On May 11, 2022 TRACON Pharmaceuticals, Inc. (Nasdaq:TCON), a clinical stage biopharmaceutical company focused on the development and commercialization of novel targeted cancer therapeutics and utilizing a cost efficient, CRO-independent product development platform to partner with companies to develop and commercialize innovative products in the U.S., reported financial results for the first quarter ended March 31, 2022 (Press release, Tracon Pharmaceuticals, MAY 11, 2022, View Source [SID1234614213]). The Company will host a conference call and webcast today at 4:30 PM Eastern Time / 1:30 PM Pacific Time.

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"We are pleased with the pace of enrollment under the amended ENVASARC protocol and remain on track to deliver interim efficacy data in the second half of this year," said Charles Theuer, M.D., Ph.D., President and CEO of TRACON. "Additionally, with the arbitration hearing now completed we look forward to the outcome of the binding arbitration for the TJ4309 and Bispecific Antibody agreements during the second half of this year. We also continue preparations to initiate dosing of the Phase 1/2 clinical trial of envafolimab with our potential best-in-class CTLA-4 antibody, YH001, as well as doxorubicin chemotherapy in the second half of 2022."

Recent Corporate Highlights

In March, we announced the amended ENVASARC protocol using a higher dose of envafolimab was approved by the FDA.

In April, we announced the amended ENVASARC protocol was approved by internal review boards or ethic committees at each of the 30 clinical sites in the U.S. and U.K. and that all sites were open for enrolment, with more than 10 patients enrolled.
Expected Key Upcoming Milestones

Two interim safety reviews and the interim efficacy data review by the ENVASARC Independent Data Monitoring Committee (IDMC) in the second half of 2022.

Initiate dosing of a Phase 1/2 clinical trial of envafolimab with our potential best in class CTLA-4 antibody YH001 as well as with doxorubicin chemotherapy in the second half of 2022.

Report the International Chamber of Commerce (ICC) Arbitration Panel’s binding decisions on the legal disputes involving the TJ4309 and bispecific antibody agreements with I-Mab this year.

Complete the TJ4309 Phase 1 trial permitting I-Mab the opportunity to terminate the license for $9M this year.

Initiate dosing of a randomized Phase 2 trial of TRC102 in locally advanced non-small cell lung cancer sponsored and funded by the National Cancer Institute this year.
First Quarter 2022 Financial Results

Cash, cash equivalents and short-term investments were $16.6 million at March 31, 2022, compared to $24.1 million at December 31, 2021. The Company expects that its current cash and cash equivalents will fund operations into 2023.

Research and development expenses for the first quarter of 2022 were $3.0 million, compared to $2.3 million for the first quarter of 2021.

General and administrative expenses for the first quarter of 2022 were $6.5 million, compared to $2.7 million for the first quarter of 2021. The increase was primarily attributable to legal expenses incurred due to the arbitration hearing held in February 2022 with I-Mab related to the TJ4309 and bispecific antibody agreements, and the Company expects general and administrative expenses to decrease significantly for the remainder of the year.

Net loss for the first quarter of 2022 was $9.5 million, compared to $5.1 million for the first quarter of 2021.
Conference Call Details

A live webcast of the conference call will be available online from the Investor/Events and Presentation page of the Company’s website at www.traconpharma.com.

After the live webcast, a replay will remain available on TRACON’s website for 60 days.

About Envafolimab

Envafolimab (KN035), a single-domain antibody against PD-L1 invented by Alphamab Oncology, is the first approved subcutaneously injected PD-(L)1 inhibitor. Envafolimab was approved by the Chinese NMPA in November 2021 in adult patients with MSI-H/dMMR advanced solid tumors who failed systemic treatment and have no satisfactory alternative treatment options. In December 2019, Alphamab Oncology, 3D Medicines and TRACON entered into a collaboration whereby TRACON has the right to develop and commercialize envafolimab in soft tissue sarcoma in North America. Envafolimab is currently being studied in the pivotal ENVASARC Phase 2 trial in the United States sponsored by TRACON and a Phase 3 pivotal trial in combination with gemcitabine and oxaliplatin in advanced biliary tract cancer patients in China sponsored by TRACON’s corporate partners, Alphamab Oncology and 3D Medicines.

