On January 17, 2019 Roche (SIX: RO, ROG; OTCQX: RHHBY) reported that the US Food and Drug Administration (FDA) has accepted the company’s supplemental Biologics License Application (sBLA) for Tecentriq (atezolizumab) in combination with Abraxane [albumin-bound paclitaxel; nab-paclitaxel]) and carboplatin for the initial (first-line) treatment of people with metastatic non-squamous non-small cell lung cancer (NSCLC) who do not have EGFR or ALK genomic tumour aberrations (Press release, Hoffmann-La Roche, JAN 17, 2019, View Source [SID1234532700]). The FDA is expected to make a decision on approval by 2 September 2019.

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"We look forward to working with the FDA in order to bring this Tecentriq-based combination to people with non-squamous non-small cell lung cancer as soon as possible," said Sandra Horning, MD, Roche’s Chief Medical Officer and Head of Global Product Development. "Lung cancer is a challenging disease to treat, and this review takes us one step closer towards offering a new treatment option that has shown a clinically meaningful survival benefit in the treatment of this type of disease."

This sBLA is based on results from the Phase III IMpower130 study, which met its co-primary endpoints of overall survival (OS) and progression-free survival (PFS) in the initial treatment of people with metastatic non-squamous NSCLC.

The FDA recently approved Tecentriq in combination with Avastin, paclitaxel and carboplatin (chemotherapy) for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations. Tecentriq is also approved by the FDA to treat people with metastatic NSCLC who have disease progression during or following platinum-containing chemotherapy. Patients with EGFR or ALK genomic tumour aberrations should have disease progression on FDA approved therapy for NSCLC harbouring these aberrations prior to receiving Tecentriq.

About the IMpower130 study
IMpower130 is a Phase III, multicentre, open-label, randomised study evaluating the efficacy and safety of Tecentriq in combination with carboplatin and nab-paclitaxel versus chemotherapy (carboplatin and nab-paclitaxel) alone for chemotherapy-naïve patients with stage IV non-squamous NSCLC. The study enrolled 724 people who were randomised in a 2:1 ratio to receive:

Tecentriq plus nab-paclitaxel and carboplatin (Arm A), or
Nab-paclitaxel and carboplatin (Arm B, control arm)
During the treatment-induction phase, people in Arm A received Tecentriq and carboplatin on day 1 of each 21-day cycle, and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until loss of clinical benefit, whichever occurred first. People in Arm A received Tecentriq during the maintenance treatment phase until loss of clinical benefit was observed.

During the treatment-induction phase, people in Arm B received carboplatin on day 1 and nab-paclitaxel on days 1, 8 and 15 of each 21-day cycle for 4 or 6 cycles or until disease progression, whichever occurred first. People in Arm B received best supportive care during the maintenance treatment phase. Switch maintenance to pemetrexed was also permitted. People who were consented prior to a protocol revision were given the option to crossover following disease progression to receive Tecentriq as monotherapy until further disease progression.

The co-primary endpoints were:

PFS as determined by the investigator using RECIST v1.1 in people without EGFR or ALK mutations, assessed in the ITT-WT population
OS in the ITT-WT population
The IMpower130 study met its OS and PFS co-primary endpoints as per the study protocol. The interim analysis showed that Tecentriq plus chemotherapy helped people live significantly longer compared with chemotherapy alone (median OS=18.6 versus 13.9 months; hazard ratio [HR]=0.79; 95% CI: 0.64–0.98; p=0.033) in the intention-to-treat wild-type (ITT-WT) population.[1] The Tecentriq-based combination also significantly reduced the risk of disease worsening or death (PFS) compared with chemotherapy alone (median PFS=7.0 versus 5.5 months; HR=0.64; 95% CI: 0.54–0.77; p<0.0001) in the ITT-WT population.[1] Safety for the Tecentriq plus chemotherapy combination appeared consistent with the known safety profiles of the individual medicines, and no new safety signals were identified with the combination. Grade 3-4 treatment-related adverse events (AEs) were reported in 73.2% of people receiving Tecentriq plus chemotherapy compared to 60.3% of people receiving chemotherapy alone.

