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InnoCare (Beijing) Prices Hong Kong IPO at Top of Range, Raises $288 Million

On March 17, 2020 InnoCare Pharma reported that Beijing priced its Hong Kong IPO at the top end of its proposed range to raise $288 million at a $1 billion valuation, according to insiders (Press release, InnoCare Pharma, MAR 17, 2020, View Source [SID1234555664]). The company develops immunotherapies for cancer and autoimmune diseases. It has three molecules in clinical trials, including its lead product, a BTK inhibitor under NDA review in China for leukemia and lymphoma. The company discovers candidates through its own research and in-licenses products from other biopharmas. Hong Kong has not completed an IPO since January because of the coronavirus outbreak.

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4D Pharma Presents Additional Interim Clinical Data From Combination Study for Lead Oncology Candidate

On March 17, 2020 4D pharma plc (AIM: DDDD), a pharmaceutical company leading the development of Live Biotherapeutics, reported an update on the previously reported interim data from an ongoing phase I/II clinical trial, in collaboration with MSD, a tradename of Merck & Co., Inc., Kenilworth, NJ, USA, to evaluate 4D pharma’s lead oncology candidate, MRx0518, in combination with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab), in patients with advanced malignancies who have previously responded and whose disease has then progressed on PD-1/PD-L1 inhibitors (Press release, 4d Pharma, MAR 17, 2020, View Source [SID1234555662]).

The additional data has been presented to delegates of Chardan’s virtual 2nd Annual Microbiome Medicines Summit, on March 16, 2020. The data was presented by Duncan Peyton, CEO and Alex Stevenson, CSO, 4D pharma. The presentation provides additional detail on headline interim results from the phase I/II clinical trial announced on November 6, 2019. The trial is being conducted, and data compiled at MD Anderson, University of Texas, US.

The data is the first global clinical confirmation of a live biotherapeutic product (LBP) initiating a response in cancer patients. The patients in the live biotherapeutic clinical trial had all previously received multiple lines of treatment with little efficacy, exhausting all currently approved treatment options. 4D pharma believes that the data provide evidence that adding the Company’s product, MRx0518, to the checkpoint inhibitor treatment regimen can induce tumour responses in patients who have previously become refractory to these therapies. 4D believes that, if demonstrated in larger studies, the addition of MRx0518 to checkpoint therapy will enable approved checkpoint inhibitors to work more effectively, for a longer duration, and in a wider patient population.

The phase I/II 4D pharma study is an open label trial to evaluate the safety and preliminary efficacy of MRx0518 and KEYTRUDA in patients with renal cell carcinoma (RCC), melanoma, non-small cell lung cancer (NSCLC) and bladder cancer, who have developed resistance to PD-1/PD-L1 inhibitors. Checkpoint therapies, whilst capable of producing durable anti-tumour responses, are not effective in all patients. In addition, those who do respond can develop resistance over time, leading to disease progression. The study has been designed to investigate this effect in patients with advanced metastatic disease.

Clinical observations from the first six patients in part A were presented, including:

Two partial responses (PR) with evidence of tumor shrinkage who remain on study (one patient for over 10 months)
One patient with stable disease (SD), remains on study for over eight months
Evidence of increased tumor-infiltrating lymphocytes (TILs) following treatment
No drug related serious adverse events
Specifically, one stage IV NSCLC patient had received seven lines of therapy over nearly three years with little response. In this patient the combination of MRx0518 + KEYTRUDA achieved an overall 51% reduction in target tumors at last assessment. The patient has now been on drug for 41 weeks.

"The further interim data from the Phase I/II trial provide significant potential for fresh treatment options for oncology patients that have exhausted all other currently approved therapies," said Duncan Peyton, CEO, 4D pharma.

He added: "4D pharma is now delivering the first global clinical evidence of the therapeutic potential of oral live biotherapeutics in cancer. This confirms the significant impact of microbiome immuno-oncology to the pharmaceutical industry in providing additional treatments for patients with underserved needs and little available therapeutic options. This clinical validation of live biotherapeutics to impact diseases external to the gut significantly supports our wider clinical pipeline in other areas such as neurodegeneration and other cancers."

