On August 8, 2024 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 an update on the Company’s clinical progress and plans for expansion (Press release, Bio-Path Holdings, AUG 8, 2024, View Source [SID1234645558]).

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"The Bio-Path team continues to work diligently toward advancing our important clinical work and have made meaningful progress in a number of areas critical to each program’s success," said Peter H. Nielsen, President and Chief Executive Officer of Bio-Path. "With the increased clinical data that we have generated, we are now able to develop the biomarkers needed to incorporate into our oncology studies. In addition, we have completed preparations for preclinical work to support advancing prexigebersen as a potential treatment for obesity. In tandem, we are designing development plans for first-in-human clinical studies in this expansive global market for weight loss."

"The incremental advances that we are making across these programs collectively push our DNAbilize platform closer to delivering these medicines to patients. Moreover, we are continuing to see the broader potential of our platform beyond oncology and look forward to realizing its potential across multiple indications, starting with obesity," continued Mr. Nielsen. Clinical Program Overview Bio-Path’s clinical development program consists of one Phase 2 clinical trial and three Phase 1 or 1/1b clinical trials.

Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment and is currently expanding prexigebersen preclinical studies for the treatment of obesity. Development of Molecular Biomarkers – Bio-Path has developed a molecular biomarker package to accompany prexigebersen treatment, the goal of which is to identify patients with a genetic profile more likely to respond to treatment, thereby improving the probability of success for this program. The emerging role of biomarkers has enhanced cancer development over the past decade and has become a more common companion to many oncology programs.

Prexigebersen Phase 2 Clinical Trial – Bio-Path’s Phase 2 clinical trial is treating Acute Myeloid Leukemia (AML) patients. This trial is comprised of three separate cohorts of patients and treatments, each separately approvable by the FDA as a new drug indication. The first two cohorts are treating patients with the triple combination of prexigebersen, decitabine and venetoclax. The first cohort includes untreated AML patients, and the second cohort includes relapsed/refractory AML patients. Finally, the third cohort is treating relapsed/refractory AML patients, who are venetoclax-resistant or intolerant, with the two-drug combination of prexigebersen and decitabine. Based on recent interim data for safety and efficacy, the Company plans to pursue next development steps by applying molecular biomarkers to future patient selection for enrollment into the Phase 2 clinical trial. Outcomes for these older patients who are unable to receive intensive chemotherapy due to the challenging side effect profile remain suboptimal with a median survival of only five to ten months. The study is currently paused for an interim analysis, amendment preparation and U.S. Food and Drug Administration (FDA) review. Bio-Path expects to complete enrollment in cohorts 1 and 2 of the study over the next eighteen months. Phase 1/1b Clinical Trial in BP1001-A in

Advanced Solid Tumors – A Phase 1/1b clinical trial of BP1001-A in patients with advanced or recurrent solid tumors, including ovarian and uterine, pancreatic and breast cancer, is ongoing. BP1001-A is a modified product candidate that incorporates the same drug substance as prexigebersen but has a slightly modified formulation designed to enhance nanoparticle properties. The Phase 1 study has advanced to the second, higher dose level. The Phase 1b portion of the study is expected to commence after successful completion of the three

BP1001-A monotherapy dose level cohorts and is intended to assess the safety and efficacy of BP1001-A in combination with paclitaxel in patients with recurrent ovarian or endometrial tumors. Phase 1b studies are also expected to be opened in combination with gemcitabine in late stage pancreatic cancer. In recent months, Bio-Path advanced to dose level 2 and expects to complete enrollment in order to advance to dose level 3 by year-end.

Phase 1/1b Clinical Trial in BP1002 in Relapsed/Refractory AML – A Phase 1/1b clinical trial for BP1002 to treat relapsed/refractory AML patients, including venetoclax-resistant patients, is ongoing. BP1002 targets the protein Bcl-2, which is responsible for driving cell survival in up to 60% of all cancers. The drug venetoclax treats AML patients by blocking the activity of the Bcl-2 protein in AML patients. However, patients become resistant to venetoclax. BP1002 treats the Bcl2 target by blocking the cell’s ability to produce Bcl-2, and could have the potential to eliminate the need for venetoclax.

AML patients that fail frontline venetoclax-based therapy have very poor prognosis with median overall survival of less than three months. The first dose cohort consisted of a starting dose of 20 mg/m2, and there were no dose limiting toxicities. Bio-Path recently completed the second dose cohort of 40 mg/m2 and is completing an analysis of PK/PD data to be submitted to the FDA in order to advance to the next dose level. Upon submission of data and approval from FDA, Bio-Path expects to advance to dose level 3 in the fourth quarter of 2024.

Phase 1 Clinical Trial in BP1002 in Refractory/Relapsed Lymphoma and Chronic Lymphocytic Leukemia (CLL) – A Phase 1 clinical trial to evaluate the ability of BP1002 to treat refractory/relapsed lymphoma and refractory/relapsed chronic lymphocytic leukemia (CLL) patients is currently ongoing. The Phase 1 clinical trial is being conducted at the Georgia Cancer Center, The University of Texas Southwestern and New York Medical College. In January 2024, Bio-Path announced successful completion of the first dose cohort in the Phase 1 clinical trial. A total of six evaluable patients are scheduled to be treated over two dose levels with BP1002 monotherapy in a standard 3+3 design, unless there is a dose limiting toxicity which would require an additional three patients to be tested. There were no dose limiting toxicities in the first dose cohort (20 mg/m2). Enrollment has continued for patients in the second BP1002 dose cohort of 40 mg/m2 and the Company expects to complete enrollment and to review these data by year-end.

