On December 9, 2021 OncoPep, Inc., a developer of transformative immunotherapeutics, reported $11 million in Series D funding (Press release, OncoPep, DEC 9, 2021, View Source [SID1234596716]). The Series D was led by Tera Science and Kukje Pharma with participation from SX Company and CrystalBioScience.

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The Series D funding will enable OncoPep to continue its clinical trials and advance preclinical development of novel pipeline agents. OncoPep’s lead investigational candidate, PVX-410, is a cancer vaccine in clinical development for smoldering multiple myeloma (SMM) and triple negative breast cancer (TNBC).

"The financial support provided by these global investors is a crucial step in our journey to transform cancer care," said Michael Krepps, SVP of OncoPep. "This funding will allow us to continue clinical exploration of our cancer vaccine in combination with proven cancer therapeutics such as pembrolizumab and lenalidomide, and also accelerate preclinical studies for our novel cell therapies and immunotherapeutics," he added.

In anticipation of expanding its discovery pipeline and clinical development programs, the Massachusetts-based OncoPep has secured new laboratory space in Waltham, MA and office space in Boston’s Kendall Square. OncoPep is also growing its advisory team with the addition of Dr. Dennis Klinman, MD, PhD and Dr. Christopher Bahl, PhD to the Scientific Advisory Board.

Dr. Klinman has given pivotal contributions to the field of immuno-oncology and vaccinology by being the first to discover CpG oligonucleotides (TLR9 agonists), which are used as immune modifiers in FDA-approved vaccines and for cancer therapy. He spent 15 years at the National Cancer Institute as a Senior Investigator and served as the head of the NCI Cancer and Inflammation Program’s Immune Modulation Section. Dr. Klinman earned his MD and PhD in Medicine from the University of Pennsylvania. His extensive experience in pre-clinical and clinical trial development of novel immunotherapeutics will be a valuable contribution to OncoPep’s efforts to improve cancer patient outcomes.

Dr. Bahl is fusing cutting-edge computer science with synthetic protein biology to develop a new class of therapeutics. In 2019, Dr. Bahl was selected as a TED Fellow for his pioneering work on the de novo design of novel mini-proteins and constrained peptides, an innovative approach for creating therapeutics with potential to tackle long-standing challenges in medicine. In his postdoctoral studies, he successfully developed computational design methods to create constrained peptides, molecules that meld the best attributes of antibodies and small molecules into promising biologic drugs. He is the former Head of Protein Design at the Institute for Protein Innovation and his experience in advancing the protein design field will contribute immensely to OncoPep’s efforts to develop transformative immunotherapeutics. He earned his PhD in Biochemistry from Dartmouth University and holds a BS and MS from the University of Maine.

On December 9, 2021 LianBio (Nasdaq: LIAN), a biotechnology company dedicated to bringing innovative medicines to patients in China and other major Asian markets, reported financial results for the third quarter ended September 30, 2021 (Press release, LianBio, DEC 9, 2021, View Source [SID1234596662]).

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"Over the past several months, the LianBio team has achieved multiple meaningful milestones, including initiating our first clinical trial, completing dosing in our first PK study and successfully completing our initial public offering," said Yizhe Wang, Ph.D., Chief Executive Officer of LianBio. "In the year ahead, we intend to continue to advance our pipeline of innovative medicines and expect to initiate four pivotal studies to support regulatory approval in our territories. I’m confident we have the leadership and expertise at hand, as well as the capital resources necessary to deliver on our commitment to bring transformative medicines to patients across Asia."

