On March 2, 2021 Genmab A/S (Nasdaq: GMAB) reported that it will increase its share capital by 41,574 shares as a consequence of the exercise of employee warrants (Press release, Genmab, MAR 2, 2021, View Source [SID1234575928]).

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The increase is effected without any preemption rights for the existing shareholders of the company or others. The shares are subscribed in cash at the following price per share of nominally DKK 1:

600 shares at DKK 31.75,
21,690 shares at DKK 40.41,
125 shares at DKK 55.85,
300 shares at DKK 220.40,
1,000 shares at DKK 225.30,
73 shares at DKK 815.50,
3,563 shares at DKK 939.50,
10,005 shares at DKK 1,032.00,
250 shares at DKK 1,136.00,
3,176 shares at DKK 1,145.00,
300 shares at DKK 1,233.00,
367 shares at DKK 1,408.00,
85 shares at DKK 1,424.00, and
40 shares at DKK 1,432.00.

Proceeds to the company are approximately DKK 19.9 million. The increase corresponds to approximately 0.06% of the company’s share capital.

The new shares are ordinary shares without any special rights and are freely transferable negotiable instruments. The new shares give rights to dividends and other rights in relation to the company as of subscription, i.e. inter alia full rights to dividends for the financial year 2020. The new shares will be listed on Nasdaq Copenhagen after registration with the Danish Business Authority. The capital increase is expected to be finalized shortly.

Pursuant to section 32 of the Danish Capital Markets Act No. 1767 of November 27, 2020, it is hereby announced, that the total nominal value of Genmab A/S’ share capital after the capital increase is DKK 65,587,322 which is made up of 65,587,322 shares of a nominal value of DKK 1 each, corresponding to 65,587,322 votes.

On March 2, 2021 Vedanta Biosciences, a leading clinical-stage microbiome company developing a new category of oral therapies using rationally defined bacterial consortia manufactured from clonal cell banks, reported that members of its executive team will present and host one-on-one meetings at the following virtual investor conferences (Press release, Vedanta Biosciences, MAR 2, 2021, View Source [SID1234575927]):

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Chardan 3rd Annual Microbiome Medicines Summit

Date: Monday, March 8, 2021

Presentation Time: 2:00 PM ET

H.C. Wainwright Global Life Sciences Conference

Date: Tuesday, March 9, 2021

Presentation Time: 7:00 AM ET

Credit Suisse 2021 Healthcare Innovators Series: Life Sciences Private Company Event

Date: Thursday, March 11, 2021

Presentation Time: 12:20 PM ET

On March 2, 2021 Spectrum Pharmaceuticals (NasdaqGS: SPPI), a biopharmaceutical company focused on novel and targeted oncology therapies, reported results from Cohort 3 and initial twice daily (BID) dosing safety and efficacy data for poziotinib from Cohort 5 of the ZENITH20 clinical trial (Press release, Spectrum Pharmaceuticals, MAR 2, 2021, View Source [SID1234575926]). These preliminary data demonstrate improved tolerability with BID dosing, reduced dose interruption compared to once daily (QD) dosing, and a reduction in treatment emergent Grade 3 or higher adverse events. The preliminary data also suggest improved anti-tumor activity with 8mg BID dosing. The presentation is part of the European Society for Medical Oncology Targeted Anticancer Therapies (ESMO TAT) Virtual Congress 2021 being held March 1-2, 2021.

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"As predicted by the pharmacokinetic modeling, the 8mg BID arm is showing an improved therapeutic effect and a lowered adverse event rate in this early data," said Francois Lebel, M.D., Chief Medical Officer of Spectrum Pharmaceuticals. "The data build on the positive results we have reported for Cohort 2 which will be the basis for our NDA submission later this year. We look forward to reporting additional data at AACR (Free AACR Whitepaper) in April."

A copy of the ESMO (Free ESMO Whitepaper) presentation titled "Safety, tolerability and preliminary efficacy of poziotinib with twice daily strategy in EGFR/HER2 Exon 20 mutant non-small cell lung cancer" is available on Spectrum’s website at View Source

ZENITH20 Trial Design and Preliminary Safety and Efficacy Data for Cohort 5

Cohort 5 of the ZENITH20 trial includes previously treated NSCLC patients with EGFR or HER2 exon 20 insertion mutations. This cohort is investigating the efficacy of poziotinib with a BID dosing strategy. For the first 20 patients randomized to poziotinib 16 mg QD or 8 mg BID in Cohort 5, a trend towards improved responses was reported in the BID arm with 30% of patients reaching a partial response and two patients still too early to evaluate.

Improved tolerability was also observed, with a greater than 30% reduction in Grade 3 or higher adverse events for the BID arms relative to QD. In addition, there were 23% fewer dose interruptions for 8mg BID vs 16mg QD and 43% fewer dose interruptions for 6mg BID vs 12mg QD.

BID Dosing Exposure and Safety

While preliminary, these data support the hypothesis that BID dosing could improve the therapeutic effect for patients receiving poziotinib and result in better outcomes. Cohort 5 is continuing to enroll patients and a presentation of additional results is expected later this year at a medical conference.

