On May 13, 2021 Compass Therapeutics, Inc. ("Compass"; OTCQB: CMPX), a clinical-stage biotechnology company developing proprietary antibody therapeutics to treat cancer, and TRIGR Therapeutics, Inc. ("TRIGR"), a private biotechnology oncology company, reported that the companies have entered into a definitive merger agreement, under which Compass, through a subsidiary, will acquire TRIGR, a private cancer drug development company founded by George Uy, an industry veteran and a former commercial executive at Roche, in a stock-for-stock transaction (Press release, Compass Therapeutics, MAY 13, 2021, View Source [SID1234579959]). Under the terms of the agreement, Compass’ subsidiary will acquire all of the outstanding shares of TRIGR. In addition, Miranda Toledano, TRIGR’s Chief Financial Officer and Chief Operating Officer, will be joining the Compass Board of Directors. The transaction was unanimously approved by the Boards of Directors of both companies.

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At the core of this transaction is a differentiated bispecific antibody targeting both DLL4 and VEGF-A, which inhibits both DLL4-mediated Notch signaling and VEGF signaling, which has been renamed CTX-009 (formerly designated TR009/ABL001/NOV1501). CTX-009 has completed a Phase 1 dose escalation study and is in a Phase 1b study in patients with solid tumors in S. Korea, where it has been observed to be well tolerated. In addition, there have been multiple confirmed partial responses (PRs) by RECIST criteria in several tumors in those studies, including PRs in colorectal cancer, cholangiocarcinoma, gastric cancer, and pancreatic cancer. The Phase 1b study in combination with chemotherapy is expected to be completed in the second half of this year. Compass plans to file an IND in the US in H2 2021 and initiate clinical studies in patients with cholangiocarcinoma, ovarian cancer and advanced colorectal cancer. Exclusive global rights to the program, except for S. Korea and China, are held by TRIGR through a license with ABL Bio Inc. (KOSDAQ: 298380). South Korean rights are held by Handok Inc. (KOSDAQ: 002390) and China rights were out-licensed to Elpiscience Biopharmaceuticals Co., Limited, under a license agreement executed on Jan 20th, 2021.

"The time now has come to maximize the therapeutic potential of this promising bispecific antibody, and I am confident that Compass has the management and development capabilities supporting the goal to advance CTX-009 to Phase 2 and Phase 3 studies in multiple indications" said George Uy, TRIGR Founder and Chief Executive Officer. "I am honored to join the Compass board and look forward to CTX-009’s success as part of Compass’ stellar immunotherapy pipeline" said Miranda Toledano, TRIGR’s Chief Operating Officer and Chief Financial Officer.

"CTX-009 presents an important addition to our pipeline of novel therapeutic antibodies and bispecific antibodies. It is uncommon to see multiple confirmed partial responses in a Phase 1 study in such an advanced patient population, and we are excited to begin to develop a robust Phase 2 program to evaluate the therapeutic potential of CTX-009 across all of the indications where this bispecific has shown substantial promise to-date" said Thomas Schuetz, MD, Ph.D., Co-Founder and Chief Executive Officer of Compass Therapeutics. "When we reviewed the data for CTX-009, we immediately saw the fit with our corporate strategy of advancing the best therapeutic candidates forward, regardless of origin" said Vered Bisker-Leib, Compass President and Chief Operating Officer. "We then moved quickly to conduct due diligence and reach agreement on a merger structure designed to deliver enhanced value for the shareholders of both companies".

Under the terms of the agreement, TRIGR will be acquired by Compass’ wholly owned subsidiary, Compass Acquisition Company, LLC, subject to certain customary conditions including the consent of the holders of a majority of TRIGR’s common shares. Consideration payable to TRIGR shareholders at closing totals an aggregate of 10,265,154 shares of Compass’ common stock, issued as unregistered shares in a private placement. In addition, TRIGR shareholders are eligible to receive up to $9 million, representing earnout payments that depend on certain events, including $5 million upon BLA approval of CTX-009 in the United States. Following the issuance of the share consideration, Compass has agreed to register such shares for resale by the recipients thereof. The transaction is expected to close in the second quarter of 2021.

