On August 12, 2022 Seagen Inc. (Nasdaq: SGEN) reported a statement regarding the outcome of the arbitration with Daiichi Sankyo Co. Ltd. ("Daiichi Sankyo") relating to the parties’ 2008 collaboration agreement for the use of Seagen’s antibody-drug conjugate (ADC) technology (Press release, Seagen, AUG 12, 2022, https://investor.seagen.com/press-releases/news-details/2022/Seagen-Statement-on-Outcome-of-Daiichi-Sankyo-Arbitration/default.aspx [SID1234618248]). The arbitrator ruled in favor of Daiichi Sankyo, citing statute of limitations and disagreement with Seagen on the interpretation of the contract.

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"While we are disappointed with the arbitration decision, it was important for us to pursue this legal action," said Roger Dansey, M.D., interim Chief Executive Officer and Chief Medical Officer, Seagen. "This does not impact our existing business. Looking forward, we are well-positioned to drive continued innovation and growth with four commercial products and a deep and diverse pipeline of promising programs. Seagen remains focused on developing innovative medicines that make a meaningful difference in the lives of cancer patients."

On August 12, 2022 Ipsen (Euronext: IPN; ADR: IPSEY) reported the closing of the definitive merger agreement under which Ipsen has acquired Epizyme, Inc. (Epizyme) (Press release, Ipsen, AUG 12, 2022, View Source [SID1234618247]). Pursuant to the transaction, Ipsen acquires all outstanding shares of Epizyme for $1.45 per share plus a contingent value right (CVR) of $1.00 per share. Epizyme now operates as ‘an Ipsen company’ at deal close.

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As part of the transaction, Ipsen acquires Epizyme’s lead medicine, Tazverik (tazemetostat), a first-in-class, chemotherapy-free EZH2a inhibitor, which was granted Accelerated Approval by the U.S. Food and Drug Administration (FDA) in 2020. It is currently indicated for adults with relapsed or refractory follicular lymphoma (FL) whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies, and for adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options, as well as for adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.1

Ipsen also acquires Epizyme’s first-in-class, oral SETD2 inhibitor development candidate, EZM0414, which was granted FDA Fast Track status in 2021 and is currently under evaluation in a recently initiated Phase I/Ib trial in adult patients with relapsed or refractory multiple myeloma and diffuse large B-cell lymphoma, as well as a portfolio of preclinical programs focusing on epigenetic targets.

"Throughout the pre-close phase of planning, we have continued to be impressed by the potential of Tazverik, as well as the rest of the pipeline. Now that the deal is closed, we are excited to be working closely with our Epizyme colleagues to leverage Ipsen’s established infrastructure so that these medicines may reach more patients. Additionally, through this transaction Ipsen gains scientific expertise and we look forward to integrating the two teams which share the goal of delivering innovative treatment options to underserved patients," said David Loew, Chief Executive Officer of Ipsen.

About Tazverik (tazemetostat)

Tazverik is a methyltransferase inhibitor indicated for the treatment of:

Adults and pediatric patients aged 16 years and older with metastatic or locally advanced epithelioid sarcoma not eligible for complete resection.
Adult patients with relapsed or refractory follicular lymphoma whose tumors are positive for an EZH2 mutation as detected by an FDA-approved test and who have received at least two prior systemic therapies.
Adult patients with relapsed or refractory follicular lymphoma who have no satisfactory alternative treatment options.
These indications are approved under accelerated approval based on overall response rate and duration of response. Post marketing studies are required to confirm the anticipated clinical benefit and retain the labeled Accelerated Approval indications.

The most common (≥20%) adverse reactions in patients with epithelioid sarcoma are pain, fatigue, nausea, decreased appetite, vomiting and constipation. The most common (≥20%) adverse reactions in patients with follicular lymphoma are fatigue, upper respiratory tract infection, musculoskeletal pain, nausea and abdominal pain.

