On March 25, 2021 Black Diamond Therapeutics, Inc. (Nasdaq: BDTX), a precision oncology medicine company pioneering the discovery and development of small molecule, tumor-agnostic therapies, reported financial results for the fourth quarter and full year ended December 31, 2019, while providing a corporate update (Press release, Black Diamond Therapeutics, MAR 25, 2021, View Source [SID1234577128]).

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"Black Diamond has achieved important scientific, clinical, and operational milestones over the past year," said David M. Epstein, Ph.D., President and CEO. "Our IND for our lead product candidate, BDTX-189, was allowed in December and we have initiated our Phase 1/2 clinical trial. We believe the $316 million raised since November, including via our initial public offering, will enable us not only to execute on the clinical development of BDTX-189, but also to continue to invest in our proprietary MAP platform, and to progress our early stage pipeline of small molecule, tumor-agnostic precision medicine programs."

2019 Corporate Highlights

Advanced BDTX-189, Black Diamond’s mutation spectrum-selective, oral, irreversible small molecule inhibitor product candidate which targets cancer-causing driver mutations in human epidermal growth factor receptor 2 (HER2) and epidermal growth factor receptor (EGFR) that have not yet been drugged, to investigational new drug (IND) application submission in November 2019 and IND allowance by the U.S. Food and Drug Administration in December 2019.
Initiated a Phase 1/2 clinical trial of BDTX-189, which is actively enrolling and dosing patients in the Phase 1 portion.
— The Phase 1 portion of the trial will evaluate escalating doses of BDTX-189 and is designed to determine the recommended Phase 2 dose and to assess preliminary indications of anti-tumor activity. The Phase 2 portion will determine the objective response rate and duration of response in patients with solid tumors that have an allosteric HER2 mutation or EGFR or HER2 exon 20 insertion mutation determined using next-generation sequencing.
Continued to advance its program in glioblastoma (GBM) toward nominating a development candidate that targets a range of driver mutations in GBM and progress the Company’s other earlier stage programs derived from Black Diamond’s Mutation-Allostery-Pharmacology (MAP) platform.
— Black Diamond’s MAP platform is built on three central pillars – discover, reveal, and target. The Company uses population-level cancer genetic data obtained from all tumor types to identify potential families of mutations that occur within individual oncogenes and rank the mutations for potential oncogenicity. Black Diamond then uses its MAP platform to understand the mechanism for oncogenic activation and the Company’s team of experienced medicinal chemists then develops mutation spectrum-selective drugs for the identified targets.
Raised $85.0 million in an oversubscribed Series C financing round in November 2019 led by Boxer Capital of the Tavistock Group. Additional new investors Wellington Management Company, BVF Partners L.P., Deerfield Management, funds managed by Janus Henderson Investors, Casdin Capital, and Logos Capital joined existing investors Versant Ventures, New Enterprise Associates, RA Capital Management, Nextech Invest, Invus, Perceptive Advisors, City Hill Ventures, and Roche Venture Fund in the round.
Strengthened Black Diamond’s management team and Board of Directors in 2019 by adding Brent Hatzis-Schoch as Chief Operating Officer and General Counsel, Thomas (Tommy) Leggett as Chief Financial Officer, and Christopher D. Roberts, Ph.D., as Chief Scientific Officer, along with Samarth (Sam) Kulkarni, Ph.D., CEO of CRISPR Therapeutics AG, to its Board of Directors.
Recent Developments

In February 2020, Black Diamond completed an initial public offering pursuant to which it issued and sold 12,174,263 shares of common stock, including full exercise of the underwriters’ over-allotment option, resulting in gross proceeds of $231.3 million before deducting underwriting discounts and commissions and other offering expenses.
Financial Highlights