About CTX-009

CTX-009 (formerly designated TR009/ABL001/NOV1501) is an anti-DLL4 X VEGF-A bispecific antibody. In November 2018, TRIGR licensed the exclusive, global rights to CTX-009, outside of South Korea, from ABL Bio, Inc. (KOSDAQ: 298380), a South Korea-based clinical-stage company focused on developing antibody therapeutics. A Phase 1 dose escalation study and a Phase 1b dose expansion monotherapy study have been completed and a Phase 1b combination study is ongoing in S. Korea. Data from CTX-009’s Phase 1 dose escalation and dose expansion monotherapy study demonstrates an approximately 20% Overall Response Rate (ORR) at the targeted therapeutic doses, with confirmed partial responses per RECIST criteria in heavily pre-treated colorectal and gastric cancer patients in whom multiple therapies have failed, including VEGF-targeted therapeutics, anti-PD-1/PD-L1 regimens and chemotherapies. Interim results from the ongoing Phase 1b combination study testing the tolerability and activity of CTX-009 in combination with irinotecan or paclitaxel, have also shown deep and sustained partial responses in difficult to treat intrahepatic cholangiocarcinoma (biliary tract cancer) patients in whom multiple lines of therapy have failed. In contrast to historical anti-DLL4 antibodies and other Notch targeted therapies, the administration of CTX-009 has not been associated with severe pulmonary hypertension. Full data from the ongoing Phase 1b studies is expected to be provided later in 2021.

On May 13, 2021 Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative biopharmaceutical company dedicated to discovering, developing and commercializing global first-in-class and/or best-in-class therapeutics in hematology and oncology, reported that China’s National Medical Products Administration (NMPA) has approved the initiation of a Phase Ib/II open-label, multicenter, dose-escalation study of eltanexor (ATG-016) in patients with advanced solid tumors (the REACH study) (Press release, Antengene, MAY 13, 2021, View Source [SID1234580029]).

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This study aims to assess the safety and efficacy of eltanexor monotherapy in patients with advanced solid tumors. The Phase Ib part of the study will be carried out in patients with advanced solid tumors, including those with KRAS-mutant, p53 wild-type, human papillomavirus (HPV)-associated, Epstein–Barr virus (EBV)-positive and other solid tumors; and the Phase II part of the study will enroll patients with recurrent or metastatic penile squamous cell carcinoma, and patients with recurrent or metastatic nasopharyngeal carcinoma.

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound which exerts antitumor effects by inhibiting the nuclear export protein XPO1 leading to the accumulation and activation of tumor suppressor proteins in the nucleus, while simultaneously blocking the expression and translation of oncogenic proteins. For cancer patients, high XPO1 expression is commonly associated with a poor prognosis and resistance to chemotherapies. Pre-clinical data showed that eltanexor has potent pro-apoptotic activity in a broad spectrum of tumor cells without affecting normal cells. Moreover, eltanexor has also showed potent antitumor activity in animal models with multiple solid tumors including hepatocellular carcinoma, prostate cancer, pancreatic cancer, colon cancer and breast cancer.

"This IND approval marks an important step for Antengene’s clinical development of eltanexor, one that we hope will ultimately allow patients with solid tumors to benefit from eltanexor’s novel mechanism of action," said Dr. Jay Mei, founder, chairman and CEO of Antengene. "Based on the compelling pre-clinical and clinical data, eltanexor monotherapy has the potential of bringing renewed hope and higher quality of life to patients with advanced solid tumors in China."

About Eltanexor (ATG-016)

Eltanexor is a next-generation selective inhibitor of nuclear export (SINE) compound. Compared to the first-generation SINE compound, eltanexor has lower blood-brain barrier penetration and broader therapeutic window which allows more frequent dosing and a longer period of exposure at higher levels with better tolerability. Therefore, eltanexor may be used to target a broader range of indications. Antengene is currently conducting clinical trials of eltanexor in patients with myelodysplastic syndrome (MDS) or advanced solid tumors in China.

On May 13, 2021 Checkmate Pharmaceuticals, Inc. (NASDAQ: CMPI) ("Checkmate"), a clinical stage biopharmaceutical company focused on developing its proprietary technology to harness the power of the immune system to combat cancer, reported first quarter 2021 financial results and provided an update on recent progress (Press release, Checkmate Pharmaceuticals, MAY 13, 2021, View Source [SID1234580045]).

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"Since the start of 2021, we have initiated patient dosing in our core clinical trials evaluating vidutolimod (CMP-001) in combination with PD-1 blockade in melanoma and head and neck cancer. We are pleased to have also recently announced our intention to broaden our vidutolimod clinical development program into non-melanoma skin cancers in combination with Libtayo (cemiplimab), under a collaboration agreement with Regeneron," said Barry Labinger, President and Chief Executive Officer of Checkmate.

