On November 18, 2020 Halozyme Therapeutics, Inc. (NASDAQ: HALO) reported that Dr. Helen Torley, president and chief executive officer, will participate in a fireside chat presentation for the Piper Sandler 32nd Annual Virtual Healthcare Conference. The virtual conference will be held from December 1-3, 2020 (Press release, Halozyme, NOV 18, 2020, View Source [SID1234571331]).

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The pre-recorded fireside chat will be available online Wednesday, November 25 in the investor relations section of the company’s website at View Source

On November 18, 2020 Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the "Company"), a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery, reported the publication of an abstract at the San Antonio Breast Cancer Symposium (SABCS) (Press release, Greenwich LifeSciences, NOV 18, 2020, View Source [SID1234571360]). The abstract will be displayed as a poster on Wednesday, December 9, 2020 in a virtual format.

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The study met all of its clinical endpoints for HER2/neu 3+ patients, concluding that the first 6 intradermal injections of GP2+GM-CSF safely elicited a potent immune response and reduced recurrence rates to 0% in HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery, and this reduction of recurrence rate was maintained over the gold standard of 5 years of follow-up. A pivotal Phase III trial is being initiated to treat HER2/neu 3+ patients in the neoadjuvant setting. GP2 may also be effective when used in parallel to trastuzumab based therapeutics or in combination with trastuzumab based therapeutics in HER2/neu 1-2+ or other HER2/neu expressing cancers.

Snehal Patel, CEO of Greenwich LifeSciences, commented, "Approximately 50% of recurring patients do not respond to Herceptin or Kadcyla and still recur with metastatic breast cancer and a poor prognosis, where approximately 80-85% of recurring patients do not survive."

"The publication of this abstract shows that we met all of the endpoints for our Phase IIb clinical trial for HER2/neu 3+ patients, including safety, where no serious adverse events were observed. By substantially reducing the recurrence rate of the non-responders, we are addressing a large unmet need of women. If we are successful in reproducing our Phase IIb clinical trial data in a Phase III clinical trial, we could make a major impact in reducing metastatic breast cancer recurrence in this patient population, potentially saving thousands of lives per year. We are excited to begin our Phase III clinical trial."

"Based on our analysis of the potential market in our IPO prospectus, GP2 could initially treat 17,000 newly diagnosed patients per year in the US or approximately 50% of the Herceptin adjuvant market of $2-3 billion, and could expand to 2.4x that of the Herceptin market through additional Phase II trials and indications, reaching a potential peak revenue exceeding $5 billion. Not included in these estimates are the 3 million breast cancer survivors in the US of whom 25% are HER2/neu 3+. These survivors could also be candidates for a safe and effective preventative therapy," Patel concluded.

The abstract highlights the final 5 year follow-up efficacy and demographic data across all patient populations from the completed prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb clinical trial evaluating the reduction of recurrences. The poster presentation includes the disease-free survival curves for both HER2/neu 3+ and HER2/neu 1-2+ patient populations, including the demographics for stage of cancer, hormone receptor status, node status, and prior treatment with chemotherapy, radiation, endocrine therapy, or trastuzumab.

This 168 patient (ITT: n=180) basket trial across 16 clinical sites explored 96 HER2/neu 3+ patients, who received a standard course of trastuzumab after surgery and subsequently completed the first 6 intradermal injections or placebo, starting GP2 treatment at median 17.1 months after surgery, and 72 HER2/neu 1-2+ patients, who did not receive trastuzumab after surgery and subsequently completed the first 6 intradermal injections or placebo, starting the GP2 treatment at median 10.8 months after surgery.

Since GP2 is synergistic with trastuzumab, and the HER2/neu 1-2+ patients did not receive trastuzumab, it was prespecified to compare recurrence rates ITT versus per protocol in these 2 distinct, independently reported populations, excluding those patients who did not complete the first 6 intradermal injections. GP2 was shown to be well tolerated with no SAEs and elicited a potent immune response measured by local skin tests and immunological assays, which suggest peak immunity is reached at 6 months upon completion of the first 6 intradermal injections.

After 5 years of follow-up, the Kaplan-Meier estimated 5-year DFS rate in the 46 HER2/neu 3+ patients treated with GP2+GM-CSF, if the patient completed the first 6 intradermal injections, was 100% versus 89.4% (95% CI:76.2, 95.5%) in the 50 placebo patients treated with GM-CSF (p = 0.0338). The treated versus placebo HER2/neu 3+ patients were well-matched, where approximately 53% were stage T1, 41% were stages T2-T4, 55% were node positive, 58% were HR positive and received endocrine therapy, 77% received adjuvant radiation, 77% received adjuvant chemotherapy, and 89% received trastuzumab. There was no benefit to GP2 treatment in the HER2/neu 1-2+ patients where trastuzumab was not administered.

