On March 17, 2021 Evotec SE (Frankfurt Stock Exchange: EVT, MDAX/TecDAX, ISIN: DE0005664809) reported that it will announce its financial results for 2020 on Thursday, 25 March 2021 (Press release, Evotec, MAR 17, 2021, View Source;announcements/press-releases/p/evotec-se-to-announce-results-for-fiscal-year-2020-on-25-march-2021-6034 [SID1234576846]).

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The Company is going to hold a conference call to discuss the results as well as to provide an update on its performance. The conference call will be held in English.

Conference call details

Date: Thursday, 25 March 2021
Time: 02.00 pm CET (09.00 am EDT, 01.00 pm GMT)

On March 17, 2021 111, Inc. ("111" or the "Company") (Nasdaq: YI), a leading tech-enabled healthcare platform company committed to digitally connecting patients with medicine and healthcare services in China, reported it has entered into a strategic cooperation agreement with BeiGene, Ltd. (NASDAQ:BGNE; HKEX:06160), a commercial-stage biotechnology company focused on developing and commercializing innovative medicines worldwide (Press release, BeiGene, MAR 17, 2021, View Source [SID1234576828]).

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BeiGene currently markets two internally discovered oncology medicines in China: BTK inhibitor, BRUKINSA (zanubrutinib), and anti-PD-1 antibody, tislelizumab. It also markets or plans to market in China additional oncology products licensed from Amgen Inc., Celgene Logistics Sàrl, a Bristol Myers Squibb (BMS) company, and EUSA Pharma.

Cancer is the leading cause of death in China, and the number of cancer patients is on the rise. According to data from the International Agency for Research on Cancer (IARC) of the World Health Organization (WHO), in 2020, 4.6 million new cases of cancers were diagnosed in China, accounting for 23.7% of the world’s total cases, and there were 3 million cancer deaths in the country, accounting for 30% of the world’s total. Meanwhile, cancer treatment resources are mostly concentrated in China’s first- and second-tier cities. Therefore, the current challenge in the treatment of cancer in China lies not only in the availability of safe and efficacious drugs, but also in the fact that a large number of cancer patients in the country face the unfortunate situation of needing to seek both immediate medical treatment and long-term follow-up care outside of their local communities.

Answering the urgent call to make cancer care more efficient and patient-friendly in China, the two companies will cooperate around a "Internet + Medicine & Healthcare" model, leveraging 111’s Internet hospital, smart supply chain network, data-driven AI solutions, such as digital advertising, and online and offline direct-to-patient (DTP) delivery of medicines to create an unique oncology management platform. The platform will further empower doctors to improve the efficiency of patient management, especially for patients outside of the hospital, and will not only extend their service cycles, but also expand their service radius. At the same time, through this efficient and convenient doctor-patient communication platform, it will be possible to provide patients with a digital, one-stop service for medical care and medicine, improving the accessibility of BeiGene’s innovative oncology drugs.

According to Dr. Wu Xiaobin, president of BeiGene, the Internet+ model will be a catalyst for driving innovation in oncology, and he hopes that this partnership with 111 will enable BeiGene to further its innovative goals through the wings of digitization. By leveraging the power of the Internet, BeiGene will be able to bring its innovative drugs and services to more patients nationwide.

Ms. Wu Qingyi, Chief Commercial Officer of BeiGene Greater China, said, "In order to further promote the commercialization of oncology innovative drugs, we hope to use 111’s industry leading technology and digital service to establish the "last mile" delivery of oncology disease medical services in China. This will allow us to provide more high-quality innovative medicines and improve the accessibility of our medical resources to patients in China."

Dr. Yu Gang, Co-founder and Executive Chairman of 111, Inc., commented, "We are excited to partner with a leading company specializing in the development of innovative therapies in oncology. Both inside and outside of China, traditional pharmaceutical product marketing mainly targets clinicians, with relatively little attention devoted to end patients. However, in the era of digital healthcare services, and through the empowerment of the Internet, pharmaceutical companies can now deliver "patient-centered" care by prioritizing the needs of the patients. With the Internet’s ability to transcend the boundaries of time and geography, it can help doctors establish truly integrated online and offline disease management services throughout the patient care continuum – from diagnosis to treatment to post treatment follow-up care. We are confident that, by relying on our comprehensive digital "medical care + medicine" platform, 111 can help expand the commercial reach of BeiGene’s innovative oncology drugs as well as advance the adaption of innovative medical service models in China."

