On March 27, 2020 Alphamab Oncology (stock code: 9966HK) reported that Jiangsu Alphamab Biopharmaceuticals Co., Ltd. ("Jiangsu Alphamab"), a wholly-owned subsidiary of the Company, has entered a clinical supply agreement with Pfizer Inc. ("Pfizer") to advance a clinical study to investigate KN026 in combination with Ibrance (palbociclib), an oral CDK4/6 inhibitor, in patients with previously-treated locally advanced and/or metastatic HER2-positive breast cancer (Press release, Alphamab, MAR 27, 2020, View Source [SID1234555955]). Jiangsu Alphamab, as the study sponsor, will oversee and run the trial, and Pfizer will supply palbociclib.

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Dr. Ting XU, Founder, Chairman and CEO of Alphamab Oncology commented, "Through the collaboration with Pfizer, we are on the right track to investigate the combination of KN026 and a CDK4/6 inhibitor for patients with HER2-positive breast cancer as a chemo-free regimen. By combining KN026 with palbociclib, we believe it has the potential to provide more effective treatment options for patients with HER2‑positive breast cancer."

This Phase Ib/II clinical trial is a multicenter, open-label study, aiming to evaluate efficacy, safety and tolerability of KN026 in combination with palbociclib in patients with locally advanced unresectable or metastatic HER2-positive breast cancer.

KN026 received IND approval from the National Medical Products Administration of China and U.S. Food and Drug Administration in 2018. Currently, it is in multiple phase I/II clinical trials in China and phase I clinical trials in the United States, targeting HER2 expression solid tumors cancers, such as breast cancer, gastric cancer, urothelial cancer and gynecological cancers.

About KN026

KN026 is an anti-HER2 bispecific antibody developed by Alphamab Oncology using the proprietary Fc-based heterodimer bispecific platform technology called CRIB (Charge Repulsion Induced Bispecific). KN026 can bind two non-overlapping epitopes of HER2 simultaneously, leading to a dual HER2 signal blockade. In pre-clinical studies, KN026 has demonstrated potentially equivalent or superior efficacy compared with Trastuzumab w/o combination with Pertuzumab. KN026 has increased binding capacity as well as better inhibition in HER2-positive tumor cell lines. Additionally, KN026 has also shown inhibitory effect on tumor cells with medium or low HER2 expression or Trastuzumab-resistant cell lines. KN026 phase I trials have shown good safety and preliminary efficacy.

On March 27, 2020 ThermoGenesis Holdings, Inc. (Nasdaq: THMO), a market leader in automated cell processing tools and services in the cell and gene therapy field, reported that it closed its previously announced registered direct offering for the purchase and sale of 1,000,002 shares of the Company’s common stock, at a purchase price of $3.50 per share, which has been priced at-the-market under Nasdaq rules (Press release, Thermogenesis, MAR 27, 2020, View Source [SID1234555954]).

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H.C. Wainwright & Co. acted as the exclusive placement agent for the offering.

The gross proceeds to ThermoGenesis from this offering were approximately $3.5 million, before deducting the placement agent’s fees and other offering expenses payable by ThermoGenesis. The Company intends to use the net proceeds from this offering for working capital and general corporate purposes.

