On July 8, 2020 Zymeworks Inc. (NYSE: ZYME), a clinical-stage biopharmaceutical company developing multifunctional biotherapeutics, reported a webcast and conference call highlighting its progress and key accomplishments in the first half of 2020 (Press release, Zymeworks, JUL 8, 2020, View Source [SID1234561766]).

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"I’m proud to say we’ve taken a major step towards achieving our goal of bringing an important new therapeutic to patients with HER2-expressing cancers," said Ali Tehrani, Ph.D., President and CEO of Zymeworks. "ZW25, which we will now refer to as zanidatamab, has started its first registration-enabling trial in HER2+ 2L biliary tract cancer targeting a potential BLA in 2022."

Dr. Tehrani added, "This achievement, supported by the updated zanidatamab clinical data in BTC and GEA as well as the two partnership updates, highlights a productive first half of 2020 and sets the stage for more to come in the second half of the year."

Zanidatamab Clinical Updates

Registration-Enabling Trial in HER2+ Biliary Tract Cancer
Zymeworks initiated a global Phase 2 trial of single agent zanidatamab in patients with previously treated HER2 gene amplified BTC to support accelerated approval based on a primary endpoint of objective response rate, and secondary endpoints of duration of response and safety. This study may enable filing of a BLA as early as 2022.

Updated Single Agent Biliary Tract Cancer Data
In 15 response-evaluable refractory BTC patients, the response rate with single agent zanidatamab was 47% with a disease control rate of 67%. Results compare favorably to the single digit response rates typically seen with chemotherapy in this setting.

Updated Single Agent Gastroesophageal Adenocarcinoma Data
In 34 response evaluable patients with HER2-expressing GEA, zanidatamab continues to demonstrate exciting single agent anti-tumor activity with a 38% response rate, and 62% disease control rate in patients who have received a median of 3 prior lines of treatment, including Herceptin.

Updated Chemotherapy Combination Gastroesophageal Adenocarcinoma Data
Twenty response-evaluable HER2-expressing GEA patients were treated with zanidatamab in combination with either paclitaxel or capecitabine, both of which are used as single agent chemotherapies for patients with progression after first line treatment. The overall response rate was 55%, including a 60% response rate in combination with paclitaxel. As a comparator, the response rate for paclitaxel alone in 2nd line HER2+ GEA is ~ 20%. Responses were observed in patients with FISH+ and FISH- disease.

Business Highlights

New Azymetric Partnership with Merck
Zymeworks signed a new licensing agreement with its long-term partner Merck to develop additional multispecific antibody therapeutic candidates using the Azymetric and EFECT platforms. Zymeworks is eligible to receive up to US$411 million in option exercise fees and clinical development and regulatory approval milestone payments and up to US$480 million in commercial milestone payments, as well as tiered royalties on worldwide sales.

Expanded Partnership with Bristol-Myers Squibb
BMS (formerly Celgene) expanded its Azymetric collaboration with Zymeworks, gaining access to the EFECT platform and extending its research term, with the objective of developing up to 10 therapeutic candidates as per the original agreement. The expanded partnership resulted in a US$12 million upfront payment to Zymeworks. Milestones remain at up to US$1.7 billion plus tiered royalties on global sales.

On July 8, 2020 Median Technologies (Paris:ALMDT), The Imaging Phenomics Company, reported a strong business activity for the first half of 2020 (unaudited figures) (Press release, MEDIAN Technologies, JUL 8, 2020, View Source [SID1234561765]).

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As of June 30th, Median Technologies’ revenue reached €5.9 million, up 49.7% compared with the first half of 2019 (€4 million). In total, the company’s revenues have been consistently growing over the past seven quarters. Median’s iCRO1 Business Unit, which provides imaging solutions and services for clinical trials in oncology, accounts for 100% of the company’s revenue. The iBiopsy activity is still in the R&D investment phase and does not generate any income at this stage.

