On December 16, 2019 Aptose Biosciences Inc. ("Aptose" or the "Company") (NASDAQ: APTO, TSX: APS), reported that it has commenced an underwritten public offering of its common shares (the "Offering") (Press release, Aptose Biosciences, DEC 16, 2019, View Source [SID1234552390]). In addition, Aptose intends to grant the Underwriters a 30-day option to purchase up to an additional 15% of the common shares offered in the Offering. The Offering is subject to market and other conditions, and there can be no assurance as to whether or when the Offering may be completed, or as to the actual size or terms of the offering. All of the common shares to be sold in the proposed offering will be sold by the Company.

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Aptose intends to use all or a portion of the net proceeds to (i) accelerate and expand clinical trials for CG-806; (ii) accelerate and expand our clinical trials for APTO-253; (iii) acquire and fund (including through partnerships and in-licensing) additional clinical assets; and (iv) for working capital and general corporate purposes relating to (i), (ii) or (iii) above.

Piper Jaffray & Co. is acting as the sole active book-running manager and Canaccord Genuity is acting as passive book-running manager for the Offering.

No common shares will be offered or sold in Canada as part of this Offering. The Offering is subject to the approval of the Toronto Stock Exchange ("TSX") and Nasdaq. For the purposes of TSX approval, the Company is relying on the exemption set forth in Section 602.1 of the TSX Company Manual, which provides that the TSX will not apply its standards to certain transactions involving eligible interlisted issuers on a recognized exchange, such as Nasdaq.

The securities described above are being offered by Aptose pursuant to a shelf registration statement on Form S-3 (File. No. 333-230218), including a base prospectus, that was previously filed by Aptose with the Securities and Exchange Commission ("SEC") and declared effective on April 25, 2019. The offering is being made only by means of a written prospectus and prospectus supplement that form a part of the registration statement. Before you invest, you should read the prospectus supplement and the accompanying prospectus and other documents the Company has filed with the SEC for more complete information about the Company and this offering. You may get these documents for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, copies of the the prospectus supplement and the accompanying prospectus may be obtained, once available, from Piper Jaffray & Co., Attention: Prospectus Department, 800 Nicollet Mall, J12S03, Minneapolis, MN 55402, by email at [email protected] or by phone: 1-800-747-3924.

This press release does not constitute an offer to sell or the solicitation of offers to buy any securities of Aptose, and shall not constitute an offer, solicitation or sale of any security 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.

On December 16, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported the commercial launch of its Cchek Prostate Cancer Confirmation test (Cchek PCC), the first test developed with the Cchek artificial intelligence driven, flow cytometry based, liquid biopsy technology platform (Press release, Anixa Biosciences, DEC 16, 2019, View Source [SID1234552389]).

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The Cchek PCC test will be offered as a CLIA validated test through Anixa’s partner laboratory, ResearchDx. This test has been independently validated by ResearchDx and is designed to confirm the need for prostate biopsy, as a means to minimize unnecessary invasive procedures and reduce healthcare costs associated with traditional methods of prostate cancer diagnosis and the associated adverse events.

Amit Kumar, Ph.D., Chief Executive Officer of Anixa, stated, "This is a major milestone for Anixa and our partner-based business model. From the start, our goal with Cchek has been to develop an inexpensive blood test that accurately detects the existence of cancer by measuring the body’s immune response."

Data shows that more than 90% of prostate biopsies performed in the U.S. are negative, which indicates that over a million men undergo unnecessary, painful and anxiety-provoking procedures every year. The goal of Cchek PCC is to reduce the number of unnecessary biopsies by between 40% and 50%, while still accurately identifying those patients that require a biopsy to diagnose their prostate cancer.

Dr. Kumar continued, "In the coming months, we expect to conduct a number of activities to support the marketing of Cchek PCC, including the development of marketing materials, education of key opinion leaders in urology, and development of a reimbursement path for the test. We expect Cchek PCC to be broadly available throughout the U.S. by April 2020."