Abstract PS10-23 is entitled: Five year median follow-up data from a prospective, randomized, placebo-controlled, single-blinded, multicenter, Phase IIb study evaluating the reduction of recurrences using HER2/neu peptide GP2 + GM-CSF vs. GM-CSF alone after adjuvant trastuzumab in HER2/neu positive women with operable breast cancer. The full abstract can be viewed here on page 654.

About SABCS

The 43rd annual SABCS has grown to be the industry’s premier breast cancer conference for basic, translational, and clinical cancer research professionals. It is well-known for presenting the latest breast cancer data from all over the world. More than 7,500 health care professionals from more than 90 countries attend annually. Baylor College of Medicine became a joint sponsor of SABCS in 2005. The Cancer Therapy & Research Center at UT Health Science Center San Antonio and American Association for Cancer Research (AACR) (Free AACR Whitepaper) began collaborations with SABCS in 2007. For more information, please visit the conference website at: View Source

About Breast Cancer and HER2/neu Positivity

One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 266,000 new breast cancer patients and 3.1 million breast cancer survivors in 2018. HER2/neu (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.

On November 18, 2020 Enosi Life Sciences Corp. ("Enosi" or the "Company"), a drug research and development company focused on providing industry-leading therapeutics for autoimmune disease, cancer, and acute inflammation, reported it has filed a patent for its proprietary molecules (Press release, Enosi Life Sciences, NOV 18, 2020, View Source [SID1234572277]). These include EN1001 for autoimmune disease; EN2001 for autoimmune disease and cancer; and EN3001 for autoimmune disease and cancer.

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The EN1001 molecule blocks Tumor Necrosis Factor Receptor-1 (TNFR1), which is a principal culprit in autoimmune disease, acute inflammation and has a role in cancer. EN1001 will be a significant enhancement compared to existing TNF-blocking technologies which inhibit both TNFR1 and TNFR2, which have limited efficacy as a result of co-inhibition of the naturally anti-inflammatory TNFR2.

Enosi’s EN2001 molecule offers a completely different option for the treatment of rheumatoid arthritis. Inflammatory EGF-like growth factors stimulate the growth of the pannus, a tumor-like structure in a Rheumatoid Arthritis (RA) joint which contains cells that produce tumor necrosis factor (TNF) and other destructive cytokines. Enosi has shown that its lead molecule (EN2001), which traps these growth factors, can prevent tissue destruction by inhibiting the growth of cells that form the pannus. This is a new mechanism of action for autoimmune disease drugs. Since Enosi’s growth factor trap is not expected to have adverse immunosuppressive activity, it can be combined with other RA therapeutics without fear of increasing immunosuppression. This is important because all of the approved RA therapies are immunosuppressive and make the patient susceptible to infection, cancer and even cardiovascular problems. Its ability to inhibit the proliferation of diseased cells may allow Enosi’s growth factor trap EN2001 to also be useful in the treatment of solid tumors.

For cancer and fibrotic diseases where TNFR2 is a "bad actor" instead of a "good actor," Enosi’s proprietary EN3001 molecule will counter TNFR2 activation. The function of TNFR2 is to protect the body from the effects of inflammation, but too much TNFR2 occurs in tumors and leads to inactivation of immunity against cancer. TNFR2 does this by inducing the proliferation of regulatory T cells that suppress the immune response. Thus, EN3001 will act like a checkpoint inhibitor by increasing immunity, which will be particularly useful in the treatment of cancer.

Each Enosi therapeutic will offer use in multiple diseases. EN1001 will be tested in RA and a number of autoimmune diseases, however, research has shown that TNF-mediated inflammation is important in other diseases as well, ranging from acute inflammation associated with viral infections like COVID-19, to endometriosis and Alzheimer’s disease. These three therapeutics from Enosi; EN1001, EN2001 and EN3001 are still in development and are at least five years away from clinical trials.

The market for TNF inhibitor drugs is expected to reach $43 billion by 2023, and $115 billion by 2026. To capitalize on this high growth industry and meet a wide and unmet demand, Enosi Life Sciences recently announced its Regulation D offering, enabling investors the opportunity to invest in next generation therapeutics for autoimmune disease and cancer.

"The filing of this patent represents a key milestone for Enosi as we seek to firmly communicate our targeted therapeutic pipeline to potential partners, industry professionals and of course, the broader investment community," said Dr. H. Michael Shepard, President, CSO and CEO of Enosi Life Sciences. "Enosi is derived from the Greek word for combinations, and we are following that philosophy. The combination of Dr. Feldmann’s experience in autoimmune diseases and my experience with antibody therapies for cancer, together with Dr. Jim Woody’s experience in management and fundraising bring a depth of knowledge to our endeavor. In addition, the candidate therapeutics we discover will likely be useful for a combination of different diseases." We believe our unique, proprietary approach represents significant potential once commercialized, and we look forward to continued updates regarding its development."

