Allogene Therapeutics Eyes IPO of up to $288 Million

Six months after officially launching and one month after securing $120 million in private financing, Allogene Therapeutics is looking to score between $272 and $288 million from an initial public offering.

On Tuesday, Renaissance Capital reported the company founded by former Kite Pharmaexecutives Arie Belldegrun, and David Chang, will offer 16 million shares at a price range of $16 to $18 per share. If the high-end pricing is hit, that would secure $288 million for the company and would, according to Renaissance Capital, give Allogene a “fully diluted market value of $2.1 billion and an enterprise value of $1.4 billion.”

South San Francisco-based Allogene announced its intentions to file for an IPO last month. The company intends to list itself on the Nasdaq Stock Exchange under the ticker symbol “ALLO.” Goldman Sachs & Co. LLC, J.P. Morgan Securities LLC, Cowen and Company, LLC and Jefferies LLC are acting as the joint book-running managers for the proposed offering.

Founded in 2017 and coming out of stealth mode in April, Allogene hit the ground running with $300 million in a Series A financing to develop off-the-shelf CAR-T therapy products. The company’s engineered T-cells are allogeneic, which means they are taken from healthy donors for intended use in any patient. Current approved CAR-T therapies, including Yescarta, which Belldegrun and Chang were instrumental in developing when they were at Kite, are autologous, meaning they are extracted from an individual patient for that patient’s use.

Following Allogene’s launch in April, the company completed an agreement for Pfizer’sallogenic CAR-T portfolio. As part of that deal, Allogene secured the rights to 16 preclinical CAR T assets licensed from Cellectis and Servier and one clinical asset licensed from Servier, UCART19, an allogeneic CAR-T therapy that is being developed for treatment of CD19-expressing hematological malignancies.

In its S-1 filing with the U.S. Securities and Exchange Commission, Allogene said UCART19 is being studied in clinical trials in patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). The company said it anticipates UCART19 will be advanced to registrational trials in the second half of 2019. Additionally, Allogene said the company plans to file an Investigational New Drug Application with the U.S. Food and Drug Administration in the first half of next year for the company’s second allogeneic anti-CD19 CAR T cell product candidate, ALLO-501. That therapy will be for the treatment of relapsed or refractory non-Hodgkin lymphoma.

Allogene also noted in its filing that it has a “deep pipeline” of allogeneic CAR T cell product candidates targeting multiple promising antigens in a host of hematological malignancies and solid tumors.

When Allogene’s stock goes public, Belldegrun and Chang will have about 10 percent and 4 percent of the company’s shares, respectively. Those shares will be worth millions, but it’s a position the two men are well acquainted with. When Gilead Sciences acquired Kite Pharmaceuticals, Belldegrun snagged a nice payday of $694 million. Chang walked away with about $98 million.

Allogene is the latest in a series of biotechs going public. Earlier this week Israel-based Gamida Cell Ltd. filed for a $69 million initial public offering.

https://www.biospace.com/article/allogene-therapeutics-eyes-ipo-of-up-to-288-million/

Neon Therapeutics to present data from NT-001 at ESMO

Neon Therapeutics announced that updated data from NT-001, its ongoing Phase 1b clinical trial evaluating NEO-PV-01 in the metastatic setting, will be presented in an upcoming oral presentation at the European Society for Medical Oncology, or ESMO.

https://thefly.com/landingPageNews.php?id=2798951

Oasmia reports Phase 2 dog study meets primary endpoint

Oasmia reported its analysis of the data from the Phase II study and it’s the follow-up has been finalized and summarized in a report. Overall, 17 dogs participated and were treated with Doxophos Vet in the main study and eight of these continuing during the follow-up part. The objective was obtained, as 75% of the dogs with B-cell lymphoma showed a response after at least two treatment cycles. Progression free survival was defined as the time from screening to progression, or death of any cause. The study results confirmed that the dose of Doxophos Vet defined in a prior dose-finding study is appropriate with regards to both efficacy and safety in dogs with lymphoma. The pharmacokinetic profile analyzed shows there is a rapid distribution of doxorubicin into the tissues, and that the Doxophos Vet formulation does not alter the release properties of doxorubicin when infused into the blood. The most frequently reported adverse reaction after Doxophos Vet treatment was myelosuppression. This is the most expected adverse reaction with chemotherapy. Of the majority of the adverse events, 88% in the main study and 69% in the follow-up were mild to moderate.

https://thefly.com/landingPageNews.php?id=2798955

PTC Therapeutics reports results of risdiplam in spinal muscular atrophy

PTC Therapeutics announced interim clinical data from the Part 1, open-label studies of FIREFISH and SUNFISH demonstrating the ‘benefit’ of risdiplam for the treatment of Type 1, 2 and 3 spinal muscular atrophy. The results showed that patients across all SMA types benefited from an oral systemic therapy indicated by increases in developmental motor milestones. Risdiplam was well tolerated at all doses across studies to date. The SMA program is a collaboration between PTC, the SMA Foundation, and Roche. In Part 1 of the FIREFISH study, at Day 245 of treatment, 43% or 6/14, of infants were able to sit with or without support, including three who achieved unassisted sitting. Natural history indicates that Type 1 SMA babies never achieve this milestone. In Part 1 of the SUNFISH study in Type 2 and 3 SMA patients, 63% or 19/30, of patients treated with risdiplam for at least one year achieved a median increase in motor function of 3.13 points versus baseline. Typically patients with Type 2 or 3 SMA decline by 0.85 to 0.67 point per year. The pivotal portion of the SUNFISH clinical study has completed enrollment. Patients enrolled in the SUNFISH trial have a broad age range (2-24 years; median age 8 years) and with broad functional characteristics.

