit from direct cost savings of 17 to 25%(1).

(1) Publications, results and clinical validation.

About prostate cancer
Prostate cancer is the second most common male cancer, and the fifth leading cause of cancer related death in men worldwide. In 2020, 1.4 million men were diagnosed with prostate cancer and 375,000 deaths were reported by GLOBOCAN. Incidence of prostate cancer is expected to increase by 70% until 2040, driven by an aging population.

On August 13, 2021 Chemomab Therapeutics Ltd. (Nasdaq: CMMB), a clinical-stage biotech company focused on the discovery and development of innovative therapeutics for fibrosis-related diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2021 and provided a business update (Press release, Anchiano Therapeutics, AUG 13, 2021, View Source [SID1234586537]).

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Recent Highlights

CM-101 Phase 2a SPRING trial in primary sclerosing cholangitis (PSC) continues to enroll patients in the UK and Israel. The SPRING study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose trial designed to evaluate CM-101’s anti fibrotic effect, as well as its safety, pharmacokinetics and pharmacodynamics in PSC patients. Due to challenges resulting from the evolving conditions caused by the COVID-19 pandemic, Chemomab is expanding the trial sites to include additional territories with significant recruitment potential, and anticipates data in the second half of 2022.

CM-101 Phase 2a SPLASH trial in liver fibrosis remains on track, with data expected in the first half of 2022. The SPLASH study is a multi-center, randomized, double-blind, placebo-controlled, multiple dose study designed to assess the mechanism of action, safety, pharmacokinetics and pharmacodynamic effects, as well as the anti-fibrotic effects of subcutaneous (SC) CM-101 in NASH patients with fibrosis stage F2-F3.

CM-101 Phase 2 clinical trial of CM-101 for the treatment of Systemic Sclerosis. Chemomab continues the preparations for the Phase 2 trial in Systemic Sclerosis. The trial is planned to be a multi-center, randomized, double-blind, placebo-controlled study designed to test CM-101’s effect on clinically relevant endpoints in diffuse Systemic Sclerosis patients. Chemomab expects to initiate the Phase 2 clinical trial in the first quarter of 2022.

Expanded partnership with AGC Biologics for the manufacture of CM-101. Under terms of the agreement, AGC Biologics, a leading global Biopharmaceutical Contract Development and Manufacturing Organization (CDMO) and Chemomab will work together to optimize, scale up and finalize the CM-101 manufacturing process under GMP conditions towards its testing in pivotal studies. AGC Biologics will manufacture the clinical trial materials at its site in Copenhagen to support Phase 2/3 clinical testing and launch readiness.

Presented a poster at the International Liver Congress 2021 (EASL) held virtually in June 2021. The poster, entitled: "The peri-ductular CCL24 rich niche promotes bile duct fibrosis related liver damage in primary sclerosing cholangitis" highlighted the pivotal role of CCL24 as a main driver of fibrosis in PSC-related pathophysiology and provided further support to the proposed CM-101 mechanism of action in PSC.

Chemomab is advancing in parallel three Phase 2 clinical trials with CM-101 in fibrotic indications; Systemic Sclerosis is planned to be initiated by early 2022 and clinical readouts from the ongoing clinical trials in PSC and liver fibrosis are expected during 2022.

"With two of our three planned Phase 2 trials enrolling patients and our strong cash position, we continue to make solid progress throughout our CM-101 pipeline. We remain highly focused on execution. In the beginning of 2022, we plan to initiate our third Phase 2 trial of CM-101 in Systemic Sclerosis and we look forward to anticipated data readouts in PSC and liver fibrosis in 2022." said Dr. Adi Mor, CEO of Chemomab. "Our agreement with AGC Biologics is an important step in ensuring the availability of clinical trial material for our future pivotal clinical studies and launch readiness. CM-101 is a very promising therapy with the potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases and we believe we are well positioned to continue advancing our pipeline and executing upon our important milestones."