View the U.S. Full Prescribing Information here: View Source

About EZM0414

EZM0414 is a potent selective, oral, small molecule, investigational drug agent that inhibits the histone methyltransferase, SETD2, which plays a role in oncogenesis. SETD2 methylates histone as well as non-histone proteins, and this activity is involved in several key biological processes including transcriptional regulation, RNA splicing, and DNA damage repair. Based on the preclinical data on SETD2 inhibition by EZM0414 in multiple settings, including high risk t(4;14) multiple myeloma (MM) and in other B-cell malignancies such as diffuse large B-cell lymphoma (DLBCL), the Company is conducting SET-101, a Phase 1/1b study of EZM0414, for the treatment of adult patients with relapsed or refractory MM and DLBCL.

About follicular lymphoma2, 3

Follicular lymphoma is a type of non-Hodgkin lymphoma (NHL) which is a cancer of the lymphatic system. Follicular lymphoma develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally helps fight infections. When a patient has a lymphoma, the abnormal lymphocytes build up in the lymph nodes or other body organs. Follicular lymphoma is generally slow growing. Each year, 15-20,000 people in the U.S. are diagnosed with follicular lymphoma. Most affected individuals are diagnosed with advanced disease.

About epithelioid sarcoma4

Epithelioid sarcoma is a rare, slow-growing type of soft tissue cancer. Most cases begin in the soft tissue under the skin of a finger, hand, forearm, lower leg or foot, though it can start in other areas of the body. Typically, epithelioid sarcoma starts as a small firm growth or lump that is painless. It usually starts out as a single growth, but multiple growths may occur by the time a person seeks medical help. Sometimes this sarcoma appears as ulcers that don’t heal, looking like open wounds over the growths. It is estimated that 13,040 individuals received a diagnosis of soft tissue sarcomas in the U.S. in 2018 with a corresponding 5,150 deaths.5

About diffuse large B-cell lymphoma6

Diffuse large B cell lymphoma (DLBCL) is a type of NHL. NHL is a cancer of the lymphatic system. It develops when the body makes abnormal B lymphocytes. These lymphocytes are a type of white blood cell that normally help to fight infections. When a patient has a lymphoma, the abnormal lymphocytes build up in lymph nodes or other body organs. DLBCL grows quickly and treatment starts soon after diagnosis. DLBCL is the most common type of NHL in the U.S. and worldwide, accounting for about 22 percent of newly diagnosed cases of B-cell NHL in the U.S. More than 18,000 people in the U.S. are diagnosed with DLBCL each year.7

About multiple myeloma8

Multiple myeloma is a rare form of cancer characterized by excessive production (proliferation) and improper function of certain cells (plasma cells) found in the bone marrow. Excessive plasma cells may eventually mass together to form a tumor or tumors in various sites of the body, especially the bone marrow. When multiple tumors are present or the bone marrow has greater than 10% plasma cells, the term multiple myeloma is used. In 2019, over 32,000 individuals in the U.S. were diagnosed with this disease. It is believed that approximately 100,000 Americans currently have the disease.

On August 12, 2022 Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) ("Processa" or the "Company"), a clinical stage company developing drugs for patients who have unmet medical conditions and/or require better treatment options to improve a patient’s survival and/or quality of life, reported financial results for the quarter ended June 30, 2022, and provided an update on its clinical programs (Press release, Processa Pharmaceuticals, AUG 12, 2022, View Source [SID1234618246]).

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Dr. David Young, President and CEO of Processa, commented, "Our efforts to enhance enrollment through adding new sites, extensive marketing campaigns and working with our CRO partners are showing results:

We expect to close out enrollment for PCS12852 for Gastroparesis within the next month and present top-line data from the trial before the end of the year.
We now have a sufficient number of patients in the screening queue for PCS6422 to complete our interim cohorts which we believe will provide valuable insights on de novo formation of DPD. We anticipate we will determine the maximum tolerated dose by early 2023.
Patients are beginning to show a willingness to travel, and we are seeing increased patient activity in our PCS499 ulcerative necrobiosis lipoidica (uNL) trial. We are optimistic that we will enroll our interim analysis cohort before the end of the year.
As part of our efforts to increase enrollment on our PCS499 trial, we recently launched a website to increase awareness of uNL and to inform patients of the ongoing Phase 2B Study of PCS499.
Advancing these 3 drugs in their respective clinical trial allows us to obtain the clinical data to better define each pivotal trial as well as provide us with more insight into how FDA will review each of these products when we submit the New Drug Applications to FDA."