111’s strategically located, technology-driven fulfillment centers currently serve more than 300,000 pharmacies in China that comprise its online and offline integrated virtual pharmacy network, empowering the Company’s ability to offer 24-hour delivery in most major cities and 72-hour delivery nationwide.

On March 17, 2021 Omega Healthcare Investors, Inc. (NYSE: OHI) ("Omega") reported the early tender results for its previously announced tender offer (the "Tender Offer") to purchase for cash up to an aggregate principal amount of $350 million (the "Aggregate Maximum Tender Amount") of its 4.375% Senior Notes due 2023 (the "Notes") (Press release, Omega Pharmaceutical, MAR 17, 2021, View Source [SID1234576827]).

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The terms and conditions of the Tender Offer are set forth in the offer to purchase, dated March 3, 2021, as amended by press release on March 3, 2021 (as the same may be further amended or supplemented, the "Offer to Purchase"). The Tender Offer will expire at 11:59 p.m., New York City Time, at the end of March 30, 2021, unless earlier terminated.

As of 5:00 p.m., New York City Time, on March 16, 2021 (such date and time, as it may be extended, the "Early Tender Time"), according to information provided by Global Bondholder Services Corporation, the tender and information agent for the Tender Offer, the aggregate principal amount of the Notes set forth in the table above under "Principal Amount Tendered at Early Tender Time" had been validly tendered and not validly withdrawn in the Tender Offer. Withdrawal rights for the Notes expired at 5:00 p.m., New York City Time, on March 16, 2021.

The "Total Consideration" for each $1,000 principal amount of Notes validly tendered and accepted for purchase pursuant to the Tender Offer will be determined in the manner described in the Offer to Purchase by reference to the fixed spread for the Notes specified in the table above plus the yield based on the bid-side price of the U.S. Treasury Reference Security specified in the table above at 10:00 a.m., New York City Time, today, and is inclusive of the Early Tender Premium (as set forth in the table above).

Omega expects to announce the pricing of the Tender Offer, the amount of Notes accepted for purchase, and the proration rates for the Notes later today.

Only holders of Notes who validly tendered and did not validly withdraw their Notes at or prior to the Early Tender Time are eligible to receive the Total Consideration for the Notes accepted for purchase. Holders of Notes will also receive accrued and unpaid interest on their Notes validly tendered and accepted for purchase from the last interest payment date up to, but not including, the settlement date.

Omega has satisfied the financing condition to the Tender Offer and, on March 18, 2021, expects to pay for the Notes that were validly tendered prior to or at the Early Tender Time and that are accepted for purchase.

Since the Tender Offer for the Notes was fully subscribed as of the Early Tender Time, Omega will not accept for purchase any Notes validly tendered after the Early Tender Time.

Information Relating to the Tender Offer

Credit Agricole Securities (USA) Inc. is serving as the Lead Dealer Manager for the Tender Offer. Investors with questions regarding the Tender Offer may contact the Lead Dealer Manager by phone at (866) 807-6030 (Toll Free) or (212) 261-7802 (Collect), by email at [email protected], or by mail addressed to Credit Agricole Securities (USA) Inc. at 1301 Avenue of the Americas, 17th Floor, New York, NY 10019, Attention: Debt Capital Markets/Liability Management.

None of Omega or its affiliates, their respective boards of directors, the dealer managers, the tender and information agent or the trustee with respect to the Notes is making any recommendation as to whether holders should tender any Notes in response to the Tender Offer, and neither Omega nor any such other person has authorized any person to make any such recommendation. Holders must make their own decision as to whether to tender any of their Notes, and, if so, the principal amount of Notes to tender.

This press release is for informational purposes only and is not an offer to buy, or the solicitation of an offer to sell, any of the Notes and the Tender Offer does not constitute an offer to buy or the solicitation of an offer to sell the Notes in any jurisdiction or in any circumstances in which such offer or solicitation are unlawful. The full details of the Tender Offer, including complete instructions on how to tender the Notes, are included in the Offer to Purchase. Holders are strongly encouraged to carefully read the Offer to Purchase, including materials incorporated by reference therein, because they contain important information. The Offer to Purchase may be downloaded from Global Bondholder Services Corporation’s website at www.gbsc-usa.com/omega/ or obtained from Global Bondholder Services Corporation, free of charge, by calling toll free at (866) 470-4300 (bankers and brokers can call collect at (212) 430-3774).

