On September 10, 2020 DURECT Corporation (Nasdaq: DRRX) reported that it will participate in the HC Wainwright 22nd Annual Global Investment Conference, Cantor Fitzgerald Virtual Global Healthcare Conference and Oppenheimer Fall Healthcare Life Sciences & MedTech Summit (Press release, DURECT, SEP 10, 2020, https://www.prnewswire.com/news-releases/durect-corporation-to-participate-in-september-virtual-investor-conferences-301127214.html [SID1234564976]).

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HC Wainwright 22nd Annual Global Investment Conference
Date Monday, September 14
Time: 2:30-2:50 PM EDT (Fireside Chat with Ed Arce)
Webcast: View Source

Cantor Fitzgerald Virtual Global Healthcare Conference
Date Tuesday, September 15
Time 10-10:30am EDT (Fireside Chat with Ellie Merle)
Webcast: View Source

Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
Date: Tuesday, September 22
Time: 11:40am-12:20pm EDT (Fireside chat with Francois Brisebois)
Webcast: View Source

On September 10, 2020 Codiak BioSciences, a company developing therapies based on tiny bubbles secreted by cells, reported that it is lining up an IPO as it prepares for the first tests of its technology in humans later this year (Press release, Codiak Biosciences, SEP 10, 2020, View Source [SID1234564997]).

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In paperwork filed with securities regulators late Wednesday, Codiak set a preliminary $100 million goal for its stock market debut. The Cambridge, MA-based biotech has applied for a Nasdaq listing under the stock symbol "CDAK."

The research of Codiak focuses on exosomes, extracellular vesicles that carry proteins, genetic material, and other substances in and out of cells. Exosomes function as a messenger system between cells, transporting molecules that alter the function of a recipient cell, Codiak says in its filing. Because these vesicles evolved with humans naturally, they don’t trigger an immune response. Exosomes can also be engineered for selective targeting of particular cells, and they can carry an array of payloads.

Codiak produces its therapies by engineering exosomes to carry drug molecules, either on the surface or the inside of the vesicle. The company says that its proprietary technology, called engEx, can produce therapeutic exosomes at scale and according to pharmaceutical standards.

The lead Codiak program, exoSTING, is being developed as a treatment for solid tumors. This Codiak exosome is engineered to carry molecules inside the vesicle that are intended to elicit an anti-tumor immune response by hitting the stimulator of interferon genes (STING) pathway of the innate immune system. Other attempts to drug this pathway have run into problems delivering the therapy to a cell while also avoiding toxic effects to healthy cells, Codiak says in its filing. The company says its exosome drug could overcome those limitations.

The cancers that Codiak aims to treat with exoSTING include metastatic head and neck squamous cell cancer, triple-negative breast cancer, cutaneous squamous cell carcinoma, and anaplastic thyroid carcinoma. If a Phase 1/2 clinical trial begins later this year as expected, the company says preliminary data could become available by the middle of 2021.

The next program in Codiak’s pipeline is exoIL-12, an exosome that’s engineered with the cytokine interleukin 12 (IL-12) on the surface of the vesicle. Other companies are also pursuing therapies that incorporate IL-12. Codiak notes IL-12 has elicited an anti-tumor immune response in its preclinical research and the clinical studies of others. But the company adds that experimental IL-12 therapies have been hampered by the unwanted spread of the therapy’s effects throughout the body, particularly the liver. Codiak says its exosome-delivered IL-12 drug could avoid such problems.

Codiak is developing exoIL-12 to treat solid tumors for which the IL-12 pathway has been established. These cancers include melanoma, Merkel cell carcinoma, Kaposi sarcoma, glioblastoma, and triple-negative breast cancer. The initial focus for this drug is early-stage cutaneous T cell lymphoma. A Phase 1 study is planned to start later this year; preliminary data are expected by the end of 2020. Additional data, including efficacy results, could become available by the middle of next year.

Other companies developing exosome therapies include Aruna Bio, AstraZeneca (NYSE: AZN), Evox Therapeutics, and PureTech Health. Startups are also getting into the mix. Harvard University spinout Vesigen emerged in July with $28.5 million in Series A financing to fund the development of its extracellular vesicle-based therapies.

The Wednesday IPO filing is Codiak’s second attempt to join the public markets. The company initially filed to go public in April 2019 but withdrew those plans three months later. Codiak’s timeline for the start of clinical trials is unchanged from last year. But Codiak can now make its case to investors with some additional validation. In June, Codiak inked a two-year research deal with Sarepta Therapeutics (NASDAQ: SRPT), which agreed to pay its new partner $72.5 million in upfront and near-term milestone payments. Sarepta is interested in exploring Codiak’s exosome technology as a way to deliver genetic medicines for muscular disorders without triggering an immune response.

The Sarepta deal is Codiak’s second partnership with a larger biopharmaceutical company. Early last year, the company began an alliance with Jazz Pharmaceuticals (NASDAQ: JAZZ), which paid $56 million up front in a deal spanning five cancer therapies.