About ENVASARC (NCT04480502)

The ENVASARC pivotal trial is a multicenter, open label, randomized, non-comparative, parallel cohort study at 30 top cancer centers in the United States and the United Kingdom that began dosing in December 2020. TRACON expects the trial to enroll more than 160 patients with UPS or MFS who have progressed following one or two lines of prior treatment and have not received an immune checkpoint inhibitor, with 80 patients enrolled into a cohort of treatment with single agent envafolimab at 600 mg every three weeks and 80 patients enrolled into a cohort of treatment with envafolimab at 600 mg every three weeks with Yervoy. The primary endpoint is objective response rate by central review with duration of response a key secondary endpoint.

About YH001

YH001 is an IgG1 antibody against CTLA-4 that has shown enhanced antibody dependent cellular cytotoxicity (ADCC) and complement dependent cytotoxicity (CDC) in vitro. In preclinical studies YH001 demonstrated superior T cell activation and superior tumor growth inhibition activity compared to ipilimumab. YH001 also demonstrated superior activity compared to ipilimumab in human transgenic mouse tumor models when combined with a PD-(L)1 antibody. In these models, single agent YH001 depleted regulatory T cells and increased CD8+ T cells in tumor tissue. YH001 is being dosed as a single agent in a Phase 1 trial in China (NCT04699929) and in combination with the PD-1 antibody toripalimab in a Phase 1 trial in Australia (NCT04357756).

About TRC102

TRC102 (methoxyamine) is a novel, small molecule inhibitor of the DNA base excision repair pathway, which is a pathway that causes resistance to alkylating and antimetabolite chemotherapeutics. TRC102 is currently being studied in multiple Phase 1 and Phase 2 clinical trials sponsored by the National Cancer Institute through a Cooperative Research and Development Agreement (CRADA) and has orphan drug designation from the FDA in malignant glioma, including glioblastoma.

About TJ004309

TJ004309 is a novel, humanized antibody against CD73, an ecto-enzyme expressed on stromal cells and tumors that converts extracellular adenosine monophosphate (AMP) to adenosine, which is highly immunosuppressive. TJ004309 is currently being studied in an ongoing Phase 1 trial to assess safety and preliminary efficacy as a single agent and when combined with the PD-L1 checkpoint inhibitor Tecentriq in patients with advanced solid tumors.

On May 11, 2022 Cleveland Diagnostics, Inc., a clinical-stage biotechnology company developing next-generation diagnostic tests for the early detection of cancers, reported that its prostate cancer test, IsoPSA, has been added to the National Comprehensive Cancer Network (NCCN) Guidelines for Prostate Cancer Early Detection (version 1.2022) (Press release, Cleveland Diagnostics, MAY 11, 2022, View Source [SID1234614246]). The NCCN panel now recommends the use of IsoPSA as an option to further define the probability of high-grade prostate cancer (Gleason score ≥ 3+4, Grade Group 2 or higher) prior to a first biopsy or after a negative biopsy.

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"We are honored that NCCN, an organization that provides valuable guidelines based on the latest evidence and expert consensus, now includes our IsoPSA test in its guidelines for prostate cancer early detection," said Arnon Chait, Ph.D., Chief Executive Officer at Cleveland Diagnostics. "The NCCN’s new recommendation highlights years of extensive clinical validation and clinical utility studies that all point to how IsoPSA could change the way prostate cancer is diagnosed and subsequently treated."

