Nordic Nanovector ASA publishes 2020 Annual Report

On March 29, 2021 the Board of Directors of Nordic Nanovector ASA reported that approved the Company’s financial statements for 2020 (Press release, Nordic Nanovector, MAR 29, 2021, View Source [SID1234577236]). The Company’s 2020 Annual Report is attached and available on Nordic Nanovector ASA’s website: www.nordicnanovector.com.

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Ikena Oncology Inc. Debuts on NASDAQ

On March 29, 2021 Ikena Oncology, Inc. (View Source Boston, MA, USA; CEO Mark Manfredi, Ikena Oncology) debuted as a public company, reported that listing its shares on the NASDAQ market on March 26, 2021 (Press release, AskAt, MAR 29, 2021, View Source [SID1234577230]). Ikena Oncology is currently developing AskAt’s EP4 antagonist, AAT-007, for immuno oncology therapy in the US. For further details, please see Ikena’s announcement (Ikena Oncology Public Offering).

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Henlius Plans to File the NDA of Novel anti-PD-1 mAb HLX10 for the Treatment of MSI-H Solid Tumours, the Phase 2 Clinical Trial has Met the Primary Endpoint

On March 28, 2021 Shanghai Henlius Biotech, Inc. (2696.HK) reported that the Phase 2 study of its innovative PD-1 inhibitor HLX10 in patients with unresectable or metastatic microsatellite instability-high or mismatch repair-deficient (MSI-H/dMMR) solid tumors that fail to respond to the standard therapy has met the primary endpoint (Press release, Henlius Biopharmaceuticals, MAR 28, 2021, View Source [SID1234577237]). Henlius plans to file a New Drug Application (NDA) to the National Drug Products Administration (NMPA) for the treatment of MSI-H solid tumours based on the results from the Phase 2 trial of HLX10, which will be presented at upcoming medical conferences. Professor Shukui Qin of No.81 Hospital of People’s Liberation Army and Professor Jin Li of Shanghai East Hospital affiliated to Shanghai Tongji University are co-leading principal investigators of this study.

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In accordance with precision medicine, MSI-H solid tumors cover a wide range of cancer types

The defect of mismatch repair (MMR) that can lead to base mismatch or insert in microsatellites during DNA replication, and the accumulation of incorrect bases usually causes microsatellite instability (MSI)[1]. MSI-H often occurs in several cancer types, such as endometrial cancer, colorectal cancer, gastric cancer, renal cell carcinoma, ovarian cancer, etc[2]. Studies have revealed that the prevalence of MSI-H across all tumor types is 14%[3]. Patients who suffer from this disease usually have higher response rates for immune checkpoint inhibitors[4-5]. Thus, MSI-H is becoming a more and more important biomarker for the immunotherapy predictions of patients with solid tumors. If the patient is MSI-H positive and meets the treatment criteria, the corresponding immunotherapy can be carried out without screening tumor sites and pathological classification, which aligns with the advanced concept of precision medicine and is applicable to a wide range of cancer types.

Currently, the U.S. Food and Drug Administration (US FDA) has approved PD-1 target mAb for the treatment of second-line MSI-H/dMMR advanced solid tumors and first/second-line MSI-H/dMMR colorectal cancers. While there are still no anti-PD-1 mAb approved for MSI-H/dMMR advanced solid tumors in China, the treatment needs are far from being met.

Excellent clinical study results lay the foundation for submitting HLX10 NDA

HLX10, a novel recombinant humanised anti-programmed cell death protein 1 (PD-1) mAb independently developed by Henlius, has the potential to treat a variety of solid tumours. HLX10 has exhibited better pharmacokinetics, pharmacodynamics properties, favourable safety, tolerability profile and anti-tumor activity in preclinical and early clinical research studies. This study is a single-arm, open-label, multi-centre, Phase 2 study, aimed to evaluate the efficacy, safety and tolerability of HLX10 in patients with unresectable or metastatic MSI-H/dMMR solid tumuors that fail to respond to the standard therapy. The primary efficacy endpoint was objective response rate (ORR) assessed by independent radiological review committee (IRRC) per RECIST v1.1. Secondary endpoints included ORR assessed by investigators, duration of response (DoR), progression-free survival (PFS), overall survival (OS), safety and tolerability. The results of this clinical study demonstrated the good efficacy and safety of HLX10 in this class of indications.

