On October 14, 2020 Y-mAbs Therapeutics, Inc. (the "Company" or "Y-mAbs") (Nasdaq: YMAB) a late-stage clinical biopharmaceutical company focused on the development and commercialization of novel, antibody-based therapeutic products for the treatment of cancer reported that the U.S. Food and Drug Administration ("FDA") has cleared the Company’s Investigational New Drug ("IND") application for 177Lu-omburtamab-DTPA for the treatment of medulloblastoma, which is the most common type of primary brain cancer in children (Press release, Y-mAbs Therapeutics, OCT 14, 2020, View Source [SID1234568471]). Medulloblastomas are invasive, rapidly growing tumors that, unlike most brain tumors, spread through the cerebrospinal fluid and frequently metastasize to different locations along the surface of the brain and spinal cord.

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177Lu-omburtamab-DTPA embodies the Company’s naked omburtamab antibody radiolabeled with lutetium-177, using DTPA to chelate the lutetium radioisotope to the antibody. Lutetium-177 is a beta-emitter with a half-life of 6.7 days and a maximum energy of 0.5 MeV, corresponding to a maximum soft-tissue penetration of approximately 1 mm.

We anticipate that an international multicenter Phase 1/2 clinical trial will be initiated for the screening of pediatric patients with medulloblastoma during the fourth quarter of 2020.

"Based on our clinical experience with 131I-omburtamab for B7-H3 positive brain metastasis, we are excited to see 177Lu-omburtamab-DTPA make its way to the clinic to establish the safety profile and to determine the maximum tolerated dose. In this study, we hope to leverage our clinical experience from treating 27 medulloblastoma patients with 131I-omburtamab, again using indwelling catheters for intracerebroventricular drug delivery," said Thomas Gad, founder, Chairman and President.

Dr. Claus Moller, Chief Executive Officer further notes, "Children with medulloblastoma represent a clear unmet medical need, and we are very pleased to move this product to the clinic. In addition, we have submitted a separate IND for a basket trial in B7-H3 positive CNS/LM cancers in adults to leverage our experience from treating more than 25 adults with 131I-omburtamab. We expect to initiate the study for the first adult patients to be treated with 177Lu-omburtamab-DTPA during the fourth quarter of 2020, and we are genuinely thrilled to widen our clinical reach to include adult indications."

Researchers at Memorial Sloan Kettering ("MSK") developed the omburtamab antibody, which is exclusively licensed by MSK to Y-mAbs. As a result of this licensing arrangement, MSK has institutional financial interests in the compound and in Y-mAbs.

On October 14, 2020 Perrigo Company plc (NYSE; TASE: PRGO), a leading provider of Quality, Affordable Self-Care Products, reported that it will release its third quarter financial results on Wednesday, November 4, 2020 (Press release, Perrigo Company, OCT 14, 2020, View Source [SID1234568470]). The Company will also host a conference call beginning at 8:00 a.m. (EST).

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The conference call will be available live via webcast to interested parties in the investor relations section of the Perrigo website at View Source or by phone at 888-317-6003, International 412-317-6061, and reference ID # 3180501. A taped replay of the call will be available beginning at approximately 12:00 p.m. (EST) Wednesday, November 4, until midnight Wednesday, November 11, 2020. To listen to the replay, dial 877-344-7529, International 412-317-0088, and use access code 10148815.

On October 14, 2020 Boehringer Ingelheim and Oxford BioTherapeutics Ltd. (OBT) reported they are building on their successful partnership and are establishing a new alliance to discover additional selective targets for strategic cancer indications to deliver first-in-class treatments for cancer patients (Press release, Boehringer Ingelheim, OCT 14, 2020, View Source [SID1234568469]). Boehringer Ingelheim will use OBT’s OGAP platform to identify novel target opportunities for new immunotherapies utilizing their T-cell engager, cancer vaccine and oncolytic virus platforms . This follows the initiation of the first patient dosing in a Phase 1 clinical trial of a bispecific antibody for the treatment of patients with small cell lung carcinoma and other neoplasms, where the target for the bispecific antibody was discovered during the first phase of the partnership.

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"This collaboration with Oxford BioTherapeutics is important for advancing therapeutic modalities that depend upon the identification of unique and specific tumor antigens within our cancer immunology portfolio," said Jonathon Sedgwick, Ph.D., Senior Vice President and Global Head Cancer Immunology & Immune Modulation Research at Boehringer Ingelheim. "We are committed to developing innovative, efficacious and safe treatment options for patients suffering from cancer, and these novel cancer target discoveries are a key step in the development of new potential treatments."

"We view the hopeful discovery of additional tumor targets as further confirmation of the value of our OGAP platform to identify novel targets that can be substrates for innovative new therapies," said Christian Rohlff, Ph.D., Chief Executive Officer of OBT. "OBT’s platforms are designed to discover and validate novel therapeutic targets and we look forward to continuing our partnership with Boehringer Ingelheim to best address difficult-to-treat cancers."

In addition to the programs in the partnership with Boehringer Ingelheim, OBT’s clinical assets have also been enabled through the OGAP discovery platform. Selecting the right target is fundamental for the successful development of a truly first-in-class oncology product. OBT’s platforms are designed to discover novel therapeutic targets and engineer antibodies to those targets, including CAR-T, other T-cell and NK cell-mediated cytotoxicity (ADCC) therapeutics to best address difficult-to-treat cancers. A major differentiator between OBTs discovery platform and other approaches is the retention of the link between individual patient samples through to the design of therapeutic antibodies and diagnostic patient selection tools, increasing the overall successful transition into clinical development.