"Most urologists follow NCCN prostate cancer guidelines as a standard in the diagnosis and treatment of the disease," said Mark Stovsky, M.D., Chief Medical Officer at Cleveland Diagnostics. "We are pleased to have IsoPSA included in these guidelines as it will give urologists more insight into the best course of action for patients for which they are evaluating for prostate cancer."

IsoPSA is a non-invasive, blood-based test that has demonstrated in large, multicenter studies superior diagnostic accuracy and clinical utility when compared to prostate-specific antigen (PSA), the current standard of care in prostate cancer, in men being considered for prostate biopsy.

"In the Introduction section of the new guidelines, the NCCN panel recognizes that maximizing early detection of prostate cancer will increase the detection of both indolent (slower-growing) and aggressive (faster-growing) prostate cancers," adds Bob Rochelle, Chief Commercial Officer at Cleveland Diagnostics. "The panel also describes a goal of minimizing immediate treatment or overtreatment of indolent cancers by accurately characterizing the biology of detected cancer, and that there are some indolent cancers and benign prostate conditions that can be monitored rather than immediately treated. This is precisely the rationale for our IsoPSA test."

On May 11, 2022 Shanghai Henlius Biotech, Inc. (2696.HK) reported it has entered into a license and collaboration agreement with Eurofarma Laboratórios SA ("Eurofarma"), a leading Brazilian pharmaceutical company with considerable experience in introducing and marketing innovative medical products throughout Latin America, for the development, manufacturing and commercialization in 16 Latin American countries of Henlius’ independently developed HANLIKANG (rituximab biosimilar), HANQUYOU (trastuzumab biosimilar, trade name in Europe: Zercepac), and HANBEITAI (bevacizumab biosimilar) (Press release, Shanghai Henlius Biotech, MAY 11, 2022, View Source [SID1234614786]). This collaboration is not only an endorsement of Henlius’ product quality and operational strength, but also a continuation of the company’s goal of advancing its worldwide footprint, building momentum for the company’s evolution from biotechnology to biopharma.

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Under the agreement terms, Henlius will receive up to a total of $50.5 million, including a $4.5 million upfront payment. Meanwhile, Eurofarma will acquire exclusive rights to rituximab HANLIKANG in 12 countries, including Mexico, Guatemala and Panama, as well as trastuzumab HANQUYOU in 11 countries, including Mexico, Chile and Ecuador, and bevacizumab HANBEITAI in 15 countries, including Mexico, Argentina and Chile. In addition, Eurofarma will obtain semi-exclusive rights to the three products in Brazil.

Mr. Jason Zhu, President of Henlius, said, "We feel really honored to partner with Eurofarma. Henlius has always adhered to our intention to improve patients’ lives by timely providing them with quality and affordable protein therapeutics. Eurofarma has one of the largest sales teams in Latin America. Its robust business network and resources will effectively promote the commercialization of Henlius products in Latin America and the availability to patients. It is hoped that our three products can become effective treatment options for more patients in Latin American countries and light up their lives."

"We are extremely proud of this new partnership, which marks our more robust coverage in biosimilars and confirms our recent moves and work to provide Latin America with the greatest products of the world. We are putting together two of our main strategies to achieve our goals: expanding our presence regionally to increase the revenues from international operations and deploying new technology to the medicine, that definitely helps us become a reference in innovative matter", says Martha Penna, Vice President of Innovation at Eurofarma.

