On January 3, 2023 Purple Biotech Ltd. ("Purple Biotech", or the "Company") (NASDAQ/TASE: PPBT), a clinical-stage company developing first-in-class, effective and durable therapies that harness the power of the tumor microenvironment to overcome tumor immune evasion and drug resistance, reported a research collaboration with Mor Research Applications (Mor), the technology transfer subsidiary of Clalit Healthcare Services (Clalit) (Press release, Purple Biotech, JAN 3, 2023, View Source [SID1234625747]). The agreement provides Purple Biotech first access to early-stage oncology product candidates owned by Mor. Under this agreement, the Company will have the option to fund early development aiming both to in-license selected drug assets and to pursue their development and commercialization.

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Clalit is Israel’s largest Health Maintenance Organization (HMO), covering approximately half the population of Israel (52%). Clalit serves approximately 4.8 million members and operates 14 hospitals. The research conducted at these hospitals is now potentially available to Purple Biotech for in-licensing and clinical development.

"To grow our pipeline of therapeutic assets, our focus at Purple Biotech is to identify unique, first-in-class oncology assets and technologies and bring them into clinical development," said Gil Efron, CEO of Purple Biotech. "This research collaboration with Mor will provide us access to numerous early-stage assets that have been developed by leading researchers and scientists in Israel. We are excited at the prospect of being able to select from among these innovative assets the ones we wish to in-license for clinical and commercial development. This collaboration leverages our expertise in cancer drug development and accelerates our vision of bringing first-in-class treatments to cancer patients worldwide."

Under this partnership, Purple Biotech has first right to review Mor’s pool of early-stage research projects and to select those that it wishes to explore in early development prior to in-licensing, which will carry worldwide exclusivity.

"We look forward to collaborating with Purple Biotech as a partner that can bring our high-value, first-in-class assets forward through further development," said Shay Marcus, Mor Research Application’s CEO. "Purple Biotech has demonstrated a commitment to pursuing breakthrough oncology treatments that have the potential to replace the standard-of-care for some of the most debilitating and intractable cancers. It is our hope that this collaboration will be the path to allow our cutting-edge research to become a therapeutic reality for cancer patients."

On January 3, 2023 PDS Biotechnology Corporation (Nasdaq: PDSB), a clinical-stage immunotherapy company developing a growing pipeline of targeted immunotherapies for cancer and infectious disease, reported an exclusive global license agreement with Merck KGaA, Darmstadt, Germany for the tumor-targeting IL-12 fusion protein M9241 (formerly known as NHS-IL12), which will join the pipeline as PDS0301 (Press release, PDS Biotechnology, JAN 3, 2023, View Source [SID1234625745]). M9241 appears to enhance the proliferation, potency and longevity of T cells in the tumor. The combination of Versamune and IL-12 is patented by PDS Biotech and is designed to overcome tumor immune suppression utilizing a different mechanism from checkpoint inhibitors.

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Under the terms of the agreement, PDS Biotech will receive from Merck KGaA, Darmstadt, Germany an exclusive license to M9241. PDS Biotech will assume responsibility for future development, commercialization, and manufacturing of M9241.

Under the terms of the agreement, Merck KGaA, Darmstadt, Germany will receive an upfront cash payment of $5 million and will be entitled to up to $11 million in development and regulatory milestone payments including first commercial sales for the first 2 indications, and up to $105 million in commercial milestones, and a 10% royalty on future sales of M9241 with standard step-down provisions. Merck KGaA will receive 378,787 shares of PDS Biotech’s common stock having a value of $5 million, based on the closing price of PDS Biotech’s common stock on December 30, 2022.

"We are pleased to have partnered with Merck KGaA, Darmstadt, Germany to advance the development of M9241, a highly innovative cytokine therapy," said Dr. Frank Bedu-Addo, PDS Biotech CEO. "Under the licensing arrangement between Merck KGaA, Darmstadt, Germany and PDS Biotech, assumption of an equity stake by Merck KGaA, Darmstadt, Germany in PDS Biotech further confirms the potential of the Versamune platform and the data generated to date with this combination therapy. I’d like to thank the Merck KGaA, Darmstadt, Germany team for their support of PDS Biotech’s mission to potentially offer more cancer patients improved treatment options."

M9241 was studied in a novel triple combination at the National Cancer Institute in a Phase 2 trial (NCT04287868) in combination with PDS0101, a Versamune based HPV16-targeted immunotherapy, and bintrafusp alfa, a bifunctional fusion protein targeting two independent immunosuppressive pathways (PD-L1 and TGF-β). The triple combination was studied in checkpoint inhibitor (CPI)-naïve and -refractory patients with advanced HPV-positive anal, cervical, head and neck, vaginal, and vulvar cancers who have failed prior therapy.