Financial Results for the Six Months Ended June 30, 2022

Our cash balance on June 30, 2022, was $12.1 million, which should be sufficient to complete our three on-going clinical trials and fund our operations into the third quarter of 2023. During the six months ended June 30, 2022, we spent $4.1 million in cash for these three clinical trials and our operations. This is significantly less than our GAAP net loss of $8.4 million due to the effect of non-cash items like amortization and stock-based compensation, and the application of amounts we had prepaid to our CROs last year.

Our net loss for the six months ending on June 30, 2022, was $8.4 million or $0.53 per share compared to a net loss of $5.3 million, or $0.35 per share for the same period of 2021. The increase in our net loss relates primarily to increased clinical trial costs we incurred in our three ongoing trials. For the six months ended June 30, 2022, we incurred $5.2 million in research and development costs, an increase of $2.1 million when compared to the same period of 2021. We anticipate clinical trial costs will continue to increase for the rest of the year as our trials continue to progress and we fund development activities for the other drugs in our pipeline.

During the six months ending June 30, 2022, our general and administrative expenses totaled $3.2 million compared to $2.1 million for the same period in 2021. The increase related primarily to increases in non-cash or stock-based compensation costs, along with other operating and consulting costs. We allocated $2.8 million of non-cash compensation costs between our R&D and G&A costs, with the majority recorded as G&A.

Our net cash used in operating activities during the six months ended June 30, 2022, decreased by $300,000 to $4.1 million, compared to $4.4 million for the same period in 2021. While we experienced increased GAAP costs related to our clinical trials and operations, we continued to make use of equity incentives to compensate our executive and development team, thereby reducing our cash outflow, and we were able to apply previously made advanced payments to our CROs against current trial costs.

As of June 30, 2022, we had 15.8 million common shares outstanding.

Conference Call Information

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On August 12, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Chemomab, AUG 12, 2022, View Source [SID1234618210]).

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"We continued to make good progress on multiple fronts in the second quarter," said Dale Pfost, PhD, Chairman and Chief Executive Officer of Chemomab. "We advanced our clinical programs for CM-101, our first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target at the confluence of fibrosis and inflammation; we added to our intellectual property portfolio for CM-101; we presented important new data at major scientific meetings; and we added several highly experienced staff essential to progressing our scientific and clinical priorities."

Dr. Pfost continued, "Congratulations to our research team for gaining issuance of a new U.S patent covering the use of CM-101 in liver diseases such as primary sclerosing cholangitis (PSC), thereby further extending our proprietary protection for disease targets involving hepatic and cholestatic conditions. I am also very pleased at how active our researchers and consultants have been in the past few months educating their scientific and medical peers by presenting data on CCL24 and CM-101 at major international scientific meetings. We recently added several outstanding research and clinical experts to our team to help ensure rapid advancement of our preclinical and clinical programs. In addition, we added a new director, Jill Quigley, JD, who brings a wealth of biotechnology strategic and operational expertise to our board. These are exciting times for our company, and I look forward to reporting more details on our progress in the coming months."

Clinical Update:

Phase 2 Liver Fibrosis Trial in NASH patients

Chemomab concluded the treatment phase of its randomized, placebo-controlled Phase 2 liver fibrosis trial that included a total of 23 NASH patients, with patients in the active arm receiving 5mg/kg of CM-101 delivered subcutaneously in 8 doses administered once every two weeks. This sets the stage for a planned topline study read-out before year-end. Importantly, these data represent the first read-out of CM-101’s activity in patients with established liver disease. The main study outcome is safety and tolerability. Additionally, based on the encouraging signs of activity observed in the CM-101 Phase 1b study in patients with non-alcoholic fatty liver disease, the company believes that evaluations of similar secondary outcomes in this patient population with more severe liver fibrosis and inflammation could be informative, and may provide useful insights in support of the overall CM-101 clinical development program. The trial results should also generate the pharmacokinetic and tolerability data needed to inform next steps in the development of the subcutaneous formulation of CM-101.