The shares of common stock were offered by ThermoGenesis pursuant to a "shelf" registration statement on Form S-3 (File No. 333-235509) previously filed with the Securities and Exchange Commission (the "SEC") on December 13, 2019 and declared effective by the SEC on January 3, 2020. The offering of the securities was made only by means of a prospectus, including a prospectus supplement, forming a part of the effective registration statement. A final prospectus supplement and accompanying prospectus relating to the shares of common stock being offered has been filed with the SEC. Electronic copies of the final prospectus supplement and accompanying prospectus may be obtained on the SEC’s website at View Source or by contacting H.C. Wainwright & Co., LLC at 430 Park Avenue, 3rd Floor, New York, NY 10022, by phone at (646) 975-6996 or e-mail 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 March 27, 2020 AVEO Oncology (NASDAQ: AVEO) and Biodesix, Inc. reported the discontinuation of their CyFi-2 study, a randomized Phase 2 clinical study evaluating ficlatuzumab, AVEO’s potent hepatocyte growth factor (HGF) inhibitory antibody product candidate, in combination with high-dose cytarabine vs. high-dose cytarabine alone in patients with relapsed and refractory acute myeloid leukemia (AML) (Press release, AVEO, MAR 27, 2020, View Source [SID1234555953]). This decision is being taken due to the urgent shift among clinical sites toward efforts to combat the COVID-19 pandemic, which has impacted the feasibility of completing the study within the shelf-life of the current ficlatuzumab clinical trial supply. The study has not yet begun patient enrollment.

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"While this is a difficult decision, as we remain optimistic about the potential of ficlatuzumab in AML, we believe it is necessary in light of the COVID-19 pandemic and its effect on the states where the CyFi-2 study was to take place," said Michael Bailey, president and chief executive officer of AVEO. "Our investigators have been informed of the closure, and we greatly appreciate their enthusiasm for the study. We remain committed to the practice of scientific discovery and will focus our resources and efforts on our ongoing initiatives."

About Ficlatuzumab

Ficlatuzumab (formerly known as AV-299) is a potent hepatocyte growth factor (HGF) inhibitory antibody that binds to the HGF ligand with high affinity and specificity to inhibit HGF/c-Met biological activities. AVEO and Biodesix, Inc. have a worldwide agreement to develop and commercialize ficlatuzumab. Ficlatuzumab is currently being evaluated in a clinical study of patients with squamous cell carcinoma of the head and neck (HNSCC).

On March 27, 2020 Castle Biosciences, Inc. (Nasdaq: CSTL), a skin and eye cancer diagnostics company providing personalized genomic information to improve cancer treatment decisions, reported to its website results from a survey performed by the Collaborative Ocular Oncology Group (COOG) for the purpose of providing a current practices survey for clinicians regarding management of patients diagnosed with uveal melanoma and other ocular tumors during the COVID-19 pandemic (Press release, Castle Biosciences, MAR 27, 2020, View Source [SID1234555952]).

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The Collaborative Ocular Oncology Group (COOG) represents most major ocular oncology centers in North America who manage patients with uveal melanoma and other ocular tumors. Twenty-three of twenty-five COOG members were able to complete the survey.

The COOG conducted an on-line survey study between March 25-26, 2020, in order to survey current management practices for patients with a range of eye tumors, including uveal melanoma, high risk choroidal nevus, retinoblastoma, intraocular metastasis, vitreoretinal lymphoma, benign intraocular tumors, conjunctival melanoma, conjunctival squamous cell carcinoma/ocular surface squamous neoplasia (OSSN), and conjunctival lymphoma.

"Telemedicine is of limited value in patients with active intraocular cancers, due to the need for specialized ophthalmic imaging, whereas it may be of more benefit in patients with treated inactive tumors, and those with ocular surface conjunctival tumors, in which the patient can take photos of the eye with their smartphone," said J. William Harbour, M.D., the Mark J. Daily Endowed Professor of Ophthalmology, Vice Chairman for Translational Research, and Director of Ocular Oncology at Bascom Palmer Eye Institute, Associate Director for Basic Research at Sylvester Comprehensive Cancer Center, and chair of the COOG. "Given these challenges, we conducted a survey of COOG investigators across North America to obtain a snapshot of current practices during the COVID-19 pandemic. Currently, most ocular oncology experts continue to promptly see new patients with eye cancers, such as uveal melanoma, retinoblastoma, intraocular metastasis and vitreoretinal lymphoma. In contrast, many experts would delay by at least a few weeks the return of established eye cancer patients who have been treated and are stable, and those with benign or low-grade tumors."

Summary results are attached, and detailed results are available on the Castle Biosciences DecisionDx-UM page: View Source The attached results were prepared by the COOG, and Castle Biosciences makes no representation or warranty as to their accuracy or completeness.

