On January 22, 2018 Nymox Pharmaceutical Corporation (NASDAQ:NYMX) reported today top-line 5-year results from Nymox’s U.S. Study NX03-0040. Study NX03-0040 was undertaken starting in 2012 at 44 investigational sites across the U.S. comprising a highly representative sample of 146 men with the biopsy confirmed diagnosis of T1c prostate cancer, which is the most common type of low grade localized prostate cancer (Press release, Nymox, JAN 22, 2018, View Source [SID1234523418]). After 5 years, the study has now shown that high dose Fexapotide 15mg single dosage treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and that both doses of Fexapotide (15mg and 2.5mg) were consistently effective (p=.0003). There were 4.4% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3% (p=.0061).

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Paul Averback MD, CEO of Nymox, said, "These major new results show the beneficial long-term effect of a single injection of Fexapotide Triflutate. The results are expected to be even better with regimens of additional or multiple treatment administrations if required."

In the studies Fexapotide triflutate was administered by a single painless injection directly into the prostate requiring several minutes or less in an office procedure guided by routine ultrasound. The drug was injected into the area of the prostate where the cancer was previously detected prior to enrollment in NX03-0040; and repeated biopsies every 18 months, serial PSA measurements and long-term follow-up were performed on all consenting treated patients and controls. After 5 years of study, high dose Fexapotide 15mg single treatment resulted in 80% less surgery or radiotherapy associated with Gleason grade progression (p=.0003), and both doses of Fexapotide (15mg and 2.5mg) were consistently effective (p=.0003). There were 4.4% patients in the entire Fexapotide group who showed increase in their Gleason primary pattern grade in the 5-year study, compared to controls where the incidence of grade 4 or higher primary pattern was 23.5%, a reduction of 81.3% (p=.0061). The new study results also indicated that after 5 years of study, all recorded instances of surgery or radiotherapy, including elective cases without Gleason upgrades, were decreased by 69.8% (p=.0002) in Fexapotide 15mg treated patients compared to the randomized control group.

Dr. Averback added, "Eight years of other related U.S. long-term Phase 3 BPH studies of Fexapotide have shown reduction in new prostate cancer incidence to 1.2%, compared to previous large BPH studies of earlier drugs where the incidence of prostate cancer is in the 10-20% range. There are therefore 2 different long-term Fexapotide programs which have now each independently shown that Fexapotide has a significant and highly beneficial effect for men with prostate cancer."

"These strong results clearly support Management’s ongoing efforts to advance both of the Company’s 2 major projects towards marketing goals. Nymox expects to report further on its U.S. development plans for registration trials for low grade prostate cancer. There is a global unmet medical need for more effective prostate treatments without the undesirable side effects of current treatments," he said.

One of the major problems with the main current prostate treatments for localized prostate cancer (radical prostatectomy, external beam radiation, brachytherapy) is the relatively high incidence of serious sexual problems post-treatment. In 9 studies, Fexapotide treatment has been shown to have a negligible significant adverse effect post-treatment on sexual function or testosterone levels.

Prostate cancer is the most commonly diagnosed cancer in men, other than skin cancer, and is the second leading cause of cancer death for men. Approximately 50% of prostate cancers are initially considered low risk.

Fexapotide has shown significant long-term benefit for prostate enlargement (benign prostatic hyperplasia, BPH). The recent results of Phase 3 studies of Fexapotide for BPH were communicated in podium and symposium presentations to the American Urological Association at four sectional Annual Meetings in 2017 in Scottsdale (North Central AUA November 15, 2017), Havana, (New York AUA November 6, 2017), Naples (South Central AUA November 27, 2017), and Savannah (Northeastern AUA October 12, 2017). The Company has filed for approval for Fexapotide in Europe for BPH for prostate enlargement in 2017, and the filing was validated in September 2017.

For more information please contact [email protected] or 800-936-9669.

On January 22, 2018 Sanofi and Bioverativ Inc., a biopharmaceutical company focused on therapies for hemophilia and other rare blood disorders, reported that they have entered into a definitive agreement under which Sanofi will acquire all of the outstanding shares of Bioverativ for $105 per share in cash, representing an equity value of approximately $11.6 billion (on a fully diluted basis) (Press release, Sanofi, JAN 22, 2018, View Source [SID1234523419]). The transaction was unanimously approved by both the Sanofi and Bioverativ Boards of Directors.