About Poziotinib

Poziotinib is a novel, oral epidermal growth factor receptor tyrosine kinase inhibitor (EGFR TKI) that inhibits the tyrosine kinase activity of EGFR as well as HER2 and HER4. Importantly this, in turn, leads to the inhibition of the proliferation of tumor cells that overexpress these receptors. Mutations or overexpression/amplification of EGFR family receptors have been associated with a number of different cancers, including non-small cell lung cancer (NSCLC), breast cancer, and gastric cancer. The company holds an exclusive license from Hanmi Pharmaceuticals to develop, manufacture, and commercialize poziotinib worldwide, excluding Korea and China. Poziotinib is currently being investigated by the company and Hanmi in several mid-stage trials in multiple solid tumor indications.

On March 2, 2021 Presage Biosciences, Inc., a biotechnology company pioneering a new cancer drug development approach using its Comparative In Vivo Oncology (CIVO) intratumoral microdosing platform, reported the closing of a $13 million financing and commencement of new research collaborations with Merck, known as MSD outside of the United States and Canada, and Maverick Therapeutics (Press release, Presage Biosciences, MAR 2, 2021, View Source [SID1234575925]).

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The financing includes $7 million raised from new investors, including the LabCorp Venture Fund, Bristol Myers Squibb, and InHarv Partners Ltd. An additional $6 million convertible note from Takeda Ventures will convert to equity. The proceeds from this financing will support expansion of Presage’s existing network of clinical sites in the U.S. and Australia, as well as development of next-generation CIVO microdose injection devices designed to access a wider spectrum of cancers. Presage has pioneered a new approach to early evaluation of investigational cancer drugs and combinations in clinical trials with a technology that enables detailed assessment of multiple drugs simultaneously in patients with solid tumors. This investment brings the total equity raised by Presage to date to $35 million.

"At Labcorp, we recognize that the future of cancer drug development will rely heavily on clinically relevant and innovative data-driven approaches to early drug candidate assessment," said Dr. Steve Anderson, Chief Scientific Officer, Labcorp Drug Development. "Presage’s CIVO technology and unique approach to early anticancer drug evaluation represent a potential solution that typical preclinical models cannot address."

The research collaborations with Merck and Maverick will utilize CIVO to evaluate novel investigational oncology agents in Phase 0 trials, bringing the total number of partners utilizing Presage’s approach to early drug evaluation to five. Presage has ongoing collaborations with Takeda and other large pharmaceutical organizations for Phase 0 trials with CIVO.

"The tumor microenvironment presents complexities that cannot be modeled outside the context of the cancer patient. Presage’s technology may provide valuable insights as an analytical tool to investigate the activation of our novel, conditionally active T cell engager and subsequent modulation of immune and anti-tumor responses early on in the drug development process," said Jeremiah Degenhardt, PhD, Vice President, Translational Oncology & Bioinformatics, Maverick Therapeutics.

"It’s gratifying to have the support of venture investors to help expand the reach, capacity and applications of our CIVO platform," said Rich Klinghoffer, PhD, Presage CEO. "In addition, we are excited to collaborate with Merck and Maverick to help investigate the potential of CIVO to streamline their early drug development efforts. We remain committed to transforming translational oncology and are actively engaged with our pharma collaborators as we apply our approach to maximize their drug discovery and development efforts."

About CIVO and Phase 0 Trials
Comparative In Vivo Oncology (CIVO) is Presage’s patented platform that enables intratumoral microdosing and analysis of multiple cancer agents. Phase 0 trials, or Exploratory Investigational New Drug studies, allow for the evaluation of minute amounts of drugs in patients to assess pharmacodynamic effects. Presage is advancing the use of CIVO in Phase 0 trials in order to rapidly evaluate multiple drug candidates and enhance knowledge applicable for future trial design. A recently completed clinical trial demonstrated that CIVO is well tolerated and highlighted drug-specific tumor cell and microenvironment responses to both small molecule and biologic agents.

On May 2, 2021 Cytocom, Inc., a leading biopharmaceutical company creating second generation immune therapies, reported that Mike Handley, President and Chief Executive Officer, will present at the H.C. Wainwright Global Life Sciences Conference taking place March 9, 2021 to March 10, 2021 (Press release, Cytocom, MAR 2, 2021, https://www.cytocom.com/2021/03/02/cytocom-to-present-at-the-h-c-wainwright-global-life-sciences-conference/?utm_source=rss&utm_medium=rss&utm_campaign=cytocom-to-present-at-the-h-c-wainwright-global-life-sciences-conference [SID1234575924]). The presentation will be available on demand during the virtual event for all registered attendees.

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During the presentation, Mr. Handley will provide an overview of Cytocom’s business and recent corporate achievements, as well as the anticipated milestones in its clinical programs for COVID-19, pancreatic cancer, Crohn’s disease, fibromyalgia and multiple sclerosis.

Details of the events are as follows:

Event: H.C. Wainwright Global Life Sciences Conference
Date: Tuesday, March 9, 2021 to Wednesday, March 10, 2021
Time: Available on Demand
Registration: View Source

Members of the Cytocom’s management team will also be available to participate in virtual one-on-one meetings with investors who are registered to attend the conference. Following the conclusion of the event, a recording of Mr. Handley’s presentation will be available under "Recent Presentations" in the Investors section of the Company’s website at www.cytocom.com.