On August 15, 2024 Ono Pharmaceutical, Co., Ltd. (Headquarters: Osaka, Japan; President: Toichi Takino; "Ono") reported that the U.S. Food and Drug Administration (FDA) accepted a priority review for the New Drug Application (NDA) on August 14 US time for vimseltinib, a colony stimulating factor 1 receptor (CSF1R), for the treatment of patients with tenosynovial giant cell tumor (TGCT), which is under development by Deciphera Pharmaceuticals, Inc. ("Deciphera"), a wholly-owned subsidiary of Ono (Press release, Deciphera Pharmaceuticals, AUG 15, 2024, View Source [SID1234645943]). The FDA assigned a Prescription Drug User Fee Act (PDUFA) goal date of February 17, 2025. In mid-July, the European Medicines Agency (EMA) accepted a Marketing Authorization Application (MAA) of vimseltinib and has begun the start of the EMA’s centralized review process.

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"Building upon positive results from the MOTION pivotal Phase 3 study and following our recent announcement that EMA review of the vimseltinib MAA has begun, we are excited to initiate the regulatory review process in the US and we look forward to working with the FDA to deliver a new treatment option to patients with TGCT" said Steve Hoerter, President and Chief Executive Officer of Deciphera Pharmaceuticals.

The submission is supported by the data from the pivotal Phase 3 MOTION study, evaluating the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior antiCSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed), compared to placebo. In the study, vimseltinib demonstrated a statistically significant and clinically meaningful objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by Blinded Independent Radiologic Review (BIRR) per Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo (40% in vimseltinib arm vs 0% in placebo arm, p <0.0001). Additionally, vimseltinib demonstrated statistically significant and clinically meaningful improvements versus placebo in all key secondary endpoints. The safety profile of vimseltinib is manageable and safety data from MOTION are consistent with data previously disclosed in the Phase 1/2 clinical trial of vimseltinib*. Results from the MOTION study were presented at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting and published concurrently in Lancet.

About MOTION Study

The MOTION study is a two-part, randomized, double-blind, placebo-controlled Phase 3 clinical study to assess the efficacy and safety of vimseltinib in patients with TGCT not amenable to surgery with no prior anti-CSF1/CSF1R therapy (prior therapy with imatinib or nilotinib allowed). The primary endpoint of the study is an objective response rate (ORR) at Week 25 in the intent-to-treat (ITT) population, as assessed by Blinded Independent Radiologic Review (BIRR) per using Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1), versus placebo. The secondary endpoint includes ORR per tumor volume score (TVS), active range of motion (ROM), physical function, stiffness, quality of life, and pain, all assessed at Week 25. This study consists of two Parts. In Part 1, patients were randomized to receive either vimseltinib or placebo for 24 weeks. In Part 2, patients randomized to placebo in Part 1 have the option to receive vimseltinib, and all patients receive vimseltinib for a long-term period in an open-label setting.

About Tenosynovial Giant Cell Tumor (TGCT)

TGCT is a rare disease caused by a translocation in colony-stimulating factor 1 (CSF1) gene resulting in overexpression of CSF1 and recruitment of colony-stimulating factor 1 receptor (CSF1R)-positive inflammatory cells into the lesion. TGCT is a rare, non-malignant tumor that develops inside or near joints. TGCT is caused by dysregulation of the CSF1 gene leading to overproduction of CSF1. TGCT is also known as giant cell tumor of the tendon sheath (GCT-TS) or pigmented villonodular synovitis (PVNS), a diffuse-type of TGCT. Although benign, these tumors can grow and cause damage to surrounding tissues and structures inducing pain, swelling, and limitation of movement of the joint. Surgery is the main treatment option; however, these tumors tend to recur, particularly in diffuse-type TGCT. If untreated or if the tumor continually recurs, damage and degeneration may occur in the affected joint and surrounding tissues, which may cause significant disability. For a subset of patients who are not amenable to surgery, systemic treatment options are limited and a new therapeutic option for TGCT is needed.

About Vimseltinib

Vimseltinib is an investigational, oral switch-control tyrosine kinase inhibitor specifically designed to selectively and potently inhibit CSF1R. Vimseltinib has been developed using Deciphera’s proprietary switch-control kinase inhibitor platform.

On August 15, 2024 BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a commercial stage biopharmaceutical company pursuing life-changing therapies in oncology and rare diseases, reported its unaudited financial results for the second quarter ended June 30, 2024, and provided recent corporate and portfolio updates (Press release, BioLineRx, AUG 15, 2024, View Source [SID1234645942]).