As of June 30th, 2020, the order backlog2 stood at €53.6 million, i.e. €15.3 million more than as of December 31st, 2019, and €9.2 million more than as of March 30th, 2020. Over a one-year period, the order backlog increased by 74.6% (Median’s order backlog was of €30.7 million as of June 30th, 2019, a €22.9 million increase in one year). Median’s order backlog increased over the first semester mainly thanks to very large orders in Europe, for phase III studies involving major pharmaceutical companies. The company’s order backlog allows to approach the coming quarters with full confidence in terms of expected revenue.

Cash and cash equivalents are expected to reach around €19.4 million as of June 30th, 2020. That amount includes a received payment of €15 million, as part of the first installment of a €35 million loan granted to the company by the European Investment Bank (EIB). This loan aims to boost investments in Median’s imaging phenomics platform, iBiopsy. The amount of cash and cash equivalents also takes into account a Research Tax Credit of €1.4 million, which was cashed by the company. During the first half of 2020, and excluding impacts from the EIB first tranche disbursement and the Research Tax Credit reimbursement, Median spent €4.6 million in cash, with a burn rate of €3.7 million in the first quarter, dropping to €0.9 million in the second quarter.

In the first half of 2020, Median increased investments in the development and validation of its imaging phenomics platform, iBiopsy; signed its first partnership with Assistance Publique – Hôpitaux de Paris (AP-HP); structured iBiopsy around three clinical development plans, for which the first clinical validation stages have been launched. Median also announced promising first validation results for its iBiopsy technology, as part of a study assessing the risk of recurrence for patients with primary liver cancer (HCC – hepatocellular carcinoma).

Median’s iCRO Business Unit continued to develop itself in China, where it is now fully operational to manage projects contracted with Chinese companies. As of June 30th, iCRO order intake worldwide had largely exceeded the compan’s first-half forecasts, despite the health crisis caused by Covid-19.

"These first-half results show a significant increase of our order backlog, up €15.3 million over the period, including an acceleration of the trend during the second quarter. As anticipated, the Covid-19 health crisis had an extremely limited impact on our results in the first half of 2020. This impact was limited to payment delays, which were resolved in the second quarter. We’re also recording a 47.9% revenue increase compared with the first half of 2019, as our sales remarkably grew for the 7th consecutive quarter," said Fredrik Brag, CEO and co-founder of Median. "With major events, such as the signing of a collaboration agreement with AP-HP, the receipt of the first payment from our EIB loan and the publication of promising first validation results, the first six month of 2020 also brought very positive news for iBiopsy. And we’re confident that these trends will continue."

The preliminary results set forth above are based on management’s initial review of the Company’s operations for the period ending June 30th, 2020 and are subject to revision based upon the Company’s H1 closing procedures and upon the completion and external audit of the Company’s half year financial statements. Actual results may differ materially from these preliminary results as a result of the completion of H1 closing procedures, final adjustments and other developments arising between now and the time that the Company’s financial results are finalized, and such changes could be material. In addition, these preliminary results are not a comprehensive statement of the Company’s financial results for the first half of 2020, should not be viewed as a substitute for full, audited financial statements prepared in accordance with generally accepted accounting principles, and are not necessarily indicative of the Company’s results for any future period.

On July 8, 2020 RefleXion Medical, a therapeutic oncology company pioneering biology-guided radiotherapy* (BgRT) as a new modality for treating all stages of cancer, and Telix Pharmaceuticals Limited (ASX: TLX), a radiopharmaceutical company developing molecularly-targeted radiation (MTR) products, reported a strategic collaboration to investigate the clinical utility of combining the companies’ technologies to improve treatment for high-risk or recurrent prostate and aggressive kidney cancers (Press release, RefleXion Medical, JUL 8, 2020, View Source [SID1234561764]).

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Under the agreement, the parties will evaluate several new positron emission tomography (PET) tracers, including 68Ga-PSMA-11 for prostate cancer and 89Zr-Girentuximab for kidney cancer1, to evaluate their potential in guiding BgRT to treat disease.