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"With Bioverativ, a leader in the growing hemophilia market, Sanofi enhances its presence in specialty care and leadership in rare diseases, in line with its 2020 Roadmap, and creates a platform for growth in other rare blood disorders. Together, we have a great opportunity to bring innovative medicines to patients worldwide, building on Bioverativ’s success in driving new standards of care with its extended half-life factor replacement therapies," commented Olivier Brandicourt, Sanofi’s Chief Executive Officer. "Combined, we will continue to leverage our scientific know-how, disciplined focus and development expertise that best position us to drive value for our shareholders and create breakthrough treatments for patients."

Bioverativ Chief Executive Officer, John Cox, noted, "Bioverativ was created to bring meaningful progress to people living with hemophilia and other rare blood disorders, and I am extremely proud of the accomplishments we’ve made toward that mission over the past year. We have expanded upon the success of Eloctate and Alprolix, which are making a difference in the lives of people with hemophilia every day, and built a pipeline of novel programs for people with rare blood disorders. Sanofi brings proven capabilities and a global infrastructure, which we believe will help to more rapidly expand access to our medicines globally and further our mission of transforming the lives of people with rare blood disorders. Our Chairman, Brian Posner, our entire Board and I strongly believed our spin-off would create meaningful value for shareholders, and this transaction delivers tremendous value for the shareholders who have invested in and supported our mission."

Business EPS is a non-GAAP financial measure (see appendix to Sanofi quarterly financial release for definitions)
Creating a Leading Hemophilia Portfolio

With approximately $10 billion in annual sales and 181,0002 people affected worldwide, hemophilia represents the largest market for rare diseases and is expected to grow above 7%3 per year through 2022. Treatment options for patients are shaped by shifting standards of care worldwide and include prophylaxis and extended half-life products, and the development and adoption of innovative therapies.

Bioverativ’s extended half-life therapies, Eloctate [Antihemophilic Factor VIII (Recombinant), Fc Fusion Protein] and Alprolix [Coagulation Factor IX (Recombinant), Fc Fusion Protein] for the treatment of hemophilia A and B, respectively, represented the first major advancements in the hemophilia market in nearly two decades when launched. In 2016, Bioverativ generated $847 million in sales and $41 million in royalties.

Bioverativ currently markets the two products in the United States, Japan, Canada and Australia, and plans to expand into additional geographies. The therapies are also commercialized in the European Union and other countries under a collaboration agreement.

Sanofi believes factor replacement therapy will remain the standard of care in hemophilia for many years due to excellent safety and its increasingly superior long-acting profile. Sanofi will be able to leverage Bioverativ’s clinical expertise and existing commercial platform to advance fitusiran, an investigational RNA interference (RNAi) therapeutic for hemophilia A and B, with or without inhibitors. Sanofi recently announced a restructuring of its rare disease alliance with Alnylam Pharmaceuticals, with Sanofi obtaining global development and commercialization rights to fitusiran.

Strengthening Sanofi’s Specialty Care Portfolio

One of the priorities of Sanofi’s 2020 roadmap is to "Reshape the Portfolio" and focus on areas where the company currently has, or can effectively build, a leadership position. The addition of Bioverativ supports this priority by adding to our portfolio a differentiated offering of innovative therapies and providing a platform for growth in rare blood disorders, which will expand our presence in specialty care, further strengthen our leadership position in rare diseases and meet the needs of the patient community.

Beyond its two marketed products, Bioverativ’s pipeline includes a program in Phase 3 testing for cold agglutinin disease, and early stage research programs and collaborations in hemophilia, and other rare blood disorders, including sickle cell disease and beta thalassemia. Sanofi’s R&D organization will support Bioverativ in bringing these important therapies to patients faster. Furthermore, Sanofi’s global presence, proven expertise and success in launching specialty medicines, and established footprint in key emerging markets will help Bioverativ fully capitalize on growth opportunities for Bioverativ’s current and future products.

Delivering Shareholder Value

The addition of Bioverativ is expected to drive meaningful value for Sanofi’s shareholders, with strong cash flows from Bioverativ’s growing products expected to increase Sanofi’s financial and operational scale. The acquisition is expected to be immediately accretive to Sanofi’s Business EPS in FY2018 and up to 5% accretive in FY2019. Sanofi is also projected to achieve ROIC in excess of cost of capital within three years. Sanofi expects to preserve its strong credit rating.