About NSCLC
Lung cancer is the leading cause of cancer death globally.2 Each year 1.76 million people die as a result of the disease; this translates into more than 4,800 deaths worldwide every day.[2] Lung cancer can be broadly divided into two major types: NSCLC and small cell lung cancer. NSCLC is the most prevalent type, accounting for around 85% of all cases.[3] NSCLC comprises non-squamous and squamous-cell lung cancer, the squamous form of which is characterised by flat cells covering the airway surface when viewed under a microscope.[3]

About Tecentriq
Tecentriq is a monoclonal antibody designed to bind with a protein called PD-L1 expressed on tumour cells and tumour-infiltrating immune cells, blocking its interactions with both PD-1 and B7.1 receptors. By inhibiting PD-L1, Tecentriq may enable the activation of T cells. Tecentriq has the potential to be used as a foundational combination partner with cancer immunotherapies, targeted medicines and various chemotherapies across a broad range of cancers.

Currently, Roche has nine Phase III lung cancer studies evaluating Tecentriq alone or in combination with other medicines.

Tecentriq is already approved in the European Union, United States and more than 85 countries for people with previously treated metastatic NSCLC and for certain types of untreated or previously treated metastatic urothelial carcinoma (mUC). Tecentriq was also recently approved in the United States for the initial treatment of people with metastatic non-squamous NSCLC with no EGFR or ALK genomic tumour aberrations.

About Roche in cancer immunotherapy
For more than 50 years, Roche has been developing medicines with the goal to redefine treatment in oncology. Today, we’re investing more than ever in our effort to bring innovative treatment options that help a person’s own immune system fight cancer.

By applying our seminal research in immune tumour profiling within the framework of the Roche-devised cancer immunity cycle, we are accelerating and expanding the transformative benefits with Tecentriq to a greater number of people living with cancer. Our cancer immunotherapy development programme takes a comprehensive approach in pursuing the goal of restoring cancer immunity to improve outcomes for patients

On January 17, 2019 Actinium Pharmaceuticals, Inc. (NYSE AMERICAN: ATNM) reported that it has successfully completed the first module of its previously announced research and option agreement with Astellas Pharma Inc. Within the collaboration, the Company is using its Actinium Warhead Enabling (AWE) Platform to conjugate and label select Astellas targeting agents with the potent actinium-225 (Ac-225) payload (Press release, Actinium Pharmaceuticals, JAN 17, 2019, View Source [SID1234532701]).

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"This collaboration represents Actinium and Astellas’ shared commitment to employ cutting-edge technology in the research of new drug candidates for patients. Therefore, we are delighted that Astellas has opted to progress our ground-breaking collaborative research activities to the next stage of research," said Dr. Dale Ludwig, Actinium’s Chief Scientific Officer. "I am very pleased with the results we have generated in our efforts with Astellas to date, which I believe showcase the capabilities of our AWE Platform Technology. My team and I are excited to execute the next module of the collaboration and are optimistic that we will continue to move the program forward."

Since launching its AWE Program in November 2017, Actinium has achieved a number of milestones including:

Appointed Dr. Dale Ludwig, a leading antibody therapeutics and antibody conjugate expert, as Chief Scientific Officer
Presented positive data at ASH (Free ASH Whitepaper) 2017 demonstrating the superior in vitro cell killing properties of Ac-225 labeled daratumumab or Darzalex, Johnson & Johnson’s blockbuster CD38 targeting therapy for multiple myeloma
Presented additional positive data from in vivo animal studies at AACR (Free AACR Whitepaper) 2018 demonstrating enhanced tumor control and survival with Ac-225 labeled daratumumab
Signed collaborative research and option agreement with Astellas
Actinium’s Chairman and Chief Executive Officer Sandesh Seth added, "Actinium’s AWE technology platform encompasses not only our Ac-225 payload but also our intellectual property, know-how, clinical experience, and exoskeleton of a commercial supply chain that uniquely positions us in the industry. The strong execution of this collaboration thus far showcases Actinium’s expanded R&D capabilities that give us great excitement for what we can accomplish in the future with our team and technology. Combined with the continued clinical progress across our pipeline, particularly our pivotal Phase 3 trial for Iomab-B and expansion of our CD33 program into targeted conditioning and new disease indications, we are motivated to capitalize on the significant opportunities that lie ahead of us."