"The Telix tracers show considerable potential for detecting metastatic disease," said Phuoc Tran, M.D., Ph.D., professor of radiation oncology and molecular radiation sciences, oncology and urology at the Johns Hopkins School of Medicine. "Combining them with RefleXion’s BgRT, which is designed to treat metastatic disease, could bring us a step closer to improving outcomes for these cancer types."

BgRT uses biological emissions from a patient’s cancer cells created by injecting a small amount of a targeting molecule carrying a positron-emitting radioisotope known as a PET tracer to guide external-beam radiotherapy (EBRT). As the PET tracer binds to the tumor cells, it produces emissions that signal the cancer’s location. The RefleXion X1 machine detects these emissions using PET detectors and responds in real-time to direct BgRT to each tumor and destroy it, even in moving tumors. The most commonly used PET tracer is 18F-fluorodeoxyglucose (FDG), which can detect many different cancer types. However, its performance in certain tumor types and organs remains limited, particularly for kidney and prostate cancers. Telix’s new PET tracers are designed to target specific cancer types and are expected to be more accurate in this clinical setting.

"Telix’s cancer-specific PET tracers may provide a more complete and robust signal to guide BgRT for difficult-to-treat cancers of the prostate and kidney," said Thorsten Melcher, Ph.D., chief business officer at RefleXion. "This collaboration is an important step in providing proof-of-concept that PET-based tumor emissions can guide our BgRT using different tracers and in different cancer types."

Prostate specific membrane antigen (PSMA) imaging with 68Ga-PSMA-11 is suited for imaging high-risk or recurrent prostate cancer due to its ability to detect the spread of cancer outside the prostate bed. PSMA imaging is emerging as a potential new standard of care for detecting and staging prostate cancer, subject to approval by regulators2. For renal cancer applications, Telix’s 89Zr-Girentuximab, the first zirconium-labeled PET tracer in late-stage clinical development, targets carbonic anhydrase IX (CA9), an antigen that may differentiate renal cancer, including metastases, from benign disease.

"The use of Telix’s cancer-specific PET tracers may enable us to guide RefleXion’s BgRT in patients with more advanced forms of prostate and kidney cancer," said Christian Behrenbruch, Ph.D., CEO at Telix. "This collaboration also allows us to leverage the investment we’ve made in these tracers by expanding both their indications and overall procedure volumes."

On July 8, 2020 Xencor, Inc. (NASDAQ: XNCR), a clinical-stage biopharmaceutical company developing engineered monoclonal antibodies for the treatment of cancer and autoimmune diseases, and 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 that the companies have entered into a collaboration and license agreement to research, develop and commercialize T cell engaging bispecific antibodies as potential therapeutics in oncology (Press release, Xencor, JUL 8, 2020, View Source [SID1234561763]).

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Bispecific antibodies that direct T cells to tumor cells, by simultaneously binding CD3 on T cells and a target on tumor cells, have the potential to drive tumor cell killing. This collaboration will leverage Xencor’s XmAb engineering platform to design and manufacture CD3 bispecific antibodies and Atreca’s ability to generate novel antibody-target pairs through its discovery platform, including its Immune Repertoire Capture (IRC) technology.

Under the terms of the agreement, the companies will engage in a three-year discovery program. Atreca will provide antibodies against novel tumor targets from which Xencor will engineer XmAb bispecific antibodies that also bind to the CD3 receptor on T cells. Up to two joint programs will be mutually selected for further development and commercialization, with each partner sharing 50 percent of costs and profits. Each company will lead development, regulatory and commercialization activities for one of the joint programs. In addition, the agreement allows for each partner to pursue up to two programs independently, with a mid- to high-single digit percent royalty payable on net sales. Atreca and Xencor began working together in 2019 under a material transfer agreement to accelerate this new collaboration agreement.

"We are proud to be partnering with Xencor, a leader in the engineering and development of antibody therapeutics," said John A. Orwin, chief executive officer of Atreca. "We believe this collaboration leverages two approaches with the potential to be highly complementary and underscores the value of novel antibody-target pairs in the development of cancer therapeutics. We are encouraged by the work already completed under our initial agreement and look forward to a productive partnership, as well as the prospect of adding T cell engaging bispecific product candidates to our clinical pipeline."