Second Quarter 2021 Financial Highlights

Cash and cash equivalents (including bank deposits) as of June 30, 2021 were $67 million compared to $58.2 million as of March 31, 2021 and $11.7 million as of December 31, 2020. The existing cash position is expected to fund the Company’s current operating plan until mid 2023.
Number of ADSs outstanding on a fully diluted basis as of June 30, 2021 was 12,584,362 (or 251,687,240 ordinary shares) which includes 699,806 ADSs (or 13,996,120 ordinary shares) sold during the quarter ended June 30, 2021 under the Company’s ATM program.
Research and Development expenses for the three months ended June 30, 2021 were $1.3 million, compared to $0.8 million for the three months ended June 30, 2020. The increase of $0.5 million was primarily related to clinical and pre-clinical activities. R&D expenses are expected to substantially increase over the next several quarters as Chemomab continues to advance the clinical programs.
General and administrative expenses were $1.4 million for the three months ended June 30, 2021, compared to $0.2 million for the three months ended June 30, 2020. The increase of $1.2 million is primarily derived from expenses associated with public company operations.
Basic and diluted net loss for the three months ended June 30, 2021 was $2.8 million or ($0.01) per ordinary share, compared to $1.1 million, or ($0.01) per ordinary share, for the prior year period.
For further details on the Company’s financial results, including the results for the six and three months ended June 30, 2021, refer to the Form 10-Q filed with the SEC.

On August 13, 2021 Soligenix, Inc. (Nasdaq: SNGX) (Soligenix or the Company), a late-stage biopharmaceutical company focused on developing and commercializing products to treat rare diseases where there is an unmet medical need, reported its recent accomplishments and financial results for the quarter ended June 30, 2021 (Press release, Soligenix, AUG 13, 2021, View Source [SID1234586553]).

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Christopher J. Schaber, PhD, President and Chief Executive Officer of Soligenix stated, "2021 remains a crucial year for Soligenix. Under our Specialized BioTherapeutics business segment, our HyBryte (SGX301) positive pivotal Phase 3 FLASH (Fluorescent Light Activated Synthetic Hypericin) study in cutaneous T-cell lymphoma (CTCL) was recently selected for presentation at the United States Cutaneous Lymphoma Consortium (USCLC) Annual Meeting. Additionally, HyBryte received a Pediatric Investigation Plan (PIP) waiver from the European Medicines Agency (EMA), which is a key component of the regulatory process for marketing authorization in Europe. We continue to move our pipeline forward with multiple data readouts expected this year under our Public Health Solutions business segment. This data is critial in our efforts to advance our therapeutic and vaccine candidates such as CiVax, our heat stable COVID-19 vaccine."

Dr. Schaber continued, "With approximately $29 million in cash, not including our non-dilutive government funding, we anticipate having sufficient capital to achieve multiple inflection points as we advance our rare disease pipeline, including NDA filing in the first half of 2022 and U.S. commercialization of HyBryte in CTCL, where we estimate peak U.S. annual net sales to exceed $90 million and the total U.S. revenues during the 10-year forecast period to be greater than $700 million. We are also aggressively exploring and evaluating multiple strategic options moving forward, including but not limited to, partnership and merger and acquisition opportunities."

Soligenix Recent Accomplishments

On June 22, 2021, the Company announced that Ellen Kim, MD, Medical Director, Dermatology Clinic, Perelman Center for Advanced Medicine, Professor of Dermatology at the Hospital of the University of Pennsylvania, and the Lead Principal Investigator for the Phase 3 FLASH study in CTCL, would present key details of HyBryte (hypericin ointment 0.25%) efficacy and safety profile demonstrated in the FLASH study at the USCLC Annual Meeting, to be held on June 26, 2021. To view this press release, please click here.
On June 10, 2021, the Company announced that it had received a PIP waiver from the EMA for HyBryte, which has recently and successfully concluded a Phase 3, pivotal clinical study for the treatment of early stage CTCL. To view this press release, please click here.
On June 9, 2021, the Company announced that it had received approximately $865,000, net of transaction costs, in non-dilutive financing via the state of New Jersey’s Technology Business Tax Certificate Transfer Program. To view this press release, please click here.
On May 20, 2021, the Company announced that the Japan Patent Office had allowed the patent application titled "Systems and Methods for Producing Synthetic Hypericin". The allowed claims are directed to unique, proprietary methods to produce a novel, highly purified form of synthetic hypericin, and are similar to those previously allowed in the United States. To view this press release, please click here.
Financial Results – Quarter Ended June 30, 2021
Soligenix’s revenues for the quarter ended June 30, 2021 were $0.2 million as compared to $0.5 million for the quarter ended June 30, 2020. Revenues included payments on grants received to support the development of: SGX943 for treatment of emerging and/or antibiotic-resistant infectious diseases; ThermoVax, our thermostabilization technology; and CiVax, our vaccine candidate for the prevention of COVID-19.