Phase 2 Trial in Primary Sclerosing Cholangitis patients

Chemomab previously indicated its intention to increase its efforts in the rare disease primary sclerosing cholangitis, or PSC, including expanding the size and scope of the ongoing randomized, placebo-controlled Phase 2 trial. The company is adding an open label extension and a dose finding component intended to better inform selection of the optimal dose of CM-101 to advance into late development. These revisions have been finalized and global regulatory filings supporting the trial expansion have been initiated, while new sites in Europe and the U.S. continue to open. The company plans to enroll a total of 93 patients: 25 patients in each of the three dosing cohorts, which include the current 10mg/kg dose along with a lower 5 mg/kg dose and a higher 20mg/kg dose. Another 18 patients are receiving placebo. All outcome measures in the trial, including evaluations of serum ALP levels, serum biological markers, and Fibroscan, remain unchanged, except that the primary outcome now is safety. Consistent with this change, the study is not formally powered to assess efficacy. However, cohort sizes sufficient to detect, with expected variability, a clinically relevant improvement in serum ALP levels (defined as change from baseline), which is a key secondary outcome for studies in PSC, have been maintained. A blinded interim Drug Monitoring Committee safety review of the current cohort is planned for late this year, and Chemomab anticipates reporting topline data from the trial in the second half of 2024.

Phase 2 Trial in Systemic Sclerosis patients

Chemomab has made significant progress in delineating the design of its upcoming Phase 2 trial in systemic sclerosis, or SSc, working closely with a number of top systemic sclerosis experts. The company aims to establish biological proof of concept on clinically relevant aspects of this complex disease, focusing on CM-101’s potential activity in modifying the skin, lung and vascular pathophysiology observed in SSc patients. Plans to launch the trial by the end of this year remain on track. A special webcast to provide details on the final trial design is planned in the next several months.

Recent Highlights:

Awarded U.S. Patent No.11365246, "Anti CCL24 (eotaxin 2) Antibodies for Use in the Treatment of Hepatic Disease," a new method of use patent that covers the use of CM-101 and other anti-CCL24 antibodies and binding fragments in the treatment of a range of fibro-inflammatory liver diseases, including primary sclerosing cholangitis and other cholestatic-related disorders. The new patent extends Chemomab’s intellectual property protection for CM-101 in the U.S. for another three years through at least 2038, with additional extensions possible.
At a poster presentation at the EULAR European Congress of Rheumatology (June 1-4, Copenhagen, DK), Chemomab collaborator Professor Francesco Del Galdo of the University of Leeds presented a poster further supporting the role of CCL24 as a therapeutic target for systemic sclerosis. This study, which examined the role of CCL24 in longitudinal cohorts of diffuse cutaneous SSc patients, reported elevated serum levels of CCL24 in these patients and showed that high circulating CCL24 levels were correlated with disease activity and worse prognosis, as reflected by high fibrotic activity and deterioration of lung function over time.
In an oral presentation at the 2022 EASL International Liver Congress (June 22-26, London, UK), Chemomab researchers presented data from a preclinical PSC model that used advanced technologies to reveal unique liver macrophage subpopulations as the major source of CCL24 production in the area of the bile duct that is damaged in PSC. Chemomab scientists also demonstrated in this model that treatment with CM-101 interfered with core PSC disease pathways in a way that is potentially associated with therapeutic activity.
At the first international Extracellular Matrix Pharmacology Conference (June 23-25, Copenhagen DK), Chemomab researchers presented a poster that included both preclinical and early clinical data demonstrating that CM-101 attenuates biomarkers associated with extracellular matrix (ECM) expression. ECM expression is involved in PSC pathophysiology and is closely related to CM-101’s mechanism of action. Importantly, this dataset supports the company’s efforts to translate findings on preclinical biomarkers associated with ECM remodeling in the liver to the use of similar serum biomarkers in patients in its clinical trials.
Appointed Jill M. Quigley, JD, to the Chemomab board of directors. Ms. Quigley brings more than 20 years of biotechnology industry leadership experience encompassing executive management, corporate operations, legal affairs, financings, and board membership. Previously Ms. Quigley was Chief Operating Officer at Passage Bio.
Appointed Ilan Vaknin, PhD, MBA, as Vice President of Research & Development. Dr. Vaknin brings Chemomab more than 20 years of biotechnology drug discovery and development experience in immunology, translational research, antibody development and manufacturing, and bioassay development, including more than a decade in senior science roles at Compugen, Ltd.
Appointed Christina Crater, MD, as Vice President of Clinical Development. Dr. Crater brings Chemomab an extensive background in medical affairs and clinical trial design and execution, across a broad range of therapeutic indications. She has served as medical monitor, safety physician, therapeutic expert and study director in all phases of clinical development. Dr. Crater’s experience spans pharmaceutical firms including Bristol-Myers Squibb, as well as major clinical research organizations including PRA Health Sciences and PAREXEL International.
Presented at the JMP Securities Life Sciences and HC Wainwright Global Investment Conferences. Recorded webcasts from these events can be accessed at Chemomab’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
Second Quarter 2022 Financial Highlights