About Cchek
Cchek is an early cancer detection technology, which measures a patient’s immunological response to a malignancy by analyzing immune system cells in peripheral blood. The goal is to utilize the technology to determine a patient’s cancer status from a simple blood draw, eliminating the need for a biopsy, which can be an expensive, painful and invasive procedure. Further, conventional methods using current cancer screening tests often lack accuracy and reliability. Anixa’s orthogonal approach using flow cytometry coupled with artificial intelligence provides an alternative method with greater affordability, efficacy and efficiency. To date, Anixa has successfully used Cchek to detect the presence of 20 different cancers including lung, colon, breast and prostate. The robust cancer detection performance of Cchek makes it a platform from which multiple cancer diagnostic tests may be developed.

On December 16, 2019 Agios Pharmaceuticals, Inc. (NASDAQ:AGIO), a leader in the field of cellular metabolism to treat cancer and rare genetic diseases, reported that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation for TIBSOVO (ivosidenib) for the treatment of adult patients with relapsed or refractory myelodysplastic syndrome (MDS) with a susceptible IDH1 mutation as detected by an FDA-approved test (Press release, Agios Pharmaceuticals, DEC 16, 2019, View Source [SID1234552388]). MDS is a group of bone marrow disorders that can cause severe complications, such as infections and uncontrolled bleeding, and can lead to the development of acute myelogenous leukemia (AML).

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"There is a significant need for new targeted therapeutic approaches for individuals with MDS whose disease continues to progress despite treatment with standard of care," said Chris Bowden, M.D., chief medical officer at Agios. "The Breakthrough Therapy designation is based on results from the initial 12 patients in the MDS arm of our Phase 1 study in advanced hematologic malignancies with an IDH1 mutation and recognizes the potential for single-agent treatment with TIBSOVO to make an impact on these patients. We recently re-opened the MDS arm of this study with the goal of generating sufficient data to pursue a regulatory filing in this indication."

The FDA’s Breakthrough Therapy designation is intended to expedite the development and review of a drug candidate that is under investigation to treat a serious or life-threatening disease or condition when preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapies on one or more clinically significant endpoints.

Results from the MDS arm of the ongoing TIBSOVO Phase 1 dose-escalation and expansion study in hematologic malignancies were presented at the 7thSociety of Hematologic Oncology Annual Meeting, held September 11-14, 2019, in Houston, Texas. These demonstrate that TIBSOVO administered as a monotherapy was well tolerated and associated with durable remissions as well as the achievement and maintenance of transfusion independence in patients with relapsed or refractory MDS with an IDH1 mutation. Among the 12 patients who received 500 mg of oral TIBSOVO daily, the median treatment duration was 11.4 months. The median age was 72.5 years, and 42% of patients were age 75 or older. As of the November 2, 2018 data cut-off, 75% (9/12) of patients had a response and 42% (5/12) had a complete response (CR). The median duration of CR had not been reached (95% CI, 2.8 months, NE). Of the patients who had a CR, 60% remained relapse-free at 12 months. In addition, 9 (75%) patients were transfusion-independent for 56 days or longer during study treatment. The most common adverse events (AEs) of any grade were back pain, diarrhea, fatigue and rash. Grade 2 IDH differentiation syndrome was observed in 1 of 12 patients. No AEs resulted in permanent discontinuation of treatment.

TIBSOVO Clinical Development in MDS
The MDS arm of the Phase 1 dose-escalation and expansion study evaluating TIBSOVO (ivosidenib) in adults with advanced hematologic malignancies with IDH1 mutations is assessing the clinical activity, safety, tolerability, pharmacokinetics and pharmacodynamics of TIBSOVO in adult patients with relapsed or refractory MDS with a susceptible IDH1 mutation. The arm was re-opened in October 2019 and will enroll up to 25 total patients with the goal of generating sufficient data to pursue a potential regulatory filing in this indication. Study recruitment is ongoing across 22 sites in the U.S. and France.

