On December 16, 2019 MEI Pharma, Inc. (Nasdaq: MEIP), a late-stage pharmaceutical company focused on advancing new therapies for cancer, reported that it plans to offer shares of its common stock in an underwritten public offering (Press release, MEI Pharma, DEC 16, 2019, View Source [SID1234552400]). In connection with the offering, the Company intends to grant the underwriters a 30-day option to purchase up to an additional 15% of the shares of common stock offered in the public offering. The offering is subject to market 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.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The Company plans to use the net proceeds of the offering, together with other available funds, to progress its clinical development programs, as well as for working capital and other general corporate purposes.

Stifel and Wells Fargo Securities are acting as joint book-running managers for the offering.

The securities described above are being offered pursuant to a "shelf" registration statement previously filed and declared effective by the Securities and Exchange Commission (SEC). The offering is being made only by means of a prospectus supplement and accompanying base prospectus. When available, copies of the preliminary prospectus supplement and accompanying base prospectus relating to the offering may be obtained from Stifel, Nicolaus & Company Incorporated, Attention: Syndicate, One Montgomery Street, Suite 3700, San Francisco, CA 94104, by telephone at 415-364-2720 or by email at [email protected]; or Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, New York NY 10152, by telephone at 800-326-5897 or by email at [email protected]. An electronic copy of the preliminary prospectus supplement and accompanying base prospectus relating to the offering will also be available on the website of the SEC at www.sec.gov.

This release does 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 jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

On December 15, 2019 N. N. The Alexandrov National Cancer Centre reported that begins phase II case-control clinical trial of its immuno-oncology agent, Elenagen (Press release, N N The Alexandrov National Cancer Centre, DEC 15, 2019, View Source [SID1234553262]). Inoperable late-stage cancer patients with triple-negative breast cancer, ovarian cancer, stomach cancer or prostate cancer will be randomized and then subsequently receive either standard chemotherapy or chemotherapy combined with Elenagen. For each disease, the experimental and control groups will be compared for time to disease progression, overall survival, as well as tumor regression and the dynamics of clinical conditions. One can also expect a reversal of a tumor grade to an operable stage, which would make the tumor surgically removable.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"We have conducted a comprehensive worldwide search for the most promising adjuvants to standards of care and selected Elenagen", said prof. Oleg Sukonko MD, Ph.D., D.Sc., Head of the Alexandrov National Cancer Centre, "We assessed hundreds of potential products according to the following criteria: high safety as demonstrated in phase I/IIa clinical trial, encouraging first signs of synergistic effects with chemo-, radio- and immunotherapies, the economic feasibility of the future product and its accessibility for the healthcare system, and scientific novelty. Elenagen satisfied all of these criteria".

Elenagen was developed by, CureLab Oncology, Inc., a Boston-based biotech startup which provided the product to Belarussian colleagues. Aldevron, Inc. (Fargo, ND) was the contract manufacturer for the product. "Although in the coming year we are planning to start phase II clinical trials of Elenagen in breast and ovarian cancers in the US and multiple other countries, it was very important for us to begin with Belarus, the country which was the most hit by Chernobyl", said Dr. Alex Shneider, CEO of CureLab Oncology.

"We are very thankful to our colleagues from NYU and MD Andersen Cancer Centers who donated their ideas and expertise, went with us through multiple iterations of the clinical protocol, and helped to create the final version which we will now implement in our studies. Without their generous assistance and continuous expert support, we would not be where we are now", said prof. Sergey Krasny MD, Ph.D., D.Sc., deputy director of the Alexandrov National Cancer Centre and corresponding member of the Belarus National Academy of Science. The study is unanimously approved by the Belarus Ministry of Health. The team of clinical scientists conducting the trial in Belarus will maintain constant contact and consistently exchange information with their colleagues in the US, EU, and Israel serving as observers and scientific co-authors to the study.

