On January 25, 2022 Immix Biopharma, Inc. (Nasdaq: IMMX) ("ImmixBio", "Company", "We" or "Us"), a biopharmaceutical company pioneering Tissue-Specific Therapeutics (TSTx) targeting oncology and immuno-dysregulated diseases, reported data showing that IMX-110 + anti-PD-1 produced 63-day median survival in a genetic pancreatic cancer mouse model in which mice develop their own pancreatic cancer and have an intact immune system (Press release, Immix Biopharma, JAN 25, 2022, View Source [SID1234606772]). Historically, according to Winograd et al., 2015, 42-days is the median survival produced by a 4-drug combination: 2 chemotherapies (gemcitabine, nab-paclitaxel) and 2 immunotherapies (anti-PD-1, anti-CD40) in the same genetic pancreatic cancer mouse model.

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"This data highlights why we are excited to collaborate with BeiGene on our planned 2022 Phase 1b/2a combination clinical trial of IMX-110 + BeiGene anti-PD-1 tislelizumab in advanced solid tumors," said Ilya Rachman, MD PhD, CEO of ImmixBio. "We believe this upcoming combination clinical trial will allow us to rapidly expand into multiple oncology indications."

The U.S. Food and Drug Administration ("FDA") has approved orphan drug designation ("ODD") for IMX-110 for the treatment of soft tissue sarcoma. Additionally, the FDA has approved rare pediatric disease ("RPD") designation to IMX-110 for the treatment of a life-threatening pediatric cancer in children, rhabdomyosarcoma.

In January 2021, BeiGene and Novartis entered into a collaboration and license agreement granting Novartis rights to develop, manufacture, and commercialize anti-PD-1 tislelizumab in North America, Europe, and Japan in exchange for an upfront payment by Novartis of US$650 million plus royalties and milestone payments.

As of January 2022, anti-PD-1 tisleizumab has been approved or granted conditional approval in 6 cancer indications in China, including non-squamous non-small cell lung cancer ("NSCLC"), squamous NSCLC, classical Hodgkin’s lymphoma, Hepatocellular Carcinoma, and urothelial carcinoma.

On January 25, 2022 Sierra Oncology, Inc. (NASDAQ: SRRA), a late-stage biopharmaceutical company dedicated to delivering targeted therapies for rare cancers, reported that it intends to offer and sell $100.0 million of shares of its common stock in an underwritten public offering (Press release, Sierra Oncology, JAN 25, 2022, View Source [SID1234606788]). The proposed offering is subject to market and other conditions, and there can be no assurance as to whether or when the proposed offering may be completed, or as to the actual size or terms of the offering. In addition, Sierra Oncology intends to grant the underwriters a 30-day option to purchase up to $15.0 million of additional shares of its common stock. Sierra Oncology intends to use the net proceeds of the offering to prepare for potential commercialization of momelotinib, clinical development activities of its other product candidates, research, clinical and process development and manufacturing of its product candidates, working capital, and capital expenditures and other general corporate purposes.

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Jefferies and Cantor are acting as the joint book-running managers for the proposed offering. LifeSci Capital, Oppenheimer & Co. and H.C. Wainwright & Co. are acting as lead managers for the proposed offering.

A shelf registration statement on Form S-3 relating to the common stock offered in the public offering described above was filed with the Securities and Exchange Commission (SEC) on November 5, 2021 and declared effective by the SEC on November 12, 2021. A preliminary prospectus supplement and the accompanying prospectus relating to the proposed offering will be filed with the SEC and will be available on the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the accompanying prospectus relating to this proposed offering may also be obtained, when available, by contacting Jefferies LLC, Attention: Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388, or by email at [email protected]; or Cantor Fitzgerald & Co., Attention: Capital Markets, 499 Park Avenue, New York, New York 10022, or by email at [email protected].

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

On January 25, 2022 – Merus N.V. (Nasdaq: MRUS) ("Merus", "the Company", "we", or "our"), a clinical-stage oncology company developing innovative, full-length multispecific antibodies (Biclonics and Triclonics), reported the appointment of Shannon Campbell as Executive Vice President & Chief Commercial Officer (Press release, Merus, JAN 25, 2022, View Source [SID1234607410]). Ms. Campbell is an accomplished healthcare leader with demonstrated success leading commercial businesses across a range of specialty markets, including oncology.

