On December 21, 2017 FLX Bio, Inc., a biopharmaceutical company focused on the discovery and development of oral small-molecule drugs to activate the immune system against cancer, reported the completion of a $60 million Series C private financing (Press release, FLX Bio, DEC 21, 2017, View Source [SID1234522770]). The financing included new investments from GV (formerly Google Ventures) and other undisclosed investors as well as existing investors including The Column Group, Kleiner Perkins, Topspin Partners and Celgene Corporation.

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"With a discerning syndicate of investors committed to our science, our strategy and our team, we look forward to using the proceeds of this Series C financing to advance our robust pipeline of small molecule immuno-oncology compounds focused on regulatory T cell and tumor myeloid cell modulation," said Brian Wong, M.D., Ph.D., President and CEO. "In addition to initiating Phase 1 testing for our lead molecule FLX475, a highly potent and selective oral CCR4 antagonist for the treatment of cancer, we intend to select a clinical candidate targeting USP7 and continue advancement of our GCN2 program, with all three programs representing differentiated and important mechanisms to stimulate an immune response within the tumor microenvironment."

Initiation of Phase 1 Clinical Study of FLX475, CCR4 Antagonist
In addition to announcing its financing, FLX Bio recently dosed its first subject in a Phase 1 clinical trial for FLX475, a best-in-class, oral small molecule antagonist of CCR4. The company’s strategy is to accelerate early clinical development in cancer patients by first rapidly obtaining pharmacokinetic, pharmacodynamic, and preliminary safety data in healthy volunteers. Findings from the healthy volunteer study will enable a more focused and efficient Phase 1 study in cancer patients, potentially resulting in faster achievement of clinical proof of concept.

"We are pleased to move our lead program forward into the clinic," commented Bill Ho, M.D., Ph.D., Chief Medical Officer of FLX Bio. "Regulatory T cells are highly potent suppressors of the adaptive immune response and their presence in most tumors are correlated with a poor prognosis. With very few agents in development selectively inhibiting these cells, we believe targeting CCR4 represents a differentiated and exceptionally promising approach to treating cancer."

About FLX475
FLX475 is a best-in-class oral, small molecule antagonist of CCR4. In preclinical studies, FLX475 inhibited tumor growth and increased tumor regression as a single agent. In addition, FLX475 enhanced the antitumor effects of various checkpoint inhibitors including anti-PD-L1 and anti-CTLA4 antibodies as well as immune agonists such as anti-4-1BB. FLX475 also has the potential to enhance cell-based immunotherapies such as CAR-T and cancer vaccines. Unlike antibodies to CCR4, FLX475 selectively blocks the recruitment of regulatory T cells to the tumor site, and does not deplete cells beneficial to an anti-tumor response or regulatory T cells in healthy tissue such as blood, spleen and skin cells. In addition to the study ongoing in healthy volunteers, FLX Bio intends to initiate a clinical trial of FLX475 alone and in combination with a checkpoint inhibitor in oncology patients in 2018.

About USP7
Ubiquitin specific protease 7 (USP7) plays a key role in two important cancer pathways: it promotes the formation and function of regulatory T cells by deubiquitinating and stabilizing FOXP3; and it maintains low levels of p53, a prevalent tumor suppressor protein, thereby allowing the tumor to grow unchecked. USP7 is an enzyme that removes a tag called ubiquitin from proteins and stabilizes the expression of those proteins in the cell. USP7 stabilizes a regulatory protein called FOXP3 found within regulatory T cells, and promotes the number and activity of regulatory T cells. In addition, USP7 stabilizes MDM2, causing p53 levels go down, thus allowing cancer cells to proliferate. A USP7 inhibitor elicits two beneficial effects – increased immune system response to the tumor and enhanced tumor suppression by p53. FLX Bio expects to select a clinical candidate in late 2018.

About GCN2
GCN2 is a myeloid-derived suppressor cell (MDSC) target that works downstream of IDO and arginase. GCN2 inhibition has the potential for superior efficacy as it can reverse immune-suppression caused by depletion of both tryptophan and arginine. We are developing orally-bioavailable, highly-selective GCN2 inhibitors that stimulate an immune response by limiting myeloid derived suppressor cell functions as well as encouraging effector T cell proliferation in the amino acid-deprived tumor microenvironment.

