On April 6, 2021 OBI Pharma, Inc. (TPEx: 4174) reported the data highlighting the characteristics and antitumor efficacy of OBI-3424 and animal studies of OBI-998, as well as the T-cell inhibitory roles of Globo-H and SSEA-4 in the tumor microenvironment, will be presented at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting from April 10–15, 2021 (Press release, OBI Pharma, APR 6, 2021, View Source [SID1234577650]).

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OBI’s Chief Scientific Officer, Ming-Tain Lai, Ph. D stated that "OBI Pharma is proud to present at the AACR (Free AACR Whitepaper) Annual Meeting our latest findings on our Cancer portfolio products, OBI-3424 and OBI-998. OBI-3424’s impressive anti-AKR1C3 tumor activities in various cancer models, and enhanced efficacy when used in combination with standard-of-care chemotherapy. We are also excited to share, for the first-time, results from our early development program of OBI-998, an SSEA-4 antibody-drug conjugate." "Our research team have revealed interesting T-Cell inhibitory activities of Globo H and SSEA-4 in the tumor microenvironment. We will continue our investigation on the immunosuppressive activities of Globo H and SSEA-4, and the potential combination uses of anti-Globo H and Anti-SSEA-4 products with other cancer immunotherapeutic agents," added Dr. Lai.

The e-posters will be available for browsing at the virtual AACR (Free AACR Whitepaper) Annual Meeting from 8:30 a.m. ET on April 10–June 21 and on the OBI Pharma website (www.obipharma.com) on April 11.

Title: Selective and Broad Anti-tumor Activity of AKR1C3-activated Prodrug AST-3424/OBI-3424

Poster Number: 1220 / Abstract number: 1062

Authors: Fanying Meng 1, Wan-Fen Li 2, Donald Jung 1, Chun-Chung Wang 2, Tianyang Qi 1, Chi-Sheng Shia 2, Ren-Yu Hsu 2, Yin-Cheng Hsieh 2, Jianxin Duan 1.

(1) Ascentawits Pharmaceuticals, Ltd., Shenzhen, China.

(2) OBI Pharma, Inc., Taipei, Taiwan.

Title: Preclinical characterization of a novel SSEA4-targeting antibody drug conjugate, OBI-998

Poster number: 955 / Abstract number: 1238

Authors: I-Ju Chen, Chun-Chung Wang, Chi-Sheng Shia, Chung-Chen Su, Chi-Huan Lu, Hui-Wen Chang, Ping-Tzu Chiu, Yueh-Chin Wu, Ming-Tain Lai, Wei-Chien Tang, Hsin-Yi Tung, Ren-Yu Hsu.

(OBI Pharma, Inc., Taipei, Taiwan)

Title: Inhibitory activity of Globo-H and SSEA-4 on activated T cells

Poster number: 3176 / Abstract number: 1294

Authors: Tzer-Min Kuo, Chin-Chan Lee, Jiann-Shiun Lai, Chung-Chen Su and Ming-Tain Lai.

(OBI Pharma, Inc., Taipei, Taiwan)

About OBI-3424

OBI-3424 is a first-in-class novel small-molecule prodrug that selectively targets cancers overexpressing the enzyme aldo-keto reductase 1C3 (AKR1C3), and selectively releases a potent DNA alkylating agent in the presence of the AKR1C3 enzyme. This selective mode of activation distinguishes OBI-3424 from traditional alkylating agents, such as cyclophosphamide and ifosfamide, which are non-selective.

AKR1C3 overexpression has been documented in a number of treatment-resistant and difficult-to-treat cancers including hepatocellular carcinomas (HCC), castrate-resistant prostate cancer (CRPC), and T-cell acute lymphoblastic leukemia (T-ALL). AKR1C3 is highly expressed in up to 15 solid and liquid tumors.

Furthermore, individualized patient selection by staining for AKR1C3 overexpression by immunohistochemistry can be performed based on tumor biopsies or circulating tumor cells to identify patients with other tumor types most likely to respond to treatment with OBI-3424, and thus offering the possibility for a streamlined clinical development strategy.

About OBI-998

OBI-998 is a novel ADC comprising a humanized anti-SSEA4 antibody that is conjugated to the highly potent microtubule-disrupting agent monomethyl auristatin E (MMAE). It possesses desired properties such as high target specificity, rapid internalization, potent cytotoxicity, and significant bystander effects. OBI-998 showed high level of deposition and persistent presence of MMAE in tumors and significant anti-tumor efficacy in variety of animal models. OBI-998 is currently in preclinical research and development.