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"Shannon will be instrumental in advancing Merus’ mission to become a commercial-stage company, further advancing the strategy for our lead clinical program, zenocutuzumab for neuregulin 1 fusion cancer and developing our commercial approach for our pipeline of innovative multispecific antibody product candidates," said Bill Lundberg, M.D., President, Chief Executive Officer of Merus. "Her leadership and depth of experience in launching products, managing partnerships, and delivering sustained performance in highly competitive oncology markets will be a great asset to our organization."

Ms. Campbell will join Merus as Executive Vice President & Chief Commercial Officer in February to lead the commercial strategy for the most advanced clinical candidate, zenocutuzumab (Zeno), as well as Merus’ robust pipeline of multispecific product candidates in development. This includes petosemtamab (MCLA-158), currently under investigation in second-line head and neck squamous cell carcinoma; MCLA-145, under investigation for solid tumors; and MCLA-129, under investigation for patients with lung and other solid tumors, particularly those that do not respond to EGFR inhibitors. Merus holds global rights to all four clinical candidates, apart from MCLA-129, for which Merus licensed to Betta Pharmaceuticals the exclusive right to develop and commercialize in China.

Ms. Campbell brings over 25 years of pharmaceutical commercialization experience and joins Merus from Novartis Pharmaceuticals, where she led Novartis’s U.S. Oncology Solid Tumor Franchise and was responsible for a broad portfolio of therapies in oncology and rare diseases. Prior to Novartis, Ms. Campbell was with Bayer HealthCare Pharmaceuticals, where she was instrumental in helping to build, launch and lead Bayer’s U.S. Oncology business.

"I am excited to join Merus at this pivotal time," said Ms. Campbell. "The Merus pipeline of clinical-stage assets has the potential to offer meaningful benefit to patients, and I look forward to building and leading the commercial strategy for these programs."

Merus also announced today that Incyte (Nasdaq: INCY) has elected to opt-out of its ex-U.S. development of MCLA-145, restoring full global rights to Merus. MCLA-145 is currently enrolling a global, phase 1, open-label, single-agent clinical trial evaluating MCLA-145 in patients with solid tumors. The trial consists of a dose escalation phase, followed by a planned dose expansion phase. Merus is also planning to evaluate the combination of MCLA-145 with a PD-1 blocking antibody.

"Regaining worldwide rights to MCLA-145 opens up new possibilities for Merus," said Dr. Lundberg. "We remain committed to continuing the development of MCLA-145 to explore the potential of this compound as monotherapy, as well as in combination, to address the high unmet medical need for patients with solid tumors. We look forward to the further progress and continued success of our other joint projects in research and development with Incyte under this collaboration."

Under the terms of a 2017 Collaboration and License Agreement ("Agreement") between Merus and Incyte, Incyte received ex-U.S. rights to MCLA-145. Incyte’s opt-out of ex-U.S. rights to MCLA-145 provides Merus the exclusive right to develop and commercialize potential MCLA-145 products globally. As part of the Agreement, Incyte will continue to support the program for a limited time while ex-U.S. activities are transitioned to Merus, and Incyte will also retain a right to a residual royalty of up to 4% on sales of future commercialization of MCLA-145, if approved.

Additionally, per the Agreement, the parties will continue to collaborate on the development and commercialization of up to ten bispecific or monospecific antibody programs. Merus also has the option to co-fund development of product candidates arising from two programs. For any program for which Merus exercises its co-development option, Merus would be responsible for 35 percent of global development costs in exchange for a 50 percent share of U.S. profits and losses and tiered royalties ranging from 6 to 10 percent on ex-U.S. sales by Incyte for these programs. Merus also has the right to elect to provide up to 50 percent of detailing activities for product candidates arising from one of these programs in the U.S.

On January 25, 2022 Immutep Limited (ASX: IMM; NASDAQ: IMMP) ("Immutep" or "the Company"), a biotechnology company developing novel LAG-3 related immunotherapy treatments for cancer and autoimmune disease, reported an update on the ongoing development of its product candidates, eftilagimod alpha ("efti") and IMP761 for the quarter ended 31 December 2021 (Press release, Immutep, JAN 25, 2022, View Source [SID1234606773]).

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Efti Development Program for Cancer

AIPAC – Phase IIb clinical trial – final data

Immutep reported final Overall Survival (OS) data from its Phase IIb AIPAC clinical trial evaluating efti in metastatic breast cancer (MBC) in November 2021, as a late breaker poster at the Society for Immunotherapy of Cancer (SITC) (Free SITC Whitepaper) Annual Meeting.