Data highlights for patients who had failed prior treatments including CPIs:

Median overall survival for treated patients is 21 months in 29 CPI refractory patients. The reported historical median OS in patients with CPI refractory disease is 3-4 months.

63% (5/8) of treated patients with the optimal dose combination had significant tumor shrinkage of over 30% (objective response). With the standard of care, the reported percentage of patients having an objective response is less than 10%.

79% (11/14) of treated patients demonstrated a greater than two-fold increase in HPV16-targeted T cells.

Results for patients who had failed prior treatments but were CPI-naïve also continue to appear to be encouraging:

88% (7/8) of CPI naïve patients had an objective response.

38% (3/8) of responders had a complete response.

In CPI naïve subjects, 75% (6/8) remain alive at a median follow-up of 27 months. As a result, median OS has not yet been reached. Historically median OS for similar patients with platinum experienced CPI naïve disease is 7-11 months.

PDS Biotech has a scheduled meeting with the Food and Drug Administration (FDA) to discuss a registrational trial for investigating the triple combination of M9241, PDS0101 and a checkpoint inhibitor in recurrent/metastatic HPV-positive cancers.

Dr. Lauren V. Wood, Chief Medical Officer at PDS Biotech, commented, "M9241 seems to be unique in its ability to target the tumor’s microenvironment and appears to further promote proliferation of Versamune-induced T cells in the tumors while also potentially enhancing the killing potency of the T cells. With the addition of M9241 to our Versamune-based pipeline products, our goal is to develop and achieve checkpoint inhibitor-agnostic and independent combinations in advanced cancers. We look forward to expanding clinical development of our novel investigational combination products."

Conference Call and Webcast
PDS Biotech will host a conference call and webcast on Tuesday, January 3, 2023, beginning at 8:00 AM EST. Participants should dial 877-407-3088 (United States) or 201-389-0927 (International) and reference conference ID 13734890. To access the webcast, please use the following link. The event will be archived in the investor relations section of PDS Biotech’s website for six months.

On January 3, 2023 ORIC Pharmaceuticals, Inc. (Nasdaq: ORIC), a clinical stage oncology company focused on developing treatments that address mechanisms of therapeutic resistance, reported that Jacob M. Chacko, M.D., chief executive officer, will present a company overview at the 41st Annual J.P. Morgan Healthcare Conference on Tuesday, January 10, 2023, at 11:15 a.m. PT (Press release, ORIC Pharmaceuticals, JAN 3, 2023, View Source [SID1234625744]).

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A live webcast of the company presentation will be available through the investor section of the company’s website at www.oricpharma.com. A replay of the webcast will be available for 90 days following the event.

On January 03, 2023 OPKO Health, Inc. (Nasdaq: OPK) reported that management will be participating in the 41st Annual J.P. Morgan Healthcare Conference being held January 9-12, 2023 at the Westin St. Francis in San Francisco. Management will be hosting one-on-one meetings with investors and will be presenting on Wednesday, January 11th at 4:30 p.m. Pacific time (Press release, Opko Health, JAN 3, 2023, View Source [SID1234625743]).

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The presentation will be webcast live and available for replay in the Investors section of OPKO Health’s website and accessible by clicking here.

On Januray 3, 2023 Oncternal Therapeutics, Inc. (Nasdaq: ONCT), a clinical-stage biopharmaceutical company focused on the development of novel oncology therapies, reported that it has granted inducement awards to two new non-executive employees (Press release, Oncternal Therapeutics, JAN 3, 2023, View Source [SID1234625742]).

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The awards were made on January 3, 2023 under Oncternal’s 2021 Employment Inducement Incentive Award Plan, which provides for the granting of equity awards to new employees of Oncternal as an inducement to join the Company. The awards consist of options to purchase a total of 79,500 shares of Oncternal common stock. The options have a 10-year term and an exercise price equal to the closing price of Oncternal’s common stock on the date of grant. The options vest over a four-year period, with 25% of the shares subject to the options vesting on the first anniversary of each new employee’s start date, and the rest vesting in equal monthly installments over three years thereafter. The awards were approved by Oncternal’s compensation committee, comprised entirely of independent directors, as required by Nasdaq Rule 5635(c)(4), and were granted as an inducement material to the employees entering into employment with Oncternal in accordance with Nasdaq Rule 5635(c)(4).