About Myelodysplastic Syndrome (MDS)
MDS comprises a diverse group of bone marrow disorders in which immature blood cells in the bone marrow do not mature or become healthy blood cells. The National Cancer Institute estimates that more than 10,000 people are diagnosed with MDS in the U.S. each year. Failure of the bone marrow to produce mature healthy cells is a gradual process, and reduced blood cell and/or reduced platelet counts may be accompanied by the loss of the body’s ability to fight infections and control bleeding. For roughly 30 percent of the patients diagnosed with MDS, this bone marrow failure will progress to AML. Chemotherapy, hypomethylating agents and supportive blood products are used to treat MDS.

TIBSOVO is not approved in any country for the treatment of patients with MDS.

About TIBSOVO (ivosidenib)

TIBSOVO (ivosidenib) is an isocitrate dehydrogenase-1 (IDH1) inhibitor indicated for the treatment of adult patients with relapsed or refractory acute myeloid leukemia (AML) with a susceptible IDH1 mutation as detected by an FDA-approved test. For more information, visit TIBSOVO.com.

IMPORTANT SAFETY INFORMATION

WARNING: DIFFERENTIATION SYNDROME

Patients treated with TIBSOVO have experienced symptoms of differentiation syndrome, which can be fatal if not treated. Symptoms may include fever, dyspnea, hypoxia, pulmonary infiltrates, pleural or pericardial effusions, rapid weight gain or peripheral edema, hypotension, and hepatic, renal, or multi-organ dysfunction. If differentiation syndrome is suspected, initiate corticosteroid therapy and hemodynamic monitoring until symptom resolution.

WARNINGS AND PRECAUTIONS

Differentiation Syndrome: See Boxed WARNING. In the clinical trial, 19% (34/179) of patients with relapsed or refractory AML treated with TIBSOVO experienced differentiation syndrome. Differentiation syndrome is associated with rapid proliferation and differentiation of myeloid cells and may be life-threatening or fatal if not treated. Symptoms of differentiation syndrome in patients treated with TIBSOVO included noninfectious leukocytosis, peripheral edema, pyrexia, dyspnea, pleural effusion, hypotension, hypoxia, pulmonary edema, pneumonitis, pericardial effusion, rash, fluid overload, tumor lysis syndrome, and creatinine increased. Of the 34 patients who experienced differentiation syndrome, 27 (79%) recovered after treatment or after dose interruption of TIBSOVO. Differentiation syndrome occurred as early as 1 day and up to 3 months after TIBSOVO initiation and has been observed with or without concomitant leukocytosis.

If differentiation syndrome is suspected, initiate dexamethasone 10 mg IV every 12 hours (or an equivalent dose of an alternative oral or IV corticosteroid) and hemodynamic monitoring until improvement. If concomitant noninfectious leukocytosis is observed, initiate treatment with hydroxyurea or leukapheresis, as clinically indicated. Taper corticosteroids and hydroxyurea after resolution of symptoms and administer corticosteroids for a minimum of 3 days. Symptoms of differentiation syndrome may recur with premature discontinuation of corticosteroid and/or hydroxyurea treatment. If severe signs and/or symptoms persist for more than 48 hours after initiation of corticosteroids, interrupt TIBSOVO until signs and symptoms are no longer severe.

QTc Interval Prolongation: Patients treated with TIBSOVO can develop QT (QTc) prolongation and ventricular arrhythmias. One patient developed ventricular fibrillation attributed to TIBSOVO. Concomitant use of TIBSOVO with drugs known to prolong the QTc interval (e.g., anti-arrhythmic medicines, fluoroquinolones, triazole anti-fungals, 5-HT3 receptor antagonists) and CYP3A4 inhibitors may increase the risk of QTc interval prolongation. Conduct monitoring of electrocardiograms (ECGs) and electrolytes. In patients with congenital long QTc syndrome, congestive heart failure, electrolyte abnormalities, or in those who are taking medications known to prolong the QTc interval, more frequent monitoring may be necessary.