About Actinium Warhead Enabling Platform Technology

The Actinium Warhead Enabling (AWE) Program has at its centerpiece the AWE Platform Technology. The Company’s proprietary AWE Platform Technology is supported by intellectual property and know-how that enables the creation of Actinium-225 (Ac-225) Radio-Conjugates (ARCs) wherein a biomolecular targeting agent is stably labeled with the powerful Ac-225 payload to enhance targeted cell killing. The AWE Platform is protected by intellectual property covering the use of the "gold standard" chelator DOTA, and any conceivable derivative thereof. Additionally, Actinium holds intellectual property protection covering methods of chelation or labeling of the targeting agent with Ac-225, including newer next-generation methodologies for chelation of Ac-225.

The AWE Program is structured to provide the opportunity for partners or collaborators to derive maximum value from a collaboration by leveraging Actinium’s extensive technical know-how, access to its ARC drug development infrastructure and to its underlying AWE Platform Technology. The AWE Program provides a partner or collaborator with access to Actinium’s knowledge bank and infrastructure allowing collaborators to benefit from accelerated development timelines for its ARCs.

To learn more about the AWE Technology Platform or the AWE Program please contact Eileen Geoghegan, Ph.D., at [email protected].

On January 16, 2019 NeoImmuneTech, Inc., an immunotherapy drug development company focused on advanced cancer treatments, and Genexine, reported that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug (IND) application to evaluate the combination of Hyleukin-7 (IL-7-hyFc) and atezolizumab (Tecentriq) in patients with high-risk skin cancers (Press release, NeoImmuneTech, JAN 16, 2019, View Source [SID1234532681]).

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The phase 1b/2a clinical study will be led by NeoImmuneTech and the Immune Oncology Network (ION), a network of clinical research investigators from leading cancer centers and universities in North America that conducts multicenter trial of high priority immunotherapy agents. The purpose of this study is to evaluate the safety and preliminary anti-tumor activity of Hyleukin-7 in combination with Tecentriq in approximately 80 patients with anti-PD-(L)1 naïve or relapsed/refractory high-risk skin cancers. The planned multi-center open-label trial will be conducted in the US. ION is headquartered at the Fred Hutchinson Cancer Research Center in Seattle Washington.

Martin A. "Mac" Cheever, M.D., Director of ION and the National Cancer Institute’s Cancer Immunotherapy Trials Network had stated, "Hyleukin-7 has shown in multiple studies to substantially increase the total body complement of T cells with little toxicity. Hyleukin-7 is designed to be effective when used in concert with a variety of different immunotherapy regimens, including the combination with anti-PD-(L)1 that is being tested in this trial."

"Patients with high-risk skin cancers have very poor prognosis and limited treatment options," NgocDiep Le, M.D.,Ph.D., NeoImmuneTech Chief Medical Officer added. "Although anti-PD-1/PD-L1, including Tecentriq, can induce remarkable responses in a subset of patients with skin cancers, PD-(L)1 blockade fails to induce complete responses in most patients, especially those with low tumor infiltrating lymphocytes. Based on the mechanism of action of Hyleukin-7, we believe that combining Hyleukin-7 with a checkpoint inhibitor, such as Tecentriq, would increase the frequency and/or depth of responses to PD-1/PD-L1 inhibition."

Brian Gastman, M.D., the Principal Investigator of this trial, a surgeon and otolaryngologist of Cleveland Clinic, a member of ION, also said, "With the exciting advances in checkpoint inhibitor-based immunotherapy, we are at an inflection point to identify the next generation of cancer treatments to enhance both survival outcome and quality of life for our patients. Hyleukin-7 has all of the aspects of a therapy that should work to enhance current immunotherapies especially in the various high-risk skin cancer patient populations. I am personally excited to witness this class of drug entering the clinical trial phase as the pre-clinical results have been so promising and the need for an additional novel immunotherapy class of drugs has never been so pressing."

