On April 16, 2020 Alphamab Oncology (stock code: 9966 HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, received Safe to Proceed Letter from the US Food & Drug Administration ("FDA") for its recombinant humanized PD-L1/CTLA-4 bispecific antibody KN046, to initiate Phase II clinical trial in anti-PD-(L)1 refractory or relapsed Non-Small-Cell Lung Cancer ("NSCLC") (Press release, Alphamab, APR 16, 2020, View Source [SID1234556395]). KN046’s Phase I clinical trials in Australia and China, along with multiple Phase II trials in China have shown a good safety profile and promising efficacy.

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KN046 is a global first-in-class programmed death ligand 1 ("PD-L1")/ cytotoxic T-lymphocyte-associated protein 4 ("CTLA-4") bispecific antibody developed by the Jiangsu Alphamab. PD-(L)1 and CTLA-4 are the only two clinically validated immune checkpoints, and their combo therapy has been approved for the treatment of melanoma, colorectal cancer and kidney cancer, but application of the combo therapy has limited application due to its toxicity. Through innovative drug design, Jiangsu Alphamab has fused a novel CTLA-4 single-domain antibody with PD-L1 antibody to form KN046, a bispecific antibody with acceptable safety. KN046 has the capacity to block both PD-(L)1 and CTLA-4, effectively activate T-cells and strengthen anti-tumor immune activity.

KN046 is the only anti-PD-L1/CTLA-4 bispecific antibody drug in clinical development phase globally, and also Jiangsu Alphamab’s third drug candidates which have been approved to enter clinical trial in the United Sates. KN046 is currently undergoing multiple Phase II clinical trials for NSCLC, triple-negative breast cancer ("TNBC"), esophageal squamous cell carcinoma ("ESCC") and pancreatic cancer. The result from these clinical trials is scheduled to be released in various occasions including international medical conferences. This Phase II clinical trial in the United States aims to evaluate the safety, tolerability and efficacy of KN046 monotherapy or in combination with chemotherapy in locally advanced unresectable or metastatic NSCLC.

Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "We are unwaveringly committed to providing world class therapeutic biologics to global patients. Represented by KN046, our innovative bispecific antibodies pipeline has given us a head start to fulfill this mission. The IND approval from FDA is an important milestone for KN046’s the global development. We will accelerate clinical development on multiple oncology indications, and work hard towards an earlier market launch and provide cancer patients with a safe and more effective treatment option."

About KN046

KN046 is the world’s first recombinant humanized PD-L1/CTLA-4 bispecific antibody independently developed by Jiangsu Alphamab. Its innovative designs include: a proprietary CTLA-4 domain antibody with a significantly improved safety profile; a bispecific antibody fused with PD-L1 antibody; engineered to target the tumor microenvironment with high PD-L1 expression, and Treg clearing function. The preclinical and clinical study results of KN046 have shown promising efficacy and significantly reduced toxicity to human peripheral system, with the potential to become the backbone of next generation immuno-oncology therapy in the future.

Previously, KN046’s phase I clinical trials in Australia and China have shown a preliminary profile of good safety and promising efficacy, and several phase II clinical trials are ongoing in China for NSCLC, TNBC, ESCC and pancreatic cancer.

On April 16, 2020 PTC Therapeutics, Inc. (NASDAQ: PTCT) reported that the Company will host a webcast conference call to report its first quarter 2020 financial results and provide an update on the company’s business and outlook on Thursday, April 30, 2020 at 4:30 p.m. (ET) after the closing of the market (Press release, PTC Therapeutics, APR 16, 2020, https://www.prnewswire.com/news-releases/ptc-therapeutics-to-host-conference-call-to-discuss-first-quarter-2020-financial-results-301040545.html [SID1234556394]).

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The call can be accessed by dialing (877) 303-9216 (domestic) or (973) 935-8152 (international) five minutes prior to the start of the call and providing the passcode 8267466. A live, listen-only webcast of the conference call can be accessed on the investor relations section of the PTC website at www.ptcbio.com. A webcast replay of the call will be available approximately two hours after completion of the call and will be archived on the company’s website for 30 days following the call.

On April 16, 2020 Avectas, an Irish based cell engineering technology business, reported that it has completed a significant new Series C equity funding of approximately $20 million, bringing the total equity invested in the business to date to $40 million (Press release, Avectas, APR 16, 2020, View Source [SID1234556393]). The funding was led by existing shareholders, including Seamus Mulligan, an experienced biopharmaceutical executive.

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The funds raised in this latest equity round will be used to accelerate the clinical translation and commercial scale-up of Avectas’ proprietary cell engineering technology platform (Solupore). To support this next phase of its activities, Avectas will also expand its commercial, regulatory and technical organisation with new hires in Ireland and the U.S., as Covid-19 related conditions permit.

"We are delighted to have completed our largest ever funding and are appreciative of our investors’ continued support at a time when scientific advances are more critical than ever," said Michael Maguire, Ph.D., Avectas’ Chief Executive Officer. He continued "Building on our recent collaborations, this Series C funding allows us to make further investments in our technology and organisation to address a significant market need in the rapidly growing gene and cell therapy market."