About DecisionDx-UM

DecisionDx-UM is a 15-gene expression profiling (GEP) test that uses an individual patient’s tumor biology to predict individual risk of metastasis. DecisionDx-UM is considered to be standard of care in the management of uveal melanoma in the majority of ocular oncology practices in the United States. Since 2009, the American Joint Committee on Cancer (AJCC; v7 and v8) Staging Manual for UM has specifically identified the GEP test as a prognostic factor that is recommended for collection as a part of clinical care. Further, the National Comprehensive Cancer Network (NCCN) guidelines for uveal melanoma include the DecisionDx-UM test result as a prognostic method for determining risk of metastasis and recommended differential surveillance regimens based on a Class 1A, 1B, and 2 result. DecisionDx-UM is the only prognostic test for uveal melanoma that has been validated in prospective, multi-center studies and it has been shown to be a superior predictor of metastasis compared to other prognostic factors such as chromosome 3 status, mutational status, AJCC stage, and cell type.

It is estimated that nearly 8 in 10 patients diagnosed with uveal melanoma in the U.S. receive the DecisionDx-UM test as part of their initial diagnostic workup. More information about the test and disease can be found at www.MyUvealMelanoma.com.

On March 27, 2020 Altimmune, Inc. (Nasdaq: ALT), a clinical-stage biopharmaceutical company, reported financial results for the year ended December 31, 2019 and provided a corporate update (Press release, Altimmune, MAR 27, 2020, View Source [SID1234555951]).

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"2019 was a productive year for the Company with the acquisition of ALT-801, a supplemental award for the development of NasoShield from BARDA, and the advancement of ALT-702 as a preclinical program," said Vipin K. Garg, Ph.D., President and Chief Executive Officer. "However, we all find ourselves in a very different world in 2020 with the COVID-19 global pandemic causing substantial disruption to many of our lives."

Dr. Garg continued, "We face an unprecedented time, which will require companies, organizations, academic institutions, and governments to come together as a united front against this pandemic. At Altimmune, we believe we can leverage our intranasal vaccine technology platform and experience with both influenza and anthrax to rapidly develop a COVID-19 vaccine candidate. Our entire Company is working tirelessly to address this crisis as we progress our vaccine candidate for COVID-19 towards the initiation of a Phase 1 clinical trial as early as Q3 of this year. We believe our vaccine platform has the potential to offer specific and substantial benefits to address a pandemic situation, and we will continue to press forward in our effort to address this challenge."

Corporate Update and 2019 Highlights

2020 Activity:

Initiated development of "AdCOVID", our single-dose intranasal COVID-19 vaccine candidate

Utilizing our proprietary intranasal vaccine technology, the Company began development of AdCOVID, a vaccine candidate to protect against COVID-19. We believe, our vaccine technology is particularly well positioned to respond to pandemic respiratory infections as it combines intranasal dosing, a broad, rapid immune response and room temperature stability with avoidance of cold chain shipping requirements, making it easier to distribute across communities. The Company designed and created the vaccine candidate in February and plans to begin animal testing in Q2 2020. The Company is engaged in discussions with a number of organizations who are addressing this crisis, including The United States Medical Countermeasures Task Force, The World Health Organization, academia, and other institutions engaged in the effort.
Announced positive results for ALT-702 in a preclinical model of colorectal cancer

ALT-702 met a key preclinical milestone with the demonstration of systemic antitumor activity in a preclinical model of colorectal cancer following its local injection into solid tumors. ALT-702 is a depot-forming immune stimulant candidate designed to safely activate tumor immunity. In these studies, regression of both treated and non-treated tumors was observed following combination treatment with ALT-702 and a CTLA-4 immune checkpoint inhibitor, with overall survival in the combination group markedly better than either agent alone. These findings highlight the potential benefits of ALT-702 in both local and metastatic disease and support continued development activities.
2019 Activity:

Acquired Spitfire Pharma, Inc. with NASH Candidate ALT-801

The Company acquired Spitfire Pharma, Inc. including the product candidate ALT-801, a potent GLP-1/Glucagon receptor dual agonist for the treatment of non-alcoholic steatohepatitis (NASH). ALT-801 is a peptide-based therapeutic candidate with balanced agonist activity on the GLP-1 and glucagon receptors and a differentiated PK profile to improve tolerability. ALT-801 is designed to treat obesity, the basic underlying cause of NASH, the most severe form of non-alcoholic fatty liver disease (NAFLD). The Company is preparing for a Phase 1 clinical trial anticipated to begin in 2020.
Awarded $3.7 million BARDA funding for NasoShield Phase 1b trial

In Q3, the Company modified its existing anthrax vaccine development contract with the Biomedical Advanced Research and Development Authority (BARDA), resulting in $3.7 million of additional funding. The supplemental funding will support the initiation and conduct of a Phase 1b clinical trial of NasoShield in 2020 to evaluate alternative methods of intranasal dosing in humans. NasoShield is being developed as a single-dose, intranasal post-exposure anthrax vaccine, and is the only anthrax product candidate supported by BARDA. We believe it offers potentially transformational improvements over the current two and three dose vaccines. The NasoShield program is funded through a contract with BARDA (HHSO100201600008C), with a total potential value of $133.7 million if all options in the contact are exercised.
Financial Results for the Year Ended December 31, 2019

At December 31, 2019, the Company had cash, cash equivalents and short-term investments of $37.3 million.
Revenue was $5.8 million for the year ended December 31, 2019 compared to $10.3 million in the prior year. The change was due to a decrease in billings under the Company’s U.S. government contracts due to timing of manufacturing and clinical trials for the NasoShield program and the 2018 completion of the primary activities under the SparVax-L contract.
Research and development expenses were $17.8 million for the year ended December 31, 2019 compared to $18.5 million in the prior year period. The decrease was attributable to lower manufacturing and clinical trial costs on existing programs offset by IPR&D expense recognized in conjunction with the acquisition of Spitfire Pharma, Inc.
General and administrative expenses were $8.5 million for the year ended December 31, 2019 compared to $9.8 million in the prior year period. The decrease was attributable to lower compensation, professional services and legal costs; offset by an increase in insurance premiums.
Impairment charges were $1.0 million for the year ended December 31, 2019 compared to $24.9 million for the prior year. Impairment in both years was due primarily to the SparVax-L program as the development contract with NIAID ended in Q3 2019, with no further funding identified. As disclosed by BARDA, U.S. government funding for anthrax will now focus on post-exposure vaccines that offer transformational improvements over a two-dose vaccine. Since SparVax-L was being developed as a two-dose vaccine candidate and our NasoShield program fits the government’s funding profile with active funding, additional development of SparVax-L is not expected.
Other income (expense) was $0.9 million for the year ended December 31, 2019 compared to ($2.5) million in the prior year. The 2019 activity is attributable to interest income earned on cash and investments while the 2018 expense was primarily due to changes in the fair value of the Company’s warrant liability, including loss on exchange.
Net loss attributed to common stockholders for the year ended December 31, 2019 was $20.97 million, or ($1.60) per share, compared to $42.48 million in the prior year, or ($15.16) per share. The difference in net loss is primarily attributable to the $24.9 million impairment recognized in 2018.
Conference Call Information

Altimmune will host a conference call to discuss the company’s year end results and other business information.

Date: Friday, March 27, 2020
Time: 8:30 am Eastern Time
Domestic: 877-423-9813
International: 201-689-8573
Conference ID: 13701071
Webcast: View Source
Following the conclusion of the call, the webcast will be available for replay on the Investor Relations page of the Company’s website at www.altimmune.com. The company has used, and intends to continue to use, the investor relations portion of its website as a means of disclosing material non-public information and for complying with disclosure obligations under Regulation FD.