On July 20, 2021 Immunicom, Inc., a clinical stage biotech, reported that shared preliminary data from its metastatic triple-negative breast cancer (mTNBC) clinical trial with its novel breakthrough Immunopheresis therapy at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting 2021 (Press release, Immunicom, JUL 20, 2021, View Source [SID1234584987]). Immunicom’s subtractive immunotherapies are designed to remove immune inhibitors and enhance patients natural immune response without compromising quality-of-life as is typically seen after treatment with chemo-/immuno-oncology agents. ASCO (Free ASCO Whitepaper)’s Annual Meeting is one of the world’s premier scientific gatherings of cancer specialists and researchers.

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Immunicom is investigating its FDA-designated breakthrough Immunopheresis therapy, which is a filtration-based subtractive treatment designed to capture sTNF-R proteins that are shed by cancer cells and inhibit a patient’s natural anti-tumor immune activity. Immunicom presented data for the second cohort of mTNBC patients treated with Immunopheresis in combination with weekly chemotherapy procedures (paclitaxel [60 mg/m2] plus carboplatin [AUC2] combination), which were found to be generally safe and provided early, promising signs of antitumor activity.

Immunicom previously presented data for the initial cohort of patients treated with Immunopheresis alone at AACR (Free AACR Whitepaper)’s Annual Meeting 2021, revealing an 80% decrease of the inhibitory sTNF-R proteins and observation of sustained quality-of-life while on therapy with minimal side effects (details here).

"The ASCO (Free ASCO Whitepaper) data expand on our breakthrough Immunopheresis therapy, specifically in combination with low-dose chemotherapy to demonstrate potential for synergistic and enhanced activity of sTNFR pulldown in late-stage patients who have failed multiple prior lines of therapy," said Dr. Robert Segal, Immunicom Chief Medical Officer. "The goal of halting disease progression and the potential of going into disease remission with this approach, where side-effects are minimal, has significant implications for the health and well-being of these patients with terminal disease. To be able to continue with normal daily activities, is in stark contrast to what these patients might normally experience if they choose to undergo a last-ditch treatment effort with yet another round of standard chemotherapy."

Immunicom’s abstract, "Extracorporeal pulldown of soluble TNFRs to unleash the activity of endogenous TNFα in chemorefractory triple-negative breast cancer patients – first-in-human experience" was published in ASCO (Free ASCO Whitepaper)’s June 2021 Journal of Clinical Oncology. The study’s principal investigator and lead author is Piotr Wysocki, MD, PhD, Department Head of Oncology at the Jagiellonian University – Medical College Hospital in Krakow, and President of the Polish Society of Clinical Oncology.

On July 20, 2021 Alexion reported with the exciting news that we have been acquired by AstraZeneca, a global, science-led biopharmaceutical company (Press release, Alexion, JUL 20, 2021, View Source [SID1234585003]). This development also marks the creation of Alexion, AstraZeneca Rare Disease.

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Alexion and AstraZeneca share a dedication to science, to innovation, and to delivering life-changing medicines to the patients who need them most. Together, we have the opportunity to add more value for more patients worldwide across a full-spectrum of care.

Alexion’s innovative complement-biology platforms and robust pipeline place AstraZeneca in a strong position for enhancing its scientific presence in the immunology sector. Most importantly, together we will be better positioned to ensure the ongoing discovery and development of medicines for rare diseases and devastating conditions.

Pascal Soriot, Chief Executive Officer of AstraZeneca, said: "Today we welcome our new colleagues from Alexion to AstraZeneca and begin a new chapter that will augment our growth for years to come. Our sustained R&D investment in oncology, cardiovascular and renal, as well as respiratory and immunology, has powered AstraZeneca’s transformation and now we add rare diseases, where fewer approved treatment options exist."

Marc Dunoyer, incoming Chief Executive Officer of Alexion and Chief Financial Officer, AstraZeneca said: "I am delighted to be working alongside my new colleagues at Alexion where we will continue to discover, develop and deliver medicines that change the lives of people suffering from rare diseases. We look forward to also applying Alexion’s complement-biology platform across areas of AstraZeneca’s broader early stage pipeline and, significantly, to the extraordinary opportunity to extend existing and future rare disease medicines to patients in many countries where AstraZeneca already has a strong presence."

On July 20, 2021 Junshi Biosciences (HKEX: 1877; SSE: 688180), a leading innovation-driven biopharmaceutical company dedicated to the discovery, development and commercialization of novel therapies, reported that the company has established a joint venture with Immorna, a fast-growing biotechnology company focusing on the process development and optimization of mRNA and delivery vehicles and the research and development of new nucleic acid drugs, to develop and commercialize new drugs for the global market in the fields of cancer, infectious diseases, rare diseases, and other diseases, based on the mRNA technology and other technology platforms (Press release, Shanghai Junshi Bioscience, JUL 20, 2021, View Source [SID1234585313]).

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Immorna’s unique mRNA construction and established versatile process platform are suitable for the development of self-replicating mRNA as well as conventional non-replicating mRNA products, enabling the construction of a customized form of mRNA molecule for a specific disease. In terms of delivery vehicles, Immorna has developed several nanoliposome particles (LNP) suitable for different administration methods and has technical capabilities in the field of research and development of new non-LNP delivery vehicles.