Cell and gene therapies offer the potential to transform the treatment of diseases, including cancer, for millions of patients worldwide. However, new cell engineering technologies are urgently needed to enable these cutting-edge therapies to achieve their potential. Avectas’ patented Solupore technology addresses it’s academic and commercial partners’ need for an efficient, non-viral cell engineering solution. The technology achieves excellent engineering efficiencies for delivery of a broad range of payloads (including mRNA, DNA, proteins and gene editing tools) to primary T cells and NK cells for immuno-oncology and gene editing applications.

Mary Martin, Ph.D., Avectas’ Executive Chair commented "Ireland has a deep history in the pharmaceutical and biotech sector and I am excited to see it build on that legacy with companies like Avectas, which are at the cutting edge of the new cell and gene therapy sector."

This funding raise follows an excellent first quarter for Avectas. In March 2020, the company announced both the issuance of a U.S. Patent core to its cell engineering technology and a collaboration with Vycellix to advance next-generation solutions for the optimized manufacture of cell & gene therapies. The company also announced, in February, that it had entered an agreement with the centre for commercialization of regenerative medicine (CCRM) based in Toronto, Canada to accelerate the translation of Avectas’ non-viral cell engineering platform (Solupore) into the clinic. In January 2020, the new competence center for next-generation NK cell-based cancer immunotherapy ("NextGen-NK") established at Karolinska Institutet ("KI"), Stockholm, Sweden welcomed Avectas as a collaborative partner.

On April 16, 2020 Heska Corporation (NASDAQ: HSKA; "Heska" or the "Company"), a provider of advanced veterinary diagnostic and specialty products, reported its first quarter 2020 financial performance in a press release on Thursday, May 7, 2020 before the market opens, and to host a earnings call to discuss the results following the release at 9 a.m. MT / 11 a.m. ET (Press release, Heska, APR 16, 2020, View Source [SID1234556392]).

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To access the conference call:

From within the United States, please dial 1-866-548-4713
From outside of the United States, please dial 1-323-794-2093
Reference Conference ID: 3918137

The earnings call will be webcast live from the Company’s website at: Heska Corporation First Quarter 2020 Earnings Call Webcast.

A telephonic replay will be available beginning at 2 p.m. ET Thursday, May 7 and will continue through 11:59 p.m. ET on Thursday, May 21, 2020. The webcast will be archived for 90 days.

On April 16, 2020 Agendia, Inc., a world leader in precision oncology for breast cancer, reported that Translational Cancer published long term analytical performance characteristics of the 80-gene BluePrint molecular subtyping assay (Press release, Agendia, APR 16, 2020, View Source [SID1234556391]).

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Breast cancer is a heterogeneous disease with distinct patient populations who experience different clinical outcomes. Traditionally, these patient groups have been identified by their estrogen receptor (ER), progesterone receptor (PR) and human epidermal growth factor receptor 2 (HER2) statuses. Determining a patient’s clinical subtype, either luminal (ER+ and/or PR+), HER2+ or triple negative (ER/PR-, HER2-), via immunohistochemical (IHC) testing is a critical part of the diagnostic workup process to inform treatment planning. As an adjunct to IHC testing, the 80-gene BluePrint molecular subtyping assay goes beyond traditional cell surface markers such as ER, PR and HER2 to determine the underlying pathway driving a tumor’s growth. In combination with MammaPrint, BluePrint categorizes patients into four distinct subtypes, Luminal A-Type, Luminal B-Type, HER2-Type or Basal-Type, to further support treatment planning.

The Translational Cancer publication demonstrated that over a three year period, the BluePrint molecular assay was highly precise and reproducible with correlations above 98% for reported numerical indices and 99% concordance for reported subtype categories. This contrasts with standard IHC and in situ hybridization assays (often used for HER2) which have variability from lab to lab due to challenges with standardization and interpretation of results. In addition to clinical validity and utility, analytical validity and reproducibility are important considerations when adopting testing methods to guide breast cancer treatment.

One of the primary benefits of BluePrint testing is identifying unique patient groups where there is discordance between IHC and molecular subtyping results. For instance, the well characterized ER+ Basal group, ER+ by IHC but Basal by molecular subtyping, has a poorer prognosis than standard ER+ patients. In a French study published by NPJ Breast Cancer and led by Pr. François Bertucci and his colleagues from the Centre de Recherche en Cancérolgie de Marseille, 65% of ER+ Basal patients had a recurrence within 3 years of diagnosis vs. only 44% in the ER+ Luminal group. This study was an in silico analysis of a data set from 36 studies that included 5,342 pathological ER+/HER2- tumors. Overall, the Basal subtype was found to be more closely related to pathologically triple negative breast cancer, yet still distinct.

Dr. Bertucci concluded, "the study results reinforce the potential clinical value of the different molecular classifications in ER+/HER2- breast cancers. The Basal and Luminal subtypes are so different with respect to therapeutic response and metastatic potential that they cannot continue to be assimilated and treated as a homogeneous ER+/HER2- group."

"By clearly understanding the molecular subtype of a patient’s tumor prior to surgery, physicians can use this information to guide treatment decisions and determine which patients will have favorable outcomes with pre-operative chemotherapy and those who would benefit by going directly to surgery," said William Audeh, MD Chief Medical Officer of Agendia.