On April 6, 2021 Panbela Therapeutics, Inc. (Nasdaq: PBLA), a clinical stage biopharmaceutical company developing disruptive therapeutics for the treatment of patients with cancer reported that an abstract for SBP-101, a proprietary polyamine analogue, reported that it has been accepted for poster presentation at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which will be held virtually from June 4-8, 2021 (Press release, Panbela Therapeutics, APR 6, 2021, View Source [SID1234583756]).

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Details of the presentation are as follows:
Poster Presentation

Title: SBP-101, a polyamine metabolic inhibitor, administered in combination with gemcitabine and nab-paclitaxel, shows signals of efficacy as first-line treatment for subjects with metastatic pancreatic ductal adenocarcinoma.

Session Name: Poster Session: Gastrointestinal Cancer—Gastroesophageal, Pancreatic, and Hepatobiliary
Additional meeting information can be found on the ASCO (Free ASCO Whitepaper) website at View Source After presenting at ASCO (Free ASCO Whitepaper), the poster will be available on the Company’s website.

About SBP-101

SBP-101 is a proprietary polyamine analogue designed to induce polyamine metabolic inhibition (PMI) by exploiting an observed high affinity of the compound for pancreatic ductal adenocarcinoma and other tumors. The molecule has shown signals of tumor growth inhibition in clinical studies of US and Australian metastatic pancreatic cancer patients, suggesting potential complementary activity with an existing FDA-approved standard chemotherapy regimen. In data evaluated from clinical studies to date, SBP-101 has not shown exacerbation of bone marrow suppression and peripheral neuropathy, which can be chemotherapy-related adverse events. Recently observed serious visual adverse evets are being evaluated and the FDA has issued a partial clinical hold for the impacted study, pending Panbela’s evaluation and response. The safety data and PMI profile observed in the current Panbela sponsored current clinical trial generally provides potential support for continued evaluation of the compound in a randomized clinical trial, subject to Panbela’s submission of a complete response and the FDA’s removal of the partial clinical hold. For more information, please visit View Source .

On April 5, 2021 Invitae (NYSE: NVTA), a leading medical genetics company, reported it has entered into a definitive agreement to acquire Genosity Inc. ("Genosity"), a genomics company offering innovative software and laboratory solutions to enable development and deployment of complex sequencing based tests (Press release, Invitae, APR 5, 2021, View Source [SID1234577562]). The acquisition would bring Genosity’s specialized capabilities onto the Invitae platform to accelerate the time to market and decentralization of Invitae’s personalized oncology offerings, including somatic and germline offerings poised to help transform how cancer is diagnosed, treated and monitored.

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Invitae’s (NVTA) mission is to bring comprehensive genetic information into mainstream medical practice to improve the quality of healthcare for billions of people. www.invitae.com (PRNewsFoto/Invitae Corporation)

"Each individual cancer is unique. The way we diagnose and treat it must be as well," said Robert Nussbaum, M.D., chief medical officer of Invitae. "Our goal is to move as quickly as we can toward the day where each cancer patient receives timely, comprehensive genetic information that is used to guide their care from diagnosis to monitoring for disease recurrence. Together with Genosity, we believe our combined novel capabilities and capacity will help us reach that day sooner for patients around the globe."

Genosity has built an industry-leading suite of highly specialized capabilities designed to support the use of next generation sequencing in oncology development and clinical care, ranging from basic research to clinical testing for regulated studies. The company currently works with Invitae on a number of projects and clinical trials. Becoming a part of Invitae is expected to provide important advantages for the development and launch of Invitae’s oncology products, which include three devices under development that have received breakthrough device designation from the U.S. Food and Drug Administration (FDA), including the capacity, speed, and efficiency required to serve mainstream medicine cost effectively both with central laboratory services and decentralized kitted products.

"Genosity, under the insightful leadership of Marc Grodman, MD, has been able to develop solutions which enable broader adoption of genomic testing. Our laboratory services, end-to-end software solutions and data management platform are an ideal fit as Invitae develops best-in-class options for MRD-based cancer monitoring," said Robert D. Daber, Ph.D., president and chief technology officer of Genosity. "In Invitae we have found a like-minded partner focused on making genomics more affordable and accessible worldwide."

Maximum flexibility to accelerate the future of cancer care worldwide

Invitae is currently developing its Personalized Cancer MonitoringTM (PCM) platform as an in vitro diagnostic (IVD) intended for regulatory submission. PCM analyzes a patient’s unique genetic profile of their specific cancer and uses it to monitor their blood to detect cancer recurrence early when it is most curable. Invitae’s PCM test, if approved for use, will be augmented by Genosity technology and capabilities to distribute PCM globally, increasing accessibility and reducing turnaround time. With this capability, we believe Invitae will be uniquely able to meet the needs of cancer patients worldwide, whether their clinicians send out to a central testing service or rely on tests that are completed locally by in-house laboratories.