Source: WFH 2016, MRB 2016, ATHN 2016, Evaluate Pharma
Note that the total estimated population with hemophilia is larger at ~400,000 estimated patients versus ~181,000 identified patients

Source: WFH 2016, MRB 2016, ATHN 2016, Evaluate Pharma
Transaction Terms

Under the terms of the merger agreement, Sanofi will commence a tender offer to acquire all of the outstanding shares of Bioverativ common stock at a price of $105 per share in cash. The $105 per share acquisition price represents a 64 percent premium to Bioverativ’s closing price on January 19, 2018.

The consummation of the tender offer is subject to various conditions, including the tender of at least a majority of the outstanding Bioverativ shares, redelivery of a tax opinion delivered at signing, the expiration or termination of the waiting period under the Hart Scott Rodino Antitrust Improvements Act and receipt of certain other regulatory approvals, and other customary conditions. Following the successful completion of the tender offer, a wholly owned subsidiary of Sanofi will merge with Bioverativ and the outstanding Bioverativ shares not tendered in the tender offer will be converted into the right to receive the same $105 per share in cash paid in the tender offer. The tender offer is expected to commence in February 2018.

Sanofi plans to finance the transaction with a combination of cash on hand and through new debt to be raised. The tender offer is not subject to any financing condition. Subject to the satisfaction or waiver of customary closing conditions, the transaction is expected to close within three months.

Lazard is acting as exclusive financial advisor to Sanofi. Guggenheim Securities and J.P. Morgan Securities LLC are acting as financial advisors to Bioverativ. Weil, Gotshal & Manges LLP is serving as legal counsel to Sanofi. Paul, Weiss, Rifkind, Wharton & Garrison LLP is serving as legal counsel to Bioverativ.

Conference Call

Sanofi will host a webcast live on Sanofi’s website at 2:00 pm CET/8:00 am EST on Monday, January 22, 2018. The webcast details and full presentation will be made available on Sanofi’s Investor Relations webpage.

On January 22, 2018 Seattle Genetics, Inc. (Nasdaq: SGEN) reported that its collaborator, Takeda Pharmaceutical Company Limited, announced that the European Commission has extended the current conditional marketing authorization for ADCETRIS (brentuximab vedotin) to include the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy (Press release, Seattle Genetics, JAN 22, 2018, View Source;p=RssLanding&cat=news&id=2327637 [SID1234523420]). ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, which is expressed on the surface of Hodgkin lymphoma cells and several types of non-Hodgkin lymphoma, including CTCL. The decision follows a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) on November 9, 2017.

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"CTCL is a debilitating and disfiguring disease with few effective and durable treatment options," said Clay Siegall, Ph.D., President and Chief Executive Officer at Seattle Genetics. "The approval of ADCETRIS for use in the European Union in CD30-positive CTCL patients represents a meaningful advance for patients with CTCL. We are pleased that our partner Takeda is able to make this therapeutic option available to patients in Europe. Since ADCETRIS was first approved by the FDA in 2011, Seattle Genetics and Takeda have made significant progress in our goal to establish ADCETRIS as the foundation of care for CD30-expressing lymphomas, and we are working together on our next milestone of securing FDA approval and European Union marketing authorization for ADCETRIS’ use as a treatment for frontline advanced Hodgkin lymphoma."

The marketing authorization for ADCETRIS is valid in 28 countries of the European Union (EU), Norway, Liechtenstein and Iceland. It is based on positive results from a phase 3 trial called ALCANZA that were presented at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) annual meeting in December 2016, published online in the Lancet in June 2017, and recently updated in a poster presentation at the 59th ASH (Free ASH Whitepaper) annual meeting in December 2017. The trial achieved its primary endpoint with the ADCETRIS treatment arm demonstrating a highly statistically significant improvement in the rate of objective response lasting at least four months (ORR4) versus the control arm as assessed by an independent review facility. The ORR4 was 56.3 percent in the ADCETRIS arm compared to 12.5 percent in the control arm (p-value <0.001). The key secondary endpoints specified in the protocol, including complete response rate, progression-free survival and reduction in skin symptom burden as measured by the Skindex-29 questionnaire, were all highly statistically significant in favor of the ADCETRIS arm. The safety profile associated with ADCETRIS from the ALCANZA trial was generally consistent with the existing prescribing information. The most common adverse events of any grade include: anemia, peripheral sensory neuropathy, nausea, diarrhea, fatigue and neutropenia.

