On April 30, 2018 Crescendo Biologics Ltd (Crescendo) the developer of multi-functional biologics with a focus on novel targeted T-cell engagers, reported that it has completed a $70 million (€57 million) Series B financing(Press release, Crescendo Biologics, APR 30, 2018, View Source [SID1234525829]). The funds will be used to advance the development of its lead programme, CB307, which stimulates local activation of tumour-specific T-cells, into the clinic and further expand its internal pipeline of products.

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Crescendo Biologics is developing potent, multi-functional Humabody therapeutics in oncology. It is pursuing novel Humabody-based product opportunities, through in-house development and strategic partnerships. To date, it has a collaboration with Takeda Pharma worth up to $790m.

The Series B round was led by Andera Partners (formerly Edmond de Rothschild Investment Partners) with Europe’s largest life science fund Biodiscovery V, and joined by Quan Capital with its leading life sciences fund, Quan Venture Fund I, and Crescendo’s existing investors Sofinnova Partners, IP Group, EMBL and Takeda Ventures. This is the largest disclosed Series B biotech financing in Europe in 2018.

Gilles Nobécourt, Partner at Andera Partners and lead investor said: "We have been very impressed with the high quality of the novel biology behind multi-functional Humabodies and Crescendo’s growing development portfolio. Crescendo is a true pioneer in the development of targeted T-cell engagement and we are looking forward to working with the team."

Graziano Seghezzi, Managing Partner at Sofinnova Partners added: "We have been supporting Crescendo since its seed round in 2009, and then through the Series A together with IP Group, the substantial size of the round and the participation of new investors of the Series B underlines the
potential and success of VH-based Humabodies."

Marietta Wu, Managing Director of Quan Capital which invested a significant amount in the round, explained: "We have been especially drawn to the Humabody platform that offers multiple potential advantages over the current antibody (IgG) approaches and could enable the Company to quickly build a
substantial portfolio of impactful therapeutics. We look forward to joining our partners to rapidly advance Crescendo’s portfolio into clinical development where we can improve patient lives."

Peter Pack CEO of Crescendo said: "We appreciate the strong support – past and present – from our current investors, who have enabled us to grow the Company to this point. In this round, we are also welcoming two new investors, Andera Partners and Quan Capital. We look forward to taking our leadprogramme, CB307 into the clinic and further exploit our technology platform with new products."

On April 27, 2018 Haihe Biopharma Co., Ltd. and 3D Medicines (Beijing) Co., Ltd. reported that the two sides have reached a strategic collaboration agreement on HaiHe Biopharma’s FGFR inhibitor (coded HH185) project (Press release, 3D Medicines, APR 27, 2018, View Source [SID1234594049]). 3DMed may carry out the R&D, manufacture and commercialization of HH185 in mainland China, Hong Kong, Macao and Taiwan for the treatment of cancer and pulmonary fibrosis.

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Dr. Ruiping Dong, CEO of Haihe Biopharma, commented,
"As a potential target in the field of anti-tumor, FGFR is undergoing rapid development in the research of its mechanisms and clinical application and more and more verifications has been made. Therefore, the R&D prospect is so promising. As a highly selective FGFR inhibitor, HH185 overcomes the adverse effect of hepatotoxicity found in the first-generation FGFR inhibitor and has the apparent anti-tumor activity. We look forward to working together with 3DMed on the further development and commercialization of HH185, so as to accelerate the launch of the domestically-manufactured new drugs and to meet the patients’ needs in China."

Dr. Gong Zhaolong, CEO of 3D Med, commented,
"We are very happy to reach the strategic collaboration agreement with HaiHe Biopharma on HH185.HH185 has a good prospect of combination with 3DMed’s PD-L1 antibody in the field of immuno-oncology therapy. Through the collaboration with HaiHe Biopharma and by virtue of 3DMed’s platform and experience in the field of precision cancer care, we hope to be able to develop new drugs that are urgently needed in clinical practice for the benefit of even more patients who suffer from cancer and pulmonary fibrosis."