On March 17, 2021 GT Biopharma, Inc. (NASDAQ: GTBP) a clinical stage immuno-oncology company focused on developing innovative therapeutics based on the Company’s proprietary NK cell engager (TriKE) protein biologic technology platform reported that updated interim Phase I/II clinical trial results for the Company’s lead therapeutic candidate, GTB-3550, being evaluated for the treatment of high-risk myelodysplastic syndromes (MDS) and refractory/relapsed acute myeloid leukemia (AML) (Press release, GT Biopharma, MAR 17, 2021, View Source [SID1234576826]).

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Reduction in Bone Marrow Blast Levels Achieved

To date, 9 patients have been enrolled in the Phase I/II Expansion clinical trial. Patients enrolled early in the Study (patients 1-4) were treated with doses of GTB-3550 below the anticipated therapeutic dose (RP2D) and maximum tolerated dose (MTD) to address possible safety concerns. All patients treated at the lower doses exhibited no signs of toxicity, and did not experience any Grade of Cytokine Release Syndrome (CRS).

Patients 5-9 were treated with increasing doses of GTB-3550 (25mcg/kg/day, 50mcg/kg/day and 100mcg/kg/day, respectively). Three of the five patients (60%) experienced reduction in bone marrow blasts with two patients (one patient treated at the 50mcg/kg/day dose level and one patient treated at the 100mcg/kg/day dose level) experiencing significant reductions in bone marrow blast levels. As previously reported, Patient 7 treated at the 50mcg/kg/day dose level achieved a 61.7% reduction in bone marrow blast levels from 12% before therapy to 4.6% after GTB-3550 therapy. Patient 9 treated at the 100mcg/kg/day dose level achieved a 63.7% reduction in bone marrow blast levels from 22% before therapy to 8% after therapy. All patients treated at these higher doses of GTB-3550 did not experience any Grade of Cytokine Release Syndrome (CRS).

No Cytokine Release Syndrome (CRS) Observed

All patients treated to date with GTB-3550 TriKE displayed no signs of any Grade of cytokine release syndrome (CRS). Of particular note, GTB-3550 is currently being administered to patients at doses significantly higher than the reported MTD (Maximum Tolerated Dose) for continuous infusion of recombinant human IL-15 (Interleukin-15) (Waldmann, TA et al, Clin Cancer Res. (2019) 25:4945–54). GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies, and a modified form of IL-15.

Improved NK Cell Function, Proliferation & Persistence

Correlative studies have shown reproducible endogenous ("native") NK cell activity in all patients. NK cell activation increases early during treatment. This finding correlated with an increase proportion and absolute number of NK cells during treatment. Targeted delivery of IL-15 to NK cells via GTB-3550 TriKE showed preferential proliferation of NK cells and significantly less effect on CD8+ and CD4+ T-cells. We also observed no CD16 shedding by patients’ NK cells, and saw enhanced HL-60 AML target cell killing. This data indicates GTB-3550 TriKE rescues the patient’s exhausted/inhibited endogenous NK cells resulting in their activation, proliferation and persistence.

Mr. Anthony Cataldo, the Chairman and Chief Executive Officer of GT Biopharma commented: "We are pleased with the continued clinical performance of our lead GTB-3550 TriKE product candidate as we continue dose escalation." Mr. Cataldo further stated "this early data indicates GTB-3550 therapy demonstrates significant bone marrow blast level reductions in AML and MDS patients without the need for expensive progenitor-derived or autologous/allogenic cell therapies. We believe as we continue to dose escalate GTB-3550 TriKE, more patients will experience greater clinical efficacy. TriKE’s ability to work in the patient without outside supplemental engineered NK cells or the need for any combination drugs, sets TriKE apart from other cancer therapies. This is also the reason why TriKE therapy will be significantly less expensive than other treatments, opening the door to an off-the-shelf therapeutic."

