Stocks in the News
Unum Therapeutics (UMRX) is a very early stage oncology targeted biopharma with a collaboration agreement with Seattle Genetics (SGEN), decent cash runway, and a platform. The company is developing a particular antibody platform called the Antibody-Coupled T-cell Receptor (ACTR) platform. The platform is “an autologous engineered T-cell therapy developed to combine with tumor-targeting antibodies to exert potent antitumor immune responses and tumor cell killing.” They further claim that the ACTR construct is “a modified ACTR construct that has been designed to allow the ACTR T cells to behave more favorably in immunosuppressive tumor microenvironments commonly found in solid tumor cancers.”
The company announced on September 17 its plans to present positive preliminary data from its Phase 1 clinical trial evaluating combination therapy of its ACTR707 with Roche's Rituxan (rituximab), in patients with relapsed/refractory CD20-positive B cell non-Hodgkin lymphoma (NHL) at the CRI-CIMT-EATI-AACR International Cancer Immunotherapy Conference on September 30 in New York City.
First dose level (40M ACTR+ T cells) achieved complete response in half of the patients (n=3/6) participating in the trial. No dose-limiting toxicities were observed in any of the four DLT-evaluable patients. The company claimed that together these two data sets vindicate their position that complete response may be achieved in the disease without cytokine release syndrome. Further, they consider it to be a validation of the potential of their proprietary ACTR technology platform. Enrollment of the second dose (60M ACTR+ T cells) cohort has been completed. ASH in December will be the most likely venue of presentation of updated data.
Lymphoma refers to a group ofblood cancers that develop from type of white blood corpuscles called lymphocytes. Lymphocytes are an important component of body’s immunity mechanism. B lymphocytes (or B Cells) are one of the three types of lymphocytes that attach to the bacteria and virus attacking the body. By attaching to these germs, the B cells mark them for destruction by other parts of the immune system.
While the term ‘refractory’ disease refers to a disease that is becoming worse or is not improving under treatment, ‘relapsed ‘ refers to a disease that initially responds to the treatment, but then returns. These present a particular kind of problem in the treatment of NHl, which otherwise has a moderate rate of survival. Nevertheless, aggressive NHL represents about 60 percent of all NHL cases in the United States.
Accounting for ~4% of all cancers patients, Non-Hodgkin lymphoma (NHL) is one of the most common cancers in the United States. According to the most recent estimates of the American Cancer Society ~74,680 people (41,730 males and 32,950 females) will be diagnosed and ~19K people will die from this particular type of cancer in 2018. The figures include both adults and children.
According to the same statistics, the risk of an average American developing NHL during her lifetime is 1in 47. Since the risk of NHL increases with advancing age (more than half of patients are 65 or older at the time of diagnosis), American Cancer Society apprehends that the “aging of the American population is likely to lead to an increase in NHL cases during the coming years.” Collectively B cell NHL are the most common hematologic malignancy. B-cell receptors (BCR) are responsible for a number of cellular processes like proliferation, apoptosis and differentiation in B cells of both normal and malignant cells.
The development pipeline of the company comprise of two main products of the ACTR platform: ACTR707 and ACTR087. Both these have reached completion stage of Phase 1 trials in combination with rituximab (the standard medication of the disease), both indicated in NHL. additionally, ACTR087 is also in combination therapy with SEA-BCMA which is also in Phase 1 trial of multiple myeloma. The development of this trial is in collaboration with Seattle Genetics.
According to the last financial reporting, the burn rate is ~$6.5M/Q and the cash stands at comfortable $97M. So, even if the candidates move into maturer stage and the burn rate increases, the company share price seems not be in danger of any immediate dilution through offering.
So, although we normally do not buy such early stage companies, this is one where they have decent cash, a solid collaborator, and some strong early stage results. The stock price is also near its annual lows. These factros make this an interesting opportunity for a high risk/reward portfolio.
New positive data from the Phase 3 program of Theravance Biopharma (TBPH) and development/commercialization partner Mylan N.V. (MYL) for YUPELRI (revefenacin) inhalation solution for the treatment of patients with moderate-to-very severe chronic obstructive pulmonary disease (COPD) was presented at the ERS International Congress in Paris.
Estimated annualized exacerbation rates of 0.57 and 0.38, respectively, for the two regimens of YUPELRI showed statistically significant improvement over Boehringer Ingelheim's Spiriva HandiHaler in a 12-month safety study. NDA for the candidate is under FDA review with a PDUFA date of November 13.
In 2016, COPD was the third leading cause of death worldwide. According to 2014 statistics, “The death rate from COPD among U.S. adults in 2014 was around 142 per 100,000 population for males and 101 per 100,000 for females.” In 2016, the global market of asthma and COPD was valued at $39,021.2M, and is estimated to increase at a CAGR of 4.2% to $ 56,507.7M by 2025.
Other Selected News:
- Cellectar Bio up 24% premarket on another RPDD tag for CLR 131
- AstraZeneca's PT010 shows treatment benefit in late-stage COPD study
- England's NICE on board with Novartis' Tafinlar + Mekinist for type of advanced skin cancer
- Eidos Therapeutics presents data from Phase 1 trial of AG10 at the 22nd HFSA
- FDA lifts partial clinical hold on Mersana's XMT-1522; shares ahead 8% premarket
- Oncolytics Biotech announces multiple myeloma study combining REOLYSIN and nivolumab with standard of care
- Positive mid-stage data on Argenx’s efgartigimod
- Kiniksa Pharma's KPL-716 shows encouraging action in early-stage dermatitis study
- MYnd Analytics surged on FDA accelerated review status for PEER 4.0
- KemPharm on go with U.S. filing for KP415 after intranasal HAP study
- Inovio develops H3N2 Influenza DNA vaccine
- Oramed on go to start clinical trials on ORMD-0901
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