On December 26, 2019 Immunomedics, Inc. (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates, reported that the U.S. Food and Drug Administration (FDA) has accepted for filing the Company’s Biologics License Application (BLA) seeking accelerated approval of sacituzumab govitecan for the treatment of patients with metastatic triple-negative breast cancer (mTNBC) who have received at least two prior therapies for metastatic disease, as a complete class 2 response (Press release, Immunomedics, DEC 26, 2019, View Source [SID1234552610]). The PDUFA target action date of the resubmitted BLA is June 2, 2020.

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"We are pleased that the FDA has accepted our resubmission, which was a top priority for us in 2019," said Dr. Behzad Aghazadeh, executive chairman of Immunomedics. "We look forward to working closely with the FDA to facilitate their review of our BLA to enable us to bring this potentially transformational treatment to patients affected by mTNBC."

Sacituzumab govitecan has been awarded both Fast Track Designation and Breakthrough Therapy Designation by the FDA.

About Triple-Negative Breast Cancer (TNBC)

TNBC is an aggressive disease with an annual incidence estimated to be about 40,000 people, approximately 15% of all breast cancer types, in the United States alone. The incidence rate is higher among younger women and highest among non-Hispanic black and Hispanic women. TNBC tumors do not have sufficient estrogen, progesterone or HER2 receptor expression to indicate the use of hormonal or HER2-directed therapy. There is currently no standard-of-care chemotherapy for people with relapsed/refractory mTNBC. An overall response rate of about 10% and median progression-free survival of 2-3 months have recently been reported in late-stage mTNBC using single-agent chemotherapy.1,2

References

Cortés J, Lipatov O, Im S, et al. KEYNOTE-119: Phase 3 study of pembrolizumab (pembro) versus single-agent chemotherapy (chemo) for metastatic triple-negative breast cancer (mTNBC). Annals of Oncology (2019) 30 (suppl_5): v851-v934. 10.1093/annonc/mdz394

Kazmi, SM, Chatterjee D, Alexis K, et al. Real-World 1-Year Survival Analysis of Patients with Metastatic Breast Cancer with Liver or Lung Metastasis Treated with Eribulin, Gemcitabine or Capecitabine. Annals of Oncology (2019) 30 (suppl_5): v104-v142. 10.1093/annonc/mdz242
About Sacituzumab Govitecan

Sacituzumab govitecan, Immunomedics’ most advanced product candidate, is a novel, first-in-class ADC delivering SN-38, a potent topoisomerase I inhibitor, directly to tumor cells by targeting the Trop-2 antigen expressed by many solid cancers. It is currently under review by the U.S. Food and Drug Administration for accelerated approval as a treatment of patients with mTNBC who have received at least two prior therapies for metastatic disease. If approved, sacituzumab govitecan would be the first and only ADC approved for the treatment of mTNBC.

On December 26, 2019 Astellas Pharma Inc. (TSE: 4503, President and CEO: Kenji Yasukawa, Ph.D., "Astellas") and Xyphos Biosciences, Inc. (CEO: James Knighton, "Xyphos") reported that Astellas has acquired Xyphos. With the acquisition Astellas will gain Xyphos’ novel and proprietary ACCEL (Advanced Cellular Control through Engineered Ligands) technology platform, as well as industry-leading immuno-oncology talent, to develop new and potentially better ways to mobilize, target and control immune cells to find, modulate and destroy targeted cells throughout the body (Press release, Astellas, DEC 26, 2019, View Source [SID1234552608]).

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"At Astellas, immuno-oncology is a Primary Focus of our research and development strategy, and we are working on the development of next-generation cancer immuno-therapy using new modalities/technologies," said Kenji Yasukawa, President and CEO, Astellas. "The innovative technology in development at Xyphos fits perfectly in advancing our immuno-oncology strategy to create and deliver value for patients. Combining this technology with our capabilities in cell therapy that we have been working on so far, we can create next-generation high-function cells and maximize the value of our technology. We look forward to working with Xyphos’ superb team to advance and expand their clinical development programs to bring their novel therapeutics to patients."