In January 2020, Invitae received Breakthrough Device Designation from the FDA for PCM.

Transaction Terms

Under the terms of the agreement, Invitae will acquire Genosity for approximately $200 million, consisting of (i) approximately $120 million in cash and (ii) approximately $80 million in shares of Invitae common stock (based upon a trailing average closing price prior to the date of closing but subject to certain potential adjustments), with such stock and cash consideration subject to reduction based upon certain debt and transaction expenses of Genosity determined at closing.

The transaction, which has been unanimously approved by the Boards of Directors of both companies, is expected to close in the second quarter, subject to customary closing conditions including the expiration or early termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976.

In connection with the transaction, Invitae will grant restricted stock units ("RSUs") having a value of up to $15 million to certain continuing employees of Genosity. These RSUs will be granted under Invitae’s 2015 Stock Incentive Plan (the "2015 Plan"), which is being amended to create an additional pool of shares of Invitae common stock to be used exclusively for the grant of inducement awards in compliance with New York Stock Exchange Rule 303A.08 ("Rule 303A.08"). These RSUs were approved by the Invitae Board of Directors and will be granted as an inducement material for continued employment following the acquisition of Genosity in reliance on the employment inducement exemption under Rule 303A.08. These RSUs will vest annually over three years and, in certain instances, the number of RSUs that vest on each vesting date will be calculated based upon a trailing average closing price prior to the date of closing of the Genosity acquisition.

Advisors

Cowen served as exclusive financial advisor to Genosity in connection with the acquisition.

Other Inducement Grants for Previous Transaction

Unrelated to the Genosity transaction, Invitae reported inducement grants in connection with the addition of certain assets and key personnel from a small organization called IntelliGene Health Informatics, LLC. which was focused on specialized software capabilities and technologies and will augment Invitae’s oncology offerings.

In connection with Invitae’s acquisition of assets from IntelliGene Health Informatics, LLC ("IntelliGene") for approximately $2.7 million, Invitae granted RSUs having a value of up to $6.225 million to certain employees and consultants of IntelliGene who continue as employees of Invitae. These RSUs were granted under the 2015 Plan, which was amended to provide for an additional pool of shares of Invitae’s common stock to be used exclusively for the grant of inducement awards in compliance with Rule 303A.08. These RSUs were approved by the Invitae Board of Directors and were granted as a material inducement for continued employment following the acquisition of assets from IntelliGene in reliance on the employment inducement exemption under NYSE Rule 303A.08. These RSUs vest in two installments at 12 months and 24 months following the acquisition of IntelliGene assets. The number of RSUs that vest on each vesting date will be calculated based on the volume-weighted average trading price of the company’s common stock on the NYSE for a trailing 20 trading day period prior to the grant date or, in certain situations, the vesting date.

On April 5, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported a poster presentation on safety and tolerability of twice daily administered poziotinib in patients with EGFR or HER2 exon 20 mutations (Press release, Spectrum Pharmaceuticals, APR 5, 2021, View Source [SID1234577580]). The company will also present a poster on the evaluation of same-day dosing of ROLONTIS (eflapegrastim) in neutropenic rats and patients with early-stage breast cancer. These poster presentations will be available at the American Association for Cancer Research (AACR) (Free AACR Whitepaper) Virtual Annual Meeting, taking place from April 10-15, 2021. Details of the presentations are as follows:

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Title: Poziotinib administered twice daily improves safety and tolerability in patients with EGFR or HER2 exon 20 mutations
Speaker: Xiuning Le, M.D., Ph.D.
Session: PO.CT02 – Phase 2 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT169

Title: Same-day administration of Eflapegrastim with chemotherapy enhances neutropenic recovery in neutropenic rats and in early-stage breast cancer patients
Speaker: John A. Barrett
Session: PO.CT01 – Phase 1 Clinical Trials
Date and Time: April 10, 2021 from 8:30 am – 11:59 pm ET
Presentation Number: CT116

The poster presentations will be available for viewing by registered participants during the conference via the AACR (Free AACR Whitepaper) website on April 10, 2021.

On April , 2021 MEI Pharma, Inc. (NASDAQ: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported its participation in the 20th Annual Needham Virtual Healthcare Conference (Press release, MEI Pharma, APR 5, 2021, View Source [SID1234577563]). MEI Pharma will present a company overview and business update on Monday, April 12, 2021 at 12:45 p.m. Eastern Time.

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A live webcast of the presentation can be accessed on the Events & Presentations page of the Investors section of MEI Pharma’s website at View Source An archived replay of the webcast will be available on MEI Pharma’s website for at least 30 days after the live event concludes.