About HH185
HH185 is a small molecule inhibitor of fibroblast growth factor receptor 1,2,3 (FGFR 1,2,3), which obtained the approval for clinical trial by CNDA in January 2018. Preclinical studies have shown that HH185 has such advantages as strong anti-tumor activity, excellent PD-PK characteristics, low toxicity and high bioavailability and so on. Moreover, it is targeting CSF1-R and is therefore suitable for combination therapy with PD-1/PD-L1 antibodies in the field ofimmune-oncology.

On May 3, 2017 Stainwei Biotech, Inc. (Stainwei), a Chinese biotech company located in Biobay industrial park in Suzhou, China, reported that it has received a patent certificate (Patent No. US9,580,498) issued by the United States Patent and Trademark Office (USPTO) for its novel humanized anti-VEGF monoclonal antibody (mAb code name: hPV19) (Press release, Suzhou Stainwei Biotech, APR 27, 2018, View Source [SID1234525751]). This patent was issued through a pathway of PCT application (PCT/CN2013/086542) filed by Stainwei in 2013. Prior to receiving the US patent, Stainwei has already received two patent certificates for this antibody from China Intellectual Property Office in 2015 and 2016. Stainwei is dedicated to innovation and development of novel therapeutic antibody drugs targeting cancers, age-related macular degeneration (AMD) and immune-related diseases.

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A phase I clinical trial evaluating the safety and efficacy of hPV19 in cancer patients is ongoing in China. According to the data released by the company, hPV19 has a unique antigen recognition site (epitope), composed of amino acid sequences different from other commercially available antibodies targeting the same antigen. In both in-vitro and in-vivo experiments, hPV19 showed a 6-8 times higher biological activity than Avastin (generic name: bevacizumab, Roche/Genentech’s anti-VEGF mAb, the world’s first and so far still the only FDA-approved anti-VEGF mAb drug on the market). "In pre-clinical animal studies and early stage clinical trials in cancer patients, hPV19 has also demonstrated an excellent safety and tolerance profile," said Dr. Qunmin Zhou, the company’s co-founder. "We are excited to test its efficacy in the ongoing clinical trials. We are also excited to hopefully bring to the market a unique, non-biosimilar, and stronger therapeutic agent that can benefit our patients."

Meanwhile, Stainwei has filed a PCT patent application for a new formulation of hPV19 mAb intended for the treatment of age-related macular degeneration (AMD), diabetic macular edema (DME) and other eye-disorders associated with VEGF-mediated vascular over-growth. Stainwei has completed preclinical experiments and an application for Investigational New Drug (IND) in AMD and DME will be submitted to China-FDA soon.

The company’s another promising product is a novel anti-PD-1 monoclonal antibody named hAb21 (humanized IgG4-kappa version). hAb21 binds to human PD-1 antigen at a unique site (epitope), which is different from that of Keytruda (Merck) and Opdivo (Bristol-Myers Squibb). hAb21 has shown a remarkable anti-tumor activity in human PD-1 gene knock-in mouse models.

View Source

Figure: Effect of hAb21 mAb on tumor growth in knock-in mice expressing human PD-1 （Human PD-1 gene knock-in mice were inoculated with 1×106 syngeneic MC38 tumor cells. When tumors reached 50 mm3 in size，mice were randomized into 3 groups. Intra-peritoneal (i.p) injections with 200 ug mAb (pembrolizumab or hAb21) or saline were given on days 6, 10, 13 and 17 after inoculation. A: Tumor growth in early-stage; B: Tumor growth in both early- and later-stage）.

As illustrated in the above figure, syngenic MC38 tumors implanted in the PD-1 gene knock-in mice were completely rejected within 7-10 days without re-growth thereafter in all 6 mice in the group treated with hAb21. Furthermore, repeated MC38 tumor inoculation was performed to those mice on day 30, and tumors were again completely rejected within 10-14 days without further hAb21 treatment. All 6 mice survived to day 60 and received MC38 inoculation for the third time (experiment on-going). In the same knock-in mice treated with Keytruda (pembrolizumab), complete tumor rejection was observed in only 1 out of 6 mice, while initial tumor regression followed by re-growth after the completion of Keytruda treatment were found in the other 5 mice, which all died of tumor progression.