Soligenix’s basic net loss was $1.9 million, or ($0.05) per share, for the quarter ended June 30, 2021, as compared to $2.8 million, or ($0.10) per share, for the quarter ended June 30, 2020. This decrease in net loss was primarily due to the gain on the forgiveness of the Payroll Protection Program loan and the sale of New Jersey NOL carryforwards offset by reduced contract revenues and the interest expense on convertible debt.

Research and development expenses were $2.1 million as compared to $2.2 million for the quarters ended June 30, 2021 and 2020, respectively. The decrease in research and development spending for the quarter ended June 30, 2021 was primarily attributable to the reduction in expense due to the completion of the HyBryte and SGX942 clinical trials.

General and administrative expenses were $0.9 million and $0.8 million for the three months ended June 30, 2021 and 2020, respectively.

As of June 30, 2021, the Company’s cash position was approximately $29.0 million.

On August 13, 2021 Ayala Pharmaceuticals, Inc. (Nasdaq: AYLA), a clinical-stage oncology company focused on developing and commercializing small molecule therapeutics for patients suffering from rare and aggressive cancers, primarily in genetically defined patient populations, reported financial results for the period ended June 30, 2021 and highlighted recent progress and upcoming milestones for its pipeline programs (Press release, Ayala Pharmaceuticals, AUG 13, 2021, View Source [SID1234593995]).

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"Ayala is well positioned for strong clinical progress throughout the remainder of this year. In the second quarter, we continued to advance our pipeline programs and we are gearing up for a data readout from AL101 in our ACCURACY trial in adenoid cystic carcinoma at the upcoming ESMO (Free ESMO Whitepaper) meeting in September, while also advancing our AL102 clinical trials in desmoid tumors and multiple myeloma," said Roni Mamluk, Ph.D., Chief Executive Officer of Ayala. "Our science is deeply rooted in the promise of predicting, identifying and addressing tumorigenic drivers of cancer and we continue to see value in our approach combining bioinformatics and next-generation sequencing. There remains a significant unmet need among patients with genetically defined cancers and we believe that our pipeline has the potential to address the ongoing shortfalls of existing therapies."

Recent Business Highlights and Upcoming Milestones:

Enrolled First Patient in the Phase 2/3 RINGSIDE Trial of AL102 for the Treatment of Desmoid Tumors: Ayala recently enrolled the first patient in its pivotal Phase 2/3 RINGSIDE trial of AL102 for the treatment of desmoid tumors with multiple sites open in the U.S. and globally. Ayala expects to report an initial interim data read-out from part A of the trial in mid-2022, with part B of the study commencing thereafter.
Dosed First Patient in the Phase 1 Trial of AL102 in Combination with Novartis’ BCMA Targeting Agent, WVT087 for the Treatment of Relapsed/Refractory Multiple Myeloma: In April 2021, Ayala announced the dosing of the first patient in the Phase 1 combination trial of AL102 with Novartis’ investigational anti-B-cell maturation antigen (BCMA) agent, WVT078, for the treatment of relapsed and/or refractory (R/R) multiple myeloma (MM).
Phase 2 TENACITY Trial of AL101 for the Treatment of Triple Negative Breast Cancer Continues to Progress: Ayala continues to enroll patients in the Phase 2 TENACITY clinical trial of its potent, selective small molecule gamma secretase inhibitor (GSI), AL101, for the treatment of patients with Notch-activated recurrent or metastatic (R/M) triple negative breast cancer (TNBC). The Company expects to report preliminary data from this ongoing trial in 2022.
On Track to Report Additional ACCURACY Phase 2 Data; Patient Enrollment in 6mg Cohort of Phase 2 ACCURACY Study Completed: Ayala completed enrollment of patients in the 6mg cohort of the Phase 2 ACCURACY study of AL101 for the treatment of R/M adenoid cystic carcinoma (ACC), which includes 42 subjects. Further trial progress updates, including additional data, will be presented at the upcoming European Society for Medical Oncology (ESMO) (Free ESMO Whitepaper) 2021 Congress being held virtually September 16-21, 2021.
Second Quarter 2021 Financial Results

Cash Position: Cash and cash equivalents were $44.4 million as of June 30, 2021, as compared to $42.0 million as of December 31, 2020.
Collaboration Revenue: Collaboration revenue was $0.8 million for the second quarter of 2021, as compared to $1.0 million for the same period in 2020.
R&D Expenses: Research and development expenses were $8.1 million for the second quarter of 2021, compared to $5.1 million for the same period in 2020. The increase was primarily driven by the advancement of Ayala’s clinical programs.
G&A Expenses: General and administrative expenses were $2.5 million for the second quarter of 2021, compared to $1.5 million for the same period in 2020. The increase was primarily related to costs associated with becoming a public company.
Net Loss: Net loss was $10.8 million for the second quarter of 2021, resulting in a basic and diluted net loss per share of $0.75 Net loss was $6.7 million for the same period in 2020, resulting in a basic and diluted net loss per share of $0.74.