About High-Risk Myelodysplastic Syndromes (MDS)

MDS is a rare form of bone marrow-related cancer caused by irregular blood cell production within the bone marrow. As a result of this irregular production, MDS patients do not have sufficient normal red blood cells, white blood cells and/or platelets in circulation. High-risk MDS is associated with poor prognosis, diminished quality of life, and a higher chance of transformation to acute myeloid leukemia. Approximately 40% of patients with High-Risk MDS transform to AML, another aggressive cancer with poor outcomes.

About Acute Myeloid Leukemia (AML)

Acute myeloid leukemia (AML) is a type of cancer in which the bone marrow makes abnormal myeloblasts (a type of white blood cell), red blood cells, or platelets. According to the National Cancer Institute (NCI), the five-year survival rate is about 35% in people under 60 years old, and 10% in people over 60 years old. Older people whose health is too poor for intensive chemotherapy have a typical survival of five to ten months. AML accounts for roughly 1.8% of cancer deaths in the United States.

About GTB-3550 TriKE

GTB-3550 is the Company’s first TriKE product candidate being initially developed for the treatment AML. GTB-3550 is a single-chain, tri-specific scFv recombinant fusion protein conjugate composed of the variable regions of the heavy and light chains of anti-CD16 and anti-CD33 antibodies and a modified form of IL-15. The natural killer (NK) cell stimulating cytokine human IL-15 portion of the molecule provides a self-sustaining signal that activates NK cells and enhances their ability to kill. We intend to study GTB-3550 in CD33 positive leukemias such as acute myeloid leukemia (AML), myelodysplastic syndrome (MDS), and other CD33+ hematopoietic malignancies.

About GTB-3550 TriKE Clinical Trial

Patients with CD33+ malignancies (primary induction failure or relapsed AML with failure of one reinduction attempt or high-risk MDS progressed on two lines of therapy) age 18 and older are eligible (NCT03214666). The primary endpoint is to identify the maximum tolerated dose (MTD) of GTB-3550 TriKE. Correlative objectives include the number, phenotype, activation status and function of NK cells and T cells.

On March 17, 2021 Cannabics Pharmaceuticals Inc. (OTCQB: CNBX), a global leader in the development of cancer related cannabinoid-based medicine, reported the concluding results of its in-vivo study evaluating the efficacy of the company’s proprietary drug candidate RCC-33 in prolonging survival rate in mice inoculated with human colorectal cancer cells (Press release, Cannabics Pharmaceuticals, MAR 17, 2021, View Source [SID1234576825]). Study results indicate a 35% prolonged survival rate in mice exposed to RCC-33 in comparison with sham control mice, as shown by Kaplan-Meier survival curve analysis, P-value = 0.08 (Figure 1).

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Cannabics(TM RCC-33 Prolongs Survival Rate of Human Colorectal Tumor Bearing Mice (Kaplan-Meier Survival Analysis)
Cannabics(TM RCC-33 Prolongs Survival Rate of Human Colorectal Tumor Bearing Mice (Kaplan-Meier Survival Analysis)
The mean survival rate observed in the experimental group was 31 days from treatment initiation vs. 23 days in the control group, reflecting a 35% increase in survival rate in the treatment group. The current results, taken together with previously obtained results of 33% reduction in tumor volume in the RCC-33 exposed group, further support the promising potential role of RCC-33 as part of the treatment armamentarium against colorectal cancer in the future. Company is aiming to schedule a pre-IND meeting with the US Food and Drug Administration by next quarter and start Phase 1/2a trials by beginning of 2022.

"Cannabics RCC-33 is the first proprietary antitumor formulation we have released for in-vivo testing. This, out of a developing pipeline of additional antitumor drug candidates that we are currently working on," said Eyal Barad, Cannabics Pharmaceuticals’ Co-founder and CEO. "Our aim with RCC-33 is to help a large and growing group of patients and assist in fulfilling a significant unmet need in an estimated $10 billion market."

Gabriel Yariv, Cannabics Pharmaceuticals’ President and COO said, "Colorectal cancer accounts for 10% of all cancer cases worldwide, with an approximated 1.8M new cases diagnosed annually. CRC is also the second most lethal cancer type accounting for over 550k deaths annually. It is also estimated that over 65% of CRC patients will have a survival rate of 5 years or longer, which creates ample opportunity for RCC-33 to potentially become a part of their treatment regime."