Preclinical Work for BP1003 – The Company continues to advance its drug candidate, BP1003, for the treatment of advanced solid tumors, including pancreatic cancer. BP1003 is an antisense RNAi nanoparticle targeting the STAT3 protein. Plans are to conduct a Phase 1 study of BP1003 in patients with refractory, metastatic solid tumors (pancreatic, non-small cell lung cancer). Prexigebersen as Potential Treatment for Obesity and Obesity-related Cancers – The RNAi target of prexigebersen is the Grb2 protein, which is involved in activating the RAS/ERK pathway for cell growth. By blocking the cell’s ability to produce Grb2, prexigebersen treatment may limit cell growth. In obesity, two such pathways are related to leptin and insulin. Activation of leptin or insulin receptors can stimulate the RAS/ERK pathway via Grb2i.

Bio-Path believes development of prexigebersen for the treatment for obesity and obesity-related cancers could be accelerated given the large amount of safety data from prexigebersen treatment of leukemia patients and the continued unmet medical need. The Company is preparing for preclinical development evaluating prexigebersen for the treatment of obesity and will continue thereafter to conduct additional Investigational New Drug (IND)-enabling studies with an aim to advance prexigebersen into first-in-human studies in this indication.

On August 7, 2024 Novo Nordisk reported Financial report for the period 1 January 2024 to 30 June 2024 (Press release, Novo Nordisk, AUG 7, 2024, View Source [SID1234647162]).

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On August 7, 2024 Assertio Holdings, Inc. ("Assertio" or the "Company") (Nasdaq: ASRT), a pharmaceutical company with comprehensive commercial capabilities oering dierentiated products to patients, today reported nancial results for the second quarter ended June 30, 2024 (Press release, Assertio Holdings, AUG 7, 2024, View Source [SID1234647065]).

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"In my rst two months at Assertio, I have been excited to work closely with the team, meet our growing list of oncology clinic customers and focus on how best to maximize our results going forward. The second quarter’s performance illustrates how we continue to diligently execute the three pillars of Assertio’s business plan: driving the nancial performance of Assertio’s key assets, including our lead asset Rolvedon, generating cash ow and identifying new assets to create further value for our stockholders," said Brendan O’Grady, who was appointed Chief Executive Ocer on May 29, 2024.

"Rolvedon has been well received by physicians and continues to increase its share of the oncology G-CSF market,
generating its sixth consecutive quarter of demand growth since launch. As a potential opportunity for further
dierentiation, we have also completed enrollment of Rolvedon’s same-day dosing trial and expect to present the
initial data at a medical conference later this year. Combined with the rest of our platform and pipeline of
prospective business development opportunities, I am excited about the potential for Assertio."

On August 7, 2024 Sumitomo Dainippon Pharma reported its first quarter 2024 results (Presentation, Sumitomo Dainippon Pharma, AUG 7, 2024, View Source [SID1234646912]).

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On August 7, 2024, Precigen, Inc. ("Precigen") reported to have entered into an underwriting agreement (the "Underwriting Agreement") with Stifel, Nicolaus & Company, Incorporated, as the representative of the several underwriters named therein (the "Underwriters"), in connection with the underwritten public offering (the "Offering") of 35,294,118 shares (the "Firm Shares") of Precigen common stock, no par value ("Common Stock"), at a price to the public of $0.85 per share (Filing, 8-K, Precigen, AUG 7, 2024, View Source [SID1234645682]). Pursuant to the Underwriting Agreement, Precigen granted to the Underwriters the option to purchase up to an additional 5,294,117 shares of Common Stock (together with the Firm Shares, the "Shares") for a period of 30 days from the date of the Underwriting Agreement.

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Net proceeds to Precigen from the offering will be approximately $31.4 million after deducting the underwriting discount and other estimated offering expenses payable by Precigen, such proceeds including the sale of 4,584,821 shares of Common Stock exercised pursuant to the Underwriters’ option to purchase additional shares.

The Offering was made pursuant to Precigen’s shelf registration statement declared effective on January 17, 2024 (Registration No. 333-276337), as supplemented by the final prospectus supplement dated August 7, 2024.

The Underwriting Agreement includes certain customary representations, warranties, and covenants by Precigen, and it provides that Precigen will indemnify the Underwriters against certain liabilities, including liabilities under the Securities Act of 1933, as amended, or contribute to payments the Underwriters may be required to make because of any of those liabilities. The representations, warranties, and covenants contained in the Underwriting Agreement were made only for purposes of such agreement and as of specific dates, were solely for the benefit of the parties to such agreement, and may be subject to limitations agreed upon by the contracting parties. The foregoing description of the Underwriting Agreement does not purport to be complete and is qualified in its entirety by reference to the Underwriting Agreement, which is filed as Exhibit 1.1 hereto and incorporated herein by reference.