Multiple major cancer types clinical trials on fast track with forward-looking global layout

Henlius has adopted a differentiated "Combo+Global" strategy on HLX10, pioneering the combination immunotherapy. Currently, HLX10 has been approved for clinical trials in China, the United States, the European Union and other countries and regions. A total of 10 immuo-oncology therapies clinical trials of HLX10 are ongoing to evaluate its safety and efficacy in a wide variety of solid tumors that cover MSI-H solid tumours, lung cancer (LC), hepatocellular carcinoma (HCC), esophageal carcinoma (EC), head and neck squamous cell carcinoma (HNSCC) and gastric cancer (GC) etc., including three Phase 3 global multi-centre clinical trials in squamous non-small cell lung cancer (sqNSCLC), extensive-stage small cell lung cancer (ES-SCLC) and neo-/adjuvant treatment for GC. It is worth mentioning that, the NDA filing of HLX10 in combination with chemotherapy for the first-line treatment of sqNSCLC in China will also be expected in the second half of 2021.

Apart from conducting international trials of HLX10, Henlius also actively seeks for international cooperation opportunities with the aim to benefit more patients in the world, especially patients in emerging markets. Henlius has reached a collaboration agreement with PT Kalbe Genexine Biologics (KG Bio), upon which KG Bio is granted exclusive rights to develop and commercialize HLX10 in relation to its first monotherapy and two combination therapies in 10 Southeast Asian countries.

AVEO Announces Closing of Public Offering of Common Stock and Full Exercise of Option to Purchase Additional Shares

On March 26, 2021 AVEO Oncology (Nasdaq: AVEO) reported the closing of its previously announced underwritten public offering of 6,900,000 shares of its common stock, which includes the full exercise by the underwriters of their option to purchase an additional 900,000 shares, at a price to the public of $8.00 per share (Press release, AVEO, MAR 26, 2021, View Source [SID1234577235]). The aggregate gross proceeds to AVEO from the offering were $55.2 million, before deducting underwriting discounts and commissions and offering expenses payable by AVEO.

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The net proceeds of the offering are expected to be used for working capital and general corporate purposes, including to support commercialization activities relating to FOTIVDA (tivozanib) and to advance AVEO’s pipeline.

SVB Leerink and Stifel acted as joint bookrunning managers for the offering. Baird acted as lead manager for the offering. H.C. Wainwright & Co. and JonesTrading acted as co-managers for the offering.

The shares were offered by AVEO pursuant to a shelf registration statement on Form S-3 that was filed with the Securities and Exchange Commission ("SEC") on November 9, 2020 and declared effective by the SEC on November 18, 2020.

A final prospectus supplement relating to, and describing the terms of, the offering has been filed with the SEC and is available on the SEC’s website at www.sec.gov.

Copies of the final prospectus supplement and the accompanying prospectus relating to this offering may also be obtained from SVB Leerink LLC, Attention: Syndicate Department, One Federal Street, 37th Floor, Boston, MA 02110, by telephone at (800) 808-7525, ext. 6105 or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at (415) 364-2720 or by email at [email protected].

This press release does not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Oncology Investors to Hear “Cancer Device Company of the Year” Immunicom Present at MedInvest Conference

On March 26, 2021 Immunicom, Inc., a global biotechnology company pioneering novel "subtractive" immunotherapies, reported CEO Amir Jafri will speak at MedInvest’s 2021 Oncology Investors Conference on March 29 at 12:30 PM. Immunicom was recently named MedInvest’s "Cancer Device Company of the Year – 2021", and Jafri will discuss the unique platform-based vision driving the many such accolades Immunicom’s FDA Breakthrough Device has garnered, and the distinct advantages the platform has over drug-based therapies (Press release, Immunicom, MAR 26, 2021, View Source [SID1234577234]).

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Jafri’s presentation, titled "A New Era in Cancer Care," will speak to the current industry shortcomings and Immunicom’s solution strategy.