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"We continue to demonstrate positive commercial launch momentum with APHEXDA, our best-in-class stem cell mobilization agent," said Philip Serlin, Chief Executive Officer of BioLineRx. "Importantly, among our targeted top 80 transplant centers, we’ve secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, surpassing our stated goal. Additionally, we doubled the number of transplant centers ordering APHEXDA during the second quarter, which is a strong leading indicator and, we believe, reflects centers’ growing recognition of the value that APHEXDA offers relative to other mobilization agents. Our goal is to achieve formulary placement at institutions representing approximately 60% of procedures by the end of year, which will support continued revenue growth and ease burdens on patients, caregivers, and transplant centers.

"Our vision is to maximize the potential of APHEXDA by expanding into key areas with high unmet need. To that end, we announced our second clinical trial collaboration, with St. Jude Children’s Research Hospital, evaluating APHEXDA for stem cell mobilization in patients with sickle cell disease (SCD) seeking gene therapy. This new collaboration complements the ongoing SCD stem cell mobilization Phase 1 trial at Washington University in St. Louis (Wash U.). APHEXDA has the potential to support the collection of the immense amount of stem cells needed for these complex gene therapies in a more predictable and condensed timeline for patients. The companies launching these new gene therapies for SCD report continued expansion of authorized treatment centers and increased numbers of patients initiating cell collection. We look forward to seeing early data from the Wash U. Phase 1 trial later this year."

APHEXDA Launch Updates

Among top 80 transplant centers, secured formulary placement to date at institutions representing ~37% of stem cell transplant procedures performed, exceeding the company’s stated goal for the quarter; on track to achieve ~60% by year-end 2024
Saw double the number of centers ordering APHEXDA during the second quarter as compared to the first quarter, which contributed to quarter-over-quarter net revenue growth of 100%
Clinical Portfolio Updates

Motixafortide

Multiple Myeloma

Presented a poster at the American Society for Apheresis (ASFA) 2024 Annual Meeting on April 17, 2024, demonstrating that transplant centers (averaging, for example, 20 transplants per month), when switching to G-CSF plus APHEXDA, could increase capacity by 52.0 patient days per month versus G-CSF alone, or by 12.3 patient days per month versus G-CSF in combination with plerixafor
Presented a poster at the International Society for Pharmacoeconomics and Outcomes Research (ISPOR) on April 6, 2024, showing that even with APHEXDA’s higher drug acquisition cost compared to other mobilization regimens, specifically G-CSF alone or G-CSF plus generic plerixafor, the combination of G-CSF plus APHEXDA may confer a similar or better overall financial impact while providing centers and patients with an improved mobilization experience
Collaboration partner Gloria Biosciences’ stem cell mobilization bridging study IND was filed and approved by the Center for Drug Evaluation of the National Medical Products Administration in China. Anticipate initiation of pivotal clinical trial in 2H 2024
Sickle Cell Disease (SCD) & Gene Therapy

Entered into clinical trial agreement with St. Jude Children’s Research Hospital to evaluate motixafortide for hematopoietic stem cell mobilization for gene therapies in sickle cell disease. The Phase 1 clinical trial is an open-label, multi-center study evaluating the safety, tolerability, and feasibility of single-agent motixafortide for the mobilization and collection of CD34+ HSCs in 12 patients (aged 18 and older) with SCD. Anticipate first patient dosed in September 2024 and initial data in 2025
Reported continuing enrollment of patients into a Phase 1 clinical trial evaluating motixafortide as monotherapy and in combination with natalizumab for stem cell mobilization for gene therapies in sickle cell disease. The trial, in collaboration with Washington University School of Medicine in St. Louis, has been expanded from five to 10 patients. Anticipate initial data in 2H 2024
Pancreatic Ductal Adenocarcinoma (mPDAC)

Presented positive biopsy data from the completed pilot phase of the ongoing CheMo4METPANC Phase 2b clinical trial collaboration with Columbia University at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) 2024 Annual Meeting held on June 1, 2024 in Chicago, IL. New analyses of paired pre- and on-treatment biopsy samples demonstrated a statistically significant increase in CD8+ T-cell density in tumors from all 11 patients treated with the combination therapy approach (P=0.007). Enrollment in the randomized trial targeting 108 patients continues with full enrollment anticipated in 2027
Completed design of Phase 2b randomized clinical trial in China with collaboration partner Gloria Biosciences intended to assess motixafortide in combination with the PD-1 inhibitor zimberelimab and standard-of-care chemotherapy as first-line treatment in patients with metastatic pancreatic cancer. Anticipate clinical trial initiation in 2025
Second Quarter 2024 Financial Results