Cash Position: Cash, cash equivalents and bank deposits were $51.8 million as of June 30, 2022, compared to $57.5 million at March 31, 2022. The company currently expects its runway to last through the end of 2023, consistent with the update provided last quarter.
Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the quarter ended June 30, 2022, compared to $1.3 million for the same quarter in 2021. The increase in R&D expense quarter-over-quarter primarily reflects the ramp-up in activities supporting the company’s clinical programs for CM-101.
General and Administrative (G&A) Expenses: G&A expenses were $3.3 million for the quarter ended June 30, 2022, compared to $1.5 million for the same quarter in 2021. The increase in cash G&A in the second quarter partly reflects key additions to the senior management team, as well as a non-cash charge for previously disclosed equity-based compensation plus a provision accrued for a potential tax liability, the majority of which arises from transactions that took place prior to the company’s reverse merger in March 2021.
Net Loss: Net loss was $6.2 million, or a net loss of approximately $0.03 cents per basic and diluted ordinary share, for the second quarter of 2022, compared to $2.8 million, or a net loss of approximately $0.01 per basic and diluted ordinary share, for the quarter ended June 30, 2021. The weighted average number of Ordinary Shares outstanding, basic and diluted were 228,173,276 (equal to 11,408,664 ADS’s) for the quarter ended June 30, 2022.
For further details on Chemomab’s financial results for the quarter ended June 30, 2022, refer to the Form 10-Q, which will be filed with the SEC today, August 12, 2022.

Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, August 12, 2022

Chemomab management will host a webcast and conference call today, Friday, August 12, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13730646. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call. The webcast link is also available on the company’s website at View Source

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.

On August 12, 2022 Chemomab Therapeutics, Ltd. (Nasdaq: CMMB), a clinical-stage biotechnology company focused on the discovery and development of innovative therapeutics for fibrotic and inflammatory diseases with high unmet need, reported financial and operating results for the second quarter ended June 30, 2022 and provided a corporate update (Press release, Anchiano Therapeutics, AUG 12, 2022, View Source [SID1234618209]).

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"We continued to make good progress on multiple fronts in the second quarter," said Dale Pfost, PhD, Chairman and Chief Executive Officer of Chemomab. "We advanced our clinical programs for CM-101, our first-in-class monoclonal antibody that neutralizes CCL24, a novel disease target at the confluence of fibrosis and inflammation; we added to our intellectual property portfolio for CM-101; we presented important new data at major scientific meetings; and we added several highly experienced staff essential to progressing our scientific and clinical priorities."

Dr. Pfost continued, "Congratulations to our research team for gaining issuance of a new U.S patent covering the use of CM-101 in liver diseases such as primary sclerosing cholangitis (PSC), thereby further extending our proprietary protection for disease targets involving hepatic and cholestatic conditions. I am also very pleased at how active our researchers and consultants have been in the past few months educating their scientific and medical peers by presenting data on CCL24 and CM-101 at major international scientific meetings. We recently added several outstanding research and clinical experts to our team to help ensure rapid advancement of our preclinical and clinical programs. In addition, we added a new director, Jill Quigley, JD, who brings a wealth of biotechnology strategic and operational expertise to our board. These are exciting times for our company, and I look forward to reporting more details on our progress in the coming months."