The late-stage trial showed very encouraging OS data, including a statistically significant and clinically meaningful benefit in three patient predefined subgroups representing a majority of patients. A survival benefit of +7.5 months was observed in patients < 65 years, reflecting a > 50% improvement compared to the control group. A +19.6 month survival benefit was seen in patients with low monocytes, a benefit of > 150% compared to the control group. Lastly, a survival benefit of +4.2 months was reported in luminal B patients, reflecting a > 33% benefit compared to the control group. The data from these subgroups was improved data versus the interim data presented by Immutep in December 2020.

In addition, a statistically significant Quality of Life preservation was demonstrated in the first 6 months from patients in the efti group in the total population. A statistically significant increase in peripheral CD8 T cells in patients in the efti group of the total population was also observed and positively correlated with improved OS.

These final results have given Immutep additional confidence efti can deliver a meaningful clinical improvement for diverse sets of cancer patients, as the Company started its preparations for a larger clinical trial in MBC via its Phase III clinical trial, AIPAC-003.

AIPAC-003 – planned Phase III trial

In October 2021, Immutep received positive feedback from the European Medicines Agency (EMA) regarding its clinical development program for efti. Immutep has also been interacting with the US FDA and is providing additional information relating to efti’s unique mechanism of action as an agonist that leads to T cell expansion and proliferation (rather than all other LAG-3 products in development which are antagonists that block an immune checkpoint). Interactions with the EMA, US FDA and other regulators are ongoing. The feedback from competent authorities, along with insights from a rigorous engagement process with Key Opinion Leaders and other stakeholders will help Immutep generate a final study design.

Immutep Limited, Level 33, 264 George St, Sydney NSW 2000

ABN: 90 009 237 889

LOGO

TACTI-003 – Phase IIb clinical trial

During the quarter, Immutep continued recruitment of patients for the TACTI-003 clinical trial. At present, 6 of approximately 154 patients with 1st line HNSCC have been enrolled into the trial at active clinical sites. The study is in its start-up phase and additional sites are planned to be initiated in the first quarter of 2022.

Immutep also presented the trial design for TACTI-003 via a poster at the SITC (Free SITC Whitepaper) 2021 conference in November 2021. It is a Phase IIb multicentre, open label, randomised and controlled trial. Fast track designation for 1st line HNSCC by the US FDA was granted in April 2021.

TACTI-002 (also designated KEYNOTE-PN798) – Phase II clinical trial

Immutep also reported data from the 2nd line HNSCC patients (Part C) of TACTI-002 at the SITC (Free SITC Whitepaper) 2021 conference.

Part C is showing encouraging antitumor activity. An encouraging Overall Response Rate (ORR) was reported, with 29.7% of patients responding to the combination therapy of efti and pembrolizumab. In addition, a favourable duration and depth of responses was observed, with 5 Complete Responses and a minimum duration of response extended to > 9 months across all responding patients. The responses continue to be reported in PD-L1 low and high expressors.

During the quarter, Immutep enrolled and dosed the last patient in the expansion stage of Part A (1st line non-small cell lung cancer (NSCLC)), completing the recruitment of all cohorts of the TACTI-002 study.

A total of 189 patients are now participating in TACTI-002 across Parts A, B, and C at approximately 20 clinical sites in Australia, Europe, and the US. Additional data from TACTI-002, particularly in NSCLC, are planned to be reported in the first half of calendar year 2022. Data from the 114 patients in Part A (1st line NSCLC) is expected to inform potential late-stage development of efti in this important indication.

INSIGHT

INSIGHT is an investigator-initiated Phase I trial at the Institute of Clinical Cancer Research, Krankenhaus Nordwest (IKF) investigating different combination treatments with efti and a different route of administration for efti. INSIGHT consists of 5 different arms from stratums A to E.

INSIGHT-003 – triple combination

In December 2021, the first five patients were enrolled and safely treated in the INSIGHT-003 study, also referred to as stratum C of INSIGHT. No additional safety signals were observed in the study which is the first time a triple combination therapy consisting of efti and an existing approved standard of care combination of chemotherapy (carboplatin) and an anti-PD-1 therapy has been administered.

Patient recruitment is ongoing with 6 out of a total of 20 patients with various solid tumours now participating in the trial. Interim results are expected to be reported in 2022.

INSIGHT-005 – combination with bintrafusp alpha

INSIGHT-005, known as stratum E of INSIGHT, will include 12 patients with solid tumours and will evaluate efti in combination with bintrafusp alfa. In the light of the suboptimal results from Merck KGaA’s bintrafusp alpha in other studies, this arm of the INSIGHT study is currently under review.