Financial terms of the expanded agreement are not being disclosed. Under the terms of the agreement, Boehringer Ingelheim is responsible for the development and commercialization of antibody product candidates that interact with the novel targets identified by OGAP. OBT will receive development and regulatory milestone payments and royalties on any future product sales. To date, Boehringer Ingelheim has exercised two options under the first agreement and has selected two therapeutic candidates for further development.

Boehringer Ingelheim Oncology is taking cancer on by leading the science with cancer cell directed agents, immuno-oncology therapies and their combinations to address unmet needs in lung and gastrointestinal cancers. The company invests significantly in early stage research to identify unexplored and undrugged pathways of cancer. Learn more about Boehringer Ingelheim’s innovation in oncology here.

On October 14, 2020 Vericel Corporation (NASDAQ:VCEL), a leader in advanced therapies for the sports medicine and severe burn care markets, reported preliminary financial results for the quarter ended September 30, 2020 (Press release, Vericel, OCT 14, 2020, View Source [SID1234568468]).

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Preliminary total net revenues for the third quarter are expected to be approximately $32 million, including approximately $24.2 million of MACI (autologous cultured chondrocytes on porcine collagen membrane) net revenue, approximately $6.7 million of Epicel (cultured epidermal autografts) net revenue, and approximately $1.2 million of revenue related to the procurement of NexoBrid (concentrate of proteolytic enzymes enriched in bromelain) by the U.S. Biomedical Advanced Research and Development Authority (BARDA) for emergency response preparedness.

The company generated approximately $4.6 million of operating cash flow in the third quarter. As of September 30, 2020, the company had approximately $85.5 million in cash and investments and no debt, compared to $79.0 million as of December 31, 2019.

"We are very pleased with our third quarter results as we generated consistent double-digit growth in revenue, implants and biopsies for MACI and achieved a record monthly high for biopsies in September," said Nick Colangelo, President and CEO of Vericel. "Moreover, the robustness of our business model was demonstrated as we generated positive operating cash flow for the quarter. While considerable uncertainties related to COVID-19 remain, given the strength of our patient pipeline, we expect to maintain strong MACI growth in the fourth quarter. We look forward to providing further updates to investors during our upcoming virtual Analyst and Investor Day webcast and our third quarter earnings call."

As previously announced, the company will host a virtual Analyst and Investor Day on October 16, 2020, at 9:00am Eastern Time. The company also will host a webcast and conference call to discuss its third quarter 2020 financial results and business highlights on November 5, 2020, at 8:30am Eastern Time. Webcast information can be found on the events and presentation section of the Investor Relations website at View Source

On October 14, 2020 PierianDx, the leading clinical genomics informatics company, and Pillar Biosciences, a leading next-generation sequencing clinical oncology company, reported a partnership that enables Pillar Biosciences to sell directly the PierianDx clinical genomic report in combination with its cancer profiling assays (Press release, PierianDx, OCT 14, 2020, View Source [SID1234568467]). Under the agreement, PierianDx will integrate the Pillar Biosciences PiVAT bioinformatics pipeline in the PierianDx environment to provide users with an accelerated implementation, including assay-specific variant filters, to produce best-in-class clinical genomics reports and enable a complete sample-to-answer solution.

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Laboratories worldwide use Pillar Biosciences’ assays to detect pivotal genetic variants for cancer and other diseases. Pillar Biosciences’ targeted panels utilize a proprietary enrichment chemistry, SLIMamp, that enables rapid, automated amplification of overlapping amplicons in a single tube using minimal sample inputs. Pillar Biosciences’ complementary bioinformatics pipeline, PiVAT, is optimized for efficiency, reducing reflex testing and enabling low-frequency variant calling for every type of variant while consuming limited computing resources. PierianDx provides the Clinical Genomics Workspace, which consists of intuitive software and a robust clinical Knowledgebase that transforms variant information into a highly-structured and comprehensive physician-ready report.

Streamlining NGS along with clinical genomic interpretation and reporting, especially for sophisticated panels, remains time-consuming and challenging. By packaging the Pillar Biosciences panels with the PierianDx report, the result will be an out-of-the-box clinical genomic report that is optimized for each assay. Furthermore, the solution will be available to customers globally through secure, and in the case of European regions, Global Data Protection Regulation (GDPR)-compliant, cloud instances. As a result, laboratories and healthcare organizations worldwide will have a highly reliable method for providing these tests to enable precision diagnostics and treatments for their patients.

"The assays from Pillar Biosciences provide robust detection for all variant types in a simplified workflow," states Gang Song, PhD, CEO of Pillar Biosciences. "By optimizing variant filters and integrating with the PiVAT pipeline, PierianDx is streamlining interpretation and reporting, which adds substantial value for our customers."

Rakesh Nagarajan, MD, PhD and Founder and Chief Technical and Visionary Officer of PierianDx, adds, "We are thrilled to provide this support for the Pillar Biosciences assays. As the market shifts to more sensitive assays in the LDT space and leading assay manufacturers seek in vitro diagnostic (IVD) approval, we are committed to addressing challenges that arise from even greater complexity in the interpretation and reporting process."