Recruitment for the trial continues to progress as expected, with recruitment for Part A now completed. 4D expects to announce data for all 12 Part A subjects in Q2 and to commence enrolment for Part B, which will expand the study based on the Part A data. It is expected that the study will be expanded to additional international trial locations and sites, initially in the US. 4D pharma also expects to discuss the findings from Part A and avenues for accelerated development with the regulatory agencies.

NeoPhore Appoints Dr Matthew Baker as Chief Executive Officer

On March 17, 2020 NeoPhore Limited, a small molecule cancer immuno-oncology company, reported the appointment of Dr Matthew Baker as Chief Executive Officer (CEO). Dr Baker was previously Vice President of Immunology at NeoPhore and will be succeeding Jeff Roix with immediate effect (Press release, NeoPhore, MAR 17, 2020, View Source [SID1234555661]).

Dr Baker has more than 20 years’ experience in the pharmaceutical and biotechnology industries. Before joining NeoPhore, Dr Baker was Chief Scientific Officer of Denceptor Therapeutics Ltd, Abzena plc and was Chief Executive Officer and cofounder of Antitope Ltd. Prior to this, he served as Vice President for Biologics Discovery at Biovation Ltd. Dr Baker has a background in B and T cell immunology and completed post-doctoral positions in Cambridge, UK, after obtaining his PhD in cellular immunology at the University of Birmingham. Dr Baker is currently Non-Executive Director at Oxgene Ltd.

Commenting on today’s announcement Robert James, Chairman of Neophore said: "On behalf of the board and management I would like to thank Jeff for his contribution to NeoPhore and am very pleased to welcome Dr Matthew Baker as CEO. This is an exciting time for NeoPhore as it continues to develop its leading position in DNA mismatch repair (MMR) drug discovery. Matthew’s leadership skills and years of experience as a research expert in cell immunology will prove invaluable as NeoPhore enters the next phase of growth."

Newly appointed Chief Executive Officer, Dr Matthew Baker added: "Having been involved in the development of NeoPhore’s drug discovery programmes since June 2019, I am extremely excited by the technology and am delighted to take on the role of CEO. NeoPhore’s highly differentiated approach to targeting MMR has real potential to generate first-in-class next-generation immuno-oncology therapeutics. Together with the management team and board, I look forward to maximising the company’s pipeline of MMR drugs, as we progress from the lab to the clinic, ultimately improving outcomes for patients."

National Research Cancer Institute UK Confirms Benefit Molecular Profiling in Multiple Myeloma

On March 17, 2020 SkylineDx shares research showing that multiple myeloma (blood cancer) patients with a high risk or aggressive course of the disease are unlikely to benefit from current treatment approaches, including lenalidomide mono-therapy for maintenance when compared to observation only (Press release, SkylineDx, MAR 17, 2020, View Source [SID1234555660]). The Institute of Cancer Research (ICR) in London (UK), derived these results from the NCRI Myeloma XI trial with 329 patients and validated the findings in MRC Myeloma IX trial after which they published the findings in Nature Leukemia. The conclusion of the paper supports the use of so-called "molecular biomarkers" in the clinic to build a molecular profile of the patient’s cancer to better guide the most effective treatment strategy at diagnosis [2].

The "aggressiveness" of the disease is measured with biomarkers per individual patient and translated into a standard-risk (normal course of the disease), a high-risk (progressive or more aggressive disease) and an ultrahigh-risk (fast progressive or most aggressive disease) profile. One of the biomarkers used is the MMprofiler with SKY92 algorithm. This biomarker reads the expression of 92 genes from the cancerous plasma cell and calculates if a patient is at high risk of progression, or in other words, if the cancer is more aggressive [2].

According to the published manuscript, the MMprofiler with SKY92 is independently able to predict the cancer’s aggressiveness in newly diagnosed patients. In 24.6% of patients, the SKY92 high-risk biomarker was present, resulting in a significant shorter period until disease progression (median of 16 months versus 33.8 months for non-SKY92 high-risk patients) and a significantly reduced overall outlook (50% of these high-risk patients died within 36.7 months versus a median that was not reached at 60 months for non-SKY92 high-risk patients). These results are regardless of induction treatment and posttransplant treatment strategy. Furthermore, if a patient bears the SKY92 high-risk marker, lenalidomide as maintenance therapy does not give the patient a significant longer relapse free period or a better overall outlook. That means that a patient can obtain the same result by being closely observed without taking the medicine and suffer accompanying adverse reactions [2].

