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, 2021 Shanghai Henlius Biotech, Inc reported the Company has entered into a license agreement with Suzhou NeuPharma Co., Ltd. (NeuPharma) in respect of a small-molecule inhibitor of BRAF V600E HLX208 (RX208) (Press release, NeuPharma, MAY 11, 2022, View Source [SID1234617726]). NeuPharma will grant Henlius an exclusive license to research, develop, produce, commercialize and sublicense the product in China (including Hong Kong, Macau and Taiwan regions). This collaboration is an important part of Henlius’ strategies to accelerate diversified innovation with a variety of drug targets and modalities to further enhance current pipeline.

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BRAF V600E inhibitors can be used in the treatment of colorectal cancer, melanoma, and certain rare diseases including Erdheim-Chester Disease (ECD). Studies have shown that BRAF V600E inhibitor in combination with anti-EGFR monoclonal antibody can effectively improve the survival and prognosis of patients with colorectal cancer. The licensed product has a proprietary new chemical structure different from other marketed BRAF inhibitors, and it exhibited excellent anti-tumor efficacy and safety in preclinical studies. This product is currently in Phase 1 clinical study, and early clinical data have also suggested preliminary efficacy and minimal side effects in patients with cancer. It has the potential to become the Best-in-Class BRAF V600E inhibitor, and may have a synergy with Henlius’ proprietary EGFR or PD-1 targeted antibodies to enhance a high-quality, innovative and differentiated product portfolio for the treatment of various cancer types.

Henlius has accumulated rich experiences in global clinical trials and product commercialization in the field of oncology over the years. Its clinical development platform strictly complies with GCP standards and has passed several GCP inspections by the NMPA and the European Medicines Agency. Henlius will accelerate the clinical development and commercialization of this licensed product to full speed, leveraging its therapeutic potential in multiple cancer types to develop innovative and effective therapies for the patients. Looking forward, Henlius will further strengthen the in-licensing and collaboration on external high-quality innovative assets, to expand and upgrade its product pipeline and bring more affordable therapies to patients around the world.

About BRAF V600E Mutation
BRAF protein is an important upstream regulator of the MAPK/ERK signaling pathway, and the V600E mutation of BRAF can activate the downstream MEK protein, which induces the proliferation and invasion of tumor cells. The V600E mutation frequently occurs in colorectal cancer, thyroid cancer, melanoma and other types of cancers, which often predicts poor prognosis. Among those cancers, colorectal cancer is the second most common cancer in China, with a 5-15% BRAF V600E mutation rate[1].

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."