Black Diamond ended 2019 with $154.7 million in cash and cash equivalents compared to $51.7 million as of December 31, 2018. Net cash from financing activities for the year ended December 31, 2019 was $127.8 million compared to $52.3 million for the year ended December 31, 2018. Net cash used in operations was $24.7 million for the year ended December 31, 2019 compared to $8.5 million for the year ended December 31, 2018.
Net loss for the year ended December 31, 2019 was $35.3 million compared to $8.9 million for the year ended December 31, 2018.
Research and development (R&D) expenses were $21.8 million for the year ended December 31, 2019 compared to $7.0 million for the year ended December 31, 2018. The increase in R&D expenses was primarily related to increase in headcount, preclinical development, and IND filing of BDTX-189.
General and administrative (G&A) expenses were $7.6 million for the year ended December 31, 2019, compared to $2.0 million for the year ended December 31, 2018. The increase in G&A expenses was primarily due to an increase in personnel and other corporate-related costs.

On March 25, 2021 Cancer Genetics, Inc. (the "Company") (Nasdaq: CGIX), an emerging leader in novel drug discovery techniques, reported the results of its March 24, 2021 shareholder meeting to approve the upcoming merger with StemoniX, Inc. ("StemoniX") (Press release, Cancer Genetics, MAR 25, 2021, View Source [SID1234577127]).

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At a Special Meeting of Stockholders, CGI’s stockholders, upon the unanimous recommendation of the board of directors of CGI: (a) voted in favor of the issuance of shares of Common Stock, warrants and options pursuant to the Agreement and Plan of Merger and Reorganization, dated as of August 21, 2020, as amended, with StemoniX; (b) voted in favor of the amendment to the certificate of incorporation of CGI effecting a reverse stock split of the issued and authorized shares of Common Stock, at a ratio in the range from 1-for-2 to 1-for-10, with such specific ratio to be determined by the CGI board; (c) voted to approve the Cancer Genetics, Inc. 2021 Equity Incentive Plan and to authorize for issuance 4,500,000 shares of Common Stock thereunder; and (d) voted to approve on an advisory basis, the compensation that may be paid or become payable to CGI’s named executive officers in connection with the merger.

Chief Executive Officer of Cancer Genetics, Jay Roberts, stated, "The Cancer Genetics team is thankful for the participation and support of our shareholders for voting in favor of the merger with StemoniX. In addition, we are thankful to our management teams and board members from both Cancer Genetics and StemoniX for their effort in bringing the merger to this point. We are proud to be combining forces and we are prepared to execute on our business plan.

On March 25, 2021 Synlogic, Inc. (Nasdaq: SYBX), a clinical stage company bringing the transformative potential of synthetic biology to medicine, reported financial results for the fourth quarter and full year ended December 31, 2020, and provided an update on programs and progress (Press release, Synlogic, MAR 25, 2021, View Source [SID1234577116]).

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"2021 is an incredibly exciting year for the company. We now have demonstrated proof of mechanism in humans from both of our lead metabolic programs, Phenylketonuria (PKU) and Enteric Hyperoxaluria, and expect to have important clinical readouts in patients from both programs later this year," said Aoife Brennan, M.B. Ch.B., Synlogic’s President and Chief Executive Officer. "We believe there is significant unmet need in PKU and Enteric Hyperoxaluria and that our Synthetic Biotic medicines can address these and other metabolic diseases in ways not possible with other modalities."

"Enteric Hyperoxaluria is a historically underserved area in which dangerously high levels of urinary oxalate cause progressive kidney damage," said Richard Riese, M.D., Synlogic’s Chief Medical Officer. "Part A of the Phase 1 study of SYNB8802 in healthy volunteers demonstrates compelling levels of Urinary Oxalate lowering at a well-tolerated dose in Dietary Hyperoxaluria cohorts, and we are thrilled to be advancing this program."

Dr. Riese further stated, "We are also excited to continue to advance the SynPheny-1 Phase 2 study of SYNB1618 for the treatment of PKU, as well as the Phase 1 clinical study of SYNB1891 in solid tumors and lymphomas. Patient interest continues to be robust. We are looking forward to top line results from both trials later in 2021."