Clinical Update:

Phase 2 Liver Fibrosis Trial in NASH patients

Chemomab concluded the treatment phase of its randomized, placebo-controlled Phase 2 liver fibrosis trial that included a total of 23 NASH patients, with patients in the active arm receiving 5mg/kg of CM-101 delivered subcutaneously in 8 doses administered once every two weeks. This sets the stage for a planned topline study read-out before year-end. Importantly, these data represent the first read-out of CM-101’s activity in patients with established liver disease. The main study outcome is safety and tolerability. Additionally, based on the encouraging signs of activity observed in the CM-101 Phase 1b study in patients with non-alcoholic fatty liver disease, the company believes that evaluations of similar secondary outcomes in this patient population with more severe liver fibrosis and inflammation could be informative, and may provide useful insights in support of the overall CM-101 clinical development program. The trial results should also generate the pharmacokinetic and tolerability data needed to inform next steps in the development of the subcutaneous formulation of CM-101.

Phase 2 Trial in Primary Sclerosing Cholangitis patients

Chemomab previously indicated its intention to increase its efforts in the rare disease primary sclerosing cholangitis, or PSC, including expanding the size and scope of the ongoing randomized, placebo-controlled Phase 2 trial. The company is adding an open label extension and a dose finding component intended to better inform selection of the optimal dose of CM-101 to advance into late development. These revisions have been finalized and global regulatory filings supporting the trial expansion have been initiated, while new sites in Europe and the U.S. continue to open. The company plans to enroll a total of 93 patients: 25 patients in each of the three dosing cohorts, which include the current 10mg/kg dose along with a lower 5 mg/kg dose and a higher 20mg/kg dose. Another 18 patients are receiving placebo. All outcome measures in the trial, including evaluations of serum ALP levels, serum biological markers, and Fibroscan, remain unchanged, except that the primary outcome now is safety. Consistent with this change, the study is not formally powered to assess efficacy. However, cohort sizes sufficient to detect, with expected variability, a clinically relevant improvement in serum ALP levels (defined as change from baseline), which is a key secondary outcome for studies in PSC, have been maintained. A blinded interim Drug Monitoring Committee safety review of the current cohort is planned for late this year, and Chemomab anticipates reporting topline data from the trial in the second half of 2024.

Phase 2 Trial in Systemic Sclerosis patients

Chemomab has made significant progress in delineating the design of its upcoming Phase 2 trial in systemic sclerosis, or SSc, working closely with a number of top systemic sclerosis experts. The company aims to establish biological proof of concept on clinically relevant aspects of this complex disease, focusing on CM-101’s potential activity in modifying the skin, lung and vascular pathophysiology observed in SSc patients. Plans to launch the trial by the end of this year remain on track. A special webcast to provide details on the final trial design is planned in the next several months.

Recent Highlights:

Awarded U.S. Patent No.11365246, "Anti CCL24 (eotaxin 2) Antibodies for Use in the Treatment of Hepatic Disease," a new method of use patent that covers the use of CM-101 and other anti-CCL24 antibodies and binding fragments in the treatment of a range of fibro-inflammatory liver diseases, including primary sclerosing cholangitis and other cholestatic-related disorders. The new patent extends Chemomab’s intellectual property protection for CM-101 in the U.S. for another three years through at least 2038, with additional extensions possible.
At a poster presentation at the EULAR European Congress of Rheumatology (June 1-4, Copenhagen, DK), Chemomab collaborator Professor Francesco Del Galdo of the University of Leeds presented a poster further supporting the role of CCL24 as a therapeutic target for systemic sclerosis. This study, which examined the role of CCL24 in longitudinal cohorts of diffuse cutaneous SSc patients, reported elevated serum levels of CCL24 in these patients and showed that high circulating CCL24 levels were correlated with disease activity and worse prognosis, as reflected by high fibrotic activity and deterioration of lung function over time.
In an oral presentation at the 2022 EASL International Liver Congress (June 22-26, London, UK), Chemomab researchers presented data from a preclinical PSC model that used advanced technologies to reveal unique liver macrophage subpopulations as the major source of CCL24 production in the area of the bile duct that is damaged in PSC. Chemomab scientists also demonstrated in this model that treatment with CM-101 interfered with core PSC disease pathways in a way that is potentially associated with therapeutic activity.
At the first international Extracellular Matrix Pharmacology Conference (June 23-25, Copenhagen DK), Chemomab researchers presented a poster that included both preclinical and early clinical data demonstrating that CM-101 attenuates biomarkers associated with extracellular matrix (ECM) expression. ECM expression is involved in PSC pathophysiology and is closely related to CM-101’s mechanism of action. Importantly, this dataset supports the company’s efforts to translate findings on preclinical biomarkers associated with ECM remodeling in the liver to the use of similar serum biomarkers in patients in its clinical trials.
Appointed Jill M. Quigley, JD, to the Chemomab board of directors. Ms. Quigley brings more than 20 years of biotechnology industry leadership experience encompassing executive management, corporate operations, legal affairs, financings, and board membership. Previously Ms. Quigley was Chief Operating Officer at Passage Bio.
Appointed Ilan Vaknin, PhD, MBA, as Vice President of Research & Development. Dr. Vaknin brings Chemomab more than 20 years of biotechnology drug discovery and development experience in immunology, translational research, antibody development and manufacturing, and bioassay development, including more than a decade in senior science roles at Compugen, Ltd.
Appointed Christina Crater, MD, as Vice President of Clinical Development. Dr. Crater brings Chemomab an extensive background in medical affairs and clinical trial design and execution, across a broad range of therapeutic indications. She has served as medical monitor, safety physician, therapeutic expert and study director in all phases of clinical development. Dr. Crater’s experience spans pharmaceutical firms including Bristol-Myers Squibb, as well as major clinical research organizations including PRA Health Sciences and PAREXEL International.
Presented at the JMP Securities Life Sciences and HC Wainwright Global Investment Conferences. Recorded webcasts from these events can be accessed at Chemomab’s website at View Source." target="_blank" title="View Source." rel="nofollow">View Source
Second Quarter 2022 Financial Highlights

Cash Position: Cash, cash equivalents and bank deposits were $51.8 million as of June 30, 2022, compared to $57.5 million at March 31, 2022. The company currently expects its runway to last through the end of 2023, consistent with the update provided last quarter.
Research and Development (R&D) Expenses: R&D expenses were $2.9 million for the quarter ended June 30, 2022, compared to $1.3 million for the same quarter in 2021. The increase in R&D expense quarter-over-quarter primarily reflects the ramp-up in activities supporting the company’s clinical programs for CM-101.
General and Administrative (G&A) Expenses: G&A expenses were $3.3 million for the quarter ended June 30, 2022, compared to $1.5 million for the same quarter in 2021. The increase in cash G&A in the second quarter partly reflects key additions to the senior management team, as well as a non-cash charge for previously disclosed equity-based compensation plus a provision accrued for a potential tax liability, the majority of which arises from transactions that took place prior to the company’s reverse merger in March 2021.
Net Loss: Net loss was $6.2 million, or a net loss of approximately $0.03 cents per basic and diluted ordinary share, for the second quarter of 2022, compared to $2.8 million, or a net loss of approximately $0.01 per basic and diluted ordinary share, for the quarter ended June 30, 2021. The weighted average number of Ordinary Shares outstanding, basic and diluted were 228,173,276 (equal to 11,408,664 ADS’s) for the quarter ended June 30, 2022.
For further details on Chemomab’s financial results for the quarter ended June 30, 2022, refer to the Form 10-Q, which will be filed with the SEC today, August 12, 2022.

Live Webcast and Conference Call at 8:00 am Eastern Time, Friday, August 12, 2022

Chemomab management will host a webcast and conference call today, Friday, August 12, 2022, beginning at 8:00 a.m. Eastern Time to discuss these results and answer questions. Shareholders and other interested parties may participate in the conference call by clicking this Webcast link to access the live webcast or replay, or by dialing 877-407-9208 (in the U.S.) or 201-493-6784 (outside the U.S. and in Israel) and entering passcode 13730646. Please call 5-10 minutes before the scheduled start time, enter the conference passcode and ask the operator for the Chemomab conference call. The webcast link is also available on the company’s website at View Source

A replay of the call will be available on Chemomab’s website for 90 days at www.chemomab.com.