Capital raised through the Regulation D 506(c) offering, and potentially a future Regulation A+ financing, will support Enosi’s efforts to progress the Company’s molecules that target autoimmune disease, cancer and acute inflammation toward clinical trials.

On November 18, 2020 AbbVie Inc. (NYSE:ABBV) ("AbbVie") reported the expiration and final results of its offers to exchange (the "Registered Exchange Offers") any and all of its outstanding (i) $30,000,000,000 aggregate principal amount of senior unsecured notes previously issued on November 21, 2019 (the "2019 USD Notes"), (ii) $13,251,781,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "2020 USD Notes" and, together with the 2019 USD Notes, the "USD Notes") and (iii) €2,517,066,000 aggregate principal amount of senior unsecured notes previously issued on May 14, 2020 (the "Euro Notes" and, together with the USD Notes, the "Original Notes"), each issued pursuant to an exemption from the registration requirements of the Securities Act of 1933, as amended (the "Securities Act"), for an equal principal amount of new notes in a transaction registered under the Securities Act (the "Registered Notes") (Press release, AbbVie, NOV 18, 2020, View Source [SID1234571333]).

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The Registered Exchange Offer expired at 5:00 p.m., New York City time, on November 17, 2020 (the "Expiration Date"). As of the Expiration Date, the aggregate principal amounts of Original Notes set forth in the table below had been validly tendered and not validly withdrawn. AbbVie has accepted for exchange all such tendered Original Notes in the Registered Exchange Offers.

Upon the settlement of the Registered Exchange Offers, holders of Original Notes who validly tendered and did not validly withdraw such Original Notes prior to the Expiration Date will receive a like principal amount of Registered Notes of the applicable series. AbbVie expects that such settlement will occur on or about November 19, 2020.

The terms of the Registered Notes to be issued in the Registered Exchange Offers are substantially identical to the terms of the corresponding series of Original Notes, except that the offering of the Registered Notes will be registered under the Securities Act and the transfer restrictions, registration rights and additional interest provisions applicable to the Original Notes will not apply to the Registered Notes. AbbVie will issue the Registered Notes under the same indentures that govern the applicable series of Original Notes. The Registered Exchange Offers do not represent a new financing transaction.

A Registration Statement on Form S-4 (File No. 333-249277) (the "Registration Statement") relating to the Registered Exchange Offers was filed with the Securities and Exchange Commission on October 2, 2020 and was declared effective on October 16, 2020. The Registered Exchange Offers were made pursuant to the terms and subject to the conditions set forth in a prospectus dated October 19, 2020 (as the same may be amended or supplemented, the "Prospectus"), which has been filed with the Securities and Exchange Commission and forms a part of the Registration Statement.

This press release is not an offer to sell or exchange or a solicitation of an offer to buy or exchange any of the securities described herein.

On November 18, 2020 Ultivue and Indivumed reported that the two companies have entered into a collaborative partnership to further accelerate research and drug development in the area of personalized oncology (Press release, Ultivue, NOV 18, 2020, View Source [SID1234571361]).

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The deal links Indivumed’s vast array of standardized and fully comparable tissue biospecimens and analytical experience in IHC technology with Ultivue’s InSituPlex platform for high-throughput multiplex immunofluorescence. Ultivue’s standardized assay development for whole tissue phenotyping, when combined with Indivumed’s multi-omics oncology tissue biobank and capabilities to perform IHC multiplex assays, will enable deeper insights into tumor biology, unveiling complex mechanisms of cancer.

"By bringing Ultivue’s technology and expertise into our workflow, we’re giving our customers access to the contextual profiling of key cellular phenotypes," says Prof. Dr. Hartmut Juhl, founder and CEO of Indivumed. "The data that can now be extracted from these valuable assets in our repository can support the full characterization of samples for biomarker and target discovery, drug development, clinical trials, and individualized therapy research. It will complete our offer in combination with the existing broad menu of IHC assays and end-to-end service"

Cambridge-based UItivue’s InSituPlex multiplexing technology is designed for fast and comprehensive exploration of biologically-relevant markers in tissue samples.

"InSituPlex is built to derive more biologically-relevant data from patient tissue samples at scale," notes Jacques Corriveau, President and CEO of Ultivue. "By providing Indivumed with this capability and complementing its extensive biospecimen resources, we can enable researchers to rapidly assess the clinical utility of tissue biomarkers to increase the success of clinical trials in the I/O space."