On December 15, 2019 Ally Bridge Group ("ABG"), a leading global life science investment group, reported that it has announced that it recently led investments in three new medical technology companies (Press release, Ally Bridge Group, DEC 15, 2019, View Source [SID1234552379]). Each of the three companies is a commercial-stage, leading innovator re-setting the standard of care in its respective category. They include:

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Imperative Care (Campbell, CA) — A company that is singularly dedicated to improving the way stroke is treated by advancing medical technology, equipping healthcare providers to evolve best practices and elevate the standard of care for stroke patients. Imperative Care has received FDA approval for its first families of access and aspiration catheters. Website: View Source
Venclose Medical (Santa Clara, CA) — A commercial-stage company developing next-generation solutions for the treatment of venous reflux disease, also known as chronic venous insufficiency. Venclose has been commercializing in the US and Europe since 2018. Website: View Source
Mavrik Dental Systems (Tel Aviv, Israel) — A company with proprietary technologies and products for in-office teeth whitening with unparalleled efficiency and outcomes, and gum care. Mavrik represents ABG’s first investment in an Israel-based company. Website: View Source
"Medtech, as with biotech, remains a must-invest sector for ABG, where we focus on best-in-class technologies to disrupt current standards of care," said Frank Yu, CEO and CIO of Ally Bridge Group. "The closing of these investments brings the aggregate amount of ABG-led private life science investments to above $500 mm over the last 18 months, which include ABG’s lead role in investments in Grail (early cancer detection), Pulmonx (interventional pulmonology), Quantum Surgical (interventional oncology). All of these companies, with the exceptions of one in Israel and one in France, are based in Silicon Valley, California, USA."

"Our active investments that leverage powerful synergies across private and public markets, coupled with our M&A knowhow and cross-border value-add, position ABG uniquely as a leading investor in late-stage best-in-class life science technologies", adds Yu.

On December 13, 2019 Anixa Biosciences, Inc. (NASDAQ: ANIX), a biotechnology company focused on harnessing the body’s immune system in the fight against cancer, reported an update regarding the chimeric antigen receptor T-cell (CAR-T) technology it is developing with its partner, Moffitt Cancer Center (Press release, Anixa Biosciences, DEC 13, 2019, View Source [SID1234552348]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Experimental results reported from the laboratory of Dr. Jose Conejo-Garcia, the inventor of Anixa’s CAR-T technology and the Chair of the Department of Immunology at Moffitt, indicate that the potential efficacy of this technology as a treatment for ovarian cancer could be greatly improved through additional genetic engineering.

CAR-T therapy begins with the extraction and isolation of T-cells from individual cancer patients. A viral vector is then used to transform these T-cells to produce on their surface a molecule that enables the cell, once re-infused into the patient, to find cancer cells and kill them. With Anixa’s CAR-T therapy, the T-cells are transformed to express on their surface, the follicle stimulating hormone (FSH), which targets cells that are expressing follicle stimulating hormone receptor (FSHR).

Dr. Conejo-Garcia’s recent experimental results indicate that with additional engineering, the transformed cells produced by the viral vector currently being used could express much higher levels of FSH, enabling a more potent cancer killer. In order to increase the potency of the transformed T-cells, researchers at Moffitt will create an improved viral vector and verify experimentally that it will result in a more powerful cancer therapy. As a result, the decision has been made to optimize the therapy and file an Investigational New Drug (IND) application with the US. Food and Drug Administration in the future. This optimization work may take an additional year, resulting in the filing of the IND in late 2020, with clinical trials to commence in 2021.

Dr. Amit Kumar, President and CEO of Anixa Biosciences stated, "While this new development may be disappointing to shareholders, we have decided that we want to go into the clinic with the best possible therapy. CAR-T technology has not worked in a clinically meaningful way for solid tumors. Making this change would result in a radically superior therapy and give us a dramatically greater chance of success against ovarian cancer, a solid tumor."

"These decisions are based on scientific developments. Our technology is the most cutting-edge science and as R&D results mandate, and for the welfare of patients, we must provide the best possible chance of success. The Anixa and Moffitt teams will strive to get into the clinic as soon as possible with the best possible therapy," commented Dr. Conejo-Garcia.