Xyphos-Acquired

Xyphos-Acquired
"At Xyphos, we are driven to advance our innovative cell therapy technology platform as an exciting new approach to potentially manage and cure cancer," said James Knighton, Chief Executive Officer, Xyphos. "Astellas’ commitment to immuno-oncology makes them an ideal partner to advance our proprietary NKG2D-based NK-cell and T-cell platform to the next stage of clinical exploration. Further, we look forward to becoming part of Astellas to accelerate this immuno-oncology research and development in the vibrant South San Francisco community."

Xyphos has developed a flexible and versatile synthetic biology platform to direct cells of the immune system to target single or multiple tumor antigens while controlling the immune cell proliferation and endurance. Xyphos’s proprietary molecules can be delivered to natural immune cells or to engineered Chimeric Antigen Receptor (CAR) cells to generate immunotherapies for oncology. Xyphos’ patented CAR technology is based on an engineered modification to a natural human receptor named NKG2D. NKG2D exists on natural killer (NK) cells and some T-cells. The designed modification of NKG2D renders it inert, that is, unable to bind to any of its natural ligands, which occur on stressed cells. Through further protein engineering, several natural ligands of NKG2D have been modified to bind exclusively to the otherwise inert NKG2D receptor. Various functional molecules (for example, antibodies that recognize specific tumor antigens) are attached to the modified ligand. The ligand-directed functional molecules then bind exclusively to immune cells expressing the inert CAR on their surface – the proprietary convertibleCAR-cells. The CAR-cells can be directed by the ligand-bound antibody to seek, become activated and attacks a targeted cancer cell. Xyphos’ first convertibleCAR-T cell product candidate is in preclinical development and scheduled to be tested in a first-in-human clinical study in 2021.

Considering the acquisition, $ 120 million was paid upon closing of the acquisition, and Xyphos became a wholly owned subsidiary of Astellas. In addition to this payment and potential future development milestone payments, it will provide a total transaction value of $ 665 million.

The impact of this transaction on Astellas’ financial results in the fiscal year ending March 31, 2020 will be limited.

On December 26, 2019 Acorda Therapeutics, Inc. (Nasdaq: ACOR) ("Acorda" or the "Company") reported it has successfully completed its previously announced private exchange of $276 million aggregate principal amount of its 1.75% Convertible Senior Notes due June 2021 (the "Existing Convertible Notes") for a combination of approximately $207 million aggregate principal amount of newly issued 6.00% Convertible Senior Secured Notes due 2024 (the "New Convertible Secured Notes ") and $55.2 million in cash (Press release, Acorda Therapeutics, DEC 26, 2019, View Source [SID1234552607]). The initial conversion rate for the New Convertible Secured Notes is 285.7142 shares of the Company’s common stock per $1,000 principal amount of New Convertible Secured Notes, which is equivalent to an initial conversion price of approximately $3.50 per share, which represents a premium of approximately 97% above the Company’s closing stock price on December 20, 2019.

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"We have taken a significant step to strengthen our capital structure by refinancing approximately $276 million of our debt that matures in 2021 and replacing it with indebtedness that will not mature until December 2024," said Ron Cohen, M.D., Acorda’s President and Chief Executive Officer. "We structured the exchange to both address our near-term obligation and to preserve shareholder value through a substantial conversion premium. This now affords us the runway needed to drive the commercial success of INBRIJA, which addresses the critical unmet need of OFF periods in people living with Parkinson’s."

The Existing Convertible Notes received by the Company in the Exchange were cancelled in accordance with their terms. Accordingly, upon completion of the exchange, $69 million of Existing Convertible Notes remain outstanding.

The Company previously announced the terms of the New Convertible Secured Notes on December 23, 2019. The Company will file a Current Report on Form 8-K with the U.S. Securities and Exchange Commission on December 26, 2019, which will describe the exchange and the terms of the New Convertible Secured Notes, and include copies of the indenture and security agreement relating to the New Convertible Secured Notes.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company. The offer and sale of the New Convertible Secured Notes or the shares of common stock issuable upon their conversion have not been registered under the Securities Act of 1933 (the "Securities Act") or the securities laws of any other jurisdiction, and these securities may not be offered or sold in the United States absent registration or an applicable exemption from the Securities Act and applicable state laws.