About Hyleukin-7TM
Hyleukin-7 TM (rhIL-7-hyFc, NT-I7), an immuno-oncology agent, is a T cell amplifier comprising a covalently linked homodimer of engineered Interleukin-7 (IL-7) molecule, biologically fused with the proprietary long-acting platform – hyFc. IL-7 is known to be a critical factor for T cells, acting to increase both the number and functionality of T cells. Hyleukin-7 could play a pivotal role in reconstituting and reinvigoratiing T cell immunity in the treatment of patients with cancer and lymphopenia, as well as providing unique opportunities for immuno-oncology (IO) combination strategies. Hyleukin-7 is being developed as an "IO enabling" therapy to harness T cell immunity in combination with current cancer treatments such as anti-PD-(L)1 agents or chemo/radiotherapy. NeoImmuneTech and Genexine, Inc. (Genexine) are collaborating for clinical trials in advanced solid tumors, glioblastoma, etc. in the US and Korea.

On January 16, 2019 Generex Biotechnology Corporation (www.generex.com) (OTCQB:GNBT) (View Source) reported an agenda for the investor conference call to be presented today, Wednesday January 16, at 4:00 p.m. Eastern time (Press release, Generex, JAN 16, 2019, View Source [SID1234532682]). Joseph Moscato, Chief Executive Officer of Generex will outline the company’s strategic and financial plans, including details on financing transactions pertaining to the previously reported acquisitions of the Veneto Group assets and Olaregen. Additionally, Mr. Moscato will review the recent anticipated acquisitions of several profitable and innovative companies in the medical and surgical supply business, which include Pantheon Medical, MediSource, and most recently, Fuse Medical, a publicly traded company with nearly $30 million in projected annual revenues. In addition, Generex has signed a letter of intent for $15 million equity line of credit on more favorable terms than the equity line of credit previously reported.

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Importantly, tomorrow, January 17, 2019 (the report date), Generex will declare a dividend in the company’s wholly-owned subsidiary, NuGenerex Immuno-Oncology (formerly Antigen Express). The dividend will be structured such that for every 4 shares of Generex stock held on February 25, 2019 (the projected dividend payment date), investors will receive 1 share of NuGenerex Immuno-Oncology. Immediately following the dividend payout, Generex plans to list NuGenerex Immuno-Oncology on a public exchange. Additional details on this dividend will be provided on the conference call and in subsequent announcements.

"Generex is advancing our strategic initiatives to build value for our investors," stated Mr. Moscato. "And we are very happy to announce that Generex has signed a Letter of Intent to acquire Fuse Medical, subject to completed due diligence. The transaction has been structured as an all-stock deal valued at $34 million of Generex common stock at $2.50 per share with the potential for earnouts based on certain performance in 2019. The deal is not dilutive to our shareholders, as the payment is being made from the Generex pool shares that are described in the December 4, 2018 8K filing. Fuse is a publicly-traded surgical supply company with revenues approaching $30 million and EBITDA of approximately $5 million. The company distributes a broad portfolio of specialty surgical products to healthcare providers nationwide, bringing not only sales and distribution channels, but also a network of customers that will advance the Generex mission to deliver innovative end-to-end solutions to our healthcare partners, physicians, and patients. I will provide details on these potential acquisitions as well as on our plan to further expand the company’s footprint through the acquisition of a health system management company with a network of 13 hospitals in several states."