2020 Highlights & 2021 Priorities

The Metabolic Portfolio:

Progression of a proof-of-concept Phase 2 clinical trial of SYNB1618 for the treatment of Phenylketonuria (PKU), with data expected in the second half of 2021. SYNB1618 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for PKU.

Synthetic Biotic medicines offer potential for a safe, tolerable, reversible and oral therapy, which reduces plasma Phe levels by consuming Phe in the GI tract.
SynPheny-1 is designed to evaluate plasma Phe lowering of a solid oral formulation of SYNB1618 in adult PKU patients who do not benefit from, or do not tolerate, existing therapies such as Kuvan or Palynziq.
SYNB1934, an evolved Synthetic Biotic medicine in the PKU portfolio, has progressed to IND enabling studies.
SYNB1934 consumes Phe in the GI tract and contains a high activity PAL enzyme developed using directed evolution from the SYNB1618 PAL enzyme.
SYNB1934 may offer additional Phe lowering capacity, or the ability to dose at lower levels, relative to SYNB1618.
Synlogic will provide full results of the SYNB1618 Phase 1 study of a solid oral formulation in healthy volunteers at the American College of Medical Genetics (ACMG) meeting in April 2021.
Completion of Part A of the Phase 1 study of SYNB8802 in Healthy Volunteers. Part B in patients with Enteric Hyperoxaluria following Roux-en-Y gastric bypass surgery has been initiated. SYNB8802 is an orally administered Synthetic Biotic medicine being developed as a potential treatment for Enteric Hyperoxaluria. Synlogic has completed dosing of five cohorts in part A, 45 total subjects. Findings include:

SYNB8802 was generally well tolerated in healthy volunteers. There were no serious or systemic adverse events. The most frequent adverse events were mild or moderate, transient, and GI-related.
Dietary Hyperoxaluria was successfully induced in Healthy Volunteers.
Subjects placed on 600 mg of daily dietary oxalate had urinary oxalate levels of 44.8 mg/24h at baseline.
Dose responsive changes in urinary oxalate levels were observed with a significant reduction in urinary oxalate relative to placebo across three dose levels.
A dose of 3e11 live cells administered three times daily with meals was selected as the dose for part B of the study.
This dose was well-tolerated and resulted in a change from baseline urinary oxalate reduction of 28.6% (90% CI: -42.4 to -11.6), compared to placebo.
At the end of dosing, the mean 24-hour urinary oxalate level was 40.1 mg for subjects treated with SYNB8802 3e11 live cells, compared to 58.1 mg for placebo subjects. Upper limit of normal urinary oxalate levels are 45 mg per 24 hours.
Full results of the study will be presented at a future medical meeting. Data from Part B in patients with Enteric Hyperoxaluria following Roux-en-Y gastric bypass surgery is expected in the second half of 2021.

The Immunomodulation Portfolio:

Advancement of SYNB1891 into combination arm dosing with PDL1 checkpoint inhibitor in an ongoing Phase 1 clinical study in patients with advanced solid tumors or lymphoma. SYNB1891 is an intratumorally administered Synthetic Biotic medicine engineered to act as a dual innate and adaptive immune activator.

SYNB1891 is currently being evaluated in a Phase 1 study that has two parts:
Part A is a monotherapy arm that has enrolled five dose cohorts to date. The maximum tolerated dose has not been reached and dose escalation continues.
Part A of the study has demonstrated target engagement and activation of the STING pathway.
Part B of the study was initiated in December 2020 and combines escalating dose levels of SYNB1891 with a fixed dose of the PD-L1 checkpoint inhibitor atezolizumab to establish a recommended Phase 2 dose for the combination regimen.
An update on the study will be shared at the American Association of Cancer Research (AACR) (Free AACR Whitepaper) meeting in April 2021.
Data from both arms will continue to be reported as appropriate over the course of 2021, with mature combination therapy data expected by the end of the year.
Corporate Update:

Synlogic expands Board of Directors. Synlogic recently appointed Michael Heffernan and Lisa Kelly-Croswell to its Board of Directors.
Mr. Heffernan is a seasoned entrepreneur and biopharmaceutical leader with over 25 years of experience building and leading development stage and commercial companies.
Ms. Kelly-Croswell is a global Human Resources executive with over 30 years of experience in assignments commonly involving rapid business growth, performance turnarounds and innovation.
Synlogic strengthens Leadership Team.
Dr. Caroline Kurtz was promoted to Chief Development Officer. Dr. Kurtz joined Synlogic in October 2016 and is responsible for program leadership and portfolio planning and progression. With over 25 years of experience in the pharmaceutical industry, Dr. Kurtz has led multiple programs through mid and late-stage clinical development.
Daniel Rosan was promoted to Senior Vice President and Head of Finance. Mr. Rosan joined Synlogic in March 2020 and has over 20 years of industry experience.
Synlogic appointed Dr. Jamie Austin to the role of Incoming Head of Regulatory Affairs. Dr. Austin has over 15 years of industry experience.
Synlogic advances strategic partnerships.
Synlogic and the MIT Voigt Lab are collaborating with the Air Force Research Laboratory (AFRL) and the Department of Defense (DoD) to engineer novel investigational medicines to address battle fatigue.
Synlogic and Ginkgo Bioworks continue to advance their long-term strategic platform collaboration that provides expanded synthetic biology capabilities to Synlogic.
Fourth Quarter 2020 Financial Results

As of December 31, 2020, Synlogic had cash, cash equivalents and short-term investments of $100.4 million.

For the three months ended December 31, 2020, Synlogic reported a consolidated net loss of $14.6 million, or $0.39 per share, compared to a consolidated net loss of $12.8 million, or $0.37 per share, for the corresponding period in 2019.

Research and development expenses were $11.4 million for the three months ended December 31, 2020 compared to $11.3 million for the corresponding period in 2019.

General and administrative expenses for the three months ended December 31, 2020 were $3.3 million compared to $3.5 million for the corresponding period in 2019.

There was no revenue for the three months ending December 31, 2020 compared to $1.2 million for the three months ended December 31, 2019. Revenue for the prior period was associated with Synlogic’s collaboration with AbbVie to develop Synthetic Biotic medicines for the treatment of Inflammatory Bowel Disease, which was terminated in May 2020.

Full Year 2020 Financial Results
For the year ended December 31, 2020, consolidated net loss was $59.2 million, or $1.65 per share, compared to a consolidated net loss of $51.4 million, or $1.70 per share, for the year ended December 31, 2019. Revenues were $0.5 million for the year ended December 31, 2020, compared to $2.2 million for the same period in 2019. Total operating expenses were $61.0 million for the year ended December 31, 2020, compared to $56.6 million for the same period in 2019.

Financial Outlook
Based upon its current operating plan, Synlogic expects to have sufficient cash to be able to fund the base operating plan into 2023.

Conference Call & Webcast Information
Synlogic will host a conference call and live webcast at 8:30 a.m. ET today, Thursday, March 25, 2021. To access the live webcast, please visit the "Event Calendar" page within the Investors and Media section of the Synlogic website. Investors may listen to the call by dialing +1 (844) 815-2882 from locations in the United States or +1 (213) 660-0926 from outside the United States. The conference ID number is 4897219. A replay will be available for 30 days on the Investors and Media section of the Synlogic website.

About PKU
Phenylketonuria (PKU) is an inherited metabolic disease that manifests at birth and is marked by an inability to break down Phe, an amino acid that is commonly found in many foods. Left untreated, high levels of Phe become toxic and can lead to serious neurological and neuropsychological problems affecting the way a person thinks, feels, and acts. Due to the seriousness of these symptoms, infants are screened at birth in many countries to ensure early diagnosis and treatment to avoid intellectual disability and other complications.