On August 13, 2021 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize liposomal delivery and antisense technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2021 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 13, 2021, View Source [SID1234586538]).

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"Throughout the second quarter and in recent weeks, we’ve made tremendous progress advancing our entire DNAbilize portfolio. In June, we were delighted to announce a new patent related to our BP1003 program which further bolsters our intellectual property portfolio," stated Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Throughout the balance of the year, we look forward to executing on our clinical development plans, including the advancement of our Phase 1 clinical trial evaluating BP1002 in refractory/relapsed acute myeloid leukemia patients."

Recent Corporate Highlights

Granted Key Mechanism of Action U.S. Patent for BP1003. In June, Bio-Path announced that the United States Patent and Trademark Office has granted a new patent relating to the Company’s BP1003 program, a novel liposome-incorporated oligodeoxynucleotide inhibitor against Signal Transduction and Activator of Transcription-3 (STAT3). The new patent builds on earlier patents that have been granted that protect the platform technology for DNAbilize, the Company’s novel RNAi nanoparticle drug platform.

Announced Publication in Biomedicines. In April, Bio-Path announced the publication of an analysis highlighting the potential of prexigebersen (BP1001) within the antisense oligonucleotide drug delivery landscape in the peer-reviewed journal, Biomedicines.

Presented BP1002 Data at 2021 AACR (Free AACR Whitepaper) Annual Meeting. In April, Bio-Path presented a poster highlighting preclinical BP1002 data at the 2021 American Association for Cancer Research (AACR) (Free AACR Whitepaper) Annual Meeting. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. High expression of Bcl-2 has been correlated with poor prognosis for patients diagnosed with AML. The data presented in the AACR (Free AACR Whitepaper) poster show that venetoclax-resistant cells are sensitive to the inhibitory effects of BP1002 combined with decitabine, suggesting that this combination is a potential treatment for patients who have relapsed from frontline venetoclax-based therapies.

Successfully Completed Safety Cohort of Triple Combination in Stage 2 of Phase 2 Clinical Trial in AML. In April, Bio-Path announced the successful completion of the safety run-in of Stage 2 of the Phase 2 clinical study of prexigebersen (BP1001), a liposomal Grb2 antisense, for the treatment of acute myeloid leukemia (AML), in combination with frontline therapies, decitabine and venetoclax, in acute myeloid leukemia (AML) patients. The safety run-in of Stage 2 of the Phase 2 clinical trial was comprised of six evaluable patients who were treated with the triple combination of prexigebersen, decitabine and venetoclax.
Financial Results for the Second Quarter Ended June 30, 2021

The Company reported a net loss of $1.8 million, or $0.26 per share, for the three months ended June 30, 2021, compared to a net loss of $2.0 million, or $0.55 per share, for the three months ended June 30, 2020.

Research and development expense for the three months ended June 30, 2021, decreased to $0.8 million, compared to $1.0 million for the three months ended June 30, 2020, primarily due to timing of activities related to our clinical trials for BP1002 in lymphoma, prexigebersen in AML and prexigebersen-A in solid tumors.

General and administrative expense for the three months ended June 30, 2021, were $1.0 million, consistent with the comparable period in 2020.

As of June 30, 2021, the Company had cash of $28.1 million, compared to $13.8 million at December 31, 2020. Net cash used in operating activities for the six months ended June 30, 2021, was $4.2 million compared to $6.0 million for the comparable period in 2020. Net cash provided by financing activities for the six months ended June 30, 2021, was $18.6 million.
Conference Call and Webcast Information

Bio-Path Holdings will host a conference call and webcast today at 8:30 a.m. ET to review these second quarter 2021 financial results and to provide a general update on the Company. To access the conference call please dial (844) 815-4963 (domestic) or (210) 229-8838 (international) and refer to the conference ID 4739446. A live audio webcast of the call and the archived webcast will be available in the Media section of the Company’s website at www.biopathholdings.com.