Interrupt TIBSOVO if QTc increases to greater than 480 msec and less than 500 msec. Interrupt and reduce TIBSOVO if QTc increases to greater than 500 msec. Permanently discontinue TIBSOVO in patients who develop QTc interval prolongation with signs or symptoms of life-threatening arrhythmia.

Guillain-Barré Syndrome: Guillain-Barré syndrome occurred in <1% (2/258) of patients treated with TIBSOVO in the clinical study. Monitor patients taking TIBSOVO for onset of new signs or symptoms of motor and/or sensory neuropathy such as unilateral or bilateral weakness, sensory alterations, paresthesias, or difficulty breathing. Permanently discontinue TIBSOVO in patients who are diagnosed with Guillain-Barré syndrome.

ADVERSE REACTIONS

The most common adverse reactions (≥20%) of any grade were fatigue (39%), leukocytosis (38%), arthralgia (36%), diarrhea (34%), dyspnea (33%), edema (32%), nausea (31%), mucositis (28%), electrocardiogram QT prolonged (26%), rash (26%), pyrexia (23%), cough (22%), and constipation (20%).
The most frequently reported ≥Grade 3 adverse reactions (≥5%) were electrocardiogram QT prolonged (10%), dyspnea (9%), leukocytosis (8%), tumor lysis syndrome (6%), and differentiation syndrome (5%).
Serious adverse reactions (≥5%) were differentiation syndrome (10%), leukocytosis (10%), and electrocardiogram QT prolonged (7%). There was one case of progressive multifocal leukoencephalopathy (PML).
DRUG INTERACTIONS

Strong or Moderate CYP3A4 Inhibitors: Reduce TIBSOVO dose with strong CYP3A4 inhibitors. Monitor patients for increased risk of QTc interval prolongation.

Strong CYP3A4 Inducers: Avoid concomitant use with TIBSOVO.

Sensitive CYP3A4 Substrates: Avoid concomitant use with TIBSOVO.

QTc Prolonging Drugs: Avoid concomitant use with TIBSOVO. If co-administration is unavoidable, monitor patients for increased risk of QTc interval prolongation.

LACTATION

Many drugs are excreted in human milk and because of the potential for adverse reactions in breastfed children, advise women not to breastfeed during treatment with TIBSOVO and for at least 1 month after the last dose.

On December 16, 2019 PDL BioPharma, Inc. ("PDL" or the "Company") (Nasdaq: PDLI) reported that its Board of Directors has authorized a $75 million increase to the $200 million common stock and convertible notes repurchase authorization that was previously announced on December 9, 2019, for a total of $275 million (Press release, PDL BioPharma, DEC 16, 2019, View Source [SID1234552385]).

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On December 13, 2019, the Company announced it entered into separate, privately negotiated exchange agreements pursuant to which it is exchanging approximately 80% of its outstanding 2.75% Convertible Senior Notes for $98.0 million in cash and 13.4 million shares of Company common stock. The cash and common stock to be distributed by PDL in this exchange will utilize approximately $143.8 million of the original $200 million authorization based on the closing price of PDL’s common stock on December 12, 2019.

Dominique Monnet, President and CEO of PDL, said, "The note exchange we announced last week was an important step towards optimizing our ability to monetize assets and return the net proceeds to our shareholders. By repurchasing approximately 80% of our convertible notes, we have made our assets more attractive to potential buyers. This may also increase the monetization proceeds that will flow to our shareholders. Today’s increased authorization will enable us to augment our efforts with common stock repurchases or additional note repurchases as we execute our strategic plan."

Purchases may be made in open-market transactions, in block transactions on or off an exchange, in privately negotiated transactions or by other means as determined by PDL’s management and in accordance with the regulations of the Securities and Exchange Commission. The repurchase program does not obligate PDL to acquire any specific number of shares or notes and may be suspended or terminated at any time.