Bearing patients’ needs in mind, Henlius has actively expanded the global markets by leveraging its strong product development, manufacturing and quality systems, and commercialization capabilities, as well as joining hands with partners in the value chain. HANQUYOU (trade name in Europe: Zercepac), the first Chinese mAb biosimilar approved in both Europe and China, and HANBEITAI are commercialized by the company’s in-house team in China market. At present, both 150mg and 60mg dosage forms of HANQUYOU have been included in China’s National Reimbursement Drug List (NRDL), benefiting over 50,000 patients to date. HANLIKANG (rituximab injection) is the first-ever China-manufactured biosimilar approved by the National Medical Products Administration (NMPA). As of now, it has benefited more than 100,000 Chinese patients. Meanwhile, Henlius has aggressively pursued international commercialization of HANQUYOU and HANLIKANG. The company actively collaborated with global partners such as Accord Healthcare, Cipla, Mabxience, and the Jacobson Group to bring its HANQUYOU to patients in the United States, Canada, Europe, and other emerging markets, covering over 80 countries and regions worldwide. Zercepac is now available in around 20 European nations and regions, including the United Kingdom, Germany, Spain, France, Italy, Ireland, Hungary, and Switzerland. Moreover, the company has also reached a cooperation agreement with Colombian pharmaceutical company Farma de Colombia to promote the commercialization of HANLIKANG in Colombia, Peru, Ecuador and Venezuela. Including the cooperation with Eurofarma, Henlius’ products have reached 19 populous countries in Latin America, covering more than 90% of the Latin American population.

On May 11, 2022 Atreca, Inc. (Atreca) (NASDAQ: BCEL), a clinical-stage biotechnology company focused on developing novel therapeutics generated through a unique discovery platform based on interrogation of the active human immune response, reported financial results for the first quarter ended March 31, 2022 and provided an overview of recent developments (Press release, Atreca, MAY 11, 2022, View Source [SID1234614169]).

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"Atreca has had an exciting start to 2022, with multiple key clinical and preclinical milestones achieved," said John Orwin, Chief Executive Officer of Atreca. "In additional to the clinical data update in March where we reported the first objective responses observed in patients treated with both ATRC-101 monotherapy and pembrolizumab combination therapy, we also provided several updates on our preclinical pipeline at our R&D Day in April, highlighted by the announcement of ATRC-301, an antibody-drug conjugate (ADC) of an Atreca-discovered antibody targeting EphA2, as our next clinical candidate. We look forward to reporting additional data later this year from both the ongoing ATRC-101 Phase 1b clinical trial and the IND-enabling toxicology studies for ATRC-301."

Recent Developments and Highlights

Atreca hosted its first R&D Day in April, focused on the Company’s preclinical pipeline, and provided several updates:
ATRC-301, an ADC that selectively targets a novel, membrane-proximal epitope on erythropoietin-producing hepatocellular receptor A2 (EphA2), was declared as Atreca’s next clinical candidate. EphA2 is a validated and potentially high value target that is widely expressed across several types of cancer, and ATRC-301 has demonstrated potent, dose-dependent in vivo tumor regression in mice with no significant toxicity signals yet observed in murine models. Atreca has initiated IND-enabling studies, including a non-human primate toxicology study which is expected to read out in 2H22, and anticipates submitting an IND application for ATRC-301 in 2H23.
Atreca announced a licensing agreement with Zymeworks Inc. (Zymeworks) to utilize their ZymeLink technology to develop novel ADCs. As part of the licensing agreement with Zymeworks, Atreca’s novel antibodies will be conjugated using ZymeLink, Zymeworks’ suite of proprietary cytotoxins, linkers, and conjugation technologies. The agreement includes a two-year research term, with an option for a third year for Atreca, to evaluate antibodies as ADCs using ZymeLink, during which period Atreca can acquire up to three commercial licenses to develop three unique ADC programs.
Atreca announced multiple additional lead-stage programs in oncology, including ADC leads APN-497444 and APN–959038, CD3-engager lead APN-346958, and IL-15 superagonist (SA) conjugate lead APN-541885. Each program is based on an antibody identified via Atreca’s discovery platform from an active human immune response antibody, and upon further evaluation displayed strong and tumor-selective immunoreactivity against targets present on multiple tumor types across groups of patient samples. In their weaponized formats, each lead has demonstrated anti-tumor activity in in vivo preclinical studies. The targets bound by the antibodies vary in class and include both novel epitopes of known cancer targets as well as entirely novel target antigens in oncology.
To date, 55 total participants have been enrolled in the monotherapy and pembrolizumab-combination cohorts of the Phase 1b trial of ATRC-101, and participant selection based on target expression is expected to commence in 2Q22. Atreca anticipates reporting additional monotherapy and combination data in 2H22.
First Quarter 2022 Financial Results