Under the terms of the agreement, Junshi Biosciences will inject at most 799 million RMB in cash into the joint venture. The initial investment is 200 million RMB, of which 50 million RMB will be used to subscribe to 50% of the registered capital of the joint venture. Immorna will invest in the joint venture company with intellectual property rights involved in the mRNA technology platform. The 50 million RMB in the estimated asset value of the platform will be used to subscribe to other 50% of the registered capital of the joint venture company.

"As the mRNA Technology Platform gradually matures, its potential in a variety of fields—including infectious diseases, cancer, rare diseases, and other diseases—has become increasingly evident," says Dr. Ning Li, Chief Executive Officer of Junshi Biosciences. "This is highly consistent with the therapeutic areas covered by Junshi Biosciences’ R&D pipeline and our desire to explore the next generation of innovative therapeutics. Immorna has a wealth of experience and expertise in mRNA industrialization. We look forward to working together to develop more revolutionary therapeutics for patients worldwide through our mRNA Technology Platform with domestic intellectual property rights and promote public health on a global scale."

"Immorna is very pleased to reach a strategic collaboration agreement with Junshi Biosciences, under which a joint venture company has been created," says Dr. Zihao Wang, Chief Executive Officer of Immorna Therapeutics. "We are very confident that this new entity will allow us to take advantage of each other’s core competency, quickly and efficiently utilize the versatile mRNA platform technology in immunotherapy and infectious disease prevention, and continue our search for new directions of the application."

On July 20, 2021 Imago BioSciences, Inc. ("Imago") (NASDAQ: IMGO), a clinical stage biopharmaceutical company discovering new medicines for the treatment of myeloproliferative neoplasms (MPNs), reported the closing of $134.4 million in gross proceeds from its previously announced initial public offering and $20.0 million in gross proceeds from its concurrent private placement (Press release, Imago BioSciences, JUL 20, 2021, View Source [SID1234584970]).

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The initial public offering of 8,400,000 shares of common stock at a public offering price of $16.00 per share resulted in aggregate gross proceeds to Imago of $134.4 million, before deducting underwriting discounts, commissions and offering expenses. All of the shares in the initial public offering were offered by Imago.

Imago’s common stock is now listed on The Nasdaq Global Select Market under the ticker symbol "IMGO".

Jefferies, Cowen, Stifel and Guggenheim Securities acted as joint book-running managers for the offering.

A registration statement relating to the securities has been filed with the Securities and Exchange Commission and became effective on July 15, 2021. The offering of these securities is being made only by means of a prospectus, copies of which may be obtained from: Jefferies LLC, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by email at [email protected] or by phone at 877-821-7388; or Cowen and Company, LLC, c/o Broadridge Financial Solutions, Attn: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at (833) 297-2926 or by email at [email protected]; or Stifel, Nicolaus & Company, Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, or by telephone at (415) 364-2720, or by email at [email protected]; or Guggenheim Securities, LLC, Attention: Equity Syndicate Department, 330 Madison Avenue, 8th Floor, New York, NY 10017, by telephone at (212) 518-9544 or by email at [email protected].

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

On July 20, 2021 Agilent Technologies Inc. (NYSE: A) reported that the company’s PD-L1 IHC 22C3 pharmDx assay is now labeled for expanded use in patients with non-small cell lung cancer (NSCLC) in the European Union (Press release, Agilent, JUL 20, 2021, View Source [SID1234584988]). PD-L1 IHC 22C3 pharmDx can now be used as an aid in identifying NSCLC patients with tumor PD-L1 expression of Tumor Proportion Score (TPS) ≥ 50% for treatment with Libtayo (cemiplimab). This announcement underscores Agilent’s continuing commitment to the development of IHC-based diagnostics for cancer therapy.

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"This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Lung cancer is the leading cause of cancer death overall and the 2nd most commonly diagnosed cancer in Europe.1 NSCLC makes up approximately 85% of all lung cancer cases.2 In Europe, the average five-year survival rate for lung cancer is less than 20%.3

"This expanded indication for PD-L1 IHC 22C3 pharmDx will enable pathologists in Europe to identify patients with NSCLC who may be eligible for treatment with Libtayo," said Sam Raha, president of Agilent’s Diagnostics and Genomics Group. "This further demonstrates Agilent’s commitment to partnering with leading pharmaceutical companies to develop IHC-based diagnostics for targeted cancer therapy."

Anti-PD-1 immunotherapies such as Libtayo offer new treatment options for patients with advanced NSCLC.4 Sanofi and Regeneron developed Libtayo and partnered with Agilent for the use of PD-L1 IHC 22C3 pharmDx to evaluate PD-L1 expression in patients in the pivotal EMPOWER-Lung 1 (Study 1624) clinical trial.4

Libtayo is a fully-human monoclonal antibody targeting the immune checkpoint receptor PD-1 on T-cells. By binding to PD-1, Libtayo has been shown to block cancer cells from using the PD-1 pathway to suppress T-cell activation.4