For further details about the European Commission decision, please visit the European Medicines Agency website: www.ema.europa.eu/ema.

In November 2017, the U.S. Food and Drug Administration (FDA) approved ADCETRIS for the treatment of adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy based on the results of the phase 3 ALCANZA clinical trial. Together, pcALCL and CD30-expressing MF comprise approximately 70 percent of CTCL diagnoses and the majority of patients who require systemic therapy. ADCETRIS is currently not approved as a frontline therapy for Hodgkin lymphoma.

About CTCL

Lymphoma is a general term for a group of cancers that originate in the lymphatic system. There are two major categories of lymphoma: Hodgkin lymphoma and non-Hodgkin lymphoma. Cutaneous lymphomas are a category of non-Hodgkin lymphoma that primarily involve the skin. According to the Cutaneous Lymphoma Foundation, CTCL is the most common type of cutaneous lymphoma and typically presents with red, scaly patches or thickened plaques of skin that often mimic eczema or chronic dermatitis. The most common subtypes of CTCL include mycosis fungoides and primary cutaneous anaplastic large cell lymphoma. Progression from limited skin involvement may be accompanied by skin tumor formation, ulceration and exfoliation, complicated by itching and infections. Advanced stages are defined by involvement of lymph nodes, peripheral blood and internal organs. The standard treatment for CTCL patients includes skin-directed therapies, radiation and systemic therapies. Prior to the FDA approval of ADCETRIS, systemic therapies approved for treatment demonstrated 30 to 45 percent objective response rates, with low complete response rates.

About ADCETRIS

ADCETRIS is being evaluated broadly in more than 70 clinical trials, including three phase 3 studies: the completed ECHELON-1 trial in frontline classical Hodgkin lymphoma that supported the recent FDA Breakthrough Therapy Designation and submission of the supplemental Biologics License Application (BLA) for use in this setting, the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, and the ongoing CHECKMATE 812 trial of ADCETRIS in combination with Opdivo (nivolumab) for relapsed/refractory Hodgkin lymphoma.

ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells.

ADCETRIS injection for intravenous infusion has received FDA approval for four indications: (1) regular approval for adult patients with primary cutaneous anaplastic large cell lymphoma (pcALCL) or CD30-expressing mycosis fungoides (MF) who have received prior systemic therapy, (2) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (3) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (4) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials.

Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL in 2013, and non-conditional approval for post-ASCT consolidation treatment of Hodgkin lymphoma patients at increased risk of relapse or progression.

ADCETRIS received conditional marketing authorization from the European Commission for four indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, (2) the treatment of adult patients with relapsed or refractory sALCL, (3) for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT, and (4) for the treatment of adult patients with CD30-positive cutaneous T-cell lymphoma (CTCL) after at least one prior systemic therapy.

ADCETRIS has received marketing authorization by regulatory authorities in 70 countries for relapsed or refractory Hodgkin lymphoma and sALCL. See important safety information below.

Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs.

On January 22, 2018 TLC (4152.TT) reported that it has signed an agreement with Jixi Biotechnology Partners to form a joint venture in TLC Biopharmaceuticals (H.K.) Limited (TLCHK) with the purpose to conduct clinical studies, register, and commercialize TLC’s pipeline for the China market (Press release, Taiwan Liposome Company, JAN 22, 2018, View Source [SID1234523434]).

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The new partnership’s efforts will take place pursuant to recent reforms by the China Food and Drug Administration office (CFDA), which include initiatives designed to accelerate drug approvals and encourage innovation, including greater alignment of China’s review process with that of the US and the EU.

"We are delighted to be collaborating with Jixi Biotechnology, which has resources and networks in regulatory affairs and commercialization in this critically important territory," says TLC President George Yeh. "This is an important step forward in our support toward China’s ongoing healthcare reforms and is a milestone in our efforts to address the needs of patients worldwide."

Under the terms of the agreements, TLC is entitled to receive US$20 million from Jixi Biotechnology in exchange for a minority stake in TLCHK and TLC will initially retain a majority stake in TLCHK. TLC will grant an exclusive right to TLCHK in the clinical trials, registration and commercialization of TLC’s products and product candidates in China. Upon the achievement of certain milestones prior to obtaining drug approval, Jixi Biotechnology will have the option to acquire additional stakes in exchange for aggregate payments of an additional US$50 million to TLC. Moreover, if TLCHK further fulfills certain corporate events, TLC would also be entitled to an additional payment up to US$60 million.

