On June 4, 2020 At the 2020 American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Virtual Annual Meeting, Noxopharm, a clinical-stage Australian oncology drug development company, has reported two sets of clinical data relating to the development of NOX66 (Veyonda) as a treatment for end-stage cancer (Press release, Noxopharm, JUN 4, 2020, View Source [SID1234560844]).

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The posters addressed how NOX66 may improve treatment responses in men with mCRPC and also its contribution to restoring sensitivity to apoptosis and potentially modulating the immune microenvironment of nasopharyngeal carcinoma (NPC).

"We have been unaware of any therapies under development that come close to offering an anticancer effect to anything like the same degree that we are seeing with Veyonda, and in particular, delivering this level of benefit in a well-tolerated, minimally invasive, and cost-effective manner," said Dr. Graham Kelly, Noxopharm CEO. "In the context of what has been reported at ASCO (Free ASCO Whitepaper) 2020, the high response rates we are seeing with Veyonda mark it as a major drug prospect."

An estimated 300,000 men die worldwide each year from prostate cancer after exhausting available treatment options. Add to that the generally high pain levels associated with the typical spread of prostate cancer to bone, and the need for a last-line treatment offering a meaningful effect once everything else has failed becomes compelling.

"This is an exciting outcome that supports our belief in the anticancer properties of Veyonda," Dr. Kelly said. "To our knowledge, this is the first time that anyone has been able to obtain a meaningful abscopal response rate in prostate cancer. Prostate cancer has developed a reputation as a cancer with poor immune responsiveness, but this data suggests that this isn’t the case. Today’s result positions Veyonda at the forefront of this emerging area of oncology and suggests that we have an exciting new prospective treatment for end-stage prostate cancer."

On June 4, 2020 PharmaEssentia Corporation (TPEx: 6446), a global biopharmaceutical innovator leveraging deep expertise and proven scientific principles to deliver new biologics in hematology and oncology, reported that the U.S. Food and Drug Administration (FDA) has recently accepted its Biologics License Application (BLA) for ropeginterferon alfa-2b (P1101), a novel pegylated interferon intended for the treatment of the rare blood cancer polycythemia vera (PV) in the absence of symptomatic splenomegaly (Press release, PharmaEssentia, JUN 4, 2020, View Source [SID1234560843]). The company expects an agency decision in early 2021.

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PharmaEssentia has focused its efforts on therapeutic innovation in the category of myeloproliferative neoplasms (MPNs), which are caused by specific genetic mutations that lead to overproduction of blood components including white or red blood cells, or platelets. In PV, which is caused by a JAK2 V617F mutation, the bone marrow produces excessive red blood cells, causing the blood to be thicker than normal and potentially leading to a range of complications.1,2 PV is estimated to affect more than 160,000 people in the U.S. alone,1 who have progressively burdensome symptoms. Without proper management, the disease progresses into malignancies including myelofibrosis and acute myeloid leukemia.3

Ropeginterferon alfa-2b was invented by scientists at PharmaEssentia in Taiwan and is a structurally novel monopegylated proline interferon designed for administration once every two weeks. The U.S. filing is supported by robust, durable 24-36-month data from the Phase 3 PROUD/CONTI-PV clinical trial, which demonstrated that the investigational treatment offered high and durable hematologic responses and symptom control with good tolerability and low rates of depression observed, with effects on relevant MPN mutations supporting a potential disease modifying capability.4

The findings were shown among patients who received either Ropeginterferon alfa-2b (n=95) or hydroxyurea/best available therapy (HU/BAT, n=74). At 36 months of treatment, patients who received Ropeginterferon alfa-2b maintained a complete hematological response longer than those who received HU/BAT (70.5% vs. 51.4%). Response rates steadily increased in the Ropeginterferon alfa-2b arm throughout 24 months of treatment and remained constant after 36 months. Further, after 36 months, two thirds (66.0%) of patients who received Ropeginterferon alfa-2b achieved a molecular response, compared with 27% in the HU/BAT arm. Importantly, these molecular responses were closely related to complete hematological responses. There were similar rates of adverse events in both arms; the most common (>10%) treatment-related adverse events included anemia, thrombocytopenia and leukopenia, which occurred more frequently under HU.4

"Our focus is on stunting these rare malignancies, preserving patient well-being and slowing the progression into more aggressive and deadly cancers," said Meredith Manning, U.S. General Manager for PharmaEssentia. "We believe Ropeginterferon alfa-2b could become an important new therapeutic tool and look forward to engaging with the regulators in our efforts to introduce this option to the underserved PV community in the U.S."