On December 21, 2017 TARIS Biomedical LLC, a company developing targeted new therapies for millions of patients suffering from difficult-to-treat bladder diseases, reported that it has raised $25M in a Series B financing. This round was led by Yonghua Capital, with participation from new investors Bristol-Myers Squibb and Norma Investments, representing businessman Roman Abramovich (Press release, TARIS Biomedical, DEC 21, 2017, View Source [SID1234522767]). Existing investors Flagship Pioneering, Polaris Partners, and RA Capital Management, also participated in the Series B round.

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In a separate announcement (link), TARIS also announced that it has entered into a clinical research collaboration with Bristol-Myers Squibb to study the combination of Opdivo (nivolumab) and TARIS’ lead program TAR-200 (GemRIS) in the treatment of muscle invasive bladder cancer.

"We have made substantial progress on our lead programs in bladder cancer and overactive bladder," said Purnanand Sarma, Ph.D., President and CEO of TARIS. "Both programs demonstrate our unique approach to designing novel therapeutics that may dramatically change the management of these serious diseases. Funds from this round will be used to rapidly advance both indications through key clinical milestones."

"TARIS is thrilled to add new investors to our syndicate, and we are grateful to Flagship Pioneering, Polaris Partners, and RA Capital Management for their ongoing support," Sarma continued.

"We are excited to join the new and existing investors in this financing round, and to help TARIS build substantial long-term value as a focused urology company," said Moses Zhao, Managing Partner, North American Healthcare Investment for Yonghua Capital.

About the TARIS System

The TARIS System is designed to continuously release drugs in the bladder over weeks to months. It is deployed and retrieved using minimally-invasive, in-office procedures. This technology allows drug release to be tailored to match the needs of each disease.

Den 21 december 2017 rapporterade Xspray Pharma att de ingått ett tillverknings- och leveransavtal med NerPharMa S.r.l, ett farmaceutiskt tillverkningsbolag i Milano, Italien, för produktion av sin ledande produktkandidat HyNap-Dasa (Press release, Xspray, DEC 21, 2017, View Source [SID1234523287]). Avtalet omfattar tillverkning av HyNap-Dasa för det kliniska prövningsprogrammet och för kommersiell produktion och inkluderar både läkemedelssubstans och färdig produkt. HyNap-Dasa är en av tre produktkandidater som Xspray för närvarande har under utveckling. Bolagets mål är att lansera HyNap-Dasa på den amerikanska marknaden 2021.

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Enligt villkoren i avtalet har Xspray kontrakterat NerPharMa för att tillverka läkemedelssubstans och färdig produkt för till kliniska program och framtida kommersiell försäljning. Xspray utvecklar HyNap-Dasa både som en fullständigt utbytbar variant av Sprycel som ska registreras i USA genom Abbreviated New Drug Application (ANDA) eller som en förbättrad produkt under 505(b)(2)-förfarandet. NerPharMa är ett farmaceutiskt tillverkningsbolag och dotterbolag till Nerviano Medical Sciences S.r.l. i Milano, Italien.

NerPharMas GMP tillverkningsanläggning är godkänd av både den italienska läkemedelsmyndigheten (AIFA), den nationella myndighet som ansvarar för läkemedelsreglering i Italien, och amerikanska Food and Drug Administration (FDA).

"Det här kontraktet är ett viktigt steg i vår utveckling av HyNap-Dasa," säger Per Andersson, vd för Xspray Pharma. "Vi är glada över att ha säkrat tillgången till GMP-produktion i en av amerikanska FDA godkänd anläggning av läkemedelssubstans och färdig produkt, det gäller för både våra fortsatta kliniska program men framför allt för vår framtida försäljning av produkt i USA."

"Vi är glada över att jobba med Xspray Pharma för att producera och tillgodose färdig produkt för deras utvecklings- och kommersiella behov," säger Angelo Colombo, vd för NerPharMa.

On December 21, 2017 Humanigen, Inc. (OTCQB: HGEN), a biopharmaceutical company pursuing cutting-edge science to develop its proprietary monoclonal antibodies for immunotherapy and oncology treatments, reported it has entered into definitive agreements with its lenders to, among other things, exchange the entire balance of approximately $16.3 million in term loans for common stock of the company (Press release, KaloBios, 21 21, 2017, View Source [SID1234522783]). The transactions are expected to close in the first quarter of 2018 subject to the satisfaction of certain conditions contained in the definitive agreements.