Total revenue for the three months ended June 30, 2024 was $5.4 million. The Company did not record any revenue during the second quarter of 2023. Revenue for the quarter reflects a portion of the upfront payment from the Gloria Biosciences license, which amounted to $3.6 million, as well as $1.8 million of net revenue from product sales of APHEXDA in the U.S.
Cost of revenue for the three months ended June 30, 2024 was $0.9 million. The Company did not record any cost of revenue during the second quarter of 2023. Cost of revenue for the quarter primarily reflects the amortization of intangible assets, royalties on net product sales of APHEXDA in the U.S., and cost of goods sold on product sales
Research and development expenses for the three months ended June 30, 2024 were $2.2 million, compared to $3.0 million for the same period in 2023. The decrease resulted primarily from lower expenses related to motixafortide New Drug Application (NDA) supporting activities, termination of the development of AGI-134 and a decrease in share-based compensation
Sales and marketing expenses for the three months ended June 30, 2024 were $6.4 million, compared to $5.6 million for the same period in 2023. The increase resulted primarily from the ramp-up in headcount costs associated with a fully hired field team
General and administrative expenses for the three months ended June 30, 2024 were $1.6 million, compared to $1.3 million for the same period in 2023. The increase resulted primarily from an increase in legal and certain other expenses
Net income for the three months ended June 30, 2024 was $0.5 million, compared to net loss of $18.5 million for the same period in 2023. The net income for the 2024 period included $7.8 million in non-operating income, compared to non-operating expenses of $7.7 million for the same period in 2023, both primarily related to the non-cash revaluation of warrants
As of June 30, 2024, the Company had cash, cash equivalents, and short-term bank deposits of $40.1 million. The Company anticipates that this amount will be sufficient to fund operations, as currently planned, into 2025
Conference Call and Webcast Information

To access the conference call, please dial +1-888-281-1167 from the U.S. or +972-3-918-0685 internationally. A live webcast and a replay of the call can be accessed through the event page on the Company’s website. Please allow extra time prior to the call to visit the site and download any necessary software to listen to the live broadcast. The call replay will be available approximately two hours after completion of the live conference call. A dial-in replay of the call will be available until August 19, 2024; please dial +1-888-295-2634 from the US or +972-3-925-5904 internationally.

On August 15, 2024 Bio-Path Holdings, Inc., (NASDAQ:BPTH), a biotechnology company leveraging its proprietary DNAbilize antisense RNAi nanoparticle technology to develop a portfolio of targeted nucleic acid cancer drugs, reported its financial results for the second quarter ended June 30, 2024 and provided an update on recent corporate developments (Press release, Bio-Path Holdings, AUG 15, 2024, View Source [SID1234645941]).

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"The first half of 2024 was marked by considerable corporate and clinical progress across the organization. We were encouraged by the bolus of data we presented at ASCO (Free ASCO Whitepaper) and EHA (Free EHA Whitepaper) as they underscore the potential of a prexigebersen combination regimen as a safe and effective treatment for some of the most vulnerable cancer patients," said Peter Nielsen, President and Chief Executive Officer of Bio-Path Holdings. "Moving forward, we are excited to advance these important programs in support of our mission to deliver effective therapies without harsh side effects so that even the most fragile patients can have tolerable treatment options."

Recent Corporate Highlights

● Presented Data at American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting. In June, Bio-Path presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of acute myeloid leukemia (AML) in an oral presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting in Chicago, IL.

● Showcased Data at European Hematology Association (EHA) (Free EHA Whitepaper) Congress. In June, the Company presented interim results from the Company’s Phase 2 study of prexigebersen (BP1001) in combination with decitabine and venetoclax for the treatment of AML in a poster presentation at 2024 European Hematology Association (EHA) (Free EHA Whitepaper) Congress in Madrid, Spain.

● Closed $4.0 Million Private Placement. In June, Bio-Path closed a private placement for the issuance and sale of an aggregate of 1,809,955 shares of its common stock (or common stock equivalents in lieu thereof), series A warrants to purchase up to 1,809,955 shares of common stock and short-term series B warrants to purchase up to 1,809,955 shares of common stock at a purchase price of $2.21 per share of common stock (or per common stock equivalent in lieu thereof) and accompanying warrants priced at-the-market under Nasdaq rules.

Financial Results for the Second Quarter Ended June 30, 2024

● The Company reported a net loss of $1.9 million, or $1.16 per share, for the three months ended June 30, 2024, compared to a net loss of $4.2 million, or $10.64 per share, for the three months ended June 30, 2023.