Ms. Manning was recently appointed to the U.S. GM role to guide the expansion of the company’s U.S. presence, with near-term focus on the commercial preparations for the first target indication in PV. Ms. Manning brings PharmaEssentia dynamic expertise in commercialization and market strategy. She joined from resTORbio, where she served as Chief Commercial Officer to define the corporate strategy and the commercial launch approach for an aging-related therapeutic.

About Ropeginterferon alfa-2b

Ropeginterferon alfa-2b is a novel, long-acting, mono-pegylated proline interferon that has been engineered with an optimized profile to support improved pharmacokinetic properties and demonstrated tolerability and convenience compared with conventional interferons. It is designed for administration once every two weeks, or once every four weeks during long-term maintenance. Ropeginterferon alfa-2b has Orphan Drug designation for treatment of polycythemia vera (PV) in the United States. Marketed as Besremi in Europe, the product was approved by the European Medicines Agency (EMA) in 2019. Ropeginterferon alfa-2b was discovered and is manufactured by PharmaEssentia in its Taichung plant, which was cGMP certified by TFDA in 2017 and by EMA in January 2018.

About Polycythemia Vera

Polycythemia Vera (PV) is a cancer originating from a disease-initiating stem cell in the bone marrow resulting in a chronic increase of red blood cells, white blood cells, and platelets. This condition may result in cardiovascular complications such as thrombosis and embolism, as well as transformation to secondary myelofibrosis or leukemia. While the molecular mechanism underlying PV is still subject of intense research, current results point to a set of acquired mutations, the most important being a mutant form of JAK2.3

On June 4, 2020 Immatics Biotechnologies GmbH, a clinical-stage biopharmaceutical company active in the discovery and development of T cell redirecting cancer immunotherapies, reported that Cedrik Britten, MD, has been appointed as Chief Medical Officer (CMO) effective June 1, 2020 (Press release, Immatics Biotechnologies, JUN 4, 2020, View Source [SID1234560841]). Trained as a physician, Cedrik Britten will join Immatics with more than a decade of experience in clinical development including his most recent position as Vice President and Head of the Oncology Cell Therapy Research Unit at GlaxoSmithKline. He will be responsible for the management and global development of Immatics’ clinical pipeline.

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In parallel, Carsten Reinhardt, MD, PhD, the current Chief Medical Officer at Immatics, will assume the newly created role as Chief Development Officer to lead Immatics’ product development strategy. Carsten will also continue to lead the TCR Bispecifics platform and pipeline and the Immunology and Translational Development functions at Immatics.

Stephen Eck, MD, PhD, the current Chief Medical Officer at Immatics US in Houston (TX), will step down and remain with the Company until the end of June to support the transition.

"We are excited about Cedrik joining Immatics. He has an extensive background in cell therapy, translational oncology and immunology as well as great experience in leading clinical and preclinical development programs in immuno-oncology. His appointment will complement Immatics’ existing strengths and capabilities as we continue the clinical development of our targeted immunotherapies with an emphasis on treating solid tumors through our two therapeutic modalities, Adoptive Cell Therapy and TCR Bispecifics," commented Harpreet Singh, PhD, Chief Executive Officer at Immatics. "Cedrik’s appointment enables Carsten to take on the leadership for Immatics’ product development strategy, as Chief Development Officer, as well as retain leadership of the very promising TCR Bispecifics platform and pipeline. We extend our thanks and gratitude to Stephen for his contributions to our success and wish him all the best for his future endeavors."

"Immatics is bringing together three synergizing core elements that attracted me: excellent science, powerful proprietary technology platforms for the discovery of relevant targets and T cell receptors tailored for use across a range of therapeutic modalities and a vibrant corporate culture focused on serving patients in need. These three cornerstones have enabled Immatics to reach a dynamic stage of growth with four ongoing clinical trials and a promising pipeline of several product candidates in development," added Cedrik Britten.

"Immatics will have significant new opportunities to exploit the full potential of its science and capabilities and I am very much looking forward to leading our future product development strategy to enable us to do so," commented Carsten Reinhardt. "Working together with a clinical leader of Cedrik’s caliber will benefit both the Company and, hopefully, also the patients in need of innovative and effective new treatments."