About Enteric Hyperoxaluria
Enteric Hyperoxaluria is an acquired metabolic disorder caused by increased absorption of dietary oxalate, which is present in many healthy foods, making it almost impossible to control with diet alone. Enteric Hyperoxaluria often occurs as a result of a primary insult to the bowel, such as inflammatory bowel disease, short bowel syndrome, or as a result of surgical procedures such as Roux-en-Y bariatric weight-loss surgery.

Enteric Hyperoxaluria results in dangerously high levels of urinary oxalate, which causes progressive kidney damage, kidney stone formation, and nephrocalcinosis. Enteric Hyperoxaluria has no approved treatment options.

On March 25, 2021 Istari Oncology, Inc., a clinical-stage biotechnology company, reported the publication of "Viral infection of cells within the tumor microenvironment mediates antitumor immunotherapy via selective TBK1-IRF3 signaling" in Nature Communications (Press release, Istari Oncology, MAR 25, 2021, View Source [SID1234577115]). This mechanistic study found that intratumoral PVSRIPO, via unique activation of antigen presenting cells (APCs) in the tumor microenvironment (TME), stimulates functional CD8+ T cell responses capable of mediating effective, systemic antitumor immunity.1

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Research from multiple laboratories has demonstrated the importance of APCs, especially dendritic cells, in stimulating antigen-specific immunity.2,3 When activated, these cells produce an inflammatory response marked by type-I/III IFN. The current research demonstrates that nonlethal infection of APCs by PVSRIPO triggers a distinctive pattern of robust, sustained type-I/III IFN secretion, with minimal release of unwanted proinflammatory cytokines, due to PVSRIPO’s selective effect on a specific signaling pathway. The result is effective generation of functional antitumor CD8+ T cells. The functionality of these cells was confirmed by gold-standard methods in which antitumor T cells generated in tumor-bearing mice treated with PVSRIPO could be transferred to untreated tumor-bearing mice, resulting in decreased cancer growth.

"The potential utility of a RNA virus-based immunotherapy like PVSRIPO is its natural ability to prime and activate functional cytotoxic T cell responses," said Dr. Matthias Gromeier, the senior author of the study. "PVSRIPO is genetically engineered to elicit potent, sustained innate antiviral inflammatory patterns, which yield vigorous CD8+ T cell responses in the TME, without significant toxicity. PVSRIPO’s activation of a specific pattern recognition receptor, MDA5, leads to the optimal cytokine signature — the sustained, type-I/III IFN-dominant response that is required to achieve robust anticancer immunity."

Dr. Garrett Nichols, Istari Chief Medical Officer added, "Uniquely, PVSRIPO intratumoral replication also triggers CD4-mediated immunologic recall responses made possible by prior polio vaccination, which directly engages the powerful adaptive arm of the immune system. Along with the enduring, nonlethal infection of APCs demonstrated in this report and others,4 PVSRIPO triggers the critical steps required for both a direct anticancer effect and establishment of long-term anticancer immunologic memory to help keep cancer at bay. Our upcoming LUMINOS-102 study (NCT04577807) will further evaluate the ability of PVSRIPO to generate a systemic immune response that fights cancer in both injected and noninjected tumors and suppresses cancer growth over time, expanding on the observations in the phase 1 trial in patients with unresectable, advanced, anti–PD-1 refractory melanoma.5"

"To appreciate the importance of these results, you need to consider the approach of other investigational immunotherapies," commented Matt Stober, President and CEO. "In contrast to PVSRIPO, many viral agents being studied as cancer therapies are based on pathogens that employ strategies to evade the immune system by interfering with or blocking CD8+ T cell responses — the exact responses that are required for systemic anticancer immunity."

For more information about Istari Oncology and their ongoing clinical trials and research in PVSRIPO, visit istarioncology.com.