● Research and development expense for the three months ended June 30, 2024 decreased to $1.9 million, compared to $3.1 million for the three months ended June 30, 2023 primarily due to decreased manufacturing expenses related to drug product releases partially offset by an increase in expense related to our clinical trial for BP1002 in lymphoma due to increased patient enrollment in 2024.

● General and administrative expense for each of the three months ended June 30, 2024 and June 30, 2023 was $1.2 million.

● As of June 30, 2024, the Company had cash of $4.0 million, compared to $1.1 million as of December 31, 2023. Net cash used in operating activities for the six months ended June 30, 2024 was $4.3 million compared to $6.9 million for the comparable period in 2023. Net cash provided by financing activities for the six months ended June 30, 2024 was $7.2 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 2024 financial results and to provide a general update on the Company. To access the conference call please dial (844) 481-3014 (domestic) or (412) 317-1879 (international). 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.

On August 15, 2024 Aligos Therapeutics, Inc. (Nasdaq: ALGS, "Aligos", "Company"), a clinical stage biopharmaceutical company focused on developing novel therapeutics to address unmet medical needs in liver and viral diseases, reported that it will effect a 1-for-25 reverse stock split of its shares of common stock (Press release, Aligos Therapeutics, AUG 15, 2024, View Source [SID1234645940]). The reverse stock split will become effective at 12:01 am ET on Monday, August 19, 2024. The Company’s common stock is expected begin trading on the Nasdaq Capital Market under the same symbol (ALGS) on a split-adjusted basis at the market open on August 19, 2024 with the new CUSIP number 01626L 204.

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At the effective time, all outstanding stock options, warrants, and equity incentive plans will be proportionally affected. Every 25 shares of issued and outstanding shares of the company’s common stock will automatically be reclassified into one issued and outstanding share of common stock without any change in the par value of $0.0001 per share. No fractional shares will be issued in connection the reverse stock split and stockholders will be entitled to a cash payment in lieu of fractional shares. The reverse stock split will affect all stockholders uniformly and will not affect any stockholder’s ownership percentage of Aligos’s shares, except for those stockholders receiving a cash payment in lieu of fractional shares.

The Company is primarily implementing the reverse stock split to enable it to regain compliance with the Nasdaq $1.00 minimum bid price requirement. The reverse stock split was approved by the Company’s stockholders at the Annual Meeting of Stockholders on June 27, 2024. Subsequently, the Board of Directors approved the reverse stock split at a ratio of 1-for-25.

Continental Stock Transfer & Trust Company is acting as the exchange and transfer agent for the reverse stock split. Continental will provide instructions to stockholders with registered shares and those receiving a cash payment for fractional shares, if any. Those stockholders with shares in "street name" will have their positions automatically adjusted, subject to each broker’s processes. If any action is required, each stockholder will receive instructions directly from their broker.

Additional information about the reverse stock split can be found in the definitive proxy statement filed with the Securities and Exchange Commission (SEC) on April 29, 2024, which is available on the SEC’s website, www.sec.gov, and the company’s website at www.aligos.com.

On August 15, 2024 AstraZeneca reported supplemental Biologics License Application (sBLA) for Imfinzi (durvalumab), based on the results from the positive ADRIATIC Phase III trial in patients with limited-stage small cell lung cancer (LS-SCLC) whose disease has not progressed following platinum-based concurrent chemoradiotherapy (cCRT), has been accepted and granted Priority Review in the US (Press release, AstraZeneca, AUG 15, 2024, View Source [SID1234645933]).

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The Food and Drug Administration (FDA) grants Priority Review to applications for medicines that, if approved, would offer significant improvements over available options by demonstrating safety or efficacy improvements, preventing serious conditions or enhancing patient compliance.1 The Prescription Drug User Fee Act date, the FDA action date for their regulatory decision, is anticipated during the fourth quarter of 2024.

Imfinzi was also recently granted Breakthrough Therapy Designation (BTD) by the FDA in this setting. BTD accelerates the development and regulatory review of potential new medicines intended to treat a serious condition and address a significant unmet medical need.2

Small cell lung cancer (SCLC) is a highly aggressive form of lung cancer that typically recurs and progresses rapidly despite initial response to chemotherapy and radiotherapy in LS-SCLC patients.3-4 The prognosis for LS-SCLC is particularly poor, as only 15-30% of these patients will be alive five years after diagnosis.5

Susan Galbraith, Executive Vice President, Oncology R&D, AstraZeneca, said: "This Priority Review reinforces the potential of Imfinzi to transform outcomes for patients as the first and only immunotherapy to demonstrate a survival benefit in limited-stage small cell lung cancer. There is an urgent need for new treatment options that improve upon the standard of care in this setting, which has not changed in forty years, and we look forward to working with the FDA to bring Imfinzi to patients as quickly as possible."