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Humanigen will also receive a new $3 million investment from an affiliate of Black Horse Capital, one of the lenders, to fund the company and its transformational new strategy of developing the monoclonal antibodies lenzilumab and ifabotuzumab in the fast-growing and exciting areas of immunotherapy and oncology.

The company has begun work with leading key opinion leaders in the chimeric antigen receptor T-cell (CAR-T) therapy field to advance lenzilumab into phase 1 trials for the prevention of neurotoxicity associated with CAR-T therapy. Lenzilumab is an antagonist of circulating granulocyte-macrophage colony-stimulating factor (GM-CSF). GM-CSF is thought to be a potential key factor in neurotoxicity, and perhaps other side-effects, associated with CAR-T therapy.

By neutralizing circulating GM-CSF, and upon demonstrating meaningful effects on neurotoxicity without hampering the efficacy of CAR-T, lenzilumab has the potential to make CAR-T therapy:
·
safer by lessening neurotoxicity
·
more effective by allowing higher CAR-T doses, greater CAR-T expansion, and potentially reducing myeloid-derived suppressor cells (MDSC) that inhibit T cell function
·
a more routine out-patient procedure

Humanigen also continues to enroll patients in its phase 1 study of lenzilumab for the treatment of chronic myelomonocytic leukemia (CMML), a rare hematologic cancer, with interim data expected in the first half of 2018.

In addition, the other key asset in the Humanigen monoclonal antibody portfolio, ifabotuzumab, has been dosed in the first patient in an investigator-sponsored phase 0/1 radio-labeled imaging trial in glioblastoma multiforme (GBM), a particularly aggressive and deadly brain cancer. According to the investigators at the Olivia Newton-John Cancer Research Institute in Australia, the trial will seek to confirm the safety of ifabotuzumab and potentially determine the best dose to effectively penetrate brain tumors. The investigators expect 12 patients to participate in the trial, for which eligibility criteria are recurrent GBM and receipt of only one type of chemotherapy for disease recurrence. The company also is exploring partnering opportunities to enable further development of ifabotuzumab as a potential treatment for certain solid and hematologic cancers as an antibody-drug conjugate (ADC) and as a CAR-T construct.

"This transaction resets Humanigen as a cutting-edge science immunotherapy and oncology biotechnology company," said Cameron Durrant, MD, chairman and CEO. "By following the recent, exciting, ground-breaking science related to lenzilumab’s potential utility to help in CAR-T therapy, as well as a new clinical trial for ifabotuzumab, we are writing a new history for Humanigen driven by science to help patients with new medical innovations."

At the transactions’ closing, the company will issue 59,786,848 new shares of common stock to the lenders in exchange for the satisfaction and extinguishment of the company’s obligations with respect to its outstanding secured loans. In addition, at closing, Humanigen will assign all of its assets and rights related to its former benznidazole drug candidate to a new entity formed and controlled by one of the lenders. As previously reported, these assets and rights are no longer relevant to the company’s forward-looking business plan as described above. And the company will issue 32,028,669 new shares of common stock to an affiliate of Black Horse Capital for $3 million, of which $1.5 million in new capital is expected to be received by the company on December 22, 2017 in the form of a secured loan that will be converted into common stock at the close. In total, these transactions provide $19.3 million of value to the company in return for the issuance of approximately 91.8 million shares of stock; common stock currently outstanding will represent 14% of the post-closing total outstanding shares.

The total number of new shares to be issued to affiliates of Black Horse Capital at the closing of these transactions, when combined with their existing ownership stakes, will result in Black Horse Capital and its affiliates owning more than 50% of the company’s outstanding shares of common stock.

On December 21, 2017 Hookipa Biotech AG ("Hookipa"), a clinical stage biotech company pioneering an innovative class of immune activation therapies for oncology and infectious diseases, reported that CEO Joern Aldag will be presenting at the 36th Annual J.P. Morgan Healthcare Conference that is being held in San Francisco, CA from January 8-11, 2018 (Press release, Hookipa Biotech, DEC 21, 2017, View Source [SID1234522766]). The Company’s presentation is scheduled for Wednesday, January 10 at 04:30 PM Pacific Standard Time.

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Mr. Aldag will provide an overview of the Company´s strategy as well as an update on its development programs, including its progress on two proof-of concept clinical trials and its plan to expand its technology platform into other disease areas.