About PVSRIPO
PVSRIPO is an investigational immunotherapy based on the live attenuated Sabin type 1 poliovirus vaccine that has been genetically modified for safety. PVSRIPO has a distinct target (the poliovirus receptor, CD155), which is widely expressed in neoplastic cells of most solid tumors. Via CD155, PVSRIPO targets tumors with two primary mechanisms: 1) direct damage to and killing of cancerous cells; and 2) engaging innate and adaptive antitumor immune responses via nonlethal infection of antigen presenting cells in the tumor, which stimulates a specific signaling pathway resulting in a sustained, robust type-I/III IFN-dominant response, with minimal release of unwanted cytokines. Its effects are potentiated by prior vaccination against poliovirus. PVSRIPO has been granted Breakthrough Therapy Designation and Orphan Status by the FDA in recurrent glioblastoma. PVSRIPO has also been granted Orphan Status by the FDA for advanced melanoma.

On March 25, 2021 Immodulon Therapeutics reported that First patient enrolled in a phase I/II study for IMM-101 in limited metastatic pancreatic cancer patients at Erasmus University Medical Center (Press release, Immodulon Therapeutics, MAR 25, 2021, View Source [SID1234577114])

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Erasmus MC initiates recruitment for new investigator-sponsored phase I/II study to investigate the safety and efficacy of IMM-101 in limited metastatic pancreatic cancer

Uxbridge, UK – 25 March 2021 – Immodulon, the immuno-oncology company, is pleased to announce enrolment of the first patient in MEPANC-1, an investigator-sponsored, multi-centre, phase I/II, open label study in patients with limited metastatic (oligo-metastatic) pancreatic cancer. This study is being conducted in collaboration with Professor van Eijck and his team at the Erasmus University Medical Center Rotterdam ("Erasmus MC").

This study follows the initial collaborative study, LAPC-2, a phase I/II study combining IMM-101 with stereotactic radiotherapy in locally advanced pancreatic cancer which has completed its recruitment and is nearing completion. MEPANC-1 is designed to enrol 100 eligible patients and evaluate the safety and efficacy of IMM-101 administered in combination with stereotactic radiotherapy in patients with oligo-metastatic pancreatic cancer, who have either completed at least eight cycles of FOLFIRINOX or who could not tolerate FOLFIRINOX. The primary efficacy endpoint is one-year progression-free survival calculated from the start of the FOLFIRINOX regimen. The study was approved in December 2020 by the local Erasmus MC Medical Ethics Review Committee and the national Central Committee on Research Involving Human Subjects.

Professor Casper H J van Eijck, hepatobiliary surgeon and Professor in surgery, commented:
"We look forward to this new original study which has not been performed before in patients with limited metastatic pancreatic cancer. Since the recruitment in the LAPC-2 study was highly successful, we expect to include patients from all Dutch Pancreatic Cancer Group hospitals within the allocated time frame. We are pleased that Immodulon is providing us with the IMM-101 study drug again as well as their support. We hope that combining IMM-101’s positive effects on the immune system with those of radiotherapy will potentially lead to a major step forward in the search for new and effective treatments for pancreatic cancer."

Dr. Jaap Kampinga, Chief Executive Officer of Immodulon, commented:
"We are extremely pleased to announce our continued collaboration with Professor van Eijck and his team at this Centre of Excellence for pancreatic cancer at Erasmus MC. The MEPANC-1 study is designed to complement the ongoing LAPC-2 study. Immodulon is dedicated and highly motivated to develop better therapies for pancreatic cancer, a vision that is strongly shared by Professor van Eijck and his team. Pancreatic cancer is a devasting disease and remains exceedingly challenging to treat effectively, despite the advances in other cancer treatments."

Dr. Cellia Habita, Chief Medical Officer of Immodulon, added:
"Professor van Eijck and his team are a fantastic group to collaborate with. The MEPANC-1 study recruited its first patient which is exciting news. We hope that IMM-101 may help to improve the prognosis for these patients."