Based on these encouraging results, Stainwei has filed a patent application for hAb21, and is currently carrying out IND-enabling studies. An IND indication for advanced solid tumors is expected to be submitted to China-FDA and US-FDA in the second-half of 2017.

On April 27, 2018 Sanofi reported financial results for the first quarter ended March 31, 2018 (Press release, Sanofi, APR 27, 2018, View Source [SID1234525827]).

First-quarter 2018 reflected strong Specialty Care sales offset by U.S. Lantus and sevelamer exclusivity losses

Net sales were €7,898 million, down 8.7% on a reported basis, down 0.4%(3) at CER and down 1.1% at CS/CER(4).
Sanofi Genzyme sales grew strongly, up 16.2%(5), driven by contribution from the new immunology franchise.
Vaccines sales (-0.9%) reflected strong performance in EU, offset by expected Pentaxim supply constraint in China.
CHC sales grew 2.0% supported by double-digit growth in Emerging Markets(6).
Diabetes and Cardiovascular GBU sales down 15.7%; global Diabetes franchise sales declined 10.0%.
Emerging Markets sales(6) increased 8.3%, driven by double-digit growth in China and Latin America.
2018 guidance confirmed

First-quarter 2018 business EPS(1) increased 1.4% at CER to €1.28.
First-quarter 2018 IFRS EPS was €0.81 (-82.0%) due to a gain on disposal of the Animal Health business in 2017.
Sanofi continues to expect 2018 Business EPS to grow between 2% and 5% at CER(7) barring unforeseen major adverse events. Applying the average April 2018 exchange rates, the currency impact on 2018 Business EPS is estimated to be around -7%.
Announcement of a €1.5bn share buyback program(8) expected to be completed in mid-2019

Sanofi strengthens leadership in Specialty Care through the addition of a Rare Blood Disorder franchise

Sanofi completed the acquisition of Bioverativ and consolidated its financial results from March 9.
First patient dosed with fitusiran, a novel RNAi therapeutic for hemophilia, in phase 3 ATLAS program.
Ablynx acquisition(9) will add caplacizumab for aTTP(10) (submitted in EU) and innovative Nanobody platform.
Sustaining innovation in R&D

Praluent significantly reduced the risk of cardiovascular events in high risk patients in the ODYSSEY OUTCOMES study and was associated with a lower death rate.
Dupixent supplemental BLA filed in the U.S., Japan and EU for moderate-to-severe asthma in adults and adolescents.
Cemiplimab filed in EU for metastatic cutaneous squamous cell carcinoma.
Sotagliflozin submitted in the U.S. and EU for type 1 diabetes.

On April 27, 2018 Compugen Ltd. (Nasdaq: CGEN), a leader in predictive discovery and development of first-in-class therapeutics for cancer immunotherapy, reported that the U.S. Food and Drug Administration (FDA) requested that the Company provide additional CMC information in support of its IND application for COM701, initially submitted in late March 2018 (Press release, Compugen, APR 27, 2018, View Source [SID1234525798]). COM701 is a first-in-class immuno-oncology therapeutic antibody targeting PVRIG. FDA recommended a lower starting dose of COM701 for the trial, which now requires a more sensitive COM701 assay detection method for this dose. The FDA informed the Company that the IND application review can be completed and the application can be taken off clinical hold once the requested information is provided by Compugen. The IND is intended to support initiation of a planned Phase 1 clinical trial of COM701 in patients with advanced solid tumors. This trial is not yet active at any investigational sites and has not recruited any patients.

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"We are working closely with the FDA to provide the additional information requested as quickly as possible. In anticipation for FDA clearance, site selection activities in multiple centers in the United States are currently ongoing to allow future patient enrollment, and we look forward to evaluating COM701 in a clinical setting," stated Anat Cohen-Dayag, PhD, President and CEO of Compugen. "We continue to be encouraged by the preclinical data for COM701, which suggest that targeting PVRIG may be a primary means of stimulating an anti-tumor immune response in certain cancers that may be unresponsive to available treatments."

The Company will continue to provide updates on this matter as appropriate.