Codiak launched in 2015 with financial backing from an investor group that included Flagship Pioneering (known then as Flagship Ventures), Arch Venture Partners, and Fidelity Management & Research. Those firms are Codiak’s largest stockholders, owning 28.3 percent, 18.9 percent, and 14.1 percent of the company respectively, according to the filing.

Codiak reported that its cash holdings as of June 30 totaled $50.9 million. The company says it will use the IPO proceeds to fund clinical tests of its two lead exosome drug candidates, and to finance further development of programs in earlier stages of development.

On September 10, 2020 University of California at Los Angeles reported that Despite the success of checkpoint inhibitors that remove the blockade that cancer cells impose on the immune system, the drugs only work in some patients (Press release, University of California at Los Angeles, SEP 10, 2020, View Source [SID1234565053]). A research team led by scientists at the University of California, Los Angeles figured that understanding how responders’ immune cells act differently from those of nonresponders could point to new ways to enhance the efficacy of immuno-oncology therapies.

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In a new study published in Cancer Cell, the UCLA team pinpointed two main drivers that help the immune system attack cancer in response to I-O treatment: T-cell infiltration of tumors and interferon-gamma signaling.

The researchers analyzed tumor biopsies from melanoma patients treated with Bristol Myers Squibb’s PD-1 inhibitor Opdivo, either on its own or in tandem with the company’s anti-CTLA-4 drug Yervoy, in the CheckMate-038 trial. They compared genomic data from the tumors collected before and during treatment in both patients who had a clinical response and those who didn’t respond.

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As previous researchers had reported, the UCLA scientists found that high levels of CD8 T cells traveling to tumors were associated with the clinical response to the checkpoint inhibitors.

So, they examined the expression of cancer cell-killing cytokines as a result of tumor antigen-specific T-cell activation. The team discovered that cytokine expression followed the pattern of interferon-gamma, which was found at high levels in biopsies of patients who had responded well to checkpoint inhibitors.

Further analysis of genes that are related to interferon-gamma exposure revealed that the main difference separating patients who had responded and those who resisted I-O therapy was an increase in antigen-presenting machinery.

"The cancer is blocking how the immune system attacks cancer cells by the immune checkpoints," Antoni Ribas, M.D., Ph.D., the study’s senior author, explained in a statement. "And whenever we’ve released them, then there’s an increased immune activation that depends on the strength of the T cells to produce [interferon gamma], resulting in the activation of over 600 genes that amplify the antitumor immune response."

RELATED: New insights into cancer cell escape mechanisms could boost immuno-oncology treatments

Numerous research efforts have focused on identifying methods to boost the efficacy of immuno-oncology treatments. These include combining the targeting of immune checkpoints. For example, Roche recently demonstrated that combining its PD-L1 blocker Tecentriq with experimental anti-TIGIT antibody tiragolumab shrank non-small lung cancer better than Tecentriq alone.

Researchers in China recently found that inhibiting AKT with Merck’s MK-2206 boosted T-cell infiltration in glioblastoma in mice. They argued that combining the drug with an anti-PD-1 medicine could improve the anti-tumor effect.

The UCLA-led team’s findings provide hope that combination therapies that "increase interferon signaling inside tumors to jump-start an anti-tumor immune response when it is not already pre-existing" may dial up the efficacy of immune checkpoint inhibitors so that they can help more patients, the scientists wrote in the study.

On September 10, 2020 Advaxis, Inc. (Nasdaq: ADXS), a clinical-stage biotechnology company focused on the development and commercialization of immunotherapy products reported an update on its clinical pipeline and financial results for the third quarter ended July 31, 2020 (Press release, Advaxis, SEP 10, 2020, View Source [SID1234564925]).

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Key recent corporate and clinical pipeline updates:

Presented updated clinical data from the ongoing Phase 1/2 trial of ADXS-503 in non-small cell lung cancer (NSCLC) demonstrating durable clinical benefit in two out of 3 evaluable patients with immediate prior progression on KEYTRUDA including one durable response now out to 34 weeks with 25% reduction in target lesion and another sustained response now out to 33 weeks with a 60% reduction in site lesions. Both patients remain on treatment in Part B, the combination arm with KEYTRUDA
Clinical benefit achieved after immediate prior progression on KEYTRUDA with previous best responses of stable disease suggest ADXS-503 may re-sensitize or enhance response to KEYTRUDA
Initiated ADXS-503 Part B combination arm efficacy expansion which will enroll up to 15 patients to evaluate the potential of ADXS-503 in combination with KEYTRUDA to restore and/or enhance responsiveness to checkpoint inhibitors in PD-1/L-1 refractory NSCLC patients
Initiated ADXS-503 Part C combination arm to evaluate ADXS-503 in combination with KEYTRUDA as a first line treatment in patients with NSCLC with PD-L1 expression ≥ 1% or who are unfit for chemotherapy
ADXS-503 monotherapy and in combination with KEYTRUDA appeared safe and well tolerated with no dose limiting toxicities or added toxicity in the combination setting
Announced common stock purchase agreement for up to $20 million with Lincoln Park Capital
Management Commentary
"We are highly encouraged by the clinical and on-mechanism biomarker data from our ongoing Phase 1/2 study of ADXS-503 in NSCLC and have continued to execute on our expansion of the evaluation of the potential of ADXS-503 to synergistically enhance and/or restore sensitivity to checkpoint inhibitors," said Kenneth A. Berlin, President and Chief Executive Officer of Advaxis. "This quarter, we have begun enrollment in the expansion of Part B to further evaluate the promising signals of sustained clinical benefit observed in the first dose cohort of Part B in NSCLC patients with immediate prior progression on KEYTRUDA. This could yet be another strategy to rechallenge the tumor with a checkpoint inhibitor without having to stop the drug at progression. In addition, we have started enrollment in Part C which will evaluate ADXS-503 in combination with KEYTRUDA, moving our HOT program to a first line treatment for patients with metastatic NSCLC that would receive KEYTRUDA alone as per label indication (i.e., PD-L1 expression ≥ 1%) and patients who are unfit to receive the standard of care regimen of KEYTRUDA in combination with platinum based-chemotherapy. We believe these two clinical evaluations in Part B and Part C of this study will elucidate the potential of ADXS-503 to improve responses to checkpoint inhibitors in diverse clinical settings and for patients who have limited treatment options. We anticipate having additional data on this program by the end of the year."

Mr. Berlin continued, "We are particularly encouraged by the safety and tolerability profile of ADXS-503 as a monotherapy and in combination KEYTRUDA, and with no dose limiting toxicities observed, we believe this can be an important addition to standard of care for those patients whose illness makes them ineligible for other forms of chemotherapy. Our recently announced common stock purchase agreement allows us to continue the prioritization of our HOT program with the ongoing expansions in NSCLC as well as the initiation of a Phase 1 study of ADXS-504 in prostate cancer patients with biochemical recurrence before year end."

Third Quarter Ended July 31, 2020 Financial Results

Research and development expenses for the third quarter of fiscal year 2020 were $3.5 million, compared with $7.1 million for the third quarter of fiscal year 2019. The decrease is largely attributable to the winding down of the Phase 3 AIM2CERV and Phase 1 ADXS-NEO studies as announced in June 2019 and October 2019, respectively.

General and administrative expenses for the three months ended July 31, 2020 were approximately $2.4 million compared to $3.1 million in the same three-month period in 2019. The decrease in expenses is mainly attributable to lower legal fees and business development costs.

As of July 31, 2020, the Company had approximately $23.8 million in cash and cash equivalents. The Company believes this is sufficient capital to fund its obligations, as they become due, in the ordinary course of business until July 2021.

On September 10, 2020 Immunomic Therapeutics, Inc., ("ITI"), a privately-held clinical-stage biotechnology company pioneering the study of nucleic acid immunotherapy platforms, reported that originating in the United States recently opened its first office in South Korea (Press release, Immunomic Therapeutics, SEP 10, 2020, View Source [SID1234564944]). This continues to build on ITI’s overall strategy to be the partner-of-choice for innovative biotechnology companies in emerging centers of excellence worldwide.

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ITI is bringing its strategic business model to South Korea – designed to bring together the world’s leading experts and cutting-edge science to advance research in the Glioblastoma (GBM) field and to deploy ITI-1000 to the Asian population. ITI-1000 is a cell therapy powered by ITI’s UNITE platform that is currently being evaluated in a Phase II clinical trial (ATTAC-II) in collaboration with researchers at the University of Florida and Duke University. ITI-1001 is an alternative, cell-free approach to treating GBM. The company held a pre-IND meeting earlier this year for ITI-1001 and expects to be able to file an Investigational New Drug Application (IND) with the U.S. Food and Drug Administration (FDA).

The recent $61.3M financing led by HLB Co., LTD, a global pharmaceutical company focused on developing novel cancer drugs enables ITI to expand and form partnerships with local companies and research institutions to accelerate the development and commercialization of Korean pharmaceutical discoveries for the global markets.

"South Korea is an emerging center of biopharma research innovation, and we are excited to open ITI’s new office in a location where talented Korean researchers are doing groundbreaking work," said William G. Hearl, CEO, Immunomic Therapeutics. "We look forward to collaborating with HLB Bio Group to raise Korea’s profile as a global center of biopharma innovation and make exceptional therapies available for patients."

The new ITI office in South Korea is located in Teheran-ro, Gangnam-gu, Seoul, an area well established as a high-tech business zone in the city. Many Korean biopharma and biotech companies have headquarters in this area of Seoul.

In addition to its newly opened South Korean office, ITI headquarters is located in the U.S.