https://thefly.com/landingPageNews.php?id=2798987

Genentech presents new data for risdiplam in Spinal Muscular Atrophy

Genentech, a member of the Roche Group (RHHBY), announced interim clinical data from the dose-finding parts of the pivotal FIREFISH and SUNFISH studies investigating risdiplam in spinal muscular atrophy. In the FIREFISH study in Type 1 SMA, six out of 14 infants were able to sit, including three who achieved unassisted stable sitting after eight months of treatment. In addition, four infants demonstrated rolling to the side; seven kicking and six achieved upright head control. These milestones were assessed according to the Hammersmith Infant Neurological Examination (HINE) Module 2 and are key secondary endpoints in the confirmatory part of FIREFISH. Roche and Genentech are leading the clinical development of risdiplam, an oral SMN2 splicing modifier, as part of a collaboration with the SMA Foundation and PTC Therapeutics (PTCT). Updated analyses of the Children’s Hospital of Philadelphia Infant Test of Neuromuscular Disorders, a scale developed to assess motor function in infants with Type 1 SMA, demonstrated that eight out of 14 infants in FIREFISH achieved a score of 40 or above at their eight-month visit. Typically, an infant with Type 1 SMA does not demonstrate any motor improvement and can decline during this time period. The median CHOP-INTEND scores increased over time. The median age at first dose in FIREFISH was 6.7 months and median treatment duration was 9.5 months. Nineteen out of 21 infants enrolled remain alive with two having discontinued due to the fatal progression of their disease. Three patients are now over 24 months old. No infant has required a tracheostomy or permanent ventilation since study initiation, and no infant has lost the ability to swallow. The most common adverse events were fever, diarrhea, upper respiratory tract infections, ear infections, pneumonia, constipation, vomiting, cough and upper respiratory tract inflammation. In Part 1 of the SUNFISH study in Type 2 and 3 SMA, SMN protein median increases of greater than two-fold, as measured in blood, were seen after 12 months. A very broad patient population aged between two to 24 years was included, ranging in functional status from weak non-ambulant to strong ambulant, and with varying degrees of scoliosis from none to severe. Twenty-one patients initially received lower doses of risdiplam for at least 12 weeks. Of the patients treated with risdiplam for at least one year, the median change from baseline in Motor Function Measure, the primary endpoint in the confirmatory part of SUNFISH and a scale used to assess motor function in neuromuscular diseases, was a 3.1-point improvement. Sixty-three percent of patients experienced an improvement in MFM over baseline of three points or more after one year. Such improvements were seen both in patients under 12 years old and over 12 years old. When considering patients who experienced any amount of improvement over baseline, the percentages were 70 percent overall, 76 percent for the younger age group, and 62 percent for the older patients. Serious adverse events that occurred in two or more of the 51 patients exposed to risdiplam were nausea, upper respiratory tract infection and vomiting. To date there have been no drug-related safety findings leading to withdrawal from any study.

https://thefly.com/landingPageNews.php?id=2798989

Express Scripts: Diabetes Care Value program delivers savings of $42.6M

Express Scripts released new data showing significantly improved clinical outcomes and reduced drug spending for diabetes. In its inaugural year, the Diabetes Care Value program, part of the technology-supported, value-based SafeGuardRx platform, reduced diabetes drug spending by 19% – $360 per member per year – for the more than 800 plan sponsors enrolled in the program, delivering a total savings of $42.6M in 2017. In addition, Express Scripts diabetes specialist pharmacists, using advanced clinical analytics, improved compliance with recommended treatment guidelines by starting an additional 15% of enrolled patients at risk for heart attack or stroke on statin therapy. If all Express Scripts plans were to similarly increase statin use among their members with diabetes for better cholesterol control, they could prevent an estimated 13,000 heart attacks over the next 10 years.

https://thefly.com/landingPageNews.php?id=2799045

Trovagene signs license agreement with MIT for prostate cancer therapy

Trovagene has entered into an exclusive patent license agreement with the Massachusetts Institute of Technology, MIT, under which Trovagene has exclusive rights to develop combination therapies that include anti-androgen or androgen antagonist and a Polo-like Kinase inhibitor for the treatment of cancer. The exclusive license agreement is part of the company’s strategy to explore the efficacy of Onvansertib, its oral PLK1 inhibitor, in combination with anti-androgen drugs in cancers including prostate, breast, pancreatic, lung and gastrointestinal. In this Phase 2 trial, Onvansertib in combination with the standard dose of Zytiga and prednisone is being evaluated for safety and efficacy. The trial will enroll up to 45 patients with mCRPC showing early signs of disease progression. The primary efficacy endpoint is the proportion of patients achieving disease control after 12 weeks of study treatment.

https://thefly.com/landingPageNews.php?id=2799095