Dr. Robert Wenham, Chair of the Department of Gynecologic Oncology at Moffitt, and the investigator who will be leading the clinical trial, noted, "Mortality rates from ovarian cancer have not changed for decades, with most women relapsing after initial therapy. Based on the pre-clinical data and promise of this CAR-T therapy, I look forward to launching the clinical trial with the more optimized therapy in order to give our patients the best chance of a successful outcome."

On December 13, 2019 BeiGene, Ltd. (NASDAQ: BGNE; HKEX: 06160), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly-targeted and immuno-oncology drugs for the treatment of cancer, and Mirati Therapeutics (NASDAQ:MRTX), a clinical-stage targeted oncology company, reported preliminary data from an ongoing Phase 1b trial of investigational anti-PD-1 antibody tislelizumab in combination with investigational tyrosine kinase inhibitor sitravatinib in patients with platinum-resistant ovarian cancer, which demonstrated antitumor activity and was generally well tolerated (Press release, BeiGene, DEC 13, 2019, View Source [SID1234552364]). Results from the Phase 1b clinical trial were presented at the 2019 European Society for Medical Oncology Immuno-Oncology (ESMO I-O) Congress on December 13, 2019 in Geneva, Switzerland.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"Tislelizumab and sitravatinib have both demonstrated antitumor activity as single agents, so we’re encouraged by the early evidence showing the potential for these two agents to work together to treat advanced solid tumors, including platinum-resistant ovarian cancer," said Yong (Ben) Ben, M.D., Chief Medical Officer, Immuno-Oncology at BeiGene. "We continue to make progress in the collaboration with Mirati Therapeutics and we look forward to continued enrollment in the trial and further clinical data on the combination of tislelizumab and sitravatinib, a compound that has a unique tyrosine kinase inhibition profile."

"We were eager to enter into this collaboration with BeiGene because we believe sitravatinib, a spectrum-selective receptor tyrosine kinase inhibitor, may help increase the activity of anti-PD-1 antibodies such as tislelizumab in patients whose solid tumors exhibit resistance," said Charles M. Baum, M.D., Ph.D., President and Chief Executive Officer, Mirati Therapeutics, Inc. "The initial results from this Phase 1b trial suggest further development of this combination for the treatment of advanced solid tumors, including platinum-resistant ovarian cancer, is warranted."

Summary of Preliminary Results from the Phase 1b Trial in Platinum-Resistant Ovarian Cancer

Abstract 94O

This open-label, multi-center Phase 1b trial (NCT03666143) of tislelizumab in combination with sitravatinib consists of nine disease-specific cohorts in patients with advanced solid tumors. The results presented at ESMO (Free ESMO Whitepaper) I-O were from cohort E in 20 patients with recurrent platinum-resistant ovarian cancer who did not have prior exposure to anti-PD-1/PD-L1 agents. Patients were treated with tislelizumab at 200 mg IV every three weeks and sitravatinib at 120mg orally once daily. At the data cutoff of July 17, 2019, 17 patients were evaluable and preliminary results included:

Seven patients achieved a partial response (PR), including four confirmed PRs; the overall response rate (ORR) was 23.5% (4/17, 95% CI: 6.8%, 49.9%); eight patients achieved stable disease (SD);

The median duration of response (DoR) was not reached (95% CI: 12.29 weeks, not reached);

The median progression-free response (PFS) was 18 weeks (95% CI: 12.29 weeks, not reached), and the PFS rate at 3 months and 6 months was 88.2% (95% CI: 60.6%, 96.9%) and 35.3% (95% CI: 9.0%, 63.8%), respectively;

All 20 patients in this cohort experienced treatment-emergent adverse events (TEAEs) of any grade;

Fifteen patients (75%) experienced at least one grade ≥ 3 TEAE, with the most common being hypertension (25%) and fatigue (10%);

Immune-related TEAEs were hypothyroidism (20%), diarrhea (15%), and rash (15%);

Six patients (30%) discontinued the study treatment due to TEAEs; and

Two patients experienced TEAEs leading to death, abdominal pain and respiratory failure, both of which were considered unrelated to treatment by the study investigator.
BeiGene and Mirati entered into an exclusive license agreement for the development, manufacturing and commercialization of Mirati’s sitravatinib in Asia (excluding Japan), Australia, and New Zealand in January 2018. Clinical trials for tislelizumab and sitravatinib are ongoing in patients with non-small cell lung cancer, renal cell carcinoma, melanoma, hepatocellular cancer and gastric cancer.