Cedrik Britten, MD, brings over ten years of experience in clinical and preclinical research as well as drug development in the field of immuno-oncology. He most recently served as Vice President and Head of the Oncology Cell Therapy Research Unit at GlaxoSmithKline in the United Kingdom, where he was responsible for the early cell therapy pipeline in Oncology R&D which included clinical development to proof-of-concept. In this role, he also established research and development teams and led the development of TCR-T as well as early-stage CAR-T programs. Prior to that, he held various senior positions at BioNTech including Vice President for R&D. During his time at BioNTech, he built and established clinical research teams, was responsible for early drug development and led clinical, as well as non-clinical, oncology development programs for personalized cancer immunotherapy products. Cedrik Britten graduated from the Johannes Gutenberg-University in Mainz, Germany, with both a medical and doctoral degree.

On June 4, 2020 Oragenics, Inc. (NYSE American: OGEN), reported that Alan Joslyn, Ph.D., President and CEO of Oragenics, Inc., will give a virtual corporate presentation at the June 2020 Virtual Summer Investor Summit taking place online from June 9th to 12th, 2020 (Press release, Oragenics, JUN 4, 2020, View Source [SID1234560840]).

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The presentation will be held on Wednesday, June 10, 2020 at 2:10 pm ET, followed by a live Q&A session with registered investors and other conference attendees. A live webcast of the presentation will be available here View Source Dr.. Joslyn will be available for one-on-one meetings online as well. Interested investors may request a meeting time by emailing: [email protected].

On June 1, 2020, Humanigen, Inc. (the "Company") reported that entered into a securities purchase agreement (the "Purchase Agreement") with certain accredited investors (the "Investors") to complete a private placement (the "Private Placement") of the Company’s common stock, par value $0.001 per share (the "Common Stock") (Filing, 8-K, Humanigen, JUN 1, 2020, View Source [SID1234560838]). The closing of the Private Placement occurred on June 2, 2020 (the "Closing Date"). At the closing, the Company issued and sold 82,528,718 shares of Common Stock (the "Shares") at a purchase price of $0.87 per share, for aggregate gross proceeds of approximately $71.8 million. The purchase price represented a 7% discount from the volume weighted average price of the Common Stock over the prior 20 trading days ending May 29, 2020. Effective upon completion of the Private Placement, the Company has an aggregate of 208,931,973 shares of Common Stock outstanding.

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On the Closing Date, the Company and the Investors also entered into a registration rights agreement (the "Registration Rights Agreement") pursuant to which the Company agreed to prepare and file a registration statement (the "Resale Registration Statement") for the resale of the Shares with the Securities and Exchange Commission (the "SEC"), within 10 business days of the Closing Date, and use reasonable best efforts to have the Resale Registration Statement declared effective by the SEC at the earliest possible date. Subject to certain limitations and an overall cap, the Company may be required to pay liquidated damages to the investors at a rate of 2% of the invested capital for each instance in which:

·The Company fails to make the initial filing of the Resale Registration Statement by June 16, 2020;
·
The Company fails to cause the Resale Registration Statement to be declared effective prior to the earlier of (i) three business days after the SEC informs the Company that no review of the Resale Registration Statement will be made or that the SEC has no further comments on the Resale Registration Statement (but subject to the last sentence of Section 9.7 of the Purchase Agreement), or (ii) July 2, 2020 (or August 31, 2020 if the Staff has informed the Company that it will be reviewing or monitoring the Resale Registration Statement); or

·The prospectus included in the Resale Registration Statement ceases to be available for use by the investors for more than 30 consecutive days or more than 50 days in any 12-month period.

The Purchase Agreement also provides that the Company will use its commercially reasonable efforts to achieve a listing of the Common Stock on a national securities exchange, subject to certain limitations set forth in the Purchase Agreement. The Company’s ability to obtain approval of the listing of the Common Stock on a national securities exchange will require the Company to satisfy a number of conditions, including the effectiveness of the Resale Registration Statement, the Company’s ability to obtain certain stockholder and third party consents and approvals, and the Company’s ability to meet certain listing criteria including a minimum stock price and total value of public float. Accordingly, the Company may not be able to achieve a listing of the Common Stock on a national securities exchange in any particular time frame or at all.