The sBLA is based on data from the ADRIATIC Phase III trial recently presented during the Plenary Session at the 2024 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting.

In the trial, Imfinzi reduced the risk of death by 27% versus placebo (based on an overall survival [OS] hazard ratio [HR] of 0.73; 95% confidence interval [CI] 0.57-0.93; p=0.0104). Estimated median OS was 55.9 months for Imfinzi (95% CI 37.3-not estimable [NE]) versus 33.4 months for placebo (95% CI 25.5-39.9). An estimated 57% of patients treated with Imfinzi were alive at three years compared to 48% on placebo.

Imfinzi also reduced the risk of disease progression or death by 24% (based on a progression-free survival [PFS] HR of 0.76; 95% CI 0.61-0.95; p=0.0161) versus placebo. Median PFS was 16.6 months for Imfinzi (95% CI 10.2-28.2) versus 9.2 months for placebo (95% CI 7.4-12.9). An estimated 46% of patients treated with Imfinzi had not experienced disease progression at two years compared to 34% on placebo.

The safety profile for Imfinzi was generally manageable and consistent with the known profile of this medicine. No new safety signals were observed.

Notes

Small cell lung cancer
Lung cancer is the leading cause of cancer death among men and women, accounting for about one-fifth of all cancer deaths.6-7 Lung cancer is broadly split into non-small cell lung cancer (NSCLC) and SCLC, with about 15% of cases classified as SCLC.8

LS-SCLC (Stage I-III) is classified as SCLC that is generally only in one lung or one side of the chest.9 LS-SCLC accounts for approximately 30% of SCLC diagnoses and the prognosis remains poor despite curative-intent treatment with standard-of-care cCRT.10

ADRIATIC
The ADRIATIC trial is a randomised, double-blind, placebo-controlled, multi-centre global Phase III trial evaluating Imfinzi monotherapy and Imfinzi plus Imjudo (tremelimumab) versus placebo in the treatment of 730 patients with LS-SCLC who had not progressed following cCRT. In the experimental arms, patients were randomised to receive a 1500mg fixed dose of Imfinzi with or without Imjudo 75mg every four weeks for up to four doses/cycles each, followed by Imfinzi every four weeks for up to 24 months.

The dual primary endpoints were PFS and OS for Imfinzi monotherapy versus placebo. Key secondary endpoints included OS and PFS for Imfinzi plus Imjudo versus placebo, safety and quality of life measures. The trial included 164 centres in 19 countries across North and South America, Europe and Asia.

Imfinzi 
Imfinzi (durvalumab) is a human monoclonal antibody that binds to the PD-L1 protein and blocks the interaction of PD-L1 with the PD-1 and CD80 proteins, countering the tumour’s immune-evading tactics and releasing the inhibition of immune responses.

Imfinzi is the only approved immunotherapy and the global standard of care in the curative-intent setting of unresectable, Stage III NSCLC in patients whose disease has not progressed after chemoradiotherapy. Imfinzi in combination with chemotherapy (etoposide and either carboplatin or cisplatin) is also approved for the treatment of extensive-stage SCLC and in combination with a short course of Imjudo and chemotherapy for the treatment of metastatic NSCLC.

Imfinzi also demonstrated statistically significant and clinically meaningful event-free survival results in patients with resectable early-stage NSCLC based on the AEGEAN Phase III trial. Imfinzi in combination with neoadjuvant chemotherapy before surgery and as adjuvant monotherapy after surgery is approved for patients in the UK, Switzerland and Taiwan (China) based on this trial.

In addition to its indications in lung cancers, Imfinzi is approved in combination with chemotherapy (gemcitabine plus cisplatin) in locally advanced or metastatic biliary tract cancer and in combination with Imjudo in unresectable hepatocellular carcinoma (HCC). Imfinzi is also approved as a monotherapy in unresectable HCC in Japan and the EU and in combination with chemotherapy (carboplatin plus paclitaxel) followed by Imfinzi monotherapy in primary advanced or recurrent endometrial cancer that is mismatch repair deficient in the US.

Since the first approval in May 2017, more than 220,000 patients have been treated with Imfinzi. As part of a broad development programme, Imfinzi is being tested as a single treatment and in combinations with other anti-cancer treatments for patients with SCLC, NSCLC, breast cancer, bladder cancer, several gastrointestinal and gynaecologic cancers, and other solid tumours.