About Tislelizumab

Tislelizumab (BGB-A317) is an investigational humanized IgG4 anti–PD-1 monoclonal antibody specifically designed to minimize binding to FcγR on macrophages. In pre-clinical studies, binding to FcγR on macrophages has been shown to compromise the anti-tumor activity of PD-1 antibodies through activation of antibody-dependent macrophage-mediated killing of T effector cells. Tislelizumab is the first drug candidate produced from BeiGene’s immuno-oncology biologics program and is being developed as a monotherapy and in combination with other therapies for the treatment of a broad array of both solid tumor and hematologic cancers.

Select ongoing clinical trials of tislelizumab include a Phase 3 clinical trial in patients with second-line or third-line non-small cell lung cancer (NSCLC); a Phase 3 clinical trial in first-line patients with hepatocellular carcinoma (HCC); a Phase 3 clinical trial in second-line patients with esophageal squamous carcinoma (ESCC); a Phase 3 clinical trial in first-line patients with gastric cancer (GC); a Phase 3 clinical trial in first-line patients with ESCC; and a Phase 2 clinical trial in second- or third-line patients with HCC. The aforementioned trials are enrolling patients in multiple countries, including the United States, Europe, and China.

In addition to a pivotal Phase 2 clinical trial in patients with relapsed or refractory (R/R) classical Hodgkin’s lymphoma (cHL) and a pivotal Phase 2 clinical trial in patients with locally advanced or metastatic urothelial cancer, BeiGene is conducting a Phase 3 clinical trial in first-line patients with non-squamous NSCLC; a Phase 3 clinical trial in first-line patients with squamous NSCLC; a Phase 3 clinical trial in patients with first-line nasopharyngeal cancer (NPC); a Phase 3 clinical trial in first-line patients with urothelial carcinoma (UC); a Phase 3 clinical trial in patients with localized ESCC; and a Phase 2 trial in patients with MSI-H or dMMR solid tumors. These studies have been enrolling patients primarily in China.

New drug applications (NDA) for tislelizumab in patients with R/R cHL and in patients with previously treated locally advanced or metastatic UC have been accepted and granted priority review by the China National Medical Products Administration (NMPA, formerly known as CFDA). BeiGene has full development and commercial rights to tislelizumab worldwide.

About Sitravatinib

Sitravatinib is an investigational spectrum-selective kinase inhibitor that potently inhibits receptor tyrosine kinases (RTKs), including TAM family receptors (TYRO3, Axl, Mer), split family receptors (VEGFR2, KIT) and RET. As an immuno-oncology agent, sitravatinib is being evaluated in combinations of anti-PD-1 checkpoint inhibitors, in patients whose cancers have progressed despite treatment with a checkpoint inhibitor. Sitravatinib’s potent inhibition of TAM and split family RTKs may overcome resistance to checkpoint inhibitor therapy through targeted reversal of an immunosuppressive tumor microenvironment, enhancing antigen-specific T cell response and expanding dendritic cell-dependent antigen presentation. Sitravatinib is being evaluated in multiple clinical trials to treat patients who are refractory to prior immune checkpoint inhibitor therapy, including the ongoing potentially registration-enabling Phase 3 trial of sitravatinib in combination with a checkpoint inhibitor in non-small cell lung cancer (NSCLC). In addition, sitravatinib combinations with checkpoint inhibitors are being evaluated in selected checkpoint inhibitor naïve patients.

Sitravatinib is also being evaluated as a single-agent in a Phase 1b expansion clinical trial emphasizing enrollment of patients whose tumors harbor specific mutations in the CBL protein. When CBL is inactivated by mutation, multiple RTKs, including TAM, VEGFR2 and KIT, are dysregulated and may act as oncogenic tumor drivers in NSCLC and melanoma.