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Biopharm Development & Manufacturing A Bullish Season At The BIO Investor Forum T By Wayne Koberstein, executive editor o tweet or take notes — that was the question at this fast-paced, multitracked round of company pitches and plenary sessions that filled two whole days in the City by the Bay during October. As it happened, my tweets at #BIF13, along with selected input from others in the "hashtag" group for the BIO Investor Forum (BIF), yielded all the notes I needed. Those notes play out some general themes, along with specific company details that, all together, reflect the unique mood and makeup of this year's forum. Enthusiasm ran high, in sharp contrast to the past half decade of down times in angel/VC funding and IPO action for the life sciences industry. Yet caution remained on everyone's mind, and many people's lips, amidst the celebratory feelings. Although partnering still held primary importance at BIF, a subtle but palpable shift back to investor funding appeared in the content of plenary sessions and types of companies in the lineup. Perhaps the shift at least partly accounted for the reduced proportion of targeted cancer drugs presented, with noticeably more time given to noncancer conditions and new cancertreatment modes such as RNA-based (ribonucleic acid) and immunological therapies. In fact, the RNA and immunology approaches spilled over into other areas such as anti-infectives. INVOKING CANCER IMMUNITY Cancer immunotherapy combinations gained support in a related panel discussion by executives and scientists from Bavarian Nordic, Inovio, immatics biotechnologies, and the UCSF Medical Center. Panelists answered some sophis- 30 LifeScienceLeader.com ticated technical questions regarding the side effects, variety of approaches, and need for carefully managed combinations of immunotherapies to rally all the right forces in the immune system. Including the still-elusive multipatient cancer vaccine, such "mass immunotherapy" — moving immunotherapy away from patientcustomized treatment to something more like the normal drug or vaccine supply chain — is likely the wave of the future. A number of presenting companies are developing immune-based therapies, including therapeutic vaccines. Alas, I could not cover them all, but I managed to hit a somewhat random half dozen that suggest the range of approaches and areas companies are exploring. Immune Design threw me off at first by using the term "tumor-specific" to describe the MOA (mechanism of action) of its cancer vax technology. Rather than a patient-specific vaccination like Provenge, however, Immune Design's vaccines target dermal dendritic cells (DCs) in vivo to stimulate production of cytotoxic T lymphocytes (CTLs) that home in on antigens commonly expressed in certain tumor types. Thus, they would be deployed as any conventional vaccine. MabVax Therapeutics has produced polyvalent vaccines from monovalent forms in-licensed from the Livingston December 2013 research team at MSKCC (Memorial SloanKettering Cancer Center). The vaccines are based on pooled samples to identify antigens typically expressed in adjuvant (postsurgical or chemo) settings, which is where the vaccinations will occur. Another MabVax program is mining antigens from successfully immunized patients as targets for future therapeutic antibodies. Similarly, Galena Biopharma aims to vaccinate patients against circulating cancer cells to prevent recurrence, but using a peptide to induce immune response, starting in breast-cancer patients with the HER2 (human epidermal growth factor receptor 2) mutation but not indicated for Herceptin. Galena has also hedged its bets by licensing and marketing a sublingual cancer-pain drug. I got the impression both MabVax and Galena are lone wolves operating outside the emerging comboimmunotherapy consensus. On the other hand, Lion Biopharmaceuticals and its now-parent Genesis Biopharma believe patientspecific T-cell stimulation and enhancement — "autologous cell therapy" or "adoptive T-cell therapy" — are the only viable solutions for tumor heterogeneity and immune suppression, considering the relatively weak response to ipilumimab and other CTLA (cytotoxic T-lymphocyte antigen) or PD-1 (programmed death)