Mr. Moscato continued, "I am also pleased to announce that we have been able to restructure our $35 million debt obligation in a timely manner with the Veneto Group partners, through an agreement on the payment of $15.75 million in Generex common stock at the up-market price of $2.50 per share, that satisfies a significant portion of the $35 million obligation, plus $20 million in cash or stock to follow within 90 Days. The payment to the Veneto Group partners is being made with already accounted for shares in the Generex pool (See 8K on 12/4/18), which is non-dilutive to our current shareholders, as the total number of outstanding shares and capital structure remain the same. Additional information will be discussed at the conference call, followed by an 8k filing. The stock transaction demonstrates the Veneto Groups confidence in our strategic growth plan, because the deal is at a significant premium to our current market valuation. In addition to the Veneto deal, we have agreed to increase the Generex ownership of Olaregen Therapeutix, our regenerative medicine subsidiary, from 51% to approximately 72% through an agreement to acquire all of Olaragen’s outstanding Series A Preferred Stock in exchange for Generex stock and a second payment of either stock or cash. Again, these stock transactions are non-dilutive to our current shareholders, and reserve cash for advancing the company’s strategic plans. Further, we are in discussions with the remaining Olaregen shareholders to acquire up to 100% of the company."

Lastly, by the end of the month, Generex expects to receive the final audit report on the direct to patient pharmacy network, which the company had previously announced in a letter of intent to acquire the network of pharmacies and IT systems. The audit report will enable Generex to finalize the terms and price of the acquisition, thereby providing a path toward integration of the pharmacy network into NuGenerex Distribution Solutions in the near future. "We’re excited about the opportunity to potentially expand our pharmacy network that ultimately will enhance our distribution and direct to patient capabilities. We look forward to integrating the pharmacy’s cutting edge database systems and operational capabilities to grow our Distribution Solutions business with by introducing a number of innovative pharmacy programs," stated Terry Thompson, COO of Generex and President of NuGenerex Distribution Solutions.

On the conference call, Mr. Moscato will provide more in depth details on the Company’s financing initiatives, an overview of the recent potential acquisitions in the medical & surgical supply business, an update on the impending commercial launch of Olaregen’s wound healing product Excellagen, and a review of the pending acquisition of the pharmacy network, IT systems, and direct to patient databases. Mr. Moscato will also provide information regarding the dividend and spin out of NuGenerex Immuno-Oncology, and will wrap up the call with an update on the plan for up-listing Generex to a major stock exchange. Generex will be filing 8Ks with the SEC covering the information shared on the conference call and in corporate communications.

Mr. Moscato concluded, "As always, we will leave sufficient time at the end of call to address any and all questions from our loyal Generex shareholders, and I look forward to an informative discussion on Wednesday afternoon."

The access information for the investor conference call is as follows:

Wednesday January 16, at 4:00 p.m. Eastern time

Domestic US/Canada – 1-(866) 342-8588

Direct Toll / International – 1-(203) 518-9865

Conference ID – 85014

On January 16, 2019 Mirati Therapeutics, Inc. (Nasdaq: MRTX) reported that it intends to offer and sell, subject to market and other conditions, $75.0 million of shares of its common stock in an underwritten public offering (Press release, Mirati, JAN 16, 2019, View Source [SID1234532703]). Mirati expects to grant the underwriters a 30-day option to purchase up to an additional $11.25 million of shares of its common stock. All of the shares are being offered by Mirati. 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.

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J.P. Morgan Securities LLC, Citigroup Global Markets Inc., Cowen and Company, LLC, Barclays Capital Inc. and Credit Suisse Securities (USA) LLC are acting as joint book-running managers in the offering.

The securities described above are being offered by Mirati pursuant to a shelf registration statement filed by Mirati with the Securities and Exchange Commission ("SEC") that became automatically effective upon filing. A preliminary prospectus supplement and accompanying prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website located at View Source Copies of the preliminary prospectus supplement and the accompanying prospectus relating to the offering, when available, may be obtained from J.P. Morgan Securities LLC, Attention: Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204, or by email at [email protected]; from Citigroup Global Markets Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (800) 831-9146; from Cowen and Company, LLC, c/o Broadridge Financial Services, 1155 Long Island Avenue, Edgewood, NY, 11717, Attn: Prospectus Department, or by calling (631) 274-2806; from Barclays Capital Inc., c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by calling (888) 603-5847, or by email at [email protected]; or from Credit Suisse Securities (USA) LLC, Attention: Prospectus Department, One Madison Avenue, New York, NY 10010, or by telephone at (800) 221-1037, or by email at [email protected].

This press release shall not constitute an offer to sell or the 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.