"The consequence of the current drug-centric standard of care is the toxicity patients suffer from round after round of drug combinations, which cancers often build resistance to," Jafri said. "So instead of adding substances into the body, our therapy is subtractive – we remove immune inhibitors. These investors eagerly attend these conferences because they know how much room there is for improvement and they’re all looking for what’s next."

Jafri’s confidence in a strategy that is a literal inversion of convention is evident – after founding the company in 2013, he immediately targeted the most difficult advanced cancers to treat, and his three clinical trials underway recruited metastatic patients who had failed multiple rounds of standard therapies. One of those trials resulted in a CE Mark to reduce the immune system inhibitors, sTNFRs, addressing an unmet medical need in triple negative breast cancer patients with advanced refractory metastatic disease, showing improvement in the quality of life, and potential for extension of life, and disease stabilization in these end-of-life patients.

"There are reasons why MedInvest named us ‘Cancer Device Company of the Year 2021’ and is featuring this presentation," Jafri said. "They want to introduce investors to tomorrow’s therapies so tomorrow is better than today."

The conference has the potential, indeed, to enable next generation treatments. Sponsored by the National Foundation for Cancer, it is attended by over 200 of the largest and most serious oncology investors, spanning venture, public funds, foundations, family offices, angels, and government grant making entities. MedInvest presenters represent the industry’s most elite and promising from startups, early pre-clinical through clinical, and public and private companies worldwide.

Jafri’s presentation will follow a keynote address by 2018 Nobel Laureate Dr. Jim Allison, whose work led to development of the first immune checkpoint inhibitor drug Ipilimumab, which was approved for late-stage melanoma by the U.S. Food and Drug Administration in 2011.

Jafri’s presentation will be available on Immunicom’s website on April 2nd. See View Source

Subtractive Therapy – ImmunopheresisTM and the LW-02 Column

Immunicom’s innovative Immunopheresis approach uses the LW-02 column to extract specific immune-suppressive cytokines produced by cancer tumors. Selective removal of these targeted cytokines is intended to neutralize cancer’s ability to block a patient’s natural immune defense mechanisms which are significantly compromised in late-stage, metastatic disease and thereby "re-energizes the immune system to aggressively fight cancer." Immunopheresis is a "subtractive therapy", in contrast to drugs that are "additive", subtractive therapy is meant to avoid the side effects, toxicity and negative impact on a patient’s quality of life typical of other cancer treatments.

Immunicom believes that the LW-02 column could be used either in combination with other therapies or as a stand-alone treatment. The LW-02 Immunopheresis column has already received Breakthrough Device Designation for stage IV metastatic cancers from the U.S. Food and Drug Administration (FDA). Immunicom has obtained ISO 13485 certification for its manufacturing and related quality systems.

The LW-02 Immunopheresis column is currently being evaluated in several global oncology trials for multiple cancers, including TNBC, non-small cell lung cancer (NSCLC), metastatic melanoma and renal cell carcinoma. It is being investigated both as a monotherapy and in combination with low-dose metronomic chemotherapy and the well-known immunotherapy checkpoint inhibitors Opdivo (Bristol-Myers Squibb) and Tecentriq (Roche). These trials are being conducted in collaboration with world-renowned research organizations and thought leaders including:

Poland – at Jagiellonian University of Krakow Hospital, under the direction of Principal Investigator, Professor Piotr Wysocki, MD, PhD; and

Israel – at Sheba Medical Center’s Ella Lemelbaum Institute for Immuno-Oncology (Tel Aviv), under the direction of Dr. Ronnie Shapira, MD and Prof. Gal Markel, MD, PhD; and

Turkey – at Acıbadem Altunizade Hospital (Istanbul), a member of the Acıbadem/IHH Healthcare Group, under the direction of Principal Investigator, Prof. Dr. Gokhan Demir, MD, PhD.

For an overview of how Immunopheresis breakthrough technology works, watch Immunicom’s How it Works video.

Immunopheresis and the LW-02 column is considered an investigational therapy by the U.S. FDA and other regulatory authorities. The clinical efficacy of the LW-02 column has not yet been demonstrated. Clinical investigations evaluating the clinical efficacy of the LW-02 column for TNBC are ongoing.