"The publication by this esteemed group of researchers and clinicians is the independent confirmation that molecular biomarkers like SKY92 need to be adopted in clinical practice to avoid true fast progressing high-risk patients being missed at diagnosis," comments Dharminder Chahal, CEO of SkylineDx that developed the MMprofiler with SKY92 algorithm. "It shows that SKY92 identifies an additional 12% of high-risk patients for whom this information is currently not available but would impact their treatment decision. These patients need to be informed since they could clearly follow a different clinical path," concludes Dharminder Chahal.

GEMoaB Announces Publication of Pre-Clinical Proof-of-Concept Data on UniCAR-modified Off-the-shelf Natural Killer Cells in ‘Nature Scientific Reports’

On March 17, 2020 GEMoaB, a biopharmaceutical company focused on the development of next-generation immunotherapies for hard-to-treat cancers, reported that "Nature Scientific Reports" has published pre-clinical proof-of-concept data on UniCAR-modified off-the-shelf Natural Killer (NK) cells targeting GD2-expressing tumors (Mitwasi et al. 2020, 10:2141) (Press release, GEMoaB, MAR 17, 2020, View Source [SID1234555659]). The data generated by researchers of the Helmholtz-Center Dresden-Rossendorf (HZDR) provide further evidence on the unique flexibility of GEMoaB´s proprietary UniCAR platform.

CAR-T cell therapy holds great promise for treating a wide range of malignancies. Nevertheless, the CAR-T approach faces multiple challenges, including the risk of acute and long-term toxicities, a current lack of suitable targets, insufficient engraftment and persistence especially in solid tumors. In addition, currently commercially available CAR-T products can only be derived from individual patients, adding significant complexity and cost to the autologous manufacturing process.

GEMoaB’s rapidly switchable universal CAR platform UniCAR promises an improved therapeutic window and increased efficacy and safety over conventional CAR-T therapies in hematological malignancies and solid tumors. As soluble adaptors termed targeting modules (TMs) are used to provide the antigen-specificity to activate UniCAR gene-modified T-cells (UniCAR-T), the manufacturing process is significantly simplified by the ability to use the same UniCAR-T effector cell against multiple antigens and tumor types.

Natural killer (NK) cells genetically engineered to express a CAR (CAR-NK) have recently emerged as promising candidates for effective cancer treatment. Off-the-shelf CAR-NK cells from an allogeneic source, such as cord blood, can be safely administered without the need for full HLA matching, therefore eliminating the need to produce a unique CAR product for each patient. Furthermore, allogeneic CAR-NK cells have a proven track record of safety due to their lack of causing cytokine release syndrome (CRS).

In a recent publication in Nature Scientific Reports (Mitwasi et al. 2020, 10:2141), researchers of the HZDR combined the advantages of the UniCAR approach with the off-the shelf capabilities of NK cells. The publication provides proof-of-concept for a universal off-the-shelf cellular therapeutic based on UniCAR-modified NK-92 cells retargeted to GD2-expressing tumors by GD2-specific TMs. Redirected UniCAR-NK-92 cells induced specific and effective killing of GD2-expressing cells in vitro and in vivo, associated with enhanced interferon-γ production.

"We are very pleased that our co-founder Prof. Michael Bachmann and researchers of the HZDR could demonstrate that GEMoaB’s highly flexible UniCAR system can be readily applied to continuously expanding off-the-shelf NK cells, which in combination with GD2-specific TMs efficiently target and lyse GD2-expressing tumor cells such as neuroblastoma and melanoma," said Prof. Gerhard Ehninger, co-founder and CMO of GEMoaB. "UniCAR-NK cells could represent an additional universal and modular off-the-shelf platform that would allow the use of TMs against multiple antigen targets for an effective and safe therapy of cancer."

"As we are progressing with our clinical development plans for UniCAR-T-CD123 in hematological malignancies and UniCAR-T-PSMA in solid tumors, we are developing a deep pipeline of TMs directed against a wide variety of blood and solid tumor cancers," said Dr. Armin Ehninger, Chief Scientific Officer of GEMoaB. "We believe that UniCAR-NK cells could further enhance the unique flexibility of our platform by combining the advantages of UniCAR with the safety and off-the-shelf capabilities of NK cells."