Recent Business Highlights and Clinical Development Updates:

Initiated and completed enrollment and dosing in pharmacokinetic study of mavacamten

In November, LianBio initiated and completed enrollment and dosing in a pharmacokinetic (PK) study of mavacamten in healthy Chinese volunteers.
Initiated Phase 2a clinical trial of infigratinib in gastric cancer and other advanced solid tumors

In August, LianBio announced that the first patient was dosed in a Phase 2a clinical trial of infigratinib in locally advanced or metastatic gastric cancer or gastroesophageal junction adenocarcinoma with fibroblast growth factor receptor-2 (FGFR2) gene amplification and other advanced solid tumors with FGFR genomic alterations.
Appointed two independent directors to LianBio Board of Directors

In October, LianBio appointed Jesse Wu to the Company’s Board of Directors. Mr. Wu is the former Chairman of Johnson & Johnson China.

In October, LianBio appointed Susan Silbermann to the Company’s Board of Directors. Ms. Silbermann is the former Global President, Emerging Markets at Pfizer.
Strengthened LianBio leadership team with key China-based hires

In October, LianBio appointed Michael Humphries, MBBS as Chief Scientific Advisor to guide the Company’s research and development (R&D) strategy, advance the Company’s pipeline, and lead assessment of new in-licensing opportunities.

In August, LianBio appointed Pascal Qian as China General Manager to build out the Company’s operations and commercial infrastructure.
Completed Initial Public Offering

In November, LianBio completed an initial public offering (IPO) of its ordinary shares through the sale and issuance of 20,312,500 American Depositary Shares (ADSs) at a public offering price of $16.00 per ADS. Following the close of the IPO, pursuant to the partial exercise of their option to purchase additional ADSs, the underwriters purchased an additional 593,616 ADSs at the IPO price of $16.00 per ADS.

LianBio received gross proceeds of $334.5 million in connection with the IPO and subsequent exercise of the underwriters’ option and aggregate net proceeds of $311.1 million after deducting underwriting discounts and commissions.
2022 Key Anticipated Milestones

Mavacamten
Bristol Myers Squibb (BMS)-partnered cardiac myosin inhibitor in development for the treatment of hypertrophic cardiomyopathy and certain forms of heart failure

LianBio expects to initiate the Phase 3 EXPLORER-CN trial of mavacamten in Chinese patients with obstructive hypertrophic cardiomyopathy in the first quarter of 2022 to support regulatory approval in China.
LianBio’s partner BMS has announced a Prescription Drug User Fee Act (PDUFA) target action date of April 28, 2022 for the Company’s New Drug Application to the U.S. Food and Drug Administration (FDA) for mavacamten for the treatment of patients with symptomatic obstructive hypertrophic cardiomyopathy (oHCM).
TP-03
Tarsus Pharmaceuticals-partnered GABA-Cl channel blocker in development for the treatment of Demodex blepharitis (DB) and meibomian gland disease

LianBio expects to initiate a Phase 3 trial of TP-03 in Chinese patients with DB in the second half of 2022 to support regulatory approval in China.
LianBio’s partner Tarsus has announced that the Company expects to report topline data in the first quarter of 2022 from the ongoing Phase 3 Saturn-2 trial of TP-03 in DB patients.
NBTXR3
Nanobiotix-partnered radioenhancer in development for multiple solid tumor indications

LianBio expects to begin dosing Chinese patients in Nanobiotix’s planned global pivotal Phase 3 trial of NBTXR3 for the treatment of locally advanced head and neck squamous cell carcinoma in elderly patients ineligible for cisplatin in the second half of 2022.
LYR-210
Lyra Therapeutics-partnered anti-inflammatory implantable drug matrix in development for the treatment of surgically-naïve, medically refractory chronic rhinosinusitis

LianBio expects to begin dosing Chinese patients in Lyra’s planned global pivotal Phase 3 trial of LYR-210 for the treatment of surgically naïve chronic rhinosinusitis in the second half of 2022.
Third Quarter 2021 Financial Results:

Research & Development Expenses

R&D expenses were $4.7 million for the three months ended September 30, 2021, as compared to $116.9 million for the three months ended September 30, 2020. For the three months ended September 30, 2021, research and development cost was primarily attributable to $1.9 million in personnel-related expenses and $2.1 million in professional fees for development activities to support clinical trials.