As of March 31, 2022, cash and cash equivalents and investments totaled $125.8 million.
Research and development expenses for the quarter ended March 31, 2022, were $17.1 million, including non-cash share-based compensation expense of $2.1 million.
General and administrative expenses for the three months ended March 31, 2022, were $8.6 million, including non-cash share-based compensation expense of $2.3 million.
Atreca reported a net loss of $24.9 million, or basic and diluted net loss per share attributable to common stockholders of $0.65, for the three months ended March 31, 2022.

On May 11, 2022 Targovax ASA (OSE: TRVX), a clinical-stage immuno-oncology company developing immune activators to target hard-to-treat solid tumors, reported that it has entered into a clinical collaboration and supply agreement with Agenus Inc. (NASDAQ: AGEN) to combine Targovax’s oncolytic immunotherapy ONCOS-102 with two of Agenus´ checkpoint inhibitors in a multi-cohort phase 2 trial to treat anti-PD1 refractory malignant melanoma (Press release, Targovax, MAY 11, 2022, View Source [SID1234614186]).

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Targovax has previously reported a highly competitive 35% objective response rate (ORR) for ONCOS-102 in a phase 1 trial in anti-PD1 refractory melanoma. Importantly, deep translational analyses revealed broad and powerful ONCOS-102-induced immune activation, which correlated with tumor responses and demonstrated strong scientific evidence for additional combination treatments beyond anti-PD1 blockade. Based on these encouraging clinical findings, Targovax is preparing for a multi-cohort phase 2 trial to test ONCOS-102 with novel immunotherapy combinations in a larger number of patients.

Agenus is an immuno-oncology company with an extensive pipeline of therapeutics designed to activate immune response to cancers and infections. Agenus and Targovax plan to test ONCOS-102 in combination with Agenus´ two proprietary checkpoint inhibitors, balstilimab and botensilimab. Balstilimab is an anti-PD1 blocking antibody currently in clinical development in several solid tumors. Botensilimab is an Fc-enhanced anti-CTLA4 antibody that has shown promising activity in early trials in several treatment-resistant solid tumors as monotherapy and in combination with balstilimab.

Dr. Lone Ottesen, Chief Medical Officer of Targovax, said: "The excellent efficacy, immune activation potency and safety profile of ONCOS-102 argues strongly for moving into later stage development in combination with complementary immunotherapies. Based on our clinical biomarker and genomic data, we firmly believe we can further boost response rates in anti-PD1 refractory melanoma patients with novel combinations. I am particularly excited about the opportunity to work with Agenus´ new anti-CTLA4 candidate botensilimab, which has the potential to significantly improve on both efficacy and toxicity compared to ipilimumab, as well as enhancing the systemic activity of ONCOS-102."

Under the agreement, Targovax will be the sponsor and responsible for operational execution of the combination trial, and Agenus will provide drug supply and scientific support. Following demonstration of competitive clinical efficacy in the planned phase 2 study, the parties intend to extend the collaboration into a registrational development program.

Dr. Erik Digman Wiklund, Chief Executive Officer of Targovax ASA, added: "We are thrilled to extend our existing relationship with Agenus. We were looking for a collaboration partner with a portfolio of innovative, complementary immunotherapies, and in Agenus we have found the perfect fit. Together, we will test novel and differentiated combination treatments in melanoma with the goal to achieve response rates beyond the already observed 35% ORR. We are confident this will confirm ONCOS-102 as a leading candidate to address the growing unmet medical need for immune activators that can effectively reverse resistance to checkpoint inhibitor therapy."