Recent Progress

Vidutolimod Clinical Updates

Year to date, Checkmate has initiated patient dosing across all three of our core clinical trials evaluating vidutolimod.
A randomized Phase 2/3 trial of vidutolimod in combination with nivolumab vs. nivolumab monotherapy in first-line metastatic or unresectable melanoma.
A Phase 2 trial of vidutolimod in combination with nivolumab in anti-PD-1 refractory advanced melanoma. Both melanoma trials are supported by a clinical collaboration with Bristol Myers Squibb.
A Phase 2 trial of vidutolimod in combination with pembrolizumab in recurrent or metastatic squamous cell head and neck cancer. Initial data in a subset of patients are expected before the end of 2021.
New translational data were presented from our Phase 1b trial of vidutolimod in combination with pembrolizumab in patients with melanoma refractory to PD-1 blockade at the 2021 American Association for Cancer (AACR) (Free AACR Whitepaper) Annual Meeting.
Collaboration and New Indication Expansion

In May, Checkmate announced the planned expansion of the development program for vidutolimod into non-melanoma skin cancers supported by a clinical supply agreement with Regeneron to evaluate the combination of vidutolimod and Libtayo (cemiplimab). The companies will collaborate on a Phase 2, proof of concept, multi-indication trial with patient cohorts in anti-PD-1 naïve and anti-PD-1 refractory cutaneous squamous cell carcinoma and anti-PD-1 refractory Merkel cell carcinoma.
First Quarter 2021 Financial Results

Research and development expenses (R&D): R&D expenses for the first quarter of 2021 were $10.4 million, compared to $6.3 million for the same period in the prior year. This increase reflected a milestone payment of $2.0 million in the first quarter of 2021 triggered by initiation of patient dosing in our Phase 2, first-line melanoma trial, as well as increases in personnel and operating expense for the planning and initiation of additional clinical trials with vidutolimod.
General and administration expenses (G&A): G&A expenses for the first quarter of 2021 were $3.8 million, compared to $1.5 million for the same period in the prior year. This increase was primarily attributable to increases in personnel and operating expense incurred in connection with Checkmate operating as a publicly traded company.
Cash, cash equivalents and investments: Cash, cash equivalents and available-for-sale investments were $111.5 million as of March 31, 2021.

On May 13, 2021 CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of infectious and inflammatory disease, reported financial results for the first quarter ended March 31, 2021 and provided an update on recent business events (Press release, CorMedix, MAY 13, 2021, View Source [SID1234580200]).

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Recent Business Highlights:

CorMedix announced the appointment of Tom Nusbickel as the Company’s Executive Vice President and Chief Commercial Officer.
CorMedix successfully completed the agreed upon protocol for the manual extraction study identified in the Complete Response Letter that FDA is requiring as confirmation of in-process controls to demonstrate that the labeled volume can be consistently withdrawn from the vials.
CorMedix continues to focus our efforts on resolving the deficiencies sent to the third-party manufacturer in the Post-Application Action Letter. Based on our analyses, we have concluded that additional process qualification will be needed with subsequent validation to address the deficiencies identified by FDA.
CorMedix strengthened its balance sheet via equity financing activity during the first quarter, raising net proceeds of approximately $41.5 million.
CorMedix has been approved by the New Jersey Economic Development Authority (NJEDA) to transfer substantially all of the $1.3 million of its available tax benefits to an unrelated, profitable New Jersey corporation pursuant to the New Jersey Technology Business Tax Certificate Transfer (NOL) program for State Fiscal Year 2020, for approximately $1.3 million in net proceeds. Closing is anticipated in 2Q of 2021.
Khoso Baluch, CorMedix CEO commented, "As we continue to work through the items required by FDA for resubmission of the NDA, we remain confident in our efforts to bring DefenCath to hemodialysis patients as an important novel antimicrobial catheter lock solution to reduce catheter related blood stream infections in patients receiving hemodialysis via central venous catheters. We believe we have the right team and resources to accomplish this as we advance DefenCath through the regulatory approval process."

First Quarter 2021 Financial Highlights

For the first quarter of 2021, CorMedix recorded a net loss of $7.2 million, or $0.20 per share, compared with a net loss of $5.6 million, or $0.21 per share, in the first quarter of 2020, an increase of $1.6 million, driven by an increase in operating expenses.

Operating expenses in the first quarter 2021 were $7.2 million, compared with $5.6 million in the first quarter of 2020, an increase of approximately 29%. The increase was driven by higher SG&A, which rose by 45% to $4.6 million, primarily due to increased non-cash charges for stock compensation, increased costs related to market research in preparation for the potential approval of DefenCath and higher staffing costs due to additional hires. R&D expense increased approximately 7% to $2.6 million, driven primarily by increases in personnel expenses and non-cash charges for stock compensation, offset by a decrease in manufacturing costs and clinical trial expenses.

The Company reported cash and short-term investments of $81.2 million at March 31, 2021, excluding restricted cash. The Company believes that, based on its current cash resources, it has sufficient resources to fund operations at least into the second half of 2022.