General & Administrative Expenses

G&A expenses were $8.9 million for the three months ended September 30, 2021, as compared to $2.1 million for the three months ended September 30, 2020. The increase was primarily attributable to increases in payroll and personnel-related expenses (including share-based compensation expense) for increased employee headcount and increases in legal service costs, consulting costs and accounting services.

Net Loss

Net loss was $13.1 million for the three months ended September 30, 2021, or a net loss per share of $0.63, as compared to a net loss of $120.2 million for the three months ended September 30, 2020, or a net loss per share of $11.71.

Cash and Cash Equivalents

Cash and cash equivalents were $109.0 million as of September 30, 2021, which excludes the net proceeds of $311.1 million from the Company’s initial public offering, as compared to $254.4 million as of December 31, 2020. The Company expects its current cash and cash equivalents, inclusive of the IPO net proceeds subsequently received in November 2021, will be sufficient to fund its operating expenses and capital expenditure requirements through 2023.

On December 9, 2021 Sesen Bio (Nasdaq:SESN), a late-stage clinical company developing targeted fusion protein therapeutics for the treatment of patients with cancer, reported its anticipated regulatory path forward for Vicineum for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC) following its Clinical Type A meeting with the US Food and Drug Administration (FDA), which occurred on December 8, 2021 (Clinical Type A Meeting) (Press release, Sesen Bio, DEC 9, 2021, View Source [SID1234596692]).

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Following the productive Clinical Type A Meeting, the Company believes it has greater clarity regarding the requirements for resubmission of the BLA and the trial design, which may include these elements:

A randomized clinical trial assessing the safety and efficacy of Vicineum compared to investigators’ choice of intravesical chemotherapy;
Trial may include both patients who have received adequate BCG1 and patients who have received less-than-adequate BCG;
Company encouraged to submit the final VISTA trial results with the resubmission; and
Anticipated randomized trial design is aligned with guidance the Company has received from the European Medicines Agency, which may help to coordinate the regulatory paths forward for Vicineum in the US and the European Union.
The Company expects to hold a Type C meeting with the FDA in early 2022 to discuss the protocol for the additional clinical trial.

"We are pleased to have greater clarity on the regulatory path forward to resubmit the BLA and ultimately bring Vicineum to market if approved," said Dr. Thomas Cannell, president and chief executive officer of Sesen Bio. "Our team looks forward to working productively with regulators as we continue to focus on our mission of saving and improving the lives of patients."

About Vicineum

Vicineum, a locally administered fusion protein, is Sesen Bio’s lead product candidate being developed for the treatment of BCG-unresponsive non-muscle invasive bladder cancer (NMIBC). Vicineum is comprised of a recombinant fusion protein that targets epithelial cell adhesion molecule (EpCAM) antigens on the surface of tumor cells to deliver a potent protein payload, Pseudomonas Exotoxin A. Vicineum is constructed with a stable, genetically engineered peptide tether to ensure the payload remains attached to the antibody binding fragment until it is internalized by the cancer cell. This fusion protein design is believed to decrease the risk of toxicity to healthy tissues, thereby improving its safety. In prior clinical trials conducted by Sesen Bio, EpCAM has been shown to be overexpressed in NMIBC cells with minimal to no EpCAM expression observed on normal bladder cells. Sesen Bio is currently in the follow-up stage of a Phase 3 clinical trial in the US for the treatment of BCG-unresponsive NMIBC. In February 2021, the FDA accepted the Company’s Biologics License Application (BLA) file for Vicineum for the treatment of BCG-unresponsive NMIBC, granted Priority Review for the BLA and set a Prescription Drug User Fee Act (PDUFA) date of August 18, 2021. On August 13, 2021, the Company received a Complete Response Letter (CRL) from the FDA regarding its BLA for Vicineum. Additionally, Sesen Bio believes that cancer cell-killing properties of Vicineum promote an anti-tumor immune response that may potentially combine well with immuno-oncology drugs, such as checkpoint inhibitors. For this reason, the activity of Vicineum in BCG-unresponsive NMIBC is also being explored at the US National Cancer Institute in combination with AstraZeneca’s immune checkpoint inhibitor durvalumab.