J. Wood Capital Advisors LLC is acting as the Company’s financial advisor for the Exchange and Covington & Burling LLP is acting as the Company’s legal advisor.

On December 26, 2019 Chugai Pharmaceutical Co., Ltd. (TOKYO: 4519) reported that it obtained an approval for the expanded use of FoundationOne CDx Cancer Genomic Profile as a companion diagnostic for anti-cancer agent/tyrosine kinase inhibitor, Rozlytrek (generic name: entrectinib) for the treatment of ROS1 fusion-positive, locally advanced or metastatic non-small cell lung cancer (NSCLC) from the Ministry of Health, Labour and Welfare on December 25, 2019 (Press release, Chugai, DEC 26, 2019, View Source [SID1234552604]). The approval allows physicians to identify NSCLC patients who could benefit from Rozlytrek by detecting ROS1 fusion genes. Chugai filed an application for this additional indication of Rozlytrek for the treatment of ROS1 fusion-positive, locally advanced or metastatic NSCLC on March 15, 2019.

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"We are pleased that the FoundationOne CDx Cancer Genomic Profile is now approved as a companion diagnostic against ROS1 fusion gene, which is one of the driver mutations in NSCLC. Although the frequency of ROS1 fusion gene expression in NSCLC is only about 1 to 2%1), treatment using ROS1 inhibitors can become one of the important therapeutic options for patients with ROS1-positive cancer," said Dr. Minoru Watanabe, Chugai’s Vice President, Head of Foundation Medicine Unit. "I am convinced that comprehensive cancer genomic profiling can further contribute to patients by enhancing its companion diagnostic functions. We will further expand companion diagnostic functions for both our in-house products and collaborations with biopharma partners."

Developed by Foundation Medicine Inc., FoundationOne CDx Cancer Genomic Profile is a next-generation sequencing based in vitro diagnostic device for the detection of substitutions, insertion and deletion alterations, and copy number alterations in 324 genes and select gene rearrangements, as well as genomic signatures including microsatellite instability (MSI) and tumor mutational burden (TMB) using DNA isolated from formalin-fixed, paraffin-embedded (FFPE) tumor tissue specimens. The program is available as a companion diagnostic for multiple molecular-targeted drugs approved in Japan.

As a leading company in the field of oncology, Chugai is committed to realize advanced personalized oncology care and contribute to patients and healthcare professionals through improving access to comprehensive genomic profiling.

On December 24, 2019 CEL-SCI Corporation (NYSE American: CVM), a Phase 3 cancer immunotherapy company, reported the pricing of an underwritten public offering with gross proceeds to the Company expected to be approximately $5.5 million before deducting underwriting discounts and other estimated offering expenses (Press release, Cel-Sci, DEC 24, 2019, View Source [SID1234552602]). The proposed offering equates to 606,395 shares of the Company’s common stock at a price of $9.07 per share. The Company intends to use the net proceeds from this offering to fund the continued development of Multikine*, LEAPS and for other general corporate purposes.

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The Company has also granted the underwriters a 45-day option to purchase up to 90,959 additional shares of common stock to cover over-allotments at the public offering price. The offering is expected to close on or about December 27, 2019, subject to customary closing conditions.

Aegis Capital Corp. is acting as sole bookrunner for the offering. This offering is being made pursuant to an effective shelf registration statement on Form S-3 (No. 333-226558) previously filed with the U.S. Securities and Exchange Commission (the "SEC") and declared effective by the SEC on August 24, 2018. A final prospectus supplement and accompanying prospectus describing the terms of the proposed offering will be filed with the SEC and will be available on the SEC’s website located at View Source

Electronic copies of the final prospectus supplement and the accompanying prospectus, when available, may be obtained by contacting Aegis Capital Corp., Attention: Syndicate Department, 810 7th Avenue, 18th floor, New York, NY 10019, by email at [email protected], or by telephone at (212) 813-1010. Before investing in this offering, interested parties should read in their entirety the prospectus supplement and the accompanying prospectus and the other documents that the Company has filed with the SEC that are incorporated by reference in such prospectus supplement and the accompanying prospectus, which provide more information about the Company and such offering.

This press release shall 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.