Conference Call Information

The management team of CorMedix will host a conference call and webcast today, May 13, 2021, at 4:30 PM Eastern Time, to discuss recent corporate developments and financial results. Call details and dial-in information are as follows:

Following the live webcast, an archived version will be available for approximately 30 days on the Company’s website, www.cormedix.com.

On May 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 first quarter ended March 31, 2021 and provided a business update (Press release, Anchiano Therapeutics, MAY 13, 2021, View Source [SID1234579844]).

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"This quarter has been truly exciting for Chemomab as we accessed the public markets and began to trade on the Nasdaq exchange, successfully closed on a private offering of $45 million, announced positive data from our Phase Ib study in NAFLD, and initiated a Phase IIa study in PSC." said Dr. Adi Mor, CEO of Chemomab. "We also started treating patients in our Phase IIa liver fibrosis trial with our subcutaneous formulation of CM-101 and will look to build upon our substantial progress and positive momentum in the coming quarters with the initiation of our additional planned Phase II study of CM-101 in Systemic Sclerosis (SSc). CM-101 is a very promising therapy with the potential to treat multiple severe and life-threatening inflammatory and fibrotic diseases. With a strong financial position, and our unique development track record we believe we are well positioned to continue to advance our pipeline and execute our important milestones this year."

First Quarter and Recent Highlights

·Announced positive results from its Phase Ib SPARK study evaluating CM-101 in nonalcoholic fatty liver disease (NAFLD) patients. The SPARK study was a double-blind, placebo-controlled study designed to evaluate the safety, tolerability and pharmacokinetic (PK) profile of CM-101 in NAFLD patients with normal liver function. In this study repeated CM-101 administrations were found to be safe and well-tolerated for both tested doses when administered as intravenous (IV) infusion or subcutaneous (SC) injection. No safety signals or unexpected adverse events were observed for CM-101 in either the IV or SC formulation and all reported adverse events were mild or moderate in intensity. Exploratory analysis of multiple pharmacodynamic parameters, including measurement of collagen turnover and fibrotic biomarkers, demonstrated that CM-101 treatment resulted in reduction of fibrotic and fibrogenesis markers compared to no change or slight elevation in the placebo treated group. In addition, there was a reduction in liver stiffness measured by FibroScanTM in the CM-101 treated group.

·Enrolled the first patient in its Phase IIa SPRING clinical trial of CM-101 for the treatment of patients with primary sclerosing cholangitis (PSC). The SPRING 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 antifibrotic effect of IV CM-101 in PSC patients. The trial will enroll and randomize up to 45 patients and is anticipated to complete enrollment by early 2022 with data expected in 1H 2022.

·Enrolled the first patient in its Phase IIa SPLASH clinical trial of CM-101 for the treatment of patients with nonalcoholic steatohepatitis (NASH). 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 SC CM-101 in NASH patients with fibrosis stage F2-F3. The trial will enroll 40 patients and is anticipated to complete enrollment by the end of 2021 with data expected in 1H 2022.

·Completed a merger with Anchiano Therapeutics Ltd, and began trading on the Nasdaq Capital Market exchange under the symbol "CMMB" on March 17, 2021.

·Completed the successful pricing of a private placement of $45 million into the combined company led by new and certain existing investors including Cormorant Asset Management, OrbiMed, Peter Thiel, Christian Angermayer’s Presight Capital and Apeiron Investment Group, as well as other healthcare-focused and institutional investors.

·Strengthened its Board of Directors with the appointment of four new directors: Dr. Alan Moses, Dr. Claude Nicaise, Mr. Joel Maryles, and Mr. Neil Cohen. Dr. Stephen Squinto remains as Chairman of Chemomab’s Board, with Dr. Adi Mor and Dr. Nissim Darvish continuing in their roles as Directors.

Upcoming Milestones:

Chemomab is advancing in parallel three Phase 2 clinical trials with CM-101 in three distinct fibrotic indications; Systemic Sclerosis (SSc) is planned to be initiated by the end of 2021, and clinical readouts from the ongoing clinical trials in PSC and NASH are expected during 2022.

First Quarter 2021 Financial Highlights

·Cash and cash equivalents as of March 31, 2021 were $58.2 million which includes $45.5 million of gross proceeds from the private placement completed on March 22, 2021.

·Research and Development expenses for the three months ended March 31, 2021 were $1.2 million, compared to $1.6 million for the three months ended March 31, 2020. The decrease of $0.4 million was primarily related to a decrease in expenses to sub-contractors.

·General and administrative expenses were $0.5 million for the three months ended March 31, 2021, compared to $0.1 million for the three months ended March 31, 2020. The increase of $0.4 million was primarily related to merger related expenses.

·Net loss for the three months ended March 31, 2021 and 2020 was $1.7 million.