BofA Securities is acting as financial advisor to PDL in connection with the repurchase program.

On December 16, 2019 Athenex, Inc. (Nasdaq: ATNX), a global biopharmaceutical company dedicated to the discovery, development, and commercialization of novel therapies for the treatment of cancer, reported that it has expanded its strategic partnership with Chinese drug company, Guangzhou Xiangxue Pharmaceutical Co., Ltd. ("Xiangxue"), to exclusively develop and commercialize Athenex’s oncology product candidates Oral Paclitaxel (both the capsule and the tablet formulations), Oral Irinotecan, as well as Tirbanibulin (KX2-391, also known as KX-01) Ointment, including for the treatment of actinic keratosis (AK) in the Territory (Press release, Athenex, DEC 16, 2019, View Source [SID1234552384]).

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Under the terms of the license agreement, subject to the satisfaction of certain conditions, Athenex will receive an upfront payment of $30 million. Athenex will also be eligible to receive development, sales and other milestone payments up to $170 million, and tiered royalties ranging from the sub-teen to low twenties based on annual net sales of licensed products in the Territory and a percentage of sublicensing revenue. The total deal size is potentially $200 million, excluding the royalty payments.

The agreement provides for joint decision making through a Joint Steering Committee with respect to the development and commercialization of the licensed products in the Territory. Athenex and Xiangxue will jointly lead the clinical development programs with Athenex to coordinate the global drug development efforts while Xiangxue will oversee commercialization activities in the Territory.

Mr. YongHui Wang, Chairman and CEO of Xiangxue, said, "We are thrilled about this strategic partnership extension with Athenex in China which complements our successful collaboration on KX2-361 (also known as KX-02) for brain tumors (including glioblastoma multiforme) and TCR-T immunotherapy. Our collaboration has been highly rewarding, and we have also witnessed Athenex’s strong execution track record, in terms of research and development as well as business expansion. The oral paclitaxel and encequidar data are extremely exciting, with clear benefits on tumor response, improved survival and less neuropathy. We believe the results pave the way for oral irinotecan to follow its success. The promising tirbanibulin data have also shown significant clinical benefits to patients with AK in two randomized, controlled

clinical studies. Our assessment is that there is compelling market potential for oral paclitaxel and encequidar in China, and that tirbanibulin ointment will address an underserved market in AK."

"This extended strategic partnership, together with KX2-361, expands our novel drug portfolio into a strong pipeline consisting of two Phase 3 product candidates with positive clinical trial results, one product candidate with proof-of-concept data that is ready to advance to Phase 2, and one Phase 1 product candidate," continued Mr. YongHui Wang. "We expect the partnership will enable us to lead these innovative therapies into commercialization and position us to further tap into one of the largest and most promising healthcare markets worldwide. We will be expanding our marketing and sales capacity to allow us to maximize the potential of these exciting opportunities."

Dr. Johnson Lau, Chief Executive Officer and Chairman of Athenex, stated, "We are pleased with the extension on the strategic partnership with Xiangxue, and their confidence in our clinical data. We believe this serves as an important validation of our science and product portfolio. We have selected Xiangxue as our partner based on our long term productive collaboration, and because their commitment to develop this portfolio is aligned with our global strategy. Xiangxue also plans to expand its marketing and sales infrastructure to focus on China to capture the full potential of these products. We look forward to leading the global clinical development of these advanced clinical stage products with the ultimate goals of serving patients and addressing the attractive market opportunities that exist in China."

The Orascovery platform was initially developed by Hanmi Pharmaceuticals and licensed exclusively to Athenex for all major worldwide territories except Korea, which is retained by Hanmi.

Athenex has an exclusive license agreement with Almirall, S.A. to the rights to tirbanibulin ointment in the following territories: USA, European Union, Russia and Turkey. Details of this arrangement were disclosed in December 2017.