On December 9, 2021 IceCure Medical Ltd. (NASDAQ: ICCM) (TASE: ICCM) (the "Company" or "IceCure"), developer of minimally-invasive cryoablation technology, the ProSense System, reported that destroys tumors by freezing as an alternative to surgical tumor removal, reported the pricing of an underwritten public offering of 3,313,827 shares of the Company’s ordinary shares (the "Ordinary Shares") at a price to the public of $3.45 per share, before underwriting discounts and commissions, and to certain investors in lieu of Ordinary Shares, pre-funded warrants to purchase up to an aggregate of 1,034,000 Ordinary Shares at a price to the public of $3.449 per pre-funded warrant, which represents the per share public offering price for the Ordinary Shares less the $0.001 per share exercise price for each such pre-funded warrant (Press release, IceCure Medical, DEC 9, 2021, View Source [SID1234596717]). The gross proceeds of the offering to the Company are expected to be approximately $15 million, before deducting underwriting discounts, commissions, and other estimated offering expenses. The Company has granted the underwriters a 45-day option to purchase up to an additional 652,173 Ordinary Shares at the public offering price to cover over-allotments, if any. The offering is expected to close on or about December 13, 2021, subject to satisfaction of customary closing conditions.

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A.G.P./Alliance Global Partners is acting as sole book-running manager for the offering. Brookline Capital Markets, a division of Arcadia Securities, LLC, is acting as a co-manager for the offering.

The Company intends to use the net proceeds from the offering for next generation product development, business development, working capital and general corporate purposes.

The offering is being conducted pursuant to IceCure Medical Ltd. registration statement on Form F-1 (File No. 333-261487) previously filed with the Securities and Exchange Commission ("SEC") and declared effective on December 8, 2021. A final prospectus relating to the offering will be filed with the SEC and will be available on the SEC’s website at View Source Electronic copies of the prospectus relating to this offering, when available, may be obtained from A.G.P./Alliance Global Partners, 590 Madison Avenue, 28th Floor, New York, NY 10022 at (212) 624-2060.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

On December 9, 2021 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that the company will host a conference call and webcast to discuss their CD73 inhibitor program in multiple myeloma (Press release, ORIC Pharmaceuticals, DEC 9, 2021, View Source [SID1234596666]). On the call, management will be joined by Kenneth C. Anderson, M.D., Kraft Family Professor of Medicine at Harvard Medical School and Director of the Lebow Institute for Myeloma Therapeutics and Jerome Lipper Multiple Myeloma Center at Dana-Farber Cancer Institute, who will share his perspectives on CD73 inhibition and its promise in overcoming immune suppression in multiple myeloma.

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Specifically, the call will focus on new ex vivo data from patients with multiple myeloma being presented at the American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting, on the role of adenosine in immunosuppression, and on the ability of an ORIC CD73 inhibitor to restore antitumor immune activity as a single agent.

Details of the ASH (Free ASH Whitepaper) poster presentation are as follows:

Title: CD73 inhibition overcomes immunosuppression and triggers autologous T-cell mediated multiple myeloma cell lysis in the bone marrow milieu
Abstract #: 2675
Date & Time: Sunday, December 12, 2021, 6:00 – 8:00 pm ET
Session: 651. Multiple Myeloma and Plasma Cell Dyscrasias: Basic and Translational
KOL Webcast and Conference Call Details

ORIC will host a conference call and webcast, Monday, December 13, 2021, at 5:30 p.m. ET. To participate in the conference call, please dial (833) 651-0991 (domestic) or (918) 922-6080 (international) and refer to conference ID 7989199. A live webcast and audio archive of the conference call will be available through the investor section of the company’s website at www.oricpharma.com. The webcast will be available for replay for 90 days following the presentation.