Immutep Limited, Level 33, 264 George St, Sydney NSW 2000

ABN: 90 009 237 889

LOGO

EAT COVID – Phase II clinical trial – ongoing

The investigator-initiated EAT COVID study is continuing at the University Hospital Pilsen in the Czech Republic. Immutep will provide an update on the trial in due course.

IMP761 Development Program for Autoimmune Disease

During the quarter, Immutep appointed Northway Biotech, an end-to-end biopharmaceutical contract development and manufacturing organisation (CDMO), to manufacture IMP761 ahead of clinical testing.

Northway has commenced development of a GMP-compliant manufacturing process of IMP761 and will manufacture IMP761 in large scale bioreactors. After Immutep completes the required preclinical development evaluations, the material will be used for clinical trials of IMP761. Planning for preclinical and clinical development is ongoing.

Intellectual Property

Immutep was granted two new patents by the Chinese Patent Office, protecting Immutep’s intellectual property relating to combined therapeutic preparations comprising efti and either a PD-1 pathway inhibitor or a chemotherapy agent. These new patents follow the grant of corresponding patents in other key global markets announced previously.

Financial Summary – Q2 FY221

Cash receipts from customers for the quarter were $14k, compared to $56k in Q1 FY22 (i.e., the quarter ended 30 September 2021).

The net cash used in G&A activities in the quarter was $0.2 million compared to $1.0 million in Q1 FY22. The difference compared with the last quarter is mainly due to capital raising expenses included in Q1 FY22. Payments to Related Parties, detailed in Item 6 of the Appendix 4C cash flow report for the quarter includes $217k in payment of Non-Executive Director’s fees and Executive Director’s remuneration.

The net cash used in Research and Development activities in the quarter was $4.67 million, compared to $6.83 million in Q1 FY22. The higher cash outflows in Q1 FY2022 is mainly due to an upfront payment associated with the commencement of the TACTI-003 clinical trial. Total net cash outflows used in operating activities in the quarter was $6.06 million. In comparison, total net cash outflows from operating activities in Q1 FY22 was $5.37 million, which was net of the $3.42m research and development (R&D) tax incentive payment received in cash in Q1 FY22 from the French Government under its Crédit d’Impôt Recherche scheme (CIR).

The Company’s cash and cash equivalent balance as at 31 December 2021 was $99.66 million compared to a balance of $106.39 million as at 30 September 2021. Immutep’s cash balance puts the company in a strong financial position with an estimated cash reach of December 2023.

On January 25, 2022 CytoDyn Inc. (OTCQB: CYDY) ("CytoDyn" or the "Company"), a biotechnology company developing leronlimab, a CCR5 antagonist with the potential for multiple therapeutic indications, reported a leadership transition plan (Press release, CytoDyn, JAN 25, 2022, View Source [SID1234607497]). Effective immediately, Antonio Migliarese, currently CytoDyn’s Chief Financial Officer, has been appointed interim President. The Board of Directors terminated the employment of Nader Z. Pourhassan, Ph.D., as President and CEO of the Company and he is no longer a member of the Board of Directors, effective January 24, 2022. The rest of CytoDyn’s executive team is continuing with the Company and is united in their commitment to advance the Company’s objectives.

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A committee of three Board members has been appointed to initiate the search for a new permanent CEO, with a focus on identifying a candidate possessing the requisite pharmaceutical industry experience to enhance the Company’s efforts to achieve regulatory approval and commercialization of leronlimab. Mr. Migliarese will also continue in his role as CFO of the Company during this interim period.

Scott A. Kelly, M.D, Chairman of the Board and Chief Medical Officer of CytoDyn, stated, "Now is the right time for the next phase of CytoDyn’s evolution, as we focus on continuing the clinical progress of leronlimab and ultimately securing regulatory approval and commercialization. Our Board is fully focused on identifying the best possible candidate to lead the Company forward, and we are focusing our search on finding an individual with the appropriate experience and skillsets to maximize the potential of leronlimab for patients, partners, and shareholders. In addition, in an effort to enhance the Board’s independence, I have elected to step down as Chairman of the Board but will remain on the Board of Directors. The Board has elected Tanya Durkee Urbach, an independent director who has experience in corporate governance, corporate finance, business growth and securities litigation, compliance and regulatory issues, as Chairman of the Board. We thank Dr. Pourhassan for his vision and passion for developing leronlimab into a platform molecule with the potential for multiple therapeutic indications."

CytoDyn will keep shareholders and stakeholders informed on the Company’s progress in implementing its leadership transition plan as and when appropriate.