TLC’s pipeline focuses on the pain management, ophthalmology, and oncology spaces. The leading product candidate, TLC599, is a sustained release dexamethasone injection which has the potential to alleviate pain suffered by some of the estimated 42 million people with knee osteoarthritis in China. TLC399 is a sustained release dexamethasone injection which aims to treat macular edema due to retinal vein occlusion, a disease estimated to affect around 7.4 million patients in China. TLC590 is a sustained release post-surgical analgesic which has the potential to manage pain following surgical operations, of which there are nearly 40 million in China per year. TLC178 is a liposomal formulation of the anticancer drug vinorelbine which has received a Rare Pediatric Disease Designation from the FDA for rhabdomyosarcoma, which will qualify TLC178 in this indication for priority review in the US and may result in the granting of a transferable Priority Review Voucher that can reduce the standard ten-month FDA review time to six months. TLC has two approved products in oncology which are branded generics or off-patent drugs, a fast-growing sector in China.

On January 22, 2018 The biopharmaceutical company MOLOGEN AG (ISIN DE0006637200; Frankfurt Stock Exchange Prime Standard: MGN) reported data on its lead compound, the TLR9 agonist and immune surveillance reactivator lefitolimod, at the Annual 2018 Gastrointestinal Cancers Symposium (ASCO GI) in San Francisco (18 – 20 January 2018) (Press release, Mologen, JAN 22, 2018, View Source [SID1234523467]).

Monotherapy with lefitolimod resulted in a beneficial modulation of the tumor microenvironment (TME) associated with a reduced tumor growth in a murine model of colorectal cancer. The beneficial lefitolimod-induced modulation of the TME strongly supports its potential as cancer immunotherapeutic agent. Hence, in addition to its potential in monotherapy, lefitolimod may also be an ideal partner for immuno-oncology combination approaches, i.e. with checkpoint inhibitors.

"Beneficial modulation of the TME, in other words making immunologically "cold" tumors "hot", is a crucial requirement for the response to immunotherapeutic approaches. The presented data clearly support the mode-of-action of lefitolimod in our late-stage IMPALA study with single-agent lefitolimod in colorectal cancer. In addition they provide an excellent rationale for combining lefitolimod with checkpoint inhibitors. We know that checkpoint inhibitors need help to fully unfold their enormous potential and we believe that our TLR9 agonist lefitolimod will play a major role also in this context", said Dr Matthias Baumann, CMO of MOLOGEN AG.

Beneficial lefitolimod-induced modulation of the TME

After intratumoral injection of lefitolimod an increased infiltration of T cells (CD3+ T cells, especially CD8+ T cells) into the tumor was observed. Furthermore, also an increase of activated CD8+ T cells with cytolytic ("cell destruction capability") potential was determined. In addition, the injection of lefitolimod had a positive impact regarding so-called tumor-associated macrophages – immune cells that interact with tumor cells to influence the initiation, growth and metastasis of tumors. Lefitolimod led to an increase of anti-tumor M1-type macrophages within the tumor, accompanied with a decrease of pro-tumorigenic M2-type macrophages.
Importantly, this beneficial TME modulation from an immunosuppressed ("cold") towards a more immunoreactive ("hot") stage translated into a reduction of tumor growth in the mice.

Lefitolimod as a partner for immuno-oncological combination therapies

The lefitolimod-induced pathway provides the rationale for combining lefitolimod with checkpoint inhibitors. Response rates to checkpoint inhibitor immunotherapy vary between different tumor entities and depend on the nature of the TME. "Hot" tumors with a T cell infiltrated TME show better responses. Therefore modulation of the TME is a crucial requirement for the response to immunotherapeutic approaches.
First combination data of lefitolimod with checkpoint inhibitors have been presented at the ASCO (Free ASCO Whitepaper) GI 2017. The data showed that lefitolimod can significantly improve the anti-tumor effect of checkpoint inhibitors, particularly anti-PD-1 and anti-PD-L1 antibodies, and thus prolong survival in murine tumor models.

For more information on ASCO (Free ASCO Whitepaper) GI please visit the website:
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