"Xencor is building a broad portfolio of drug candidates based on our XmAb technologies, which enable us to create therapeutic antibodies and other proteins with enhanced properties and new mechanisms of action," said Bassil Dahiyat, Ph.D., president and chief executive officer at Xencor. "Atreca’s unique discovery platform complements our protein engineering capabilities and bispecific platform by providing novel, tumor-selective antibodies and targets to engage with cytotoxic T cell killing. This collaboration offers both Xencor and Atreca with several opportunities to advance novel first-in-class CD3 bispecific antibodies for the potential treatment of patients with cancer."

About XmAb Bispecific Fc Technology and CD3 Bispecific Antibodies

XmAb bispecific Fc domains enable the rapid design and simplified development of bispecific antibodies, and other protein structures, that can bind two or more different targets simultaneously using an engineered heterodimer Fc domain. CD3 bispecific antibodies contain an anti-tumor associated antigen binding domain and a second binding domain targeted to CD3, an activating receptor on T cells, with the goal to recruit or activate T cells against the antigen target. Xencor has developed a mixed valency format, the XmAb 2+1 bispecific antibody, with two domains that bind a tumor target, which preferentially may bind and kill tumor cells with high target expression while potentially sparing low-expression normal tissues.

On July 8, 2020 VelosBio Inc. ("VelosBio"), a clinical-stage biopharmaceutical company committed to developing novel, first-in-class cancer therapies targeting receptor tyrosine kinase-like orphan receptor 1 (ROR1), reported the completion of an oversubscribed Series B financing of $137 million led by Matrix Capital Management and Surveyor Capital (a Citadel company) (Press release, VelosBio, JUL 8, 2020, View Source [SID1234561762]). The Company has raised a total of $202 million in gross proceeds from private financings since its founding in 2017.

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New investors participating in the Series B financing round include Adage Capital Management LP, Cormorant Asset Management, Farallon, Foresite Capital, Janus Henderson Investors, Logos Capital, OrbiMed, funds and accounts advised by T. Rowe Price Associates, Inc., Venrock Healthcare Capital Partners, Viking Global Investors, and Wellington Management Company, which are joining existing investors Arix Bioscience, Decheng Capital, Pappas Capital, Sofinnova Ventures, and Takeda Ventures.

The proceeds from the Series B financing will be used to further advance the clinical development of the VelosBio lead antibody-drug conjugate (ADC), VLS-101, and support the continued expansion of its pipeline of ROR1-directed next-generation ADCs and bispecific antibodies. ROR1 is a cell surface antigen present on a range of hematologic and solid tumor malignancies. VLS-101 is a ROR1-directed ADC that is currently being studied in a first-in-human Phase 1 clinical trial in patients with relapsed or refractory hematologic cancers. Studies in patients with solid tumors are scheduled to begin later this year.

"We are delighted to welcome a top-tier group of leading healthcare investors to advance development of our pipeline of first-in-class ROR1-directed therapeutics. We have made tremendous progress since founding the Company in 2017, and this financing reflects strong support for our platform, people, and comprehensive development strategy," said Dave Johnson, Chief Executive Officer, VelosBio. "This investment positions us to further the development of our unique pipeline of targeted therapies, and continue the expansion of our world-class team of scientists and researchers who share a passion for developing paradigm-shifting cancer therapeutics to improve patients’ lives."

"We were attracted to VelosBio by the excellent science, experienced management team, and broad potential therapeutic applicability of its proprietary ROR1-targeting technology," said Karan Takhar, Managing Director, Matrix Capital Management. "The early clinical data with VLS-101 are very promising and support ROR1’s potential as a novel oncology target. We see tremendous opportunity for the VelosBio pipeline to produce novel targeted therapies for use as monotherapy or in combination across a broad range of cancers."